[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