70532 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

movement of injection or formation 

fluids into a USDW, provided that such 

wells meet the requirements of this 

section, even if the Director determines 

they have caused or may cause fluid 

movement into a USDW. Nothing in this 

section excuses such Class I municipal 

disposal wells from meeting all other 

applicable State and Federal 

requirements including 40 CFR 

144.12(a). 

(b) For purposes of this section, an 

existing Class I municipal disposal well 

is defined as a well for which a 

complete UIC construction permit 

application was received by the Director 

on or before December 22, 2005. 

(c) For purposes of this section, the 

determination that a Class I municipal 

disposal well has caused or may cause 

movement of injection or formation 

fluids into a USDW may be made by the 

Director based on any relevant data 

available to him/her, including ground 

water monitoring data generated 

pursuant to regulatory requirements 

governing operation of Class I municipal 

disposal wells. 

(d) In order for a Class I municipal 

disposal well to qualify for 

authorization to inject pursuant to 

paragraph (a) of this section, the Owner/ 

Operator of that well shall: 

(1) Develop and implement a 

pretreatment program that is no less 

stringent than the requirements of 

Chapter 62–625, Florida Administrative 

Code, or have no significant industrial 

users as defined in that chapter. 

(2) Treat the injectate using secondary 

treatment in a manner that is no less 

stringent than the requirements of 

Florida Rule 62–600.420(1)(d), and 

using high-level disinfection in a 

manner that is no less stringent than the 

requirements of Florida Rule 62–

600.440(5)(a)–(f), within five years after 

notification by the Director that the well 

has caused or may cause fluid 

movement into a USDW. 

(e) Where the Director issued such 

notice for a well prior to December 22, 

2005, in order for that well to qualify for 

authorization to inject pursuant to 

paragraph (a) of this section, the Owner/ 

Operator shall: 

(1) Develop and implement a 

pretreatment program that is no less 

stringent than the requirements of 

Chapter 62–625, Florida Administrative 

Code, or have no significant industrial 

users as defined in that chapter; and 

(2) Treat the injectate using secondary 

treatment in a manner that is no less 

stringent than the requirements of 

Florida Rule 62–600.420(1)(d), and 

using high-level disinfection in a 

manner that is no less stringent than the 

requirements of Florida Rule 62–

600.440(5)(a)–(f), within five years after 

December 22, 2005. 

(f) Authorization to inject wastewater 

into existing Class I municipal disposal 

wells pursuant to this section is limited 

to Class I municipal disposal wells in 

Florida in the following counties: 

Brevard, Broward, Charlotte, Collier, 

Flagler, Glades, Hendry, Highlands, 

Hillsborough, Indian River, Lee, 

Manatee, Martin, Miami-Dade, Monroe, 

Okeechobee, Orange, Osceola, Palm 

Beach, Pinellas, St. Johns, St. Lucie, 

Sarasota, and Volusia. 

■ 3. Section 146.16 is added to Subpart 

B to read as follows: 

§ 146.16 Requirements for new Class I 

municipal wells in certain parts of Florida. 

Prior to commencing injection, any 

Class I municipal disposal well in one 

of the counties identified in § 146.15(f) 

that is not an existing Class I municipal 

disposal well as defined in § 146.15(b) 

of this section shall meet all of the 

requirements for existing wells seeking 

authorization to inject pursuant to 

§ 146.15. 

[FR Doc. 05–23088 Filed 11–21–05; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 418 

[CMS–1022–F] 

RIN 0938–AJ36 

Medicare Program; Hospice Care 

Amendments 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule revises existing 

regulations that govern coverage and 

payment for hospice care under the 

Medicare program. These revisions 

reflect the statutory changes required by 

the Balanced Budget Act of 1997 (BBA), 

the Medicare, Medicaid, and SCHIP 

Balanced Budget Refinement Act of 

1999 (BBRA), and the Medicare, 

Medicaid, and SCHIP Benefits 

Improvement and Protection Act of 

2000 (BIPA). Additionally, these 

revisions reflect current policy on the 

documentation needed to support a 

certification of terminal illness, 

admission to Medicare hospice, and a 

new requirement that allows for 

discharges from hospice for cause under 

very limited circumstances. 

This final rule does not address the 

requirement for hospice data collection, 

the changes to the limitation of liability 

rules, or the changes to the hospice 

conditions of participation that were 

included in the BBA. 

The intent of this final rule is to 

expand the hospice benefit periods, 

improve documentation requirements to 

support certification and recertification 

of terminal illness, provide guidance on 

hospice admission procedures, clarify 

hospice discharge procedures, update 

coverage and payment requirements, 

and address the changing needs of 

beneficiaries, suppliers, and the 

Medicare program. 

DATES: These regulations are effective 

on January 23, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Linda Smith, (410) 786–5650. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Hospice Care 

Hospice care means a comprehensive 

set of services described in 1861(dd)(1) 

of the Social Security Act (the Act), 

identified and coordinated by an 

interdisciplinary team to provide the 

physical, psychosocial, spiritual, and 

emotional needs of a terminally ill 

patient and family members or both as 

denoted in a specific patient plan of 

care. 

The emphasis of hospice care is on 

the control of pain and the furnishing of 

services that enable the beneficiary to 

remain at home as long as possible with 

minimal disruption to normal activities. 

A hospice uses an interdisciplinary 

approach to deliver medical, social, 

psychological, emotional, and spiritual 

services through the use of a broad 

spectrum of professional and other 

caregivers, with the goal of making the 

individual as physically and 

emotionally comfortable as possible. 

Counseling and respite services are 

available to the family of the hospice 

patient. Hospice programs consider both 

the patient and the family as the unit of 

care. 

B. Medicare Hospice Before the 

Balanced Budget Act of 1997 

The Balanced Budget Act of 1997 

changed and clarified numerous aspects 

of the Medicare hospice benefit 

including the length of available benefit 

periods, the amount of annual updates, 

how local payment rates are 

determined, the time frame for 

physician certification, and what is 

considered a covered Medicare hospice 

service. Section 1861(dd) of the Act 

provides for coverage of hospice care for 

terminally ill Medicare beneficiaries 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70533 

who elect to receive care from a 

participating hospice. Beneficiaries are 

eligible to elect the Medicare hospice 

benefit if they are eligible for Medicare 

Part A; are certified as terminally ill by 

their personal physician, if they have 

one, and by the hospice medical 

director; and elect to receive hospice 

care from a Medicare-certified hospice. 

Section 1861(dd)(3)(A) of the Act 

defines terminally ill as a medical 

prognosis with a life expectancy of 6 

months or less. This definition was 

clarified to provide for a life expectancy 

of ‘‘6 months or less if the illness runs 

its normal course’’ when we amended 

42 CFR 418.3 in our December 11, 1990 

final rule with comment period titled 

‘‘Hospice Care Amendments: Medicare’’

(55 FR 50834). 

A Medicare beneficiary who has 

elected the hospice benefit can receive 

care for specific lengths of time referred 

to as benefit periods. Under the Tax 

Equity and Fiscal Responsibility Act of 

1982, hospice care was made available 

in three distinct benefit periods, the first 

two lasting 90 days, and the third 

lasting 30 days. The total amount of 

Medicare hospice coverage was 210 

days. Because of the scientific difficulty 

in making a prognosis of 6 months or 

less, the 210-day limit was repealed by 

the Medicare Catastrophic Coverage 

Repeal Act of 1989 for services 

furnished on or after January 1, 1990. 

The benefit periods were restructured 

into two periods of 90 days duration, 

one period of 30 days duration, and a 

fourth period of unlimited duration. 

Prior to the BBA of 1997, if a beneficiary 

voluntarily left the program or was 

discharged from it, he or she forfeited 

the remaining days in the benefit 

period. When this occurred during the 

fourth benefit period, the beneficiary 

could never again receive the Medicare 

hospice benefit. A beneficiary in the 

fourth benefit period who became 

ineligible for hospice care services 

because he or she no longer met the 

eligibility requirements would then 

return to normal Medicare coverage and 

would never be eligible for the Medicare 

hospice program, even if his or her 

condition once again became terminal. 

The BBA of 1997 amended the 

election and benefit period procedures 

to state that once a patient elects the 

Medicare hospice benefit, the patient 

gives up the right to have Medicare pay 

for hospice care furnished by any 

hospice provider other than the one that 

he or she has selected, unless the 

selected hospice provider arranges for 

services to be furnished by another 

provider or if the patient elects to 

change providers. Also during the 

benefit period, the beneficiary gives up 

the right to receive any other Medicare 

payment for services that are 

determined to be related to his or her 

terminal illness or other related 

conditions or that are duplicative of 

hospice care. Medicare would continue 

to pay for a beneficiary’s covered 

medical needs unrelated to the terminal 

condition. 

The Medicare hospice benefit 

includes nursing services; medical 

social services; physician services; 

counseling services, including dietary 

and bereavement counseling; short-term 

inpatient care, including respite care; 

medical appliances and drugs; home 

health aide and homemaker services; 

physical therapy; occupational therapy; 

and speech-language pathology services. 

Medicare-certified hospices furnish care 

using an interdisciplinary team of 

people who assess the needs of the 

beneficiary and his or her family and 

develop and maintain a plan of care that 

meets those needs. 

Under section 1814(i) of the Act, 

Medicare payment for hospice care is 

based on one of four prospectively 

determined rates that correspond to four 

different levels of care for each day a 

beneficiary is under the care of the 

hospice. The four rate categories are 

routine home care, continuous home 

care, inpatient respite care, and general 

inpatient care. The prospective payment 

rates are updated annually and are 

adjusted by a wage index to reflect 

geographic variation. The payment rules 

are in our regulations at 42 CFR part 

418, subpart G, ‘‘Payment for Hospice 

Care.’’

II. Hospice Provisions of the Balanced 

Budget Act of 1997, the Balanced 

Budget Refinement Act of 1999, and the 

Medicare, Medicaid, and SCHIP 

Benefits Improvement and Protection 

Act of 2000 

The Balanced Budget Act of 1997 

(BBA) included a number of provisions 

affecting the Medicare hospice benefit. 

Additionally, the Balanced Budget 

Refinement Act (BBRA) of 1999 and the 

Medicare, Medicaid, and SCHIP 

Benefits Improvement and Protection 

Act (BIPA) of 2000 made additional 

changes to the Medicare hospice benefit. 

Program Memorandum (PM A–97–11), 

released in September 1997, 

implemented most of the hospicerelated BBA provisions. 

The limitation of liability rule 

changes were implemented through the 

Program Memorandum (PM A–97–11), 

issued in September 1997. A hospice 

cost report for the hospice data 

collection requirement was developed 

and issued in April 1999. 

A. Payments for Hospice Services 

(Section 4441 of the BBA) 

Section 4441(b) of the BBA amended 

section 1814(i) of the Act to require 

hospice management to submit cost data 

for each fiscal year beginning with fiscal 

year 1999. A hospice cost report to 

collect this information was issued in 

April 1999. To allow hospices enough 

time to prepare for the new requirement, 

the implementation of the hospice cost 

report was delayed until cost reporting 

periods beginning on or after April 1, 

1999. 

B. Payment for Home Hospice Care 

Based on Location Where Care Is 

Furnished (Section 4442 of the BBA) 

Section 4442 of the BBA amended 

section 1814(i)(2) of the Act, effective 

for services furnished on or after 

October 1, 1997, required hospices to 

submit claims for payment for hospice 

care furnished in an individual’s home 

only on the basis of the geographic 

location at which the service is 

furnished. Previously, local wage index 

values were applied based on the 

geographic location of the hospice 

provider, regardless of where the 

hospice care was furnished. Hospices 

were able to inappropriately maximize 

reimbursement by locating their offices 

in high-wage areas and actually 

delivering services in a lower-wage area. 

Applying the wage index values for rate 

adjustments on the geographic area 

where the hospice care is furnished 

provides a reimbursement rate that is a 

more accurate reflection of the wages 

paid by the hospice for the staff used to 

furnish care. 

C. Hospice Care Benefit Periods (Section 

4443 of the BBA) 

Section 4443 of the BBA amended 

sections 1812(a)(4) and 1812(d)(1) of the 

Act to provide for hospice benefit 

periods of two 90-day periods, followed 

by an unlimited number of 60-day 

periods. This amendment changed the 

previous hospice care benefit periods. 

Each period requires a physician to 

certify at the beginning of the period 

that the individual has a terminal illness 

with a prognosis that the individual’s 

life expectancy is 6 months or less, 

should the illness run its normal course. 

Though it continues to be true that the 

remaining days in a benefit period are 

lost once a beneficiary revokes election 

of the hospice benefit or is discharged 

from the hospice, the restructured 

benefit periods will allow the 

beneficiary, or the hospice, to make this 

type of decision without placing the 

beneficiary at risk of losing hospice 

benefit periods in the future. 

