SENATE, No. 428

SECTION 1. Section 17 of Chapter 118E of the General Laws, as appearing in the 2002 official edition, is hereby amended by striking the words "provision of written documentation by the practitioner to the division that" and inserting in place thereof:- provisions of section 53 of this chapter and

SECTION 2. Chapter 118E of the General Laws, as appearing in the 2002 official edition, is hereby amended by adding at the end thereof the following new section:

Section 53. Drug prior authorization process

(a) The Division shall administer a drug prior authorization process to ensure the timely dispensing of drugs, for any outpatient prescription drug. In administering said process the Division shall meet the following conditions:

(1) Provide telephone, fax or other electronically transmitted approval or denial within twenty-four (24) hours after receipt of the prior authorization request;

(2) If in the prescribing physician’s opinion an emergency situation exists, including a situation in which a response to a prior authorization request is unavailable, allow for the prescribed drug to be dispensed at a physician’s discretion and until such time as the prior authorization process and subsequent appeals are determined. Any drug dispensed in said manner shall be eligible for full coverage and payment by the Division of Medical Assistance;

(3) Grant authorization of drugs prescribed for a medically accepted use supported by either approved product labeling or peer reviewed literature unless there is a therapeutically equivalent generic drug that is available without prior authorization;

(4) Allow any patient that receives benefits under a program of the division, and is receiving maintenance medications for a chronic illness, to receive said medications until the existing prescription expires, or for a period not to exceed six months, whichever is greater, without the need for any prior approvals to be granted. 

(5) Consult with the Pharmacy and Therapeutics Advisory Committee, established in Section 3 of this act, to develop and implement improvements to the drug prior authorization process and make a report to the advisory committee on the status of the prior authorization list and any changes, related hearings or other proceedings semi-annually.

(b) The division shall maintain a process for the evaluation of drugs to be placed on the prior authorization list, which shall include:

(1) A public hearing on all medications prior to a decision being made on prior authorization;

(2) publishing conspicuous notice in at least one newspaper of general circulation and on the division's website at least thirty (30) days prior to any public hearing on whether such a drug should be placed on prior authorization;

 (3) consideration of any information provided by any interested party, including but not limited to physicians, pharmacists, beneficiaries, and manufacturers or distributors of the drug;

 (4) consideration of the potential impact on patient care, safety and other sectors of the state health care systems including emergency room visits and hospitalizations as a result of placement of such drug on prior authorization;

(5) receipt of written approval by a physician who is board certified in the specialty that most commonly treats the disease or prescribes the relevant therapeutic class of drugs. Said physician shall not be employed by, nor have any financial relationship with, any pharmacy benefits management company managing Medicaid prescription benefits, nor be a member of the Pharmacy and Therapeutics Advisory Committee. Such written ratification shall be submitted to the commissioner, members of the Pharmacy and Therapeutics Advisory Committee, and shall be available to the public upon request; and,

(6) A final decision shall be made within 60 days of the public hearing and published for public comment for a period of no less than 30 days. The effective date of the decision shall not be prior to the close of the comment period and effective notice of the decision’s finality is available to prescribers.

(c) Notwithstanding any other provision of this section, no drug shall be recommended to require prior authorization by the division and placed on prior authorization, which has been approved or had any of its particular uses approved by the FDA under a priority review classification;

(d) The Division shall develop a grievance mechanism for interested parties to appeal the Department’s decision to place a drug on prior authorization, which at a minimum shall be concluded within ten days.. After participating in the grievance mechanism developed by the Department on the recommendations of the advisory committee, any interested party aggrieved by the placement of a drug on prior authorization shall be entitled to an administrative hearing before the Department;

(e) The Division shall review the prior authorization status of a drug annually;

(f) The Division shall make a report to the house and senate committees on ways and means and the house and senate committees on health care at the conclusion of all prior authorization proceedings for each therapeutic class or at least, no less often than annually. Said report shall include but not be limited to the outcomes of all public hearings and prior authorization decisions; a list of drugs which are and are not to be prior authorized along with corresponding information used to make such decisions; sectors of the state health care program that may be affected by the drug’s availability for use in treating program beneficiaries; any changes made or proposed to the prior authorization process; and recommendations including legislation that may benefit the prior authorization process and program beneficiaries; said report shall be posted on the division's website.

SECTION 3. Chapter 118E of the General Laws, as appearing in the 2002 official edition, is hereby amended by adding at the end thereof the following new section:

Section 54. Pharmacy and Therapeutics Advisory Committee

(a)    There is hereby established a Pharmacy and Therapeutics Advisory Committee for the purpose of

advising and making recommendations to the Division of Medical Assistance’s prior authorization program. Said advisory committee shall consist of thirteen (13) members to be appointed by the Governor and shall include: five physicians licensed in Massachusetts and actively involved in the practice of medicine; three pharmacists licensed to do business in the commonwealth and actively involved in the practice of pharmacy; a representative of the Massachusetts Medical Society; a representative of the Massachusetts Pharmacy Association; a representative of medical assistance beneficiaries in the commonwealth; and, two patient advocates.

In making physician appointments the Governor shall make his selections from a list of nominees provided by the Massachusetts Medical Society. In making pharmacist appointments the Governor shall make his selections form a list of nominees provided by the Massachusetts Pharmacy Association.

Advisory committee members shall serve staggered three-year terms. Two physicians, one pharmacist and the representative of medical assistance beneficiaries shall each be appointed for one-year terms. Members may be reappointed for a period not to exceed three, three-year terms. Advisory committee members shall select a chairperson and a vice-chairperson by a majority vote of the committee membership on an annual basis. Said committee shall meet at least monthly and may meet at other times at the discretion of the chairperson. Notice of any meeting of the advisory committee shall be published thirty (30) days before such meeting; and

(b) The advisory committee shall have the power and duty to:

(1)   advise and make recommendations regarding the implementation of a drug prior authorization program for the medical assistance program;

(2) advise and make recommendations regarding rules to be promulgated by the division regarding outpatient prescription drug prior authorization;

(3) make recommendations for a grievance mechanism for interested parties to appeal any decision made by the Division to place a drug on prior authorization; (4) make recommendations to the Division regarding any inpatient or outpatient prescription drug covered by the medical assistance program that is to be prior authorized as well as which drugs are exempt from the prior approval process. Said recommendation shall be supported by an analysis of prospective and retrospective DUR data demonstrating

(a) the expected impact of such a decision on the clinical care likely to be received by beneficiaries for whom the drug is medically necessary;

(b) the expected impact on physicians whose patients require the drug;

(c) the expected fiscal impact on the medical assistance program;

(d) review and make recommendations on a semi-annual basis whether drugs placed on prior authorization should remain on prior authorization; and

(e) make recommendations for a list of maintenance medications that are needed for chronic illnesses;