The Massachusetts Legislature discussed and voted on some issues critical to the life sciences industry in the 2015-2016 Session, which drew to a close on July 31st.
MassBio, working alongside and on behalf of its member organizations, engaged legislators throughout the session, educating and advocating for policies that support innovation and the continued growth of the industry.
Below is a recap of what turned out to be a successful session. We thank the companies and individuals who testified at hearings, submitted written testimony or comments, attended legislator meetings or contributed to the MassBio State PAC to support our efforts.
“Transparency” Legislation
Outcome: Sent to Study
Link: https://malegislature.gov/Bills/189/Senate/S1048
This legislation would have required manufacturers to disclose information related to the price of drugs, including marketing and research costs, and was before the Committee on Healthcare Financing for consideration this Session. The legislation would have also allowed the Massachusetts Health Policy Commission (HPC) to cap drug prices.
FY 2017 Budget – CH. 133 of the Act of 2016
Outcome: Signed by the Governor
Link: https://malegislature.gov/Budget
Section 129: Co-pay Assistance – Repeal of the sunset provision extended until 2019
(SECTION 129. Section 226 of chapter 139 of the acts of 2012 is hereby amended by striking out the figure "2017", inserted by section 2 of chapter 441 of the acts of 2014, and inserting in place thereof the following figure:- 2019.)
MassBio first supported the full repeal of the current sunset provision on the statutory exemption permitting co-pay assistance programs and discount programs to be offered in Massachusetts for prescription drugs and biologics for which no chemically identical generic alternative exists. This full repeal language appeared in the House version, but not the Senate version. The language in this section extends the sunset date for co-pay assistance programs and discount programs to 2019 and will allow companies to provide the patients who need it most, access to the innovative therapies that improve their lives. This extension may also provide the time to conduct a study that would demonstrate the value of these programs and the lack of negative impact on generic utilization in the Commonwealth.
Section 11: Cost Trends Accuracy
(SECTION 11. Section 16 of Chapter 12C of the General Laws, as appearing in the 2014 Official Edition, is hereby amended by inserting after the words “durable medical equipment” in line 15 the following:- provided, that any detailed cost growth trend in the pharmaceutical sector shall consider the effect of drug rebates and other price concessions in the aggregate without disclosure of any product or manufacturer-specific rebate or price concession information, and without limiting or otherwise affecting the confidential or proprietary nature of any rebate or price concession agreements”. )
Each year, the Center for Health Information Analysis (CHIA) is required to analyze data on health care provider costs from both private and public health care payers to determine cost trends for the previous year. CHIA’s findings are then utilized by The Health Policy Commission (HPC) in its own annual Cost Trends Reports by which it recommends policies to control the Commonwealth's health care costs under Chapter 224 of the Acts of 2012. The 2015 Cost Trends Report suggested that there was a considerable increase in overall health care costs between 2013 and 2014, including pharmaceutical costs. While the data suggested that these costs rose dramatically, Upon further analysis, it was determined that the data CHIA shared with HPC was flawed due to the lack of accounting for vital information bearing on true drug spend, including the impact of rebates and discounts on pharmaceuticals that are commonly negotiated with health plans in all cases. Both CHIA and HPC have publicly recognized this omission. This language would allow them to remedy the situation and provide more accurate pharmaceutical cost findings that are more appropriate for driving positive policy initiatives related to health care cost containment.
Drug Stewardship Program – Chapter 52 of the Acts of 2016
Outcome: Signed by the Governor
Link: https://malegislature.gov/Laws/SessionLaws/Acts/2016/Chapter52
Section 31 of this law requires pharmaceutical manufacturers of any brand name or generic opioid drug placed in Schedule II or III opioids in the Commonwealth to operate a drug stewardship program that collects, secures, transports, and safely disposes of unwanted drugs. The Department of Public Health is required to consult with the Massachusetts Biotechnology Council, the Interagency Council on Substance Abuse and other interested parties in developing requirements of a drug stewardship plan. This is not an industry wide drug take back plan. It is limited only to opioid manufacturers. If you are a Schedule II or III manufacturing company, your program has to accept all returned drugs.
Also in Section 31 subsection 6, the law provides that the Department of Public Health shall, in consultation with the Massachusetts Biotechnology Council, the Interagency Council on Substance Abuse and other interested parties, to develop an alternative plan to the drug stewardship program that would replace the program outlined in Section 31. A manufacturer who opts into an alternative plan established under this section would be exempted from the drug stewardship program. Effective date 1/1/17; sunset date 12/31/2021.
Pay Equity – Chapter 177 of the Acts of 2016
Outcome: Signed by the Governor
Link: https://malegislature.gov/Laws/SessionLaws/Acts/2016/Chapter177
Legislation to establish pay equity was unanimously approved by both braches of the Legislature and signed by the Governor this session. This law bars discrimination on the basis of gender in the payment of wages for comparable work "unless the variation is based upon a mitigating factor" including seniority, education, training, experience, or a bona-fide merit system like one that measures earnings by sales. The law would also prohibit employers from asking applicants about salary history until after a formal offer of employment and compensation has been made, and would make sure that employees cannot be punished for discussing salaries with co-workers.
Non-compete
Outcome: Died in Conference
Links: https://malegislature.gov/Bills/189/House/H4434;
https://malegislature.gov/Bills/189/Senate/S2418/History
The Massachusetts House of Representative and the Massachusetts Senate passed different versions of non-compete legislation this Session. The House version of the bill limited non-compete agreements to a year and provided for "garden leave" provisions where employees would be paid half their salary or "other mutually-agreed upon consideration." In the Senate bill, non-compete agreements would last only three months and would include full salary to the departing worker. These bills were sent to a House/Senate Conference Committee, however the Committee was unable to reach a consensus on this legislation.
Economic Development:
Outcome: Signed by the Governor
Link: https://malegislature.gov/Bills/189/House/H4569/History
Legislation relative to job creation, workforce development and infrastructure investment was sent to the Governor in the final days of the legislative session. Included in this legislation is language, Section 72, that creates an “Angel Investor Tax Credit” within the existing life sciences incentive program, and subject to its statutory cap and sunset date, to allow taxpayer investors to become eligible for a credit on a qualifying “angel” investment to startup businesses of 20 or fewer employees.
Other MassBio Policy Efforts of Note:
Financial Services Information Session (June 11, 2015)
The Financial Services Committee hosted an informational session on issues of concern to the insurance industry. The Committee invited approximately 40 stakeholders (individuals and groups) to testify at this hearing. MassBio President & CEO Bob Coughlin participated in the session and shared his views on the value of innovative medicines to the healthcare system.
Managed Care Organizations Working Group and Report (October 1, 2015)
In early 2015, MassBio President & CEO Bob Coughlin was chosen to participate in an advisory committee created by House Speaker Robert A. DeLeo to study managed care organizations (MCOs) and their impact on MassHealth costs. The committee was charged with reviewing the delivery of Medicaid health benefits by MCOs and analyzing the costs these organizations take on in their contracts with MassHealth. The group also considered the costs of rare disease treatment medications and evaluated barriers to increasing adoption of alternative payment methods. Based upon extensive research and stakeholder engagement, several areas of consensus emerged for the Working Group.