CMS-R-10 Revised Supporting Statement 2013 Rev (F) PRA corr SS

Advance Directives (Medicare and Medicaid)
and Supporting Regulations
CMS-R-10
A.

BACKGROUND
This information collection package is a request for a reinstatement of the information
collection requirements previously approved under CMS-R-10 (0938-0610). We have
made revisions to our estimates of the number of adult Americans that would require
documentation related to the presence of an Advance Directive and the number of
providers and organizations that are subject to the Advance Directives requirements.
These revisions consequently affect the number of hours required and the amount of
money expended on this requirement.
The current information collection requirement for CMS-R-10 are 42 CFR 489.102,
417.436(d), 417.801, 422.128, 430.12(c)(1)(ii), 431.20, 431.107, 438.6, 440.170, 483.10,
484.10(c)(1)(ii), 485.601 and 489.102.
The Advance Directives requirement was enacted because Congress wanted individuals
to know that they have a right to make health care decisions and to refuse treatment even
when they are unable to communicate. Steps were taken at both the Federal and State
level, to afford greater opportunity for the individual to participate in decisions made
concerning the medical treatment to be received by an adult patient in the event that the
patient is unable to communicate to others, a preference about medical treatment. The
individual may make his preference known through the use of an Advance Directive,
which is a written instruction prepared in advance, such as a living will or a durable
power of attorney. This information is required to be documented in a prominent part of
the individual’s medical record, as specified at CFR 42 Section 489.102(a)(2). Advance
Directives as described in the Patient Self-Determination Act (enacted in 1991) have
increased the individual’s control over decisions concerning medical treatment.
Prior to the enactment of the Omnibus Reconciliation Act of 1990 (OBRA ’90), P.L. 101508, there were no requirements relating to Advance Directives under Federal Medicare
or Medicaid laws. Sections 4206 of OBRA ’90 defined an Advance Directive as a
written instruction recognized under State law relating to the provision of health care
when an individual is incapacitated (those persons unable to communicate their wishes
regarding Medical treatment).
When an Advance Directive exists for a patient, health care providers and organizations
are required to follow through on the individual’s preference, to the extent that State law
permits/requires.
All states have enacted legislation defining a patient’s right to make decisions regarding
medical care, including the right to accept or refuse medical or surgical treatment and the
right to formulate Advance Directives. Participating hospitals, skilled nursing
facilities/nursing facilities, home health agencies, providers of home health care,
1

hospices, religious nonmedical health care institutions, and prepaid or eligible
organizations (including Health Care Prepayment Plans (HCPPs) and Medicare
Advantage Organizations (MAOs) such as Coordinated Care Plans, Demonstration
Projects, Chronic Care Demonstration Projects, Program of All Inclusive Care for the
Elderly, Private Fee for Service, and Medical Savings Accounts must provide written
information, at explicit time frames, to all adult individuals about: a) the right to accept or
refuse medical or surgical treatments; b) the right to formulate an Advance Directive; c) a
description of applicable State law (provided by the State); and d) the provider’s, or
organization’s policies and procedures for implementing an Advance Directive. Such
information must include a statement of limitation if the provider cannot implement an
Advance Directive as a matter of conscience. Also included is a provision to provide for
the education of staff and community on issues concerning Advance Directives. Finally,
providers and organizations must document in a prominent part of the individual’s
medical record whether or not the individual has executed an Advance Directive.
In accordance with CFR 42 Sections 489.102 and 422.128, States are required to
provide to Medicaid providers, Cost Plans, HCPPs, and MAOs, as soon as
possible but no later than 60 days, with revised copies of their description of State
laws when revisions to those laws are enacted. Within that same time frame,
States are required to amend their State plans. In turn, providers and
organizations must revise and disseminate the amended information no later than
90 days from the effective date of a change in State law. Neither the statute nor
regulation requires providers or organizations to distribute standard Advance
Directive forms, nor to collect and maintain copies of executed Advance
Directives. However, these practices are optional.
MAOs, Cost Plans, and HCPPs are permitted to contract with other entities to
furnish information concerning Advance Directives requirements, but are legally
responsible for ensuring Advance Directives statutory requirements are met.
These organizations are also not relieved of their obligation to provide this
information to the enrollee once he or she is no longer incapacitated or unable to
receive such information. Follow-up procedures must be in place to ensure
information is given directly to the individual at the appropriate time.
B.

