Federal Register, Volume 76 Issue 22 (Wednesday, February 2, 2011)

[Federal Register Volume 76, Number 22 (Wednesday, February 2, 2011)]
[Proposed Rules]
[Pages 5755-5769]
From the Federal Register Online via the Government Publishing 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 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

[[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 http://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 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 Sec. 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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Hourly labor Total labor Total
Burden per Total annual cost of cost of capital/ Total costs
Regulation section OMB Control No. Respondents Responses response burden reporting reporting maintenance ($)
(hours) (hours) ($) ($) costs ($)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 416.50(c)(1).......................... 0938-New........................ 5,174 5,174 2 10,348 49 507,052 0 507,052
Sec. 416.50(c)(3).......................... 0938-New........................ 5,174 6,332,976 .0833 527,748 35 18,471,180 0 18,471,180
Sec. 418.52(c)(9) & (d)(1)................. 0938-New........................ 3,346 3,346 2 6,692 49 327,908 0 327,908
Sec. 418.52(d)(3).......................... 0938-New........................ 3,346 1,050,644 .0833 87,554 35 3,064,390 0 3,064,390
Sec. 482.13(a)(i).......................... 0938-New........................ 4,859 4,859 1 4,859 49 238,091 0 238,091
Sec. Sec. 482.13(a)(1)(ii)................ 0938-New........................ 4,859 4,859 2 9,718 49 476,182 0 476,182
Sec. 482.13(a)(1)(ii)...................... 0938-New........................ 4,859 1,107,852 .0833 92,321 35 3,231,235 0 3,231,235
Sec. 483.10(c)(1).......................... 0938-New........................ 15,727 15,727 2 31,454 49 1,541,246 0 1,541,246
Sec. 483.10(c)(3).......................... 0938-New........................ 15,727 1,399,703 .0833 116,642 35 4,082,470 0 4,082,470
Sec. 484.10(c)(1).......................... 0938-New........................ 9,787 9,787 2 19,574 49 959,126 0 959,126
Sec. 484.10(c)(3).......................... 0938-New........................ 9,787 6,116,875 .0833 509,739 35 17,840,865 0 17,840,865
Sec. 485.56(e)(11) & (g)(1)................ 0938-New........................ 476 476 2 952 49 46,648 0 46,648
Sec. 485.56(g)(3).......................... 0938-New........................ 476 6,188 .0833 516 35 18,060 0 18,060
Sec. 485.627(c) & (d)(1)................... 0938-New........................ 1,310 1,310 2 2,620 49 128,380 0 128,380
Sec. 485.627(d)(3)......................... 0938-New........................ 1,310 1,310,000 .0833 109,167 35 3,820,845 0 3,820,845
Sec. 485.709(e) & (f)(1)................... 0938-New........................ 2,781 2,781 2 5,562 49 272,538 0 272,538
Sec. 485.709(f)(3)......................... 0938-New........................ 2,781 3,014,604 .0833 251,217 35 8,792,595 0 8,792,595
Sec. 486.106(d) & (e)(1)................... 0938-New........................ 547 547 2 1,094 49 53,606 0 53,606
Sec. 486.106(e)(3)......................... 0938-New........................ 547 1,333,039 .0833 111,086 35 3,888,010 0 3,888,010
Sec. 491.9(e) & (f)(1)..................... 0938-New........................ 8,142 8,142 2 16,284 49 797,916 0 797,916
Sec. 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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 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: [email protected].

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.

[[Page 5766]]

Table 2--Assumptions and Estimates Used Throughout the Impact Analysis
Section
------------------------------------------------------------------------
Estimated annual
Number of Medicare
Provider or supplier type providers or beneficiary
suppliers notifications
------------------------------------------------------------------------
Clinics, Rehab agencies, 2,781 3,014,604
Outpatient Physical Therapy......
Comprehensive Outpatient 476 6,188
Rehabilitation Facilities........
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 8,142 65,136
Qualified Health Centers.........
------------------------------------------------------------------------

------------------------------------------------------------------------
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 one-time 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 x $49 an hour = $98. $35 hour/60 minutes
= $0.58 minutes x 5 minutes = $3.

Table 3--Medicare Beneficiary Notification of QIO Rights Burden Assessment
----------------------------------------------------------------------------------------------------------------
Time for all
Provider or supplier type Time per patients Cost per Cost for all
patient (min.) (hours) patient patients
----------------------------------------------------------------------------------------------------------------
Clinics, Rehab Agencies, Outpatient Physical 5 251,117 $3.00 $9,065,133
Therapy........................................
Critical Access Hospitals....................... 5 109,167 3.00 3,949,225
Comprehensive Outpatient Rehabilitation 5 516 3.00 64,708
Facilities.....................................
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 5 5,428 3.00 987,896
Health Centers.................................
---------------------------------------------------------------
Total Cost (including one-time development N/A N/A N/A 68,748,323
of the QIO written notice).................
----------------------------------------------------------------------------------------------------------------

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.

[[Page 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:

Sec. 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:

Sec. 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:

Sec. 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:

Sec. 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:

Sec. 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

[[Page 5768]]

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:

Sec. 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:

Sec. 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:

Sec. 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:

Sec. 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:

Sec. 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

[[Page 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