Vol. 78 Thursday, 

No. 26 February 7, 2013 

Part III 

Department of Health and Human Services 

Centers for Medicare & Medicaid Services 

42 CFR Parts 416, 442, 482, et al. 

Medicare and Medicaid Programs; Part II—Regulatory Provisions To 

Promote Program Efficiency, Transparency, and Burden Reduction; 

Proposed Rule 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9216 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 416, 442, 482, 483, 485, 

486, 488, 491, and 493 

[CMS–3267–P] 

RIN 0938–AR49 

Medicare and Medicaid Programs; Part 

II—Regulatory Provisions To Promote 

Program Efficiency, Transparency, and 

Burden Reduction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

reform Medicare regulations that CMS 

has identified as unnecessary, obsolete, 

or excessively burdensome on health 

care providers and suppliers, as well as 

certain regulations under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA). This proposed rule 

would increase the ability of health care 

professionals to devote resources to 

improving patient care, by eliminating 

or reducing requirements that impede 

quality patient care or that divert 

resources away from providing high 

quality patient care. This is one of 

several rules that we are proposing to 

achieve regulatory reforms under 

Executive Order 13563 on improving 

regulation and regulatory review and 

the Department’s plan for retrospective 

review of existing rules. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on April 8, 2013. 

ADDRESSES: In commenting, please refer 

to file code CMS–3267–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3267–P, P.O. Box 8010, Baltimore, 

MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3267–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses prior to the close of 

the comment period: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Oviatt, (410) 786–4683. We have 

also included a subject matter expert 

and contact information under the 

‘‘Provisions of the Proposed 

Regulations’’ section for each provision 

set out in this proposed rule. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

Executive Summary for This Proposed 

Rule 

A. Purpose 

In Executive Order 13563, ‘‘Improving 

Regulations and Regulatory Review’’, 

the President recognized the importance 

of a streamlined, effective, and efficient 

regulatory framework designed to 

promote economic growth, innovation, 

job-creation, and competitiveness. To 

achieve a more robust and effective 

regulatory framework, the President has 

directed each executive agency to 

establish a plan for ongoing 

retrospective review of existing 

significant regulations to identify those 

rules that can be eliminated as obsolete, 

unnecessary, burdensome, or 

counterproductive or that can be 

modified to be more effective, efficient, 

flexible, and streamlined. This proposed 

rule responds directly to the President’s 

instructions in Executive Order 13563 

by reducing outmoded or unnecessarily 

burdensome rules, and thereby 

increasing the ability of health care 

entities to devote resources to providing 

high quality patient care. 

B. Summary of the Major Provisions 

We are proposing to reduce regulatory 

burden on providers and suppliers by 

modifying, removing, or streamlining 

current regulations that we believe are 

excessively burdensome. 

• Radiology services in ambulatory 

surgical centers: This proposed rule 

would reduce the requirements 

Ambulatory Surgical Centers (ASCs) 

must meet in order to provide 

radiological services to match those 

services they actually perform. ASCs are 

currently subject to the full hospital 

requirements for radiology services even 

though they are only permitted to 

provide limited radiologic services 

integral to the performance of certain 

surgical procedures. 

• Hospital registered dietitian 

privileges: We propose to include 

qualified dietitians as practitioners who 

may be privileged to order patient diets 

under the hospital conditions of 

participation (CoPs). 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9217 

• Hospital supervision of 

radiopharmaceutical preparation: We 

propose to revise the Nuclear medicine 

services CoP to remove the modifier 

‘‘direct’’ from the in-house preparation 

supervision requirement. The presence 

of a pharmacist, MD, or DO would no 

longer be required during the delivery of 

off-hour nuclear medicine tests. These 

proposed changes are based on the 

Society of Nuclear Medicine and 

Molecular Imaging recommendations on 

this issue. 

• Hospital reclassification of swingbed services: We propose to revise the 

requirements by relocating the swingbed CoPs to Subpart D, which would 

classify swing beds as an optional 

service. This revision would allow a 

hospital’s compliance with ‘‘swing bed’’ 

requirements to be evaluated during 

routine accrediting organization 

surveys. This would reduce the burden 

on hospitals by not requiring an 

additional survey specifically for 

‘‘swing bed’’ approval. 

• Transplant centers reports to CMS: 

The CoPs require transplant programs to 

notify CMS of certain changes related to 

the center’s transplant program. The 

current system for transplant center data 

analysis, in effect, requires the centers 

to submit data which CMS routinely 

receives through other sources. This 

creates unnecessary paperwork and 

burden on the transplant program and 

does not contribute to Federal oversight. 

We propose to eliminate this redundant 

data submission requirement. 

• Transplant center re-approval 

process: The current transplant survey 

process and regulatory criteria require 

programs be subject to an automatic 

onsite review of compliance with key 

CoPs under a 3-year re-approval cycle 

under particular conditions. This leads 

some transplant programs to undergo an 

onsite survey that may not be necessary 

to ensure a proper level of federal 

oversight, and it also does not always 

provide for the most effective method to 

target survey resources where they are 

most needed. In addition, since we are 

already receiving the data we need to 

determine if a center is complying with 

outcome requirements, eliminating this 

automatic re-approval cycle would not 

result in any reduction in Federal 

oversight of the center. It would, 

however, enable us to more efficiently 

use our survey resources. In lieu of the 

automatic 3-year re-approval cycle, we 

propose to provide more flexibility in 

the re-approval cycle to be able to focus 

survey attention where it is most 

needed. We would also clarify the 

following—(1) the review of mitigating 

factors process could occur at any time 

there was non-compliance with the 

CoPs, and (2) that compliance with the 

CoPs would be a continuous 

requirement, as already specified in 

§ 488.61(c). 

• Long term care sprinkler waiver: All 

buildings containing long term care 

(LTC) facilities are required to have 

automatic sprinkler systems installed 

throughout the building by August 13, 

2013 (§ 483.70(a)(8)). Based on recent 

public feedback, we believe that some 

facilities will not be able to meet the 

2013 deadline. In order to maintain 

access to LTC facilities, and in 

recognition of financing difficulties 

faced by some providers, we are 

proposing a provision that would allow 

LTC facilities the opportunity to apply 

for a deadline extension, not to exceed 

2 years, if certain conditions apply. An 

additional extension may be granted for 

up to 1 year, depending on the need and 

particular circumstances. 

• CAH provision of services: Critical 

Access Hospital (CAH) CoPs require that 

a CAH must develop its patient care 

policies with the advice of ‘‘at least one 

member who is not a member of the 

CAH staff.’’ We believe that this 

provision is no longer necessary and 

that the original reasons for including 

this requirement (lack of local resources 

and in-house expertise) have been 

effectively addressed. Also, based on 

our experience with CAHs and input 

from the provider community, it is a 

challenge for facilities to comply with 

this requirement. These challenges 

include the amount of time it takes to 

familiarize the non-staff member with 

the CAH’s operations, high turnover, 

and, in many cases, the expense of 

paying outside personnel. 

• CAH and RHC/FQHC physician 

responsibilities: The regulations for 

CAHs, Rural Health Clinics (RHCs), and 

Federally Qualified Health Centers 

(FQHCs), require a physician to be 

present for sufficient periods of time, at 

least once in every 2 week period, 

except in extraordinary circumstances. 

Some providers in extremely remote 

areas or areas that have geographic 

barriers have indicated that they find it 

difficult to comply with the precise 

biweekly schedule requirement. Many 

rural populations suffer from limited 

access to care due to a shortage of health 

care professionals, especially 

physicians. Recent improvements in, 

and expansion of, telemedicine services 

allow for physicians to provide certain 

types of care to remote facilities at much 

less cost. We propose to revise the CAH 

and RHC/FQHC regulations to eliminate 

the requirement that a physician must 

be onsite at least once in every 2-week 

period. 

Clinical Laboratory Improvement 

Amendments Revisions: This proposed 

rule would make a number of 

clarifications and changes pertaining to 

CMS regulations governing proficiency 

testing referrals under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA). These changes would 

prevent confusion on the part of 

laboratories, reduce the risk of 

noncompliance, and establish policies 

under which certain PT referrals by 

laboratories would not generally be 

subject to revocation of a CLIA 

certificate, or a two-year prohibition on 

laboratory ownership or operation that 

may be applied to an owner and an 

operator when a CLIA certificate is 

revoked. 

• Treatment of proficiency testing 

samples: We are proposing to add a 

clarifying statement that explicitly notes 

that the requirement to treat proficiency 

testing (PT) samples in the same manner 

as patient specimens does not mean that 

it is acceptable to refer PT samples to 

another laboratory for testing even if 

that is the protocol for patient 

specimens. 

• Intentional referral carve-out: We 

are proposing to carve out a narrow 

exception in our long-standing 

interpretation of what constitutes an 

‘‘intentional’’ referral of PT samples. In 

these instances, the laboratory would be 

subject to alternate sanctions. 

• New definitions: To clarify the 

stipulations of the intentional referral 

carve-out, we would also add the 

following terms, with their definitions, 

to the regulation: Reflex testing, 

Confirmatory testing, and repeat PT 

referral. 

Proposals That Would Remove 

Obsolete or Duplicative Regulations or 

Provide Clarifying Information: We 

would remove regulations set out in the 

Code of Federal Regulations (CFR) that 

have become obsolete and are no longer 

needed or enforced and would clarify 

other provisions. 

• Hospital medical staff: We propose 

to clarify the requirement that a 

hospital’s medical staff must be 

generally composed of physicians but 

that it may also include, in accordance 

with State laws, including scope-ofpractice laws, other categories of nonphysician practitioners who are 

determined to be eligible for 

appointment by the governing body. 

• Transplant centers outcome review: 

The transplant center CoPs state that, 

‘‘[e]xcept for lung transplants, CMS will 

review adult and pediatric outcomes 

separately when a center requests 

Medicare approval to perform both 

adult and pediatric transplants.’’ 

Changes to the transplant center 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9218 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

reporting system have made the separate 

review for lung transplant data obsolete. 

Therefore, we are proposing to remove 

this language. 

• Transplant center volume and 

clinical experience requirements: The 

transplant center CoPs state that ‘‘[t]he 

required number of transplants must 

have been performed during the time 

frame reported in the most recent SRTR 

center-specific report.’’ The Scientific 

Registry for Transplant Recipients 

(SRTR) provides statistical information 

about transplant outcomes and 

transplant programs nationwide. Under 

the current regulations, however, there 

is no requirement that a certain number 

of transplants be performed during a 

particular period that would be covered 

in a single SRTR center-specific report. 

This has resulted in transplant centers 

being confused about the volume of 

transplants they are required to perform 

during any particular period of time 

covered by the SRTR center-specific 

reports. We are proposing changes to 

clarify the transplant volume and 

clinical experience requirements. 

• RHC/FQHC definition of physician: 

The definition of a ‘‘physician’’ in the 

RHC/FQHC regulations does not 

conform to the definition of a 

‘‘physician’’ in the payment regulations. 

We propose to revise the regulation to 

conform to the definition in the 

payment regulations to eliminate 

possible confusion in the provider 

community. 

Proposals that Respond to 

Stakeholder Concerns: We have 

identified changes that would improve 

clarity and respond to concerns raised 

by the public. 

• Hospital governing body: We are 

proposing to add a new provision to the 

‘‘Medical staff’’ standard of the 

governing body CoP. This new 

provision would require a hospital’s 

governing body to directly consult at 

least periodically throughout the 

calendar year or fiscal year with the 

individual responsible for the organized 

medical staff of the hospital, or his or 

her designee. For a multi-hospital 

system using a single governing body to 

oversee multiple hospitals within its 

system, this provision would require the 

single governing body to consult 

directly with the individual responsible 

for the organized medical staff (or his or 

her designee) of each hospital within its 

system in addition to the other 

requirements proposed here. We are 

also proposing to remove the 

requirement for a medical staff member, 

or members, to be on a hospital’s 

governing body. 

• Hospital medical staff: We propose 

to revise § 482.22 to require that each 

hospital must have an organized and 

individual medical staff, distinct to that 

individual hospital, that operates under 

bylaws approved by the governing body, 

and which is responsible for the quality 

of medical care provided to patients by 

that individual hospital. 

• Practitioners permitted to order 

hospital outpatient services: We propose 

to revise the Outpatient services CoP to 

allow for practitioners who are not on 

the hospital’s medical staff to order 

hospital outpatient services for their 

patients when authorized by the 

medical staff and allowed by State law. 

• Hospital diet terminology: We 

propose to update terminology related 

to ‘‘diets’’ and ‘‘therapeutic diets’’ in the 

CoPs. 

• Request for comment on RHC 

services: In addition, this proposed 

regulation seeks comment on potential 

changes we could make to regulatory or 

other requirements that could reduce 

barriers to the provision of telehealth, 

hospice, or home health services in an 

RHC. 

Technical Corrections: We are 

proposing technical corrections to some 

regulations. 

• Organ Procurement Organizations 

(OPOs): We are proposing some 

technical corrections to the CoPs for 

OPOs. 

• Intermediate Care Facilities for 

Individuals who are Intellectually 

Disabled (ICF/IIDs): We are proposing 

some technical corrections to clarify 

state survey agency certification survey 

requirements for ICF/IIDs. 

• Rural Health Clinics (RHCs): We 

propose to correct a technical error in 

the regulations by amending 

§ 491.8(a)(6) to conform to section 

6213(a)(3) of OBRA ’89 (Pub. L. 101– 

239),which requires that an NP, PA, or 

certified nurse-midwife (CNM) be 

available to furnish patient care at least 

50 percent of the time the RHC operates. 

C. Summary of Costs and Benefits 

1. Overall Impact 

This proposed rule would create 

savings and reduce burden in many 

areas. Several of the proposed changes 

would create measurable monetary 

savings for providers and suppliers, 

while others would create less tangible 

savings of time and administrative 

burden. We estimate one-time savings of 

$22 million, and annual recurring 

savings of $654 million. 

2. Section-by-Section Economic Impact 

Estimates. 

The following table summarizes the 

provisions, which we are able to 

provide specific estimates for savings or 

burden reductions (these estimates are 

uncertain and could be substantially 

higher or lower, as explained in the 

regulatory impact analysis section of 

this rule): 

Issue Frequency 

Estimated first 

year savings 

or benefits 

($ millions) 

Ambulatory Surgical Centers: 

• Radiology Services ..................................................................................................... Recurring annually .......................... ≤41 

Hospitals: 

• Food and dietetic services .......................................................................................... Recurring annually .......................... 83 to 528 

• Nuclear medicine services .......................................................................................... Recurring annually .......................... 39 

Transplant Centers: 

• Reports to CMS & Survey Changes ........................................................................... Recurring annually .......................... <1 

Long Term Care Facilities: 

• Sprinkler Deadline Extension ...................................................................................... One-time ......................................... 22 

Rural Health: 

• CAH & RHC/FQHC Physician responsibilities ............................................................ Recurring annually .......................... 42 

• CAH Provision of services .......................................................................................... Recurring annually .......................... <1 

CLIA: 

• PT Referral .................................................................................................................. Recurring annually .......................... 2 

Total ......................................................................................................................... 231 to 676 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9219 

Table of Contents 

This proposed rule is organized as 

follows: 

I. Background 

II. Provisions of the Proposed Regulations 

A. Ambulatory Surgical Centers 

B. Intermediate Care Facilities for 

Individuals who are Intellectually 

Disabled 

C. Hospitals 

1. Governing Body (§ 482.12) 

2. Medical Staff (§ 482.22) 

3. Food and Dietetic Services (§ 482.28) 

4. Nuclear Medicine Services (§ 482.53) 

5. Outpatient Services (§ 482.54) 

6. Special Requirements for Hospital 

Providers of Long-term Care Services 

(‘‘swing-beds’’) (§ 482.66) 

D. Transplant Centers and Organ 

Procurement Organizations 

1. Reports to CMS (§ 482.74) 

2. Transplant Outcome Review 

(§§ 482.80(c) and 482.82(c)) 

3. Volume and Clinical Experience 

Requirements (§§ 482.80(c)(2) and 

482.82(c)(2)) 

4. Transplant Center Re-approval Process 

5. Technical Corrections 

E. Long-term Care Facilities 

F. Rural Health and Primary Care 

1. CAH Provision of Services (§ 485.635(a)) 

2. CAH and RHC/FQHC Physician 

Responsibilities (§§ 485.631(b)(2) and 

491.8(b)(2)) 

3. RHC/FQHC Definitions: Physician 

(§ 491.2) 

4. Technical Correction 

G. Solicitation of Comments on Reducing 

Barriers to Services in Rural Health 

Clinics (RHCs) 

1. Telehealth Services 

2. Hospice Services 

3. Home Health Services 

4. Other Services 

H. Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) 

III. Collection of Information Requirements 

IV. Response to Comments 

V. Regulatory Impact Analysis 

I. Background 

In January 2011, the President issued 

Executive Order 13563, ‘‘Improving 

Regulation and Regulatory Review.’’ 

Section 6 of that order requires agencies 

to identify rules that may be 

‘‘outmoded, ineffective, insufficient, or 

excessively burdensome, and to modify, 

streamline, expand, or repeal them in 

accordance with what has been 

learned.’’ In accordance with the 

Executive Order, the Secretary of the 

Department of Health & Human Services 

(HHS) published on August 22, 2011, a 

Plan for Retrospective Review of 

Existing Rules (http:// 

www.whitehouse.gov/21stcenturygov/ 

actions/21st-century-regulatory-system). 

As shown in the plan, the Centers for 

Medicare & Medicaid Services (CMS) 

has identified many obsolete and 

burdensome regulations that could be 

eliminated or reformed to improve 

effectiveness or reduce unnecessary 

reporting requirements and other costs, 

with a particular focus on freeing up 

resources that health care providers, 

health plans, and States could use to 

improve or enhance patient health and 

safety. CMS has also examined policies 

and practices not codified in rules that 

could be changed or streamlined to 

achieve better outcomes for patients 

while reducing burden on providers of 

care. In addition, CMS has identified 

non-regulatory changes to increase 

transparency and to become a better 

business partner. For example: 

• We have automated our review of 

Health Services Delivery tables, which 

gives Medicare Advantage (MA) 

applicants for participation as MA plans 

immediate feedback on their 

deficiencies before submitting 

applications so that they can address 

them up-front. 

• We have changed the timeframes 

during which a Medicare durable 

medical equipment (DME) supplier may 

contact a beneficiary concerning 

refilling an order from 7 days to 15 days 

before the beneficiary’s refill date. 

• We have streamlined the Skilled 

Nursing Facility Discharge Assessment 

through Minimum Data Set (MDS) 3.0 

which has been designed to improve the 

reliability, accuracy, and usefulness of 

the MDS. The change included the 

removal of data collections in the MDS 

that are not relevant to the measurement 

of quality or used for reimbursement 

purposes. 

As explained in the plan, HHS is 

committed to the President’s vision of 

creating an environment where agencies 

incorporate and integrate the ongoing 

retrospective review of regulations into 

Department operations to achieve a 

more streamlined and effective 

regulatory framework. The objectives 

are to improve the quality of existing 

regulations consistent with statutory 

requirements; streamline procedural 

solutions for businesses to enter and 

operate in the marketplace; maximize 

net benefits (including benefits that are 

difficult to quantify); and reduce costs 

and other burdens on businesses to 

comply with regulations. Consistent 

with the commitment to periodic review 

and to public participation, HHS will 

continue to assess its existing significant 

regulations in accordance with the 

requirements of Executive Order 13563. 

In accordance with these goals, we 

published two final rules on May 16, 

2012. The first rule, titled ‘‘Reform of 

Hospital and Critical Access Hospital 

Conditions of Participation,’’ finalizes 

updates to the Medicare CoPs and 

reduces regulatory burden for hospitals 

and CAHs. The second rule, titled 

‘‘Regulatory Provisions to Promote 

Program Efficiency, Transparency, and 

Burden Reduction,’’ addresses 

burdensome regulatory requirements for 

a broader range of healthcare providers 

and suppliers who provide care to 

Medicare and Medicaid beneficiaries. 

This proposed rule is a continuation of 

those efforts. 

II. Provisions of the Proposed 

Regulations 

A. Ambulatory Surgical Centers 

Section 1832(a)(2)(F)(i) of the Act 

specifies that Ambulatory Surgical 

Centers (ASCs) must meet health, safety, 

and other requirements as specified by 

the Secretary in regulation in order to 

participate in Medicare. The Secretary is 

responsible for ensuring that the 

Conditions for Coverage (CfCs) and their 

enforcement protect the health and 

safety of all individuals treated by 

ASCs, whether they are Medicare 

beneficiaries or other patients. 

To implement the CfCs, we determine 

compliance through State survey 

agencies that conduct onsite inspections 

using these requirements. ASCs also 

may be deemed to meet Medicare CfCs 

if they are accredited by one of the 

national accrediting organizations that 

have a CMS-approved Medicare ASC 

accreditation program. 

The ASC CfCs were first published on 

August 5, 1982 (47 FR 34082), and were 

subsequently amended several times in 

the last four years: A final rule 

published on November 18, 2008 (73 FR 

68502), revised four existing health and 

safety CfCs and created three new health 

and safety CfCs (42 CFR 416.41 through 

416.43 and 416.49 through 416.52); a 

subsequent final rule amended the 

Patient rights CfC on October 24, 2011 

(76 FR 65886); and most recently the 

final rule published on May 16, 2012, 

amended the requirements governing 

emergency equipment that ASCs must 

maintain (77 FR 29002). 

Section 416.49(b) of Title 42 of the 

Code of Federal Regulations outlines the 

radiologic services requirements that 

ASCs must meet in order to be 

Medicare-certified. Since ASCs are 

facilities that operate exclusively to 

provide a specific range of approved 

procedures (see § 416.2), they may 

provide radiologic services only to the 

extent that such services are an integral 

part of the procedures they perform. It 

is important to emphasize that 

radiologic services are only permitted in 

an ASC when they are integral to the 

procedure being performed. Section 

416.49(b)(1) states that the ASC must 

have procedures for obtaining 

radiological services from a Medicaremstockstill on DSK4VPTVN1PROD with PROPOSALS2

9220 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

approved facility to meet the needs of 

patients. Section 416.49(b)(2) requires 

that the ASC’s radiologic services must 

meet the hospital CoPs for radiologic 

services specified in § 482.26. However, 

since adopting this rule in 2008, we 

have learned that some of the hospital 

CoP requirements are unduly 

burdensome for ASCs to meet. In 

particular, the hospital CoP requirement 

to have a radiologist supervise the 

provision of radiologic services is 

unduly burdensome, as many ASCs are 

having great difficulty locating a 

radiologist to supervise the ASC’s 

radiologic services. In addition, we have 

discovered the inclusion of the 

radiologist supervision requirement 

from the overarching hospital radiologic 

services CoP appears to be an overly 

aggressive measure since ASCs do not 

provide radiologic services that require 

interpretation for diagnosis. The ASC 

CoPs were first published in 1982 and 

did not include a radiologist 

supervision requirement until the 2008 

final rule. Moreover, the cost of 

privileging radiologists as members of 

an ASC’s medical staff and paying 

radiologists fees for oversight of 

radiology studies that are limited to 

those which are integral to a surgical 

procedure, with the results applied 

immediately by the operating physician, 

is often needlessly burdensome. 