JUSTIFICATION
1. Need and Legal Basis
This action is authorized by sections 4206(a) and 4751 of OBRA ’90 which
amended several sections of the Social Security Act (the Act) and subjects certain
Medicare and Medicaid providers and prepaid or eligible organizations to the
requirement of maintaining written policies and procedures respecting Advance
Directives.
The initial regulation on Advance Directives, an Interim Final Rule, was published on
March 6, 1992. The Final Rule, published on June 27, 1995, confirmed the interim final
2

rule, with several minor changes based on CMS’s review and consideration of public
comments. The final rule clarified several statutory requirements; added a description of
the minimum information that should be contained in a statement of limitation if an
Advance Directive cannot be implemented because of an objection on the basis of
conscience; provided a new requirement that providers and Health Maintenance
Organizations (HMOs) must inform individuals that complaints concerning noncompliance with the Advance Directive requirements may be filed with the State survey
and certification agency; specified that a patient has the right to use the home health
hotline to lodge complaints concerning implementation of Advance Directive
requirements; specified that an HHA may furnish Advance Directive information to a
patient at the time of the first home visit, as long as the information is furnished before
care is provided; specified that providers of personal care services may furnish Advance
Directives information to a patient at the time of the first home visit, as long as the
information is furnished before care is provided; and specified that personal care
providers are permitted to contract with another entity to furnish Advance Directives
information but are still legally responsible for ensuring that the Advance Directives
requirements are met.
Section 4641 of the BBA of 1997, subsequently amended section 1866(f)(1)(B) of the
Social Security Act to require that the patient’s Advance Directives be placed in a
prominent part of his/her medical record.
Section 4001 of the BBA of 1997 established a new Part C of the Medicare program, the
Medicare+Choice (M+C) Program, 42 CFR Part 422. The term Medicare+Choice
Program was changed to Medicare Advantage (MA) Program, by the Medicare
Modernization Act on December 8, 2003. Note also that the terms health maintenance
organization (HMOs) and Managed care organizations (MCOs) have been replaced by
the terminology Medicare Advantage Organizations (MAOs). Many of the MAOs, and
Health Care Prepayment Plans (HCPPs) previously covered under part 417 are now
covered under part 422 because Section 4002 of the BBA of 1997 specifies that the
requirements of section 1866(f) of the Act, which apply to section 1876 contractors, also
applies to MAOs. MAOs are permitted to contract with other entities to furnish
information concerning Advance Directives requirements. MAOs are legally responsible
for ensuring that the Advance Directives statutory requirements are met.
Organizations which continue to have contracts under Part 417 (e.g., Cost Plans, HCPPs,
and MAOs) continue to be subject to the Advance Directives requirements in Part 417.
The MA (previously M+C) regulation package implementing the BBA provisions
concerning MA and Advance Directive requirements was published in the Federal
Register on June 26, 1998. Subpart §422.128 of this regulation requires that each MAOs
maintain written policies and procedures that meet the requirements for Advance
Directives, as set forth in subpart I of part 489. The MA program is not relieved of its
obligation to provide this information to the enrollee once he or she is no longer
incapacitated or unable to receive such information. Follow-up procedures must be in
place to ensure that the information is given directly to the individual at the appropriate
3

