65886 Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Rules and Regulations 

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. 

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 nonemergency 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 § 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 

§ 416.50(h) to provide for an exception 

for same day procedures, we proposed 

other minor revisions to § 416.50. 

Because both § 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 § 416.50. 

Further, we proposed to reorganize 

§ 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 

§ 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. 


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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 

§ 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 

§ 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 nonemergent 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 

§ 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 § 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 § 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 

§ 416.50(a)(2)(i) (redesignated as 

§ 416.50(c)(1) in this final rule). 

• We revised § 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 § 416.50(d)(6) to specify 

that the ASC must provide ‘‘the patient, 

the patient’s representative, or the 


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65888 Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Rules and Regulations 

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 § 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 § 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 § 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 § 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 § 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 


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

■ 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 revised as follows: 

■ a. Redesignate paragraph (d) as 

paragraph (g). 

■ b. Redesignate paragraph (c) as 

paragraph (f). 

■ c. Redesignate paragraph (b) as 

paragraph (e). 

■ d. Revise newly designated paragraph 

(e). 

■ e. Redesignate paragraph (a)(3) as 

paragraph (d). 

■ f. Revise newly designated paragraph 

(d). 

■ 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. 

■ 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’’. 

■ i. Redesignate paragraph (a)(1)(ii) as 

paragraph (b). 

■ j. Revise the newly designated 

paragraph (b). 

■ k. Revise paragraph (a). 

■ m. Revise the introductory text. 

The revisions read as follows: 

§ 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 


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65890 Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Rules and Regulations 

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 


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