[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Rules and Regulations]
[Pages 65886-65890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27171]



[[Page 65885]]

Vol. 76

Monday,

No. 205

October 24, 2011

Part III





Department of Health and Human Services





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Centers for Medicare & Medicaid Service





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42 CFR Chapter IV





Medicare and Medicaid Programs; Changes to the Ambulatory Surgical 
Centers Patient Rights Conditions for Coverage; Reform of Hospital and 
Critical Access Hospital Conditions of Participation; Regulatory 
Provisions To Promote Program Efficiency, Transparency, and Burden 
Reduction; Final Rule and Proposed Rules

  Federal Register / Vol. 76 , No. 205 / Monday, October 24, 2011 / 
Rules and Regulations  

[[Page 65886]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Service

42 CFR Part 416

[CMS-3217-F]
RlN 0938-AP93


Medicare Program; Changes to the Ambulatory Surgical Centers 
Patient Rights Conditions for Coverage

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule revises the ambulatory surgical centers (ASCs) 
conditions for coverage (CfC) to allow patient rights information to be 
provided to the patient, the patient's representative, or the patient's 
surrogate prior to the start of the surgical procedure. In addition, we 
made minor changes to the CfC for patient rights requirements, as 
specified in the proposed rule. This final rule reflects the Centers 
for Medicare and Medicaid Services' (CMS') commitment to the general 
principles of the President's Executive Order 13563 released January 
18, 2011, entitled ``Improving Regulation and Regulatory Review.''

DATES: Effective Date: These regulations are effective December 23, 
2011.

FOR FURTHER INFORMATION CONTACT:

Jacqueline Morgan, (410) 786-4282.
Maria Hammel, (410) 786-1775.
Jeannie Miller, (410) 786-3164.

I. Background

    This final rule reflects the Centers for Medicare and Medicaid 
Services' (CMS') commitment to the general principles of the 
President's Executive Order 13563 released January 18, 2011, entitled 
``Improving Regulation and Regulatory Review.'' As the single largest 
payer for health care services in the United States, CMS has a critical 
role in promoting high quality care for Medicare beneficiaries. CMS is 
responsible for ensuring that the conditions for coverage (CfCs) for 
Ambulatory Surgical Centers (ASCs) are adequate to protect and promote 
the health and safety of the individuals treated in ASCs. Any 
regulatory changes that we contemplate consider patient health and 
safety along with the administrative burden placed on Medicare-
participating facilities.
    Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) 
specifies that an ASC must meet health, safety, and other standards 
specified by the Secretary of Health and Human Services (HHS) (the 
Secretary) in regulation if it has an agreement in effect with the 
Secretary to accept payment by Medicare as payment in full for 
Medicare-covered services.
    Substantive requirements are set forth in 42 CFR part 416 subparts 
B and C of our regulations. The regulations at 42 CFR part 416 subpart 
B describe the general conditions and requirements for ASCs. The 
regulations at 42 CFR part 416 subpart C describe the specific CfCs for 
ASCs, which include the health and safety provisions.