time.
Sections 1102 and 1871 of the Social Security Act revised 489.102(a) in 1999 to include
Religious Nonmedical Health Care Institutions (§440.170) to the list of institutions that
must maintain written policies and procedures concerning Advance Directives. This
revision also requires that 489.102(a) include the requirement to document in a prominent
part of the individual’s current medical record or patient care record, in the case of an
individual in a religious nonmedical health care institution, whether or not the individual
has executed an Advance Directive. (It is not required to maintain a copy of the Advance
Directive in the medical/patient care record).
States are required to provide to Medicaid providers, MAOs, and MCOs, as soon as
possible but no later than 60 days, revised copies of their description of State laws when
revisions to those laws are enacted. Within that same time frame, States are required to
amend their State plans. In turn, providers and organizations must revise and disseminate
the amended information no later than 90 days from the effective date of a change in
State law. Neither the statute nor regulation requires providers or organizations to
distribute standard Advance Directive forms, nor to collect and maintain copies of
executed Advance Directives. This is, however, an option that many may take.
The CFRs on Advance Directives set forth statutory requirements for providers or
organizations as follows:
42 CFR Part §417--Health Maintenance Organizations, Competitive Medical
Plans, and Health Care Prepayment Plans
§417.436--Rules for Enrollees
□ §417.436(d)--Advance Directives - Cross-references Subpart I - Advance
Directives §489.102--Requirements for Providers
□ §417.801--Advance Directives - Cross-references §489.100 and
§417.436(d)--Advance Directives
42 CFR Part §422--Medicare Advantage Program
□ §422.128--Advance Directives - Cross-references §489.100. Extends the
full coverage of §489 to include MAOs.
□ As defined in §422 and in accordance with the BBA of 1997, no CMPs
(Section 1876 contracts) can be renewed for a contract year beginning on
or after December 31, 2002. Instead, both CMPs and MCOs will exist
under MAOs.
42 CFR Part §430--Grants to States for Medical Assistance Programs

4

□ §430.12(c)(1)(ii)--Submittal of State plans and plan amendments -- The
State plan must provide that it will be amended whenever necessary to
reflect any changes related to Advance Directives. Such amendments
must be submitted as soon as possible, but not later than 60 days from the
effective date of the change to State law.
42 CFR Part §431--State Organization and General Administration
□ §431.20--Advance Directives. Prescribes State plan requirements for the
development and distribution of a written description of State law
concerning Advance Directives.
□ §431.107--Required Provider Agreement. State plan must provide for an
agreement between the Medicaid agency and each provider or
organization providing services under the plan in which the provider or
organization agrees to comply with the Advance Directives for hospitals,
nursing facilities, providers of home health care and personal care
services, hospices, and MCOs specified in part 489, subpart 1,
and§417.436(d). Those organizations that contract with CMS only under
the MA program are covered under part §422 and are also included under
§431.107.
42 CFR §Part 438--Contracts (In Lieu of 434.28 which is obsolete)
□ §438.6--Contract Requirements - Cross references Part 489, Subpart I.
42 CFR §Part 440.170 – Religious Nonmedical Health Care Institutions
□ §440.170--Medicaid Provisions – Part 489, Subpart I - Advance
Directives. Revised §489.102(a)(2) to reflect that an individual’s Advance
Directive be placed in a “prominent part” of his or her medical record.
42 CFR §Part 483--Requirements for States and Long Term Care
□ §483.10--Resident rights. - Cross references Part 489, Subpart I
42 CFR §Part 484--Conditions of Participation: Home Health Agencies
Subpart B--Administration
□ §484.10(c)(1)(ii)--Condition of Participation: Patient rights/Right to be
informed and to participate in planning care and treatment. - Crossreferences to Part 489, Subpart I.
42 CFR §485-- Critical Access Hospitals – Cross references Part 489, Subpart I
□ §485--Conditions of Participation (CoPs) do not explicitly address
5