70534 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

Section 4449 of the BBA indicated 

that the benefit period change applied to 

the hospice benefit regardless of 

whether or not an individual had made 

an election of the benefit period before 

the date of enactment. Therefore, 

beneficiaries who elected hospice before 

the BBA and who, after the passage of 

the BBA, were discharged from hospice 

care because they were no longer 

terminally ill, were able to avail 

themselves of the benefit at some later 

date if they became terminally ill again 

and otherwise met the requirements of 

the Medicare hospice benefit. If the 

beneficiary had been discharged during 

the initial 90-day period, he or she 

would enter the benefit in the second 

90-day period. If the discharge took 

place during the final 90-day period or 

any subsequent 60-day period, the 

beneficiary would enter the benefit in a 

new 60-day period. A beneficiary who 

had been discharged from hospice 

during the fourth benefit period before 

the enactment of the BBA would be 

eligible to access the benefit again, if 

certified as being terminally ill, and 

would begin in a new 60-day period. 

The 90-day periods would not be 

available again, as amended section 

1812(d)(1) of the Act still provides only 

for two 90-day periods during an 

individual’s lifetime. There is no limit 

on the number of 60-day periods 

available as long as the beneficiary 

meets the requirements for the hospice 

benefit. 

D. Other Items and Services Included in 

Hospice Care (Section 4444 of the BBA) 

Section 1861(dd)(1) of the Act lists 

the specific services covered under the 

Medicare hospice benefit. It has always 

been Medicare’s policy that Medicare 

hospice includes not only those specific 

services listed in section 1861(dd)(1) of 

the Act, but also any service otherwise 

covered by Medicare that is needed for 

the palliation and management of the 

terminal illness. Section 4444 of the 

BBA reiterated this policy by amending 

section 1861(dd)(1) of the Act to add a 

new subparagraph ‘‘I’’ to the list of 

covered hospice services in section 

1861(dd)(1) of the Act, effective April 1, 

1998. This new provision states that any 

other service that is specified in the 

plan of care, and for which payment 

may otherwise be made under Medicare, 

is a covered hospice service. This 

change underscores our previous 

construction of the law as requiring that 

the hospice is responsible for furnishing 

any and all services indicated as 

necessary for the palliation and 

management of the terminal illness, and 

related conditions, in the plan of care. 

A Medicare beneficiary, who elects 

hospice care, gives up the right to have 

Medicare pay for services related to the 

terminal illness or related conditions, 

outside of the hospice benefit. Section 

1861(dd)(1) of the Act contains a list of 

services and therapies covered under 

the Medicare hospice benefit. This list 

does not include services like radiation 

therapy, which are often furnished by 

hospices for palliative purposes. This 

change clarifies that these additional 

necessary services are covered under the 

hospice benefit and cannot be billed 

separately to Medicare. 

E. Extending the Period for Physician 

Certification of an Individual’s Terminal 

Illness (Section 4448 of the BBA) 

Section 4448 of the BBA amended 

section 1814(a)(7)(A)(i) of the Act to 

eliminate the specific statutory time 

frame for the completion of a 

physician’s certification of terminal 

illness for admission to a hospice for the 

initial 90-day benefit period. It requires 

only that certification be done ‘‘at the 

beginning of the period.’’ In accordance 

with our understanding of congressional 

intent, this change, (for example, as 

indicated by the title of section 4448), 

was made to extend the period for 

physician certification of the terminal 

illness by allowing hospices the 

discretion to require that hospice 

certifications are on file before a 

Medicare claim is submitted. 

Before the BBA, hospices were 

required to obtain, no later than 2 

calendar days after hospice care was 

initiated, written certification that a 

person had a prognosis of a terminal 

illness with a life expectancy of 6 

months or less. For the first benefit 

period, if the written certification could 

not be obtained within the 2 calendar 

days following the initiation of hospice 

care, a verbal certification could be 

made within 2 days following the 

initiation of hospice care, with a written 

certification not later than 8 calendar 

days after care was initiated. For 

subsequent benefit periods, written 

certification was required no later than 

2 calendar days after the first day of 

each benefit period. Under the new 

certification requirement, certification 

must be done ‘‘at the beginning of the 

period.’’ To protect the beneficiaries, we 

are requiring that the hospice obtain 

written certification before it submits a 

claim for payment. 

This new certification requirement 

also applies to individuals who had 

been previously discharged during a 

fourth benefit period and are being 

certified for hospice care again to begin 

in a new 60-day benefit period. Also, 

due to the restructuring of the benefit 

periods, any individual who revoked, or 

was previously discharged from, the 

hospice benefit, and then reelects to 

receive the hospice benefit in the next 

available benefit period, will need to be 

recertified as if entering the program in 

an initial benefit period. This means 

that the hospice must obtain verbal 

certification of terminal illness no later 

than 2 days after care begins, and 

written certification before the 

submission of a claim to the fiscal 

intermediary. 

F. Effective Date (Section 4449 of the 

BBA) 

The provisions of the BBA discussed 

above, unless noted otherwise, became 

effective for services furnished on or 

after the date of enactment of the BBA, 

or August 5, 1997. Section 4444 of the 

BBA, the other services provision, was 

effective on April 1, 1998. 

G. Clarification of the Physician 

Certification Requirement (Section 322 

of BIPA) 

Section 322 of BIPA amended section 

1814(a) of the Act by clarifying that the 

certification of an individual who elects 

hospice ‘‘* * * shall be based on the 

physician’s or medical director’s 

clinical judgment regarding the normal 

course of the individual’s illness.’’ The 

amendment clarified that the 

certification is based on a clinical 

judgment regarding the usual course of 

a terminal illness, and recognizes the 

fact that making medical 

prognostications of life expectancy is 

not always exact. This amendment at 

section 322 of BIPA clarifies and 

supports our current policy. In the early 

1990’s, we discovered that in many 

cases certification and recertification 

occurred without the documentation 

that would support the terminal illness 

prognosis. Accordingly, in 1995, we 

issued program memoranda requiring 

clinical information and other 

documentation that support the medical 

prognosis. This documentation must 

accompany a certification and be filed 

in the patient’s medical record. 

We recognize that medical 

prognostications of life expectancy are 

not always exact. However, the 

amendment regarding the physician’s 

clinical judgment does not negate the 

fact that there must be a basis for a 

certification. A hospice needs to be 

certain that the physician’s clinical 

judgment can be supported by clinical 

information and other documentation 

that provide a basis for the certification 

of 6 months or less if the illness runs its 

normal course. A signed certification, 

absent a medically sound basis that 

supports the clinical judgment, is not 

sufficient for application of the hospice 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70535 

benefit under Medicare. Section 322 of 

BIPA became effective for certifications 

made on or after the date of enactment, 

December 21, 2000. 

Requirements for Issuance of 

Regulations 

Section 902 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) 

amended section 1871(a) of the Act and 

requires the Secretary, in consultation 

with the Director of the Office of 

Management and Budget, to establish 

and publish timelines for the 

publication of Medicare final 

regulations based on the previous 

publication of a Medicare proposed or 

interim final rule. Section 902 of the 

MMA also states that the timelines for 

these regulations may vary but shall not 

exceed 3 years after publication of the 

preceding proposed or interim final rule 

except under exceptional 

circumstances. 

This final rule finalizes provisions set 

forth in the November 22, 2002 

proposed regulation with some changes 

based on public comments (67 FR 

70363). In addition, this final rule has 

been published within the 3-year time 

limit imposed by section 902 of the 

MMA. Therefore, this final rule is in 

accordance with the Congress’ intent to 

ensure timely publication of final 

regulations. 

III. Provisions of the Proposed 

Regulations 

In the proposed rule published 

November 22, 2002 (67 FR 70363), we 

proposed to amend 42 CFR Chapter IV 

by revising part 418. We proposed to 

make conforming changes to the 

Medicare hospice regulations to reflect 

the statutory changes, to revise the 

regulation to reflect current policy and 

to clarify requirements regarding the 

documentation needed to support a 

certification of terminal illness and the 

admission to and discharge from a 

Medicare hospice. We proposed to add 

one new requirement that would allow 

for discharges from hospice for cause 

under very limited circumstances. 

A. Duration of Hospice Care Coverage—

Election Periods (§ 418.21) 

In § 418.21, we proposed to revise 

paragraph (a) to make hospice benefit 

periods available in two 90-day periods 

followed by an unlimited number of 60- 

day periods (requirement of section 

4443 of the BBA). 

B. Certification of Terminal Illness 

(§ 418.22) 

We proposed to revise the cross 

reference in § 418.22(a)(1) from 

‘‘§ 418.21’’ to ‘‘§ 418.21(a)’’ and remove 

the phrase ‘‘for two, three, or four 

periods’’ and replace it with ‘‘for an 

unlimited number of periods’’ to reflect 

the changes in the hospice care election 

periods (requirement of section 4443 of 

the BBA). We proposed to revise the 

basic requirement at paragraph (a)(2) to 

state that the hospice must obtain 

written certification before it submits a 

claim for payment (requirement of 

section 4448 of the BBA), and we 

proposed to revise the exception at 

paragraph (a)(3) to state that, if the 

hospice cannot obtain the written 

certification within 2 calendar days, it 

must obtain an oral certification within 

2 calendar days, and the written 

certification before it submits a claim for 

payment. Therefore, oral certifications, 

which are necessary only if the hospice 

is unable to obtain written certification 

within 2 calendar days of the start of the 

benefit period, would be required for 

each benefit period rather than for just 

the initial 90-day period. We proposed 

to maintain our requirement for verbal 

physician’s certification no later than 2 

days after hospice care begins because 

we continue to believe that proper and 

timely assessment of a patient’s 

condition is of critical importance both 

to the hospice, which becomes 

responsible for the patient, and to the 

patient, who must have a sound basis 

for choosing palliative rather than 

curative care. 

As a condition of eligibility for a 

Medicare hospice program, an 

individual must be entitled to Medicare 

Part A and be certified as terminally ill. 

The Act also requires that this 

certification be made in writing by 

either the hospice medical director or 

the physician member of the 

interdisciplinary group, and by the 

attending physician, if the patient has 

one. However, the law does not 

explicitly discuss what information a 

hospice physician needs to consider 

before making a certification of terminal 

illness. 

Operation Restore Trust (ORT), a joint 

effort among the Centers for Medicare & 

Medicaid Services, the Office of the 

Inspector General, and the 

Administration on Aging to identify 

vulnerabilities in the Medicare program 

and to pursue ways to reduce 

Medicare’s exposure to fraud and abuse, 

identified several areas of weakness in 

the hospice benefit, primarily in the 

area of hospice eligibility. In 1995, as a 

result of early ORT findings, we issued 

a letter to all Regional Offices and 

Regional Home Health Intermediaries 

(RHHIs) clarifying what should be 

included in a patient’s medical record to 

support the certification of terminal 

illness. Subsequent ORT reports, and 

medical reviews conducted by RHHIs, 

have raised concerns about 

inappropriate certifications and 

recertifications and problems with a 

lack of documentation to support a 

prognosis of terminal illness. These 

reports and reviews found that 

certifications are being made for 

patients who are chronically ill but who 

are without complications or other 

circumstances that indicate a life 

expectancy of 6 months or less. 

In response to these concerns, we 

proposed to revise § 418.22(b) by adding 

introductory text, redesignating 

paragraph (b) as paragraph (b)(1), and 

adding an additional requirement for 

the content of certification as paragraph 

(b)(2). The introductory text would state 

that certification for the hospice benefit 

would be based upon the physician’s or 

medical director’s clinical judgment 

regarding the normal course of the 

individual’s illness. In paragraph (b)(2), 

we proposed requiring that clinical 

information and other documentation 

supporting the medical prognosis 

accompany the written certification and 

be filed in the medical record as 

required under § 418.22(d). 

C. Election of Hospice Care (§ 418.24) 

In § 418.24, we proposed to add to 

paragraph (c), ‘‘Duration of election,’’ a 

new paragraph (c)(3) to state that an 

election to receive hospice care would 

be considered to continue through the 

initial election period and through the 

subsequent election periods without a 

break in care as long as the individual 

is not discharged from the hospice 

under the provisions of § 418.26. This 

addition would clarify that only 

revocation by the beneficiary or 

discharge by the hospice terminates an 

election. 

D. Admission to Hospice Care (§ 418.25) 

Also in response to concerns raised by 

ORT, we proposed to establish general 

guidance on hospice admission 

procedures. Currently, there is no 

guidance in manuals or regulations 

regarding admission procedures. We 

proposed to add a new § 418.25, 

‘‘Admission to hospice care,’’ which 

establishes specific requirements to be 

met before a hospice provider admits a 

patient to its care. 

Paragraph (a) would permit a hospice 

to admit a patient only on the 

recommendation of the medical director 

in consultation with the patient’s 

attending physician, if any. We realize 

that many hospice patients are referred 

to hospice from various ‘‘nonmedical’’

sources. This is entirely appropriate; 

however, it is the responsibility of the 

70536 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

medical director, in concert with the 

attending physician, to assess the 

patient’s medical condition and 

determine if the patient can be certified 

as terminally ill. 

Paragraph (b) would require that the 

hospice medical director consider at 

least the following information when 

making a decision to certify that a 

patient is terminally ill: diagnosis of the 

patient’s terminal condition; any related 

diagnoses or comorbidities; and current 

clinically relevant information 

supporting all diagnoses. 

