Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

On July 21, 2011, the Senate Judiciary Committee approved S. 27, the Preserve Access to Affordable Generics Act, which would prohibit certain so-called “pay-for-delay” agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays in generic entry. On July 28, 2011, the House Energy and Commerce Committee approved H.R. 2405, the Pandemic and All-Hazards Preparedness Reauthorization Act (which reauthorizes certain provisions of the Project Bioshield Act of 2004 and Pandemic and All-Hazards Preparedness Act of 2006); H.R. 1254, the Synthetic Drug Control Act (which would make illegal synthetic drugs that imitate the effect of drugs like marijuana, cocaine, and methamphetamines); and H.R. 1852, the Children's Hospital GME Support Reauthorization Act (which provides support to children’s hospitals for pediatric medical residency programs). On August 3, the Senate Health, Education, Labor and Pensions Committee Committee is scheduled to vote on S. 958, the Children's Hospital GME Support Reauthorization Act, and S.1094, the Combating Autism Reauthorization Act.

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Several Congressional committees have held hearings on various aspects of the ACA, including: A House Oversight Health Care Subcommittee hearing on “Obamacare: Why The Need For Waivers?"; a Senate Finance Committee hearing on "Health Reform: Lessons Learned During the First Year"; a Senate Health, Education, Labor and Pensions Committee hearing examining "Health Insurance Exchanges and Ongoing State Implementation of the Affordable Care Act” and House Energy and Commerce Health Subcommittee hearings on "The Implementation and Sustainability of the New, Government-Administered Community Living Assistance Services and Supports (CLASS) Program" and on the "Patient Protection and Affordable Care Act in Pennsylvania: One Year of Broken Promises." Looking ahead, the Energy and Commerce Committee has scheduled a March 30 hearing on the ACA’s impact on budget and jobs, and an April 1 hearing on the ACA’s “High Risk Pool Regime: High Cost, Low Participation," and the House Appropriations Committee is holding a hearing on April 1 to discuss health reform funding. In other areas, the House Homeland Security Emergency Preparedness Subcommittee held a hearing on "Ensuring Effective Preparedness, Response, and Recovery for Events Impacting Health Security." The House Ways and Means Committee held a hearing to examine the Medicare Payment Advisory Commission's (MedPAC) annual report to Congress on Medicare payment policies (discussed in greater detail below). The House Budget Committee held a hearing on "Fulfilling the Mission of Health and Retirement Security." 

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On October 15, 2010, the Health Resources and Services Administration (HRSA) published an interim final rule with request for comments establishing the administrative policies and procedures for the CICP, as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). The CICP provides benefits to certain persons who sustain serious physical injuries or death as a direct result of administration or use of covered countermeasures identified by the Secretary, such as vaccines, antibiotics, or devices used to protect against pandemic influenza anthrax, botulism, smallpox, and acute radiation. In addition, the CICP may provide death benefits to certain survivors of individuals who died as the direct result of such covered injuries or their health complications. The rule is effective October 15, 2010. The Secretary will consider comments received by December 14, 2010 in deciding whether to amend the current procedures and requirements.

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On August 19, 2010, HHS released a report entitled “The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs.” Prepared in response to the H1N1 pandemic flu experience, the HHS report reviews the federal government’s role in producing medical countermeasures -- medications, vaccines, equipment and supplies for a health emergency. Among other things, the report addresses the government’s need to: upgrade science and regulatory capacity at the FDA; quickly develop manufacturing processes that can be used for multiple medications or vaccines; help small, emerging biotech companies bring products to market; and identify promising research and facilitate its translation into vaccines, drugs, and treatments.

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This post was written by Paul Sheives.

The FDA has issued a guidance document seeking to encourage the creation of contingency production plans for the manufacture of medically-necessary drug products and their components during emergencies that result in high absenteeism at production facilities. Medically-necessary products are those used to treat or prevent a serious disease or medical condition for which there is no other adequately available drug product that is judged by medical staff to be an appropriate substitute.  

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On January 7, 2010, HHS released the National Health Security Strategy, which sets priorities for government and private activities designed to protect the population’s health during a large-scale emergency, such as bioterrorism, pandemics, and natural disasters. The strategy and accompanying interim implementation guide outline 10 objectives to achieve health security, including goals in such areas as communications, workforce development, integrated health care delivery systems, and access to medical countermeasures.

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CMS is encouraging hospitals and other health care providers to review a new publication, “Community Pan-Flu Preparedness: A Checklist of Key Legal Issues for Healthcare Providers," which is the result of a public interest dialogue session convened by the American Health Lawyers Association, the HHS Office of Inspector General, and the U.S. Centers for Disease Control. The guide is designed to assist providers and public health communities as they consider the legal impediments and implementation challenges to community pan-flu preparedness, and it offers practical solutions to such challenges.

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HHS Secretary Michael Leavitt has declared that a public health emergency exists in Louisiana, Texas, Mississippi, and Alabama as a result of Hurricane Gustav. The declaration triggers waivers of certain Medicare, Medicaid, and SCHIP rules in the affected states. In a related development, on September 3, 2008 HHS announced implementation of the “Disaster Case Management” demonstration program providing case managers to help Hurricane Gustov victims obtain a wide range services, ranging from emergency food and shelter to health care services. 

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On June 3, 2008, HHS announced that it has made available nearly $1.1 billion to continue assisting public health departments, hospitals and other health care organizations respond to public health and medical emergencies resulting from terrorism, pandemic influenza, and other naturally occurring emergencies. In a related development, HHS has released three draft guidance documents. designed to assist in preparation for an influenza pandemic. The documents address: (1) the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness; (2) Antiviral Drug Use during an Influenza Pandemic; and (3) Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic. Comments will be accepted until July 3, 2008.

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HHS is holding a Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop on September 24–26, 2008. This event will provide an open forum for pharmaceutical and biotechnology industry representatives, first responders, policymakers, public health advocates, and others to discuss the development, acquisition, and distribution of medical countermeasures against chemical, biological, radiological, nuclear, and naturally emerging threats, and to share their visions for the future of U.S. public health emergency preparedness.

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