Supervision of radiologic services 

should be appropriate to the types of 

procedures conducted by the ASC. The 

ASC governing body, as set out at 

§ 416.41, is responsible for the oversight 

and accountability for the quality 

assessment and performance 

improvement program, and is 

responsible for ensuring that all policies 

and services provide quality healthcare 

in a safe environment. The ASC 

governing body is responsible for 

determining if any procedures, now or 

in the future, require additional review 

by a radiologist. In addition, the 

Medical staff CfC at § 416.45 requires 

the governing body be accountable for 

the medical staff, and to ensure that 

such staff members are legally and 

professionally qualified for the positions 

to which they are appointed and for the 

performance of the privileges granted. It 

is important to note that the operating 

surgeon is expected, as part of his or her 

qualifications in order to be privileged 

to perform the procedure, to 

demonstrate competency in using 

imaging as an integral part of the 

procedure. If finalized, subsequent ASC 

interpretive guidance would include 

additional information that would assist 

surveyors in determining if the 

governing body has met these 

requirements. We believe that 

supervision of radiologic services used 

in an ASC by a doctor of medicine or 

osteopathy (MD/DO) on the ASC’s 

medical staff with appropriate 

education and experience in radiologic 

services would be effective in assuring 

the quality and safety of the radiologic 

services provided currently in ASCs. We 

welcome your comments on whether 

these proposed changes would allow for 

appropriate oversight of radiologic 

procedures conducted in ASCs. 

We propose to remove § 416.49(b)(1) 

and replace it with the requirement that 

radiologic services may only be 

provided when integral to procedures 

offered by the ASC and must meet the 

requirements specified in § 482.26(b), 

(c)(2), and (d)(2). We also propose to 

remove the existing language at 

§ 416.49(b)(2) and replace it with the 

requirement that an MD/DO who is 

qualified by education and experience 

in accordance with State law and ASC 

policy must supervise the provision of 

radiologic services. 

Also, we note that there is a technical 

error in § 416.42(b)(2) of the ASC CfCs 

and we are proposing to correct this 

error. Paragraph (b)(2) references 

‘‘paragraph (d) of this section’’ but 42 

CFR 416.42 does not have a paragraph 

(d). We propose to correct the error by 

referencing paragraph (c) of that section 

instead. 

We believe these proposed changes to 

the ASC radiologic services 

requirements will assure the safety of 

these services while being less 

burdensome for Medicare-certified ASC 

facilities. We welcome comments from 

the public on these proposed changes. 

Contact for ASC Topics: CAPT 

Jacqueline Leach, USPHS, 410–786– 

4282. 

B. Intermediate Care Facilities for 

Individuals Who Are Intellectually 

Disabled 

In the May 16, 2012, final rule 

‘‘Regulatory Provisions to Promote 

Program Efficiency, Transparency, and 

Burden Reduction,’’ (77 FR 29002) we 

eliminated the requirement for timelimited agreements for Intermediate 

Care Facilities for Individuals who are 

Intellectually Disabled (ICF/IID’s) and 

replaced it with an open-ended 

agreement which, consistent with 

nursing facilities, would remain in 

effect until the Secretary or a State 

determined that the ICF/IID no longer 

met the ICF/IID CoPs. We also added a 

requirement that a certified ICF/IID 

would be surveyed, on average, every 12 

months with a maximum 15-month 

survey interval. This requirement 

provides States with more flexibility 

relative to the current process. These 

changes were implemented by revising 

§§ 442.15, 442.109, and 442.110, and by 

the deletion of § 442.16. 

The regulation at § 442.105 describes 

circumstances for when a state survey 

agency may provide an annual 

certification of a facility found out of 

compliance with standards for ICF/IID’s. 

Since time-limited certification is no 

longer required for ICF/IID’s, this 

section serves no purpose and is 

confusing. Therefore, we propose that 

this section be deleted. We also propose 

to make a corresponding change to 

§ 442.101(d)(3) by deleting a reference to 

§ 442.105. 

A revision to § 442.110(b) made in the 

May 16, 2012 final rule extended the 

time for which a state may certify ICF/ 

IID’s with standard level deficiencies. 

However, the section inadvertently and 

incorrectly maintains time-limited 

certification for this sub-set of facilities. 

This is inconsistent with the revised 

survey regulation for ICF/IIDs put in 

place in the May 16, 2012 final rule, and 

will create confusion and barriers to its 

successful implementation. Therefore, 

we propose to delete § 442.110 in its 

entirety. 

The language in § 442.105 and 

§ 442.110 was deleted to make it 

consistent with the intent of the Burden 

Reduction I regulatory changes to 

standardize survey processes of ICF/IIDs 

with those of nursing facilities and other 

certified providers with open-ended 

certification periods. 

Contact for ICF/IID Topics: Martin 

Kennedy, 410–786–0784. 

C. Hospitals 

1. Governing Body (§ 482.12) 

On May 16, 2012, we published a 

final rule, entitled ‘‘Reform of Hospital 

and Critical Access Hospital Conditions 

of Participation’’ (77 FR 29034). In that 

rule, we finalized changes to the 

requirements of the Governing body 

CoP, § 482.12, and adopted a policy to 

allow one governing body to oversee 

multiple hospitals in a multi-hospital 

system. Additionally, we added a 

requirement for a medical staff member, 

or members, from at least one hospital 

in the system to be included on the 

governing body as a means of ensuring 

communication and coordination 

between a single governing body and 

the medicals staffs of individual 

hospitals in the system. After 

publication of the rule, we received 

considerable feedback that the mandate 

requiring medical staff representation 

on the governing body of a hospital 

could cause unanticipated 

complications for many hospitals, 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9221 

especially public and governmentowned institutions. We recognized that 

the provision to include a member of 

the medical staff on a hospital’s 

governing body creates conflicts for 

some hospitals, particularly public and 

not-for-profit hospitals. Issues include, 

but are not limited to, potential conflicts 

with some State and local laws that 

require members of a public hospital’s 

governing body to either be publicly 

elected or appointed by the State’s 

governor or by some other State or local 

official(s). 

Given the complexity of the issue, and 

in light of industry feedback, we 

reviewed this requirement and gathered 

the relevant background information on 

the issues raised by stakeholders. After 

consideration of the issues, we decided 

to use this proposed rule to rescind part 

of the new requirement and to propose 

an alternative. Therefore, we propose to 

remove the requirement for a medical 

staff member, or members, to serve on 

a hospital’s governing body. While we 

believe that it is important that our 

requirements avoid any unnecessary 

conflicts for hospitals, we believe that it 

is essential that the requirements also 

ensure that the medical staff perspective 

on quality of care is heard by a 

hospital’s governing body. Therefore, 

we propose to add a new provision to 

the ‘‘Medical staff’’ standard of the 

Governing body CoP at § 482.12(a)(10). 

This new provision would require a 

hospital’s governing body to directly 

consult with the individual responsible 

for the organized medical staff of the 

hospital, or his or her designee. At a 

minimum, this direct consultation 

would require a discussion of matters 

related to the quality of medical care 

provided to patients of the hospital and 

must occur periodically throughout the 

fiscal or calendar year. While the 

proposed language reflects our intention 

to leave some degree of flexibility for a 

hospital’s governing body (or a multihospital system’s governing body) to 

determine how often during the year its 

consultations with the chief(s) of its 

medical staff(s) would occur, we would 

expect that these consultations would 

occur at least twice during either a fiscal 

or calendar year. Moreover, we would 

expect a hospital (or multi-hospital 

system) governing body to determine 

the number of consultations needed 

based on various factors specific to a 

particular hospital. These factors would 

include, but are not limited to, the scope 

and complexity of hospital services 

offered, specific patient populations 

served by a hospital, and any issues of 

patient safety and quality of care that a 

hospital’s quality assessment and 

performance improvement program 

might periodically identify as needing 

the attention of the governing body in 

consultation with its medical staff. We 

would also expect to see evidence that 

the governing body is appropriately 

responsive to any periodic and/or 

urgent requests from the individual 

responsible for the organized medical 

staff of the hospital (or his or her 

designee) for timely consultation on 

issues regarding the quality of medical 

care provided to patients of the hospital. 

Additionally, for a multi-hospital 

system using a single governing body to 

oversee multiple hospitals within its 

system, we are proposing to require the 

single governing body to consult 

directly with the individual responsible 

for the organized medical staff (or his or 

her designee) of each hospital within its 

system in addition to the other 

requirements proposed here. We believe 

that this proposal represents the best 

solution for those hospitals that were 

unintentionally burdened by the 

requirement finalized in the May 16, 

2012, rule, while still addressing the 

concerns of many stakeholders who 

responded to the final rule, many of 

whom firmly stated their belief that 

medical staff input on a hospital’s 

governing body is essential to the 

continuing quality of patient care 

delivered in the hospital. 

1. Medical Staff (§ 482.22) 

Similar to the issues regarding 

medical staff representation on the 

governing body that were discussed in 

the previous section, we also received a 

considerable amount of feedback 

regarding our responses in the May 16, 

2012 final rule (77 FR 29061) where we 

discussed our long-standing 

interpretation of the Medical staff CoP at 

§ 482.22 as requiring that each hospital 

have its own independent medical staff. 

We also confirmed in the final rule that 

we do not allow a single corporate 

medical staff to assume responsibility 

for the quality of medical care at 

multiple hospitals within a multihospital system. Despite the fact that 

over the years some members of the 

hospital industry have repeatedly 

requested a change to the prohibition in 

the CoPs against a single medical staff 

for multiple hospitals within a corporate 

system, CMS has maintained the 

importance of each hospital having its 

own medical staff at the local level and 

has maintained that this is the best 

model for overseeing care delivery and 

for moving forward with quality 

improvements. 

Many of the comments that we 

received in response to the 

corresponding proposed rule (published 

October 24, 2011 (76 FR 65891)), 

indicated a clear awareness that we had 

considered a rule change that would 

allow for a single medical staff for 

multiple hospitals, had decided against 

it, and were nevertheless asking for 

comments on whether we should 

strengthen the language to more fully 

articulate our long-standing 

interpretation that each hospital have its 

own organized medical staff. While 

these commenters did not suggest 

clarifying changes to the regulatory 

language, a significant number 

expressed an understanding of, and 

support for, our decision to not propose 

a change and to continue to interpret the 

CoP as one that does not permit a multihospital system to have a single medical 

staff, but that instead requires that each 

individual hospital have its own 

medical staff. Other commenters 

interpreted our request for comments in 

the proposed rule as an indication that 

we were in some way proposing a 

change to the requirements or proposing 

a change in our historical interpretation 

of this CoP. 

We continue to believe that it is 

important and in the best interest of 

patient care for each hospital to have its 

own medical staff. For example, a large 

multi-hospital, multi-regional system 

that only has a single medical staff may 

not appropriately be able to address the 

needs of each individual hospital in 

each local area. We did not receive 

public comments on the prior rule that 

would have adequately addressed this 

issue. The mixed response from public 

commenters regarding our confirmation 

of the requirement and its interpretation 

has led us to consider proposing 

changes to the regulatory language of 

§ 482.22 that would more explicitly 

communicate our longstanding policy 

that each hospital must have its own 

medical staff. Therefore, we propose to 

clarify the introductory paragraph of 

§ 482.22 to require that each hospital 

must have an organized and individual 

medical staff, distinct to that individual 

hospital, that operates under bylaws 

approved by the governing body, and 

which is responsible for the quality of 

medical care provided to patients by 

that individual hospital. 

Shortly after publication of the May 

2012 final rule, it was brought to our 

attention that some of the changes made 

to the hospital requirements at 

§ 482.22(a), ‘‘Medical staff,’’ were not 

clear. Our intent in revising the 

provision was to provide the flexibility 

that hospitals need under federal law to 

maximize their medical staff 

opportunities for all practitioners, but 

within the regulatory boundaries of 

their State licensing and scope-ofmstockstill on DSK4VPTVN1PROD with PROPOSALS2

9222 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

practice laws. We believe that the 

greater flexibility for hospitals and 

medical staffs to enlist the services of 

non-physician practitioners to carry out 

the patient care duties for which they 

are trained and licensed will allow them 

to meet the needs of their patients most 

efficiently and effectively. 

Section 482.22(a) (Standard: 

Eligibility and process for appointment 

to medical staff) currently requires a 

hospital’s medical staff to be composed 

of doctors of medicine or osteopathy. It 

also allows for a hospital’s medical staff 

to include other categories of nonphysician practitioners determined as 

eligible for appointment by the 

governing body, in accordance with 

State law, including scope-of-practice 

laws. With the substitution of the term 

‘‘non-physician practitioners’’ in the 

final rule (which replaced the term 

‘‘other practitioners’’), we might have 

unintentionally given the impression 

that the requirements now excluded 

other types of practitioners previously 

included among those eligible for 

appointment to the medical staff. In our 

guidance prior to the issuance of this 

final rule, we stated that a medical staff 

could include ‘‘other practitioners’’ 

such as doctors of dental surgery or of 

dental medicine, doctors of podiatric 

medicine, doctors of optometry, and 

chiropractors, as those terms are defined 

and specified as physicians under 

section 1861(r) of the Act. Because part 

of the provision states that a hospital’s 

medical staff must include ‘‘doctors of 

medicine or osteopathy,’’ physicians 

such as those listed above are 

inadvertently excluded from the 

medical staff by the requirement. 

Similarly, the new term ‘‘non-physician 

practitioner’’ therefore might also seem 

to exclude these other types of 

physicians simply by its use of the 

modifier, ‘‘non-physician,’’ since by the 

definition described at section 1861(r) of 

the Act, the practitioners are 

‘‘physicians,’’ they cannot also be 

considered to be ‘‘non-physicians.’’ Our 

intention was not to exclude these types 

of physicians from the definition 

described in our regulations. Therefore, 

we believe that it would be appropriate 

to propose revisions to 42 CFR 482.22(a) 

that would clarify that the medical staff 

requirements still allow for these types 

of physicians as well as other types of 

non-physician practitioners to be 

eligible for appointment to a hospital’s 

medical staff. 

At § 482.22(a), we propose to revise 

the current language to require that a 

hospital’s medical staff must be 

composed of physicians and that it may 

also include, in accordance with State 

laws, including scope-of-practice laws, 

other categories of non-physician 

practitioners determined as eligible for 

appointment by the governing body. By 

the proposed substitution of the current 

terms, ‘‘doctors of medicine or 

osteopathy,’’ with the term 

‘‘physicians,’’ we would be consistent 

with the statutory language. We also 

propose to substitute ‘‘must include’’ 

with ‘‘must be composed of’’ since we 

believe that this would more accurately 

reflect the fact that hospital medical 

staffs are predominantly made up of 

physicians and that this would also 

emphasize the vital positions that 

physicians hold on these medical staffs. 

The proposed regulatory language 

would require that the medical staff 

must be composed of physicians. 

Finally, we propose to retain the 

language allowing for other types of 

non-physician practitioners (such as 

APRNs, PAs, RDs, and PharmDs) to be 

included on the medical staff since we 

continue to believe that these 

practitioners, even though they are not 

included in the statutory definition of a 

physician, nevertheless have equally 

important roles to play on a medical 

staff and on the quality of medical care 

provided to patients in the hospital. 

2. Food and Dietetic Services (§ 482.28) 

We propose to revise the hospital 

requirements at § 482.28(b), ‘‘Food and 

dietetic services,’’ which currently 

requires that a therapeutic diet must be 

prescribed only by the practitioner or 

practitioners responsible for the care of 

the patient. 

The Interpretive Guidelines (IGs) for 

this requirement, which are contained 

in the State Operations Manual (SOM) 

for surveyors, further states that ‘‘[in] 

accordance with State law and hospital 

policy, a dietitian may assess a patient’s 

nutritional needs and provide 

recommendations or consultations for 

patients, but the patient’s diet must be 

prescribed by the practitioner 

responsible for the patient’s care.’’ State 

survey agencies have applied this 

requirement to mean that registered 

dietitians (RDs) cannot be granted 

privileges by the hospital to order 

patient diets (or to order necessary 

laboratory tests to monitor the 

effectiveness of dietary plans and 

orders, or to make subsequent 

modifications to those diets based on 

the laboratory tests) since these 

practitioners have never been 

considered to be among those in the 

hospital who are ‘‘responsible for the 

care of the patient.’’ The responsibility 

for the care of the patient, and the 

attendant hospital privileges that 

accompany this responsibility, have 

traditionally and exclusively been the 

provenance of the physician, more 

specifically the MD and DO, and, to a 

lesser extent, the APRN and PA. 

Understanding the regulatory language 

and its interpretation, most hospitals 

have taken a very conservative approach 

toward the granting of privileges, 

especially ordering privileges, to other 

types of non-physician practitioners, 

including RDs. Consequently, most 

hospitals have withheld ordering 

privileges from RDs absent a clear signal 

from CMS and the subsequent and 

necessary changes to the CoPs that 

would allow them to do so. 

Through the publication of the 

October 2011 proposed rule and the 

May 2012 final rule that followed, it has 

come to our attention that the regulatory 

language and the IGs for § 482.28(b) are 

too restrictive and lack the reasonable 

flexibility to allow hospitals to extend 

these specific privileges to RDs in 

accordance with State laws. We believe 

that RDs are the professionals who are 

best qualified to assess a patient’s 

nutritional status and to design and 

implement a nutritional treatment plan 

in consultation with the patient’s 

interdisciplinary care team. In order for 

patients to receive timely nutritional 

care, the RD must be viewed as an 

integral member of the hospital 

interdisciplinary care team, one who, as 

the team’s clinical nutrition expert, is 

responsible for a patient’s nutritional 

diagnosis and treatment in light of the 

patient’s medical diagnosis. Without the 

proposed regulatory changes allowing 

them to grant appropriate ordering 

privileges to RDs, hospitals would not 

be able to effectively realize the 

improved patient outcomes and overall 

cost savings that we believe would be 

possible with such changes. Please note, 

because a few States elect not to use the 

regulatory term ‘‘registered’’ and choose 

instead to use the term ‘‘licensed’’ (or no 

modifying term at all), we are proposing 

to use the term ‘‘qualified dietitian.’’ In 

those instances where we have used the 

most common abbreviation for 

dietitians, ‘‘RD,’’ throughout this 

preamble, our intention is to include all 

qualified dietitians, regardless of the 

modifying term (or lack thereof), as long 

as each qualified dietitian meets the 

requirements of his or her respective 

State laws. 

A review of the literature (Kinn TJ. 

Clinical order writing privileges. 

Support Line. 2011; 33; 4; 3–10) 

supports that, in addition to providing 

safe patient care with improved 

outcomes, RDs with ordering privileges 

contribute to decreased patient lengths 

of stay and provide nutrition services 

more efficiently, resulting in lower costs 

for hospitals. A 2010 retrospective 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9223 

cohort study of 1,965 patients at a 613- 

bed tertiary academic medical center 

looked at the influence of the RD with 

ordering privileges on appropriate 

parenteral nutrition (PN) usage 

(Peterson SJ, Chen Y, Sullivan CA, et al. 

Assessing the influence of registered 

dietician order-writing privileges on 

parenteral nutrition use. J AM Diet 

Assoc. 2010; 110; 1702–1711). The 

study showed that inappropriate PN 

usage decreased from 482 patients to 

240 patients during the pre- and postordering privileges periods, 

respectively. The data from this study 

also demonstrated a 20 percent cost 

savings in PN usage, which translated to 

an approximately $300,000 savings to 

the hospital over the two-year period. 

Additionally, the changes proposed in 

this rule might also help hospitals to 

realize other significant quality and 

patient safety improvements as well as 

savings. A 2008 study indicates that 

patients whose PN regimens were 

ordered by RDs have significantly fewer 

days of hyperglycemia (57 percent 

versus 23 percent) and electrolyte 

abnormalities (72 percent versus 39 

percent) compared with patients whose 

PN regimens were ordered by 

physicians (Duffy JK, Gray RL, Roberts 

S, Glanzer SR, Longoria SL. 

Independent nutrition order writing by 

registered dieticians reduces 

complications associated with nutrition 

support [abstract]. J Am Diet Assoc. 

2008; 108 (suppl 1):A9). 

A number of other studies have also 

shown the prevalence of malnutrition 

among hospital patients, estimating that 

anywhere between 20 and 50 percent of 

hospital inpatients are either 

malnourished or at risk for malnutrition, 

depending on the particular patient 

population and the criteria used to 

assess these patients (Barker LA, Gout 

BS, Crowe TC. Hospital malnutrition: 

prevalence, identification and impact on 

patients and the healthcare system. Int 

J Environ Res Public Health. 2011; 8(2); 

514–527). Malnourished surgical 

patients are two to three times more 

likely to experience post-operative 

complications and increased mortality 

than their more well-nourished 

counterparts (Gallagher-Allred CR, 

Coble Voss A, Finn SC, McCamish MA. 

Malnutrition and clinical outcomes: the 

case for medical nutrition therapy. J Am 

Diet Assoc. 1996; 96; 361–369). 

Physicians, APRNs, and PAs often lack 

the training and educational background 

to manage the sometimes complex 

nutritional needs of patients with the 

same degree of efficiency and skill as 

RDs who have benefited from 

curriculums that devote a significant 

number of educational hours to this area 

of medicine. The addition of ordering 

privileges enhances the ability that RDs 

already have to provide timely, costeffective, and evidence-based nutrition 

services as the recognized nutrition 

experts on a hospital interdisciplinary 

team and saves valuable time in the care 

and treatment of patients, time that is 

now often wasted as RDs must seek out 

physicians, APRNs, and PAs to write or 

co-sign dietary orders. A 2011 review 

article discusses a number of additional 

studies that provide further evidence for 

the extensive training and education in 

nutrition that RDs experience as 

opposed to the limited exposure that 

physicians receive to this area of 

medicine, along with several other 

studies supporting the cost-effectiveness 

and positive patient outcomes that 

hospitals might achieve by granting RDs 

ordering privileges (Kinn TJ. Clinical 

order writing privileges. Support Line. 

2011; 33; 4; 3–10). 

In order for patients to have access to 

the timely nutritional care that can be 

provided by RDs, a hospital must have 

the regulatory flexibility either to 

appoint RDs to the medical staff and 

grant them specific nutritional ordering 

privileges or to authorize the ordering 

privileges without appointment to the 

medical staff, all through the hospital’s 

appropriate medical staff rules, 

regulations, and bylaws. In either 

instance, medical staff oversight of RDs 

and their ordering privileges would be 

ensured. Therefore, we are proposing 

revisions to § 482.28(b)(1) and (2) that 

would require that individual patient 

nutritional needs be met in accordance 

with recognized dietary practices. We 

would make further revisions that 

would allow for flexibility in this area 

by requiring that all patient diets, 

including therapeutic diets, must be 

ordered by a practitioner responsible for 

the care of the patient, or by a qualified 

dietician as authorized by the medical 

staff and in accordance with State law. 

