Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 5755 

26.1702 Definitions. 

26.1703 Prohibitions applying to all 

research subject to this subpart. 

26.1704 Prohibition of reliance on unethical 

human research with non-pregnant, nonnursing adults which is not subject to 

§ 26.1705. 

26.1705 Prohibition of reliance on unethical 

human research with non-pregnant, nonnursing adults initiated after April 7, 

2006, and subject to subparts A through 

L of this part, or the codification of the 

Common Rule by another Federal 

department or agency. 

* * * * * 

§ 26.1701 To what does this subpart 

apply? 

(a) For decisions under FIFRA (7 

U.S.C. 136–136y) or section 408 of 

FFDCA (21 U.S.C. 346a), this subpart 

applies to research involving intentional 

exposure of human subjects to any 

substance. 

(b) For decisions under any regulatory 

statute administered by EPA other than 

those statutes designated in paragraph 

(a) of this section, this subpart applies 

to research involving intentional 

exposure of human subjects to a 

pesticide. 

§ 26.1702 Definitions. 

The definitions in § 26.1102 and 

§ 26.1202 apply to this subpart as well. 

§ 26.1703 Prohibitions applying to all 

research subject to this subpart. 

(a) Prohibition of reliance on 

scientifically invalid research. EPA 

must not rely on data from research 

subject to this subpart unless EPA 

determines that the data are relevant to 

a scientific or policy question important 

for EPA decisionmaking, that the data 

were derived in a manner that makes 

them scientifically valid and reliable, 

and that it is appropriate to use the data 

for the purpose proposed by EPA. In 

making such determinations, EPA must 

consider: 

(1) Whether the research was 

designed and conducted in accordance 

with appropriate scientific standards 

and practices prevailing at the time the 

research was conducted. 

(2) The extent to which the research 

subjects are representative of the 

populations for the endpoint or 

endpoints in question. 

(3) The statistical power of the data to 

support the scientific conclusion EPA 

intends to draw from the data. 

(4) In a study that reports only a No 

Observed Effect Level (NOEL) or a No 

Observed Adverse Effect Level 

(NOAEL), whether a dose level in the 

study gave rise to a biological effect, 

thereby demonstrating that the study 

had adequate sensitivity to detect an 

effect of interest. 

(b) Prohibition of reliance on research 

subject to this subpart involving 

intentional exposure of human subjects 

who are pregnant women (and therefore 

their fetuses), nursing women, or 

children. Except as provided in 

§ 26.1706, EPA must not rely on data 

from any research subject to this subpart 

involving intentional exposure of any 

human subject who is a pregnant 

woman (and therefore her fetus), a 

nursing woman, or a child. 

§ 26.1704 Prohibition of reliance on 

unethical human research with nonpregnant, non-nursing adults which is not 

subject to § 26.1705. 

(a) This section applies to research 

subject to this subpart that is not subject 

to § 26.1705. 

(b) Except as provided in § 26.1706, 

EPA must not rely on data from any 

research subject to this section if there 

is clear and convincing evidence that: 

(1) The conduct of the research was 

fundamentally unethical (e.g., the 

research was intended to seriously harm 

participants or failed to obtain informed 

consent); or 

(2) The conduct of the research was 

deficient relative to the ethical 

standards prevailing at the time the 

research was conducted in a way that 

placed participants at increased risk of 

harm (based on knowledge available at 

the time the study was conducted) or 

impaired their informed consent. 

(c) The prohibition in this section is 

in addition to the prohibitions in 

§ 26.1703. 

§ 26.1705 Prohibition of reliance on 

unethical human research with nonpregnant, non-nursing adults initiated after 

April 7, 2006, and subject to subparts A 

through L of this part, or the codification of 

the Common Rule by another Federal 

department or agency. 

(a) This section applies to research 

subject to this subpart, that: 

(1) Was initiated after April 7, 2006. 

(2) Was subject, at the time it was 

conducted, either to subparts A through 

L of this part, or to the codification of 

the Common Rule by another Federal 

department or agency. 

(b) Except as provided in § 26.1706, 

EPA must not rely on data from any 

research subject to this section unless 

EPA determines that the research was 

conducted in substantial compliance 

with either: 

(1) All applicable provisions of 

subparts A through L of this part, or the 

codification of the Common Rule by 

another Federal department or agency; 

or 

(2) If the research was conducted 

outside the United States, with 

procedures at least as protective of 

subjects as those in subparts A through 

L of this part, or the codification of the 

Common Rule by another Federal 

department or agency. 

(c) Except as provided in § 26.1706, 

EPA must not rely on data from any 

research subject to this section unless 

EPA determines that the research was 

conducted in substantial compliance 

with either: 

(1) A proposal that was found to be 

acceptable under § 26.1603(c), and no 

amendments to or deviations from that 

proposal placed participants at 

increased risk of harm (based on 

knowledge available at the time the 

study was conducted) or impaired their 

informed consent. If EPA discovers that 

the submitter of the proposal materially 

misrepresented or knowingly omitted 

information that would have altered the 

outcome of EPA’s evaluation of the 

proposal under § 26.1603(c), EPA must 

not rely on that data. 

(2) A proposal that would have been 

found to be acceptable under 

§ 26.1603(c), if it had been subject to 

review under that section, and no 

amendments to or deviations from that 

proposal placed participants at 

increased risk of harm (based on 

knowledge available at the time the 

study was conducted) or impaired their 

informed consent. 

(d) The prohibition in this section is 

in addition to the prohibitions in 

§ 26.1703. 

§ 26.1706 [Amended] 

21. In paragraph (d) of § 26.1706 

remove the word ‘‘publishes’’ and add in 

its place the phrase ‘‘has published’’. 

[FR Doc. 2011–1629 Filed 2–1–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 416, 418, 482, 483, 484, 

485, 486, and 491 

[CMS–3225–P] 

RIN 0938–AP94 

Medicare and Medicaid Programs; 

Patient Notification of Right To Access 

State Survey Agencies and Medicare 

Beneficiary Notification of the Right To 

Access Quality Improvement 

Organizations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

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5756 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 

SUMMARY: This proposed rule would set 

forth new requirements for Medicare 

certified providers and suppliers. This 

proposed rule would require that the 

Medicare certified providers and 

suppliers make available to their 

Medicare beneficiaries information 

about their right to file a written 

complaint with the Quality 

Improvement Organization (QIO) in the 

State where healthcare services are 

being or were provided about the 

quality of care they are receiving or have 

received. The Medicare certified 

providers and suppliers would be 

required to provide their Medicare 

beneficiaries with written notice of the 

QIO’s contact information. In addition, 

we are proposing new requirements for 

certain Medicare providers and 

suppliers that would require facilities to 

inform all patients about State agency 

contact information. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on April 4, 2011. 

ADDRESSES: In commenting, please refer 

to file code CMS–3225–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 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–3225–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–3225–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. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by following 

the instructions at the end of the 

‘‘Collection of Information 

Requirements’’ section in this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Jacqueline Morgan, (410) 786–4282. 

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. Legislative and Regulatory 

Background 

Various sections of the Social Security 

Act (the Act) define the terms used for 

each Medicare provider and supplier. In 

some cases, those definitions describe 

requirements that Medicare certified 

providers and suppliers must meet for 

purposes of the Medicare program. 

Some of those provisions also specify 

that the Secretary of the Department of 

Health and Human Services (DHHS) 

(the Secretary) may establish other 

requirements as necessary in the interest 

of health and safety of patients. The 

Public Health Service (PHS) Act also 

specifies additional requirements that 

some Medicare certified providers and 

suppliers must meet. 

The Secretary has established in 

regulation the requirements that each 

provider and supplier must meet in 

order to participate in the Medicare and 

Medicaid programs. These requirements 

are called the Conditions of 

Participation (CoPs), or Requirements 

(for Long Term Care Facilities) for 

providers and the Conditions for 

Coverage (CfCs) for suppliers. The CoPs 

and CfCs establish health and safety 

measures that are intended to ensure 

that a minimum level of quality care is 

furnished to all Medicare patients. 

To assist with improving the quality 

of health care for Medicare patients, we 

propose to establish a new standard for 

the following 10 Medicare certified 

providers and suppliers: 

• Ambulatory Surgical Centers 

(ASCs). 

• Hospices. 

• Hospitals. 

• Long Term Care (LTC) Facilities. 

• Home Health Agencies (HHAs). 

• Comprehensive Outpatient 

Rehabilitation Facilities (CORFs). 

• Critical Access Hospitals (CAHs). 

• Clinics and Rehabilitation 

Agencies. 

• Portable X-Ray Services. 

• Rural Health Clinics (RHCs) and 

Federally Qualified Health Centers 

(FQHCs). 

II. Quality Improvement Organizations 

Section 142 of the Peer Review 

Improvement Act of 1982 (Title I, 

Subtitle C of the Tax Equity and Fiscal 

Responsibility Act (TEFRA) of 1982 

(Pub. L. 97–248)) amended section 1862 

of the Act by adding new subsection (g), 

which requires that the Secretary enter 

into contracts with utilization and 

quality control peer review 

organizations (PROs). These 

organizations make determinations 

about whether care is reasonable and 

medically necessary, or is custodial in 

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Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 5757 

nature. They also promote the effective, 

efficient, and economical delivery of 

care, and promote the quality of that 

care. In 2002, CMS began referring to 

these Peer Review Organizations as 

Quality Improvement Organizations 

(QIOs). (See 67 FR 36539.) The national 

Quality Improvement Organization 

(QIO) Program was established to 

improve the efficiency, effectiveness, 

economy and quality of services 

delivered to Medicare beneficiaries. 

CMS contracts with 53 QIOs (one in 

each State, Puerto Rico, the District of 

Columbia, and the U.S. Virgin Islands) 

for a term of 3 years. 

Section 143 of TEFRA added sections 

1151 through 1163 in Part B of Title XI 

of the Act, which established the 

Utilization and Quality Control Peer 

Review Program. Section 1151 of the 

Act sets out the purpose of Part B of title 

XI of the Act. Section 1152 of the Act 

defines the entities that can qualify as 

QIOs, including the requirement that 

the QIO must be composed of a 

substantial number of the ‘‘licensed 

doctors of medicine and osteopathy 

engaged in the practice of medicine or 

surgery’’ in the QIO’s area of 

responsibility. Alternatively, the QIO 

must have available the services of a 

sufficient number of licensed doctors of 

medicine or osteopathy engaged in the 

practice of medicine or surgery in its 

area to assure adequate peer review of 

the services provided by the various 

medical specialties and subspecialties. 