E. Discharge From Hospice Care 

(§ 418.26 and § 418.28) 

As with admission to hospice, the 

statute does not explicitly address when 

it is appropriate to discharge an 

individual from hospice care. The 

Internet Online Manual (IOM) Medicare 

Benefit Policy Manual, Section 20.2.1 

Hospice Discharge, explains that 

discharge is allowable only if the patient 

is no longer terminally ill or if the 

patient moves out of the service area. 

We proposed to add a new § 418.26, 

‘‘Discharge from hospice care,’’ to 

specify when a hospice may discharge 

a patient from its care. Paragraph (a), 

‘‘Reasons for discharge,’’ would specify 

that a hospice may discharge a patient 

if—

1. The patient moves out of the 

hospice’s service area or transfers to 

another hospice; 

2. The hospice determines that the 

patient is no longer terminally ill; or 

3. The hospice determines, under a 

policy set by the hospice for the purpose 

of addressing ‘‘discharge for cause’’ that 

also meets the requirements discussed 

in the remainder of the new paragraph 

(a), that the patient’s behavior is 

disruptive, abusive, or uncooperative to 

the extent that delivery of care to the 

patient or the ability of the hospice to 

operate effectively is seriously impaired. 

Before the hospice seeks to discharge a 

patient, we would require it to make a 

serious effort to resolve the problem(s) 

presented by the patient’s behavior or 

situation; ascertain that the patient’s 

proposed discharge is not due to the 

patient’s use of necessary hospice 

services; document the problem(s) and 

efforts made to resolve the problem(s) 

and enter this documentation into the 

patient’s medical records; and obtain a 

written physician’s order from the 

patient’s attending physician and 

hospice medical director concurring 

with the discharge from the hospice. 

Since the inception of the Medicare 

hospice program, we have received 

inquiries from hospices regarding 

patients and their family members or 

primary caregivers who elected hospice 

but subsequently became uncooperative 

or hostile (including threats of physical 

harm and to the extent that hospice staff 

could not provide care to the patient) 

when the facilities attempted to provide 

care. In the absence of regulations or 

guidance from Medicare regarding these 

situations, hospices were uncertain as to 

their authority to act to resolve this type 

of problem. We offered informal 

guidance that if the hospice had made 

a conscientious effort to resolve the 

problem and had documented that 

effort, and the patient refused to revoke 

the benefit voluntarily, a discharge 

would be indicated. Failure to revoke 

the benefit could place the patient in a 

compromised position in which the 

patient would not be able to receive 

services from the hospice but would at 

the same time be unable to obtain 

services under the standard Medicare 

program because of his or her hospice 

status. An additional concern is the 

issue of daily payments being made to 

a hospice when no services are being 

provided. 

Paragraph (b), ‘‘Effect of discharge,’’

specifies that an individual, upon 

discharge from the hospice during a 

particular election period for reasons 

other than immediate transfer to another 

hospice, is no longer covered under 

Medicare for hospice care and resumes 

Medicare coverage of the benefits 

waived under § 418.24(d). If the 

beneficiary becomes eligible for the 

hospice benefit at a future time, he or 

she would be able to elect to receive this 

benefit again. 

Although the statute does not 

explicitly address when a hospice may 

discharge a patient from its care, we 

realize that there are certain instances in 

which it is no longer appropriate for a 

hospice to provide care to a patient. A 

decision that a hospice patient is no 

longer terminally ill is generally not 

made during one assessment. However, 

once it is determined that the patient is 

no longer terminally ill, the patient is no 

longer eligible to receive the Medicare 

hospice benefit. Currently, the 

regulations do not provide any time for 

discharge planning between the 

determination that the patient is no 

longer terminally ill and discharge from 

the benefit. Since the BBA has ended 

the limitation on available benefit 

periods during a beneficiary’s lifetime, 

we expect to see an increase in the 

number of beneficiaries being 

discharged from, or revoking, the 

hospice benefit because they can no 

longer be certified as terminally ill. 

However, it is common for these 

beneficiaries to remain in medically 

fragile conditions and in need of some 

type of medical services in order to 

remain at home. It is important that 

hospice providers consider these needs 

so that support structures can quickly be 

put into place should the patient’s 

prognosis improve. 

Therefore, we proposed to add a 

paragraph (c), ‘‘Discharge planning,’’ in 

the new requirement at § 418.26. We 

require at paragraph (c)(1) that the 

hospice have in place a discharge 

planning process that takes into account 

the prospect that a patient’s condition 

might stabilize or otherwise change that 

the patient cannot continue to be 

certified as terminally ill. Additionally, 

we proposed at paragraph (c)(2) that the 

discharge planning process must ensure 

that planning for the potential of 

discharge includes consideration of 

plans for any necessary family 

counseling, patient education, or other 

services before the patient is discharged 

because he or she is no longer 

terminally ill. 

Finally, we proposed to revise 

§ 418.28(b)(1) to permit discharges for 

cause (under proposed § 418.26(a)) if a 

patient refuses to sign a revocation 

statement. A signed revocation 

statement serves to protect hospice 

patients whose hospice may seek to 

discharge them because of possible 

higher costs associated with use of 

necessary services. Under current 

regulations, if a patient, who otherwise 

would be discharged for cause, were to 

refuse to sign a revocation statement, 

the hospice would be in the position of 

receiving daily payments from Medicare 

for a person who cannot receive 

services. Paragraph (b)(1) would permit 

waiver of a signed revocation if one 

were not obtainable in cases of 

discharge for cause. Our utmost concern 

is that there are sufficient patient 

protections in place to ensure 

appropriate delivery of care and, if 

needed, discharge planning. 

F. Covered Services (§ 418.202) 

We proposed to add a new paragraph 

(i) to § 418.202 to state that any other 

service that is specified in the patient’s 

plan of care as reasonable and necessary 

for the palliation and management of 

the patient’s terminal illness and related 

conditions, and for which payment may 

otherwise be made under Medicare, is a 

covered hospice service. This change 

was made by section 4444 of the BBA 

and was a clarification of long-standing 

Medicare policy. 

G. Payment for Hospice Care (§ 418.301, 

§ 418.302, § 418.304, and § 418.306) 

In addition to reflecting the payment 

changes required by the BBA, we 

proposed to add a new paragraph (c) to 

§ 418.301, ‘‘Basic rules.’’ This paragraph 

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would restate the basic requirement, 

included in the provider agreement, that 

the hospice may not charge a patient for 

services for which the patient is entitled 

to have payment made under Medicare 

or for services for which the patient 

would be entitled to payment if the 

provider had completed all of the 

actions described in § 489.21. Since this 

requirement is currently included in the 

provider agreement, we would restate it 

in this part for clarification only. 

We proposed to add a new paragraph 

(g) to § 418.302, ‘‘Payment procedures 

for hospice care,’’ to provide that 

payment for routine home care and 

continuous home care would be made 

based on the geographic location where 

the service is provided (requirement of 

section 4442 of the BBA). 

We proposed to update the rules 

found at § 418.304, ‘‘Payment for 

physician services,’’ to reflect current 

payment methodology for physician 

services under Medicare Part B. 

References to reimbursement based on 

reasonable charges would be replaced 

with references to the physician fee 

schedule. We proposed to revise the 

first sentence of paragraph (b) to clarify 

that a specified Medicare contractor 

pays the hospice an amount equivalent 

to 100 percent of the physician fee 

schedule, rather than 100 percent of the 

physician’s reasonable charge, for those 

physician services furnished by hospice 

employees or those under arrangement 

with the hospice. We also proposed to 

revise the second sentence of paragraph 

(c) to specify that services of the 

patient’s attending physician, if he or 

she is not an employee of the hospice 

or providing services under 

arrangements with the hospice, are paid 

by the carrier under the provisions in 42 

CFR Part 414 Subpart B. 

Finally, in § 418.306, ‘‘Determination 

of payment rates,’’ we proposed to 

revise paragraph (b)(3) and to add new 

paragraphs (b)(4) and (b)(5) to set the 

payment rate in Federal fiscal years 

1998 through 2002 as the payment rate 

in effect during the previous fiscal year 

increased by a factor equal to the market 

basket percentage increase minus 1 

percentage point, with the exception 

that the payments for the first half of FY 

2001 shall be increased 0.5 percent, and 

then increased an additional 5 percent 

over the above calculation. Payments for 

all of FY 2002 were increased by 0.75 

percent. 

IV. Analysis of and Responses to Public 

Comments 

We received a total of 27 timely 

public comments in response to the 

November 22, 2002 proposed rule (67 

FR 70363). Some of the organizations 

we received letters from were hospice 

providers, national stakeholder and 

advocacy groups, national and State 

hospice associations, and other health 

care providers and suppliers. All public 

comments were reviewed and grouped 

by the same or related topics. The 

comments and our responses are 

summarized below. 

A. Duration of Hospice Care Coverage—

Election Periods (§ 418.21) 

Comment: A commenter stated that 

the regulations should make clear that if 

a beneficiary revokes the benefit and 

there are unused days remaining in the 

benefit period, the beneficiary is free to 

re-elect hospice before those unused 

days pass. 

Response: Section 418.26(b)(3) 

specifically states that the individual 

‘‘may at any time elect to receive 

hospice care if he or she is again eligible 

to receive the benefit.’’ Section 

418.28(c)(3) also contains similar 

language. 

Comment: One commenter requested 

that the new benefit period rules apply 

to State Medicaid programs that offer 

hospice. 

Response: This would be up to 

individual States, who generally follow 

Medicare hospice rules. 

Comment: A commenter asked us to 

state in the final rule that there is no 6- 

month limit on hospice eligibility as 

long as there is documentation to 

support medical reviews of cases when 

this happens. 

Response: We do not believe this 

language needs to be included in the 

final rule. The 6-month rule applies to 

eligibility for the hospice benefit, 

including a patient’s prognosis and life 

expectancy. Medical reviews are not 

automatic in the event that a patient 

lives longer than 6 months, and could 

occur at any point during an 

individual’s time in hospice including 

less than 6 months if this review were 

indicated. 

B. Certification of Terminal Illness 

(§ 418.22) 

Comment: A few commenters believe 

that the proposed rule would require 

oral certifications for each benefit 

period, and that oral certification is 

required from the medical director and 

the attending physician for all benefit 

periods, a new and unnecessary burden. 

Response: This is not correct. An oral 

certification is only needed if no written 

certification is obtained within 2 days. 

This change in regulations implements 

a BBA provision that the Congress 

intended to ease the burden of obtaining 

a written certification within 2, or at the 

latest, 8 days after the start of the initial 

benefit period. Now, the written 

certification is required before a hospice 

submits a claim for payment. Therefore, 

oral certification will be required if the 

written certification cannot be obtained 

within 2 days following the start of the 

benefit period. In fact, the rules for 

certification for periods following the 

initial period are unchanged. Section 

§ 418.22(c), the regulation concerning 

the initial certification and those that 

followed, was not part of the proposed 

changes published on November 22, 

2002 (67 FR 70363). This regulation 

requires the attending physician’s (if 

there is one) certification for the initial 

period. Subsequent periods only require 

certification by the hospice’s medical 

director or the physician member of the 

hospice IDG. 

Comment: Several commenters are 

concerned that language calling for 

‘‘specific clinical findings and other 

documentation’’ at § 418.22(3)(b)(2) 

could end up with requirements that 

would become excessively specific and 

cause access problems due to a 

perception that exacting documentation 

requirements must be met; or that 

additional tests must be performed, 

beyond what already will have 

sufficiently established that eligibility is 

met. Commenters suggested that 

physician experience and not simply lab 

or pathology reports be recognized. 

Response: It appears that the word 

‘‘specific’’ may be skewing the intention 

of the regulation. This rule is being 

added to formalize policy that came in 

response to OIG/ORT findings in the 

mid-1990s, when a number of 

admissions to hospices were happening 

with little or no documentation that 

supported a certification for hospice. 

We expect that a hospice patient’s 

medical record would contain sufficient 

information to support the certification 

of the individual as having a terminal 

illness with a life expectancy of 6 or 

fewer months, if the illness runs its 

normal course. We believe it is 

reasonable to expect documentation to 

support the certification. We are 

removing the word ‘‘specific’’ and 

changing ‘‘findings’’ to ‘‘information’’ so 

that the phrase would read ‘‘clinical 

information and other documentation.’’

Section 322 of BIPA called for the 

physician’s ‘‘clinical judgment,’’ and 

this regulation simply asks that it be 

supported. 

Comment: A commenter stated that 

the best approach to certification might 

be for the attending physician to refer 

patients he or she believes eligible, and 

for the medical director to exercise his 

or her best judgment regarding 

concurrence. 

70538 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

Response: The Medicare statute is 

clear about the responsibility of the 

hospice’s medical director to certify, 

along with the attending physician for 

the initial benefit period, the individual 

as eligible for hospice. 

Comment: Two commenters believe 

we were compromising the intent of 

BIPA by requiring oral certifications for 

each benefit period, requiring a hospice 

to expend additional resources without 

any obvious benefit. One commenter 

believes this is a new requirement. 