We believe that hospitals that choose to 

grant these specific ordering privileges 

to RDs may achieve a higher quality of 

care for their patients by allowing these 

professionals to fully and efficiently 

function as important members of the 

hospital patient care team in the role for 

which they were trained. We also 

believe hospitals would realize 

significant cost savings in many of the 

areas affected by nutritional care. We 

welcome public comments on this 

proposed change. 

3. Nuclear Medicine Services (§ 482.53) 

The current requirement at 

§ 482.53(b)(1) requires that the in-house 

preparation of radiopharmaceuticals be 

performed by, or under the direct 

supervision of, an appropriately trained 

registered pharmacist or a doctor of 

medicine or osteopathy. Direct 

supervision means that one of these 

professionals must be physically present 

in the hospital and immediately 

available during the preparation of all 

radiopharmaceuticals. Hospitals have 

reported to us that this requirement is 

extremely burdensome when the 

presence of a pharmacist or physician is 

required for the provision of off-hour 

nuclear medicine tests that require only 

minimal in-house preparation of 

radiopharmaceuticals. Information from 

stakeholders regarding this issue has 

revealed that minimal in-house 

preparation is required for most 

radiopharmaceuticals. Many are batchprepared by the manufacturer for 

hospital use as a way of reducing 

radiation exposure of hospital 

personnel, ensuring that on-site hospital 

preparation of radiopharmaceuticals 

generally requires only a few final steps, 

if any. 

We propose to revise the current 

requirement at § 482.53(b)(1) by 

removing the term ‘‘direct.’’ The revised 

requirement would then require that inhouse preparation of 

radiopharmaceuticals be performed by, 

or under the supervision of, an 

appropriately trained registered 

pharmacist or doctor of medicine or 

osteopathy. The revision to 

‘‘supervision’’ from ‘‘direct supervision’’ 

would allow for other appropriately 

trained hospital staff to prepare inhouse radiopharmaceuticals under the 

oversight of a registered pharmacist or 

doctor of medicine or osteopathy, but it 

would not require that such oversight be 

exercised by the physical presence in 

the hospital at all times of one of these 

professionals, particularly during offhours when such a professional would 

not be routinely present. 

The proposed changes would allow 

hospitals to establish their own policies 

on supervision of nuclear medicine 

personnel and the in-house preparation 

of radiopharmaceuticals. Absent a 

requirement for ‘‘direct’’ supervision, 

we would expect most hospitals to 

follow the Society of Nuclear Medicine 

and Molecular Imaging 

recommendations on this issue and to 

no longer require a registered 

pharmacist or MD/DO to be on site for 

direct supervision when 

radiopharmaceuticals are prepared inhouse by staff. The proposed change 

would directly reduce the burden of the 

current direct supervision requirement 

where it is most needed—in-house 

preparation of radiopharmaceuticals for 

after-hours/emergency performance of 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9224 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

nuclear medicine diagnostic procedures 

(for example, coronary artery disease, 

pulmonary emboli, stroke, and testicular 

torsion). Given that an estimated 16 

million nuclear medicine imaging and 

therapeutic procedures are performed 

each year in the United States, we 

would expect hospitals to achieve 

significant cost reductions in this area if 

they take advantage of the proposed 

change. We welcome the public’s 

comments on this proposed change. 

4. Outpatient Services (§ 482.54) 

We are proposing changes to the 

requirements at § 482.54, ‘‘Outpatient 

services.’’ Specifically, we are adding a 

new standard at § 482.54(c), entitled 

‘‘Orders for outpatient services.’’ We are 

taking the opportunity to propose these 

revisions in this rule so that the 

regulations would codify Interpretive 

Guideline (IG) changes that we recently 

made regarding the ordering of 

outpatient services. 

On May 13, 2011, CMS issued SC–11– 

28 (http://www.cms.gov/Medicare/ 

Provider-Enrollment-and-Certification/ 

SurveyCertificationGenInfo/Downloads/ 

SCLetter11_28.pdf). Among other 

things, this memorandum included 

preliminary guidance on who may order 

hospital rehabilitation (§ 482.56(b)) and 

respiratory care services (§ 482.57(b)(3)). 

On November 18, 2011, the final version 

of the revised IGs for these requirements 

was released. Subsequently, we received 

considerable feedback that this 

guidance, which was intended to 

expand the categories of practitioners 

who could order rehabilitation and 

respiratory care services beyond 

physicians and stated that all ordering 

practitioners had to hold medical staff 

privileges, was actually having the 

opposite effect and limiting practitioner 

orders for these services. In the area of 

outpatient rehabilitation services, in 

particular, stakeholders informed us 

that the revised guidance was posing a 

barrier to care because a substantial 

percentage of these services are 

provided in hospital outpatient 

rehabilitation facilities to patients 

referred by practitioners who are not on 

the hospital’s medical staff and who do 

not hold medical staff privileges. We 

were advised that, in many cases, the 

referring practitioners are based in other 

States where patients have traveled to 

receive specialized services. Clearly, 

these practitioners do not provide care 

in the patient’s local hospital and are 

not interested in seeking medical staff 

privileges merely to refer patients for 

outpatient services. 

It was not our intention to create 

barriers to care or to limit the ability of 

practitioners, who are appropriately 

licensed, acting within their scope of 

practice, and authorized under hospital 

policies, to refer patients for outpatient 

services. We distinguish these 

outpatient referral cases from cases 

where a practitioner provides care in the 

hospital, either to inpatients or 

outpatients, and must have medical staff 

privileges to do so. We subsequently 

issued new guidance on this rule, which 

was preceded by discussions with the 

various stakeholders groups that first 

brought the issue to our attention. On 

February 17, 2012, CMS issued SC–12– 

17 (http://www.cms.gov/Medicare/ 

Provider-Enrollment-and-Certification/ 

SurveyCertificationGenInfo/Downloads/ 

SCLetter12_17.pdf), which clarified that 

outpatient services may be ordered by 

any practitioner responsible for the care 

of the patient, who is licensed and 

acting within his or her scope of 

practice in the State where he or she 

provides care to the patient, and who 

has been authorized by the medical staff 

and approved by the governing body to 

order specific outpatient services. 

In light of the above, we believe it is 

appropriate to revise § 482.54, the CoP 

governing outpatient services, which is 

silent on the issue of who may order 

such services, in order to explicitly 

address this issue. We propose to revise 

the requirements to mean that orders for 

outpatient services may be made by any 

practitioner who is: 

• Responsible for the care of the 

patient; 

• Licensed in the State where he or 

she provides care to the patient; 

• Acting within his or her scope of 

practice under State law; and 

• Authorized in accordance with 

policies adopted by the medical staff, 

and approved by the governing body, to 

order the applicable outpatient services. 

Further, these proposed requirements 

would apply to: all practitioners who 

are appointed to the hospital’s medical 

staff and who have been granted 

privileges to order the applicable 

outpatient services; and all practitioners 

not appointed to the medical staff, but 

who satisfy the above criteria for 

authorization by the hospital for 

ordering the applicable outpatient 

services and for referring patients for 

such services. These requirements 

would also apply to all hospital services 

that may be offered on an outpatient 

basis, including services for which there 

is regulatory language that, in the 

absence of the clarifying language we 

propose herein, would appear to impose 

more stringent limits as to the 

practitioners who are permitted to order 

outpatient services. For example, 

§ 482.53(c)(4) states, ‘‘Nuclear medicine 

services must be ordered only by 

practitioner whose scope of Federal or 

State licensure and whose defined staff 

privileges allow such referrals.’’ In 

practice, however, it is not unusual for 

physicians without medical staff 

privileges to refer their patients to the 

hospital for common outpatient nuclear 

medicine tests, such as myocardial 

perfusion scans used in conjunction 

with cardiac stress tests and 

hepatobiliary scans used in the 

detection of gallbladder disease. So long 

as the hospital’s medical staff policies 

and procedures permit this, we do not 

believe our regulations should present a 

barrier. Another example concerns the 

administration of outpatient 

chemotherapy. In accordance with 

§ 482.23(c), concerning preparation and 

administration of drugs, ‘‘Drugs and 

biologicals must be prepared and 

administered in accordance with 

Federal and State laws, the orders of the 

practitioner or practitioners responsible 

for the patient’s care as specified under 

§ 482.12(c), and accepted standards of 

practice.’’ In the absence of the 

clarification we propose herein, this 

language could be confusing, as some 

hospitals might read it to preclude 

providing outpatient chemotherapy on 

the orders of a practitioner without 

privileges, which may or may not be 

desirable to the hospital. We believe 

that it is more appropriate if the 

hospital’s medical staff and governing 

body determine what types of outpatient 

services they are comfortable with 

providing on the basis of an order 

(which might commonly also be called 

a ‘‘referral’’) from a practitioner who 

does not hold medical staff privileges. 

We expect these changes would be 

primarily neutral in terms of regulatory 

burden reduction for hospitals. Prior to 

the November 2011 revisions to the IGs, 

most, if not all, hospitals were already 

operating under what was considered 

standard industry practice with regard 

to the ordering of, and referral for, 

outpatient rehabilitation services by 

practitioners who were not on the 

hospital’s medical staff. Since we 

moved quickly to clarify our outpatient 

services ordering policy through 

communications with stakeholders and 

further revisions to the IGs, we believe 

that most hospitals did not make 

changes to their policies and procedures 

that would have created burdens for 

them. We cannot rule out the possibility 

that some hospitals were deterred by the 

specific language of other CoPs, such as 

those governing nuclear medicine or 

administration of drugs, but we have not 

received information that would allow 

us to quantify this. This proposed 

change would clearly establish in 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9225 

regulation CMS policy on the ordering 

and referral of all outpatient services. 

We welcome the public’s comments on 

these proposed changes. 

5. Special Requirements for Hospital 

Providers of Long-term Care Services 

(‘‘swing-beds’’) (§ 482.66) 

Currently, these requirements are 

located in Subpart E of Part 482, 

Requirements for specialty hospitals. As 

such, the requirements fall outside of 

those requirements that can be surveyed 

by an Accreditation Organization (AO), 

such as TJC, AOA, or DNV, as part of 

its CMS-approved Medicare hospital 

accreditation program. We believe the 

requirements at § 482.66 would be more 

appropriately located under Subpart D 

of Part 482, Optional hospital services, 

since swing-bed services are optional 

hospital services for eligible rural 

hospitals. 

Therefore, we are proposing to 

reassign all of the requirements for 

swing-bed services found currently at 

§ 482.66, Subpart E, to § 482.58, Subpart 

D. This change would allow compliance 

with the swing-bed requirements to be 

evaluated during routine AO surveys. 

By no longer requiring a deemed 

hospital to undergo a separate survey by 

a State Survey Agency (SA) to 

determine continued compliance with 

the swing-bed requirements in addition 

to the AO survey for the other CoPs, this 

proposed change would likely reduce 

the burden on such a hospital. We 

welcome the public’s comments on this 

proposed change. 

Contact for all hospital topics: CDR 

Scott Cooper, USPHS, 410–786–9465. 

D. Transplant Centers and Organ 

Procurement Organizations 

1. Reports to CMS (§ 482.74) 

On March 30, 2007, we published the 

‘‘Hospital Conditions of Participation: 

Requirements for Approval and Reapproval of Transplant Centers to 

Perform Transplants Final Rule’’ 

(transplant center final rule, 72 FR 

15198). In that rule, we required that 

transplant centers, among other things, 

report to CMS any significant changes 

related to the center’s transplant 

program or changes that could affect its 

compliance with the CoPs. One of the 

instances in which transplant centers 

have to notify us, located at 

§ 482.74(a)(2), is whenever there is a 

decrease in the center’s number of 

transplants or survival rates that could 

result in the center being out of 

compliance with the clinical experience 

(number of required transplants) or 

outcome (survival) requirements at 

§ 482.82. 

We routinely receive the number of 

transplants a center performs and 

survival information for all of the 

transplant centers. All transplant 

centers are required to submit these data 

to the Organ Procurement and 

Transplantation Network (OPTN) 

national database for transplantation. 

These data are provided to the Scientific 

Registry of Transplant Recipients 

(SRTR), which publicly releases 

outcome (survival) information every 

six months, after the data have been 

risk-adjusted. CMS also receives more 

recent survival information via the 

Social Security Master Death File. CMS 

receives clinical experience data and the 

Social Security Master Death File 

quarterly, as well as the risk-adjusted 

outcomes from the SRTR data every six 

months. Thus, CMS is essentially 

receiving the same information from the 

transplant programs individually that 

we receive routinely from one or more 

of the resources cited above. 

In addition to the above, this 

notification requirement has also 

resulted in confusion for the transplant 

centers. The requirement states that 

transplant centers should notify CMS 

when they are out of compliance with 

a 3-year average of 10 transplants per 

year. Since the clinical experience 

standard is based on an average, a 

transplant center may not know if a 

given year’s volume would be low 

enough to have the average fall below 10 

per year and trigger reporting to CMS, 

particularly when the number of 

transplants to be performed in a future 

year is unknown. 

In addition, the requirement for 

notification of outcomes noncompliance is based on the difference 

between the observed and the expected 

outcomes exceeding certain thresholds. 

However, the expected outcomes are not 

calculated until at least one year later 

when the one-year post-transplant 

tracking period for patient and graft 

survival is complete. The transplant 

program would not always know 

whether a given death or graft failure 

would put them out of compliance and 

require notification to CMS. Eliminating 

this notification requirement will also 

remove this confusion for the transplant 

centers. 

Thus, the requirement for transplant 

centers to report a decrease in the 

center’s number of transplants or 

survival rates when those results could 

result in the center being out of 

compliance with the measures in 

§ 482.82 is unnecessary, confusing, and 

burdensome for transplant centers. 

Therefore, we propose to eliminate the 

requirement at § 482.74(a)(2) that 

transplant centers notify us. The 

removal of this requirement would have 

no impact on the quality of care to 

transplant recipients, living donors, or 

potential donors as our identification 

and follow-up process for programs that 

do not meet § 482.82 would remain 

unchanged. 

2. Transplant Outcome Review 

(§ 482.80(c) and § 482.82(c)) 

Subsections § 482.80(c) and 482.82(c) 

in the transplant center CoPs state that, 

‘‘[e]xcept for lung transplants, CMS will 

review adult and pediatric outcomes 

separately when a center requests 

Medicare approval to perform both 

adult and pediatric transplants.’’ At the 

time the transplant center final rule was 

published (March 30, 2007), the adult 

data cohorts for lung transplants 

included transplant patients 12 years of 

age and older. As of June 2010, the adult 

data cohort includes only those 

transplant patients that are 18 years of 

age and older. The age categories for 

lung transplant patients are now the 

same as for all of the other transplants 

reported in the SRTR center-specific 

reports (See OPTN/SRTR 2010 Annual 

Data Report, Rockville, MD: Department 

of Health and Human Services, Health 

Resources and Services Administration, 

Healthcare Systems Bureau, Division of 

Transplantation: 2011). We are 

reviewing the adult and pediatric 

outcomes separately for all programs 

that request Medicare approval to 

perform both adult and pediatric 

transplants, including the lung 

transplant program. This language, 

‘‘except for lung transplants,’’ is no 

longer necessary. Therefore, we are 

proposing to remove the exception 

language for lung transplants from 

§§ 482.80(c) and 482.82(c). 

3. Volume and Clinical Experience 

Requirements (§§ 482.80(c)(2) and 

482.82(c)(2)) 

Regulations at §§ 482.80(c)(2) and 

482.82(c)(2) both state ‘‘[t]he required 

number of transplants must have been 

performed during the time frame 

reported in the most recent SRTR 

center-specific report.’’ We propose to 

modify this language to make it 

harmonize with other parts of the 

current rule. Under the current rule, 

transplant centers are generally 

required, with some exceptions, to 

perform either 10 transplants over a 12- 

month period for initial approval 

(§ 482.80(b)) or an average of 10 

transplants each year during the 

approval period (§ 482.82(c)(2)). There 

is no requirement for a certain number 

of transplants to be performed during a 

particular period that would be covered 

in a single SRTR center-specific report. 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9226 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

Thus, this language has resulted in 

transplant centers being confused about 

the number of transplants they are 

required to perform during any 

particular period of time covered by the 

SRTR center-specific reports. Therefore, 

we are proposing to remove both 

§§ 482.80(c)(2) and 482.82(c)(2), and to 

redesignate the existing paragraph (c)(3) 

as (c)(2) to clarify the volume and 

clinical experience requirements. 

4. Transplant Center Re-Approval 

Process 

Since the effective date of the CoPs, 

June 28, 2007, we have completed the 

initial surveys of all transplant programs 

that participate or seek participation in 

Medicare (approximately 845 transplant 

centers in 245 transplant hospitals), and 

have started conducting re-approval 

surveys. The current process and 

regulatory criteria require, under 

particular conditions, an automatic 

onsite review of all CoPs under a 3-year 

re-approval cycle. Despite this 

requirement, we believe that onsite 

surveys for some of these transplant 

centers are not necessary to ensure the 

health and safety of the patients who 

receive a transplant in those centers. 

Moreover, the regulatory requirements 

described below for selecting the 

facilities that would undergo an onsite 

survey do not always effectively target 

survey resources where they are most 

needed. 

We propose to remove the automatic 

3-year re-approval process. We also 

propose to (1) clarify that the review of 

mitigating factors may occur at any time 

if there is non-compliance with the 

CoPs, and (2) remove language stating 

that a transplant program is approved 

for three years, which conflicts with 

language in § 488.61(c) specifying that 

compliance with the CoPs is a 

continuous requirement. The 

expectation that compliance with CMS 

requirements is continuous is an 

expectation that applies to all Medicare 

providers and suppliers. 

Currently the regulations require that 

we review each transplant program’s 

data before the end of 36 months after 

the program’s prior approval. The 

regulations require a review of most 

other CoPs if we find that there is noncompliance with the requirements at 

§ 482.82(a) for timeliness of data 

submission to the OPTN, or noncompliance with the requirements at 

§ 482.82(b) for clinical experience, or at 

§ 482.82(c) for patient and graft survival 

outcomes. An onsite survey is the most 

common method of conducting such a 

review, but we have found that an 

onsite review for deficiencies in these 

areas is not always necessary. We can 

enforce data submission requirements 

without conducting an onsite survey. In 

addition, we plan to maintain, via CMS 

policy, a maximum time interval within 

which we expect an onsite survey to 

occur with respect to individual 

transplant centers. 

For instance, CMS regulations require 

that transplant programs submit 95 

percent of their OPTN forms within 90 

days of their due date. On a quarterly 

basis, we receive data from the OPTN 

that provides us with the number of 

forms due for each program and the 

number that were submitted within the 

required timeframe. Based on the 3-year 

period from mid-2008 through mid2011, 73 transplant programs had data 

submission rates below 95 percent and, 

if due for re-approval, would have 

required an onsite survey. Of these 73, 

most (43 programs) had average datasubmission rates between 90 and 95 

percent. While remedial action is 

necessary in every case, it does not 

follow that these 43 programs required 

an automatic, onsite survey. We propose 

that we can take action to address the 

non-compliance while reserving for 

CMS’s discretion the decision of 

whether or not to conduct an onsite 

survey. 

We also receive data on a quarterly 

basis about the number of transplants 

performed at each center. Because of 

this data transfer, we are routinely 

aware of the average number of 

transplants being performed by or at a 

given transplant program. There are 

circumstances where it would not be in 

the public interest to spend the 

resources to perform a full onsite 

transplant center survey solely because 

the 3-year average volume is low. For 

example, if a transplant program had 

performed an average of 9.3 transplant 

surveys over the prior 3-year period 

(fewer than the current requirement of 

an average of 10 per year), and the most 

recent year indicated 14 transplants 

performed, sending a full team to do an 

onsite survey of all CoPs, for this reason 

alone, may not make the best use of 

limited resources for the hospital or for 

CMS. 

Of the approximately 845 total 

transplant programs, 442 are required to 

meet clinical experience requirements 

(that is, volume requirements). Pediatric 

transplant programs and adult heart/ 

lung and adult pancreas programs do 

not have to meet clinical experience 

requirements (§§ 482.80(d) and 

482.82(d)). Using clinical experience 

data from October 1, 2008 through 

September 30, 2011, 30 transplant 

programs that were required to meet 

experience requirements had performed 

fewer than the required number of 10 

transplants per year on average. If due 

for re-approval, these 30 programs 

would have required an onsite survey 

regardless of any other evidence CMS 

may have had from history, recent 

program improvements, or the most 

recent clinical experience. 

We monitor and enforce Medicare’s 

requirements for patient and graft 

survival rates every 6 months based on 

the most recent report from the SRTR. 

A program is out of compliance if its 

observed patient and graft survival is 

significantly lower than expected to 

such an extent that it crosses three 

thresholds outlined in the CoPs at 

§ 482.82: the observed minus expected 

is greater than 3, the observed divided 

by expected is greater than 1.5, and the 

one-sided p-value is less than .05. 

We follow up with these transplant 

programs through an offsite survey, an 

onsite complaint survey, or an onsite 

full re-approval survey. These follow-up 

activities are conducted by the CMS 

Regional Office, a federal contractor, or 

the State Survey Agency (acting on 

CMS’s behalf). The follow-up occurs at 

the time of non-compliance and does 

not wait until the re-approval survey 

occurs. Following the citation of an 

outcomes deficiency and the 

establishment of a date for prospective 

termination from Medicare 

participation, programs may submit an 

application for mitigating factors (MF) 

based on non-compliance with the 

outcomes CoP. We provide ample time 

between the citation and the 

prospectively scheduled Medicare 

termination date for the program to 

provide evidence and, via conference 

call, discussion of the evidence that 

would support the mitigating factors 

request. If the MF request is approved, 

we specify the time period for the MF 

approval and remove the prospectively 

scheduled Medicare termination. 

We also propose to provide at the new 

§ 488.61(c)(3)(v) an example of a set of 

mitigating factors that we would 

consider. We have granted a very small 

number of MF requests on the basis of 

the categories currently used as 

examples in the regulation, such as 

natural disasters (one case) or access to 

care (one case). However, we have most 

frequently granted MF requests in cases 

where the transplant center has 

implemented substantial program 

improvements that address root causes 

of past graft failures and/or patient 

deaths, has institutionalized those 

improvements so they may be sustained 

over time, and has been able to 

demonstrate recent outcomes data with 

sufficient volume and with sufficient 

post-transplant survival periods such 

that we conclude that the program is in 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9227 

present-day compliance with the 

outcomes requirements in the 

regulation, but for the data time lag 

inherent in the SRTR reports upon 

which we otherwise rely. CMS has 

approved an MF request for 35 

transplant programs on this basis since 

the implementation of the regulation in 

2007. In certain cases, the MF approval 

has been made possible pursuant to 

dialogue and agreement between CMS 

and the transplant center that the 

hospital will engage in a clear regimen 

of quality improvement and there is 

substantial completion of that regimen. 