Section 1153 of the Act provides 

specific requirements regarding how 

contracts between the QIOs and CMS 

must be structured. Section 1154(a)(1) of 

the Act describes the QIOs’ 

responsibility to determine whether a 

provider’s or practitioner’s services and 

items are reasonable and medically 

necessary, provided in the appropriate 

setting, and whether the quality of 

services meets ‘‘professionally 

recognized standards’’ of care. QIOs also 

have the specific responsibility under 

section 1154(a)(14) of the Act to conduct 

an ‘‘appropriate review of all written 

complaints about the quality of services 

(for which payment may otherwise be 

made under title XVIII) not meeting 

professionally recognized standards of 

health care. * * *’’ A complaint can 

only be reviewed and resolved by the 

QIO if filed by an individual entitled to 

benefits for such services under 

Medicare (or a person acting on the 

individual’s behalf). The QIO’s review 

responsibility applies to any 

beneficiary’s complaint, even if the 

issues raised do not appear to the QIO 

to involve serious or substantial quality 

violations. 

As part of the effort to evaluate the 

QIO program, section 109(d)(1) of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) mandated the Institute of 

Medicine (IOM) to conduct a review of 

the program and to recommend how its 

impact could be enhanced. IOM 

published the final report on March 9, 

2006 and it can be found at http:// 

www.iom.edu/Reports/2006/MedicaresQuality-Improvement-OrganizationProgram-Maximizing-Potential.aspx. 

One of the issues the report highlighted 

was that QIOs perform few beneficiary 

complaint reviews. 

We believe that a factor contributing 

to the low volume of beneficiary 

complaint reviews is that beneficiaries 

are unaware of their right to voice 

complaints to the QIO in their State. 

CMS, in the past, has instituted efforts 

to inform beneficiaries of their right to 

report to their respective QIOs, concerns 

they have about the quality of care they 

receive. These efforts have included the 

incorporation of a specific provision in 

the Hospital CoPs at § 482.13(a)(2) that 

includes a requirement that the 

grievance process must include a 

mechanism for timely referral to the 

appropriate Utilization and Quality 

Control Quality Improvement 

Organization of beneficiary concerns 

regarding quality of care. In accordance 

with section 1866(a)(1)(M) of the Act, 

hospitals and critical access hospitals 

(CAHs) must deliver, at or about the 

time of patient admission, the 

‘‘Important Message from Medicare’’ 

(IM) to all inpatient Medicare 

beneficiaries which explains their 

Medicare rights, including appeal rights. 

The IM informs beneficiaries of their 

right to report to the QIO any concerns 

about the quality of care they received. 

It also requires that the hospital provide 

the name of the QIO and the QIO’s 

contact information. The current data 

shows that QIO utilization rates are 

higher among in-patient Medicare 

beneficiaries than among Medicare 

beneficiaries who receive care in other 

settings. Under the current QIO 9th 

Statement of Work (8/1/2008 through 

7/31/11), the QIOs have received 6,379 

inpatient and 4,116 outpatient requests 

for complaint reviews. 

III. Provisions of the Proposed Rule 

Over the past decade, quality of 

health care has been of increasing 

concern. CMS recognizes this concern 

and has started revising patient health 

and safety regulations to include quality 

assessment and performance 

improvement requirements. 

Currently, Medicare beneficiaries 

receiving hospital in-patient services are 

informed of their right to communicate 

health care concerns to a QIO. We 

believe that this requirement should 

also be provided to Medicare out-patient 

beneficiaries and to those beneficiaries 

receiving care in other healthcare 

settings. To further assist in improving 

quality of health care, we are proposing 

to include a new standard for 10 

specific Medicare certified providers 

and suppliers (that is, CoPs or CfCs). 

The new standard would inform 

Medicare beneficiaries of their right to 

communicate health care concerns to a 

QIO. These standards are applicable 

only to Medicare beneficiaries because 

QIOs are only authorized to review the 

health care quality complaints of 

Medicare beneficiaries. 

As part of this effort, we propose that 

Medicare beneficiaries be informed by 

written notice at the start of care (or, for 

some providers or suppliers, at the time 

of inpatient admission or at an initial 

assessment visit in advance of 

furnishing care) of their right to voice 

concerns about the quality of care they 

are receiving (or, once services have 

been furnished, have received) to the 

QIO in the State where services are 

being or have been provided. We also 

propose that the facility document that 

it presented written notice to the 

beneficiary or the beneficiary’s 

representative or a surrogate selected by 

the beneficiary, such as a family 

member or friend of the beneficiary. 

This person may act as a liaison 

between the beneficiary and the 

provider/supplier to help the 

beneficiary communicate, understand, 

remember and cope with the 

interactions that take place during their 

visit/stay, and explain any instructions 

to the beneficiary that are delivered by 

the provider or supplier. If a patient is 

unable to fully communicate directly 

with the provider or supplier, then the 

provider or supplier may give written 

information to the beneficiary’s 

representative or surrogate. Patient 

representatives or surrogates are not 

intended to serve as interpreters for 

limited English proficient (LEP) or deaf/ 

hard of hearing persons. Under 

regulations issued pursuant to Title VI 

of the Civil Rights Act of 1964 (Title VI), 

recipients of Federal funds such as 

health care providers must take 

reasonable steps to provide LEP persons 

with meaningful access to programs and 

activities. Further, under Section 504 of 

the Rehabilitation Act of 1973, 

recipients must ensure effective 

communication with persons with 

disabilities, including those who are 

deaf or hard of hearing. Under both 

laws, interpreters necessary for 

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5758 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 

meaningful access and effective 

communication are to be provided free 

of charge. If a patient wishes his or her 

representative or surrogate to serve in 

the capacity of interpreter, the provider 

or supplier can obtain a signed waiver 

from the patient documenting that a free 

interpreter was offered and declined in 

favor of using the representative or 

surrogate. In any case, the provider or 

supplier continues to be responsible for 

ensuring the language access and 

effective communication. Where 

necessary for compliance with Title VI, 

providers and suppliers should provide 

written translations for LEP persons, 

particularly for languages that are 

commonly used by non-Englishspeaking beneficiaries, such as Spanish. 

These proposed requirements are 

based on the provisions that are already 

established for those Medicare 

beneficiaries receiving care in a hospital 

setting. At this time, we are not 

proposing to require that a specific 

format be utilized. Entities will have the 

flexibility to design their own notice 

and documentation process. 

This proposed rule would affect the 

following Medicare certified providers 

and suppliers: (1) Ambulatory Surgical 

Centers (ASCs); (2) Hospices; (3) 

Hospitals; (4) Long Term Care Facilities 

(LTCs); (5) Home Health Agencies 

(HHAs); (6) Comprehensive Outpatient 

Rehabilitation Facilities (CORFs); (7) 

Critical Access Hospitals (CAHs); (8) 

Clinics and Rehabilitation Agencies; (9) 

Portable X-ray Services; and (10) Rural 

Health Clinics (RHCs) and Federally 

Qualified Health Centers (FQHCs). 

In addition to informing Medicare 

beneficiaries about QIO contact 

information, we have also included a 

proposed requirement for seven out of 

the ten providers and suppliers that 

requires each of them to inform all 

patients, including Medicare 

beneficiaries, about State agency contact 

information. We wanted to be sure 

patients also had information about 

filing a complaint with the State survey 

agency. As we mentioned previously, 

CMS is continually updating the health 

and safety standards of various 

providers and suppliers and, as a result, 

Ambulatory Surgical Centers, Long 

Term Care Facilities, and Home Health 

Agencies already have existing 

regulations that require them to provide 

patients with State survey agency 

contact information. We propose to add 

the State agency contact information 

requirement to the following seven 

types of providers and suppliers: 

Hospices, Hospitals, CORFs, CAHs, 

Clinics and Rehabilitation Agencies, 

Portable X-ray Services and RHCs and 

FQHCs. 

Medicare health and safety standards 

are in place to protect patients. All 

patients receiving care at Medicarecertified facilities have the right to file 

a complaint or grievance with the State 

agency against a Medicare provider or 

supplier for improper care or treatment. 

The State survey agency and CMS work 

together to make sure providers and 

suppliers meet Federal standards. 

Medicare beneficiaries can file a 

complaint with the State agency and/or 

a QIO. It is our intent to ensure that, as 

part of patient rights, patients receive 

complete information about filing a 

complaint in the event they have a 

healthcare concern or complaint about 

the care they received from a Medicare 

certified facility. In the event that a QIO 

received a complaint from a nonMedicare beneficiary, we expect that the 

QIO would explain that complaints are 

covered only for Medicare beneficiaries 

and the individual should contact the 

facility directly for procedures for filing 

a complaint and information on 

contacting the appropriate State survey 

agency. 

Some Medicare certified providers 

and suppliers were determined not to be 

appropriate for inclusion in this 

proposed rule for various reasons. For 

example, End Stage Renal Disease 

(ESRD) facilities are excluded from this 

proposed requirement because they 

already have a specific complaint 

process built into the ESRD Network 

System that is similar to the QIO 

complaint process. At this time, we 

would also like to solicit comments on 

whether this QIO notice should also be 

given at the end of a Medicare 

beneficiary’s treatment, service or 

hospitalization. Another option may be 

to only require that the QIO notice be 

given upon completion of treatment or 

discharge (in addition to the notification 

upon admission) if the Medicare 

beneficiary has experienced an adverse 

event. 

CMS Data Resource 

The data regarding the number of 

Medicare certified providers and 

suppliers that would be affected by this 

proposed rule would be generated by 

CMS’ Online Survey, Certification, and 

Reporting (OSCAR) data system as of 

December 31, 2008. We note that the 

OSCAR system is updated frequently by 

individual States. Thus, the figures may 

not always total 100 percent. 

A. Ambulatory Surgical Centers 

(§ 416.50) 

Section 42 CFR 416.2 defines an 

ambulatory surgical center (ASC) as any 

distinct entity that operates exclusively 

for the purpose of providing surgical 

services to patients not requiring 

hospitalization, in which the expected 

duration of services would not exceed 

24 hours following an admission. 

The surgical services performed at 

ASCs are scheduled, primarily elective, 

non-life-threatening procedures that can 

be safely performed in an ambulatory 

setting. Patients are examined 

immediately before surgery to evaluate 

the risk of anesthesia and of the 

procedure to be performed. Patients are 

also evaluated before discharge from the 

ASC to ensure that there has been 

proper anesthesia recovery. Currently, 

there are 5,174 Medicare certified ASCs 

in the United States. Most ASCs are 

small physician-owned entities. 