II. Provisions of the Proposed Regulation

    On April 23, 2010, we published a proposed rule (75 FR 21207) in 
the Federal Register entitled, ``Medicare Programs; Ambulatory Surgical 
Centers, Conditions for Coverage,'' (hereinafter referred to as ``ASC 
patient rights proposed rule'') in which we proposed to revise one of 
the existing CfCs that ASCs must meet in order to participate in the 
Medicare program. The ASC patient rights proposed rule was based on 
feedback received after the publication of the November 18, 2008 
Hospital Outpatient PPS Update for CY 2009 final rule (73 FR 68502), 
which contained a CfC requiring an ASC to provide notice of patient 
rights in advance of the date of a procedure. We were subsequently 
informed that the CfC notice of patient rights requirement in the 
November 18, 2008 rule presented problems for ASCs that provided same-
day procedures on an emergency basis. In order to address those 
problems, we proposed in the ASC patient rights proposed rule, to 
establish an exception to that CfC that would permit notice of patient 
rights to be provided on the date of the procedure, if an ASC provided 
services to a patient on the same day he or she received a physician 
referral for the ASC service(s), and if a delay in providing the 
service(s) would adversely affect the patient's health. Since 
publishing the ASC patient rights proposed rule on April 23, 2010, we 
have learned that a number of ASCs routinely perform surgeries on the 
same day they receive physician referrals from their patients. ASCs 
that routinely serve same-day patients would like to continue doing so, 
whether the service is being performed on an emergency or non-emergency 
basis. Because we believe scheduling decisions should be between the 
patient and the ASC, rather than dictated by CMS, we are finalizing a 
different policy than we proposed.
    In our ASC patient rights proposed rule at Sec.  416.50(h) 
``Standard: Exception to the timing of the notice of patient rights,'' 
we proposed to include an exception that would allow an ASC, in the 
case of an emergency procedure, when it was not feasible to inform the 
patient or the patient's representative of the patient's rights in 
advance of the date of the procedure, to provide this information to 
the patient or the patient's representative on the day of treatment, 
immediately before the procedure, but only if (1) the signed physician 
referral was in writing, was dated the day the patient presents at the 
ASC, and was placed in the patient's medical record prior to the 
procedure; and (2) a physician in the ASC or the referring physician 
communicated in writing and the ASC documented in the medical record 
that the procedure had to be performed as soon as possible to safeguard 
the health of the patient.
    In addition to proposing to add Sec.  416.50(h) to provide for an 
exception for same day procedures, we proposed other minor revisions to 
Sec.  416.50. Because both Sec.  416.50(a)(1) and (a)(2) include the 
requirement that disclosure of information be made in advance of the 
date of the procedure, we proposed to eliminate this specific 
requirement from these sections and to include it instead in the stem 
statement, which would apply to all of the requirements in Sec.  
416.50.
    Further, we proposed to reorganize Sec.  416.50(a), (b), and (c) by 
creating separate standards for provisions that are currently required 
in these paragraphs. Specifically, we proposed to retitle and 
reorganize the requirement of Sec.  416.50, ``Conditions for coverage--
Patient rights.''

III. Analysis of and Responses to Public Comments

    We received 10 comments on the ASC patient rights proposed rule 
that addressed various issues regarding patient rights in ASCs. 
Approximately 7 comments were from ASCs and 3 comments were received 
from groups representing ASCs. A summary of the major issues and our 
responses follow:
    Comment: Several commenters applauded CMS' recognition of the need 
to address the importance of communicating patients' rights information 
when an ASC is providing services to a patient on the same day the 
patient is referred to the ASC.
    Response: We appreciate the recognition of our intent to ensure 
that important quality of care issues are addressed in our regulations.
    Comment: Several commenters stated the exception is too intrusive 
in requiring that surgeries performed on the same day as the 
physician's referral must be for emergency procedures only.

[[Page 65887]]

