Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Proposed Rules 21207 

5 ‘‘Approval Options for Generic RACT Rules 

Submitted to Meet the non-CTG VOC RACT 

Requirement and Certain NOX RACT 

Requirements,’’ November 7, 1996. 

above rules is consistent with EPA’s 

definition in 40 CFR 51.100(s). EPA is 

proposing to approve this revision. 

The March 20, 2009 version 

incorporates changes to sections 21.1 

and 21.5 that require owners/operators 

of VOC stationary storage tanks with 

floating roofs to provide additional 

emission information concerning roof 

landing operations. 

EPA evaluated New Jersey’s revisions 

for consistency with the Act, EPA 

regulations, and EPA policy and 

proposes to approve them. 

II. Conclusion 

Both Subchapters 16 and 19 contain 

provisions which require case-by-case 

RACT determinations to be submitted as 

SIP revisions. These case-by-case RACT 

determinations are needed to fulfill the 

RACT requirement of section 182 of the 

Act. The State is in the process of 

evaluating these determinations for 

approval and therefore has not yet 

submitted them as SIP revisions. EPA 

would normally propose to 

conditionally approve this SIP revision 

as meeting the RACT requirement 

pending New Jersey’s submission and 

EPA’s approval of the case-by-case 

RACT determinations. However, based 

on information provided by New Jersey, 

the quantity of NOX and VOC emissions 

relevant to these determinations is 

below 5 percent of the stationary source 

baseline of emissions which is what 

EPA considers to be de minimis. 

Therefore, pursuant to EPA guidance,5

EPA is proposing to approve 

Subchapters 16 and 19. The remaining 

element needed to fulfill the VOC RACT 

requirement is New Jersey’s Subchapter 

26, which New Jersey submitted to EPA 

on April 9, 2009, as a SIP revision and 

which EPA is currently reviewing. 

Therefore, EPA evaluated New 

Jersey’s submittal for consistency with 

the Act, EPA regulations and policy. 

The proposed new control measures 

will strengthen the SIP by providing 

additional NOX, SO2, fine particulate, 

and VOC emission reductions. 

Accordingly, EPA is proposing to 

approve the revisions to Subchapters 4, 

10, 16, 19 and related revisions to 

Subchapter 21, as adopted on March 20, 

2009, except that EPA is continuing to 

not act, for the reasons explained above 

in this rulemaking, on the phased 

compliance plans by repowering and 

innovative control technology in 

sections 19.21 and 19.23, respectively. 

In addition, EPA is proposing to delete 

40 CFR 52.1576, relating to a prior 

finding that NOX RACT was not 

included in the New Jersey SIP. 

III. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to approve a 

SIP submission that complies with the 

provisions of the Act and applicable 

Federal regulations. 42 U.S.C. 7410(k); 

40 CFR 52.02(a). Thus, in reviewing SIP 

submissions, EPA’s role is to approve 

state choices, provided that they meet 

the criteria of the Clean Air Act. 

Accordingly, this action merely 

approves state law as meeting Federal 

requirements and does not impose 

additional requirements beyond those 

imposed by state law. For that reason, 

this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Intergovernmental 

relations, Nitrogen dioxide, Ozone, 

Particulate matter, Reporting and 

recordkeeping requirements, Sulfur 

oxides, Volatile organic compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: April 14, 2010. 

Judith A. Enck, 

Regional Administrator, Region 2. 

[FR Doc. 2010–9463 Filed 4–22–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Service 

42 CFR Part 416 

[CMS–3217–P] 

RIN 0938–AP93 

Medicare Program; Ambulatory 

Surgical Centers, Conditions for 

Coverage 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS). 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

revise one of the existing conditions for 

coverage (CfC) that ambulatory surgical 

centers (ASCs) must meet in order to 

participate in the Medicare program. 

The proposed revision would modify 

the current CfC for patient rights to 

include an exception that would allow 

an ASC to provide patients or the 

patients’ representative or surrogate 

with required patient rights information 

on the day of the procedure when the 

procedure must, to safeguard the health 

of the patient, be performed on the same 

day as the physician’s referral. In 

addition, we are proposing some other 

minor changes to the CfC for patient 

right requirements. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. EST on June 22, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–3217–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

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21208 Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Proposed Rules 

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 instructions under the ‘‘More Search 

Options’’ tab. 