The ASC CfCs are located at § 416.40 

through § 416.52. Currently, the patient 

rights standard for ASCs specifies that 

the ASC must inform the patient or the 

patient’s representative of the patient’s 

rights, and must protect and promote 

the exercise of such rights. In addition, 

it states that the ASC must provide the 

patient or the patient’s representative 

with verbal and written notice of the 

patient’s rights in advance of the date of 

the procedure, in a language and 

manner that the patient or the patient’s 

representative understands. To further 

assist with improving the quality of 

health care, we are proposing to revise 

the ASC patient rights requirement at 

§ 416.50 by redesignating paragraph (c) 

as paragraph (d) and paragraph (d) as 

paragraph (e) and adding a new 

standard at paragraph (c). The proposed 

standard would require the ASC to 

inform all Medicare beneficiaries by 

written notice, at the time of admission, 

of their right to file a written complaint 

with the QIO in the State where services 

are being or were provided about the 

quality of care they are receiving or have 

received. In addition, the new standard 

would require that the ASC provide 

Medicare beneficiaries with the name, 

telephone number, electronic mail 

address, and mailing address of the QIO, 

as well as require that the ASC 

document in the beneficiary’s record 

that it has presented the written notice 

to the beneficiary or beneficiary’s 

representative or surrogate. 

B. Hospice Care (§ 418.52) 

Section 122 of TEFRA, Public Law 

97–248, added section 1861(dd) to the 

Act to provide coverage for hospice care 

to terminally ill Medicare beneficiaries 

who elect to receive care from a 

Medicare-participating hospice. Under 

section 1861(dd) of the Act, the 

Secretary has established the CoPs that 

a hospice must meet in order to 

participate in the Medicare and 

Medicaid programs or both programs. 

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Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 5759 

Under section 1861(dd) of the Act, the 

Secretary is responsible for ensuring 

that the CoPs and their enforcement are 

adequate to protect the health and safety 

of individuals under hospice care. The 

hospice care CoPs at § 418.52 through 

§ 418.116 apply to a hospice as an 

entity, as well as to the services 

furnished to each individual under 

hospice care. 

Hospice care provides palliative care 

rather than traditional medical care and 

curative treatment to terminally ill 

individuals. Palliative care improves the 

quality of life of patients and their 

families facing the problems associated 

with life-threatening illness through the 

prevention and relief of suffering by 

means of early identification, 

assessment, and treatment of pain and 

other issues. Hospice care allows the 

patient to remain at home as long as 

possible by providing support to the 

patient and family, and by keeping the 

patient as comfortable as possible while 

maintaining his or her dignity and 

quality of life. A hospice uses an 

interdisciplinary approach to deliver 

medical, social, physical, emotional, 

and spiritual services through the use of 

a broad spectrum of caregivers. 

Currently, there are 3,346 hospice 

agencies nationally. 

The patient’s rights standard for 

hospice care currently states that the 

patient has the right to be informed of 

his or her rights, and that the hospice 

must protect and promote the exercise 

of these rights. However, it does not 

state that the patient is to receive State 

survey agency information to report 

complaints or to be informed of his or 

her right to communicate health care 

quality concerns to a QIO. Therefore, we 

are proposing to include these 

requirements by revising the hospice 

patient’s rights requirements at § 418.52 

by adding a new requirement at 

proposed paragraph (c)(9). We are also 

proposing to add a new standard at 

proposed paragraph (d). At proposed 

paragraph (c)(9), we are proposing that 

the hospice provide patients with the 

mailing address, electronic mail 

address, and telephone number of the 

State survey agency in the event they 

wish to report a grievance. The 

proposed new standard at paragraph (d) 

would require the hospice to inform all 

Medicare beneficiaries by written 

notice, during the initial assessment 

visit in advance of furnishing care, of 

their right to file a written complaint 

about the quality of care they are 

receiving or have received to the QIO in 

the State where services are being 

provided or were provided. In addition, 

the proposed standard would require 

the hospice to provide Medicare 

beneficiaries with the name, telephone 

number, electronic mail address, and 

mailing address of the QIO, as well as 

require that the hospice document in 

the beneficiary’s records that it 

presented the written notice to the 

beneficiary or beneficiary’s 

representative or surrogate. 

C. Hospitals (§ 482.13) 

Section 1861(e)(1) through (8) of the 

Social Security Act (the Act) defines the 

term ‘‘hospital’’ and lists the 

requirements that a hospital must meet 

to be eligible for Medicare participation. 

Section 1861(e)(9) of the Act specifies 

that a hospital must also meet such 

other requirements as the Secretary 

finds necessary in the interest of the 

health and safety of the hospital’s 

patients. Under the authority of 1861(e), 

the Secretary has established in 

regulations at 42 CFR part 482 the 

requirements that a hospital must meet 

to participate in the Medicare program. 

Section 1905(a) of the Act provides 

that Medicaid payments may be applied 

to hospital services. Regulations at 

§ 440.10(a)(3)(iii) require hospitals to 

meet the Medicare conditions of 

participation (CoPs) to qualify for 

participation in Medicaid. The hospital 

CoPs are found at § 482.1 through 

§ 482.66. 

We are proposing to amend the 

patient’s rights requirements at § 482.13 

by adding a new requirement at 

subparagraph (a)(1)(i). To remain 

consistent among providers and 

suppliers, we are proposing to require 

that hospitals provide patients with the 

address and telephone number of the 

State survey agency to report 

complaints. Currently, our patient’s 

rights regulation at § 482.13(a)(2) 

already requires hospitals to provide all 

patients with a grievance process. This 

regulation also includes the timely 

referral, for Medicare beneficiaries, to a 

QIO about complaints regarding the 

quality of care and discharges, similar to 

the proposals we are making here for 

other providers and suppliers. We are 

also proposing to add new standards at 

§ 482.13(a)(1)(ii) which would require 

that the hospital inform all Medicare 

beneficiaries by written notice, at the 

time of inpatient admission or 

outpatient service, of their right to file 

a written complaint about the quality of 

care they are receiving or have received 

to the QIO in the State where services 

are being or were provided. In addition, 

the new standard would require the 

hospital to provide beneficiaries with 

the name, telephone number, electronic 

mail address, and mailing address of the 

QIO, as well as require that the hospital 

document in the beneficiary’s record 

that it has presented the written notice 

to the beneficiary or beneficiary’s 

representative or surrogate. 

D. Requirements for Long Term Care 

Facilities (§ 483.10) 

Section 1819(a) of the Act defines a 

skilled nursing facility (SNF) for 

Medicare purposes as an institution or 

a distinct part of an institution that is 

primarily engaged in providing skilled 

nursing care and related services to 

residents that require medical or 

nursing care or rehabilitation services 

due to an injury, disability, or illness. 

Section 1919(a) of the Act defines a 

nursing facility (NF) for Medicaid 

purposes as an institution or a distinct 

part of an institution that is primarily 

engaged in providing to residents: 

Skilled nursing care and related services 

for residents who require medical or 

nursing care; rehabilitation services due 

to an injury, disability, or illness; or, on 

a regular basis, health-related care and 

services to individuals who, due to their 

mental or physical condition, require 

care and services (above the level of 

room and board) that are available only 

through an institution. 

To participate in the Medicare and 

Medicaid programs, long-term care 

(LTC) facilities, that is, SNFs and NFs, 

must meet certain Federal requirements 

specified at § 483.1 through § 483.75. 

SNFs must be certified as meeting the 

requirements of section 1819(a) through 

section (d) of the Act. NFs must be 

certified as meeting the requirements in 

section 1919(a) through section (d) of 

the Act. 

LTC facilities provide a substantial 

amount of care to Medicare beneficiaries 

and Medicaid recipients, as well as 

‘‘dual eligibles,’’ who qualify for both 

Medicare and Medicaid. As of December 

2008, there were 15,727 LTC facilities 

and each year they provided care for 

about 1.7 million individuals. In 2007, 

SNFs and NFs accounted for more than 

10 and 15 percent, respectively, of 

Medicare and Medicaid expenditures. 

The current regulation for LTC 

facilities contains specific requirements 

that address resident rights. However, it 

does not require LTC facilities to inform 

beneficiaries of their right to 

communicate with a QIO. Therefore, we 

are proposing to revise the resident 

rights requirements at § 483.10 by 

redesignating paragraphs (c) through (o) 

as paragraphs (d) through (p). We are 

proposing to add a new standard at 

paragraph (c). The proposed new 

standard would require the LTC facility 

to inform all Medicare beneficiaries by 

written notice, at the time of admission, 

of their right to file a written complaint 

with the QIO in the State where services 

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5760 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 

are being or were provided about the 

quality of care they are receiving or have 

received. In addition, the proposed new 

standard would require the LTC facility 

to provide the beneficiary with the 

name, telephone number, electronic 

mail address, and mailing address of the 

QIO, as well as require that the LTC 

facility document in the beneficiary’s 

record that it has presented the written 

notice to the beneficiary or his or her 

representative or surrogate. 

E. Home Health Agencies (§ 484.10) 

Under sections 1861(m), 1861(o), and 

1891 of the Act, the Secretary has 

established in regulations the 

requirements that a Home Health 

Agency (HHA) must meet in order to 

participate in the Medicare program. 

Home health services are covered for the 

elderly and disabled under the Hospital 

Insurance (Part A) and Supplemental 

Medical Insurance (Part B) benefits of 

the Medicare program. These services 

must be furnished by, or under 

arrangement with, a HHA that 

participates in the Medicare program 

and, as a general rule, must be provided 

on a visiting basis in the beneficiary’s 

home. 

As of December 2008, there were 

9,787 HHAs participating in the 

Medicare program. Medicare-certified 

HHAs provided home health services to 

3.2 million patients nationwide in FY 

2006. The effective delivery of quality 

home health services is essential to the 

care and prevention of recurrent illness 

and hospitalizations. 

The home health services CoPs 

requirements are located at § 484.1 

through § 484.55. Currently the patient 

rights standard for HHAs specifies that 

the HHA must provide the patient with 

a written notice of the patient’s rights in 

advance of furnishing care to the patient 

or during the initial evaluation visit 

before the initiation of treatment. To 

further assist with improving quality of 

health care, we are proposing to revise 

the HHA patient rights requirement at 

§ 484.10 by redesignating paragraphs (c) 

through paragraphs (f) as paragraphs (d) 

through paragraphs (g). We are also 

proposing to add a new standard at 

paragraph (c). The proposed new 

standard would require the HHA to 

inform all Medicare beneficiaries by 

written notice, at the time of initiation 

of treatment, of their right to file a 

written complaint about the quality of 

care they are receiving or have received 

to the QIO in the State where services 

are being or were provided. In addition, 

the proposed standard would require 

the HHA to provide the beneficiary with 

the name, telephone number, electronic 

mail address, and mailing address of the 

QIO, and to document in the 

beneficiary’s record that the written 

notice was presented to the beneficiary 

or beneficiary’s representative or 

surrogate. 