We believe that the addition of this 

example in the body of the regulation 

will provide better guidance for 

transplant centers, offer encouragement 

for the productive application of 

hospital staff expertise in making 

program improvements that increase 

patient and graft survival, and promote 

government transparency. 

We have a variety of sources we use 

to generate targeted quality information 

that can be used to determine the 

circumstances and frequency under 

which an onsite survey is best 

conducted. Examples include previous 

complaint surveys, prior onsite survey 

results, issues found during surveys of 

the broader hospital CoPs, data and 

information from the Health Resources 

and Services Administration (HRSA) 

and the SRTR, notifications of program 

inactivity, key personnel changes, 

articles from the press about quality 

issues, and information submitted by 

the program through the MF process. 

5. Technical Corrections 

On May 31, 2006, we published the 

Conditions for Coverage for Organ 

Procurement Organizations (OPOs) 

Final Rule (OPO final rule 71 FR 30982). 

We have discovered that there were 

some technical errors in that rule. 

Therefore, we are proposing to make the 

following technical corrections: 

• Section 486.306 states, in paragraph 

(a), that ‘‘An OPO must make available 

to CMS documentation verifying that 

the OPO meets the requirements of 

paragraphs (b) through (d) of this 

section * * * ’’ This section only 

contains paragraphs (a), (b), and (c). We 

propose to delete the reference to ‘‘(d)’’ 

in paragraph (a) and insert ‘‘(c)’’ in its 

place. This paragraph would then read, 

‘‘the OPO meets the requirements of 

paragraphs (b) and (c) of this section 

* * *.’’ 

• Section 486.308(b)(1) reads, in part, 

‘‘if additional time is needed to select a 

successor OPO to an OPO that has been 

de-certified.’’ We propose to remove the 

‘‘to’’ between the two ‘‘OPOs’’ and 

replace it with ‘‘for’’ in this sentence. 

The paragraph would then read, ‘‘if 

additional time is needed to select a 

successor OPO for an OPO that has been 

de-certified.’’ 

• Section 486.344(d)(2)(ii) reads, in 

part, ‘‘If the identify of the intended 

recipient is known * * * ’’ We intended 

to say the ‘‘identity’’ of the intended 

recipient. We propose to remove the 

word ‘‘identify’’ and replace it with 

‘‘identity.’’ The clause would then read, 

‘‘If the identity of the intended recipient 

is known * * * ’’ 

Contact for all transplant center and 

OPO topics: Diane Corning, 410–786– 

8486. 

E. Long-Term Care Facilities 

On August 13, 2008, we published a 

final rule requiring all buildings 

containing long term care facilities to 

have automatic sprinkler systems 

installed throughout the building (73 FR 

47075). The deadline for meeting this 

requirement is August 13, 2013. The 

final rule was based on a CMS analysis 

of fire safety in nursing homes, and the 

agency’s conclusion that fire safety 

protections would clearly be improved 

by ensuring that all facilities be fully 

sprinklered within a reasonable period 

of time. The Government Accountability 

Office (GAO) also studied this issue and 

issued a report entitled ‘‘Nursing Home 

Fire Safety: Recent Fires Highlight 

Weaknesses in Federal Standards and 

Oversight’’ (GAO–04–660, July 16, 2004, 

http://www.gao.gov/products/GAO-04- 

660). The GAO analyzed two long term 

care facility fires in 2003 that resulted 

in 31 total resident deaths. The report 

examined Federal fire safety standards 

and enforcement procedures, as well as 

results from the fire investigations of 

these two incidents. The report 

recommended that fire safety standards 

for unsprinklered facilities be 

strengthened and cited sprinklers as the 

single most effective fire protection 

feature for long term care. Based on both 

CMS’s analysis and the GAO’s report, 

and under the Secretary’s authority at 

sections 1819(d)(4)(B) and 1919(d)(4)(B) 

of the Act, to issue regulations that 

promote the health and safety of the 

residents of long-term care facilities, we 

finalized a requirement that all long 

term care facilities must be fully 

sprinklered by August 13, 2013. 

Based on recent public comments and 

input, we believe that some facilities 

will not be able to meet the August 2013 

deadline due to the magnitude of the 

enterprise they are undertaking (such as 

large scale construction of a 

replacement facility) combined with 

recent financial and construction 

constraints. We therefore propose to 

allow a long term care facility to apply 

for a temporary deadline extension of 

the sprinkler system requirement, under 

very limited circumstances, if they are 

unable to meet the deadline. An 

extension will avoid spending funds on 

structures that will be obsolete in the 

near future. Our intent is to establish a 

rigorous review process for all deadline 

extension requests. 

We are proposing to add a provision 

at § 483.70(a)(8)(iii) that would allow 

long term care facilities the opportunity 

to apply for a deadline extension, not to 

exceed 2 years, if all of the following 

conditions apply: 

• The facility is in the process of 

replacing its current building, or 

undergoing major modifications in all 

unsprinklered living areas and that 

requires the movement of corridor, 

room, partition, or structural walls or 

supports to improve the living 

conditions for residents, in addition to 

the installation of a sprinkler system; 

• The facility demonstrates that it has 

made the necessary financial 

commitments to complete the building 

replacement or modification; 

• The facility has submitted 

construction or modification plans to 

the State and local authorities that are 

necessary for approval of the 

replacement building or modification 

prior to applying for the deadline 

extension; and 

• The facility agrees to complete 

interim steps to improve fire safety of 

the building while the construction is 

being completed, as determined by 

CMS. This could include a fire watch, 

installation of temporary exits and 

temporary smoke detection systems, or 

additional smoke detection systems in 

the area of construction, increased fire 

safety inspections, additional training 

and awareness by staff, and additional 

fire drills. 

An extension may be granted for up 

to 2 years, depending on the need and 

particular circumstances. We would 

determine the length of the extension 

based on the information submitted by 

the facility. 

Applications for the extension will 

only be considered if the delay in 

meeting the August 13, 2013 deadline is 

due to the plan for facility replacement 

or major modification, as described 

above. A number of facilities, for 

example, have had plans to replace an 

old structure with a new replacement 

nursing home, but have found that it is 

requiring more time to complete the 

necessary arrangements and 

construction. The nursing home’s 

residents will benefit from the improved 

living environment of the new facility, 

and an extension of the deadline could 

avoid wasting funds on sprinklering an 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9228 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

old structure that will soon be replaced. 

Similarly, nursing home residents may 

benefit from a nursing home that is 

undertaking a major modification to 

improve living conditions, such as 

converting two-person or three-person 

rooms to single occupancy. If there is a 

delay due to such plans, and the 

construction is cost-effective if the 

sprinklering is done at the same time as 

the major modification of the 

unsprinklered area, then we would 

consider an extension of the deadline 

date. We are soliciting public comment 

as to whether the extension should be 

limited to just situations in which a 

replacement facility is being 

constructed. We are also soliciting 

public comment regarding these or other 

factors that may be important when 

determining whether to approve or deny 

an extension request, and when 

determining the appropriate length of 

the extension time period. However, it 

is our intent to fashion an extension that 

is very narrowly defined. The current 

rule has provided a five-year 

implementation period designed to 

ensure time for planning and resource 

mobilization. We propose to add the 

possibility of a time-limited extension 

in order to accommodate plans for major 

investments by a nursing home in a 

replacement facility or major 

modification where the investment, 

planning, and construction time 

involved may warrant a further 

extension and yield even better long 

term benefits for residents. We also 

propose to add a provision at 

§ 483.70(a)(8)(iv) that would allow for a 

renewal of the deadline extension for an 

additional period, not to exceed 1 

additional year. We propose that a 

facility could only apply for a single 

extension renewal. The facility may be 

granted the additional extension if CMS 

finds that there are extenuating 

circumstances beyond the control of the 

facility that will prevent the facility 

from being in compliance by the end of 

the first waiver period. An example is 

a situation where residents have not yet 

been able to move to a substantially 

completed replacement facility due to 

last minute construction delays outside 

the control of the facility. Additionally, 

the facility would be required to meet 

all other conditions in paragraph 

(a)(8)(iii) related to applying for the 

approval by CMS, submitting its plans 

to the State and local authorities, and 

taking the appropriate interim steps to 

improve safety of the building until the 

work is completed. We also welcome 

comments on this proposed provision. 

Contact for long term care topics: 

Kristin Shifflett, 410–786–4133. 

F. Rural Health and Primary Care 

We have identified several priority 

areas in the CoPs for CAHs (42 CFR part 

485), the CfCs for both RHCs and FQHCs 

(42 CFR part 491), and the payment 

provisions for RHCs (42 CFR part 405) 

for updates and revisions. We believe 

that these proposed revisions may 

eliminate or significantly reduce burden 

where CoPs and CfCs are duplicative, 

unnecessary and/or burdensome. 

1. CAH Provision of Services 

(§ 485.635(a)) 

CAHs are currently required to 

develop their policies and procedures 

with the advice of a group of 

professional personnel that includes one 

or more doctors of medicine or 

osteopathy and one or more physician 

assistants, nurse practitioners, or 

clinical nurse specialists, if they are on 

staff. At least one member of the 

professional group must not be a staff 

member. We propose to remove the 

requirement that a CAH must develop 

its patient care policies with the advice 

of a non-CAH staff member and instead 

are proposing to allow CAHs flexibility 

in their approach to developing their 

patient care policies and procedures. 

That is, we are proposing that a CAH 

will no longer be required to include a 

non-staff member among the group of 

professional personnel to develop its 

patient care policies. We believe that 

this provision is no longer necessary 

and that the original reasons (lack of 

local resources and in-house expertise) 

for including this requirement have 

been effectively addressed. Also, based 

on our experience with CAHs and input 

from the provider community, we 

believe it is a challenge for facilities to 

comply with this requirement. These 

challenges include the amount of time 

it takes to familiarize the non-staff 

member with the CAH’s operations, 

high turnover rates of the non-staff 

member, and, in many cases, the 

expense of paying outside personnel a 

consultation fee. 

In 1993, when we finalized the rules 

on the predecessor to the current CAH 

program, Essential Access Community 

Hospitals (EACHs) and Rural Primary 

Care Hospitals (RPCHs) (58 FR 30630, 

May 26, 1993), we declined to expand 

the policy planning requirements at 

§ 485.635 in a way that would have been 

more prescriptive and would have 

required additional sources of expertise 

and objectivity. At that time, we 

determined that it was not necessary to 

require the RPCHs to consult with rural 

health networks or to ensure alignment 

with their State’s rural health plan when 

deciding which services to furnish. In 

responding to comments suggesting 

such coordination, we remarked that 

while such coordination was desirable, 

no statute actually mandated this, and 

clinics were already free to work out 

such arrangements without regulation. 

Subsequently, changes were made to 

the law which responded exactly to 

those concerns. The Balanced Budget 

Act (BBA) of 1997 amended the Act at 

Section 1820 (42 U.S.C. 1395i–4) and 

replaced the EACH/RPCH program with 

the Medicare Rural Hospital Flexibility 

Program (MRHFP). These changes 

established the CAH program we know 

today, and, importantly, predicated a 

State’s eligibility to participate in the 

program on its establishment of a State 

rural health plan providing for the 

creation of one or more rural health 

networks in that State. As set forth in 

the BBA of 1997, codified at § 1820(b) 

of the Act, a State’s rural health plan 

must promote regionalization of rural 

health services and improved access to 

hospital and other health services for 

that State’s rural residents. Moreover, it 

must be developed in consultation with 

the hospital association of the State, 

rural hospitals located in the State, and 

the State Office of Rural Health. 

The plan must also provide for the 

creation of at least one rural health 

network. A rural health network is an 

organization consisting of at least one 

CAH and at least one acute care 

hospital, the members of which have 

entered into agreements regarding 

patient referral and transfer, the 

development and use of 

communications systems, and the 

provision of emergency and 

nonemergency transportation. In 

addition, each CAH in a network must 

have an agreement for credentialing and 

quality assurance with at least one 

hospital that is a member of the 

network, or with a QIO or equivalent 

entity, or with another appropriate and 

qualified entity identified in the rural 

health care plan for the State. Taken 

together, the statutory requirements for 

a State rural health plan and (at least 

one) rural network, these mechanisms 

set out specific processes that serve to 

promote and support the sound 

development of a CAHs’ patient care 

policies, such as are required at 

§ 485.635. The additional statutory 

framework, established in the years 

since these regulations were first set 

forth, provides further support for our 

proposal to set aside the regulatory 

requirement that a CAH’s patient care 

policies require the input of at least one 

professional who is not a member of the 

CAH’s staff. Therefore, we propose to 

remove the statement at the end of 

§ 485.635(a)(2) that states, ‘‘* * * at 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9229 

least one member is not a member of the 

CAH staff.’’ 

2. CAH and RHC/FQHC Physician 

Responsibilities (§§ 485.631(b)(2) and 

491.8(b)(2)) 

Except in extraordinary 

circumstances, a physician is required 

under §§ 485.631(b)(2) and 491.8(b)(2) 

to be present in the CAH, RHC or FQHC 

for sufficient periods of time, meaning 

at a minimum at least once in every 2- 

week period, to provide medical 

direction, medical care services, 

consultation and supervision of other 

clinical staff. The regulation further 

requires a physician to be available 

through telecommunication for 

consultation, assistance with medical 

emergencies or patient referral. Section 

1861(aa)(2)(B) of the Act requires 

supervision, guidance, and a periodic 

physician review of covered services 

furnished by physician assistants and 

nurse practitioners in an RHC or an 

FQHC but it does not prescribe the 

frequency of the physician visits nor 

does it require onsite supervision. 

Section 1820(c)(2)(B)(iv) of the Act 

requires a CAH to provide physician 

oversight by a doctor of medicine (MD) 

or a doctor of osteopathy (DO) for 

inpatient care that is provided by a 

physician assistant (PA), nurse 

practitioner (NP), or clinical nurse 

specialist (CNS). The statute does not 

require the physician to be physically 

present in the facility to provide the 

required oversight. 

Some providers in extremely remote 

areas or areas that have geographic 

barriers have indicated that they find it 

difficult to comply with the precise 

biweekly schedule requirement. Many 

rural populations suffer from limited 

access to care due to a shortage of health 

care professionals, especially 

physicians. Oftentimes, non-physician 

practitioners provide these important 

care services to rural communities with 

physicians providing oversight. We 

believe that specifying a specific 

timeframe for a physician to visit the 

facility does not ensure better health 

care. With the development of 

technology that facilitates 

‘‘telemedicine,’’ a physician should 

have the flexibility to utilize a variety of 

ways and timeframes to provide medical 

direction, consultation, supervision, and 

medical care services, including being 

on-site at the facility. For example, a 

physician supervising a RHC or FQHC 

might visit the facility more frequently 

than biweekly during peak seasons for 

certain illnesses and make less frequent 

visits during other times of the year. 

Among CAHs there is great variation 

in the size of the populations they serve 

and the range and extent of services 

they offer. We do not believe that a onesize-fits-all requirement as found in the 

current regulation is appropriately 

responsive to this variation. In the case 

of very small CAHs in frontier areas that 

offer very limited services and have 

only one physician on staff, the 

requirement for an onsite visit at least 

every 2 weeks may be unduly 

burdensome. On the other hand, for 

CAHs that offer a wide range of complex 

services, have more than one physician 

on staff, and have busy emergency 

departments and/or extensive outpatient 

services, a visit by a physician only 

once every 2 weeks could well be 

grossly inadequate. By eliminating the 

required 2-week visit, we believe CAHs 

will have the flexibility to determine the 

appropriate frequency of physician 

visits. 

We therefore propose to revise the 

CAH regulations at § 485.631(b)(2) and 

the RHC/FQHC regulations at 

§ 491.8(b)(2) to eliminate the 

requirement that a physician must be 

onsite at least once in every 2-week 

period (except in extraordinary 

circumstances) to provide medical care 

services, medical direction, consultation 

and supervision. For CAHs, we propose 

that a doctor of medicine or osteopathy 

would be present for sufficient periods 

of time to provide medical direction, 

consultation and supervision for the 

services provided in the CAH, and is 

available through direct radio or 

telephone communication for 

consultation, assistance with medical 

emergencies, or patient referral. For 

RHCs and FQHCs, we propose that 

physicians would periodically review 

the clinic or center’s patient records, 

provide medical orders, and provide 

medical care services to the patients of 

the clinic or center. 

We believe that proposing language to 

remove these barriers will enhance 

patient access to care in rural and 

remote areas. We note that the present 

review requirements at 

§ 485.631(b)(1)(v) can be fulfilled by a 

physician working from a remote 

location. 

3. RHC/FQHC Definitions: Physician 

(§ 491.2) 

We propose to expand the definition 

of ‘‘physician’’ at § 491.2 in a way that 

mirrors the definition of ‘‘physician’’ 

that appears under the rules governing 

payment and Medicare agreements in 

Part 405 at § 405.2401(b). We believe 

that this change will provide clarity to 

the supplier community with respect to 

the requirements for RHCs and FQHCs. 

We propose to revise the definition as 

follows: Physician means a practitioner 

who meets the requirements of sections 

1861(r) and 1861(aa)(2)(B) and (aa)(3)(B) 

of the Act and includes (1) a doctor of 

medicine or osteopathy legally 

authorized to practice medicine and 

surgery by the State in which the 

function is performed; and (2) within 

limitations as to the specific services 

furnished, a doctor of dental surgery or 

of dental medicine, a doctor of 

optometry, a doctor of podiatry or 

surgical chiropody or a chiropractor (see 

section 1861(r) of the Act for specific 

limitations). 

4. Technical Correction 

We propose to correct a technical 

error in the regulations by amending 

§ 491.8(a)(6) to conform to section 

6213(a)(3) of OBRA ’89 (Pub. L. 101– 

239) which requires that an NP, PA, or 

certified nurse-midwife (CNM) be 

available to furnish patient care at least 

50 percent of the time the RHC operates. 

We welcome public comments on this 

correction and on the other changes 

proposed for rural health care providers 

and suppliers. 

Contacts for rural health and primary 

care CoP/CfC issues: Mary Collins, 410– 

786–3189; Sarah Richardson 

Fahrendorf, 410–786–3112. 

G. Solicitation of Comment on Reducing 

Barriers to Services in Rural Health 

Clinics (RHCs) 

We are requesting comment on 

potential changes we could make to 

regulatory or other requirements to 

reduce barriers to the following services: 

1. Telehealth Services 

RHCs that are located in a rural 

Health Professional Shortage Area 

(HPSA) or in a county outside of a 

Metropolitan Statistical Area (MSA) are 

authorized by law to be telehealth 

originating sites (the location of an 

eligible Medicare beneficiary at the time 

the service being furnished via a 

telecommunications system occurs). 

However, RHCs are not authorized to be 

distant site providers (practitioners 

furnishing covered telehealth services). 

Authorized distant site providers 

include physicians, NPs, PAs, CNMs, 

clinical nurse specialists (CNSs), CPs, 

CSWs, and registered dietitians or 

nutrition professionals. 

Although RHC practitioners are 

eligible to furnish and bill for telehealth 

distant site services when they are not 

working at the RHC, they cannot furnish 

and bill for telehealth services as an 

RHC practitioner because RHCs are not 

authorized distant site providers. Also, 

these practitioners cannot bill Medicare 

Part B while they are working for a 

Medicare RHC since Medicare is paying 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9230 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

the RHC through the Medicare RHC cost 

report an all-inclusive rate per visit that 

includes all direct and indirect costs, 

such as the practitioner’s services, space 

to provide those services, support staff 

services, related supplies, records costs, 

and other services. To allow separate 

Medicare Part B physician fee schedule 

payment to a practitioner while that 

practitioner is working for the RHC 

would result in duplicate Medicare 

payment for the telehealth service; once 

through the Medicare RHC cost report 

and again through the Medicare Part B 

physician fee schedule payment. 

We are interested in exploring ways to 

allow RHC practitioners to furnish 

distant site telehealth services in a way 

that will not result in duplicate 

payment, especially for services such as 

mental health services, which are 

particularly limited in rural areas. 

Therefore, we are requesting comments 

on potential changes we could make to 

Medicare Provider Reimbursement 

Principles contained in Health 

Insurance Manual 15–1, Medicare RHC 

cost report/instructions contained in 

Health Insurance Manual 15–2, and 

other Medicare policies that would 

allow RHCs to furnish telehealth 

services. Commenters should address 

how any suggestions for changes or 

exceptions would prevent duplicate 

payment—that is, ensure Medicare is 

not paying for the same costs to the RHC 

on the basis of allowable cost and the 

physician fee schedule under the 

telehealth benefit. We are particularly 

interested in comments that address 

these concerns without adding undue 

additional cost reporting and 

compliance burdens on RHCs to ‘‘carve 

out’’ or separate those costs that would 

otherwise be paid under the RHC 

benefit when Medicare is making 

physician fee schedule payments. Given 

the interest in encouraging the provision 

of mental health services in rural areas, 

we are interested in comments 

addressing whether changes should 

apply to all services that could 

potentially be provided through 

telehealth or only specific services such 

as mental health. If commenters believe 

these changes should only apply to 

specific services, we are interested in 

which services should be subject to 

these special rules and a policy 

justification for why these services are 

different than other services that could 

potentially be subject to special 

commingling rules. 

2. Hospice Services 

The hospice statute (section 1861(dd) 

of the Act) authorizes physicians and 

NPs to be attending physicians for 

Medicare beneficiaries that elect the 

Medicare hospice benefit. RHCs are not 

statutorily authorized to be hospice 

providers, and can only treat hospice 

beneficiaries for medical conditions not 

related to their terminal illness. 

In some rural areas, the RHC may be 

the only source of health care in the 

community, and there may be no other 

providers available during RHC hours to 

provide services that are related to a 

beneficiary’s terminal illness. While 

RHC practitioners are eligible to furnish 

and bill for hospice services when they 

are not working at the RHC, they cannot 

furnish and bill for hospice services as 

an RHC practitioner because RHCs are 

not authorized to be attending 

physicians for hospice. Also, these 

practitioners cannot bill Medicare Part B 

while they are working for a Medicare 

RHC since Medicare is paying the RHC 

through the Medicare RHC cost report 

an all-inclusive rate per visit that 

includes all direct and indirect costs, 

such as the practitioner’s services, space 

to provide those services, support staff 

services, related supplies, records costs, 

and other services. To allow separate 

Medicare Part B physician fee schedule 

payment to a practitioner while that 

practitioner is working for the RHC 

would result in duplicate Medicare 

payment for the hospice service; once 

through the Medicare RHC cost report 

and again through the Medicare Part B 

physician fee schedule payment. 

We are interested in exploring ways to 

allow RHC practitioners to furnish 

hospice services in a way that will not 

result in duplicate payment, especially 

in areas with limited hospice providers. 

Therefore, we are requesting comments 

on potential changes we could make to 

Medicare Provider Reimbursement 

Principles contained in Health 

Insurance Manual 15–1, Medicare RHC 

cost report/instructions contained in 

Health Insurance Manual 15–2, and 

other Medicare policies that would 

allow RHCs to furnish hospice services. 

