Which state will be the next to expand Medicaid?

The last week has yielded significant progress in several states currently debating Medicaid expansion. Thirty-one states and DC have already expanded the program, made an option for states due to the Supreme Court’s NFIB v Sebelius decision. Many state legislatures are coming back into session from summer recesses bringing into focus discussions on the budget implications of Medicaid. Additionally, as we approach a looming Presidential election with expected high voter turnout, politicians have an opportunity to push for the expansion to gain support from certain stakeholders. While significant action is needed in each of these states before any Medicaid expansion legislation is passed or their governors act to implement their plans, it is worth keeping an eye on all of these states in the coming months.

Utah- It has been over a year and a half since Governor Herbert announced his support for Medicaid expansion. This week, details of the new plan, UtahAccess+, have been released. The plan, formulated by the Governor and Republican legislative leaders, is similar to the Healthy Utah plan that was passed the Utah Senate but was struck down in the House with the exception of the financing model which puts the burden on providers that would benefit from additional funds through expansion.

Louisiana- This is one of the more surprising states to appear on a list of upcoming states to expand Medicaid, however the tides may be shifting in this largely conservative state. Louisiana is in the process of electing a new governor as Presidential candidate Bobby Jindal is ineligible due to term limits. All four candidates have indicated some level of support for expansion (to varying degrees) since April. These candidates’ positions reflect the push by business groups in the state which have called for expansion, as well as the recent legislative change that gave the new governor the necessary state authority to expand in the first months in office.

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Research Ethics Extravaganza: New Draft CIOMS Guidelines

As if the proposed revisions to the Common Rule weren’t enough to process, the Council for International Organizations of Medical Sciences (CIOMS) just released its proposed changes to the current CIOMS Ethical Guidelines for Biomedical Research (last revised in 2002).  CIOMS invites public comments until March 1, 2016, at which point the CIOMS Working Group will process and review them and submit the final document to the CIOMS Executive Committee for approval.

According to CIOMS, most guidelines have been substantially revised in this draft, several have been merged, and new guidelines have been added.  The proposal also merges the guidelines for biomedical research with those for epidemiological research, and the scope has been broadened from biomedical research to health-related research with humans.

A busy and exciting time in research ethics!

NPRM Symposium: Resources from PRIM&R

Our colleagues at PRIM&R (Public Responsibility in Medicine & Research) have compiled several resources to help those interested in the proposed changes to the Federal Policy for the Protection of Human Subjects, or the Common Rule.  These include an NPRM Resources page, with a chart comparing the current Common Rule with the proposed changes by section, and other materials.  PRIM&R has also recently released a freely available (till December 11, when it becomes available only to members) annotated version of the current Common Rule, which provides the regulatory text, hyperlinked to further information in the form of guidance, frequently asked questions, and regulatory resources from the Office for Human Research Protections.

PRIM&R will be blogging about the NPRM in the coming weeks, and we will cross-post here.  Stay tuned.

NPRM Symposium: Helpful Resources to Understand What the NPRM Proposes to Change

For those trying to make sense of the NPRM, the Academic and Clinical Research Group at Verrill Dana has issued two very helpful resources: 

  1. A redline of HHS’s current Common Rule regulations at 45 C.F.R Part 46, Subpart A against the proposed regulations in the NPRM.
  2. Several decision charts walking through the following issues: 
  • the scope of covered human subject research and clinical trials,
  • the key definitions of “human subject” and “research,”
  • the exclusions (and conditions for exclusion) from the proposed regulations, and
  • the exemptions (and associated requirements) from the proposed regulations.

For those interested, the firm’s full client advisories on the NPRM are available here

[Posted with Verrill Dana’s permission]

Presidential Campaigns Focus on Drug Costs

By Katherine Kwong

Drug prices have become a hot topic on the presidential campaign trail following recent stories such as the sudden spike in price from $13.50 to $750 for the parasitic infection treatment Daraprim. This story is the latest example of a growing number of complaints about steep increases and high prices for many drugs, including those used to treat multiple sclerosis and cancer, as well as commonly-used generic drugs used to treat everything from high cholesterol to bacterial infections.

In contrast with the Republican presidential candidates, who have generally not supported additional government regulation of drug pricing, Democratic presidential candidates responded to the Daraprim story by urging greater government action to lower drug costs.

Hillary Clinton cited Daraprim as an example when unveiling a proposal to cap drug costs to $250 per month, require pharmaceutical companies to spend a minimum amount on research and development, and allow Medicare to negotiate drug prices. She would also end tax credits for drug advertising to consumers and allow the importation of drugs from other countries.

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TOMORROW (9/30): Non-Human Primates in Research – Legal and Ethical Considerations

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Non-Human Primates in Research: Legal and Ethical Considerations
September 30, 2015, 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

Description:

Please join us for a discussion of critical legal, ethical, scientific, and social issues raised by research involving non-human primates, and the research centers that house them.  What does the current regulatory structure require and permit, what gaps exist, what enforcement problems have arisen, and how are they being addressed at Harvard and elsewhere?  How should scientific and medical interests be balanced against the interests of the animals, and how might the ethical and/or regulatory analysis differ depending on the type of primate involved?  What trends are emerging with regard to funding, scientific approaches, and public opinion?  Our panelists will address these questions and others in the course of a lively debate.

Panelists: Read More