Another commenter indicated that it 

ignores Congressional intent. 

Response: In a sense, this is a new 

requirement, but it protects and ensures 

timely medical care for the beneficiary 

as well as significantly eases the written 

certification burden on the hospice. The 

hospice regulations have always 

required written certification at the start 

of each benefit period. The Congress 

made no indication that this rule should 

end. Now, all that is required, if a 

written physician certification cannot be 

completed within 2 calendar days after 

a period begins, is that an oral 

certification be obtained. Previously a 

written certification was required 

within 2 days for every period after the 

initial benefit period, or the hospice 

would be faced with the possibility of 

a claim being denied. We are following 

Congressional intent, in that the 

Congress indicated that the written 

hospice certification rule should follow 

the home health rule, and be on file 

before a claim is submitted. 

Comment: A commenter believes that 

clinical information and documentation 

do not need to accompany the 

certification, and urged that we delete 

‘‘accompany’’ in the requirement at 

§ 418.22(b)(2), replacing it with simply 

a requirement that the information be in 

the medical record. The commenter 

believes that if documentation had to 

accompany the certification, care could 

be delayed or even denied, and an 

unnecessary burden would be placed 

upon the hospice and other providers. 

Several commenters pointed out that 

frequently hospices obtain certifying 

information over the phone from the 

referring physician, which is then 

recorded and placed in the patient’s 

medical record. 

Response: We believe that clinical 

information and documentation are 

critical to the certification decision. We 

recognize that some documentation may 

physically arrive at the hospice and be 

placed in the medical record after the 

start of care; however, that should not 

mean that the information does not 

come to the attention of the hospice and 

be included in the certification and 

admission process. The attending 

physician may well report clinical 

information by telephone or interview, 

with written documents to arrive later. 

It is the information needed for the 

hospice’s IDG to develop the initial plan 

of care for the new patient, and 

therefore we would expect the 

information to accompany, in some 

fashion, the certification, although some 

of it may not arrive physically at the 

hospice until later. We are revising this 

final rule to indicate that clinical 

information may initially arrive verbally 

and is documented in the patient’s 

medical record as part of the hospice’s 

assessment of eligibility for hospice. 

Comment: A commenter objected to 

oral certification within 2 days after the 

start of each benefit period, believing it 

is unnecessary record keeping. 

Response: Certification no later than 2 

days after the start of each benefit 

period is not a new requirement. Past 

regulations required that certification be 

in writing no later than 2 days after the 

start of care for all periods after the 

initial period. The oral certification is a 

way to protect and ensure timely 

medical care for the beneficiary as well 

as easing the written certification 

burden on the hospice. This final rule 

requires oral certification (if needed) for 

all benefit periods, and in writing before 

a claim for the period is submitted. 

Comment: A few commenters stated 

that it was burdensome and unnecessary 

to require clinical information and 

documentation as part of the 

certification that supports the 

physician’s clinical judgment that the 

individual is terminally ill with a 

prognosis of 6 months or less to live if 

the illness runs its normal course. There 

were suggestions that BIPA’s 

amendment of the statute, which 

provides for ‘‘certification based on the 

physician’s or medical director’s 

clinical judgment * * *’’ was sufficient, 

without any supporting documentation 

at the time of certification. It was noted 

that prognosis is inexact at best, and 

that we seemed to be requiring accurate 

predictions (with possible penalties for 

failure to be precise). 

Response: As discussed in the 

preamble of the November 22, 2002 

proposed rule (67 FR 70363), the 

Medicare statute does not explicitly 

describe what a physician needs to 

consider before certifying a patient for 

hospice. In that preamble, we cited early 

ORT findings (which were partly based 

upon other OIG and intermediary 

medical reviews of patient records) as 

clearly indicating a need for 

requirements that certifications be 

supported by clinical findings and 

documentation. (Elsewhere in this 

preamble, we discuss the replacing of 

the word ‘‘findings’’ with ‘‘information’’

in the final rule.) Our 1995 letters to 

RHHIs clarified expectations for 

supporting documentation, and this 

information was widely disseminated to 

the hospices and the hospice industry. 

Response to our effort was positive. At 

that time, claims were coming under 

closer scrutiny, and failure to find 

documentation in medical records that 

supported certification and the need for 

hospice caused denial of claims. CMS 

has sent out widely disseminated letters 

that made it clear that Medicare 

supports accessibility to the hospice 

benefit. The letters recognized that 

prognosis is not an exact science, and 

that the impact of a hospice’s services 

may sometimes lead to brief periods of 

improvement. Nevertheless, it is 

reasonable to expect that information 

supporting physician certifications be 

provided to ensure that patients 

beginning hospice are appropriate for 

this type of care. 

Comment: One commenter stated that 

written certifications did not need to be 

obtained by the hospice before 

submission of claims for periods 

following the initial period and could be 

obtained later. 

Response: A written certification has 

been required by statute since the 

inception of the Medicare hospice 

program. 

Comment: There was a comment that 

certification of the terminal illness 

should be based on either the attending 

physician’s certification or the hospice’s 

medical director’s certification. 

Response: This is a statutory 

requirement. Section 1814(a)(7)(A) of 

the Social Security Act requires that 

both the hospice’s physician (either the 

medical director or physician member 

of the interdisciplinary group) and the 

attending physician (if the patient has 

one) must certify patients for the 

Medicare hospice benefit for the initial 

period. For subsequent benefit periods, 

the hospice physician alone may certify 

patients for the hospice benefit. The 

attending physician does not have sole 

or surrogate power to certify for 

admission for any benefit period. 

C. Election of Hospice Care (§ 418.24) 

No comments were received. 

D. Admission to Hospice Care (§ 418.25) 

Comment: A commenter suggested 

that the medical director alone certify 

patients for hospice. 

Response: Though the medical 

director or physician member of the 

hospice interdisciplinary group must 

certify for each election period, the 

attending physician (if any) is also 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70539 

required, by statute, to do so for the first 

election period. 

Comment: Some commenters believe 

the regulation would require the 

attending physician to participate in all 

certifications that may be required, and 

that it imposes a barrier to obtaining 

hospice care. Further, it would subvert 

the role of the IDG. It would also 

increase costs unnecessarily, since some 

patients are near death by time of 

admission. 

Response: This is not correct. An 

attending physician (if the patient has 

one) does certify for the initial period, 

but is not required or expected to do any 

subsequently needed certifications. We 

would expect the attending physician to 

be consulted by the medical director or 

IDG if he or she has maintained 

significant involvement in the case. 

Comment: A commenter believes this 

rule negates the role of the IDG in the 

admission process. 

Response: The role of the IDG is not 

changed by this rule. Regulations at 

§ 418.22(c)(1)(i), which includes the 

physician member of the 

interdisciplinary group as a party who 

may certify terminal illness, remain the 

same. 

Comment: A commenter believes that 

the November 22, 2002 proposed rule 

requires excessive involvement by the 

Medical Director in the patients’

admission to hospice, such as 

physically seeing the patient before 

admission, making telephone calls to 

the attending physician, and obtaining 

original history and physical reports. 

Response: Currently, to be admitted to 

hospice, the patient must meet the 

eligibility requirements at § 418.20(b) 

‘‘certified as being terminally ill in 

accordance with § 418.22.’’ It is the 

physician’s responsibility to assess the 

patient’s medical condition and 

determine if the patient can be certified 

as terminally ill. This is reflected in 

Section 418.22(c)(i) and (ii), Sources of 

Certification, which states that for the 

initial 90-day period, certification 

statements must be obtained from ‘‘the 

medical director of the hospice or the 

physician member of the hospice 

interdisciplinary group; and the 

individual’s attending physician if the 

individual has an attending physician.’’

The new requirements at § 418.25 

provides clarification of the physician’s 

responsibilities as it relates to the 

admission process. 

Comment: Some commenters 

suggested that this final rule would 

require the medical director to consult 

directly with the attending physician, 

and that it would be a poor and 

expensive use of the director’s time. 

Some commenters stated that it would 

be a needless impediment that would 

add delays to the start of hospice care. 

One commenter stated that the final rule 

required every piece of medical 

documentation be in the hands of the 

medical director before an admission 

decision is made. One commenter stated 

that the hospice nurse, while obtaining 

pre-admission information, would be 

the more appropriate individual to 

obtain an attending physician’s input in 

the admission process. 

Response: It is not our intent to 

require a face-to-face or any type of 

direct consultation between the Director 

and the attending physician. We are 

revising the language to indicate that the 

medical director has considered patient 

information from the attending 

physician that may be obtained through 

consultation, or through information 

obtained indirectly. Information could 

be obtained through the hospice nurse 

or others who would bring the attending 

physician’s knowledge of the patient to 

the medical director when the 

admission decision is being made. We 

also note that the medical 

documentation does not necessarily 

need to be physically in the hands of the 

medical director, but that the 

information presented is considered in 

the decision. The medical reports may 

arrive later for retention in the patient’s 

medical record. 

Comment: A commenter suggested 

that the proposed rule required an 

attending physician to be consulted, 

which would be impossible if the 

patient did not have one. 

Response: The proposed rule 

included the phrase ‘‘if any’’ following 

‘‘attending physician’’ but preceded by 

a comma. We have made ‘‘if any’’ a 

parenthetical phrase after attending 

physician to make it clearer that we 

recognize that there may not be an 

attending physician in all cases. 

Comment: One commenter is 

concerned that small hospices that use 

volunteer medical directors would be 

forced to hire a Medical Director at a big 

expense. The commenter believes that 

volunteers would be reluctant to offer 

their time because consultation with 

attending physicians at the time of 

admission would require more time 

than they would be willing to provide. 

Other commenters believe that hospices, 

especially small ones with part-time 

medical directors with separate private 

practices, will face considerable 

increased costs if medical directors were 

forced to consult with attending 

physicians. 

Response: We cannot know whether 

this final rule would cause volunteer 

physicians to cease participating in any 

particular hospice program, or what 

additional costs a hospice would face 

with respect to its part-time medical 

directors. However, no matter what the 

status of the hospice medical director—

employee or volunteer—that individual 

(or the physician member of the IDG) 

has always had a responsibility to 

review the appropriateness of admission 

of new patients to hospice. The ORT/ 

OIG reports from the mid-1990s 

investigations made it clear that we 

need to make sure that certifications 

were not simply a physician signature 

upon a document alone, but that there 

was documentation supporting the 

admission decision that had been 

considered. The medical director’s 

certification is an essential part of the 

admission procedure, and the director 

considering the attending physician’s 

knowledge of the patient is part of the 

certification decision. As we discussed 

elsewhere in the preamble, the 

consultation need not be direct, but the 

attending physician’s input should be 

considered in the admission process. 

Comment: A commenter stated that 

the medical director must submit 

documentation regarding his or her 

consideration of the documentation. 

Response: The medical director 

would only need to document that the 

pertinent clinical information had been 

considered in the certification process. 

The documentation includes a diagnosis 

of the patient’s terminal condition; any 

related diagnoses or comorbidities; and 

current clinically relevant findings 

supporting all diagnoses. 

Comment: A commenter objected to 

§ 418.25(b) describing the information 

that should be considered by the 

medical director when certifying a 

patient. 

Response: We believe that this final 

rule clarifies the expectation that 

underlies the basis for making a 

significant decision about an individual 

accepting his or her terminal condition 

and the treatment plans that are to 

come. It is information that should be 

considered, and we do not think that the 

final rule should be modified. 

Comment: One commenter opposes 

this admission section of the proposed 

regulations entirely, citing election and 

certification as the only requirements 

for beginning hospice. The commenter 

believes that the admission rules would 

make it impossible for a hospice to 

admit certain individuals for care for a 

terminal illness that does not meet the 

Medicare eligibility requirements for the 

benefit, but for whom the hospice 

would not submit claims to Medicare. 

Response: As we explained in the 

preamble to the proposed rule (67 FR 

70367), this regulation would establish 

guidance on hospice admission 

70540 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

procedures. It clarifies and supports the 

election and certification rules by 

describing the process by which a 

medical director must certify that a 

patient is terminally ill and, thus, admit 

that patient to the hospice. In addition, 

the admission rules, along with election 

and certification rules would not 

necessarily pertain to an individual that 

does not meet Medicare eligibility rules 

but whom the hospice otherwise 

decides to offer services to without cost 

to Medicare. 

E. Discharge From Hospice Care 

(§ 418.26) 

We received some comments that 

indicated that a discharge for cause rule 

offered helpful guidance in cases where 

patients consistently refused to permit 

the hospice to visit or deliver care, or it 

was dangerous for staff to visit the 

home, or when the patient repeatedly 

left the service area. Other commenters 

asked for specificity in the regulations 

regarding circumstances when the 

discharge for cause rule might apply. 

We do not believe it is possible to do 

this without creating either an 

excessively lengthy regulation or one 

that due to over-specificity would 

unintentionally take the flexibility that 

the hospice may need to act. We do plan 

to offer some guidance and examples in 

the hospice manual. 

Comment: Some commenters want 

family added along with the patient as 

a source of problems that could be a 

reason to consider a discharge for cause. 

