PRINTER'S NO. 1472
No. 1225 Session of 2003
INTRODUCED BY VANCE, NAILOR, NICKOL, BUXTON, ARMSTRONG, BARD,
BARRAR, BELFANTI, CAPPELLI, CLYMER, CREIGHTON, CURRY, DeLUCA,
FLEAGLE, FLICK, GINGRICH, GRUCELA, HARHAI, HERMAN, JAMES,
LAUGHLIN, LEH, LEVDANSKY, MACKERETH, MANDERINO, MARSICO,
McILHATTAN, McNAUGHTON, S. MILLER, MUNDY, PHILLIPS, PISTELLA,
PRESTON, RUBLEY, SAINATO, SAYLOR, SCHRODER, SCRIMENTI,
SEMMEL, SHANER, B. SMITH, SOLOBAY, T. STEVENSON,
E. Z. TAYLOR, THOMAS, TIGUE, WALKO, WANSACZ, WASHINGTON,
WATSON, WHEATLEY, WILT AND YOUNGBLOOD, APRIL 24, 2003
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
APRIL 24, 2003
AN ACT
1 Amending the act of June 13, 1967 (P.L.31, No.21), entitled "An
2 act to consolidate, editorially revise, and codify the public
3 welfare laws of the Commonwealth," providing for the Pharmacy
4 Best Practices and Cost Control Program.
5 The General Assembly of the Commonwealth of Pennsylvania
6 hereby enacts as follows:
7 Section 1. The act of June 13, 1967 (P.L.31, No.21), known
8 as the Public Welfare Code, is amended by adding sections to
9 read:
10 Section 449.1. Advisory Committee.--(a) The Pharmacy Best
11 Practices and Cost Control Advisory Committee is established in
12 the department.
13 (b) The committee is comprised of the following:
14 (1) The secretary or a designee, who shall serve as
15 chairperson.
1 (2) Four members appointed by the Governor. Members under
2 this clause must possess expertise in medicine or pharmacy.
3 (3) One member appointed by the President pro tempore of the
4 Senate and one member appointed by the Minority Leader of the
5 Senate.
6 (4) One member appointed by the Speaker of the House of
7 Representatives and one member appointed by the Minority Leader
8 of the House of Representatives.
9 (c) Terms are as follows:
10 (1) The secretary shall serve ex officio.
11 (2) A member under subsection (b)(2) shall serve a term of
12 six years.
13 (3) A member under subsection (b)(3) shall serve a term of
14 four years but may be removed at the pleasure of the appointing
15 authority.
16 (4) A member under subsection (b)(4) shall serve a term of
17 two years but may be removed at the pleasure of the appointing
18 authority.
19 (5) An appointment to fill a vacancy shall be for the period
20 of the unexpired term or until a successor is appointed and
21 qualified.
22 (d) A majority of the members of the committee constitutes a
23 quorum.
24 (e) Members shall receive no payment for their services.
25 Members who are not employes of State government shall be
26 reimbursed for necessary and reasonable expenses incurred in the
27 course of their official duties.
28 Section 449.2. Pharmacy Best Practices and Cost Control
29 Program.--(a) The secretary shall establish a Pharmacy Best
30 Practices and Cost Control Program for medical assistance
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1 enrollees designed to reduce the cost of providing prescription
2 drugs, while maintaining high quality in prescription drug
3 therapies. The program shall be implemented consistent with
4 section 1927 of the Social Security Act (49 Stat. 620, 42 U.S.C.
5 § 1396r-8). The program shall include all of the following:
6 (1) A preferred list of covered prescription drugs which
7 identifies preferred choices within selected therapeutic classes
8 for particular diseases and conditions, including generic
9 alternatives. Therapeutic classes and drugs to be preferred in
10 the classes shall be selected by the department upon
11 recommendations by the Pharmacy Best Practices and Cost Control
12 Committee.
13 (2) Utilization review procedures, including a prior
14 authorization review process which meets the requirements of
15 section 1927(d)(5) of the Social Security Act (42 U.S.C. §
16 1396r-8(d)(5)).