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–3217–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–3217–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

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, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

FOR FURTHER INFORMATION CONTACT: Joan 

A. Moliki, (410) 786–5526, Jacqueline 

Morgan, (410) 786–4282, Steve Miller, 

(410) 786–6656, or Jeannie Miller, (410) 

786–3164. 

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. 

I. Background 

A. Legislative and Regulatory Authority 

for the Ambulatory Surgical Centers, 

Conditions for Coverage 

As the single largest payer for health 

care services in the United States, the 

Centers for Medicare & Medicaid 

Services (CMS) has a critical role in 

promoting high quality care for 

Medicare beneficiaries. CMS is 

responsible for ensuring that the 

conditions for coverage (CfCs) of 

Ambulatory Surgical Center (ASC) 

services, and enforcement of those 

conditions, are adequate to protect the 

health and safety of the individuals 

treated in such ASCs. Any regulatory 

changes that we contemplate must 

consider patient health and safety along 

with the administrative burden placed 

on Medicare-participating facilities. 

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

Security Act (the Act) specifies that an 

ASC must meet health, safety, and other 

requirements specified by the Secretary 

of Health and Human Services (HHS) 

(the Secretary) in regulation if it has an 

agreement in effect with the Secretary to 

perform procedures covered by 

Medicare. Under the agreement, the 

ASC agrees to accept the standard 

Medicare amount determined under 

section 1833(i)(2) of the Act as full 

payment for services, and to accept 

assignment of benefits as described in 

section 1842(b)(3)(B)(ii) of the Act for 

payment for all services furnished by 

the ASC to enrolled individuals. 

Substantive requirements are set forth in 

42 CFR part 416 subpart B and subpart 

C of our regulations. The regulations at 

42 CFR part 416 subpart B describe the 

general conditions and requirements for 

ASCs, and the regulations at 42 CFR 

part 416 subpart C describe the specific 

CfCs for ASCs. 

B. Updates and Revisions to the 

Ambulatory Surgical Centers Conditions 

for Coverage 

On August 31, 2007, we published a 

proposed rule (72 FR 50470) in the 

Federal Register entitled, ‘‘Medicare and 

Medicaid Programs; Ambulatory 

Surgical Centers, Conditions for 

Coverage,’’ in which we proposed to 

update the ASC CfCs by revising some 

of the definitions and the CfCs regarding 

governing body and management, and 

laboratory and radiologic services, to 

reflect current ASC practices. In 

addition, we proposed to add several 

new CfCs regarding quality assessment 

and performance improvement; patient 

rights; infection control; and patient 

admission, assessment and discharge. 

We proposed these CfCs in order to 

promote and protect patient health and 

safety. 

In the proposed rule at § 416.50, we 

proposed to divide the patient rights 

CfC into four standards. Under the first 

standard, § 416.50(a)(1), ‘‘Notice of 

rights,’’ we proposed that ASCs be 

required to provide the patient or the 

patient’s representative with verbal and 

written notice of the patient’s rights in 

a language and manner the patient 

understood in advance of providing care 

to the patient. In addition, we set out 

what information would be required 

and where the ASC would have to post 

the information for the patient to see 

while waiting for treatment. 

On November 18, 2008, we published 

a final rule (73 FR 68502), entitled 

‘‘Medicare Program; Changes to the 

Hospital Outpatient Prospective 

Payment System and CY 2009 Payment 

Rates’’. The final rule, among other 

changes, finalized the new CfC for 

patient rights in ASCs. In response to 

the proposed patient rights provision, 

several commenters expressed concern 

about the amount of paperwork patients 

would be required to complete on the 

day of the procedure and stated that 

patients would benefit from reviewing 

pertinent information before they 

arrived at the ASC for the procedure 

(see 73 FR 68718). Therefore, in 

response to comments, we revised our 

proposed requirement for patient rights 

at § 416.50(a)(1), (a)(1)(ii) and (a)(2)(i), to 

specify that ambulatory surgical centers 

(ASCs) provide patient rights 

information to patients or the patient’s 

representative in advance of the date of 

the procedure. 