These commenters also stated that the restriction could create patient 
scheduling inconveniences and patient travel issues. They believe the 
CfC should be expanded so that urgent (nonemergency) procedures can be 
performed on the same day as the physician referral of the patient.
    Response: We agree with these commenters. The restrictive patient 
rights exception could create patient scheduling inconveniences and 
patient travel issues. After considering the public comments and the 
potential negative impact of the proposed exception on ASC patients, 
their families and ASC operations, we have revised the patient rights 
CfC. In this final rule, we have eliminated proposed Sec.  416.50(h) 
and, at 416.50(a), we have amended the patient rights CfC to specify 
that patient rights information can be provided to the patient prior to 
the start of the surgical procedure. With this new requirement, ASCs 
will have ample time to give the patient and/or the patient's 
representative patient rights information. This revision will provide 
the patient, the patient's provider of transportation, and the ASC with 
the flexibility of having the surgical procedure completed on the same 
day the notice of patient rights is provided, when appropriate. This 
policy promotes ASC health and safety standards by allowing the use of 
optimal scheduling practices that address the routine, urgent and 
emergent needs of ASCs and their patients without compromising patient 
safety.
    Comment: Some commenters stated that there were several urgent 
procedures for which patients (many of whom may not have a primary-care 
physician) self-refer to ASCs. In such instances, under the proposed 
rule, these patients would be unable to have the procedure completed on 
the same day they present at the ASC.
    Response: We agree with these commenters. There are times when 
patients visit ASCs for urgent matters even though these patients do 
not have primary care physicians to provide them with referrals. 
Patients such as these are seen in some ASCs across the country to 
obtain the necessary urgent care, sometimes on the same day they 
contact the ASC. We agree that the ASC patient rights proposed rule 
could negatively impact the patient's receipt of care in those 
situations. The revisions we have made in this final rule, reflected in 
Sec.  416.50(a), will allow for the completion of such urgent 
procedures within the timeframes that best meet the schedules of the 
patient and the ASC.
    Comment: Some commenters believe that implementing the proposed 
limited exception for same day surgeries will unreasonably disadvantage 
ASCs in the services they can provide to patients compared to the 
services that can be provided at hospital outpatient departments. The 
commenters also believe that these restrictions could have the 
consequence of increasing health care costs to the Medicare program and 
limiting the choices of those patients who prefer to receive care in 
the ASC.
    Response: We agree that placing limitations on the types of 
surgeries an ASC can perform on the same day patients present at the 
ASC with physician referrals is unduly restrictive and that ASCs could 
be unreasonably disadvantaged compared to hospital outpatient 
departments. We agree with these commenters that these restrictions 
could limit patient access to non-emergent procedures at ASCs and limit 
patient choices, create patient scheduling inconveniences, and create 
patient travel issues. Therefore, in this final rule, we are revising 
the ASC patient rights proposed rule at Sec.  416.50(a) to allow ASCs 
to continue providing services based on the criteria determined by 
applicable ASC patient scheduling standards and policies that were in 
effect prior to implementing the patient rights final rule published on 
November 18, 2008. We are confident that our latest revisions will 
ensure that ASCs are in a position to continue serving the needs and 
promoting the health and safety of their patients.
    Comment: Several commenters stated that the requirement to have the 
patient obtain a written referral is an unrealistic expectation to meet 
when a patient is presenting to the ASC for an immediate procedure.
    Response: We do not believe that the requirement of obtaining a 
referral would be a burden for most patients who generally seek an 
opinion and obtain a referral from their primary physician. However, we 
are eliminating the proposed requirement at Sec.  416.50(h), which 
includes the provision that a patient must obtain a written referral. 
Instead, ASCs should continue to use their current referral policies 
for such procedures. We have taken this approach because we believe 
ASCs are in the best position to know whether it is appropriate to 
require patients to bring referrals for procedures performed on the 
same day the patient comes to the ASC for treatment.
    Comment: One commenter stated that the guidelines for surveyors in 
the State Operations Manual have recognized the appropriateness of 
surgical procedures performed on the same day that a referral is made 
when medical necessity is documented.
    Response: We regard the interpretive guidelines as a tool to assist 
ASCs in determining when ``same day'' surgeries are appropriate. The 
policy currently set out in our regulation is still binding until the 
effective date of this rule.
    Comment: Several commenters stated that the ASC may be hesitant to 
document in the medical record that a procedure was an emergency which 
needed to be performed as soon as possible to safeguard the health of 
the patient, because a plaintiff's attorney could use the documentation 
in the medical record against the ASCs or physician in an attempt to 
demonstrate negligence.
    Response: Standard medical practice requires the ASC surgeon to 
systematically document the patient's medical record with information 
concerning the illness, injury or condition that brought the patient to 
the ASC, as well as the care and services received by the patient while 
at the ASC. Since medical records are legal documents and are subject 
to State and Federal laws, the documentation thereof must be complete, 
comprehensive, and accurate to ensure adequate patient care. ASCs 
continue to be responsible for determining if a surgical procedure can 
be performed safely at the ASC. Additionally, we do not have any 
control over how a medical record may be used in a legal proceeding.
    Comment: Several commenters stated that patient notice requirements 
should be applied equally in all provider settings.
    Response: We agree with these commenters. We reviewed the 
conditions set out for other providers and suppliers when finalizing 
this rule. The patient rights requirement for ASCs is now comparable to 
other CMS providers and suppliers, as appropriate.