Commenters cited examples such as 

threats from the patient’s family, or drug 

stealing and drug dealing by members of 

the patient’s household. 

Response: We agree, and have 

amended the proposed rule to take other 

persons (which would include family) 

in the patient’s home into account. To 

the extent that the situation interferes 

with the ability of the hospice staff to 

provide care efficaciously, it may be 

appropriate to discharge the patients. 

However, we would expect the hospice 

to make every effort to rectify the 

situation before ending its services, with 

documentation of what transpired in the 

case. Alternative suggestions and 

referrals for care should be presented to 

the patient and his or her caregiver 

before ending services. 

Comment: A commenter suggested 

that failure on the part of the patient to 

follow the plan of care be identified as 

a reason for discharge. Instances of the 

patient going to the emergency room 

without first contacting the hospice 

were cited, particularly with respect to 

financial issues where the patient would 

be responsible for care not arranged for 

through the hospice. 

Response: We do not think that single 

instances of the patient/family going to 

the emergency room without prior 

authorization from the hospice would 

necessarily be a valid reason for 

discharge. Failure to follow important 

clinical features of the POC may be a 

reason to consider discharge, but a 

panicked reaction to an emergency 

should not be, by itself, a reason to 

terminate services. It is important for 

the patient and family to be educated 

before the start of care that hospice 

entails certain limits in the way care 

will be provided once hospice services 

begin, among them being restrictions on 

obtaining care outside those provided or 

arranged for by the hospice, and the 

patient’s potential liability for care 

received without the hospice’s 

involvement. It is particularly important 

that the patient and caregiver be 

instructed on what to do in a crisis or 

emergency. 

Comment: Some commenters believe 

that it would be very difficult to obtain 

a patient’s attending physician’s 

signature when discharging a patient for 

cause, and that in any event many 

attending physicians cease following 

their patients after hospice begins. Some 

patients never had an attending 

physician. Other commenters worry that 

an attending physician could override 

an IDG decision, when the attending 

physician’s opinion was not needed or 

that in the case of an attending 

physician who disagreed with 

discharge, it would place him or her in 

a compromised position with his or her 

patient. Further, the commenter stated 

that it is ultimately the hospice’s 

responsibility to decide upon discharge 

of patients. 

Response: If there is no attending 

physician involved in a patient’s care, 

then such a requirement would seem to 

create a problem. At the same time, a 

discharge for cause is a serious matter 

where we believe the patient needs 

some protection from a hospice that 

may behave unethically and try to 

discharge a patient because he or she 

may require more attention or care than 

the hospice wished to offer. If there is 

an attending physician, his or her 

opinion matters. However, to reduce a 

burden that the proposed rule might 

have created if it were finalized, we are 

revising the requirement at § 418.26(b) 

to read, ‘‘Prior to discharging a patient 

for any reason listed in subsection (a), 

the hospice must obtain a written 

physician’s discharge order from the 

hospice medical director. If the patient 

has an attending physician involved in 

his or her care, the physician should be 

consulted before discharge and his or 

her view included in the discharge 

note.’’ This would help ensure that the 

attending physician’s position on 

discharge for cause is taken into 

account, as well as giving the attending 

physician an opportunity to participate 

in post-discharge planning for the 

patient. 

Comment: Some commenters 

suggested that either the attending 

physician or medical director could sign 

a discharge order. 

Response: We cannot accept this 

suggestion. It is the responsibility of the 

hospice to make this decision, just as it 

is the hospice’s decision to admit the 

new patient. Elsewhere in this 

preamble, we have indicated that the 

final rule has been revised to indicate 

that the attending physician is to be 

consulted and his or her views included 

in the discharge note. 

Comment: Commenters want the 

discharge-planning rule made 

conditional upon the possibility that 

there will be time to plan, or that 

planning only be done when possible, 

since some patients may need 

immediate discharge because they are 

no longer terminally ill. Requests were 

made for a time frame for determining 

stability requiring discharge. 

Response: The rule requires that the 

hospice have in place a process ‘‘that 

takes into account the prospect that a 

patient’s condition might stabilize or 

otherwise change’’. We do not expect 

that a discharge would be the result of 

a single moment that does not allow 

time for some post-discharge planning. 

Rather, we would expect that the 

hospice’s IDG is following their patient, 

and if there are indications of 

improvement in the individual’s 

condition such that hospice may soon 

no longer be appropriate, then planning 

should begin. If the patient seems to be 

stabilizing and the disease progression 

has halted, then it could be the time to 

begin preparing the patient for 

alternative care. Discharge planning 

should be a process, and planning 

should begin before the date of 

discharge. We have tried to avoid 

prescriptive time frames for discharge 

planning, since we have long been 

aware that merely the attention that 

hospice services give to a patient can 

have a beneficial effect, creating the 

impression that the individual may no 

longer be ‘‘actively dying’’ and therefore 

ineligible for the Medicare hospice 

benefit. Therefore, we cannot offer a 

specific number of days or weeks that a 

patient may be stable and thus not 

eligible. We see this issue as one 

requiring physician/IDG judgment and 

would only ask that the judgment be 

supported by documentation in the 

medical record indicating the reason 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70541 

why hospice should continue if there 

seems to be improvement such that 

discharge is under consideration. 

Comment: A commenter wanted the 

discharge of a patient who moves out of 

the service area or who transfers to 

another hospice to include patients who 

temporarily leave the hospice’s service 

area without notifying or making 

arrangements with the hospice. 

Response: If the patient transfers to 

another hospice, then the assumption is 

that arrangements have been made, and 

end and start dates of care have been 

worked out. This is not a temporary 

move, and discharge issues should not 

arise. Concerning patients who leave the 

hospice service area temporarily, this 

issue should have been addressed by the 

hospice at the time of admission when 

the hospice explains to the patient the 

waiver of benefits that occur upon 

election of the hospice benefit. If the 

hospice patient leaves the service area 

and attempts to obtain care for his or her 

terminal condition for which hospice 

was elected, then the patient assumes 

financial responsibility for this care. It 

is not necessarily a reason to discharge 

a patient unless there is a repeated 

pattern of such activity and it interferes 

with the care that the hospice plan of 

care calls for. The hospice should 

counsel the patient regarding the 

consequences of obtaining care from 

sources other than the hospice. The 

patient may even decide to revoke the 

benefit under the circumstances. 

Comment: A commenter does not 

believe a discharge plan should be 

required for all patients, since live 

discharges are rare. Imposing this 

requirement for every patient would be 

an unnecessary and costly burden. 

Response: We believe that the 

commenter may have misunderstood 

the purpose of the proposed rule. A 

hospice would need to have a process 

in place should the condition of a 

patient show indications that hospice 

possibly may no longer be the 

appropriate treatment for that 

individual. We do not expect that every 

patient will have a discharge plan 

prepared. However, should a hospice 

patient’s condition seem to be 

improving (beyond just brief periods of 

improvement that sometimes occur 

simply because the individual is 

receiving attention and some symptom 

relief), the hospice IDG should have a 

discharge planning process available in 

order to help make plans for the 

individual’s discharge and follow-up 

care as may be needed. We would 

expect most patients would not have a 

discharge plan ever; however, when 

indicated, the hospice would have the 

ability to begin the process timely. 

Comment: A commenter believes that 

requiring a written physician’s order for 

discharge of a patient, ignored the role 

of the IDG, including the attending 

physician if he or she is participating. 

Response: We agree about the 

essential role of the IDG, and we would 

expect their participation in any 

discharge decisions. However, it is the 

commonly accepted practice for a 

physician to sign an admission or 

discharge order in hospitals. Similarly, 

it is the hospice physician who signs a 

certification for hospice care in order to 

begin care, and that individual also 

would consequently be the one to sign 

the discharge order. Elsewhere in this 

preamble, we have advised that an 

attending physician would not be 

required to sign discharge papers. 

Comment: A commenter urged that in 

cases of discharge for cause the patient 

should be notified of this possible 

action. 

Response: We agree, and have revised 

the regulation to reflect this suggestion. 

Comment: A commenter wants the 

beneficiary advised of appeal rights 

when a discharge for cause is being 

considered. One commenter noted the 

potential for misuse of the discharge for 

cause rule to discharge high-cost 

patients. 

Response: There are no specific 

appeal rights for the beneficiary 

regarding such considerations. 

However, for the protection of the 

beneficiary, we added to the regulation, 

a provision that the beneficiary must be 

notified, by the hospice, that discharge 

for cause is being considered. 

Comment: A commenter suggested 

that we monitor, analyze, and identify 

ways to reduce discharge for cause, and 

perhaps then establish a forum for 

sharing best practices on maintaining 

hospice care for difficult patients. 

Response: We appreciate the 

suggestion and will consider it for 

future program evaluations. 

Comment: A commenter complained 

that having a physician sign a discharge 

order was creating an additional 

paperwork burden. 

Response: We see the signing of a 

discharge order in the patient’s medical 

record as part of the physician’s 

administrative activities. Signing the 

order would simply be the final action 

at the end of discharge process. 

Comment: Some commenters believe 

that it was inappropriate to ask the 

hospice, in considering a discharge for 

cause, to ‘‘ascertain that * * * is not 

due to * * * use of necessary hospice 

services,’’ and that it would be difficult 

to prove a negative that the use of 

services was not a factor in discharge. 

Commenters did agree that use of 

necessary services would not be an 

appropriate reason to discharge. 

Response: We believe that this 

requirement is appropriately in this 

section of the rule. It is one of our 

concerns that discharge for cause could 

be a rule that offers opportunity for 

abuse, and we want to make it clear that 

the hospice needs to make sure that it 

is planning to discharge a patient 

because of behavior issues, not time or 

effort or cost factors in providing 

services to a particular individual. We 

believe that ascertaining that discharge 

is not due to the use of necessary 

services is simply a reminder that some 

of a hospice’s patients require more 

services. This fact should not influence 

a discharge decision. 

Comment: One commenter suggested 

that the regulations should not list any 

reasons for a cause discharge and 

instead the hospice should set its own 

policy for discharge for cause. This was 

based upon the assertion that it is 

impossible to set forth rules that could 

address every possible circumstance 

that would be a reason to seek a cause 

discharge. 

Response: We agree that it is 

impossible to list every possible reason 

that an individual might be discharged 

under this rule. That being said, we 

believe that the circumstances under 

which this type of discharge could be 

considered are adequately addressed by 

the rule we published. The types of 

behavior discussed in the rule that 

seriously impair the hospice’s ability to 

operate effectively and provide care to 

the patient and the requirements 

imposed on the hospice are necessary to 

place some parameters on discharges for 

cause. 

Comment: One commenter is 

concerned that the hospice would be 

responsible for post-discharge care of 

patients discharged for cause, when 

generally these would be patients that it 

had already found to be a problem to the 

extent that it could not provide needed 

services. 

Response: We recognize that it may be 

very difficult to implement postdischarge care plans for a patient that 

has proven to be disruptive, abusive, or 

uncooperative to the extent that services 

cannot be provided, but post-discharge 

care would not be the responsibility of 

the hospice. The hospice would engage 

in and prepare for after hospice care, but 

it is up to the patient (and the patient’s 

supporters) to take advantage of other 

sources of care after discharge. Though 

not entirely analogous, it is similar to a 

physician prescribing medication, but it 

is the responsibility of the patient to 

take the medication, even after the 

70542 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

physician has fully informed the patient 

of the importance of doing so. 

F. Revoking Election of Hospice Care 

(§ 418.28) 

Comment: A commenter believes that 

the waiver of a signed revocation when 

a patient revocation cannot be obtained 

in cases of discharge for cause should be 

placed in the section of regulations 

addressing discharge. The commenter 

stated that it is confusing to have it in 

its present location as it mixes discharge 

and revocation. The commenter also 

pointed out that a discharge for cause is 

not revocation. Revocation is voluntary, 

and mixing it with discharge for cause 

is confusing and unnecessary. 

Response: We agree that this proposal 

is unneeded, and it has been deleted 

from the final rule. 

G. Covered Services (§ 418.202) 

Comment: Commenters objected to 

‘‘other covered services’’ applying to 

‘‘related conditions’’ (to the terminal 

illness), and asked that it be removed 

from the proposed rule. The 

commenters feared it would be 

misinterpreted to mean that the hospice 

would be responsible for services not 

related to the terminal illness. 

Response: A hospice has always been 

responsible for the care of the patient’s 

terminal illness and related conditions, 

and this rule should not be interpreted 

to mean what the commenter fears, that 

is, that the hospice provides care 

unrelated to the terminal illness. At the 

same time, if the hospice staff notices, 

for example, that the patient has an eye 

infection that is unrelated to the 

terminal illness, then sound health care 

practices suggest that the hospice staff 

refer that person to his or her doctor for 

treatment. Commenters should review 

the hospice regulation at 42 CFR 

418.402, which addresses this concern 

when it states that ‘‘* * * services not 

considered hospice care include * * * 

treatment of an illness or injury not 

related to the individual’s terminal 

condition.’’

Comment: One commenter asked how 

‘‘covered services’’ might be interpreted 

by contractors reviewing claims, and 

whether the lack of specificity defining 

these services could cause denial of 

payment if ‘‘covered services’’ were 

determined to be non-covered. 