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Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Proposed Rules 21209 

When we published the final rule for 

the ASC CfCs on November 18, 2008, we 

specified at § 416.50(a)(1) that patient 

rights information was to be provided 

by the ASC in advance of the date of the 

procedure. It was, and continues to be, 

our intent to require that ASCs provide 

patients or the patient’s representative 

or surrogate with information we 

believe they need in order to make an 

informed choice about the facility where 

their procedure will be performed. 

Likewise, we continue to believe that 

this information should be imparted in 

advance of the date of the procedure. 

The patient’s representative or 

surrogate, who could be a family 

member or friend that accompanies the 

patient, may act as a liaison between the 

patient and the ASC to help the patient 

communicate, understand, remember, 

and cope with the interactions that take 

place during the visit, and explain any 

instructions to the patient that are 

delivered by the ASC staff. If a patient 

is unable to fully communicate directly 

with the ASC staff, then the ASC may 

give patient rights information to the 

patient’s representative or surrogate. 

The patient has the choice of using an 

interpreter of his or her own, or one 

supplied by the ASC. A professional 

interpreter is not considered to be a 

patient’s representative or surrogate. 

Rather, it is the professional 

interpreter’s role to pass information 

from the ASC to the patient. In 

following translation practices, we 

recommend, but do not propose 

requiring, that a written translation be 

provided in languages that non-English 

speaking clients can read, particularly 

for languages that are most commonly 

used by non-English-speaking clients of 

the ASC. We note that there are many 

hundreds of languages (not all written) 

that are used by one or more residents 

of the United State, but that in most 

geographic areas the most common nonEnglish language, by far, is Spanish. 

While we propose this standard under 

the authority of title 18, section 

1832(a)(2)(F)(i), there are other legal 

requirements, most notably, those under 

title VI of the Civil Rights Act of 1964. 

Our proposed requirement has been 

designed to be compatible with recent 

guidance on title VI. The Department of 

Health and Human Services’ (HHS) 

guidance related to Title VI of the Civil 

Rights Act of 1964, ‘‘Guidance to Federal 

Financial Assistance Recipients 

Regarding Title VI Prohibition Against 

National Origin Discrimination 

Affecting Limited English Proficient 

Persons’’ (August 8, 2003, 68 FR 47311) 

applies to those entities that receive 

federal financial assistance from HHS, 

including ASCs. This guidance may 

assist ASCs in ensuring that patient 

rights information is provided in a 

language and manner the Medicare 

patient understands. 

In the November 18, 2008, ASC 

regulation, we also specified at 

§ 416.50(a)(1)(ii) (physician financial 

interest or ownership), and 

§ 416.50(a)(2)(i) (Advance directives) 

that ASCs are also required to provide 

this information to patients in advance 

of the date of the procedure. We believe 

that the current organization of § 416.50 

is confusing relative to the need for 

ASCs to furnish information to patients 

prior to the date of the procedure. 

Therefore, we are proposing to revise 

this section. 

II. Provisions of the Proposed 

Regulation 

As stated above, the November 18, 

2008 final rule finalized the patient’s 

right provision at § 416.50, to require 

ASCs to provide specific patients’ rights 

information to patients in advance of 

the date of the procedure. We believed 

this modification would alleviate 

provider concerns while at the same 

time afford patients sufficient time to 

review pertinent information before 

undergoing a procedure. However, since 

the publication of the final rule, it has 

come to our attention that a few ASCs 

sometimes provide same-day 

procedures on an emergency basis. 

Therefore, the current patient rights CfC 

requirement has been problematic for 

those ASCs that perform procedures on 

the same day they receive physician 

referrals (for example, a patient is 

referred to an ASC due to severe eye 

trauma). 

