[Federal Register Volume 65, Number 143 (Tuesday, July 25, 2000)]
[Rules and Regulations]
[Pages 45712-45713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18572]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1306

[DEA-190I]
RIN 1117-AA54


Facsimile Transmission of Prescriptions for Patients Enrolled in 
Hospice Programs

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Interim rule.

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SUMMARY: DEA is amending Title 21, Code of Federal Regulations (CFR) 
1306.11(g) to clearly include articulate that prescriptions for 
Schedule II narcotic substances for patients enrolled in hospice care 
certified by Medicare under Title XVIII or licensed by the state may be 
transmitted by facsimile. The regulation as it is currently worded 
grants this allowance for Schedule II prescriptions for patients 
``residing in a hospice * * *''. This phrase has been perceived by the 
regulated industry as requiring that the patient reside in a hospice 
facility to the exclusion of other care settings, such as home hospice 
care. It was never DEA's intent to omit the significant number of 
patients receiving hospice care who reside at home. This interim rule 
clarifies DEA regulations in response to industry questions.

DATES: Effective Date: July 25, 2000.
    Comments: Written comments must be submitted on or before September 
25, 2000.

ADDRESSES: Comments should be submitted in triplicate to the Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537, Attention: DEA Federal Register 
Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537, telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

What Do DEA Regulations Currently Provide?

    DEA regulations permit a pharmacy to dispense a Schedule II 
narcotic substance pursuant to a prescription transmitted to the 
pharmacy via facsimile for a patient residing in a hospice certified by 
Medicare under Title XVIII or licensed by the state (21 CFR 
1306.11(g)). The faxed prescription

[[Page 45713]]

serves as the original prescription for recordkeeping purposes. 
However, the use of the language ``residing in a hospice certified by 
Medicare under Title XVIII or licensed by the state'' has been 
perceived by the regulated industry as requiring that the patient 
reside in a hospice facility to the exclusion of other care settings, 
such as home hospice care. DEA has received letters from home hospice 
care providers inquiring about the requirements for facsimile 
transmission of Schedule II prescriptions for their patients. It was 
never DEA's intent to create an exclusion for these patients. DEA 
regulations were meant to cover all patients enrolled in hospice 
programs certified by Medicare under Title XVIII or licensed by the 
state, regardless of where the patient resides. Consistent with DEA's 
interpretation of its regulations, DEA has responded to the inquiries 
it has received with letters stating that its regulations allow for 
facsimile transmission of prescriptions to such patients.

What Change Does This Rulemaking Make?

    The inquiries DEA has received indicate that the use of the term 
``residing'' did not fully convey DEA's intended result. Therefore, DEA 
is modifying the language of 21 CFR 1306.11(g) to clarify that the 
permission for facsimile transmission of Schedule II narcotic 
prescriptions covers all patients enrolled in hospice programs 
certified by Medicare under Title XVIII or licensed by the state.

Regulatory Certifications

Administrative Procedure Act (5 U.S.C. 553)

    This rule is minor and technical in nature, merely clarifying 
existing DEA regulations and requirements, the intent of which was 
clearly indicated in the original notices. Further, to the extent that 
regulated parties were following a more restrictive interpretation of 
existing regulations, the clarification this rule makes lessens a 
perceived regulatory restriction to the benefit of Medicare-certified 
or state licensed hospice program patients needing Schedule II narcotic 
substances. The original rulemakings (proposed rule 61 FR 8503, DEA-
139P, RIN 1117-AA33; final rule 62 FR 13938, DEA-139F, RIN 1117-AA33) 
clearly indicate that DEA's intent was to permit the facsimile 
transmission of Schedule II prescriptions for all patients enrolled in 
hospice programs, regardless of where the patient resides. This interim 
rule does not change DEA practice or policy. Rather, the regulations 
are being amended to more accurately reflect DEA's intention in the 
rule promulgated at 62 FR 13938 and to alleviate public confusion. 
Accordingly, DEA finds good cause to exempt this rule from the 
provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring 
notice of proposed rulemaking, the opportunity for public comment, and 
delay in effective date.

Regulatory Flexibility Act

    The Deputy Assistant Administrator hereby certifies that this 
rulemaking has been drafted in a manner consistent with the principles 
of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). It will not 
have a significant economic impact on a substantial number of small 
business entities. This rulemaking clarifies the regulations regarding 
the facsimile transmission of prescriptions for Schedule II narcotic 
substances for patients enrolled in hospice programs.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
rulemaking has been drafted in accordance with the principles in 
Executive Order 12866, Section 1(b). DEA has determined that this is 
not a significant rulemaking action. This rulemaking clarifies the 
regulations regarding the facsimile transmission of prescriptions for 
Schedule II narcotic substances for patients enrolled in hospice 
programs. Therefore, this action has not been reviewed by the Office of 
Management and Budget.

Executive Order 12988--Civil Justice Reform

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

    This action has been analyzed in accordance with the principles and 
criteria in Executive Order 13132, and it has been determined that this 
rule does not have sufficient federalism implications to warrant the 
preparation of a Federalism Assessment.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This rule 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

Plain Language Instructions

    The Drug Enforcement Administration makes every effort to write 
clearly. If you have suggestions as to how to improve the clarity of 
this regulation, call or write Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, telephone (202) 307-7297.

List of Subjects in 21 CFR Part 1306

    Drug traffic control, Prescription drugs.


    For the reasons set out above, 21 CFR part 1306 is amended to read 
as follows:

PART 1306--[AMENDED]

    1. The authority citation for Part 1306 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 829, 871(b).


    2. Section 1306.11 is amended by revising paragraph (g) to read as 
follows:


Sec. 1306.11  Requirement of prescription.

* * * * *
    (g) A prescription prepared in accordance with Sec. 1306.05 written 
for a Schedule II narcotic substance for a patient enrolled in a 
hospice care program certified and/or paid for by Medicare under Title 
XVIII or a hospice program which is licensed by the state may be 
transmitted by the practitioner or the practitioner's agent to the 
dispensing pharmacy by facsimile. The practitioner or the 
practitioner's agent will note on the prescription that the patient is 
a hospice patient. The facsimile serves as the original written 
prescription for purposes of this paragraph (g) and it shall be 
maintained in accordance with Sec. 1304.04(h).

    Dated: July 14, 2000.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 00-18572 Filed 7-24-00; 8:45 am]
BILLING CODE 4410-09-M