Response: As we discussed in the 

preamble to the proposed rule, the BBA 

clarified and codified what had been a 

Medicare rule, but had not always been 

well understood: that a ‘‘service that is 

specified in the patient’s plan of care as 

reasonable and necessary for the 

palliation and management of the 

terminal illness and related conditions, 

and for which payment may otherwise 

be made under Medicare, is a covered 

hospice service.’’ The decision as to 

whether a patient requires and receives 

any particular service from the hospice 

is, as before, the responsibility of the 

hospice. A medical review by a 

contractor would not necessarily 

consider whether an item was not 

required and therefore subject to a 

denial or payment, but rather whether 

the patient had received the appropriate 

necessary care for his or her particular 

terminal condition. Hospice payment is 

a prospectively-set daily payment to the 

hospice, and is made without regard to 

the cost of care on any particular day, 

nor with regard to the total cost of care 

during the entire time period that the 

hospice cares for the patient. 

Comment: One commenter believes 

that the phrase ‘‘otherwise covered by 

Medicare’’ would result in limitations 

on what patients could receive by way 

of care, since items not covered by the 

regular Medicare program would not be 

available due to this phrase. 

Response: The BBA expressly used 

the cited phrase in amending the law 

and in a congressional document, 

indicating that Medicare services that 

had not previously been specified in 

section 1861(dd)(1) of the Act were 

indeed to be made available under the 

hospice benefit if determined to be 

medically necessary and ordered in the 

plan of care. 

Comment: A commenter believes that 

hospices would use this phrase to use 

unqualified and untrained persons to 

provide services. 

Response: Hospices must meet 

conditions of participation, which 

require that their staff be qualified to 

provide the particular service the 

patient needs. 

Comment: The American Association 

for Respiratory Care asked whether 

respiratory therapy, when part of a 

hospice patient’s plan of care, is a 

Medicare covered hospice service. 

Response: Respiratory therapy would 

be a covered hospice service if the 

hospice decides its patient requires the 

service. Provision of the service would 

be paid for out of the hospice daily rate 

made to the hospice. 

Comment: One commenter suggested 

that psychologists be recognized as 

equivalent practitioners to physicians 

for purposes of payment for mental 

health services required by a hospice 

patient. The commenter argued that as 

an otherwise covered Medicare service, 

certain patients could benefit from a 

psychologist’s specialized training, but 

because of the high cost of these 

services, a hospice would avoid 

arranging for them. This would be due 

to the fact that payment would come out 

of the hospice’s daily rate, a limited 

source of payment for all needed 

hospice services for individual patients. 

Response: The Medicare law, with 

respect to hospice, only recognizes 

physicians as defined by statute, that is, 

medical doctors and osteopaths, and we 

therefore limit separate additional 

payments to those practitioners. If a 

hospice recognizes that its terminally ill 

patient requires the services of a 

psychologist, it is free to arrange for it. 

H. Payment for Hospice Care (§ 418.301, 

§ 418.302, § 418.304 and § 418.306) 

Comment: A commenter requested 

that § 418.301(c) indicate that hospices 

pay for medical services not related to 

the hospice-covered terminal illness. 

Another commenter asked that we 

clarify that hospices are only 

responsible for the care and services 

related to the terminal illness. 

Response: Conditions not related to 

the terminal illness may be covered 

under the regular Medicare program, a 

right that the beneficiary does not lose 

when hospice is elected. Even though 

other non-hospice care may be written 

into the hospice’s plan of care to 

address care and services not related to 

the terminal illness, which help assure 

proper care to the patient, the hospice’s 

responsibility is for care and services 

related to the terminal illness. Of 

course, the hospice would be expected 

to make the proper referrals when 

needed. 

Comment: One commenter asked 

about the change proposed in 

§ 418.304(b), where the phrase 

‘‘physician’s reasonable charge’’ is 

replaced by ‘‘physician fee schedule’’. 

The commenter wanted to know if this 

change was the change discussed in the 

preamble of the proposed rule. 

Response: The change in the 

regulation is the same one discussed in 

the preamble of the proposed rule. 

I. Miscellaneous Comments 

Comment: Some commenters believe 

that we were tightening up the 6-month 

prognosis, and that it would make 

physicians more reluctant to refer 

patients to hospice. Commenters stated 

that physicians are ‘‘terrible’’ at 

determining prognoses. They feared 

they would be exposed to scrutiny and 

penalty if they failed to make accurate 

prognoses. 

Response: As we have noted 

elsewhere in this section, we know that 

‘‘prognosis’’ indicates expectancy. It 

does not connote exact predictions 

regarding the expected date of death of 

an individual with a terminal illness. 

We merely want the certification of the 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70543 

patient for hospice care to be 

accompanied by documentation that 

supports the appropriateness of the 

hospice benefit. 

Comment: One commenter seems 

concerned by references to ORT, and 

what was perceived as a disregard for 

the intent of Congress to make hospice 

more accessible. 

Response: We believe that ORT and 

other investigations by the OIG are what 

helped guide the Congress in changes 

affecting the Medicare hospice benefit, 

and that we adhered to this effort to 

make the benefit more accessible. 

Payments for hospice care increased in 

response to industry complaints that 

payments were inadequate, but payment 

based upon the location at which the 

services were provided (the individual’s 

home) made it more appropriate in that 

it reflected the wages paid in the home’s 

location rather than the high cost area 

where the hospice’s home office might 

be located. The unlimited number of 

benefit periods permitted the hospice 

industry and all potential patients to no 

longer worry that an individual might 

live into a fourth but final benefit period 

and then be forced out of hospice care 

because of improvement in health, only 

to face permanent loss of access to 

hospice care in the future because of 

pre-BBA rules. Physician certification 

rules were eased, but as discussed 

elsewhere, the Congress gave no 

indication that it was dissatisfied with 

our clarification of requirements that a 

physician certification of terminal 

illness be supported by documentation. 

In addition, the growth of hospice since 

the ORT/OIG investigations indicates 

that our clarification has not adversely 

affected the industry, considering the 

increases in patient enrollment and 

Medicare payments for the care. 

Comment: A commenter asked about 

relief from the 24-hour registered nurse 

requirement for respite care. 

Response: This issue is being taken 

into consideration as CMS drafts the 

new Hospice Conditions of 

Participation. 

V. Provisions of the Final Regulations 

For the most part, this final rule 

incorporates the provisions of the 

proposed rule. The provisions of this 

final rule that differ from the proposed 

rule are as follows and changes are 

based on public comments to provide 

clarifying language: 

Certification of Terminal Illness 

(§ 418.22) 

(a) Timing of certification: (3) 

Exception. Added, ‘‘after a period 

begins’’ to clarify timeframe for written 

certification within 2 days. 

(b) Content of certification: Deleted 

the term ‘‘specific’’ and changed 

‘‘findings’’ to ‘‘information.’’ Also 

added, ‘‘Initially, the clinical 

information may be provided verbally, 

and must be documented in the medical 

record and included as part of the 

hospice’s eligibility assessment.’’

Admission To Hospice Care (§ 418.25) 

(a) Added clarifying language ‘‘or 

with input from’’ the patient’s attending 

physician and added parentheses 

around the phrase ‘‘if any.’’

Discharge From Hospice Care (§ 418.26) 

(a) Reasons for discharge. 

(3) Added clarifying language ‘‘(or 

other persons in the patient’s home)’’ to 

address public comment that the 

patient’s family may be the problem 

necessitating a discharge for cause. Also 

added the following language ‘‘(i) 

Advise the patient that a discharge for 

cause is being considered’’ to address 

the public comment that there should be 

requirements for notification to 

beneficiaries. 

(b) Renumbered and revised proposed 

paragraph (a)(3)(iv) for clarity as follows 

‘‘Prior to discharging a patient for any 

reason listed in subsection (a), the 

hospice must obtain a written 

physician’s discharge order from the 

hospice medical director. If a patient 

has an attending physician involved in 

his or her care, this physician should be 

consulted before discharge and his or 

her review and decision included in the 

discharge note.’’

Revoking the Election of Hospice Care 

(§ 418.28) 

Deleted proposed change to 

§ 418.28(b)(1). 

Payment for Physician Services 

(§ 418.304) 

As a technical correction we are 

replacing the language ‘‘reasonable 

charges’’ with physician fee schedule: to 

reflect the current payment 

methodology. Additionally, the crossreference to ‘‘subparts D or E, Part 405 

of this chapter’’ will be changed to 

‘‘subpart B, Part 414 of this chapter.’’

VI. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995 (PRA), we are required to 

provide 30-day notice in the Federal 

Register and solicit public comment 

when a collection of information 

requirement is submitted to the Office of 

Management and Budget (OMB) for 

review and approval. In order to fairly 

evaluate whether an information 

collection report should be approved by 

OMB, section 3506(c)(2)(A) of the PRA 

requires that we solicit comments on the 

following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We are soliciting public comment on 

each of these issues for the following 

sections of this document that contain 

information collection requirements: 

Sections 418.22 and 418.26 of this 

final regulation contain information 

collection requirements that are subject 

to review by OMB under the PRA. 

Certification of Terminal Illness 

(§ 418.22) 

The current collection requirements 

referenced in § 418.22 have been 

approved by OMB under approval 

number 0938–0302, with a current 

expiration date of September 30, 2006. 

However, this rule imposes a new 

collection requirement, which requires 

CMS to solicit comment on the new 

information collection requirement and 

resubmit 0938–0302 to OMB for review 

and approval, as a revision to a 

currently approved collection. 

The newly imposed requirement as 

referenced under paragraph (b)(2) of this 

section stipulates that clinical 

information and other documentation 

that support the medical prognosis must 

accompany the certification of terminal 

illness and must be filed in the medical 

record with the written certification as 

set forth in paragraph (b)(2) of this 

section. 

While this requirement is subject to 

the PRA, we believe the burden 

associated with this requirement is 

exempt from the PRA as stipulated 

under 5 CFR 1320.3 (b)(2) and (b)(3) 

because the requirement is considered a 

reasonable and customary business 

practice and/or is required under State 

or local laws and/or regulations. 

Discharge From Hospice Care (§ 418.26) 

Paragraph (a)(3)(iv) of this section 

requires documentation of the 

problem(s) related to the patient and 

efforts made to resolve the problem(s) 

into the patient’s medical records. 

Paragraph (b) of this section requires 

that a written physician’s discharge 

order from the hospice medical director 

and the decision of the patient’s 

attending physician (if any) concurring 

with discharge from hospice care be 

70544 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

obtained and included in the patient’s 

medical record. 

While these requirements are subject 

to the PRA, we believe the burden 

associated with these requirements is 

exempt from the PRA as stipulated 

under 5 CFR 1320.3(b)(2) and (b)(3) 

because the requirements are considered 

reasonable and customary business 

practices and/or are required under 

State or local laws and/or regulations. 

We have submitted a copy of this final 

rule to OMB for its review of the 

information collection requirements 

described above. These requirements are 

not effective until they have been 

approved by OMB. 

If you comment on any of these 

information collection and record 

keeping requirements, please mail 

copies directly to the following: Centers 

for Medicare & Medicaid Services, 

Office of Strategic Operations and 

Regulatory Affairs, Regulations 

Development Group, Attn: Melissa 

Musotto, CMS–1022–F, Room C5–11–

04, 7500 Security Boulevard, Baltimore, 

MD 21244–1850; and Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

Room 10235, New Executive Office 

Building, Washington, DC 20503, Attn: 

Carolyn Lovett, CMS Desk Officer. 

Comments submitted to OMB may also 

be e-mailed to the following address: email: Carolyn_Lovett@omb.eop.gov or 

faxed to OMB at (202) 395–6974. 

VII. Regulatory Impact 

The provisions of this final rule are 

based upon provisions in the BBA, 

BBRA, and BIPA, with statutorily-set 

timeframes, and have already been 

implemented through program 

memoranda. These include changes in 

election periods; timing requirements 

for written certification; covered 

services; payment based upon site of 

service; and annual payment update 

amounts. Other proposed provisions 

address documentation supporting 

certification; admission requirements; 

discharge from hospice; and 

clarification of current policy that has 

not previously been captured in 

regulations. 

A. Overall Impact 

We have examined the impacts of this 

final rule as required by Executive 

Order 12866 (September 1993, 

Regulatory Planning and Review), the 

Regulatory Flexibility Act (RFA) 

(September 19, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act, the Unfunded Mandates Reform 

Act of 1995 (Pub. L. 104–4), and 

Executive Order 13132. 

Executive Order 12866 (as amended 

by Executive Order 13258, which 

merely reassigns responsibility of 

duties) directs agencies to assess all 

costs and benefits 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). We 

have determined that this rule is not a 

major rule for the reasons discussed 

below. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and 

government agencies. Most hospitals 

and most other providers and suppliers 

are small entities, either by nonprofit 

status or by having revenues of $6 

million to $29 million in any 1 year. 

Individuals and States are not included 

in the definition of a small entity. For 

purposes of the RFA, in 2001, there 

were approximately 2,277 Medicarecertified hospices. Of those 2,277, 

approximately 73 percent can be 

considered small entities because they 

were identified as being voluntary, 

government, or other agency. 