F. Comprehensive Outpatient 

Rehabilitation Facilities (§ 485.56) 

Section 1861(cc) of the Act defines 

the term ‘‘comprehensive outpatient 

rehabilitation facility’’ (CORF) and lists 

the requirements that a CORF must meet 

to be eligible for Medicare participation. 

By definition, under 42 CFR 485.51(a), 

a CORF is a non-residential facility that 

is established and operated exclusively 

for the purpose of providing diagnostic, 

therapeutic, and restorative services to 

outpatients for the rehabilitation of 

injured, disabled, or sick persons, at a 

single fixed location, by or under the 

supervision of a physician. As of 

December 2008, there were 476 

Medicare-certified CORFs in the United 

States. 

Section 1861(cc)(2)(J) of the Act also 

states that the CORF must meet other 

requirements that the Secretary finds 

necessary in the interest of the health 

and safety of a CORF’s patients. Under 

this authority, the Secretary has 

established requirements at § 485.50 

through § 485.74, that a CORF must 

meet to participate in the Medicare 

program. 

We are proposing to amend the 

governing body and administration 

requirements at § 485.56 by adding a 

new requirement at paragraph (e)(11). 

We are also proposing to add a new 

standard by adding a new paragraph (g). 

At proposed paragraph (e)(11), we are 

proposing to require that CORFs provide 

patients with the mailing address, 

electronic mail address, and telephone 

number of the State survey agency to 

report complaints. The proposed new 

standard in paragraph (g) would require 

the CORF to inform all Medicare 

beneficiaries by written notice, at the 

time of initiation of treatment, of their 

right to file a written complaint about 

the quality of care they are receiving or 

have received to the QIO in the State 

where services are being or were 

provided. In addition, the proposed 

standard would require the CORF to 

provide the beneficiary with the name, 

telephone number, electronic mail 

address, and mailing address of the QIO, 

and document in the beneficiary’s 

record that it has presented the written 

notice to the beneficiary or beneficiary’s 

representative or surrogate. 

G. Critical Access Hospitals (§ 485.627) 

Sections 1820 and 1861(mm) of the 

Act provide that critical access hospitals 

participating in Medicare and Medicaid 

meet certain specified requirements. 

CMS has implemented these provisions 

in 42 CFR part 485, subpart F, 

Conditions of Participation for Critical 

Access Hospitals (CAHs). There are 

1,305 CAHs that must meet the CAH 

CoPs. CAHs are small, generally rural, 

limited-service facilities with low 

patient volume. The intent of 

designating facilities as ‘‘critical access 

hospitals’’ is to preserve access to 

primary care and emergency services 

that meet community needs. A CAH 

designation is a core component of the 

State’s Medicare Rural Hospital 

Flexibility Program (Flex Program). To 

be designated as a CAH, a facility must 

be located in a State that has established 

a Flex program, be located in a rural 

area or be treated as rural in accordance 

with existing § 485.610(b), which, 

among other things, allows qualified 

hospital providers in urban areas to be 

treated as rural for purposes of 

becoming a CAH. Facilities that are so 

designated and meet the CAH 

conditions of participation (CoPs) under 

42 CFR part 485, subpart F, will be 

certified as CAHs by CMS. 

The current regulations at § 485.601 

through § 485.647 do not contain patient 

rights requirements. Therefore, we are 

proposing to revise the organizational 

structure requirements by adding two 

new standards at § 485.627(c) and (d). 

The first proposed standard would 

require the CAH to provide CAH 

patients with the mailing address, 

electronic mail address, and telephone 

number of the State survey agency if the 

patient wishes to report complaints. The 

second proposed standard would 

require the CAH to inform all Medicare 

beneficiaries by written notice, at the 

time of service, of their right to file a 

written complaint with the QIO in the 

State where services are being or were 

provided about the quality of care they 

are receiving or have received. In 

addition, the new standard would 

require the CAH to provide the 

beneficiary with the name, telephone 

number, electronic mail address, and 

mailing address of the QIO, and to 

document in the beneficiary’s record 

that the CAH has presented the written 

notice to the beneficiary or beneficiary’s 

representative or surrogate. 

H. Clinics and Rehabilitation Agencies, 

and Public Health Agencies as Providers 

of Outpatient Physical Therapy and 

Speech-Language Pathology Services 

(§ 485.709) 

Under section 1861(p) of the Act, the 

Secretary has established CoPs that 

clinics and rehabilitation agencies must 

meet when they provide outpatient 

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language pathology services. Section 

1861(p) of the Act describes ‘‘outpatient 

physical therapy services’’ to mean 

physical therapy services furnished by a 

provider of services, a clinic or 

rehabilitation agency, or by others under 

an arrangement with, and under the 

supervision of, such provider, clinic or 

rehabilitation agency to an individual as 

an outpatient. The patient must also be 

under the care of a physician. 

The term also includes speechlanguage pathology services furnished 

by a provider of services, a clinic, or a 

rehabilitation agency, or by others under 

an arrangement. There are 2,781 

Medicare certified clinics and 

rehabilitation agencies that provide 

outpatient physical therapy and speechlanguage pathology services. 

The current regulations at § 485.701 

through § 485.729 do not contain patient 

rights requirements, therefore, we are 

proposing to revise the administrative 

management requirements by adding 

two new standards at § 485.709(e) and 

§ 485.709(f). The first proposed standard 

would require that the clinic or 

rehabilitation agency provide all 

patients with the mailing address, 

electronic mail address, and telephone 

number of the State survey agency in 

order to permit patients to report 

complaints. The second proposed 

standard would require the clinics or 

rehabilitation agencies to inform all 

Medicare beneficiaries by written 

notice, at the time of initiation of 

treatment, of their right to file a written 

complaint with the QIO in the State 

where services are being or were 

provided about the quality of care they 

are receiving or have received. In 

addition, the new standard would 

require the facility to provide the 

beneficiary with the name, telephone 

number, electronic mail address, and 

mailing address of the QIO, and would 

require that clinics or rehabilitation 

agencies document in the beneficiary’s 

record that they have presented the 

written notice to the beneficiary or 

beneficiary’s representative or surrogate. 

I. Portable X-Ray Services (§ 486.100) 

The Conditions for Coverage (CfC) for 

portable x-ray services are specified 

under section 1861(s)(3) of the Act and 

were adopted in January 1969. X-ray 

services are provided under the 

supervision of a qualified physician. 

Diagnostic x-ray services furnished by a 

portable x-ray supplier are covered 

under Medicare when furnished in a 

place of residence used as the patient’s 

home. Suppliers of portable x-ray 

services must conform to the 

requirements specified at § 486.100 

through § 486.110. 

We are proposing to amend the 

requirements at § 486.106 by adding 

new standards at § 486.106(d) and (e). 

The first proposed new standard would 

require suppliers of portable x-ray 

services to provide patients with the 

mailing address, electronic mail 

address, and telephone number of the 

State survey agency to report 

complaints. The second proposed 

standard would require the suppliers to 

inform all Medicare beneficiaries by 

written notice, at the time services are 

provided, of their right to file a written 

complaint with the QIO in the State 

where services are being or were 

provided about the quality of care they 

are receiving or have received. In 

addition, the new standard would 

require the supplier to provide 

beneficiaries with the name, telephone 

number, electronic mail address, and 

mailing address of the QIO, and to 

document in the beneficiary’s record 

that they presented written notice to the 

beneficiary or beneficiary’s 

representative or surrogate. 

J. Rural Health Clinics: Conditions for 

Certification; and FQHCs Conditions for 

Coverage (§ 491.9) 

Rural Health Clinics (RHCs) and 

Federally Qualified Health Centers 

(FQHCs) under section 1861(aa) of the 

Act were established to improve and 

maintain primary care for rural and 

underserved communities. To qualify as 

an RHC, a facility must be located in a 

medically underserved area (MUA), a 

health professional shortage area 

(HPSA) either by population or 

geographic area or location, or a State 

Governor-designated shortage area. To 

qualify as an FQHC, a facility may be 

located in either an urban or rural area. 

The distinction between urban and rural 

is based on whether or not the area in 

which a clinic is located is part of a 

Metropolitan Statistical Area. 

Primary health care services for RHCs 

and FQHCs are defined as the treatment 

of acute or chronic medical problems 

which usually brings a patient to a 

physician’s office. An RHC may be any 

primary care practice (for example, 

family practice, pediatric, obstetrics, 

gynecology, or internal medicine). An 

FQHC must provide primary care for all 

life-cycle ages. Therefore, primary care 

specialty practices are not eligible for 

FQHC status unless they provide 

primary care for all life-cycles. The 

FQHC program is funded under Section 

330 of the Public Health Service Act. 

RHCs and FQHCs improve access to 

primary health care in rural or 

underserved communities and promote 

a collaborative model of health care 

delivery using physicians and nonphysician practitioners. Currently, there 

are 3,758 Medicare-approved RHCs and 

approximately 4,384 FQHCs. To qualify 

for Medicare reimbursement, RHCs and 

FQHCs must comply with conditions for 

certification and CfCs, respectively, at 

CFR part 491, subpart A. The current 

conditions for RHCs and FQHCs, are 

located at § 491.1 through § 491.11. 

We are proposing to revise the 

provision of services condition at 

§ 491.9 by adding two new standards at 

§ 491.9(e) and (f). The first proposed 

new standard would require the clinic 

or center to provide all patients with the 

mailing address, electronic mail 

address, and telephone number of the 

State survey agency in order to allow 

patients to report complaints. The 

second proposed standard would 

require RHCs and FQHCs to inform all 

Medicare beneficiaries by written 

notice, at the time of service, of their 

right to file a written complaint with the 

QIO in the State where services are 

being or were provided about the 

quality of care they are receiving or have 

received. In addition, the RHC or FQHC 

would be required to provide 

beneficiaries with the name, telephone 

number, electronic mail address, and 

mailing address of the QIO, and to 

document in the beneficiary’s record 

that they have presented the written 

notice to the beneficiary or beneficiary’s 

representative or surrogate. 

IV. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995 (PRA), 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 PRA requires 

that we solicit comment 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. 

