A&B Healthcare Week in Review, March 6, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On March 5, 2015, the Food and Drug Administration (FDA) announced the availability of draft guidance for industry entitled ‘‘Clinical Trial Imaging Endpoint Process Standards.’’ This guidance assists sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products. This guidance focuses on imaging acquisition, display, archiving, and interpretation process standards that FDA regards as important when imaging is used to assess a trial’s primary endpoint or a component of that endpoint. This draft guidance revises the draft guidance entitled ‘‘Standards for Clinical Trial Imaging Endpoints’’ issued on August 19, 2011. Comments on the draft guidance should be submitted by May 4, 2015. More information may be found here. 
• On March 5, 2015, FDA announced the availability of guidance for industry entitled ‘‘Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.’’ This guidance provides information in response to questions that FDA has received from manufacturers on demonstrating the substantial equivalence of a new tobacco product, including questions on when a modification to the label requires a premarket submission and review by FDA. 
• On March 5, 2015, the Department of Health and Human Services (HHS) announced that it is extending the comment period for the Department’s Solicitation of Written Comments on the Draft National Adult Immunization Plan. HHS, through the National Vaccine Program Office (NVPO) is extending the public comment period for a draft document entitled ‘‘The National Adult Immunization Plan (NAIP).’’ The availability of that draft document was published in the Federal Register on February 6, 2015, Volume 80, Number 25, pages 6721–6722. The comment period is extended by 14 days and thus will end on March 23, 2015. 
• On March 3, 2015, FDA announced that an information collection request entitled “Investigational New Drug Applications” had been submitted to the Office of Management and Budget (OMB) for review. FDA is requesting OMB approval for the reporting and recordkeeping requirements contained in FDA regulations entitled ‘‘Investigational New Drug Application’’ in part 312 (21 CFR part 312). Part 312 implements provisions of section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) to issue regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted. Comments on the proposal are due April 2, 2015. 
• On March 3, 2015, FDA announced that an information collection request entitled “Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and ‘‘Lookback’’” had been submitted to OMB for review. Comments on the proposal are due April 2, 2015. 
• On March 6, 2015, the Centers for Medicare and Medicaid Services (CMS) announced that it had submitted a number of information collection requests to OMB for review. They are as follows: 1) Survey Report Form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations; 2) Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision (NCD); and 3) Employer Notification to HHS of its Objection to Providing Coverage for Contraceptive Services. More information may be found here. 
• On March 6, 2015, CMS announced an opportunity for the public to comment on an information collection activity entitled “Agent/Broker Data Collection in Federally Facilitated Health Insurance Exchanges”. CMS collects personally identifiable information from agents/brokers to register them with the Federally-Facilitated Marketplace (FFM) and permit them to assist individuals and employers in enrolling in the FFM. CMS uses this collection of information to ensure agents/brokers possess the basic knowledge required to enroll individuals and SHOP employers/ employees through the Marketplaces. Agents/brokers will use CMS or third-party systems to enter identifying information and register with the FFM. Comments are due May 5, 2015.

Event Notices

• April 1, 2015: FDA has announced a public workshop entitled ‘‘Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges.’’ The purpose of the public workshop is to provide updates on accomplishments, challenges, and ongoing efforts in the use of clinical outcome assessments (COAs), and plan for the future of COA development and utilization in drug development programs, including how to incorporate the patient voice in drug development using well-defined and reliable patient-centered outcome measures. The public workshop will also discuss standards for COA use and collaborative processes for COA development and dissemination. The public workshop will be held on April 1, 2015, from 8:30 a.m. to 5 p.m. at FDA’s White Oak Campus in Silver Spring, Maryland, and will be broadcast live via webcast. More information may be found here. 
• June 5, 2015: On March 5, 2015, FDA announced that the Agency will convene a public hearing to provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders—industry, academia, patient advocates, professional societies, and other interested parties—as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public hearing into account in developing the fiscal year (FY) 2016 Regulatory Science Plan. The public hearing will be held on June 5, 2015, from 9 a.m. to 5 p.m. at the FDA White Oak Campus in Silver Spring, Maryland. More information may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate 

• In the March 1st edition of the Washington Post, Senate Finance Chairman Orrin Hatch (R-UT), Senate Health Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN), and Senate Republican Policy Committee Chairman John Barrasso (R-WY) provided a high-level outline of the GOP’s plan should the Court rule in favor of the plaintiffs in King v Burwell (see next section for more details on the case, currently pending at the Supreme Court). In the article, lawmakers insist that if premium subsidies stop flowing in states with a Federally-Facilitated Health Insurance Marketplace, Congress will “provide financial assistance to help Americans keep the coverage they picked for a transitional period”, and that they will “…give states the freedom and flexibility to create better, more competitive health insurance markets offering more options and different choices.”