ASCs contemplating providing 

services to a patient on the same day he 

or she receives a referral must either 

refuse serving the patient for fear of 

violating Medicare requirements or 

accept the patient for service and be out 

of compliance with Medicare patient 

rights requirements. ASCs that serve 

same-day patients would like to 

continue to serve this constituency; 

however, potential non-compliance 

with the current Medicare requirement 

is a deterrent. 

This rule proposes to establish an 

exception when an ASC is providing 

services to a patient on the same day he 

or she receives a physician referral for 

the ASC service(s) and when a delay in 

providing the service(s) would 

adversely affect the patient’s health. In 

general, the ASC would continue to be 

required to provide information as 

specified at § 416.50. However, the 

proposed exception would apply only 

if: (1) The written referral was signed 

and dated by the physician on the date 

the patient was presented at the ASC for 

the service(s); and (2) a physician in the 

ASC or the referring physician 

communicates in writing and the ASC 

documents in the medical record that 

the procedure must be performed as 

soon as possible to safeguard the health 

of the patient. This proposed exception 

attempts to balance our responsibility to 

promote the health and safety of ASC 

patients with undue burden on 

facilities. 

In addition to modifying § 416.50 to 

provide for an exception for same-day 

procedures, we are proposing minor 

revisions to this section. Currently 

§ 416.50(a)(1) and (a)(2) require 

disclosure of information to be made in 

advance of the date of the procedure. 

We are proposing to eliminate this 

specific requirement from these sections 

and add this requirement to the stem 

statement at § 416.50 since the stem 

statement applies to all of the proposed 

requirements at § 416.50. 

The current provisions at § 416.50(a), 

(b), and (c) require that an ASC provide 

verbal and written notice of patient 

rights to the patient or the patient’s 

representative. This encompasses the 

posting of rights, disclosure of physician 

financial interest or ownership, the 

provision of advance directives, the 

submission and investigation of 

grievances, the exercise of rights, 

privacy and safety, and the 

confidentiality of clinical records. We 

are proposing to reorganize § 416.50(a), 

(b), and (c) by creating separate 

standards for provisions that are 

currently required in these paragraphs. 

Specifically, we are proposing to retitle 

and reorganize the requirements of 

§ 416.50, ‘‘Patient rights,’’ as follows: (a) 

Standard: Notice of rights; (b) Standard: 

Disclosure of physician financial 

interest or ownership; (c) Standard: 

Advance directives; (d) Standard: 

Submission and investigation of 

grievances; (e) Standard: Exercise of 

rights and respect for property and 

person; (f) Standard: Privacy and safety; 

(g) Standard: Confidentiality of medical 

records; and (h) Standard: Exception to 

the timing of the notice of patient rights. 

We believe this reorganization would 

eliminate confusion about the patient 

rights information to be provided to 

patients. We note that these are not new 

requirements. 

In addition, as stated above, we are 

proposing to add a new exception to 

§ 416.50 (proposed Standard (h)) that 

would allow an ASC in the case of an 

emergency procedure, and when it was 

not feasible to provide notice of patient 

rights information in advance of the 

date of the procedure, to provide this 

information to the patient or the 

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21210 Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Proposed Rules 

patient’s representative or surrogate on 

the day of treatment before the 

procedure. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 60- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comments on the following 

issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

Proposed § 416.50 (h)(1) and (h)(2) 

would require an ASC facility to furnish 

information as specified when an ASC 

accepts a patient for a procedure that 

must be performed on the same day as 

a physician referral. Specifically, 

proposed § 416.50(h)(2) states that a 

physician in the ASC or the referring 

physician must communicate in writing 

and the ASC must document in the 

medical record that the procedure be 

performed as soon as possible to 

safeguard the health of the patient. The 

burden associated with this requirement 

is the time and effort necessary for an 

ASC physician or a referring physician 

to make the aforementioned written 

communication and documentation. 

We believe the burden associated 

with this requirement in proposed 

§ 416.50 constitutes a usual and 

customary business practice as defined 

in 5 CFR 1320.3(b)(2). The medical 

record requirement at § 416.47, which 

remains unchanged, also specifies that 

ASCs must maintain complete, 

comprehensive and accurate medical 

records to ensure adequate patient care. 