We are soliciting public comment on 

each of these issues for the following 

sections of this document: 

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5762 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 

A. ICRs Regarding Condition for 

Coverage: Patient Rights—Ambulatory 

Surgical Centers (ASCs) (§ 416.50) 

Proposed § 416.50(c)(1) would require 

that at the time of admission, an ASC 

must inform all Medicare beneficiaries 

by written notice of their right to file a 

written complaint with the QIO in the 

State where services are being or were 

provided about the quality of care they 

are receiving or have received. Proposed 

§ 416.50(c)(3) would require the ASC to 

document that the written notice was 

presented to the beneficiary, 

beneficiary’s representative or surrogate. 

The burden associated with these 

requirements is the time and effort 

associated with developing and 

distributing a standard written notice 

and documenting receipt of the notice. 

We believe 5,174 ASCs must comply 

with these requirements. We estimate 

that proposed § 416.50 will impose a 

one-time 2 hour burden for the 

development of a standard written 

notice containing the name, address, 

and telephone number of the QIO. The 

total burden associated with this task is 

10,348 hours. Similarly, we estimate 

that each ASC will distribute 

approximately 1,224 notices per year for 

a total of 6,332,976 annual notices. We 

estimate that it will take a total of 5 

minutes to notify the beneficiary, 

beneficiary’s representative or surrogate 

and to document distribution of the 

notification. The estimated annual 

burden for this requirement is 527,748 

hours. The total estimated annual 

burden associated with all of the 

requirements in proposed § 416.50 is 

538,096 hours. The total cost associated 

with this requirement is $18,978,232. 

B. ICRs Regarding Condition of 

Participation: Patient’s Rights— 

Hospices (§ 418.52) 

Proposed § 418.52(c)(9) would require 

that hospices provide patients with the 

address and telephone number of the 

State survey agency to report 

complaints. Proposed § 418.52(d)(1) 

would require that at the time of 

admission, a hospice must inform all 

Medicare beneficiaries by written notice 

of their right to file a written complaint 

to the QIO in the State where services 

are being or were provided about the 

quality of care they are receiving or have 

received. Proposed § 418.52(d)(3) would 

require the hospice to document that the 

written notice was presented to the 

beneficiary, the beneficiary’s 

representative or surrogate. The burden 

associated with these requirements is 

the time and effort associated with 

developing and distributing a standard 

written notice and documenting the 

receipt of the notice. 

We believe 3,346 hospice facilities 

must comply with these requirements. 

We estimate that proposed § 418.52 will 

impose a one-time 2-hour burden for the 

development of a standard written 

notice containing the address and 

telephone number of the State survey 

agency and the name, address, and 

telephone number of the QIO. The total 

burden associated with this task is 6,692 

hours. Similarly, we estimate that each 

hospice will distribute approximately 

314 notices per year for a total of 

1,050,644 annual notices. We estimate 

that it will take a total of 5 minutes to 

notify the beneficiary, the beneficiary’s 

representative or surrogate and to 

document the distribution of the notice. 

The estimated annual burden for this 

requirement is 87,554 hours. The total 

estimated annual burden associated 

with all of the requirements in proposed 

§ 418.52 is 94,246 hours. The total cost 

associated with this requirement is 

$3,392,298. 

C. ICRs Regarding Patients Rights— 

Hospitals (§ 482.13) 

Proposed § 482.13(a)(1)(i) would 

require that hospitals provide patients 

with the address and telephone number 

of the State survey agency to report 

complaints. We believe a total of 4,859 

hospitals must comply with this 

requirement. We estimate that proposed 

§ 482.13 will impose a one-time one 

hour burden for the development of a 

standard written notice containing the 

address and telephone number of the 

State survey agency. The total burden 

associated with this task is 4,859 hours 

at a cost of $238,091. This notice can be 

incorporated into existing admission 

paperwork documents that are already 

required and given to the beneficiary, 

beneficiary’s representative or surrogate, 

therefore we are not assigning 

additional burden hours. 

Proposed § 482.13(a)(1)(ii) would 

require that at the time of inpatient 

admission or outpatient service, the 

hospital must inform all Medicare 

beneficiaries by written notice of their 

right to file a written complaint with the 

QIO in the State where services are 

being or were provided about the 

quality of care they are receiving or have 

received. 

Proposed § 482.13(a)(1)(ii) would also 

require the hospital to document that 

the written notice was presented to the 

beneficiary, beneficiary’s representative 

or surrogate. The burden associated 

with these requirements is the time and 

effort associated with developing and 

distributing a standard written notice 

and documenting the distribution of the 

notice. 

We believe 4,859 hospitals must 

comply with these requirements. We 

estimate that proposed § 482.13 will 

impose a one-time two hour burden for 

the development of a standard written 

notice containing the name, address, 

and telephone number of the QIO. The 

total burden associated with this task is 

9,718 hours. Similarly, we estimate that 

each hospital will distribute 

approximately 228 notices per year for 

a total of 1,107,852 annual notices. We 

estimate that it will take a total of 5 

minutes to notify the beneficiary, the 

beneficiary’s representative or surrogate 

and to document the distribution of the 

notice. The estimated annual burden for 

this requirement is 92,321 hours at a 

cost of $3,231,235. The total estimated 

annual burden associated with all of the 

requirements in proposed § 482.13 is 

102,039 hours. The total cost associated 

with this requirement is $3,707,417. 

D. ICRs Regarding Resident Rights— 

Long Term Care Facilities (§ 483.10) 

Proposed § 483.10(c)(1) would require 

that at the time of admission, a LTC 

facility must inform all Medicare 

beneficiaries by written notice of their 

right to file a written complaint with the 

QIO in the State where services are 

being or were provided about the 

quality of care they are receiving or have 

received. Proposed § 483.10(c)(3) would 

require the LTC facility to document 

that the written notice was presented to 

the beneficiary, beneficiary’s 

representative or surrogate. The burden 

associated with these requirements is 

the time and effort associated with 

developing and distributing a standard 

written notice and documenting the 

distribution of the notice. 

We believe 15,727 LTC facilities must 

comply with these requirements. We 

estimate that proposed § 483.10 will 

impose a one-time 2 hour burden for the 

development of a standard written 

notice containing the name, address, 

and telephone number of the QIO. The 

total burden associated with this task is 

31,454 hours. Similarly, we estimate 

that each LTC facility will distribute 

approximately 89 notices per year for a 

total of 1,399,703 annual notices. We 

estimate that it will take a total of 5 

minutes to notify the beneficiary, the 

beneficiary’s representative or surrogate 

and to document the distribution of the 

notice. The estimated annual burden for 

this requirement is 116,642 hours. The 

total estimated annual burden 

associated with all of the requirements 

in proposed § 483.10 is 148,096 hours. 

The total cost associated with this 

requirement is $5,623,716. 

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E. ICRs Regarding Condition of 

Participation: Patient Rights—Home 

Health Agencies (§ 484.10) 

Proposed § 484.10(c)(1) would require 

that at the time of initiation of 

treatment, an HHA must inform all 

Medicare beneficiaries by written notice 

of their right to file a written complaint 

with the QIO in the State where services 

are being or were provided about the 

quality of care they are receiving or have 

received. Proposed § 484.10(c)(3) would 

require the HHA to document that the 

written notice was presented to the 

beneficiary, beneficiary’s representative 

or surrogate. The burden associated 

with these requirements is the time and 

effort associated with developing and 

distributing a standard written notice 

and to document the distribution of the 

notice. 

We believe 9,787 HHAs must comply 

with these requirements. We estimate 

that proposed § 484.10 will impose a 

one-time 2 hour burden for the 

development of a standard written 

notice containing the name, address, 

and telephone number of the QIO. The 

total burden associated with this task is 

19,574 hours. Similarly, we estimate 

that each HHA will distribute 

approximately 625 notices per year for 

a total of 6,116,875 annual notices. We 

estimate that it will take a total of 5 

minutes to notify the beneficiary, 

beneficiary’s representative or surrogate 

and to document the distribution of the 

notice. The estimated annual burden for 

this requirement is 509,739 hours. The 

total estimated annual burden 

associated with all of the requirements 

in proposed § 484.10 is 529,313 hours. 

The total cost associated with this 

requirement is $18,799,991. 

F. ICRs Regarding Condition of 

Participation: Governing Body and 

Administration—Comprehensive 

Outpatient Rehabilitation Facilities 

(§ 485.56) 

Proposed § 485.56(e)(11) would 

require that the CORF provide patients 

with the address and telephone number 

of the State survey agency to report 

complaints. Proposed § 485.56(g)(1) 

would require that at the time of 

initiation of treatment, a CORF must 

inform all Medicare beneficiaries by 

written notice of their right to file a 

written complaint to the QIO in the 

State where services are being or were 

provided about the quality of care they 

are receiving or have received. Proposed 

§ 485.56(g)(3) would require the CORF 

to document that the written notice was 

presented to the beneficiary, 

beneficiary’s representative or surrogate. 

The burden associated with these 

requirements is the time and effort 

associated with developing and 

distributing a standard written notice 

and documenting the distribution of the 

notice. 

We believe 476 CORFs must comply 

with these requirements. We estimate 

that proposed § 485.56 will impose a 

one-time 2 hour burden for the 

development of a standard written 

notice containing the address and 

telephone number of the State survey 

agency and the name, address, and 

telephone number of the QIO. The total 

burden associated with this task is 952 

hours. Similarly, we estimate that each 

CORF will distribute approximately 13 

notices per year for a total of 6,118 

annual notices. We estimate that it will 

take a total of 5 minutes to notify the 

beneficiary, the beneficiary’s 

representative or surrogate and to 

document distribution of the notice. The 

estimated annual burden for this 

requirement is 516 hours. The total 

estimated annual burden associated 

with all of the requirements in proposed 

§ 485.56 is 1,468 hours. The total cost 

associated with this requirement is 

$64,708. 

G. ICRs Regarding Condition of 

Participation: Organizational 

Structure—Critical Access Hospitals 

(§ 485.627) 

Proposed § 485.627(c) would require 

that the CAHs provide all patients with 

the address and telephone number of 

the State survey agency to report 

complaints. Proposed § 485.627(d)(1) 

would require that at the time of service, 

the CAH must inform all outpatient 

Medicare beneficiary patients by written 

notice of their right to file a written 

complaint to the QIO in the State where 

services are being or were provided 

about the quality of care they are 

receiving or have received. Proposed 

§ 485.627(d)(3) would require the CAH 

to document that the written notice was 

presented to the beneficiary, 

beneficiary’s representative or surrogate. 

The burden associated with these 

requirements is the time and effort 

associated with developing and 

distributing a standard written notice 

and documenting the distribution of the 

notice. 