17 (3) A supplemental rebate program or any other strategy
18 designed to negotiate with pharmaceutical manufacturers to lower
19 the cost of prescription drugs for the department's Medicaid
20 program.
21 (4) Education programs, including a counterdetailing
22 program, designed to provide information and education on the
23 therapeutic and cost-effective utilization of prescription drugs
24 to physicians, pharmacists and other health care professionals
25 authorized to prescribe and dispense prescription drugs.
26 (5) Any other cost containment activity adopted by the
27 department which is designed to reduce the cost of providing
28 prescription drugs while maintaining high quality in
29 prescription drug therapies.
30 (b) The secretary shall evaluate the benefits of
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1 participating, but is not required to participate, in joint
2 prescription drug purchasing agreements or pooling arrangements
3 with other states. Such actions shall include:
4 (1) The execution of any lawful joint purchasing or pooling
5 agreements with other participating states which the secretary
6 determines will lower the Medicaid cost of prescription drugs
7 while maintaining high quality in prescription drug therapies.
8 (2) Renegotiation and amendment of existing contracts to
9 which the department is a party if renegotiation and amendment
10 will be of economic benefit to the department.
11 (c) The secretary shall report quarterly to the committee on
12 the department's progress in securing participation in joint
13 purchasing or pooling agreements.
14 (d) The program shall authorize pharmacy benefit coverage
15 when a patient's health care provider prescribes a prescription
16 drug not on the preferred drug list or a prescription drug which
17 is not the list's preferred choice under the same terms as
18 coverage for preferred choice drugs if any of the following
19 apply:
20 (1) The preferred choice has not been effective or, with
21 reasonable certainty, is not expected to be effective in
22 treating the patient's condition.
23 (2) The preferred choice causes or is reasonably expected to
24 cause adverse or harmful reactions in the patient.
25 (3) Other clinical criteria recommended by the committee and
26 approved by the department is complied with.
27 (4) If the prescriber does not wish substitution to take
28 place, the prescriber shall write "brand necessary" or "no
29 substitution" in the prescriber's own handwriting on the
30 prescription blank, together with a written statement that the
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1 generic or therapeutic equivalent has not been effective, or
2 with reasonable certainty is not expected to be effective, in
3 treating the patient's medical condition or causes or is
4 reasonably expected to cause adverse or harmful reactions in the
5 patient. In the case of an unwritten prescription, there shall
6 be no substitution if the prescriber expressly indicates to the
7 pharmacist that the brand name drug is necessary and
8 substitution is not allowed because the generic or therapeutic
9 equivalent has not been effective, or with reasonable certainty
10 is not expected to be effective, in treating the patient's
11 medical condition or causes or is reasonably expected to cause
12 adverse or harmful reactions in the patient.
13 (e) The department, with recommendations from the committee,
14 shall determine diseases and therapeutic classes relating to
15 treatment for diseases excluded from the program as to Medicaid
16 enrollees already taking specified drugs at the time the program
17 is implemented.
18 (f) The program's prior authorization process shall ensure
19 that there will be a response to a request for prior
20 authorization by telephone or other telecommunication device
21 within twenty-four hours after receipt of the request for prior
22 authorization and that a seventy-two-hour supply of the drug
23 prescribed will be provided in an emergency or when the program
24 does not provide a response within twenty-four hours. The prior
25 authorization process shall be designed to minimize
26 administrative burdens on prescribers, pharmacists and
27 consumers.
28 (g) The program shall establish procedures for the timely
29 review of prescription drugs newly approved by the Food and Drug
30 Administration, including procedures for the review of newly
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1 approved prescription drugs in emergency circumstances.
2 (h) The department shall submit annual reports on the
3 programs under subsection (a) and (b) to the Aging and Youth
4 Committee, the Appropriations Committee and the Public Health
5 and Welfare Committee of the Senate and the Aging and Older
6 Adult Services Committee, the Appropriations Committee and the
7 Health and Human Services Committee of the House of
8 Representatives. The reports shall include classes of drugs,
9 exceptions, cost-effectiveness, movement of market share and
10 increased utilization of generic drugs.
11 Section 2. This act shall take effect in 60 days.
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