A physician referral letter is considered 

part of the patient’s medical history and 

is always part of the medical record. 

If you comment on these information 

collection and recordkeeping 

requirements, please do either of the 

following: 

1. Submit your comments 

electronically as specified in the 

ADDRESSES section of this proposed rule; 

or 

2. Submit your comments to the 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Attention: CMS Desk Officer, 

CMS–3217–P, Fax: (202) 395–6974; or 

E-mail: OIRA_submission@omb.eop.gov. 

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 Statement 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), 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 (Pub. L. 

104–4), Executive Order 13132 on 

Federalism (August 4, 1999), and the 

Congressional Review Act (5 U.S.C. 

804(2)). 

Executive Order 12866 directs 

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). This rule does not reach 

the economic threshold and thus is not 

considered a major rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $7.0 million to $34.5 million in any 

1 year. Individuals and States are not 

included in the definition of a small 

entity. We estimate there are 

approximately 5,100 Medicare 

Participating ASCs with average 

admissions of approximately 1,240 

patients per ASC (based on the number 

of patients seen in ASCs in 2008). Most 

ASCs are considered to be small 

entities, either by nonprofit status or by 

having revenues of $7 million to $34.5 

million in any 1 year. For purposes of 

burden estimates, we are unable to 

accurately determine the exact number 

of ASCs that provide services to patients 

on the same day as referral by their 

physicians. However, one national ASC 

chain informed us in September 2009 

that approximately 3 percent of its ASCs 

provide services to patients on the same 

day as referral by their physicians. 

Using this percentage, we estimate that 

153 ASCs overall perform these same 

day services. Due to this small 

percentage, we have determined that the 

ASC industry on average will 

experience a slightly reduced burden 

associated with mailing out patient 

rights informational packets to patients 

prior to providing the service(s). 

Instead, a small percentage of patients 

would be informed in person on the day 

of the procedure. Thus, we believe this 

exception rule should have little or no 

effect on the benefit cost of ASC 

services. 

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. However, this proposed rule only 

affects ambulatory surgical centers and 

not hospitals. As a result, we are not 

preparing an analysis for section 1102(b) 

of the Act because we believe and the 

Secretary has determined that this rule 

will not have a significant impact on the 

operations of a substantial number of 

small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year by State, local or tribal 

governments, in the aggregate, or by the 

private sector of $100 million in 1995 

dollars, updated annually for inflation. 

In 2010, that threshold level is 

approximately $135 million. This 

proposed rule is not expected to reach 

this spending threshold. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This proposed rule has no Federalism 

implications and does not impose any 

costs on State or local governments. 

Therefore, the requirements of 

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Federal Register / Vol. 75, No. 78 / Friday, April 23, 2010 / Proposed Rules 21211 

Executive Order 13132 are not 

applicable. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was not reviewed by the Office of 

Management and Budget. 

List of Subjects in 42 CFR Part 416 

Health facilities, Health professions, 

Medicare, Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR part 416 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 416.50 is revised to read as 

follows: 

§ 416.50 Condition for coverage—Patient 

rights. 

The ASC must inform the patient or 

the patient’s representative or surrogate 

of the patient’s rights and must protect 

and promote the exercise of these rights, 

as set forth in this section. The ASC 

must also post the written notice of 

patient rights in a place or places within 

the ASC likely to be noticed by patients 

waiting for treatment or by the patient’s 

representative or surrogate, if 

applicable. 

(a) Standard: Notice of rights. Except 

as set forth in paragraph (h) of this 

section, an ASC must, in advance of the 

date of the procedure, provide the 

patient or the patient’s representative or 

surrogate with verbal and written notice 

of the patient’s rights in a language and 

manner that ensures the patient or the 

patient’s representative or surrogate 

understands all of the patient’s rights as 

set forth in this section. The ASC’s 

notice of rights must include the 

address and telephone number of the 

State agency to whom patients may 

report complaints as well as the Web 

site for the Office of the Medicare 

Beneficiary Ombudsman. 