We believe a total of 1310 CAHs must 

comply with these requirements. We 

estimate that proposed § 485.627 will 

impose a one-time 2 hour burden for the 

development of a standard written 

notice containing the address and 

telephone number of the State survey 

agency and the name, address, and 

telephone number of the QIO. The total 

burden associated with this task is 2620 

hours. Similarly, we estimate that each 

CAH will distribute approximately 1000 

notices per year for a total of 1,310,000 

annual notices. We estimate that it will 

take a total of 5 minutes to notify the 

beneficiary, the beneficiary’s 

representative or surrogate and to 

document distribution of the notice for 

a total annual burden of 109,167. The 

estimated annual burden associated 

with all of the requirements in proposed 

§ 485.627 is 111,787 hours. The total 

cost associated with this requirement is 

$3,949,225. 

H. ICRs Regarding Condition of 

Participation: Administrative 

Management—Clinic and Rehabilitation 

Agencies (§ 485.709) 

Proposed § 485.709(e) would require 

that the clinic or rehabilitation agency 

provide patients with the address and 

telephone number of the State survey 

agency to report complaints. Proposed 

§ 485.709(f)(1) would require that at the 

time of initiation of treatment, the clinic 

or rehabilitation agency must inform all 

Medicare beneficiaries by written notice 

of their right to file a written complaint 

with the QIO in the State where services 

are being or were provided about the 

quality of care they are receiving or have 

received. Proposed § 485.709(f)(3) 

would require the clinic, or 

rehabilitation agency to document that 

the written notice was presented to the 

beneficiary, beneficiary’s representative 

or surrogate. The burden associated 

with these requirements is the time and 

effort associated with developing and 

distributing a standard written notice 

and documenting the distribution of the 

notice. 

We believe a total of 2,781 clinics and 

rehabilitation agencies must comply 

with these requirements. We estimate 

that proposed § 485.709 will impose a 

one-time 2 hour burden for the 

development of a standard written 

notice containing the address and 

telephone number of the State survey 

agency and the name, address, and 

telephone number of the QIO. The total 

burden associated with this task is 5,562 

hours. Similarly, we estimate that each 

clinic or rehabilitation agency will 

distribute approximately 1,084 notices 

per year for a total of 3,014,604 annual 

notices. We estimate that it will take a 

total of 5 minutes to notify the 

beneficiary, the beneficiary’s 

representative or surrogate and to 

document distribution of the notice. The 

estimated annual burden for this 

requirement is 251,217 hours at a cost 

of $8,792,595. The total estimated 

annual burden associated with all of the 

requirements in proposed § 485.709 is 

256,779 hours. The total cost associated 

with this requirement is $9,065,133. 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

5764 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 

I. ICRs Regarding Condition for 

Coverage: Referral for service and 

preservation of records—Portable X-ray 

Services (§ 486.106) 

Proposed § 486.106(d) would require 

that the supplier of portable x-ray 

services provide patients with the 

address and telephone number of the 

State survey agency to report 

complaints. Proposed § 486.106(e)(1) 

would require that at the time that 

services are provided, a supplier of 

portable x-ray services must inform all 

Medicare beneficiaries by written notice 

of their right to file a written complaint 

about the quality of care they are 

receiving or have received to the QIO in 

the State where services are being or 

were provided. Proposed § 486.106(e)(3) 

would require the supplier of portable 

x-ray services to document that the 

written notice was presented to the 

beneficiary, beneficiary’s representative 

or surrogate. The burden associated 

with these requirements is the time and 

effort associated with developing and 

distributing a standard written notice 

and documenting the distribution of the 

notice. 

We believe 547 suppliers of portable 

x-ray services must comply with these 

requirements. We estimate that 

proposed § 486.106 will impose a onetime 2 hour burden for the development 

of a standard written notice containing 

the address and telephone number of 

the State survey agency and the name, 

address, and telephone number of the 

QIO. The total burden associated with 

this task is 1,094 hours at a cost of 

$53,606. Similarly, we estimate that 

each supplier of portable x-ray services 

will distribute approximately 2,437 

notices per year for a total of 1,333,039 

annual notices. We estimate that it will 

take a total of 5 minutes to notify the 

beneficiary, the beneficiary’s 

representative or surrogate and to 

document distribution of the notice. The 

estimated annual burden for this 

requirement is 111,086 hours at a cost 

of $3,888,010. The total estimated 

annual burden associated with all of the 

requirements in proposed § 486.106 is 

112,180 hours. The total cost associated 

with this requirement is $3,941,616. 

J. ICRs Regarding Provision of 

Services—Rural Health Clinics or 

Federally Qualified Health Centers 

(§ 491.9) 

Proposed § 491.9(e) would require 

that the RHC or FQHC provide patients 

with the address and telephone number 

of the State survey agency to report 

complaints. Proposed § 491.9(f)(1) 

would require that at the time of service, 

an RHC or FQHC must inform all 

Medicare beneficiaries by written notice 

of their right to file a written complaint 

with the QIO in the State where services 

are being or were provided about the 

quality of care they are receiving or have 

received. Proposed § 491.9(f)(3) would 

require the RHC or FQHC to document 

that the written notice was presented to 

the beneficiary, beneficiary’s 

representative or surrogate. The burden 

associated with these requirements is 

the time and effort associated with 

developing and distributing a standard 

written notice and documenting the 

distribution of the notice. 

We believe a total of 8,142 RHCs or 

FQHCs must comply with these 

requirements. We estimate that 

proposed § 491.9 will impose a one-time 

2 hour burden for the development of a 

standard written notice containing the 

address and telephone number of the 

State survey agency to report complaints 

and the name, address, and telephone 

number of the QIO. The total burden 

associated with this task is 16,284 hours 

at a cost of $797,916. Similarly, we 

estimate that each RHC or FQHC will 

distribute approximately 8 notices per 

year for a total of 65,136 annual notices. 

We estimate that it will take a total of 

5 minutes to notify the beneficiary, the 

beneficiary’s representative or surrogate 

and to document distribution of the 

notice. The estimated annual burden for 

this requirement is 5,428 hours at a cost 

of $189,980. The total estimated annual 

burden associated with all of the 

requirements in proposed § 491.9 is 

21,712 hours. The total cost associated 

with this requirement is $987,896. 

TABLE 1—ESTIMATED ANNUAL BURDEN FOR RECORDKEEPING AND REPORTING REQUIREMENTS

Regulation 

section 

OMB Control 

No. Respondents Responses Burden per response (hours) 

Total annual 

burden 

(hours) 

Hourly labor 

cost of 

reporting ($) 

Total labor 

cost of 

reporting ($) 

Total capital/ 

maintenance 

costs ($) 

Total costs 

($) 

§ 416.50(c)(1) ..... 0938–New ...... 5,174 5,174 2 10,348 49 507,052 0 507,052 

§ 416.50(c)(3) ..... 0938–New ...... 5,174 6,332,976 .0833 527,748 35 18,471,180 0 18,471,180 

§ 418.52(c)(9) & 

(d)(1).

0938–New ...... 3,346 3,346 2 6,692 49 327,908 0 327,908 

§ 418.52(d)(3) ..... 0938–New ...... 3,346 1,050,644 .0833 87,554 35 3,064,390 0 3,064,390 

§ 482.13(a)(i) ...... 0938–New ...... 4,859 4,859 1 4,859 49 238,091 0 238,091 

§§ 482.13(a)(1)(ii) 0938–New ...... 4,859 4,859 2 9,718 49 476,182 0 476,182 

§ 482.13(a)(1)(ii) 0938–New ...... 4,859 1,107,852 .0833 92,321 35 3,231,235 0 3,231,235 

§ 483.10(c)(1) ..... 0938–New ...... 15,727 15,727 2 31,454 49 1,541,246 0 1,541,246 

§ 483.10(c)(3) ..... 0938–New ...... 15,727 1,399,703 .0833 116,642 35 4,082,470 0 4,082,470 

§ 484.10(c)(1) ..... 0938–New ...... 9,787 9,787 2 19,574 49 959,126 0 959,126 

§ 484.10(c)(3) ..... 0938–New ...... 9,787 6,116,875 .0833 509,739 35 17,840,865 0 17,840,865 

§ 485.56(e)(11) & 

(g)(1).

0938–New ...... 476 476 2 952 49 46,648 0 46,648 

§ 485.56(g)(3) ..... 0938–New ...... 476 6,188 .0833 516 35 18,060 0 18,060 

§ 485.627(c) & 

(d)(1).

0938–New ...... 1,310 1,310 2 2,620 49 128,380 0 128,380 

§ 485.627(d)(3) ... 0938–New ...... 1,310 1,310,000 .0833 109,167 35 3,820,845 0 3,820,845 

§ 485.709(e) & 

(f)(1).

0938–New ...... 2,781 2,781 2 5,562 49 272,538 0 272,538 

§ 485.709(f)(3) .... 0938–New ...... 2,781 3,014,604 .0833 251,217 35 8,792,595 0 8,792,595 

§ 486.106(d) & 

(e)(1).

0938–New ...... 547 547 2 1,094 49 53,606 0 53,606 

§ 486.106(e)(3) ... 0938–New ...... 547 1,333,039 .0833 111,086 35 3,888,010 0 3,888,010 

§ 491.9(e) & (f)(1) 0938–New ...... 8,142 8,142 2 16,284 49 797,916 0 797,916 

§ 491.9(f)(3) ........ 0938–New ...... 8,142 65,136 .0833 5,428 35 189,980 0 189,980 

Total ............ ........................ 52,149 21,794,025 ........................ 1,920,575 ...................... ...................... ...................... 68,748,323 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 5765 

We have submitted a copy of this 

proposed rule to OMB for its review of 

the information collection requirements 

contained within this document. These 

requirements are not effective until they 

are approved by OMB. 

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–3225–P; Fax: (202) 395–6974; or 

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

V. 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. 

VI. Regulatory Impact Statement (or 

Analysis) 

A. Overall Impact 

We have examined the impact of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and Executive Order 13132. 

Executive Order 12866 (as amended 

by Executive Order 13258, which 

merely reassigns responsibility of 

duties) directs agencies to assess all 

costs and benefits or 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 

have examined the impact of this 

proposed rule, and we have determined 

that this rule is neither expected to meet 

the criteria to be considered 

economically significant, nor do we 

believe it will meet the criteria for a 

major rule. 

This proposed rule would set forth 

new requirements for certain Medicare 

certified providers and suppliers that do 

not provide hospital in-patient care. 