Advance Directives. CoPs will be revised in the future to specifically
address this requirement.
42 CFR §Part 489--Provider Agreements and Supplier Approval
□ §489.102--Requirements for Providers. With the 1999 edition of 42 CFR,
all text of §489 will be republished without revision, with the exception of
paragraph §489.102(a)(2), which will be revised to reflect that each
provider must document in a prominent part of the individual’s medical
record whether or not the individual has executed an Advance Directive.
Though 42 CFR §489.102 does not explicitly specify the point in time when the
documentation is to be made in the individual’s medical records, it does delineate specific
time frames for the required information to be disseminated to the patient.
Documentation should continue to be made at these times, unless otherwise indicated by
regulation. The statutory time frames for dissemination of information are as follows:
(a) In the case of a hospital, at the time of the individual’s admission as an inpatient.
(b) In the case of a skilled nursing facility/nursing facility, at the time of the
Individual’s admission as a resident.
(c) In the case of a home health agency, or provider of home health care or
personal care services, in advance of the individual coming under the care
of the agency or provider.
(d) In the case of a hospice program, at the time of initial receipt of hospice
care by the individual from the program.
(e) In the case of an eligible organization (as addressed in §1876(b) and
§1833(a)(1)(A), or §1903(m)(1)(A), e.g., MCO or MA organization), at the time of
enrollment of the individual with the organization.
2. Information Users
The advanced directives documentation is used only by medical or other
personnel employed by the provider or organization, on an as needed basis.
3. Use of Information Technology
The information requirement in this regulation merely specifies documentation in a
prominent part of the medical record and does not prescribe format of collection or
maintenance procedures. Since the information is collected during the course of a
personal interview of the patient by personnel from a provider or organization, more
automated or technological methods of collection are not appropriate.

6

4. Duplication
There is no duplication associated with this regulatory requirement.
5. Small Business Impact
The requirements do affect small businesses; however, the general nature of the
requirements allows flexibility for facilities to meet the requirements in a way that is
consistent with their existing operations.
6. Less Frequent Collection
This information is collected only when patients are asked about advanced directives.
The collection is mandated by law and regulation. If it were to be collected less
frequently, CMS would be unable to obtain this data.
7. Special Circumstances Leading to Information Collection
There are no special circumstances for collecting this information.
8. Federal Register Notice/ Outside Consultation
The 60-day Federal Register notice published July 26, 2013.
9. Payment or Gift to Respondent
No payments or gifts are made to respondents.
10. Confidentiality
Since this activity involves documenting the medical record, these requirements are
subject to the confidentiality requirements of the Health Insurance Portability and
Accountability Act of 1996, which includes privacy requirements for medical records.
11. Sensitive Questions
Although subject matter is of a sensitive nature to many, it does not fall into any of
the categories listed in the CMS Administrative Issuance Guidelines for OMB review.
12. Burden Estimate (Hours and Wages)
We estimate a total of 39,575 providers and organizations will be affected by this
information collection. The following list indicates the approximate number of
providers and organizations by subject and by regulation, cited for easy reference.

7

Advance Directive
Requirement
§489.102(a)(2)

§417.436(d)(iii)
§422.128

Providers/Suppliers/Organizations

Hospitals (Includes 18 RNHCIs)
Critical Access Hospitals
Hospices
SNF/NFs
HHAs
Cost Plans
HCPPs
Medicare Advantage Organizations
(MAOs) & PACE

Total # of
organizations

Current
Number

Number
of New

6,168
1,329
3,795
15,151
12,452
18
10
652

0
270
410
87
1,449
0
0
60

39,575

2,276

A. One-Time Start-Up Costs
We estimate a one-time burden of 2,276 hours will be required to develop a standard
Advance Directive for new providers and organizations. This is based on 1 hour per
provider and organization (2,276 x 1 hour = 2,276).
We estimate a one-time burden of 4,552 hours will be required to develop policies and
procedures to implement the Advance Directives requirement. This is based on 2 hours
per provider and organization (2,276 x 2 hours = 4552).
B. Annual Costs
We estimate 2,770,250 hours will be required to document this information in
FY ’13. We anticipate that 55 million individuals will receive services annually from a
total of 39,575 organizations. The number of providers and organizations was retrieved
from the CMS CASPER Data System as of May 2013. The number of Cost Plans,
HCPPs, Medicare Advantage Organization and Programs for All-Inclusive Care for the
Elderly (PACE) was retrieved from the CMS Monthly Contract and Enrollment
Summary Report. The number of patients who will receive services each year is based on
yearly adult enrollments in Medicare and Medicaid over the last 3 years. We are using
this number as a proxy for the number of patients receiving services from affected
providers and organizations because we do not have an accurate number of all patients
receiving services from all affected providers and organizations.
We estimate that it takes 3 minutes for medical or other personnel of
providers and organizations to document an individual’s Advance
Directive preference(s) in the medical record. Our calculations are:
55 million patients nationwide / 39,575 providers and organizations
nationwide = 1,390 patients per provider or organization.
8