Given the general lack of hospice data 

and the unpredictable nature of hospice 

care, it is extremely difficult to predict 

the savings or costs associated with the 

changes contained in this final rule. 

Originally, we estimated the Medicare 

hospice rate reductions required by 

section 4441 of the BBA would result in 

a $120 million savings to the Medicare 

program in FY 2002. Increases required 

by section 321 of BIPA, however, added 

$150 million to Medicare program costs, 

and increases required by section 131 of 

BBRA added another $20 million in 

costs, for a net of $50 million in costs 

for that fiscal year. While it is likely that 

all of the Medicare-certified hospices 

considered to be small entities have 

been required to make changes in their 

operations in some way due to the 

implementation of these statutory 

provisions and proposed changes, this 

final rule does not set forth any 

additional changes that are likely to 

significantly impact the operations of 

hospice providers. For these reasons, we 

certify that this final rule will not have 

a significant effect on a substantial 

number of small entities. However, we 

have prepared the following analysis to 

describe the impacts of this rule. This 

analysis, in combination with the rest of 

the preamble, is consistent with the 

standards for analysis set forth by the 

RFA and Executive Order 12866. 

In addition, section 1102(b) of the 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. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area and has 

fewer than 100 beds. This final rule 

largely codifies existing hospice 

requirements and will not result in a 

significant impact on a substantial 

number of small rural hospitals. 

Therefore, no analysis is required. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

also requires that agencies assess 

anticipated costs and benefits before 

issuing any rule that may result in 

expenditure in any 1 year by State, 

local, or tribal governments, in the 

aggregate, or by the private sector, of 

$110 million. This final rule does not 

impose unfunded mandates, as defined 

by section 202 of UMRA, as it will not 

result in the expenditure in any 1 year 

by either State, local or tribal 

governments, or by the private sector of 

$110 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This final rule has no impact on State 

or local governments. We have reviewed 

this final rule under the threshold 

criteria of Executive Order 13132 and 

we believe that it will not have 

substantial Federalism implications. 

Section 1902(a)(13)(B) of the Act 

requires the Medicaid payment 

methodology for hospice care to be 

determined using the same methodology 

that is used for Medicare. State 

Medicaid programs with the optional 

Medicaid hospice benefit would be 

required to implement sections 4441(a) 

and 4442 of the BBA. We remain 

unaware of any impact of these 

provisions on State Medicaid programs 

since these provisions became effective. 

Nevertheless, it is possible that these 

payment-related provisions could 

impact particular State Medicaid 

programs. However, because each State 

Medicaid program is unique, it is 

impossible to quantify meaningfully an 

estimate of the effect of the costs on 

State and local governments. 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70545 

B. Anticipated Effects 

1. Effects on Hospice Providers 

Given the general lack of hospice data 

and the unpredictable nature of hospice 

care, it is extremely difficult to quantify 

the impact this final rule will have on 

hospice providers. Nevertheless, we 

have tried to estimate the impact of the 

following changes on hospice providers. 

In general, we believe that the effect of 

the final rule will have minimal 

economic impact on hospice providers 

or on the regulatory burden of small 

business. In the following sections, we 

have indicated implementation actions 

already taken, and anticipated effects 

the final rule may have. 

2. Effects on Payments 

The BBA required hospice providers 

to bill for routine and continuous home 

care based on the geographic location 

where the service was provided. We 

expect that Medicare would experience 

some savings with this provision; 

however, it is impossible to predict the 

size of the savings attributable to this 

provision. These Medicare savings may 

reflect a cost to hospice providers. This 

BBA change has been implemented 

through program memoranda. This final 

rule merely codifies this statutorily 

required change. 

3. Effects on Benefit Period Change 

Medicare hospice is now available in 

two 90-day periods and an unlimited 

number of 60-day benefit periods. 

Because there is no longer a limit on the 

number of benefit periods available to a 

beneficiary, it is possible that this 

change will result in an increase in the 

number of revocations and re-elections. 

However, we anticipate that this change 

will have a negligible effect on hospice 

providers. The change in benefit periods 

was implemented by a program 

memorandum issued shortly after 

passage of the BBA and has already 

been incorporated into hospice program 

operations. 

4. Effects on Covered Services 

The BBA clarified that the Medicare 

hospice benefit covers any service 

otherwise covered by Medicare and 

listed in the hospice plan of care as 

reasonable and necessary for the 

palliation and management of a terminal 

illness. This change should not generate 

any additional costs for Medicare 

hospices because it is merely a statutory 

clarification of existing Medicare policy. 

This clarification of covered hospice 

services was implemented through a 

program memorandum issued before the 

April 1, 1998 effective date set by the 

BBA and is merely being codified by 

this regulation. It helped providers to 

better determine the services they must 

provide. 

5. Effects of Physician Certification 

The requirement that a written 

certification of terminal illness for 

admission to a hospice for the initial 90- 

day benefit period be on file before a 

claim for payment is submitted will not 

impose any additional costs on hospice 

providers and removes the problem of 

obtaining the written certification 

according to a rigid timeframe. This 

requirement will provide hospices with 

more flexibility to establish costefficient procedures for obtaining the 

required certifications. However, the 

expansion of the requirement for verbal 

certifications to every benefit period 

may impose costs on hospice providers. 

Before enactment of the BBA, verbal 

certifications were required within 2 

days of the start of care during the first 

benefit period if a written certification 

could not be obtained within those 2 

days. We are requiring that, absent 

written certification, verbal 

certifications of terminal illness be 

obtained within those 2 days for each 

benefit period. Although we believe the 

impact of this requirement would be 

negligible, it is difficult to estimate the 

exact size of the impact of this 

requirement because some costs may be 

negated by the increased flexibility, and 

time, a hospice provider has in 

obtaining the required written 

certifications. 

Additionally, we believe that 

requiring that written certifications of 

terminal illness be accompanied by 

clinical information and documentation 

supporting the prognosis will not 

impose any new costs on hospice 

providers. We released a policy 

memorandum in 1995 to all hospice 

providers, through the fiscal 

intermediaries, requesting that all 

hospices maintain documentation 

demonstrating a beneficiary’s terminal 

status. Because it has been 10 years 

since we issued the policy calling for 

clinical information and other 

documentation supporting the terminal 

prognosis, we do not anticipate that the 

requirement will alter hospices’ current 

practices. 

6. Effects on Admission to Hospice Care 

We believe that the final rule 

describing admission responsibilities 

will impose no additional burden upon 

hospices. The responsibilities were 

referred to in various regulations, 

manuals, program memoranda, and 

other correspondence; this regulation 

brings them together in an organized 

rule. ORT and OIG investigations and 

reviews found that admission activities 

were not always executed fully, or when 

done, they were not always 

documented. This final rule specifies 

the consultation between the attending 

physician and the hospice and its 

medical director that normally does or 

should take place when a physician 

seeks hospice care for his or her patient. 

The final rule also describes the 

consideration that the medical director 

gives when deciding upon certification, 

to the patient’s diagnosis, related 

diagnoses, medical information that 

support those diagnoses, the overall 

medical management needs of the 

patient, and the attending physician’s 

future plans for the patient. We do not 

believe any new costs are associated 

with these requirements, and the 1995 

policy memorandum had made clear the 

hospice admission responsibilities and 

the need to document their execution. 

We found that the hospice provider 

community was generally pleased that 

we had issued the guidance, which 

alleviated previous problems associated 

with admission of beneficiaries to 

hospice care. 

7. Effects on Discharge and Discharge 

Planning 

This final rule may add a small 

additional burden to hospices providing 

services to Medicare beneficiaries, but at 

the same time, it also should reduce 

certain other burdens they may 

currently experience, particularly with 

respect to making appropriate 

discharges. In the absence of specific 

regulations, hospices have often been 

uncertain what to do when a patient 

appeared appropriate for discharge from 

the program. There was limited manual 

guidance, although following the ORT 

and OIG investigations, some additional 

information on the appropriate time to 

discharge patients was communicated to 

the hospice industry. Our final rule 

would incorporate discharge planning, a 

normal part of health care provision, 

into the hospice’s care planning 

procedures. Regular, ongoing care 

planning, including the potential for 

discharge, has always been part of a 

hospice’s responsibilities, and the 

regulation would simply recognize this 

responsibility. It is not a new additional 

burden. 

Discharge for certain disruptive, 

abusive, or uncooperative patients will 

entail a small additional burden upon 

very few hospices, based on past 

discussions with some providers before 

preparation of this final rule. We believe 

the burden is small, because we have 

rarely received requests from hospices 

over the years for relief in cases 

involving this type of behavior. In the 

70546 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

preamble to the proposed rule, we 

elicited input on this particular final 

rule, particularly with respect to 

protection of patients. We are aware of 

the burden that individual providers 

have had when faced with difficult 

patients, and this regulation would 

provide a way for them to resolve it, 

and, we believe, also lessen burdens 

currently experienced when trying to 

provide care to this type of patient. 

The section of this final rule that 

discusses the effect of discharge, that is, 

that a beneficiary discharged from 

hospice care immediately resumes full 

coverage under the regular Medicare 

program, has always been the law. 

However, it has not been stated in 

regulation in a straightforward manner, 

and doing so offers reassurance to both 

the beneficiary and the hospice that 

discharge from the hospice does not 

mean the loss of Medicare benefits. This 

section also assures a beneficiary that he 

or she may again elect hospice at any 

future time if he or she meets eligibility 

requirements. 

8. Effects on Other Providers 

We do not anticipate that this rule 

will have any effects on other provider 

types. 

9. Effects on the Medicare and Medicaid 

Programs 

As discussed above, it is very difficult 

to estimate the size of any savings to the 

Medicare program attributable to this 

final rule. We have estimated that the 

hospice rate reduction as required by 

section 4441 of the BBA, temporary 

increases in hospice care payments for 

FY 2001 and FY 2002 due to section 131 

of BBRA, and a 5 percent increase in 

hospice payments due to section 321 of 

BIPA, would result in a net savings of 

$80 million for FY 1998–2002 and an 

overall net cost of $120 million for FY 

1998–2007. Given that after FY 2001 the 

annual costs attributable to section 321 

of BIPA exceed the annual savings 

attributable to section 4441 of BBA, 

there are net costs in the out-years 

attributable to these two provisions. 

Below is a table indicating the year-byyear costs and savings attributable to the 

various provisions. 

COSTS ASSOCIATED WITH THE VARIOUS HOSPICE PROVISIONS

FY 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 

BBA Sec. 4441 ................................................. ¥20 ¥40 ¥70 ¥90 ¥120 ¥130 ¥140 ¥140 ¥150 ¥160 

BBRA Sec. 131 ................................................ ............ ............ ............ 10 20 ............ ............ ............ ............

BIPA Sec. 321 .................................................. ............ ............ ............ 80 150 160 170 180 200 210 

Total Costs ................................................ ¥20 ¥40 ¥70 0 50 30 30 40 50 50 

All dollar figures are in millions and rounded to the nearest $10 million. Costs are shown as positive, savings as negative. 

BBA Sec. 4441: Payments for Hospice Services. 

BBRA Sec. 131: Temporary increase in payment for hospice care. 

BIPA Sec. 321: 5% Increase in Payment. 

Also, as discussed above, it is very 

difficult to estimate the size of any 

implementation costs to State Medicaid 

programs with optional Medicaid 

hospice benefits. However, it should be 

noted that the BBA provisions that State 

Medicaid programs are required to 

implement (rates of payment, payment 

based on location where care is 

furnished, other items and services, 

physician contracting) have been 

effective since August 5, 1997. Since 

that time, we have not received any 

correspondence from State Medicaid 

programs indicating that these 

provisions have had significant costs 

associated with implementation. 

C. Alternatives Considered 

Most sections of this final rule are 

mandated requirements of the BBA, 

BBRA, and BIPA, and have already been 

implemented by CMS Program 

Memoranda, published in the month 

after passage of the BBA, and the month 

after the passage of BIPA. BBRA changes 

only concerned hospice payment 

amounts but did not affect the basic law. 

Discharge for cause will enable us to 

implement policies that permit hospices 

to act in those rare events that indicate 

the need, but with protection for the 

beneficiary included in the rules. 

Alternatively, hospices may continue to 

address this particular problem without 

certainty as to their authority in these 

special situations. Other sections of this 

final rule represent current policies that 

have been implemented and recognized 

by the industry, clarification of current 

regulations, or suggested policies that 

the industry and CMS believe may help 

improve the Medicare hospice program. 

D. Conclusion 

For these reasons, we are not 

preparing analyses for either the RFA or 

section 1102(b) of the Act because we 

have determined that this final rule will 

not have a significant economic impact 

on a substantial number of small entities 

or a significant impact on the operations 

of a substantial number of small rural 

hospitals. 