This rule will implement regulations 

that are intended to increase awareness 

by Medicare beneficiaries of their right 

to contact the QIO in their State about 

the quality of care they are currently 

receiving or have received. In addition, 

the Medicare certified providers and 

suppliers would be required to provide 

their Medicare beneficiaries with 

written notice of the QIOs contact 

information, and document that the 

written notice was presented to the 

beneficiary, beneficiary’s representative 

or surrogate. The RFA requires agencies 

to analyze options for regulatory relief 

of small entities. For purposes of the 

RFA, small entities include small 

businesses, nonprofit organizations, and 

small government jurisdictions. 

Individuals and States are not included 

in the definition of small entity. Most 

Medicare certified providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $6 million to $29 million in any 1 

year. For purposes of the RFA, most 

entities affected by this proposed rule 

are considered small businesses 

according to the Small Business 

Administration’s size standards, with 

total revenues of $29 million or less in 

any 1 year (for details, see 65 FR 96432). 

We are not preparing analyses for either 

the RFA or section 1102(b) of the Act 

because we have determined, and we 

certify, that this rule will not have a 

significant economic impact on a 

substantial number of small entities or 

a significant impact on the operations of 

a substantial number of small rural 

facilities. 

Section 202 of the unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule that may result in expenditures in 

any year by state, local or tribal 

governments, in the aggregate, or by the 

private sector, of $120 million. This rule 

has no impact on the expenditures of 

State, local, or tribal governments, and 

the impact on the private sector is 

estimated to be less than $120 million. 

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 rule will not have any effect on 

State and local governments and does 

not have any Federalism implications. 

B. Anticipated Effects 

As described in the preamble, the 

proposed regulation will require ten 

different Medicare certified providers 

and suppliers to notify their Medicare 

beneficiaries by written notice of their 

right to contact the QIO in the State 

where services are being or were 

provided about the quality of care they 

are receiving or have received. Six of the 

eleven Medicare certified providers and 

suppliers that would be affected by this 

proposed rule already have a current 

patient rights condition that would be 

amended by this proposed rule. We 

believe that those Medicare certified 

providers and suppliers will be able to 

incorporate the proposed requirements 

into their normal business practices, 

and that the requirements will not 

present a significant additional 

workflow burden. 

All Medicare certified providers and 

suppliers covered by this proposed rule 

would have to meet the notification of 

QIO rights standard by informing 

Medicare beneficiaries by written notice 

at the start of care (or for some providers 

or suppliers, at the time of inpatient 

admission or at an initial assessment 

visit in advance of furnishing care) of 

their right to file a written complaint to 

the QIO in the State where services are 

being or were provided regarding the 

quality of care they are receiving or have 

received. The written notice must 

contain the name of the QIO, its mailing 

address, electronic address and 

telephone number. 

We recognize that in describing the 

effect of this rule on the different 

Medicare certified providers and 

suppliers, suggested burden estimates 

may not accurately reflect the 

experience of all of them. Facilities vary 

in the complexity of operations and 

processes, and therefore, associated 

costs may differ. 

Table 2 contains data that is 

frequently used in this impact 

statement. The salary-related cost data is 

referenced from the Salarywizard.com 

Web site at http:// 

hrsalarycenter.salary.com. 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

5766 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 

TABLE 2—ASSUMPTIONS AND ESTIMATES USED THROUGHOUT THE IMPACT ANALYSIS SECTION

Provider or supplier type 

Number of 

providers or 

suppliers 

Estimated annual 

Medicare beneficiary notifications 

Clinics, Rehab agencies, Outpatient Physical Therapy .............................................................................. 2,781 3,014,604 

Comprehensive Outpatient Rehabilitation Facilities .................................................................................... 476 6,188 

Home Health Agencies ................................................................................................................................ 9,787 6,116,875 

Hospices ...................................................................................................................................................... 3,346 1,050,644 

Long Term Care Facilities ........................................................................................................................... 15,727 1,399,703 

Hospitals ...................................................................................................................................................... 4,859 1,107,852 

Critical Access Hospitals ............................................................................................................................. 1,310 1,310,000 

Ambulatory Surgical Centers ....................................................................................................................... 5,174 6,332,976 

Portable X-ray Services ............................................................................................................................... 547 1,333,039 

Rural Health Clinics and Federally Qualified Health Centers ..................................................................... 8,142 65,136 

Job description/title Hourly rate 

Administrator ......................... $49 

Registered Nurse .................. 35 

Note: All salary estimates include a benefits 

package worth 30% of the fringe base salary. 

We estimate that an administrator, 

earning $49.00 per hour, would be 

largely responsible for developing the 

written notice and ensuring the 

accuracy of the information that will be 

given to Medicare beneficiaries. We 

believe that Medicare certified providers 

and suppliers will use the approved 

Federal IM notice as an example to 

develop their written notice in order to 

avoid time spent on re-creating a similar 

document. We estimate that the onetime cost for one provider or supplier to 

develop and implement Medicare 

beneficiary notification of QIO rights 

and State agency contact information 

will be approximately 2 hours at $49.00 

per hour for a total cost of $98.00. 

We estimate that it will take a 

registered nurse approximately five 

minutes to provide each Medicare 

beneficiary with the written notice and 

document that the written notice was 

presented to the beneficiary, 

beneficiary’s representative or surrogate. 

At the average hourly rate for a 

registered nurse ($35.00), it will cost $3 

per patient to fulfill the requirement. 

The total cost to implement the 

requirement of presenting and 

documenting the written QIO notice to 

the Medicare Beneficiary for all ten 

Medicare certified providers and 

suppliers would be $68,748,323. 2 hours 

× $49 an hour = $98. $35 hour/60 

minutes = $0.58 minutes × 5 minutes = 

$3. 

TABLE 3—MEDICARE BENEFICIARY NOTIFICATION OF QIO RIGHTS BURDEN ASSESSMENT

Provider or supplier type Time per 

patient (min.) 

Time for all 

patients 

(hours) 

Cost per 

patient 

Cost for all 

patients 

Clinics, Rehab Agencies, Outpatient Physical Therapy .................................. 5 251,117 $3.00 $9,065,133 

Critical Access Hospitals ................................................................................. 5 109,167 3.00 3,949,225 

Comprehensive Outpatient Rehabilitation Facilities ........................................ 5 516 3.00 64,708 

Home Health Agencies .................................................................................... 5 509,739 3.00 18,799,991 

Hospices .......................................................................................................... 5 87,554 3.00 3,392,298 

Hospitals .......................................................................................................... 5 92,231 3.00 3,707,417 

Long term Care Facilities ................................................................................. 5 116,642 3.00 5,623,716 

Ambulatory Surgical Centers ........................................................................... 5 527,748 3.00 18,978,232

Portable X-ray Services ................................................................................... 5 111,086 3.00 3,941,616 

Rural Health Clinics & Federally Qualified Health Centers ............................. 5 5,428 3.00 987,896 

Total Cost (including one-time development of the QIO written notice) .. N/A N/A N/A 68,748,323 

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 418 

Health facilities, Hospice care, 

Medicare, 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 484 

Health facilities, Health professions, 

Medicare, Reporting and recordkeeping 

requirements. 

42 CFR Part 485 

Grant programs—health, Health 

facilities, Medicaid, Medicare, 

Reporting and recordkeeping 

requirements. 

Critical Access Hospitals? 

42 CFR Part 486 

Grant programs—health, Health 

facilities, Medicare, Reporting and 

recordkeeping requirements, X-rays. 

42 CFR Part 491 

Grant programs—health, Health 

facilities, Medicaid, Medicare, 

Reporting and recordkeeping 

requirements, Rural areas. 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 5767 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services propose to amend 42 

CFR chapter IV 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 amended by 

redesignating paragraphs (c) and (d) as 

paragraphs (d) and (e), respectively, and 

adding a new paragraph (c) to read as 

follows: 

§ 416.50 Condition for coverage—Patient 

rights. 

* * * * * 

(c) Standard: Notification of the right 

to access a Quality Improvement 

Organization (QIO). (1) At the time of 

admission, the ASC must inform all 

Medicare beneficiaries by written notice 

of their right to file a written complaint 

with the QIO in the State where services 

are being or were provided about the 

quality of care they are receiving or have 

received. 

(2) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(3) The ASC must document in the 

beneficiary’s record that the written 

notice was presented to the beneficiary 

or beneficiary’s representative or 

surrogate. 

* * * * * 

PART 418—HOSPICE CARE 

3. The authority citation for part 418 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

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

1395hh). 

Subpart C—Conditions of 

Participation: Patient Care 

4. Section 418.52 is amended by 

adding paragraphs (c)(9) and (d) to read 

as follows: 

§ 418.52 Condition of participation: 

Patient’s rights. 

* * * * * 

(c) * * * 

(9) Receive the mailing address, 

electronic mail address, and telephone 

number of the State survey agency to 

report complaints. 

(d) Standard: Notification of the right 

to access a Quality Improvement 

Organization (QIO). (1) During the 

initial assessment visit in advance of 

furnishing care, the hospice must 

inform all Medicare beneficiaries by 

written notice of their right to file a 

written complaint with the QIO in the 

State where services are being or were 

provided about the quality of care they 

are receiving or have received to the 

QIO in the State where services are 

being or were provided. 

(2) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(3) The hospice must document in the 

beneficiary’s record that the written 

notice was presented to the beneficiary 

or beneficiary’s representative or 

surrogate. 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

5. 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 B—Administration 

6. Section 482.13 is amended by 

adding paragraphs (a)(1)(i) and (ii) to 

read as follows: 

§ 482.13 Condition of participation: 

Patients rights. 

(a) * * * 

(1) * * * 

(i) The hospital must provide all 

patients with the mailing address, 

electronic mail address and telephone 

number of the State survey agency to 

report complaints. 

(ii) At the time of inpatient admission 

or outpatient service, the hospital must 

inform all Medicare beneficiaries by 

written notice of their right to file a 

written complaint with the QIO in the 

State where services are being or were 

provided about the quality of care they 

are receiving or have received. 

(A) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(B) The hospital must document in 

the beneficiary’s record that the written 

notice was presented to the beneficiary 

or beneficiary’s representative or 

surrogate. 

PART 483—REQUIREMENTS FOR 

STATES AND LONG TERM CARE 

FACILITIES 

8. 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 Long 

Term Care Facilities 

9. Section 483.10 is amended by— 

A. Redesignating paragraphs (c) 

through (o) as paragraphs (d) through 

paragraphs (p). 

B. Adding a new paragraph (c). 

The addition reads as follows: 

§ 483.10 Resident rights. 

