In addition to this year’s notable national policy updates – such as the Supreme Court upholding the ACA, and PDUFA reauthorization being secured through FDASIA – the Massachusetts Legislature voted on some important issues for the biotechnology industry in the 2011-2012 session. Here’s a recap of their decisions on co-pay assistance, the gift ban, and payment reform:

The final Fiscal Year 2013 budget includes co-pay assistance and partial repeal of the gift ban.

On July 8, 2012, Governor Deval Patrick signed into law the Fiscal Year 2013 budget, which includes language that allows Massachusetts residents to take advantage of co-payment assistance programs. Up to that point, Massachusetts was the only state in the nation that banned these programs. The budget also includes language to allow certain interactions between companies and physicians that had been barred under the “gift ban” previously enacted.

The details: FY 2013 Budget – H4200

1. Co-pay assistance – Sections 128, 129, 130, 131, 201 and 226
Allows co-pay assistance programs and discount programs to be used in Massachusetts for prescription drugs and biologics for which no chemically identical generic drug exists.

2. Gift ban – Sections 108-114
Permits pharmaceutical and medical device manufacturers to pay for “modest meals and refreshments” outside of the practitioner’s office or hospital setting in connection with non-CME educational presentations for the purpose of informing practitioners about prescription drugs, medical devices, disease states or other scientific information.

Payment Reform includes access to breakthrough technologies.

On August 6, 2012, the Governor signed into law payment reform legislation which ensures patient access to breakthrough technologies and treatment.  Of concern are provisions for cost containment and bulk purchasing. Letters addressing these concerns were sent to the Governor, Majority Leader Ron Mariano, and the Health Care Committee Conferees. (Click the links provided to see the letters.)

The details: Payment Reform – S2400

1. Breakthrough technologies  – Section 15(c)(3)
Ensures patient access to health care services across the care continuum, including access to breakthrough technologies and treatments.

2. Advisory Council to the Health Policy Commission – Section 4
Ensures a representative from the biotechnology industry is a member of the Advisory Council to the Health Policy Commission.

3. Cost Containment Commission – Section 273(a) and (c)
Section 273(a) establishes the Commission and directs the Commission to study methods to reduce the cost of prescription drugs for both public and private payers.  Section 273(c) directs the Commission to report its findings, together with any recommendations for legislation, programs and funding, no later than 12 months after the passage of this act.

4. Bulk purchasing – Section 273(b)
Directs the Cost Containment Commission to examine:

• The Commonwealth’s ability to enter into bulk purchasing agreements and renegotiate current contracts;
• Aggregate purchasing methodologies designed to lower prescription pharmaceutical costs for state and non-state providers;
• The Commonwealth’s ability to operate as a single payer prescription pharmaceutical provider; and
• The feasibility of creating a program to provide all citizens access to prescription pharmaceutical at prices negotiated by the Commonwealth.