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, 5755-5769 [2011-2275]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 22 (Wednesday, February 2, 2011)]
[Proposed Rules]
[Pages 5755-5769]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2275]


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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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[[Page 5756]]

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 https://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: https://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

[[Page 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 https://www.iom.edu/Reports/2006/Medicares-Quality-Improvement-Organization-Program-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 Sec.  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

[[Page 5758]]

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-
English-speaking 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 Medicare-certified 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 non-Medicare 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 (Sec.  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 Sec.  416.40 through Sec.  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 
Sec.  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 (Sec.  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.

[[Page 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 Sec.  418.52 through Sec.  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 Sec.  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 (Sec.  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 Sec.  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 Sec.  482.1 through Sec.  482.66.
    We are proposing to amend the patient's rights requirements at 
Sec.  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 Sec.  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 
Sec.  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 (Sec.  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 Sec.  483.1 through Sec.  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 Sec.  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

[[Page 5760]]

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 (Sec.  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 Sec.  
484.1 through Sec.  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 Sec.  
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 (Sec.  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 Sec.  485.50 
through Sec.  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 Sec.  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 (Sec.  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 Sec.  
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 Sec.  485.601 through Sec.  485.647 do 
not contain patient rights requirements. Therefore, we are proposing to 
revise the organizational structure requirements by adding two new 
standards at Sec.  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 (Sec.  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 physical therapy (OPT) and speech-

[[Page 5761]]

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 speech-language 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 speech-language pathology services.
    The current regulations at Sec.  485.701 through Sec.  485.729 do 
not contain patient rights requirements, therefore, we are proposing to 
revise the administrative management requirements by adding two new 
standards at Sec.  485.709(e) and Sec.  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 (Sec.  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 Sec.  486.100 
through Sec.  486.110.
    We are proposing to amend the requirements at Sec.  486.106 by 
adding new standards at Sec.  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 (Sec.  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 non-physician 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 Sec.  491.1 through Sec.  491.11.
    We are proposing to revise the provision of services condition at 
Sec.  491.9 by adding two new standards at Sec.  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:

[[Page 5762]]

A. ICRs Regarding Condition for Coverage: Patient Rights--Ambulatory 
Surgical Centers (ASCs) (Sec.  416.50)

    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 (Sec.  418.52)

    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  418.52 is 94,246 hours. The total cost 
associated with this requirement is $3,392,298.

C. ICRs Regarding Patients Rights--Hospitals (Sec.  482.13)

    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 (Sec.  
483.10)

    Proposed Sec.  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 Sec.  
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 Sec.  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 Sec.  483.10 is 
148,096 hours. The total cost associated with this requirement is 
$5,623,716.

[[Page 5763]]

E. ICRs Regarding Condition of Participation: Patient Rights--Home 
Health Agencies (Sec.  484.10)

    Proposed Sec.  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 Sec.  
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 Sec.  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 Sec.  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 
(Sec.  485.56)

    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 (Sec.  485.627)

    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 (Sec.  485.709)

    Proposed Sec.  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 Sec.  
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 Sec.  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 Sec.  
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 Sec.  485.709 is 256,779 hours. The total 
cost associated with this requirement is $9,065,133.

[[Page 5764]]

I. ICRs Regarding Condition for Coverage: Referral for service and 
preservation of records--Portable X-ray Services (Sec.  486.106)

    Proposed Sec.  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 Sec.  
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 Sec.  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 Sec.  486.106 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 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 Sec.  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 (Sec.  491.9)

    Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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