* * * * * 

(c) Standard: Notification of the right 

to access a Quality Improvement 

Organization (QIO). (1) At the time of 

admission, the LTC facility must inform 

all Medicare beneficiaries by written 

notice of their right to file a written 

complaint with the QIO in the State 

where services are being or were 

provided about the quality of care they 

are receiving or have received. 

(2) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(3) The LTC facility must document in 

the beneficiary’s record that the written 

notice was presented to the beneficiary 

or beneficiary’s representative or 

surrogate. 

* * * * * 

PART 484—HOME HEALTH SERVICES 

10. The authority citation for part 484 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

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

1395(hh)) unless otherwise indicated. 

Subpart B—Administration 

11. Section 484.10 is amended by— 

A. Redesignating paragraphs (c) 

through (f) as paragraphs (d) through (g). 

B. Adding a new paragraph (c). 

The addition reads as follows: 

§ 484.10 Condition of participation: Patient 

rights. 

* * * * * 

(c) Standard: Notification of the right 

to access a Quality Improvement 

Organization (QIO). (1) At the time of 

initiation of treatment, the HHA must 

inform all Medicare beneficiaries by 

written notice of their right to file a 

written complaint with the QIO in the 

State where services are being or were 

provided about the quality of care they 

are receiving or have received. 

(2) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(3) The HHA must document in the 

beneficiary’s record that the written 

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5768 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 

notice was presented to the beneficiary 

or beneficiary’s representative or 

surrogate. 

* * * * * 

PART 485—CONDITIONS OF 

PARTICIPATION: SPECIALIZED 

PROVIDERS 

12. 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 B—Conditions of 

Participation: Comprehensive 

Outpatient Rehabilitation Facilities 

13. Section 485.56 is amended by 

adding paragraphs (e)(11) and (g) to read 

as follows: 

§ 485.56 Condition of participation: 

Governing body and administration. 

* * * * * 

(e) * * * 

(11) A requirement that patients 

receive the mailing address, electronic 

mail address, and telephone number of 

the State survey agency to report 

complaints. 

(g) Standard: Notification of the right 

to access a Quality Improvement 

Organization (QIO). (1) At the time of 

initiation of treatment, the CORF must 

inform all Medicare beneficiaries by 

written notice of their right to file a 

written complaint with the QIO in the 

State where services are being or were 

provided about the quality of care they 

are receiving or have received. 

(2) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(3) The CORF must document in the 

beneficiary’s record that the written 

notice was presented to the beneficiary 

or beneficiary’s representative or 

surrogate. 

Subpart F—Conditions of 

Participation: Critical Access Hospitals 

(CAHs) 

14. Section 485.627 is amended by 

adding paragraphs (c) and (d) to read as 

follows: 

§ 485.627 Condition of participation: 

Organizational structure. 

* * * * * 

(c) Standard: Patient complaints. The 

CAH must provide all hospital 

outpatients with the mailing address, 

electronic mail address and telephone 

number of the State survey agency to 

report complaints. 

(d) Standard: Notification of the right 

to access a Quality Improvement 

Organization (QIO). (1) At the time of 

service, the CAH must inform all 

outpatient Medicare beneficiaries by 

written notice of their right to file a 

written complaint with the QIO in the 

State where services are being or were 

provided about the quality of care they 

are receiving or have received. 

(2) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(3) The CAH must document in the 

beneficiary’s record that the written 

notice was presented to the beneficiary 

or beneficiary’s representative or 

surrogate. 

Subpart H—Conditions of Participation 

for Clinics, Rehabilitation Agencies, 

and Public Health Agencies as 

Providers of Outpatient Physical 

Therapy and Speech-Language 

Pathology Services 

15. Section 485.709 is amended by 

adding paragraphs (e) and (f) to read as 

follows: 

§ 485.709 Condition of participation: 

Administrative management. 

* * * * * 

(e) Standard: Patient complaints. The 

clinic or rehabilitation agency must 

provide patients with the mailing 

address, electronic mail address, and 

telephone number of the State survey 

agency to report complaints. 

(f) Standard: Notification of the right 

to access a Quality Improvement 

Organization (QIO). (1) At the time of 

initiation of treatment, the clinic or 

rehabilitation agency must inform all 

Medicare beneficiaries by written notice 

of their right to file a written complaint 

with the QIO in the State where services 

are being or were provided about the 

quality of care they are receiving or have 

received. 

(2) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(3) The clinic or rehabilitation agency 

must document in the beneficiary’s 

record that the written notice was 

presented to the beneficiary or 

beneficiary’s representative or surrogate. 

PART 486—CONDITIONS FOR 

COVERAGE OF SPECIALIZED 

SERVICES FURNISHED BY 

SUPPLIERS 

17. 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 C—Conditions for Coverage: 

Portable X-Ray Services 

18. Section 486.106 is amended by 

adding paragraphs (d) and (e) to read as 

follows: 

§ 486.106 Condition for coverage: Referral 

for service and preservation of records. 

* * * * * 

(d) Standard: Patient complaints. The 

supplier of portable x-ray services must 

provide patients with the mailing 

address, electronic mail address, and 

telephone number of the State survey 

agency to report complaints. 

(e) Standard: Notification of the right 

to access a Quality Improvement 

Organization (QIO). (1) At the time 

services are provided, the supplier of 

portable x-ray services must inform all 

Medicare beneficiaries by written notice 

of their right to file a written complaint 

with the QIO in the State where services 

are being or were provided about the 

quality of care they are receiving or have 

received. 

(2) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(3) The supplier of portable x-ray 

services must document in the 

beneficiary’s record that the written 

notice was presented to the beneficiary 

or beneficiary’s representative or 

surrogate. 

PART 491—CERTIFICATION OF 

CERTAIN HEALTH FACILITIES 

19. 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 

20. Section 491.9 is amended by 

adding paragraphs (e) and (f) to read as 

follows: 

§ 491.9 Provision of services. 

* * * * * 

(e) Standard: Patient complaints. The 

clinic or center must provide patients 

with the mailing address, electronic 

mail address, and telephone number of 

the State survey agency to report 

complaints. 

(f) Standard: Notification of the right 

to access a Quality Improvement 

Organization (QIO). (1) At the time of 

service, the clinic or center must inform 

all Medicare beneficiaries by written 

notice of their right to file a written 

complaint with the QIO in the State 

where services are being or were 

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Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Proposed Rules 5769 

provided about the quality of care they 

are receiving or have received. 

(2) The written notice must contain 

the name of the QIO, its mailing 

address, electronic mail address, and 

telephone number. 

(3) The clinic or center must 

document in the beneficiary’s record 

that the written notice was presented to 

the beneficiary or beneficiary’s 

representative or surrogate. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) (Catalog of Federal 

Domestic Assistance Program No. 93.778, 

Medical Assistance Program) 

Dated: August 26, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: January 27, 2011 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2011–2275 Filed 2–1–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2011–0002; Internal 

Agency Docket No. FEMA–B–1174] 

Proposed Flood Elevation 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Proposed rule. 

SUMMARY: Comments are requested on 

the proposed Base (1% annual-chance) 

Flood Elevations (BFEs) and proposed 

BFE modifications for the communities 

listed in the table below. The purpose 

of this proposed rule is to seek general 

information and comment regarding the 

proposed regulatory flood elevations for 

the reach described by the downstream 

and upstream locations in the table 

below. The BFEs and modified BFEs are 

a part of the floodplain management 

measures that the community is 

required either to adopt or to show 

evidence of having in effect in order to 

qualify or remain qualified for 

participation in the National Flood 

Insurance Program (NFIP). In addition, 

these elevations, once finalized, will be 

used by insurance agents and others to 

calculate appropriate flood insurance 

premium rates for new buildings and 

the contents in those buildings. 

DATES: Comments are to be submitted 

on or before May 3, 2011. 

ADDRESSES: The corresponding 

preliminary Flood Insurance Rate Map 

(FIRM) for the proposed BFEs for each 

community is available for inspection at 

the community’s map repository. The 

respective addresses are listed in the 

table below. 

You may submit comments, identified 

by Docket No. FEMA–B–1170, to Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–4064, or (e-mail) 

luis.rodriguez1@dhs.gov. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–4064, or (e-mail) 

luis.rodriguez1@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) proposes to make 

determinations of BFEs and modified 

BFEs for each community listed below, 

in accordance with section 110 of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4104, and 44 CFR 67.4(a). 

These proposed BFEs and modified 

BFEs, together with the floodplain 

management criteria required by 44 CFR 

60.3, are the minimum that are required. 

They should not be construed to mean 

that the community must change any 

existing ordinances that are more 

stringent in their floodplain 

management requirements. The 

community may at any time enact 

stricter requirements of its own or 

pursuant to policies established by other 

Federal, State, or regional entities. 

These proposed elevations are used to 

meet the floodplain management 

requirements of the NFIP and also are 

used to calculate the appropriate flood 

insurance premium rates for new 

buildings built after these elevations are 

made final, and for the contents in those 

buildings. 

Comments on any aspect of the Flood 

Insurance Study and FIRM, other than 

the proposed BFEs, will be considered. 

A letter acknowledging receipt of any 

comments will not be sent. 

National Environmental Policy Act. 

This proposed rule is categorically 

excluded from the requirements of 44 

CFR part 10, Environmental 

Consideration. An environmental 

impact assessment has not been 

prepared. 

Regulatory Flexibility Act. As flood 

elevation determinations are not within 

the scope of the Regulatory Flexibility 

Act, 5 U.S.C. 601–612, a regulatory 

flexibility analysis is not required. 

Executive Order 12866, Regulatory 

Planning and Review. This proposed 

rule is not a significant regulatory action 

under the criteria of section 3(f) of 

Executive Order 12866, as amended. 

Executive Order 13132, Federalism. 

This proposed rule involves no policies 

that have federalism implications under 

Executive Order 13132. 

Executive Order 12988, Civil Justice 

Reform. This proposed rule meets the 

applicable standards of Executive Order 

12988. 

List of Subjects in 44 CFR Part 67 

Administrative practice and 

procedure, Flood insurance, Reporting 

and recordkeeping requirements. 

Accordingly, 44 CFR part 67 is 

proposed to be amended as follows: 

PART 67—[AMENDED] 

1. The authority citation for part 67 

continues to read as follows: 

Authority: 42 U.S.C. 4001 et seq.; 

Reorganization Plan No. 3 of 1978, 3 CFR, 

1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 

3 CFR, 1979 Comp., p. 376. 

§ 67.4 [Amended] 

2. The tables published under the 

authority of § 67.4 are proposed to be 

amended as follows: 

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