IV. Provisions of the Final Regulation

    In this final rule, we are adopting the provisions as set forth in 
the April 23, 2010 proposed rule with the following revisions:
     We revised Sec.  416.50(a)(1) to delete the reference to 
the timing of the notice of patient rights exception. We are making a 
conforming change to Sec.  416.50(a)(2)(i) (redesignated as Sec.  
416.50(c)(1) in this final rule).
     We revised Sec.  416.50(a)(1) to change the timing of the 
notice of patient rights from ``in advance of the date of the 
procedure'' to ``prior to the start of the surgical procedure.''
     We revised Sec.  416.50(d)(6) to specify that the ASC must 
provide ``the patient, the patient's representative, or the

[[Page 65888]]

patient's surrogate'' with written notice of a grievance decision. The 
proposed rule only included the ``patient.'' Although this change was 
not proposed in the proposed rule, we are making it because it is a 
minor technical correction to bring this provision into accordance with 
the other notice provisions for ASCs as well as other providers.
     We revised Sec.  416.50(e)(2) to delete the words ``health 
and safety'' because competency is not a ``health and safety'' law. 
This is a technical correction and makes no change in established 
policy.
     We removed the exceptional requirement at Sec.  416.50(h) 
which allowed an ASC in the case of an emergency to provide patients 
rights information in advance of the date of the procedure.

V. Waiver of Notice Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule. The 
notice of proposed rulemaking includes a reference to the legal 
authority under which the rule is proposed, and the terms and 
substances of the proposed rule or a description of the subjects and 
issues involved. This procedure can be waived, however, if an agency 
finds good cause that a notice-and-comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporates a 
statement of the finding and its reasons in the rule issued. In 
completing this final rule, we determined that there were two instances 
in the proposed rule which were incorrectly stated. These two 
statements have been corrected in this final rule, as follows:
    In the proposed rule, at Sec.  416.50(d)(6), we did not specify 
that the patient's representative (if applicable) should also be 
provided with written notice of its grievance decision. However, 
throughout the preamble portion of the rule, we indicated that the 
patient or the patient's representative should receive patient rights 
information. The omission from Sec.  416.50(d)(6) was an oversight, 
which did not in any way reflect our intent to include the 
representative in all instances where patient rights information was 
provided. Additionally, in the proposed rule, at Sec.  416.50(e)(2), we 
proposed that if a patient was adjudged incompetent under applicable 
State health and safety laws by a court of proper jurisdiction, the 
rights of the patient would be exercised by the person appointed under 
State law to act on the patient's behalf. However, State laws that 
address a patient's competency are not health and safety laws. 
Therefore, in this final rule, we have deleted the words ``health and 
safety''. The deletion of these words in no way impact the intent or 
the protection of patient's rights in the ASC. Because of the 
nontechnical nature of both of these corrections, and in accordance 
with the Administrative Procedure Act, we find it unnecessary to 
provide notice and comment to correct these omissions. Therefore, we 
are waiving notice of proposed rulemaking and an opportunity to comment 
on the nontechnical corrections in this rule.

VI. Collection of Information Requirements

    The information collection and recordkeeping requirements for the 
ASC Patient Rights CfC were previously accounted for in the November 
18, 2008 final rule entitled ``Changes to the Ambulatory Surgical 
Center Conditions for Coverage.'' This ASC Patient Rights final rule 
does not impose information collection and recordkeeping requirements. 
Consequently, it need not be reviewed by the Office of Management and 
Budget under the authority of the Paperwork Reduction Act of 1995 (44 
U.S.C. 35).