The general lack of hospice data and 

the unpredictable nature of hospice care 

have made it extremely difficult to 

predict the savings or costs associated 

with the changes contained in this final 

rule. However, we believe that these 

changes will create very little, if any, 

new economic or regulatory burdens on 

hospice providers. These changes are 

either statements of current policy or 

clarifications of policy that would 

benefit hospice providers. We believe 

that we have made every effort to 

mitigate the effects of these changes on 

hospice providers. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects in 42 CFR Part 418 

Health facilities, Hospice care, 

Medicare, Reporting and recordkeeping 

requirements. 

■ For reasons set forth in this preamble, 

the Centers for Medicare & Medicaid 

Services amend 42 CFR chapter IV as 

follows: 

PART 418—HOSPICE CARE 

■ 1. The authority citation for part 418 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart B—Eligibility, Election and 

Duration of Benefits 

■ 2. In § 418.21, paragraph (a) is revised 

to read as follows: 

§ 418.21 Duration of hospice care 

coverage—Election periods. 

(a) Subject to the conditions set forth 

in this part, an individual may elect to 

receive hospice care during one or more 

of the following election periods: 

(1) An initial 90-day period; 

(2) A subsequent 90-day period; or 

(3) An unlimited number of 

subsequent 60-day periods. 

* * * * * 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70547 

■ 3. In § 418.22, paragraphs (a) and (b) 

are revised to read as follows: 

§ 418.22 Certification of terminal illness. 

(a) Timing of certification—(1) 

General rule. The hospice must obtain 

written certification of terminal illness 

for each of the periods listed in § 418.21, 

even if a single election continues in 

effect for an unlimited number of 

periods, as provided in § 418.24(c). 

(2) Basic requirement. Except as 

provided in paragraph (a)(3) of this 

section, the hospice must obtain the 

written certification before it submits a 

claim for payment. 

(3) Exception. If the hospice cannot 

obtain the written certification within 2 

calendar days, after a period begins, it 

must obtain an oral certification within 

2 calendar days and the written 

certification before it submits a claim for 

payment. 

(b) Content of certification. 

Certification will be based on the 

physician’s or medical director’s 

clinical judgment regarding the normal 

course of the individual’s illness. The 

certification must conform to the 

following requirements: 

(1) The certification must specify that 

the individual’s prognosis is for a life 

expectancy of 6 months or less if the 

terminal illness runs its normal course. 

(2) Clinical information and other 

documentation that support the medical 

prognosis must accompany the 

certification and must be filed in the 

medical record with the written 

certification as set forth in paragraph 

(d)(2) of this section. Initially, the 

clinical information may be provided 

verbally, and must be documented in 

the medical record and included as part 

of the hospice’s eligibility assessment. 

* * * * * 

■ 4. In § 418.24, paragraph (c) is revised 

to read as follows: 

§ 418.24 Election of hospice care. 

* * * * * 

(c) Duration of election. An election to 

receive hospice care will be considered 

to continue through the initial election 

period and through the subsequent 

election periods without a break in care 

as long as the individual—

(1) Remains in the care of a hospice; 

(2) Does not revoke the election; and 

(3) Is not discharged from the hospice 

under the provisions of § 418.26. 

* * * * * 

■ 5. New § 418.25 and § 418.26 are 

added to read as follows: 

§ 418.25 Admission to hospice care. 

(a) The hospice admits a patient only 

on the recommendation of the medical 

director in consultation with, or with 

input from, the patient’s attending 

physician (if any). 

(b) In reaching a decision to certify 

that the patient is terminally ill, the 

hospice medical director must consider 

at least the following information: 

(1) Diagnosis of the terminal 

condition of the patient. 

(2) Other health conditions, whether 

related or unrelated to the terminal 

condition. 

(3) Current clinically relevant 

information supporting all diagnoses. 

§ 418.26 Discharge from hospice care. 

(a) Reasons for discharge. A hospice 

may discharge a patient if—

(1) The patient moves out of the 

hospice’s service area or transfers to 

another hospice; 

(2) The hospice determines that the 

patient is no longer terminally ill; or 

(3) The hospice determines, under a 

policy set by the hospice for the purpose 

of addressing discharge for cause that 

meets the requirements of paragraphs 

(a)(3)(i) through (a)(3)(iv) of this section, 

that the patient’s (or other persons in 

the patient’s home) behavior is 

disruptive, abusive, or uncooperative to 

the extent that delivery of care to the 

patient or the ability of the hospice to 

operate effectively is seriously impaired. 

The hospice must do the following 

before it seeks to discharge a patient for 

cause: 

(i) Advise the patient that a discharge 

for cause is being considered; 

(ii) Make a serious effort to resolve the 

problem(s) presented by the patient’s 

behavior or situation; 

(iii) Ascertain that the patient’s 

proposed discharge is not due to the 

patient’s use of necessary hospice 

services; and 

(iv) Document the problem(s) and 

efforts made to resolve the problem(s) 

and enter this documentation into its 

medical records. 

(b) Discharge order. Prior to 

discharging a patient for any reason 

listed in paragraph (a) of this section, 

the hospice must obtain a written 

physician’s discharge order from the 

hospice medical director. If a patient 

has an attending physician involved in 

his or her care, this physician should be 

consulted before discharge and his or 

her review and decision included in the 

discharge note. 

(c) Effect of discharge. An individual, 

upon discharge from the hospice during 

a particular election period for reasons 

other than immediate transfer to another 

hospice—

(1) Is no longer covered under 

Medicare for hospice care; 

(2) Resumes Medicare coverage of the 

benefits waived under § 418.24(d); and 

(3) May at any time elect to receive 

hospice care if he or she is again eligible 

to receive the benefit. 

(d) Discharge planning. (1) The 

hospice must have in place a discharge 

planning process that takes into account 

the prospect that a patient’s condition 

might stabilize or otherwise change 

such that the patient cannot continue to 

be certified as terminally ill. 

(2) The discharge planning process 

must include planning for any necessary 

family counseling, patient education, or 

other services before the patient is 

discharged because he or she is no 

longer terminally ill. 

Subpart F—Covered Services 

■ 6. In § 418.202, the introductory text 

is republished, and a new paragraph (i) 

is added to read as follows: 

§ 418.202 Covered services. 

All services must be performed by 

appropriately qualified personnel, but it 

is the nature of the service, rather than 

the qualification of the person who 

provides it, that determines the coverage 

category of the service. The following 

services are covered hospice services: 

* * * * * 

(i) Effective April 1, 1998, any other 

service that is specified in the patient’s 

plan of care as reasonable and necessary 

for the palliation and management of 

the patient’s terminal illness and related 

conditions and for which payment may 

otherwise be made under Medicare. 

Subpart G—Payment for Hospice Care 

■ 7. Section 418.301 is amended by 

adding a new paragraph (c) to read as 

follows: 

§ 418.301 Basic rules. 

* * * * * 

(c) The hospice may not charge a 

patient for services for which the patient 

is entitled to have payment made under 

Medicare or for services for which the 

patient would be entitled to payment, as 

described in § 489.21 of this chapter. 

■ 8. Section 418.302 is amended by 

adding a new paragraph (g) to read as 

follows: 

§ 418.302 Payment procedures for hospice 

care. 

* * * * * 

(g) Payment for routine home care and 

continuous home care is made on the 

basis of the geographic location where 

the service is provided. 

§ 418.304 [Amended] 

■ 9. In § 418.304, the following changes 

are made: 

■ a. In paragraph (b), the phrase 

‘‘physician’s reasonable charge’’ is 

70548 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

removed and is replaced with 

‘‘physician fee schedule.’’

■ b. In paragraph (c), the phrase 

‘‘subparts D or E, part 405 of this 

chapter’’ is removed and the phrase 

‘‘subpart B, part 414 of this chapter’’ is 

added in its place. 

■ 10. In § 418.306, the introductory text 

of paragraph (b) is republished, 

paragraph (b)(3) is revised, and new 

paragraphs (b)(4) and (b)(5) are added to 

read as follows: 

§ 418.306 Determination of payment rates. 

* * * * * 

(b) Payment rates. The payment rates 

for routine home care and other services 

included in hospice care are as follows: 

* * * * * 

(3) For Federal fiscal years 1994 

through 2002, the payment rate is the 

payment rate in effect during the 

previous fiscal year increased by a factor 

equal to the market basket percentage 

increase minus—

(i) 2 percentage points in FY 1994; 

(ii) 1.5 percentage points in FYs 1995 

and 1996; 

(iii) 0.5 percentage points in FY 1997; 

and 

(iv) 1 percentage point in FY 1998 

through FY 2002. 

(4) For Federal fiscal year 2001, the 

payment rate is the payment rate in 

effect during the previous fiscal year 

increased by a factor equal to the market 

basket percentage increase plus 5 

percentage points. However, this 

payment rate is effective only for the 

period April 1, 2001 through September 

30, 2001. For the period October 1, 2000 

through March 31, 2001, the payment 

rate is based upon the rule under 

paragraph (b)(3)(iv) of this section. The 

payment rate in effect during the period 

April 1, 2001 through September 30, 

2001 is considered the payment rate in 

effect during fiscal year 2001. 

(5) The payment rate for hospice 

services furnished during fiscal years 

2001 and 2002 is increased by an 

additional 0.5 percent and 0.75 percent, 

respectively. This additional amount is 

not included in updating the payment 

rate as described in paragraph (b)(3) of 

this section. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: May 24, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: October 11, 2005. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 05–23078 Filed 11–21–05; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

49 CFR Part 10 

FAA Accident and Incident Data 

System Records Expunction Policy 

AGENCY: Federal Aviation 

Administration, DOT. 

ACTION: Policy statement. 

SUMMARY: The Federal Aviation 

Administration (FAA) has adopted a 

policy which, when implemented, will 

result in the expunction of airman 

identities from certain FAA accident 

and incident records. 

DATES: This policy is effective 

November 22, 2005, with 

implementation as discussed herein. 

FOR FURTHER INFORMATION CONTACT: 

Joseph R. Standell, Aeronautical Center 

Counsel, Aeronautical Center (AMC–7), 

Federal Aviation Administration, 6500 

S. MacArthur, Oklahoma City, OK 

73169. Telephone (405) 954–3296. 

SUPPLEMENTARY INFORMATION: 

Background 

Under sections 40101, 40113, and 

44701 of the U.S. Transportation Code, 

as amended, 49 U.S.C. 40101, 40113 and 

44701, the FAA may maintain records of 

aviation accidents and incidents 

containing identifying information of 

individual airmen if safety in air 

commerce or air transportation and the 

public interest require. These records 

include all accidents that were 

investigated by the FAA and incidents 

reported to or investigated by the FAA. 

Part 10 of the Department of 

Transportation Regulations, 49 CFR 10.1 

et seq., sets forth the conditions for 

maintenance and access to records 

pertaining to individuals. 

Presently, written accident and 

incident records are destroyed in 

accordance with the applicable 

retention guidelines contained in FAA 

Order 1350.15C. Certain essential 

information is extracted from written 

accident and incident records and 

maintained in the Accident and 

Incident Data System (AIDS). 

Currently, computer based electronic 

AIDS records are maintained 

indefinitely by the FAA. The custodian 

of AIDS is the Aviation Data Systems 

Branch, AFS–620, at the Mike 

Monroney Aeronautical Center, 

Oklahoma City, Oklahoma. AIDS 

records may be accessed by FAA 

personnel at the FAA’s Headquarters in 

Washington, DC and the FAA’s field 

and regional offices. See, System of 

Records DOT/FAA 847, 65 FR 19527 

(April 11, 2000). One of the reasons the 

FAA maintains these records is for 

safety related statistical research. 

Aviation Safety Inspectors may also use 

these records to determine whether an 

airman should be re-examined. AIDS 

records are considered to be basic 

qualification information and may be 

released to the public pursuant to the 

routine uses listed in DOT/FAA 847. 

In 1989, the FAA conducted a System 

Safety and Efficiency Review (SSER) of 

its General Aviation Compliance and 

Enforcement Programs. The SSER 

review team comprised both FAA 

personnel and representatives of various 

industry organizations, including the 

Aircraft Owners and Pilots Association, 

the Experimental Aircraft Association, 

and the National Business Aircraft 

Association. The establishment of an 

accident and incident expungement 

policy was one of the many topics 

discussed during the System Safety and 

Efficiency Review. However, no 

accident and incident expungment 

policy was implemented at that time. 

From 1996 until the present, the FAA 

has expunged the identity of airmen 

from AIDS records on an ad hoc basis, 

where it was determined that their 

identity no longer served a relevant 

purpose. Those determinations were 

made in response to individual requests 

for correction of accident or incident 

record pursuant to the Privacy Act, 5 

U.S.C. 552a. Absent a request for 

correction of records under the Privacy 

Act, the record remained in AIDS 

indefinitely. There has been growing 

concern within the FAA that this 

practice is unfair to those airmen who 

do not know their identity may be 

removed from an AIDS record by 

making a request under the Privacy Act. 

In 2003, the FAA reevaluated its 

policy of indefinitely retaining AIDS 

records on individuals, and 

subsequently adopted a policy of 

expunging certain electronic AIDS 

records. This policy is explained in 

detail herein. This policy applies to 

individuals who have been identified in 

electronic AIDS records. This policy 

applies to individuals who hold airman 

certificates, as well as to those who do