(b) Standard: Disclosure of physician 

financial interest or ownership. The 

ASC must disclose, in accordance with 

Part 420 of this subchapter, and where 

applicable, provide a list of physicians 

who have financial interest or 

ownership in the ASC facility. 

Disclosure of information must be in 

writing. 

(c) Standard: Advance directives. The 

ASC must comply with the following 

requirements: 

(1) Provide the patient or, as 

appropriate, the patient’s representative 

or surrogate with written information 

concerning its policies on advance 

directives, including a description of 

applicable State health and safety laws 

and, if requested, official State advance 

directive forms. 

(2) Inform the patient or, as 

appropriate, the patient’s representative 

or surrogate of the patient’s right to 

make informed decisions regarding the 

patient’s care. 

(3) Document in a prominent part of 

the patient’s current medical record, 

whether or not the individual has 

executed an advance directive. 

(d) Standard: Submission and 

investigation of grievances. The ASC 

must establish a grievance procedure for 

documenting the existence, submission, 

investigation, and disposition of a 

patient’s written or verbal grievance to 

the ASC. The following criteria must be 

met: 

(1) All alleged violations/grievances 

relating, but not limited to, 

mistreatment, neglect, verbal, mental, 

sexual, or physical abuse, must be fully 

documented. 

(2) Allegations of neglect, 

mistreatment, sexual or physical abuse 

must be immediately reported to a 

person in authority in the ASC. 

(3) Only substantiated allegations of 

neglect, mistreatment, sexual or 

physical abuse must be reported to the 

applicable State authority or the local 

authority, or both. 

(4) The grievance process must 

specify timeframes for review of the 

grievance and the provisions of a 

response. 

(5) The ASC, in responding to the 

grievance, must investigate all 

grievances made by a patient or the 

patient’s representative or surrogate 

regarding treatment or care that is (or 

fails to be) furnished. 

(6) The ASC must document how the 

grievance was addressed, as well as 

provide the patient with written notice 

of its decision. The decision must 

contain the name of an ASC contact 

person, the steps taken to investigate the 

grievance, the result of the grievance 

process, and the date the grievance 

process was completed. 

(e) Standard: Exercise of rights and 

respect for property and person. 

(1) The patient has the right to 

(i) Be free from any act of 

discrimination or reprisal. 

(ii) Voice grievances regarding 

treatment or care that is (or fails to be) 

provided. 

(iii) Be fully informed about a 

treatment or procedure and the expected 

outcome before it is performed. 

(2) If a patient is adjudged 

incompetent under applicable State 

health and safety laws by a court of 

proper jurisdiction, the rights of the 

patient are exercised by the person 

appointed under State law to act on the 

patient’s behalf. 

(3) If a State court has not adjudged 

a patient incompetent, any legal 

representative or surrogate designated 

by the patient in accordance with State 

law may exercise the patient’s rights to 

the extent allowed by State law. 

(f) Standard: Privacy and safety. The 

patient has the right to the following: 

(1) Personal privacy. 

(2) Receive care in a safe setting. 

(3) Be free from all forms of abuse or 

harassment. 

(g) Standard: Confidentiality of 

medical records. The ASC must comply 

with the Department’s rules for the 

privacy and security of individually 

identifiable health information, as 

specified at 45 CFR parts 160 and 164. 

(h) Standard: Exception to the timing 

of the notice of patient rights. In the 

case of an emergency procedure, when 

it is not feasible to inform the patient or 

the patient’s representative or surrogate 

of the patient’s rights in advance of the 

date of the procedure, the ASC may 

provide the required notice and 

disclosures to the patient or the 

patient’s representative or surrogate 

immediately before the procedure only 

if the following conditions are met: 

(1) The signed physician referral is in 

writing, is dated the day the patient 

presents at the ASC, and is placed in the 

patient’s medical record prior to the 

procedure. 

(2) A physician in the ASC or the 

referring physician communicates in 

writing and the ASC documents in the 

medical record that the procedure must 

be performed as soon as possible to 

safeguard the health of the patient. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: January 21, 2010. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: April 5, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–8903 Filed 4–22–10; 8:45 am] 

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