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Autumn Report:
Planning a State Legislative Agenda for 2013
Legislators and candidates are out knocking on doors, meeting with voters, and making a final push before the election. Once elected, what will be on their 2013 agendas? We have some ideas, which we'll be rolling out over the next few months in greater detail. Here are our initial thoughts on a state legislative agenda for 2013, including:
 Cracking down on compounding pharmacies. With the death count currently at 20 and 254 sickened - and more expected - from contaminated steroid injections, a spotlight has been aimed at compounding pharmacies. It turns out states are the regulators of these entities, some of which have morphed into loosely regulated drug manufacturers. Clearly, the current crisis calls out for comprehensive federal oversight. But how many of us expect that Congress will act promptly to clarify and expand the FDA's authority? In the absence of a speedy revamping of federal authority, state legislators need to review their statutes and regulations, as well as the enforcement of those rules. While it appears that Massachusetts had some key rules in place, with complaints going back to 1999, enforcement zeal remains a question. Other states may want to look to new policies in Massachusetts including surprise inspections just announced by Governor Deval Patrick.
In addition to reviewing and beefing up their pharmacy regulations, legislators should consider a focus on best practices for prescribing and review reimbursement rules for state-funded prescription drug and insurance programs. There are a lot of steroid injections being prescribed for pain. Are they warranted given the risks? According to the Wall Street Journal, patients are going ahead with these treatments despite the risks. Just as federal policymakers are scrutinizing Medicare, state policymakers should look at Medicaid and other programs where states set the rules or pay the bills and determine if changes are warranted.
Who is watching out for the kids? State legislators and policymakers need to pay attention to a growing issue: over-prescribing powerful drugs to children - drugs that often have not been tested for their effects on children and that have significant side effects and sometimes questionable value. From heavy prescribing of ADHD drugs generally to policies affecting children in foster care and patients on Medicaid, states need to review their oversight and policies. This year, Minnesota adopted a new policy requiring requiring doctors in many cases to begin using a state-funded consulting service before prescribing powerful psychiatric medications for young patients.
Medicaid rebates can and should be improved. The Affordable Care Act changes how Medicaid rebates are administered, and one outcome could be better oversight of drug industry rebate calculation and payment. The current system is rife with fraud, and the lack of a national database of drug prices has made it difficult for states to negotiate uniform pricing. The Affordable Care Act changes the way rebates must be calculated at both the state and federal levels, increasing the amount of rebates for some drugs and establishing through regulation a national price list from which rebates can be calculated.
Implementing the Affordable Care Act provides states with new levers to promote a variety of prescription drug policies. "Obamacare" includes a variety of provisions relating to pharmaceutical policy, including Medicaid drug pricing and reimbursement, benefit management and marketing. There are potentially opportunities for legislators to expand some existing state programs and look for alternative ways to implement other policies such as pharmacy benefit manager (PBM) transparency, disclosure of gifts and payments to physicians, datamining, academic detailing and more. States get to set the rules for the insurance exchanges and the federal government is promoting state flexibility, so states should investigate opportunities to promote better prescribing and pharmacy benefit practices.
Tell the US Trade Representative to protect Medicaid, 340B and other programs and to encourage generics, not lengthy monopolies for brand-name drugs.
The Korea-US Free Trade Agreement (FTA) and Australia-US FTA included provisions that for the first time directly addressed drug pricing for reimbursement purposes by government health programs like Medicaid. Now the U.S. government is involved in negotiations over the 11-country TransPacific Partnership or TPPA trade deal, and similar provisions have been proposed. These provisions are being advocated for by PhRMA and the biomedical and medical device industries, and could limit how effectively governments can negotiate prices. State legislators should read the report recently commissioned on the TPPA and pharmaceuticals by the Maine Citizen Trade Policy Commission and like the CTPC, weigh in with letters and resolutions so that the USTR doesn't negotiate away affordable medicines.
Datamining, Round 2: Look again to New Hampshire!
In 2012 the pharmaceutical and datamining lobbyists made the rounds of the Northern New England legislatures, offering up legislation to implement legal "housekeeping" by repealing the laws at issue in IMS v Sorrell, in which the US Supreme Court overturned Vermont's prescription record privacy law. While Vermont and Maine legislators duly enacted these repeals, New Hampshire lived up to its "Live Free or Die" motto and dug in its heels. NH Rep. Cindy Rosenwald, sponsor of the first prescriber privacy law in the country, reported in the NLARx summer meeting that the NH House passed, by a large margin, an amendment to the industry repeal bill that tweaked the NH privacy law by amending the state's HIPAA provisions, retaining a level of privacy protection for this data. Although the bill died because the Senate refused to go along, expect New Hampshire legislators to bring this issue back for reconsideration in 2013, and other states should consider doing the same thing.
 
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