Federal Legislative News
Senator Warren files Medical Innovation Act (MIA)
MassBio hosts roundtable discussion with Congressman Joe Kennedy
In February 2014, MassBio hosted a roundtable discussion with first-term Congressman Joe Kennedy. Congressman Kennedy was joined by MassBio President and CEO Robert Coughlin, MassBio Board Chairman Geoff MacKay, as well as executives and key stakeholders from MassBio member companies. The Congressman was very interested in learning about the legislative issues facing our industry. During his visit, Congressman Kennedy acknowledged that the research and development happening here in Massachusetts is not only important to this state but to the nation and the world.
MassBio seeks clarification of FDA Regulatory Policy on Wound Care Products
In a letter to Commissioner Margaret Hamburg, MassBio requests that the Food and Drug Administration (FDA) take proactive steps to provide clarification of FDA Regulatory Policy on Wound Care Products. MassBio believes the current lack of clarity poses significant threats to both the patient population and the ability of some of our member companies to bring new, innovative therapies to market.
Sen. Elizabeth Warren talks policy with industry leaders
In September 2013 MassBio hosted a roundtable discussion with U.S. Senator Elizabeth Warren. Senator Warren was joined by MassBio President and CEO Robert Coughlin, MassBio Board Chairman Geoff MacKay, BIO President and CEO James Geenwood, as well as executives and key stakeholders from MassBio member companies. This roundtable provided a great opportunity for the group to discuss important legislative issues and the future of innovation with Senator Warren, who has taken a keen interest in the issues facing our industry.
Senator Warren also demonstrated her commitment to research funding when she called for a nonpartisan effort to double the funding of the National Institute of Health. See the full story here.
MassBio expresses concerns regarding the proposed revisions to the CMS Hospital Outpatient Prospective Payment System (HOPPS)
MassBio has been deeply engaged on the proposed revisions to the Hospital Outpatient Prospective Payment System (HOPPS), released by CMS in July. MassBio expressed its concern in a letter to the Massachusetts Delegation that the proposed payment structure discussed in these revisions will restrict patient access to break through technologies that can solve unmet medical needs. Of particular concern is CMS’ plan to bundle a diverse group of products for reimbursement purposes.
MassBio submits comments to CMS re: Proposed Medicare Hospital Outpatient Prospective Payment Systems (HOPPS) Rules
On behalf of our members, MassBio submitted comments relative to the proposed changes to Medicare Hospital Outpatient Prospective Payment Systems (HOPPS) in CY2014.
Our fundamental concern with the Proposed HOPPS Rule is that it will stifle the incentive to innovate and bring to market the kind of new medical products that require millions of dollars of research and development and a lengthy FDA approval process. Specifically, we believe the Proposed Rule would fundamentally change the way our member companies manufacture innovative products to treat advanced, chronic, hard-to-heal wounds.
MassBio hosts Member Briefing call on Supreme Court decision on gene patents
On June 13, 2013 the Supreme Court ruled that human genes cannot be patented. The court's unanimous decision in Association for Molecular Pathology vs. Myriad Genetics bars the patenting of naturally occurring isolated biological material, but rules cDNA is patentable. Listen here as industry experts: Hans Sauer, Associate General Counsel, IP, BIO, Gregory D. Williams, Attorney at Law, Pepper Hamilton LLP, and Konstantin M Linnik, PhD, Partner / Attorney at Law, Nutter McClennen & Fish LLP, share their analysis and interpretation of this decision.
MassBio members can listen to the call here.
MassBio urges Senator Cowan to support energy title reforms and updates in the Farm Bill
MassBio signed on to a letter calling upon Senator William Cowan to help champion the key energy title reforms and updates to the new version of the Farm Bill, and to ensure that the legislation provides for at least $800 million in mandatory energy program funding. This funding is vital to the success of crucial energy programs and the reform language in the new version of the bill provides long-overdue eligibility for renewable chemicals in key energy title programs.
MassBio expresses concerns regarding the Independent Advisory Payment Board (IPAB)
MassBio recently signed on to a letter to Congress expressing opposition to the Independent Advisory Payment Board (IPAB) that was created by the Patient Protection and Affordable Care Act (PPACA). MassBio and other healthcare industry organizations share the conviction that the IPAB will not only severely limit Medicare beneficiaries’ access to quality healthcare, but also increase healthcare costs.
MassBio Urges Congress to Protect Medicare
MassBio recently urged the Massachusetts Congressional Delegation to oppose any reductions in payment for providers of drugs and biologics under Medicare Part B. Part B is vital to providing patients with access to limited and lifesaving provider- administered products, and substantial cuts to Part B payments would restrict accessibility to critically needed therapies. A copy of MassBio’s letter can be found here.
MassBio has also signed on to a letter in opposition to requiring the Secretary of Health and Human Services (HHS) to negotiate prescription drug prices in the Medicare Part D program. The letter to Congress can be viewed here.
As Sequestration Cuts Takes Effect, Impact on Massachusetts Biotech Could Be Significant
Now that the March 1st deadline to avoid sequestration has passed, national focus has shifted to how Congress can avoid government shutdown at the end of the month. In the fiscal year 2013 alone, $85 billion in reductions are set to go into effect, and its impact will be felt in the coming weeks.If the impending cuts are enacted, the biotech community in the Commonwealth can expect to be adversely impacted in a number of ways. Read more.
HHS Releases its ruling on Essential Health Benefits
On February 20, 2013, the Department of Health and Human Services (HHS) released the final rule on Essential Health Benefits for beneficiaries enrolled in state health insurance exchanges. A link to the final rule is below and formal publication is expected in the Federal Register by April. HHS’s final ruling can be viewed here.
MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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