Commenters should address how any 

suggestions for changes or exceptions 

would prevent duplicate payment—that 

is, ensure Medicare is not paying for the 

same costs to the RHC on the basis of 

allowable cost and the physician fee 

schedule under the hospice benefit. We 

are particularly interested in comments 

that address these concerns without 

adding undue additional cost reporting 

and compliance burdens on RHCs to 

‘‘carve out’’ or separate those costs that 

would otherwise be paid under the RHC 

benefit when Medicare is making 

hospice payments. 

3. Home Health Services 

RHCs that are located in an area in 

which there exists a shortage of home 

health agencies are authorized to 

provide nursing care furnished by a 

registered nurse or a licensed practical 

nurse to a homebound individual. The 

care must be provided under a written 

treatment plan that is established and 

periodically reviewed by a physician, 

NP, or PA. 

Despite the authority for RHCs to 

provide home health services, there are 

relatively few RHCs that provide this 

service. We are seeking data and 

comments on (a) The need for home 

health services in communities served 

by RHCs; (b) barriers to providing these 

services, (c) data regarding any 

difficulties beneficiaries face in 

accessing home health services in those 

communities or any shortages in home 

health agencies; and (d) possible 

strategies to reduce or eliminate the 

identified barriers that comply with our 

legislative authority and the need for 

administrative accountability. 

4. Other Services 

We welcome comments on other 

services that RHCs would like to 

provide but are not able to do so. Please 

include an explanation of why the 

service is needed, the barriers to 

providing the service, and possible 

solutions that comply with our 

legislative authority and the need for 

administrative accountability. 

Contact for RHC Comments: Corinne 

Axelrod, (410) 786–5620. 

H. Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) 

On October 31, 1988, Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA), Public Law 100–578. The 

purpose of CLIA is to provide quality 

standards for laboratory testing to 

ensure the accuracy and reliability of 

laboratory test results for all Americans. 

Under the authority of 42 U.S.C. 263a(f), 

the Secretary issued regulations 

implementing CLIA on February 28, 

1992 at 42 CFR part 493 (57 FR 7002). 

The regulations specify the standards 

and specific conditions that must be met 

to achieve and maintain CLIA 

certification. CLIA certification is 

required for all laboratories, including 

but not limited to those that participate 

in Medicare and Medicaid, which test 

human specimens for the purpose of 

providing information for the diagnosis, 

prevention, or treatment of any disease 

or impairment, or the assessment of 

health, of human beings. 

The regulations also require 

laboratories conducting moderate or 

high-complexity testing to enroll in an 

approved proficiency testing (PT) 

program that covers all of the specialties 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9231 

and sub-specialties for which the 

laboratory seeks certification. There are 

currently 229,815 CLIA certified 

laboratories. Of these laboratories, 

35,084 are required to enroll in an HHSapproved PT program and are subject to 

all PT regulations. 

Congress emphasized the importance 

of PT when it drafted the CLIA 

legislation. For example, the Committee 

on Energy and Commerce report from 

Sept. 9, 1988 (100th Congress 2nd 

Session, House of Representatives, 

Report 100–899, page 15, Identified 

Problems and Concerns) noted that 

‘‘The Committee’s investigation focused 

particularly on proficiency testing 

because it is considered one of the best 

measures of laboratory performance. It 

is arguably the most important measure, 

since it reviews actual test results rather 

than merely gauging the potential for 

good results.’’ The Committee surmised 

that, left to their own devices, some 

laboratories would be inclined to treat 

PT samples differently than their patient 

specimens, as they would know that the 

laboratory would be judged on its 

performance. For example, such 

laboratories might be expected to 

perform repeated tests on the PT 

sample, use more highly qualified 

personnel than are routinely used for 

such testing, or send the samples out to 

another laboratory for analysis. As such 

practices would undermine the purpose 

of PT, the Committee noted that the 

CLIA statute was drafted to bar 

laboratories from such practices, and to 

impose significant penalties on those 

who elected to violate those bars 

(H.R.Rep. No. 100–899, 100th Congress, 

2d Session, at 16 and 24, 1988 

U.S.C.C.A.N. 3828). 

We propose to make a number of 

clarifications and changes to the 

regulations governing PT under CLIA. 

PT is a valuable tool the laboratory can 

use to verify the accuracy and reliability 

of its testing. During PT, an HHSapproved PT program sends samples to 

be tested by a laboratory on a scheduled 

basis. After testing the PT samples, the 

laboratory reports its results back to the 

PT program for scoring. Review and 

analysis of PT reports by the laboratory 

director will alert the director to areas 

of testing that are not performing as 

expected and may also indicate subtle 

shifts or trends that, over time, could 

affect patient results. As there is no onsite, external proctor for PT testing in a 

laboratory, the testing relies in large part 

on an honor system. The PT program 

places heavy reliance on each laboratory 

and laboratory director to self-police 

their analysis of PT samples to ensure 

that the testing is performed in 

accordance with the CLIA requirements. 

For each PT event, laboratories are 

required to attest that PT samples are 

tested in the same manner as patient 

specimens are tested. PT samples are to 

be assessed by integrating them into the 

laboratory’s routine patient workload, 

and the testing itself is to be conducted 

by the personnel who routinely perform 

such testing, using the laboratory’s 

routine methods. The laboratory is 

barred from engaging in inter-laboratory 

communication pertaining to results 

prior to the PT program’s event cut-off 

date and must not send the PT samples 

or any portion of the PT samples to 

another laboratory for testing, even if it 

would send a patient specimen to 

another laboratory for reflex or 

confirmatory testing. 

By ‘‘reflex testing’’ we mean 

confirmatory or additional laboratory 

testing that is automatically requested 

by a laboratory under its standard 

operating procedures for patient 

specimens when the laboratory’s 

findings indicate test results that are 

abnormal, are outside a predetermined 

range, or meet other pre-established 

criteria for additional testing. For 

patient specimen testing, reflex testing 

may be legitimately performed by the 

same laboratory that performed the 

initial testing or may be performed by 

referral of the patient specimen for 

testing at a laboratory operating under a 

different CLIA certificate. For PT, reflex 

testing is prohibited unless it is 

performed by the same laboratory that 

performed the initial testing, is included 

in its standard operating procedure, and 

the results are reported as part of the 

proficiency testing program. 

By ‘‘confirmatory testing’’, we mean 

testing performed by a second analytical 

procedure that could be used to 

substantiate or bring into question the 

result of an initial laboratory test. For 

patient specimen testing, confirmatory 

testing may legitimately be performed 

by the same laboratory that performs the 

initial test or by a second laboratory 

operating under a different CLIA 

certificate than the laboratory 

performing the initial testing. For PT, 

confirmatory testing is prohibited unless 

it is performed by the same laboratory 

that performed the initial test, is 

included in its standard operating 

procedure, and the results are reported 

as part of the proficiency testing 

program. 

Any laboratory that we determine 

intentionally referred its PT samples to 

another laboratory for analysis may have 

its certification revoked for at least one 

year. The phrase ‘‘intentionally 

referred’’ has not been defined by the 

statute or regulations, but we have 

consistently interpreted this phrase 

from the onset of the program to mean 

general intent, as in intention to act. 

Whether or not acts are authorized or 

even known by the laboratory’s 

management, a laboratory is responsible 

for the acts of its employees. Among 

other things, laboratories need to have 

procedures in place and train employees 

on those procedures to prevent staff 

from forwarding PT samples to other 

laboratories even in instances in which 

they would normally forward a patient 

specimen for reflex or confirmatory 

testing. 

PT samples are not to be referred to 

another laboratory under any 

circumstances. However, despite the 

issuance of considerable guidance and 

the near universal inclusion of 

instructions in laboratory operations 

manuals, there continue to be cases 

where PT samples are forwarded to 

another laboratory for analysis. 

Laboratory staff are either not being 

made aware that the prohibition applies 

even in instances where they would 

normally forward a patient specimen for 

additional testing, or, due to failures in 

training or the clarity of laboratory 

operating manuals, they fail to abide by 

the laboratory’s written policies 

prohibiting the referral of PT samples to 

another laboratory. 

For example, some laboratories have 

indicated that they have been confused 

by the requirement at § 493.801(b) that 

laboratories treat PT samples in the 

same manner as patient specimens. If 

their standard operating procedure is for 

some types of patient specimens to be 

sent to another laboratory for reflex or 

confirmatory testing, they have 

erroneously believed that there would 

be a basis for also referring a PT sample. 

They have strenuously argued that their 

mistaken interpretation was innocent, 

and that we should find an improper, 

but not intentional, referral of a PT 

sample in those instances. 

We disagree with any assertions that 

such referrals are ‘‘improper’’ but not 

‘‘intentional’’ under our longstanding 

interpretation of ‘‘intentional’’. As noted 

above, we have consistently interpreted 

‘‘intentional’’ to mean general intent, as 

in intention to act, and expansive case 

law has supported this interpretation. 

That said, we recognize that, in cases of 

a PT referral involving reflex or 

confirmatory testing under standard 

operating procedures, the revocation of 

a CLIA certificate, combined with the 

resulting potential prohibition on the 

owner and operator to own or operate a 

laboratory for 2 years, may create access 

issues for patients in need of laboratory 

services. We also note that laboratory 

testing protocols have changed over 

time and reflex or confirmatory testing 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9232 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

has become more prevalent, resulting in 

an increased risk of PT referral. 

We are mindful that all healthcare 

beneficiaries depend on a functioning 

PT program conducted in accordance 

with the regulations and statute to 

ensure that laboratories provide 

accurate and reliable test results; 

however, we recognize that human error 

can and does occur. For these reasons, 

we believe it would be appropriate to 

afford an infrequent and narrowly 

crafted carve-out from the long-standing 

interpretation of ‘‘intentional’’ to allow 

for the imposition of alternative 

sanctions when there is a single 

instance of PT referral related to reflex 

or confirmatory testing. Laboratories 

would still be obligated to provide staff 

with clear standard operating 

procedures and effective training for all 

current and newly hired employees, and 

must ensure continued compliance with 

those procedures to prevent PT referral. 

Repeat referrals, even if related to reflex 

or confirmatory testing, would be 

considered ‘‘intentional’’ and may be 

subject to the sanctions of revocation 

and ban against the owner and operator. 

A PT referral is a prohibited act and will 

always involve consequences. 

In addition to the already extensive 

campaign to highlight the bar on PT 

referrals, we have considered what more 

we could possibly do to further ensure 

laboratory awareness of this prohibition. 

We believe it would be appropriate to 

insert, into that part of the regulation 

that discusses the treatment of PT 

samples in the same manner as the 

laboratory would treat a patient 

specimen, a cross reference reminding 

laboratories that such treatment must 

not include referral of a PT sample to 

another laboratory. 

We therefore propose to make two 

changes to the CLIA regulations relevant 

to PT referral. The first would be to add 

a statement to § 493.801(b) to explicitly 

note that the requirement to treat PT 

samples in the same manner as patient 

specimens does not mean that it is 

acceptable to refer PT samples to 

another laboratory for testing even if 

that is the standard operating procedure 

for patient specimens. This means that 

in instances where the laboratory’s 

patient testing standard operating 

procedures would normally require 

reflex or confirmatory testing at another 

laboratory, the laboratory should treat 

the PT sample as they would a patient 

specimen up until the point they would 

typically refer a patient specimen to a 

second laboratory for any form of 

further testing. A PT sample must never 

be sent to another laboratory under any 

circumstances. 

The second proposed change would 

be to carve out a narrow exception in 

our longstanding interpretation of what 

constitutes an ‘‘intentional’’ referral. We 

note, however, that for all other 

instances in which a PT sample is 

referred, the standard for ‘‘intentional’’ 

would continue to be a general intent to 

act—that is, to send a PT sample to 

another laboratory for analysis. For the 

narrow exception to this general rule, 

we propose that when CMS determines 

that a PT sample was referred to another 

laboratory for analysis, but the 

requested testing was limited to reflex 

or confirmatory testing, then we would 

consider the referral to be improper and 

subject to alternative sanctions in 

accordance with § 493.1804(c), but not 

intentional, provided that, if the 

specimen were a patient specimen, the 

referral would have been in full 

conformance with written, legally 

accurate, and adequate standard 

operating procedures for the laboratory’s 

testing of patient specimens, and the PT 

referral is not a repeat PT referral. 

Alternative sanctions may include any 

combination of civil money penalties, 

directed plan of correction (such as 

required remedial training of staff), 

temporary suspension of Medicare or 

Medicaid payments, or other sanctions 

specified in accordance with regulation. 

By ‘‘full conformance’’ with the 

laboratory’s written, legally accurate 

and adequate standard operating 

procedures we mean that the procedures 

adequately describe what is to be done, 

and that what is to be done is in 

conformance with applicable laws (such 

as the ban on referring PT samples to 

another laboratory for analysis). 

Furthermore, we mean that the referral 

policy does not afford any discretion to 

staff as to whether a patient specimen 

would be forwarded or not. For 

example, standard operating procedures 

do not allow for selectivity on the part 

of the laboratory staff. Rather, they 

require the application of preestablished criteria that result in a 

mandate to forward a patient specimen 

to another laboratory for further 

analysis. For example, if standard 

laboratory protocols dictate that all 

specimens showing HIV-positive test 

results be sent to a second laboratory for 

confirmatory testing, but we find that 

the individual referred only 1 of the 2 

positive HIV PT samples, we would 

consider the referral to be not in 

conformance with the laboratory’s own 

standard operating procedure. In this 

instance, the laboratory may be subject 

to the sanctions of revocation and ban 

against the owner and operator as 

opposed to alternative sanctions. 

By providing that the referral is not a 

repeat PT referral, we mean that there 

has not been an instance of identified 

PT referral in the two survey cycles 

prior to the time of the PT referral in 

question. Two survey cycles generally 

equates to a four-year period on average. 

This is not a precise calendar time 

period but is carefully recorded as a 

matter of actual and documented survey 

event dates. Both CMS and accrediting 

organizations perform initial surveys at 

least 3 months but no later than 12 

months from the effective date of CLIA 

certification. Subsequent routine 

recertification surveys are performed 

biennially. A survey cycle means the 

time between an initial survey and 

recertification survey or the time 

between a recertification survey and the 

next recertification survey, and is 

approximately two years. The time 

interval from the effective date of the 

CLIA certificate until the initial 

certification is also included as part of 

the initial certification survey cycle. 

Complaint and validation surveys are 

performed on a non-routine basis, and 

are considered to be separate from 

survey cycles for the purpose of 

determining the timeframe for two 

survey cycles. 

In other words, a referral would not 

be considered ‘‘intentional’’ if the CMS 

investigation reveals PT samples were 

sent to another laboratory for reflex or 

confirmatory testing, it is not a repeat 

PT referral, and it occurred while acting 

in full conformance with the 

laboratory’s written, legally accurate 

and adequate standard operating 

procedure as outlined in this preamble. 

The key to this carve-out is the 

expectation that laboratories will ensure 

that improper referrals are addressed 

and eliminated, or we will find that 

future referrals are intentional. The 

carve-out is meant to be a one-time 

exception to a finding of an intentional 

referral by virtue of a general intent to 

forward a PT sample to another 

laboratory. Upon learning that the 

laboratory’s training materials, training, 

or staff capabilities are inadequate to 

ensure compliance with the PT referral 

requirements, we expect the laboratory 

to correct the problems, and will treat 

subsequent referrals as ‘‘intentional’’ in 

keeping with our longstanding 

practices. We believe that it is 

reasonable to expect laboratories to 

maintain a heightened vigilance for this 

time-frame to ensure that they do not 

have any repeated difficulties. We 

welcome public comments on these 

proposed changes. 

Furthermore, we note that the 

‘‘Taking Essential Steps for Testing Act 

of 2012’’ (Pub. L. 112–202), enacted on 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9233 

December 4, 2012, amends section 353 

of the Public Health Service Act to 

provide the Secretary with the 

discretion to substitute intermediate 

sanctions in lieu of the 2-year 

prohibition on the owner and operator 

when a CLIA certificate is revoked due 

to intentional PT referral, and to 

consider imposing alternative sanctions 

in lieu of revocation in such cases as 

well. We generally intend to undertake 

further rule-making to implement the 

Taking Essential Steps for Testing Act of 

2012, and invite comment on such 

action. In the meantime, since we are 

already proposing changes in this rule 

to § 493.801, we are proposing at this 

time to change the ‘‘will’’ to ‘‘may’’ in 

the second sentence of § 493.801(b)(4) to 

ensure that this section is in compliance 

with the Taking Essential Steps for 

Testing Act of 2012. 

Contact for CLIA issues: Melissa 

Singer, (410) 786–0365. 

III. Collection of Information 

Requirements 

This proposed rule does not impose 

any new information collection, 

recordkeeping or third-party disclosure 

requirements. However, this proposed 

rule would create certain savings related 

to information collection, recordkeeping 

or third-party disclosure requirements. 

While we detail all of the estimated 

savings of this proposed rule in the 

regulatory impact analysis, the 

following paragraph provides a brief 

summary of the estimated savings 

associated with the information 

collection request (ICR) approved under 

OMB control number 0938–1069. 

This proposed rule would reduce the 

reporting requirements for transplant 

centers and organ procurement 

organizations. As stated later in the 

regulatory impact analysis, we are 

proposing to eliminate the reporting 

requirement at 42 CFR 482.74(a)(2). The 

requirement is redundant as it is a 

duplication of data submission under 

the Paperwork Reduction Act. The same 

information is currently being collected 

by the Health Services and Resources 

Administration (HRSA). After the 

requisite notice and comment periods, 

we will submit a revision of the 

currently approved ICR for OMB review 

and approval. 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Regulatory Impact Analysis 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), the Regulatory Flexibility Act 

(RFA) (September 19, 1980, Pub. L. 96– 

354), section 1102(b) of the Social 

Security Act, section 202 of the 

Unfunded Mandates Reform Act of 1995 

(March 22, 1995; Pub. L. 104–4), 

Executive Order 13132 on Federalism 

(August 4, 1999) and the Congressional 

Review Act (5 U.S.C. 804(2). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). We 

estimate that this rulemaking is 

‘‘economically significant’’ as measured 

by the $100 million threshold, and 

hence also a major rule under the 

Congressional Review Act. Accordingly, 

we have prepared a Regulatory Impact 

Analysis (RIA) that, to the best of our 

ability, presents the costs and benefits of 

the rulemaking. 

A. Statement of Need 

In Executive Order 13563, the 

President recognized the importance of 

a streamlined, effective, efficient 

regulatory framework designed to 

promote economic growth, innovation, 

job creation, and competitiveness. To 

achieve a more robust and effective 

regulatory framework, the President has 

directed each executive agency to 

establish a plan for ongoing 

retrospective review of existing 

significant regulations to identify those 

rules that can be eliminated as obsolete, 

unnecessary, burdensome, or 

counterproductive or that can be 

modified to be more effective, efficient, 

flexible, and streamlined. This proposed 

rule continues our direct response to the 

President’s instructions in Executive 

Order 13563 by reducing outmoded or 

unnecessarily burdensome rules, and 

thereby increasing the ability of health 

care entities to devote resources to 

providing high quality patient care. 

B. Overall Impact 

This proposed rule would create 

ongoing cost savings to providers and 

suppliers in many areas. Other changes 

we have proposed would clarify existing 

policy and relieve some administrative 

burdens. We have identified other kinds 

of savings that providers and patients 

will realize throughout this preamble. 

The financial savings are summarized in 

the table that follows. We welcome 

public comments on all of our burden 

assumptions and estimates. As 

discussed later in this regulatory impact 

analysis, substantial uncertainty 

surrounds these estimates and we 

especially solicit comments on either 

our estimates of likely savings or the 

specific regulatory changes that drive 

these estimates. 

TABLE 1—SECTION-BY-SECTION ECONOMIC IMPACT ESTIMATES* 

Issue Frequency 

Number of 

affected 

entities 

Likely savings 

or benefits 

($ millions) 

Ambulatory Surgical Centers: 

• Radiology Services ........................................................................................................ Recurring Annually.2544 ≤ 41 

Hospitals: 

• Food and dietetic services ............................................................................................. Recurring Annually.4,900 83 to 528 

• Nuclear medicine services ............................................................................................. Recurring Annually......................... 39 

Transplant Centers: 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9234 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

1Peterson SJ, Chen Y, Sullivan CA, et al. 

Assessing the influence of registered dietician 

order-writing privileges on parenteral nutrition use. 

J AM Diet Assoc. 2010; 110; 1702 1711. 

TABLE 1—SECTION-BY-SECTION ECONOMIC IMPACT ESTIMATES*—Continued 

Issue Frequency 

Number of 

affected 

entities 

Likely savings 

or benefits 

($ millions) 

• Reports to CMS & Survey Changes .............................................................................. Recurring Annually.60 < 1 

Long Term Care Facilities: 

• Sprinkler Deadline Extension ......................................................................................... One-time ........... 125 22 

Rural Health: 

• CAH & RHC/FQHC Physician responsibilities .............................................................. Recurring Annually.9311 42 

• CAH Provision of services ............................................................................................. Recurring Annually.665 <1 

CLIA: 

• PT Referral ..................................................................................................................... Recurring Annually.3 2 

Total ............................................................................................................................ ........................ 231 to 676 

* This table includes entries only for those proposed reforms that we think would have a measurable economic effect 

C. Anticipated Effects 

1. Effects on Ambulatory Surgical 

Centers 

The potential cost savings from the 

reduced ASC radiology services 

requirements are discussed in the 

preamble section of this rule addressing 

those reforms. We have calculated the 

savings based on the elimination of ASC 

requirements that are inappropriate and 

unnecessary in the ASC setting, 

primarily because some of the 

requirements are intended for inpatient 

hospital patients, which would not be 

applicable in the outpatient ASC setting. 

We estimate that assuming the average 

cost for affected facilities to meet the 

radiology services requirements would 

have been $16,000 annually ($4,000 × 4 

quarters), the total savings would be 

$40.7 million ($16,000 × 2544 ASCs). 

The assumption for this estimate is 

based on using ASC facilities across the 

country that provide orthopedic or pain 

management procedures, which are the 

facilities most likely to require a 

radiologist on staff. We reached out to 

the Ambulatory Surgery Center 

Association for assistance on the 

average cost and usage of radiologists in 

ASCs across the United States. Based on 

a survey of ASCs and depending on the 

market, location of the ASC and 

frequency of the visits, we utilized a 

$4,000 average cost per quarter that 

ASCs are paying for radiologist fees. In 

addition, we considered the total 

number of ASCs affected by the current 

radiology services requirements at an 

average 48 percent, or 2544 ASCs, based 

on current data and the total number of 

Medicare certified ASCs (5300 as of 

December 2011). 

We note that the $40.7 million 

estimated savings to ASCs may 

represent an overstatement of the 

provision’s net social benefits. To the 

extent that radiologists are putting forth 

effort (for example, transporting 

themselves to ASCs) to perform 

radiology supervision, society’s 

resources would indeed be freed for 

other uses by the proposed change. 