VII. Regulatory Impact Statement

    We have examined the impact of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). This rule 
does not reach the economic threshold and thus is not considered a 
major rule.
    The rule does, however, create substantial savings for both 
patients and facilities. In 2009, there were approximately 7 million 
ASC admissions. Of this amount, we estimate that approximately one in 
five (which would ordinarily require two medical visits, one on each of 
two separate days) would be reduced to one visit by allowing ASCs to 
perform surgical procedures on the same day a patient is referred to 
the ASC. As a result, about 1,400,000 visits can be avoided. We 
estimate that the average visit to an ASC requires two and one half 
hours of patient time (30 minutes to get to the ASC, a 30 minute wait 
to be seen, 60 minutes for the visit, and 30 minutes to return home). 
We value patient time at $10 an hour. We therefore project a savings in 
patient time of about 35 million dollars a year from 1,400,000 trips 
avoided because of ASCs performing procedures on the same day patients 
are referred to the ASC. We also project that the average provider cost 
for the visit eliminated is about $20, which includes 15 minutes of 
doctor's time, 15 minutes of a nurse's time and 15 minutes of clerical 
processing time, to provide the patient with an assortment of forms and 
informational materials (including patient rights). Taking into account 
time spent on patients' rights at the remaining visit, we believe that 
the net time saving would be about $10. We project that this will 
result in 17.5 million dollars a year in provider cost savings. On 
average, a facility would realize savings of about $3,500, assuming 
that one-fifth of 1,400 visits were avoided. These savings would be 
slightly offset by additional time spent on mailing costs. We did not, 
however, calculate the cost for mailing out patient rights information 
because these documents would be included in the informational packets 
that ASCs typically mail to their patients.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses in cases were rules would impose a ``significant 
economic impact on a substantial number of small entities.'' For 
purposes of the RFA, small entities include small businesses, nonprofit 
organizations, and small governmental jurisdictions. Most hospitals and 
most other providers and suppliers are small entities, either by 
nonprofit status or by having revenues of $7.0 million to $34.5 million 
in any 1 year. Individuals and States are not included in the 
definition of a small entity. We estimate there are approximately 5,200 
Medicare participating ASCs with average admissions of approximately 
1,432 patients per ASC (based on the number of patients seen in ASCs in 
2009). Many ASCs are considered to be small entities, by having annual 
revenues of less than $7 million. Based on our

[[Page 65889]]

estimate that on average facilities would save about $3,500, we do not 
believe that this would be an ``economically significant'' amount. 
Accordingly, we have determined that this rule does not require a 
regulatory flexibility analysis.
    Section 1102(b) of the Social Security Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. 
However, this final rule only affects ambulatory surgical centers and 
not hospitals. As a result, we are not preparing an analysis for 
section 1102 (b) of the Act because we believe and the Secretary has 
determined that this rule will not have a significant impact on the 
operations of a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year by 
State, local or tribal governments, in the aggregate, or by the private 
sector of $100 million in 1995 dollars, updated annually for inflation. 
In 2011, that threshold level is approximately $136 million. This final 
rule will not reach this spending threshold.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct requirement costs on State and local governments, 
preempts State law, or otherwise has Federalism implications. This 
final rule has no Federalism implications and does not impose any costs 
on State or local governments. Therefore, the requirements of Executive 
Order 13132 are not applicable.
    In accordance with the provisions of Executive Order 12866, this 
regulation was not reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 416

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR part 416 as set forth below:

PART 416--AMBULATORY SURGICAL SERVICES

0
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

0
2. Section 416.50 is revised as follows:
0
a. Redesignate paragraph (d) as paragraph (g).
0
b. Redesignate paragraph (c) as paragraph (f).
0
c. Redesignate paragraph (b) as paragraph (e).
0
d. Revise newly designated paragraph (e).
0
e. Redesignate paragraph (a)(3) as paragraph (d).
0
f. Revise newly designated paragraph (d).
0
g. Redesignate paragraphs (a)(2) introductory text, (a)(2)(i), 
(a)(2)(ii) and (a)(2)(iii) as paragraphs (c) introductory text, (c)(1), 
(c)(2), and (c)(3) respectively.
0
h. Amend newly redesignated paragraph (c)(1) by removing the words ``in 
advance of the date of the procedure, with information'' and replacing 
it with ``with written information''.
0
i. Redesignate paragraph (a)(1)(ii) as paragraph (b).
0
j. Revise the newly designated paragraph (b).
0
k. Revise paragraph (a).
0
m. Revise the introductory text.
    The revisions read as follows:


Sec.  416.50  Condition for coverage--Patient Rights.

    The ASC must inform the patient or the patient's representative or 
surrogate of the patient's rights and must protect and promote the 
exercise of these rights, as set forth in this section. The ASC must 
also post the written notice of patient rights in a place or places 
within the ASC likely to be noticed by patients waiting for treatment 
or by the patient's representative or surrogate, if applicable.
    (a) Standard: Notice of Rights. An ASC must, prior to the start of 
the surgical procedure, provide the patient, the patient's 
representative, or the patient's surrogate with verbal and written 
notice of the patient's rights in a language and manner that ensures 
the patient, the representative, or the surrogate understand all of the 
patient's rights as set forth in this section. The ASC's notice of 
rights must include the address and telephone number of the State 
agency to which patients may report complaints, as well as the Web site 
for the Office of the Medicare Beneficiary Ombudsman.
    (b) Standard: Disclosure of physician financial interest or 
ownership. The ASC must disclose, in accordance with Part 420 of this 
subchapter, and where applicable, provide a list of physicians who have 
financial interest or ownership in the ASC facility. Disclosure of 
information must be in writing.
* * * * *
    (d) Standard: Submission and investigation of grievances. The ASC 
must establish a grievance procedure for documenting the existence, 
submission, investigation, and disposition of a patient's written or 
verbal grievance to the ASC. The following criteria must be met:
    (1) All alleged violations/grievances relating, but not limited to, 
mistreatment, neglect, verbal, mental, sexual, or physical abuse, must 
be fully documented.
    (2) All allegations must be immediately reported to a person in 
authority in the ASC.
    (3) Only substantiated allegations must be reported to the State 
authority or the local authority, or both.
    (4) The grievance process must specify timeframes for review of the 
grievance and the provisions of a response.
    (5) The ASC, in responding to the grievance, must investigate all 
grievances made by a patient, the patient's representative, or the 
patient's surrogate regarding treatment or care that is (or fails to 
be) furnished.
    (6) The ASC must document how the grievance was addressed, as well 
as provide the patient, the patient's representative, or the patient's 
surrogate with written notice of its decision. The decision must 
contain the name of an ASC contact person, the steps taken to 
investigate the grievance, the result of the grievance process and the 
date the grievance process was completed.
    (e) Standard: Exercise of rights and respect for property and 
person. (1) The patient has the right to the following:
    (i) Be free from any act of discrimination or reprisal.
    (ii) Voice grievances regarding treatment or care that is (or fails 
to be) provided.
    (iii) Be fully informed about a treatment or procedure and the 
expected outcome before it is performed.
    (2) If a patient is adjudged incompetent under applicable State 
laws by a court of proper jurisdiction, the rights of the patient are 
exercised by the person appointed under State law to act on the 
patient's behalf.
    (3) If a State court has not adjudged a patient incompetent, any 
legal representative or surrogate designated by the patient in 
accordance with State

[[Page 65890]]

law may exercise the patient's rights to the extent allowed by State 
law.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: August 11, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.

    Approved: October 7, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2011-27171 Filed 10-18-11; 11:15 am]
BILLING CODE 4120-01-P