Legislators from the New England states and Iowa, Georgia, Pennsylvania and West Virginia met in Portland, Maine recently following the Council of State Governments Eastern Regional Conference to learn about the impact of the Affordable Care Act on state prescription drug policy and to share strategies and policy ideas with their colleagues.
Jude Neveux, Director, Business Development, Goold Health Systems, presented on "State Medicaid Rebates after National Health Reform" (Part 1 - "Rebates 101"). This presentation provoked numerous questions and much discussion among legislators and members of the audience concerning the impact of rebate changes, how PDL changes could be effected without harming patients or causing needless burdens on prescribers, and whether states had a role in litigation over drug pricing data disclosure. The takeaway message for legislators was to pass the NLARx model law giving states authority to collect rebate data directly from drug companies.
Nancy B. Kelleher, Maine State Director, AARP, presented"Donuts and Dollars: How Federal Health Reform Affects Medicare Part D." This presentation also spurred discussion about the opportunities for states to participate in advocacy to promote generic biosimilars and changes to the pay-for-delay system allowed today.
Robin Lunge, Esq., of the Vermont Legislative Council and staff to the Health Committee, presented on "Federal Health Care Reform: One State's Perspective on Prescription Drug Initiatives". This presentation focused on the details of Vermont's gift ban and disclosure law and the impact of the Federal Sunshine Act provisions, and on Vermont's sample disclosure policy as adopted by the Legislature. Vermont Rep. Suzi Wizowaty provided a "Legislative Response: Vermont's Sample Policy and Impact of Affordable Care Act" which filled in the strategic and other details from a legislator's point of view. Although the Senate threatened to stripped the samples disclosure policy from the health bill, the House members refused to negotiate and were willing to let the entire bill die if the samples policy was stripped out. Despite the threat of a veto, the bill was finally passed with the samples disclosure included and signed into law by the Governor.
The LEGISLATORS' ROUNDTABLE was particularly lively and informative. Maine Senator Elizabeth Schneider reported on her legislation enacted last year which banned predatory internet marketing of drugs to minors. In the 2010 session, this law was repealed despite comprehensive hearings and a report by the Judiciary Committee over the summer, and excellent testimony by NLARx counsel Professor Sean Flynn, American University; Executive Director Ann Woloson, PPC; Maine doctors and parents. Opposition came from many directions, including AOL and other internet companies, the pharmaceutical industry, and Planned Parenthood.
Vermont Rep. Suzi Wizowaty reported on Vermont's major health care legislation and the provision disclosing free samples to later in the program, noting that the sample disclosure policy ended up being more controversial than anything else in the comprehensive public option/single payer planning legislation it was part of.
Maine Rep. Sharon Treat, NLARx Executive Director, reported on the successful outcome in the IMS v. Mills case, where the US Court of Appeals for the First Circuit upheld the Maine opt-out law relating to the use of prescriber data for drug marketing purposes. Both the full 82-page decision and a summary prepared by NLARx consulting attorney Meredith Jacob are posted on the NLARx website. There are now 3 datamining laws that have been upheld by two different federal circuits - NH (1st Circuit court of Appeals), Maine (1st Circuit Court of Appeals), and VT (Vermont District Court, in the 2d Circuit- this is still on appeal). These positive decisions should give a boost to this legislation nationally. Rep. Treat noted that NLARx was involved in all three cases, through amicus briefs written by Prof. Sean Flynn and Attorney Meredith Jacob of American University.
In other Maine news, Rep. Treat reported on two PBM bills that were enacted this year. Rep. Treat sponsored LD 1339, "An Act To Improve Oversight of Pharmaceutical Purchasing" (Public Laws 2010, chapter 581) which amended Maine's PBM law to provide for registration with the Bureau of Insurance, which allows for the Bureau to conduct market conduct exams, and gave the Department of Audit authority to provide audit and contracting guidance to state agencies. Senator Peter Mills sponsored another PBM law which established prompt pay and other provisions. Rep. Treat withdrew her bill seeking to expand Maine's gift and payment disclosure so that it could be reintroduced in the future to make Maine's laws consistent with the federal Sunshine Act which was enacted as part of federal health care reform.
New Hampshire Rep. Cindy Rosenwald reported on the continuing interest in New Hampshire in privacy issues, and the attempts by IMS to find a sponsor for legislation to repeal her datamining law (so far unsuccessful).
West Virginia Senator Dan Foster discussed West Virginia's groundbreaking 2004 availability & affordability act, which required the drug prices not reflect advertising costs and eventually led to adoption of a drug marketing disclosure rule which collects limited data on marketing. Legislators have tried to address the datamining issue with hearings, and although the hearings have been useful, they have not made headway in passing legislation on that issue. They hope to get funding for academic detailing to partner with a large scale program at the University of West Virginia. Another issue of interest is immunizations policy- West Virginia is one of two states that do not have a non medical exemption for immunizations.
Iowa Senator Jack Hatch provided an overview of his state's laws reforming health care to cover all children with insurance, medical homes, a limited public option for those under 300% of poverty. He noted Iowa has done less on prescription drug policy and pricing, but held meetings where NLARx Executive Director Treat presented on policy options. Senator Hatch himself introduced bills on datamining, PBMs and disclosure but was unsuccessful. His immediate goal is to educate other legislators on drug policy.
Maine Rep. Linda Sanborn, a doctor, submitted a MERSA reporting bill this year. She discussed the excellence of Maine's academic detailing program, and the position of the Maine Association of Family Physicians which discourages samples and gifts.
Georgia Rep. Pat Gardner- who represents an Atlanta district that includes the CDC and Emory University, noted her past experience as a lobbyist for the psychological society in Georgia, which has created a post-doc training program to train doctors to prescribe properly. Rep. Gardner introduced a bill that pharmacists would have to print the price of the drugs on the receipt.
Connecticut Rep. Kevin Ryan reported on public hearings on PBMs and disclosure. Connecticut passed a bill to open up the state health care law to municipalities (vetoed by governor). Connecticut did open up prescription during purchasing for municipalities and state employees on contract and not part of the state system. Also enacted this year was a chemotherapy law requiring coverage of drugs by insurance companies.
Massachusetts Senator Richard Moore, the new NCSL President, reported on last year's prescription drug ethics provision that limit gifts to what legislators are allowed, and required disclosure. This year was defensive, protecting laws enacted in previous sessions. Academic detailing is running but underfunded; there was also an effort to amend the ethics law to allow restaurants to host dinners and be exempted. High end restaurants and caterers led this fight; such catering is very lucrative for restaurants near academic medical centers. The repeal effort was defeated in a 19-18 vote in the Senate, with Senate President Theresa Murray holding strong. The measure to repeal the ethics bill of 2008 was tucked into an economic development bill, but did not pass. Senator Moore also reported on a bill to allow coupons - apparently Massachusetts is the only state that does not allow coupons. Biotech and Pharma have tried to repeal this law for the past 8 - 10 years. The House voted 156- 0 to repeal; the Senate has amended to require coupons to last the entire time of a prescription. The outcome of this legislation is not yet known, as the Legislature is still in session.
The next NLARx meeting will be after the elections, most likely in january. Stay tuned for details!