However, because the radiologic 

services in question do not involve any 

diagnostic activity, some portion of the 

radiology supervision fees may not 

represent actual labor costs, but would 

instead involve a transfer of value from 

radiologists (who currently receive 

supervision fees without having any 

diagnostics to supervise) to ASCs 

(which, if the proposed rule is finalized, 

would no longer pay those fees). We 

lack data to estimate how much of the 

$40.7 million total is a transfer of this 

type, rather than a net social benefit. We 

welcome your comments on these 

estimates. 

2. Effects on Intermediate Care Facilities 

for Individuals who are Intellectually 

Disabled 

Because we are proposing only 

technical corrections, we do not 

estimate any costs or savings for ICF/ 

IIDs based on this proposed rule. 

3. Effects on Hospitals 

There are about 4,900 hospitals that 

are certified by Medicare and/or 

Medicaid. We use these figures to 

estimate the potential impacts of this 

proposed rule. We use the following 

average hourly wages for registered 

dietitians, advanced practice registered 

nurses, physician assistants, 

pharmacists, and physicians 

respectively: $35, $57, $57, $69, and 

$124 (BLS Wage Data by Area and 

Occupation, including both hourly 

wages and fringe benefits, at http:// 

www.bls.gov/bls/blswage.htm and 

http://www.bls.gov/ncs/ect/). 

Ordering Privileges for Registered 

Dietitians (RDs) (Food and Dietetic 

Services § 482.28) 

We propose to revise the hospital 

requirements at 42 CFR 482.28 (b), 

‘‘Food and dietetic services,’’ which 

currently requires that therapeutic diets 

must be prescribed by the practitioner 

or practitioners responsible for the care 

of the patients. Specifically, we are 

proposing revisions to § 482.28(b)(1) 

and (2) that would change the CMS 

requirements to allow for flexibility in 

this area by requiring that all patient 

diets, including therapeutic diets, must 

be ordered by a practitioner responsible 

for the care of the patient, or a qualified 

dietitian as authorized by the medical 

staff and in accordance with State law. 

With these proposed changes to the 

current requirements, a hospital would 

have the regulatory flexibility either to 

appoint RDs to the medical staff and 

grant them specific dietary ordering 

privileges (including the capacity to 

order specific laboratory tests to monitor 

nutritional interventions and then 

modify those interventions as needed) 

or to authorize the ordering privileges 

without appointment to the medical 

staff, all done through the hospital’s 

medical staff and its rules, regulations, 

and bylaws. In either instance, medical 

staff oversight of RDs and their ordering 

privileges would be ensured. 

As we discussed previously in this 

rule, a 2010 retrospective cohort study1

of 1,965 patients at an academic medical 

center looked at the influence of RDs 

with ordering privileges on appropriate 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9235 

2Weil, Sharon D., Linda Lafferty, Kathryn S. 

Keim, Diane Sowa and Rebecca Dowling. Registered 

Dietitian Prescriptive Practices in Hospitals. J AM 

Diet Assoc. 2008; 108; 1688–1692. 

3 Duffy JK, Gray RL, Roberts S, Glanzer SR, 

Longoria SL. Independent nutrition order writing 

by registered dieticians reduces complications 

associated with nutrition support [abstract]. J Am 

Diet Assoc. 2008; 108 (suppl 1):A9 

parenteral nutrition (PN) usage and 

showed a reduction in medically 

inappropriate PN usage, which 

translated to an approximately $135,233 

annual savings to the hospital after RDs 

were granted ordering privileges; 

included in this savings estimate were 

solution, materials and pharmacy labor 

costs specifically related to PN. In order 

to estimate the reduced costs that our 

proposed changes to § 482.28 might 

bring to hospitals, we based our 

calculations on this study and its 

finding of $135,233 savings for a single 

hospital that granted ordering privileges 

to RDs. The study presented its figures 

in 2003 dollars, and to adjust to a 

comparable figure in 2012 dollars we 

used the increase in the Consumer Price 

Index (CPI–U) over this period. Since 

that index is up about 25 percent, our 

savings estimate, rounded, is $169,000. 

We estimate that possibly 5 percent 

(that is, 245) of all hospitals are out of 

compliance with the CoPs and already 

granting RDs ordering privileges 

through appointment to the medical 

staff or other mechanisms and have 

already realized these savings (included 

in this estimate would also be those 

hospitals who might decide against 

granting these privileges and therefore 

would also not realize these savings). 

Additionally, an October 2008 study2

surveyed 1,500 clinical nutrition 

managers in acute healthcare facilities 

nationwide in an attempt to describe the 

level of RD independent prescriptive 

authority and to explore the barriers to 

obtaining that authority. The authors of 

the study found that roughly 15 percent 

of the respondents cited ‘‘regulatory 

agencies’’ as a barrier to obtaining 

independent prescriptive authority (or 

dietary ordering privileges as we refer to 

it in this rule). However, several 

limitations inherent in this study led us 

to question how heavily we should rely 

on it for the purposes of estimating how 

many hospitals would take advantage of 

this proposed allowance under the 

CoPs. The survey only looked at the 

perceptions of clinical nutrition 

managers regarding barriers to RD 

ordering privileges and did not survey 

hospital administrators or governing 

body members on the reasons why 

hospitals were unable to grant these 

privileges to RDs at this time. We 

believe that such a study, had it been 

performed, would have been much more 

meaningful and reliable for our 

purposes in estimating how many 

hospitals would possibly implement the 

granting of ordering privileges to RDs. 

The authors of the study also state that 

‘‘* * * the limitations of this study 

must be considered and a major 

limitation was the small response rate 

(23.4 percent) * * *’’ (or only 351 

respondents from the 1,500 clinical 

nutrition managers surveyed). Weil et 

al. also reference current CMS 

requirements and policy regarding RD 

ordering privileges in their study’s 

discussion where they state, ‘‘* * * 

independent prescriptive authority via 

clinical privileges would not be a CMSaccepted pathway for RDs to write 

orders * * *’’ Mention of the CMS 

requirements here leads us to believe 

that our requirements (included in the 

survey response ‘‘regulatory agencies’’ 

as used in the study) might present a 

more significant barrier than the results 

of the survey indicate. 

Because there is still some degree of 

uncertainty involved in estimating how 

many hospitals would actually take 

advantage of this proposed allowance 

under the CoPs, we have chosen to 

present a range of savings estimates, 

using 4,655 (or 95 percent) as both our 

most likely estimate and as the upper 

bound of affected hospitals and 15 

percent (from the survey cited above), or 

735 hospitals, as the lower bound. 

However, our extensive experience with 

hospitals, hospital organizations, and 

RD professional organizations leads us 

to believe that if the change proposed 

here is finalized, a significant number of 

hospitals would move to grant RDs 

ordering privileges. Therefore, we 

believe that the upper bound estimate of 

potential hospital savings provided here 

is the more realistic and reliable end of 

the range. 

We also based our savings estimates 

on the following assumptions: 

• The Peterson et al study was 

conducted at a 613-bed tertiary 

academic medical center; hospitals 

smaller than the one studied would 

have lower PN usage due to lower 

patient censuses and would thus have 

lower savings; 

• We adjusted the savings relative to 

average bed size for hospitals of 164 

beds (from AHA Hospital Statistics), 

meaning that average annual savings 

would be $36,513 per hospital using the 

2003 figure, but $45,641 after adjusting 

for inflation; and 

• The savings are based on the impact 

that RD ordering privileges had on 

reducing inappropriate PN usage alone 

and do not include other positive 

impacts that RD ordering privileges 

might have on reducing costs to 

hospitals. 

Based on the studies and these 

assumptions, we estimate savings 

ranging from $33,546,135 (735 hospitals 

× $45,641 in savings from reduced 

inappropriate PN usage = $33,546,135) 

to $212,458,855 (4,655 hospitals × 

$45,641 in savings from reduced 

inappropriate PN usage = $212,458,855). 

As noted above, the proposed changes 

might also help hospitals to realize 

other significant savings. One 2008 

study3 indicates that patients whose PN 

regimens were ordered by RDs have 

significantly fewer days of 

hyperglycemia (57 percent versus 23 

percent) and electrolyte abnormalities 

(72 percent versus 39 percent) compared 

with patients whose PN regimens were 

ordered by physicians. This would most 

likely translate into decreased length of 

stays for these patients as well as 

quicker recovery times and reduced 

incidents of readmissions after 

discharge from the hospital. However, 

we do not have any reasonable means 

for estimating these potential cost 

savings at this time. 

More obviously, RDs with ordering 

privileges would also be able to provide 

medical nutrition therapy (MNT) and 

other nutrition services at lower costs 

than physicians (as well as APRNs and 

PAs, two categories of non-physician 

practitioners that have traditionally also 

devised and written patient dietary 

plans and orders). This cost savings 

stems in some part from significant 

differences in the average salaries 

between the professions and the time 

savings achieved by allowing RDs to 

autonomously plan, order, monitor, and 

modify services as needed and in a more 

complete and timely manner than they 

are currently allowed. While we can 

estimate with reasonable certainty the 

savings that might be realized by 

hospitals through our proposed changes 

in terms of the physician/APRN/PA 

time and salaries saved, it would be 

more difficult to reasonably estimate the 

potential savings and benefits that 

would result from these professionals 

now having potentially more time to 

devote their attentions to those aspects 

of patient care for which they are 

trained and qualified. Physicians, 

APRNs, and PAs often lack the training 

and educational background to manage 

the nutritional needs of patients with 

the same efficiency and skill as RDs. 

The addition of ordering privileges 

enhances the ability that RDs already 

have to provide timely, cost-effective, 

and evidence-based nutrition services as 

the recognized nutrition experts on a 

hospital interdisciplinary team. A 2011 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9236 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

4 Kinn TJ. Clinical order writing privileges. 

Support Line. 2011; 33; 4; 3–10. 

5Barker LA, Gout BS, Crowe TC. Hospital 

malnutrition: prevalence, identification and impact 

on patients and the healthcare system. Int J Environ 

Res Public Health. 2011; 8(2); 514–527. 

review article4 discusses a number of 

additional studies that provide further 

evidence for the significant differences 

in nutrition education that exist 

between physicians and RDs, along with 

several other studies supporting the 

cost-effectiveness and positive patient 

outcomes that hospitals might achieve 

by granting RDs ordering privileges. 

To calculate these cost savings for 

hospitals, we based our savings 

estimates on the following assumptions: 

• Using the wide range of estimates 

established above, between 735 and 

4,655 hospitals would realize these 

savings; 

• There is an average hourly salary 

difference of $44 between RDs on one 

side ($35 per hour) and the hourly 

salary average for physicians, APRNs, 

and PAs ($79 per hour) on the other; 

• There are on average 7,000 

inpatient hospital stays per hospital per 

year (from AHA Hospital Statistics) with 

each of these stays requiring at least one 

dietary plan and orders; 

• The average hospital stay is about 5 

days (from AHA Hospital Statistics); 

• On average, each non-complex 

dietary order, including ordering and 

monitoring of laboratory tests, 

subsequent modifications to orders, and 

dietary orders for discharge/transfer/ 

outpatient follow-up as needed, would 

take 10 minutes (0.17 hours) of a 

physician’s/APRN’s/PA’s/RD’s time per 

patient during an average 5-day stay; 

• On average, MNT or more complex 

dietary orders (for example, PN, tube 

feedings, patients with multiple comorbidities, transition of patient from 

parenteral to enteral feeding, etc.), 

including ordering and monitoring of 

laboratory tests, subsequent 

modifications to orders, and dietary 

plans and orders for discharge/transfer/ 

outpatient follow-up as needed, would 

take 25 minutes (0.42 hours) of a 

physician’s/APRN’s/PA’s/RD’s time per 

patient during an average 5-day stay; 

and 

• The average number of hospital 

inpatient stays where the patient is 

determined to be either ‘‘at risk for 

malnutrition’’ or ‘‘malnourished’’ and/ 

or requires MNT or a more complex 

dietary plan and orders for other clinical 

reasons is 1,400 (or 20 percent of 

inpatient hospital stays) 5 per hospital 

per year, with a remaining average of 

5,600 (or 80 percent) of hospital 

inpatient stays per hospital per year 

where the patient is determined to be 

‘‘not at risk for malnutrition’’ and/or 

requires a less complex dietary plan and 

orders. 

The resulting savings estimate ranges 

from $49,803,600 ((735 hospitals × 5,600 

inpatient hospital stays × 0.17 hours of 

a physician’s/APRN’s/PA’s/RD’s time × 

$44 per hourly wage difference) + (735 

hospitals × 1,400 inpatient hospital 

stays × 0.42 hours of a physician’s/ 

APRN’s/PA’s/RD’s time × $44 per 

hourly wage difference)) to 

$315,422,800 annually ((4,655 hospitals 

× 5,600 inpatient hospital stays × 0.17 

hours of a physician’s/APRN’s/PA’s/ 

RD’s time × $44 per hourly wage 

difference) + (4,655 hospitals × 1,400 

inpatient hospital stays × 0.42 hours of 

a physician’s/APRN’s/PA’s/RD’s time × 

$44 per hourly wage difference)). When 

combined with the savings estimate of 

$33,546,135 to $212,458,855 from 

reduced inappropriate PN usage, this 

brings the total savings estimate from 

the proposed CoP changes $83,349,735 

to $527,881,655 (or approximately $528 

million) annually. 

We acknowledge several additional 

kinds of uncertainty in our estimates of 

the proposed provision’s savings. For 

instance, we have assumed that the time 

physicians, APRNs or PAs save due to 

being relieved of diet-ordering duties 

would equal the time spent by RDs on 

those duties. RDs, being the experts in 

this area and more proficient in 

evaluating and treating the nutritional 

needs of patients, might actually need 

less time than physicians, PAs, or 

APRNs. As we have stated previously, 

we have based many of our assumptions 

and estimates on what we believe is the 

conservative side of the best available 

evidence we have from our review of 

the literature in this area. We have also 

based our overall assumptions and best 

estimates on our practical, ongoing 

experiences with hospitals and 

prevailing conventional wisdom in 

these matters. Finally, we have 

restricted our estimates to inpatient 

hospital stays and we did not include a 

discussion of hospital outpatient visits 

for nutritional services and the impact 

that these proposed changes might have 

on hospital costs in this area. We 

welcome public comments on the 

assumptions and estimates we have put 

forth in this analysis. 

Nuclear Medicine Services (§ 482.53) 

We propose a change to the current 

requirement at § 482.53(b)(1), which 

requires that the in-house preparation of 

radiopharmaceuticals be performed by, 

or under the direct supervision of, an 

appropriately trained registered 

pharmacist or a doctor of medicine or 

osteopathy. We propose to remove the 

term ‘‘direct’’ from the current 

requirement. This revision would allow 

for other appropriately trained hospital 

staff to prepare in-house 

radiopharmaceuticals under the 

supervision or oversight of a registered 

pharmacist or doctor of medicine or 

osteopathy, but it would not require that 

such supervision or oversight be 

exercised by the physical presence in 

the hospital of one of these 

professionals, particularly during offhours when such a professional would 

not be routinely present. The proposed 

change would directly reduce the 

burden of the current direct supervision 

requirement where it is most needed— 

in-house preparation of 

radiopharmaceuticals for after-hours/ 

emergency performance of nuclear 

medicine diagnostic procedures. 

Based on statistics from the Society of 

Nuclear Medicine and Molecular 

Imaging, an estimated 16 million 

nuclear medicine imaging and 

therapeutic procedures are performed 

each year in the United States. We based 

our estimated savings for this change on 

the conservative assumptions that: 

• Most hospitals would take 

advantage of this proposed allowance 

on supervision since it is consistent 

with the Society of Nuclear Medicine 

and Molecular Imaging 

recommendations on this issue; 

• The percentage of nuclear medicine 

procedures performed off-hours (7 p.m.– 

7 a.m.) is only 10 percent of all 

procedures performed (or 1.6 million); 

• It would require 15 minutes of an 

MD/DO/PharmD’s time for direct 

supervision; and 

• The average hourly salary for these 

two categories of practitioners is $97. 

Therefore, we estimate hospitals 

savings would be $38.8 million for the 

change proposed (1.6 million off-hour 

procedures × $97 hourly salary for MD/ 

DO/PharmD × 15 minutes for direct 

supervision). 

We proposed other revisions to the 

Hospital CoPs, but we do not believe 

those provisions would create tangible 

savings for hospitals. We welcome 

public comments on these assumptions 

and estimates. 

4. Effects on Transplant Centers and 

Organ Procurement Organizations 

Existing section 482.74(a)(2) requires 

transplant centers to notify CMS 

whenever there was a decrease in the 

center’s number of transplants or 

survival rates that could result in the 

center being out of compliance with the 

clinical experience (number of required 

transplants) or outcome (survival) 

requirements at § 482.82. We are 

proposing to eliminate this requirement, 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9237 

which would reduce the burden to any 

transplant center that must currently 

report this information to CMS. This 

requirement functionally duplicates the 

data reporting and analysis 

requirements administered through the 

Health Resources and Services 

Administration (HRSA) of HHS, HRSA’s 

contractor for the Scientific Registry for 

Transplant Recipients (SRTR), and a 

CMS-funded analysis of these SRTR 

data. These data (hereafter the SRTR 

data) are equally if not more timely, and 

equal if not better at identifying 

transplant center performance problems, 

than the data we currently collect 

directly. 

We estimate that transplant centers 

make about 60 notifications each year to 

CMS according to § 482.74(a)(2). We 

believe that a staff member, probably the 

transplant center administrator, who 

would be responsible for this 

notification would need to review the 

data and notify the medical director of 

the possibility that the center’s volume 

and/or survival statistics may result in 

failure to comply with the requirements 

in § 482.82 of the CoPs. Then the 

transplant center administrator would 

need to make the actual submission to 

CMS. We believe this would require 15 

minutes, or .25 hours, of the medical 

director’s time at an hourly wage of 

$140 and 30 minutes, or .5 hours, of the 

transplant center administrator’s time at 

an average hourly wage of $70 ($140 

hourly wage for medical director × .25 

hours = $35 (+) $70 hourly wage for 

administrator × .5 hours = $35 for a total 

of $70) for each notification to CMS. 

Based on our experience with transplant 

centers, we estimate that transplant 

centers make about 60 of these 

notifications each year. Thus, the 

annual savings to transplant centers 

from eliminating this requirement for all 

transplant centers would be about 

$4,200 ($70 for each notification × 60 

notifications = $4,200). 

In addition to the savings for 

transplant centers, the federal 

government would also sustain a 

savings due to federal staff not having 

to review and maintain these 60 

notifications. Based on our experience 

with these notifications, we estimate 

that federal staff spend 20 minutes or 

.33 hours for each notification. The 

federal staff involved in reviewing and 

maintaining these notifications earn an 

average of $55 an hour. Thus, we 

estimate that the federal government 

would realize a savings of $18 ($55 × .33 

= $18.15 or about $18) for each 

notification. For all 60 notifications, the 

federal government would realize an 

annual savings of $1,080 ($18 for each 

notification × 60 notifications = $1,080). 

We expect that the changes proposed 

to the transplant center survey process 

would improve federal oversight of 

organ transplant programs by allowing 

more effective targeting of survey and 

enforcement activities to those programs 

that most need such attention, and 

would reduce the burden of hospitals 

undergoing surveys that may not be 

necessary. We estimate that the cost of 

an onsite survey is $10,400 per survey 

multiplied by a reduction of 10 surveys 

per year for a total of $104,000 per year. 

The per survey cost represents an 

estimate of the cost of personnel time 

spent during the onsite survey (hourly 

rate multiplied by the amount of time 

spent during a one-week onsite survey). 

This is consistent with costs reported by 

several transplant administrators which 

ranged between $7,334 and $15,000. 

The reduction of 10 surveys each year 

out of the approximately 80 annual 

surveys completed each year represents 

a 12.5 percent reduction in the number 

of surveys. We estimate that these 10 

surveys could have follow-up through 

alternative methods (for example, 

conference calls, plans of correction, 

etc.). This estimate is based on recent 

information that 43 programs that had 

non-compliance with data submission 

(that would require an onsite survey, if 

due for re-approval), were only slightly 

below the compliance threshold of 95 

percent and effective follow-up could 

occur in some cases without an onsite 

survey. In addition, as part of our 

follow-up process every six months for 

non-compliance with patient and graft 

outcomes, we review about 15 programs 

every 6 months (approximately 30 

programs per year). We estimate 

$104,000 in total savings for transplant 

hospitals each year. 

In addition to the savings realized by 

the transplant centers, the federal 

government would realize savings from 

both the cost of conducting the surveys 

and the cost of federal staff time in 

reviewing and maintaining the survey 

results. The surveys of the organ 

transplant facilities are usually 

conducted by both state surveyors and 

contractors paid by the Federal 

government. A survey requires an 

average of 182 hours to complete. We 

estimate that the combined average 

hourly salary for the surveyors is $146. 

Thus, to conduct a survey costs about 

$26,572 (182 hours × $146 hourly wage 

= $26,572). By reducing the number of 

surveys by 10, the federal government 

would sustain an annual savings of 

$265,720 ($26,572 for each survey × 10 

surveys = $265,720). 

The federal government would also 

realize a savings due to the staff time 

required to review and maintain the 

results of these 10 surveys. We estimate 

that federal staff spend about 5 hours on 

each survey reviewing survey results 

and maintaining those results. Thus, for 

each survey, we estimate that the federal 

government would realize a savings of 

$275 (5 hours for each survey × $55 

hourly wage = $275). For all 10 surveys, 

we estimate the annual savings would 

be $2,750 ($275 for each survey × 10 

surveys = $2,750). 

We believe that the other changes we 

have proposed for transplant centers 

and OPOs (at §§ 482.80(c), 482.82(c), 

486.306, 486.308(b)(1), and 

486.344(d)(2)(ii)) would be burden 

neutral. 

These reforms will enable all three 

types of affected organizations— 

hospitals, State survey agencies, and 

Federal oversight staff—to focus 

resources more effectively and 

efficiently on detecting and dealing with 

genuine and important problems in 

transplant center performance. 

5. Effects on Long Term Care Facilities 

In issuing the original 2008 rule, we 

anticipated that the cost of the sprinkler 

requirement would be substantially 

reduced by allowing a 5-year transition 

period (2008–2013). The extended 

transition period would permit the cost 

of new sprinkler systems to be 

subsumed (at much less expense) under 

a facility’s normal (or accelerated) 

capital replacement schedule. Due to 

the financial recession of 2008 and 

problems in the real estate market, 

however, the plans for replacement or 

major modification for some nursing 

homes have been delayed. 

We recently received communications 

from a number of owners who plan to 

replace or substantially improve an 

existing structure, but are unable to do 

so by the August 13, 2013 deadline. In 

such a case, the owner is faced with the 

prospect of investing significant 

resources to install a system of 

automatic sprinklers in the old structure 

by August 13, 2013, only to have those 

improvements soon superseded by the 

superior environment of the new 

structure. We wish to avoid the 

unnecessary costs involved in 

sprinklering an old structure that will 

soon be replaced. We therefore propose 

to permit time-limited extensions of the 

due date for achieving full sprinkler 

status. Each case-specific extension 

would then enable more time for full 

sprinkler systems to be implemented 

through the capital replacement or 

renovation schedule that is feasible for 

the facility. 