1,390 patients per provider or organization x 3 minutes per patient = 4,170
minutes per provider or organization / 60 = 70 hours per provider or
organization.
70 hours per provider or organization x 39,575 providers and
organizations nationwide = 2,770,250 hours nationwide.
We estimate that it takes 2 hours annually for providers and organizations to revise
policies and procedures and to train staff, patients, and community on the Advance
Directives requirement.
Cost Estimates to Respondent or Record keeper
(a) We estimate the one-time cost associated with developing the appropriate policies
and procedures to implement the Advance Directives requirement to be $154,768.
We expect that a nurse would develop the policies and procedures based on
recommendations from the Director. (The Bureau of Labor Statistics for 2012
specifies that the hourly salary of a nurse is $34). We estimate that complying with
this specific requirement will take 2 hours.
(b) There is a one-time cost associated with developing an Advance Directive. We
estimate that a typical Advance Directive message might be in three parts: An
introduction; the information section; and a section for follow-up questions and issues.
We expect that a nurse would initially develop the Advance Directive resource. We
estimate the effort to develop this one-time message would not exceed one hour at a cost
of $34 for each provider or organization. We estimate that there will be 2,276 new
providers and organizations entering the Medicare program over the next 3 years. We
estimate the total one time cost associated with developing the Advance Directive to be
$77,384.
(c) All providers and organizations subject to this Advance Directive requirement must
develop and implement policies and procedures that ensure documentation, in a
prominent part of the individual’s medical record that specifies whether or not the
individual has executed an Advance Directive. We estimate $47,094,250 as the
annualized costs for all respondents to document medical records with this information.
Our estimation that it takes approximately 3 minutes for a provider’s or organization’s
staff to complete this documentation is unchanged. We estimate that documenting the
patient’s record will likely be performed by a Billing and Posting Clerk. Based on
Bureau of Labor Statistics for 2012, the hourly salary of a Billing and Posting Clerk is
$17 an hour.
(d) We have also developed an estimate of the annual cost of 1 ½ hours, which we
estimate to be required to maintain policies and procedures and to update staff, patients
and the community annually for Advance Directives. We estimate $2,018,342 as the
annualized costs for respondents to train and update policies and procedures for Advance
9

Directives.
Activity

Responsible
Staff

Hrly
Wage

# of
Prvdrs
& Orgs

(a) Develop
Policies &
Procedures

Nurse

$34

2,276

# of Hrs
Total #
per
of Hrs for
Total
Prvdr
all Prvdrs
Costs
& Org.
& Orgs
2
4,552
$154,768

(b) Develop
Advance
Directive
(c)
Document
Record with
Advance
Directives
Information

Nurse

$34

2,276

1

2,276

Billing and
Posting
Clerk

$17

39,575

70

2,770,250 $47,094,250

(d) Yearly
training &
update of
policies and
procedures
TOTAL

Nurse

$34

39,575

1.5

59,363

2,27639,575

2,836,441

$77,384

$2,018,342

49,344,744

13. Capital Costs
There are no capital costs.
14. Cost to Federal Government
We estimate no Federal costs associated with this information collection
requirement.
15. Changes to Burden
Changes to the burden estimates have changed due to the increase in the number of
individuals who will receive services annually. Additionally, the total of
organizations increased as a whole but there is a decrease in the amount of providers
that will now be affected by the 1one-time burden. There was an increase to the
wages of the Billing and Posting Clerk.
16. Publication and Tabulation Dates
10

There are no publication and tabulation dates.
17. Expiration Date
This collection does not lend itself to the displaying of an expiration date. It is revised
every three years.

11