Out of approximately 15,800 nursing 

homes nationwide, our information 

system indicates that there were 169 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9238 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

facilities as of January 2012 that were 

not sprinklered, and another 1386 that 

were partially sprinklered for a total of 

1555 facilities. Nursing homes have 

made steady progress in sprinkler 

installation, and we expect these 

numbers to decline considerably as 

August 13, 2013 approaches. We 

therefore project that 50 unsprinklered 

facilities will request and qualify for a 

deadline extension because they are 

building a full replacement facility that 

will not be ready by the deadline date, 

and an additional 75 partiallysprinklered nursing homes will request 

and qualify for an extension. These 

estimates are based on our examination 

of requests we have received from 

nursing homes in one large State, and 

generalized to the nation. We invite 

public comment on these estimates and 

on the fiscal savings estimates, 

described below. 

In the case of a deadline extension for 

replacement of a nursing home, the 

unsprinklered facilities that are being 

replaced would still incur the cost of 

installing sprinklers in the new facility, 

but they would not need to pay twice 

for such installation (once in the old 

facility to meet the August 13, 2013 

deadline, and again in the new facility). 

At an average estimated installation cost 

of $7.95 per square foot and an average 

space of 50,000 square feet, the avoided 

cost would be approximately 

$19,875,000 (50 facilities times 50,000 

S.F. times $7.95). The partially 

sprinklered facilities may save some 

expense since they are combining the 

sprinkler installation with major 

modifications. We assume that the 

partially sprinklered facilities would 

avoid $1.00 per square foot in savings 

through such economies, and assume 

that the average unsprinklered area is 

25,000 square feet. For the partially 

sprinklered facilities, we therefore 

project that the aggregate savings is 

approximately $1,875,000. The 

combined aggregate, one-time savings 

would total $21,750,000. 

6. Effects on Rural Health and Primary 

Care Providers and Suppliers 

CAH and RHC/FQHC Physician 

Responsibilities (§§ 485.631(b)(2) and 

491.8(b)(2)) 

We propose to revise the CAH 

regulations at § 485.631(b)(2) and the 

RHC/FQHC regulations at § 491.8(b)(2) 

to eliminate the requirement that a 

physician must be on-site at least once 

in every 2-week period (except in 

extraordinary circumstances) to provide 

medical care services, medical 

direction, consultation, and supervision. 

Based on our experience with CAHs, we 

estimate that about 15 percent of the 

1,330 CAHs (that is, 200 CAHs) would 

be affected by the removal of this 

provision and that its removal would 

produce estimated annual savings of 

nearly $1.6 million for CAHs. 

We estimate that the majority of CAHs 

do not incur a burden due to the 

relatively large volume of services they 

provide. For these higher-volume CAHs, 

physicians are regularly onsite to 

supervise and provide consultation. We 

believe that these facilities will continue 

to have frequent physician visits 

(biweekly or more often), simply as a 

matter of operation. Therefore, for the 

majority of CAHs, we do not believe that 

eliminating the requirement for a 

biweekly physician visit will 

significantly reduce their financial and 

administrative expenses. For about 15 

percent of CAHs, roughly 200 CAHs, we 

estimate the current burden as follows. 

First, we estimate that a physician, at an 

hourly salary of $95, spends 6 hours 

each visit and makes approximately two 

visits per month (26 visits per year) in 

a facility to perform the duties required 

at § 485.631(b)(2). We estimate these 

annual visits alone cost $14,820 per 

CAH per year (6 hours per visit × 26 

visits × $95 an hour = $14,820 per CAH 

per year). 

Next, we estimate current travel 

expenses associated with the biweekly 

requirement. Based on our experience 

with CAHs, we estimate that they spend 

approximately $780 for physician travel 

expenses each year. We estimate that, 

for each visit, a physician drives an 

average of 50 miles round trip and is 

reimbursed for gas at a rate of $0.55 (the 

IRS mileage reimbursement rate) per 

mile. Thus, each visit costs 

approximately $30 (50 miles per visit × 

$0.55 per mile) for a total annual burden 

of $780 per CAH ($30 per visit × 26 

visits = $780 annual cost per CAH). We 

understand that a small number of 

CAHs, such as those in Hawaii and 

Alaska, most likely incur significant 

additional cost for airfare and overnight 

accommodations. However, we do not 

have enough data to estimate these 

various costs and request comment in 

this area. 

We believe that, in the absence of a 

requirement for biweekly physician 

visits, about half of all CAHs will 

increase their use of telemedicine, 

where appropriate, and will be able to 

reduce the total number of visits as a 

result of following efficient, site-specific 

planning efforts prompted by real-time 

needs. These changes would result in 

savings in both hourly and travel 

expenses for CAHs that choose to 

increase their use of telemedicine. We 

believe that eliminating the on-site, biweekly physician supervision would 

produce an annual estimated savings of 

half of all current physician supervision 

costs for approximately 200 CAHs. We 

estimate the savings as follows: $1.5 

million for on-site visits ($14,820/2 × 

200 CAHs=$1,482,000) and $78,000 in 

travel costs ($780/2 × 200 = $78,000). 

Since CAHs are required to document 

the events in which an extraordinary 

circumstance would prevent a doctor 

from visiting the CAH, at a minimum, 

once in a 2-week period, we estimate 

the administrative expenses associated 

with the documentation requirements at 

§ 485.631(b)(2) to be $2,699.84 per year. 

Based on sample data from the Health 

Resources and Services Administration 

(HRSA), we estimate that such 

circumstances may impact about 11 

percent of all presently required visits 

for this subset of 200 CAHs. We estimate 

that a clerical worker earning $18.88 per 

hour would be responsible for 

completing the paperwork, with each 

incident taking about 0.25 hours to 

record. Assuming 26 visits per year per 

CAH, with approximately 11 percent of 

the required visits being prevented, we 

estimate that the yearly cost of 

compliance for these 200 CAHs would 

be $2,670 (26 visits per year per CAH × 

11 percent × 200 CAHs × 0.25 hour × 

$18.88 per hour =$2,699.84 per year). 

Thus, we estimate a total annual 

savings for CAHs of nearly $1.6 million 

($2,670 + $1,482,000 + $78,000 = 

$1,562,670). For RHCs and FQHCs, we 

believe our proposal would reduce 

burden on all such facilities. We 

estimate that, presently, to perform the 

duties required at § 491.8(b)(2), each 

month a physician spends 

approximately 8 hours (4 hours each 

visit, twice a month) on-site at an RHC 

or FQHC and that these visits require an 

additional 4 hours of travel time. We 

estimate a 2-hour round-trip travel time 

for visits to most RHCs and FQHCs, thus 

approximately 4 hours per month, and 

we note that many RHCs and FQHCs 

require special means of transport 

which may be more expensive than 

traveling by car. We estimate travel 

costs at $1,950 per clinic annually ($75 

travel cost per visit × 26 visits per year 

= $1,950 per clinic per year). We 

estimate the costs for time spent for onsite visits to be $9,880 per RHC or FQHC 

per year (4 hours/visit × $95 an hour × 

26 visits per year = $9,880 per year). 

By eliminating the provision, for each 

RHC or FQHC we estimate travel 

expenses would drop by about twothirds (by $1,287, or from $1,950 to 

$663, per year); we further estimate that 

the time spent on biweekly visits would 

decrease by a third (by $3,260), thus 

from $9,880 to $6,620 per year. Just as 

with CAHs, we believe clinics’ and 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9239 

centers’ travel expenses would decrease 

in conjunction with an increase in the 

use of telemedicine, where appropriate, 

and as a result of site-specific planning 

efforts prompted by real-time needs 

rather than routine. For RHCs (3,977 

total), we estimate an annual savings of 

$5.1 million on travel ($1,287 per year 

× 3,977 = $5,118,399). For FQHCs (5,134 

total), we estimate they would realize 

$6.6 million in annual savings on travel 

expenses ($1,287 per year × 5,134 = 

$6,607,458). 

RHCs would realize $12.9 million, 

and FQHCs $16.7 million, in annual 

savings from fewer hours for on-site 

clinician visits ($3,260 per year per RHC 

or FQHC per year). For RHCs, ($3,260 × 

3,977 = $12,965,020); for FQHCs, this 

means $16.7 million in annual savings 

($3,260 × 5,134 = $16,736,840). 

We also estimate the administrative 

expenses associated with the 

documentation requirements at 

§ 491.8(b)(2), which are triggered in the 

event of any ‘‘extraordinary 

circumstances’’ preventing any of the 

required bi-weekly physician visits. By 

comparison to travel and hourly visit 

costs, these expenses are relatively 

small. As we estimated for CAHs, we 

similarly estimate that such 

circumstances impact about 11 percent 

of the presently required visits for all 

RHCs and FQHCs. We estimate that a 

clerical worker earning $18.88 per hour 

would be responsible for completing the 

paperwork, with each incident taking 

about 0.25 hours to record. Assuming 26 

visits per year, with approximately 11 

percent of these being prevented, we 

estimate the yearly cost of compliance 

for RHCs and FQHCs to be $122,991 (26 

visits × 11 percent × [3977 RHCs +5134 

FQHCs] × 0.25/hour × $18.88 per hour 

= $122,991 per year for RHCs and 

FQHCs). Eliminating the biweekly 

requirement would eliminate this 

particular administrative cost entirely 

for all RHCs and FQHCs, producing a 

total annual savings of $53,686 for RHCs 

and $69,305 for FQHCs, respectively. 

In total, we believe that eliminating 

the provision would produce annual 

estimated savings of $18.1 million for 

RHCs in travel, hourly, and 

administrative costs ($5,118,399 travel + 

$12,965,020 hourly + $53,686 

administrative = $18, 137,105). For 

FQHCs, we estimate that eliminating the 

provision would produce $23.4 million 

in annual savings. ($6,607,458 travel + 

$16,736,840 hourly + $69,305 

administrative = $23,413,603 per year). 

We note that a portion of these savings 

may be offset by equipment or other 

costs associated with increased use of 

telemedicine; however, we lack data 

with which to reliably estimate such 

costs. 

We welcome public comments on 

these assumptions and estimates. 

Provision of Services (§ 485.635(a)) 

We propose to remove the 

requirement that CAHs consult an 

individual who is not a member of the 

CAH staff in the development of its 

patient care policies; instead, we would 

allow CAHs greater flexibility in their 

approach. We estimate that removing 

this requirement would result in a total 

annual savings of $266,000 for CAHs 

which are not part of a rural health 

network and therefore, in the absence of 

this proposed rule, would need to 

provide orientation for a volunteer to be 

able to serve in this capacity. No 

original estimates were made regarding 

this requirement, which was in fact 

initially developed for another provider 

type (43 FR 30520 and 43 FR 5373), but 

later assumed as a requirement for 

CAHs in 1997 (62 FR 46037). 

Based on our experience, we are 

aware that many CAHs use volunteers, 

such as current board members, 

community residents with a medical 

background, or others, to fulfill the 

current requirements at § 485.635(a)(2). 

That is, many CAHs use a volunteer as 

the non-CAH staff person who provides 

advice and assists in the development of 

the CAH’s patient care policies. In some 

cases, the CAH must also invest time to 

make such an individual familiar with 

the CAH’s policies and procedures. 

Based on our experience, we estimate 

that a CAH typically spends about $50 

an hour for eight hours, annually, 

including any time required for 

orientation, to involve an outside 

individual in the development of its 

patient care policies. We also estimate 

that 665 of about 1,330 CAHs are part 

of a rural health network and can utilize 

a non-staff individual that is part of the 

network to fulfill this requirement. 

Thus, we estimate the savings based on 

the CAHs that are not in a network and 

are therefore required to pay an 

individual to assist with developing the 

policies and procedures. Thus, we 

estimate a total annual savings of 

$266,000 ($50 × 8 hours = $400 per CAH 

× 665 CAHs = $266,000). We welcome 

public comments on these assumptions 

and estimates. 

RHC/FQHC Definition of a Physician 

(§ 491.2) 

The definition of a physician in the 

RHC/FQHC CoP regulations does not 

conform to the definition of a physician 

in the payment and Medicare agreement 

regulations in Part 405 for these types of 

suppliers. We propose to revise the 

regulation at § 491.2 to more closely 

conform with the physician definition 

in the Part 405 regulations to eliminate 

possible confusion in the supplier 

community and to facilitate the 

development of more specialized 

primary care clinics, such as those 

providing dental services. We believe 

that this change will allow for an 

expansion of patient services and for 

additional health benefits for which we 

do not have a basis to estimate. 

7. Effects on Laboratories 

In this proposed rule, we would make 

a number of clarifications and changes 

pertaining to the regulations governing 

PT referral under CLIA. The first would 

be to add a statement to § 493.801(b) to 

explicitly note that the requirement to 

treat PT samples in the same manner as 

patient specimens does not mean that it 

is acceptable to refer PT samples to 

another laboratory for testing even if 

that is the protocol for patient 

specimens. The second proposed 

change would carve out a narrow 

exception in our longstanding 

interpretation of what constitutes an 

‘‘intentional’’ referral. In these 

instances, the laboratory would be 

subject to alternative sanctions in lieu of 

potential principal sanctions. 

Alternative sanctions may include any 

combination of civil money penalties, 

directed plan of correction (such as 

required remedial training of staff), 

temporary suspension of Medicare or 

Medicaid payments, or other sanctions 

specified in accordance with CMS 

regulations. Finally, we propose that 

definitions for the following three terms 

would be added to the regulation: Reflex 

testing, Confirmatory testing, and repeat 

PT referral. 

From 2007 through 2011 there were 

41 cases of cited, intentional PT referral. 

Of these 41 cases, we estimate that 13 

would have fit the terms of this 

proposed rule, ranging from a low of 1 

in any year (in 2009) to a high of 5 (in 

2011). Based on discussions with the 

most recently affected laboratories, we 

estimate that the average cost of the 

sanctions applicable under current 

regulations is approximately $578,400 

per laboratory. The largest single type of 

cost is the expense to the laboratory or 

hospital to contract out for management 

of the laboratory, and to pay laboratory 

director fees, due to the 2-year ban of 

the owner and operator pursuant to 

revocation of the CLIA certificate. We 

have not included legal expenses in this 

cost estimate, as it is not possible to 

estimate the extent to which laboratories 

may still appeal the imposition of the 

alternative sanctions in this proposed 

rule. We therefore estimate the annual 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9240 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

fiscal savings of the proposed changes to 

range from a low of $578,400 (1 

laboratory) to a high of $2.9 million (5 

laboratories), with an annual average 

estimated savings of $1.7 million (about 

3 laboratories per year on average). 

While the macro savings may not be 

large, the costs to the individual 

laboratory or hospital that is affected 

can be significant. 

We note, however, that the $1.7 

million estimated savings to laboratories 

may overstate or understate the 

provision’s net benefits. For example, if 

the prior management is fired instead of 

being reassigned to other duties for the 

two year period, some of the costs of 

paying for the new management’s 

salaries, benefits and training may be 

able to be drawn from funding that had 

previously been earmarked to pay those 

expenses for their predecessors. That is, 

the costs associated with the new 

employee could be offset by the savings 

gained when the former employee is 

terminated. Any such offset would 

result in lower savings than is estimated 

above. There are also, however, 

unknowns that may result in larger 

savings than estimated above. For 

example, we have no data on whether 

terminated management historically 

received severance packages. If they did, 

those costs would have to be added to 

the costs we noted above. While we 

recognize these potential inaccuracies in 

our estimates, we lack data to account 

for these considerations. We welcome 

comments on this issue. 

8. Effects on Small Entities 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities, if a rule has a significant impact 

on a substantial number of small 

entities. For purposes of the RFA, we 

estimate that the great majority of the 

providers that would be affected by 

CMS rules are small entities as that term 

is used in the RFA. The great majority 

of hospitals and most other health care 

providers and suppliers are small 

entities, either by being nonprofit 

organizations or by meeting the SBA 

definition of a small business. 

Accordingly, the usual practice of HHS 

is to treat all providers and suppliers as 

small entities in analyzing the effects of 

our rules. 

This proposed rule would save 

affected entities almost $700 million a 

year. Most of these savings would 

accrue to hospitals. While this is a large 

amount in total, the average saving per 

affected hospital is less than one half 

million dollars per year. Although the 

overall magnitude of the paperwork, 

staffing, and related cost reductions to 

hospitals and CAHs under this rule is 

economically significant, these savings 

are likely to be a fraction of one percent 

of total hospital costs. Total national 

inpatient hospital spending is 

approximately nine hundred billion 

dollars a year, or an average of about 

$150 million per hospital, and our 

primary estimate of the net effect of 

these proposals on reducing hospital 

costs is less than $700 million annually. 

This is an average of about $90,000 in 

savings for the 6,200 hospitals 

(including CAHs) that are regulated 

through the CoPs and is well under one 

percent of annual spending. It would be 

higher in larger hospitals, and lower in 

smaller hospitals, since these savings 

would be roughly proportional to 

patient volume. 

Under HHS guidelines for RFA, 

actions that do not negatively affect 

costs or revenues by more than 3 

percent a year are not economically 

significant. We believe that no hospitals 

of any size will be negatively affected. 

Accordingly, we have determined that 

this proposed rule would not have a 

significant economic impact on a 

substantial number of small entities, 

and certify that an Initial RFA is not 

required. Notwithstanding this 

conclusion, we believe that this RIA and 

the preamble as a whole meet the 

requirements of the RFA for such an 

analysis. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 603 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a metropolitan statistical area and has 

fewer than 100 beds. For the preceding 

reasons, we have determined that this 

proposed rule will reduce costs and will 

therefore not have a significant negative 

impact on the operations of a substantial 

number of small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

also requires that agencies assess 

anticipated costs and benefits before 

issuing any rule whose mandates 

require spending in any 1 year of $100 

million in 1995 dollars, updated 

annually for inflation. In 2012, that is 

approximately $139 million. This 

proposed rule does not contain any 

mandates. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it issues a proposed 

rule (and subsequent final rule) that 

would impose substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This rule would not have a substantial 

direct effect on State or local 

governments, preempt States, or 

otherwise have a Federalism 

implication. 

D. Alternatives Considered 

From within the entire body of CoPs 

and CfCs, the most viable candidates for 

reform were those identified by 

stakeholders, by recent research, or by 

experts as unusually burdensome if not 

unchanged. This subset of the universe 

of standards is the focus of this 

proposed rule. For all of the proposed 

provisions, we considered not making 

these changes. Ultimately, we saw no 

good reasons not to propose these 

burden reducing changes. We welcome 

comments on whether we properly 

selected the best candidates for change, 

and welcome suggestions for additional 

reform candidates from the entire body 

of CoPs. 

For LTC facilities, we considered the 

option of not making any changes to the 

rule. However, we were persuaded by 

the contacts we received that bona fide 

efforts were being made by the nursing 

homes in question to achieve the best 

results for residents. We believe that the 

benefits to residents of having new, 

modern and fully-equipped facilities are 

substantial, and that the public interest 

is served by avoiding wastage of funds 

spent on retrofitting an older structure 

when that structure is soon to be 

replaced or substantially improved. We 

also considered the option of granting 

extensions of the due date when a 

replacement or substantial renovation is 

not contemplated. However, we believe 

that an approach that limits extensions 

to situations where a replacement 

facility or substantial renovation is 

involved would best balance the 

advisability of timely achievement to 

full sprinkler status and the special 

challenges involved in large-scale 

construction projects. 

Regarding the proposed revisions to 

the CLIA regulations, we focused our 

proposals exclusively on reflex or 

confirmatory testing. Such cases, where 

the laboratory has followed its standard 

operating procedure in full, provide a 

reasonable basis for the Secretary to 

determine that the referral was not 

intentional. 

E. Uncertainty 

Our estimates of the effects of this 

regulation are subject to significant 

uncertainty. While the Department is 

confident that these reforms will 

provide flexibilities to facilities that will 

yield major cost savings, there are 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9241 

uncertainties about the magnitude of 

these effects. In addition, as we 

previously explained, there may be 

significant additional health benefits. 

Thus, we are confident that the rule will 

yield substantial net benefits. In this 

analysis we have provided estimates to 

suggest the potential savings these 

reforms could achieve under certain 

assumptions. We appreciate that those 

assumptions are simplified, and that 

actual results could be substantially 

higher or lower. Although there is 

uncertainty concerning the magnitude 

of all of our estimates, we do not have 

the data to provide probable estimates 

as to the range of possibilities, or to 

estimate all categories of possible 

benefits, including health effects. We 

have illustratively presented one 

possible lower bound—for food and 

dietetic services—in the preceding 

analysis and in the Accounting 

Statement that follows. We welcome 

comments addressing this lower bound 

estimate, as well as the missing or 

uncertain effects of other provisions, by 

professional societies, individual 

providers, provider associations, 

academics, and others. 

F. Accounting Statement 

As required by OMB Circular A–4 

(available at http:// 

www.whitehouse.gov/omb/circulars/ 

a004/a-4.pdf), we have prepared an 

accounting statement. As previously 

explained, achieving the full scope of 

potential savings will depend on future 

decisions by hospitals, by State 

regulators and others. Many other 

factors will influence long-term results. 

We estimate the overall cost savings that 

this rule would create would be 

approximately $231 million to $676 

million in the first year, and $209 

million to $654 million per year 

thereafter, or about $214 million to $659 

million annualized over the next 5 

years. Over a 5-year period, our primary 

estimate is that cost savings would be 

approximately $3.3 billion, though they 

could be as low as about $1 billion. 

TABLE 2—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COSTS AND SAVINGS

($ In millions) 

Category 

Primary estimate and 

upper 

bound 

Lower 

bound 

Units 

Year dollars Discount 

rate 

Period 

covered 

Benefits .................................................................................................... None 

Costs: 

Annualized Monetized reductions in Costs ............................................. ¥$659 ¥$214 2012 7% 2013–17 

¥$659 ¥$214 2012 3% 2013–17 

Transfers .................................................................................................. None 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects 

42 CFR Part 416 

Health facilities, Health professions, 

Medicare, Reporting and recordkeeping 

requirements 

42 CFR Part 442 

Administrative practice and 

procedure, Health facilities, Health 

maintenance organizations (HMO), 

Medicare, Penalties, Privacy, Reporting 

and recordkeeping requirements 

42 CFR Part 482 

Grant programs—health, Hospitals, 

Medicaid, Medicare, Reporting and 

recordkeeping requirements 

42 CFR Part 483 

Grant programs—health, Health 

facilities, Health professions, Health 

records, Medicaid, Medicare, Nursing 

homes, Nutrition, Reporting and 

recordkeeping requirements, Safety 

42 CFR Part 485 

Grant programs—health, Health 

facilities, Medicaid, Medicare, 

Reporting and recordkeeping 

requirements 

42 CFR Part 486 

Grant programs—health, Health 

facilities, Medicare, Reporting and 

recordkeeping requirements, X-rays 

42 CFR Part 488 

Administrative practice and 

procedure, Health facilities, Medicare, 

Reporting and recordkeeping 

requirements 

42 CFR Part 491 

Grant programs—health, Health 

facilities, Medicaid, Medicare, 

Reporting and recordkeeping 

requirements, Rural areas 

42 CFR Part 493 

Administrative practice and 

procedure, Grant programs-health, 

Health facilities, Laboratories, Medicaid, 

Medicare, Penalties, Reporting and 

recordkeeping requirements 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR as set forth below: 

PART 416—AMBULATORY SURGICAL 

SERVICES 

■ 1. The authority citation for part 416 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart C—Specific Conditions for 

Coverage 

■ 2. Section 416.42 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 416.42 Condition for coverage—Surgical 

services. 

* * * * * 

(b) * * * 

(2) A physician qualified to 

administer anesthesia, a certified 

registered nurse anesthetist (CRNA), or 

an anesthesiologist’s assistant as defined 

in § 410.69(b) of this chapter, or a 

supervised trainee in an approved 

educational program. In those cases in 

which a non-physician administers the 

anesthesia, unless exempted in 

accordance with paragraph (c) of this 

section, the anesthetist must be under 

the supervision of the operating 

physician, and in the case of an 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9242 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

anesthesiologist’s assistant, under the 

supervision of an anesthesiologist. 

* * * * * 

■ 3. Section 416.49 is amended by 

revising paragraph (b) to read as follows: 

§ 416.49 Condition for coverage— 

Laboratory and radiologic services. 

* * * * * 

(b) Standard: Radiologic services. (1) 

Radiologic services may only be 

provided when integral to procedures 

offered by the ASC and must meet the 

requirements specified in § 482.26(b), 

(c)(2), and (d)(2) of this chapter. 

(2) A doctor of medicine or 

osteopathy who is qualified by 

education and experience in accordance 

with State law and ASC policy must 

supervise the provision of radiologic 

services. 

PART 442—STANDARDS FOR 

PAYMENT TO NURSING FACILITIES 

AND INTERMEDIATE CARE 

FACILITIES FOR INDIVIDUALS WITH 

INTELLECTUAL DISABILITIES 

■ 4. The authority citation for part 442 

continues to read as follows: 

Authority: Sec. 1102 of the Social Security 

Act (42 U.S.C. 1302), unless otherwise noted. 

Subpart C—Certification of ICF/IIDs 

■ 5. Section 442.101(d)(3)(ii) is revised 

to read as follows: 

§ 442.101 Obtaining certification 

* * * * * 

(d) * * * 

(3) * * * 

(ii) The facility submits an acceptable 

plan of correction covering the 

remaining deficiencies. 

* * * * * 

§ 442.105 [Removed and Reserved] 

■ 6. Section 442.105 is removed and 

reserved. 

§ 442.110 [Removed and Reserved] 

■ 7. Section 442.110 is removed and 

reserved. 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

■ 8. The authority citation for part 482 

continues to read as follows: 

Authority: Secs. 1102, 1871 and 1881 of 

the Social Security Act (42 U.S.C. 1302, 

1395hh, and 1395rr), unless otherwise noted. 

Subpart C—Basic Hospital Functions 

■ 9. Section 482.12 is amended by 

revising the introductory text and 

adding paragraph (a)(10) to read as 

follows: 

§ 482.12 Condition of participation: 

Governing body. 

There must be an effective governing 

body that is legally responsible for the 

conduct of the hospital. If a hospital 

does not have an organized governing 

body, the persons legally responsible for 

the conduct of the hospital must carry 

out the functions specified in this part 

that pertain to the governing body. 

(a) * * * 

(10) Consult directly with the 

individual assigned the responsibility 

for the organization and conduct of the 

hospital’s medical staff, or his or her 

designee. At a minimum, this direct 

consultation must occur periodically 

throughout the fiscal or calendar year 

and include discussion of matters 

related to the quality of medical care 

provided to patients of the hospital. For 

a multi-hospital system using a single 

governing body, the single multihospital system governing body must 

consult directly with the individual 

responsible for the organized medical 

staff (or his or her designee) of each 

hospital within its system in addition to 

the other requirements of this 

paragraph. 

* * * * * 

■ 10. Section 482.22 is amended by 

revising the introductory text and 

paragraph (a) introductory text to read 

as follows: 

§ 482.22 Condition of participation: 

Medical staff. 

Each hospital must have an organized 

and individual medical staff, distinct to 

that individual hospital, that operates 

under bylaws approved by the 

governing body, and which is 

responsible for the quality of medical 

care provided to patients by that 

individual hospital. 

(a) Standard: Eligibility and process 

for appointment to medical staff. The 

medical staff must be composed of 

physicians. In accordance with State 

law, including scope-of-practice laws, 

the medical staff may also include other 

categories of non-physician 

practitioners who are determined to be 

eligible for appointment by the 

governing body. 

* * * * * 

■ 11. Section 482.28 is amended by 

revising paragraphs (b)(1) and (2) to read 

as follows: 

§ 482.28 Condition of participation: Food 

and dietetic services. 

* * * * * 

(b) * * * 

(1) Individual patient nutritional 

needs must be met in accordance with 

recognized dietary practices. 

(2) All patient diets, including 

therapeutic diets, must be ordered by a 

practitioner responsible for the care of 

the patient, or by a qualified dietician as 

authorized by the medical staff and in 

accordance with State law. 

* * * * * 

Subpart D—Optional Hospital Services 

■ 12. Section 482.53 is amended by 

revising paragraph (b)(1) to read as 

follows: 

§ 482.53 Condition of participation: 

Nuclear medicine services. 

* * * * * 

(b) * * * 

(1) In-house preparation of 

radiopharmaceuticals is by, or under the 

supervision of, an appropriately trained 

registered pharmacist or a doctor of 

medicine or osteopathy. 

* * * * * 

■ 13. Section 482.54 is amended by 

adding paragraph (c) to read as follows: 

§ 482.54 Condition of participation: 

Outpatient services. 

* * * * * 

(c) Standard: Orders for outpatient 

services. Outpatient services must be 

ordered by a practitioner who meets the 

following conditions: 

(1) Is responsible for the care of the 

patient. 

(2) Is licensed in the State where he 

or she provides care to the patient. 

(3) Is acting within his or her scope 

of practice under State law. 

(4) Is authorized in accordance with 

policies adopted by the medical staff, 

and approved by the governing body, to 

order the applicable outpatient services. 

This applies to the following: 

(i) All practitioners who are 

appointed to the hospital’s medical staff 

and who have been granted privileges to 

order the applicable outpatient services. 

(ii) All practitioners not appointed to 

the medical staff, but who satisfy the 

above criteria for authorization by the 

hospital for ordering the applicable 

outpatient services for their patients. 

Subpart E—Requirements for Specialty 

Hospitals 

§ 482.66 [Redesignated as § 482.58] 

■ 14. Redesignate § 482.66 in Subpart E 

as § 482.58 in Subpart D. 

§ 482.74 [Amended] 

■ 15. Section 482.74 is amended by 

removing paragraph (a)(2) and 

redesignating paragraphs (a)(3) and (4) 

as paragraphs (a)(2) and (3) respectively. 

■ 16. Section 482.80 is amended by— 

■ a. Revising paragraph (c) introductory 

text. 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9243 

■ b. Removing paragraph (c)(2). 

■ c. Redesignating paragraph (c)(3) as 

paragraph (c)(2). 

The revision reads as follows: 

§ 482.80 Condition of participation: Data 

submission, clinical experience, and 

outcome requirements for initial approval of 

transplant centers. 

* * * * * 

(c) Standard: Outcome requirements. 

CMS will review outcomes for all 

transplants performed at a center, 

including outcomes for living donor 

transplants, if applicable. CMS will 

review adult and pediatric outcomes 

separately when a center requests 

Medicare approval to perform both 

adult and pediatric transplants. 

* * * * * 

■ 17. Section 482.82 is amended by— 

■ a. Revising paragraphs (a) and (b). 

■ b. Revising paragraph (c) introductory 

text. 

■ c. Removing paragraph (c)(2). 

■ d. Redesignating paragraph (c)(3) as 

paragraph (c)(2). 

The revisions read as follows: 

§ 482.82 Condition of participation: Data 

submission, clinical experience, and 

outcome requirements for re-approval of 

transplant centers. 

* * * * * 

(a) Standard: Data submission. No 

later than 90 days after the due date 

established by the OPTN, a transplant 

center must submit to the OPTN at least 

95 percent of the required data 

submissions on all transplants 

(deceased and living donors) performed 

during the prior 3 years. Required data 

submissions include, but are not limited 

to, submission of the appropriate OPTN 

forms for transplant candidate 

registration, transplant recipient 

registration and follow-up, and living 

donor registration and follow-up. 

(b) Standard: Clinical experience. To 

be considered for re-approval, an organspecific transplant center must generally 

perform an average of 10 transplants per 

year during the prior 3 years. 

(c) Standard: Outcome requirements. 

CMS will review outcomes for all 

transplants performed at a center, 

including outcomes for living donor 

transplants, if applicable. CMS will 

review adult and pediatric outcomes 

separately when a center requests 

Medicare approval to perform both 

adult and pediatric transplants. 

* * * * * 

PART 483—REQUIREMENTS FOR 

STATES AND LONG TERM CARE 

FACILITIES 

■ 18. The authority citation for part 483 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart B—Requirements for LongTerm Care Facilities 

■ 19. Section 483.5 is amended by 

adding paragraph (f) to read as follows: 

§ 483.5 Definitions 

* * * * * 

(f) Major modification means the 

modification of more than 50 percent, or 

more than 4,500 square feet, of the 

smoke compartment. 

■ 20. Section 483.70 is amended by 

adding paragraphs (a)(8)(iii) and (iv) to 

read as follows: 

§ 483.70 Physical environment. 

* * * * * 

(a) * * * 

(8) * * * 

(iii) Subject to approval by CMS, a 

long term care facility may be granted 

an extension of the sprinkler installation 

deadline for a time period not to exceed 

2 years from August 13, 2013, if the 

facility meets all of the following 

conditions: 

(A) It is in the process of replacing its 

current building, or undergoing major 

modifications to improve the living 

conditions for residents in all 

unsprinklered living areas that requires 

the movement of corridor, room, 

partition, or structural walls or 

supports, in addition to the installation 

of a sprinkler system. 

(B) It demonstrates that it has made 

the necessary financial commitments to 

complete the building replacement or 

modification. 

(C) Before applying for the deadline 

extension, it has submitted plans to 

State and local authorities that are 

necessary for approval of the 

replacement building or major 

modification that includes the required 

sprinkler installation, and has received 

approval of the plans from State and 

local authorities. 

(D) It agrees to complete interim steps 

to improve fire safety, as determined by 

CMS. 

(iv) An extension granted under 

paragraph (a)(8)(iii) of this section may 

be renewed once, for an additional 

period not to exceed 1 year, if the 

following conditions are met: 

(A) CMS finds that extenuating 

circumstances beyond the control of the 

facility will prevent full compliance 

with the provisions in paragraph 

(a)(8)(i) of this section by the end of the 

first waiver period. 

(B) All other conditions of paragraph 

(a)(8)(iii) of this section are met. 

* * * * * 

PART 485—CONDITIONS OF 

PARTICIPATION: SPECIALIZED 

PROVIDERS 

■ 21. The authority citation for Part 485 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)). 

Subpart F—Conditions of 

Participation: Critical Access Hospitals 

(CAHs) 

■ 22. Section 485.631 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 485.631 Condition of participation: 

Staffing and staff responsibilities. 

* * * * * 

(b) * * * 

(2) A doctor of medicine or 

osteopathy is present for sufficient 

periods of time to provide medical 

direction, consultation, and supervision 

for the services provided in the CAH, 

and is available through direct radio or 

telephone communication or electronic 

communication for consultation, 

assistance with medical emergencies, or 

patient referral. 

* * * * * 

■ 23. Section 485.635 is amended by 

revising paragraph (a)(2) to read as 

follows: 

§ 485.635 Condition of participation: 

Provision of services. 

(a) * * * 

(2) The policies are developed with 

the advice of members of the CAH’s 

professional healthcare staff, including 

one or more doctors of medicine or 

osteopathy and one or more physician 

assistants, nurse practitioners, or 

clinical nurse specialists, if they are on 

staff under the provisions of 

§ 485.631(a)(1). 

* * * * * 

PART 486—CONDITIONS FOR 

COVERAGE OF SPECIALIZED 

SERVICES FURNISHED BY 

SUPPLIERS 

■ 24. The authority citation for Part 486 

continues to read as follows: 

Authority: Secs. 1102, 1138, and 1871 of 

the Social Security Act (42 U.S.C. 1302, 

1320b-8, and 1395hh) and section 371 of the 

Public Health Service Act (42 U.S.C 273). 

Subpart G—Requirements for 

Certification and Designation and 

Conditions for Coverage: Organ 

Procurement Organizations 

■ 25. Section 486.306 is amended by 

revising paragraph (a) to read as follows: 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

9244 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

§ 486.306 OPO service area size 

designation and documentation 

requirements. 

(a) General documentation 

requirement. An OPO must make 

available to CMS documentation 

verifying that the OPO meets the 

requirements of paragraphs (b) and (c) of 

this section at the time of application 

and throughout the period of its 

designation. 

* * * * * 

■ 26. Section 486.308 is amended by 

revising paragraph (b)(1) to read as 

follows: 

§ 486.308 Designation of one OPO for each 

service area. 

* * * * * 

(b) * * * 

(1) General. An OPO is normally 

designated for a 4-year agreement cycle. 

The period may be shorter, for example, 

if an OPO has voluntarily terminated its 

agreement with CMS and CMS selects a 

successor OPO for the balance of the 4- 

year agreement cycle. In rare situations, 

a designation period may be longer, for 

example, a designation may be extended 

if additional time is needed to select a 

successor OPO to replace an OPO that 

has been de-certified. 

* * * * * 

■ 27. Section 486.344 is amended by 

revising paragraph (d)(2)(ii) to read as 

follows: 

§ 486.344 Condition: Evaluation and 

management of potential donors and organ 

placement and recovery. 

* * * * * 

(d) * * * 

(2) * * * 

(ii) If the identity of the intended 

recipient is known, the OPO has a 

procedure to ensure that prior to organ 

recovery, an individual from the OPO’s 

staff compares the blood type of the 

donor with the blood type of the 

intended recipient, and the accuracy of 

the comparison is verified by a different 

individual; 

* * * * * 

PART 488—SURVEY, CERTIFICATION, 

AND ENFORCEMENT PROCEDURES 

■ 28. The authority citation for part 488 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act, unless otherwise noted 

(42 U.S.C. 1302 and 1395(hh)); Section 6111 

of the Patient Protection and Affordable Care 

Act (Pub. L. 111–148) 

Subpart A—General Provisions 

■ 29. Section 488.61 is amended by— 

■ a. Removing paragraph (a)(7). 

■ b. Revising paragraphs (c) 

introductory text, (c)(1) introductory 

text, and (c)(1)(ii). 

■ c. Removing paragraph (c)(2) and 

redesignating paragraphs (c)(3), (4), and 

(5) as paragraphs (c)(2), (3) and (4), 

respectively. 

■ d. Revising newly designated 

paragraph (c)(2). 

■ e. Adding paragraph (c)(3)(v). 

■ f. Revising paragraph (e). 

The revisions and addition read as 

follows: 

§ 488.61 Special procedures for approval 

and re-approval of organ transplant centers. 

* * * * ** 

(c) Re-approval procedures. Once 

Medicare-approved, transplant centers, 

including kidney transplant centers, 

must be in continuous compliance with 

all the conditions of participation for 

transplant centers at §§ 482.72 through 

482.104 of this chapter, except for 

§ 482.80 (initial approval requirements). 

(1) CMS will review the transplant 

center’s data on an on-going basis and 

in making re-approval determinations. 

* * * * * 

(ii) To determine compliance with the 

clinical experience and outcome 

requirements at § 482.82(b) and 

§ 482.82(c) of this chapter, CMS will 

review the data contained in the most 

recent OPTN Data Report for the 

previous 3 years and 1-year patient and 

graft survival data contained in the most 

recent SRTR center-specific reports. 

(2) CMS may choose to review the 

transplant center for compliance with 

§§ 482.72 through 482.76 and 482.90 

through 482.104 of this chapter, using 

the procedures described at 42 CFR part 

488, subpart A. 

(3) * * * 

(v) Program improvements that 

substantially address root causes of graft 

failures or patient deaths, have been 

implemented and institutionalized on a 

sustainable basis, and that are supported 

by recent outcomes data demonstrating 

compliance with the requirement at 

§ 482.82(c)(2)(ii)(C) that the number of 

observed events divided by the number 

of expected events not be greater than 

1.5. 

* * * * * 

(e) Transplant Center Inactivity. A 

transplant center may remain inactive 

and retain its Medicare approval for a 

period not to exceed 12 months. A 

transplant center must notify CMS upon 

its voluntary inactivation as required by 

§ 482.74(a)(3) of this chapter. 

PART 491—CERTIFICATION OF 

CERTAIN HEALTH FACILITIES 

■ 30. The authority citation for Part 491 

continues to read as follows: 

Authority: Sec. 1102 of the Social Security 

Act (42 U.S.C. 1302); and sec. 353 of the 

Public Health Service Act (42 U.S.C. 263a). 

Subpart A—Rural Health Clinics: 

Conditions for Certification; and 

FQHCs Conditions for Coverage 

■ 31. Section 491.2 is amended by 

revising the definition of ‘‘physician’’ to 

read as follows: 

§ 491.2 Definitions. 

* * * * * 

Physician means a practitioner who 

meets the requirements of sections 

1861(r) and 1861(aa)(2)(B) and (aa)(3)(B) 

of the Act and includes: 

(1) A doctor of medicine or 

osteopathy legally authorized to practice 

medicine and surgery by the State in 

which the function is performed; and 

(2) Within limitations as to the 

specific services furnished, a doctor of 

dental surgery or of dental medicine, a 

doctor of optometry, a doctor of 

podiatry or surgical chiropody or a 

chiropractor (see section 1861(r) of the 

Act for specific limitations). 

* * * * * 

■ 32. Section § 491.8 is amended by 

revising paragraphs (a)(6) and (b) to read 

as follows: 

§ 491.8 Staffing and staff responsibilities. 

(a) * * * 

(6) A physician, nurse practitioner, 

physician assistant, certified nursemidwife, clinical social worker, or 

clinical psychologist is available to 

furnish patient care services at all times 

the clinic or center operates. In 

addition, for RHCs, a nurse practitioner, 

physician assistant, or certified nursemidwife is available to furnish patient 

care services at least 50 percent of the 

time the RHC operates. 

(b) Physician responsibilities. The 

physician performs the following: 

(1) Except for services furnished by a 

clinical psychologist in an FQHC, which 

State law permits to be provided 

without physician supervision, provides 

medical direction for the clinic’s or 

center’s health care activities and 

consultation for, and medical 

supervision of, the health care staff. 

(2) In conjunction with the physician 

assistant and/or nurse practitioner 

member(s), participates in developing, 

executing, and periodically reviewing 

the clinic’s or center’s written policies 

and the services provided to Federal 

program patients. 

(3) Periodically reviews the clinic’s or 

center’s patient records, provides 

medical orders, and provides medical 

care services to the patients of the clinic 

or center. 

* * * * * 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9245 

PART 493—LABORATORY 

REQUIREMENTS 

■ 33. The authority citation for Part 493 

continues to read as follows: 

Authority: Sec. 353 of the Public Health 

Service Act, secs. 1102, 1861(e), the sentence 

following sections 1861(s)(11) through 

1861(s)(16) of the Social Security Act (42 

U.S.C. 263a, 1302, 1395x(e), the sentence 

following 1395x(s)(11) through 1395x(s)(16)). 

Subpart A—General Provisions 

■ 34. Section 493.2 is amended by 

adding the definitions of ‘‘confirmatory 

testing’’, ‘‘reflex testing’’, and ‘‘repeat 

proficiency testing referral,’’ in 

alphabetical order to read as follows: 

§ 493.2 Definitions 

* * * * * 

Confirmatory testing means testing 

performed by a second analytical 

procedure that could be used to 

substantiate or bring into question the 

result of an initial laboratory test. 

* * * * * 

Reflex testing means confirmatory or 

additional laboratory testing that is 

automatically requested by a laboratory 

under its standard operating procedures 

for patient specimens when the 

laboratory’s findings indicate test results 

that are abnormal, are outside a 

predetermined range, or meet other preestablished criteria for additional 

testing. 

Repeat proficiency testing referral 

means a second instance in which a 

proficiency testing sample, or a portion 

of a sample, is referred, for any reason, 

to another laboratory for analysis prior 

to the laboratory’s proficiency testing 

program event cut-off date within the 

period of time encompassing the two 

prior survey cycles (including initial 

certification, recertification, or the 

equivalent for laboratories surveyed by 

an approved accreditation 

organizations). 

* * * * * 

Subpart H—Participation in Proficiency 

Testing for Laboratories Performing 

Nonwaived Testing 

■ 35. Section 493.801 is amended by 

revising paragraphs (b) introductory text 

and (b)(4) to read as follows: 

§ 493.801 Condition: Enrollment and 

testing of samples. 

* * * * * 

(b) Standard: Testing of proficiency 

testing samples. The laboratory must 

examine or test, as applicable, the 

proficiency testing samples it receives 

from the proficiency testing program in 

the same manner as it tests patient 

specimens. This testing must be 

conducted in conformance with 

paragraph (b)(4) of this section. If the 

laboratory’s patient specimen testing 

procedures would normally require 

reflex or confirmatory testing at another 

laboratory, the laboratory should treat 

the proficiency testing sample as it 

would a patient specimen up until the 

point it would refer a patient specimen 

to a second laboratory for any form of 

further testing. 

* * * * * 

(4) The laboratory must not send 

proficiency testing samples or portions 

of proficiency testing samples to another 

laboratory for any analysis for which it 

is certified to perform in its own 

laboratory. Any laboratory that CMS 

determines intentionally referred a 

proficiency testing sample to another 

laboratory for analysis may have its 

certification revoked for at least 1 year. 

If CMS determines that a proficiency 

testing sample was referred to another 

laboratory for analysis, but the 

requested testing was limited to reflex 

or confirmatory testing that, if the 

sample were a patient specimen, would 

have been in full conformance with 

written, legally accurate and adequate 

standard operating procedures for the 

laboratory’s testing of patient 

specimens, and if the proficiency testing 

referral is not a repeat proficiency 

testing referral, CMS will consider the 

referral to be improper and subject to 

alternative sanctions in accordance with 

§ 493.1804(c), but not intentional. Any 

laboratory that receives a proficiency 

testing sample from another laboratory 

for testing must notify CMS of the 

receipt of that sample regardless of 

whether the referral was made for reflex 

or confirmatory testing, or any other 

reason. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: August 1, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: December 26, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2013–02421 Filed 2–4–13; 11:15 am] 

BILLING CODE 4120–01–P 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2