House of Representatives

• On March 3, 2015, the House Energy and Commerce Subcommittee on Oversight and Investigations convened a hearing entitled “Understanding the Cyber Threat and Implications for the 21st Century Economy”. Witnesses for the hearing included Herbert Lin, Senior Research Scholar, Center for the International Security and Cooperation, Stanford University; Richard Bejtlich, Chief Security Strategist, FireEye, Incorporated; Gregory Shannon, Chief Scientist, CERT Program, Software Engineering Institute, Carnegie Mellon. More information on the hearing may be found here. 
• On March 4, 2015, the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies convened a hearing entitled “Budget Hearing—Food and Drug Administration”. Witnesses for the hearing included Dr. Margaret Hamburg, Commissioner, FDA; Jay Tyler, Chief Financial Officer, Food and Drug Administration; and Norris Cochran, Director, Office of Budget, Assistant Secretary for Financial Resources. More information on the hearing may be found here.

III. REPORTS, STUDIES, & ANALYSES 

• On March 2, 2015, the Office of Inspector General (OIG) released an advisory opinion which concludes that a proposed arrangement in which a preferred hospital network would provide discounts to a Medigap plan's beneficiaries in return for the beneficiaries receiving a premium credit for selecting network hospitals wouldn't result in any sanctions under the civil monetary penalties statute. Under the proposed arrangement, Network Hospitals would provide discounts of up to 100 percent on Medicare inpatient deductibles incurred by the Requestor’s Medigap plan policyholders that otherwise would be covered by the Requestor. The discounts would apply only to the Medicare Part A inpatient hospital deductibles covered by the Medigap plans, and not to any other cost-sharing amounts. The Network Hospitals would provide no other benefit to the Requestor or its Policyholders as part of the Proposed Arrangement. Each time the Requestor receives this discount from a Network Hospital, the Requestor would pay the PPO a fee for administrative services.
• The Association of American Medical Colleges released this week a report, entitled “The Complexities of Physician Supply and Demand: Projections from 2013 to 2025”. The report finds that demand for doctors will exceed the number of practicing physicians by 46,100 to 90,400 by 2025. Projected shortfalls in primary care will range between 12,500 and 31,100 physicians by 2025, while demand for non-primary care physicians will exceed supply by 28,200 to 63,700 physicians. The report finds that while growth in the supply of advanced practice nurses (APRNs) and other health occupations may help to alleviate projected shortfalls to an extent, even taking into consideration potential changes in staffing, the nation will likely face a growing shortage in many physician specialties—especially surgery-related specialties.

IV. OTHER HEALTH POLICY NEWS

• On Wednesday March 4th, the Supreme Court heard oral arguments in the King v. Burwell case, which deals with the availability of premium tax credits for individuals purchasing healthcare coverage on Health Insurance Exchanges established by the Affordable Care Act (ACA). The plaintiffs argue that regulations allowing premium tax subsidies through Federally-Facilitated Exchanges (FFEs) are invalid and that subsidies may be provided only through Exchanges established by states (State-Based Exchanges, or SBEs). If the challenge is successful, federal subsidies could cease to flow to as many as 36 states with FFEs, potentially impacting millions of Exchange enrollees. During approximately 90 minutes of oral arguments on Wednesday, the Court appear divided along expected ideological lines. In The Wall Street Journal, Louise Radnofsky and Jess Bravin report that “Justice Samuel Alito ’s suggestion that the Supreme Court could delay for months the impact of a decision to gut the health law revives the possibility that at least a dozen states could take action to limit the effect of such a ruling.” A transcript and audio from the arguments are now available.
• On March 6, 2015, the FDA approved the first U.S. biosimilar, Sandoz's filgrastim biosimilar (Zarxio) of Amgen's Neupogen, with what it calls a placeholder nonproprietary name, filgrastim-sndz. The Agency notes in a press release that, “The provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products. While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future.” The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data. Said FDA Commissioner Margaret Hamburg of the announcement: “Biosimilars will provide access to important therapies for patients who need them. Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
• The Medicare Payment Advisory Commission (MedPAC) convened a series of meetings March 5th and 6th in Washington, DC to discuss Medicare issues and policy questions and to develop and approve reports and recommendations to the Congress. The agenda included sessions on generic prices and the role of non-preferred generic tiers in Part D; Part B drug payment policy issues; sharing risk in Medicare Part D; and synchronizing Medicare policy across payment models: determining beneficiary premiums.
  
  During the meetings the Commission reviewed a number of draft recommendations related to hospital short stay issues, including:
  
  • Recommendation 1a. The Secretary of HHS (the Secretary) should direct Medicare Recovery Audit Contractors (RACs) to focus reviews of short inpatient stays on hospitals with the highest rates of this type of stay.
  • Recommendation 1b. The Secretary should modify each RAC’s contingency fees to be based, in part, on its claim denial overturn rate. 
  • Recommendation 1c. The Secretary should shorten the RAC look-back period for reviewing short inpatient stays. 
  • Recommendation 2: The Secretary should evaluate a formulaic penalty on excess short stays to substitute for RAC review of short inpatient stays. 
  • Recommendation 3: The Congress should revise the Skilled Nursing Facility (SNF) eligibility requirement, such that for beneficiaries formally admitted to the hospital as an inpatient, time spent in outpatient status counts toward the three-day prior hospitalization threshold. 
  • Recommendation 4: The Congress should require, as a condition of Medicare payment, that all acute-care hospitals notify beneficiaries place in outpatient observation status for longer than 24 hours of their observation status and that their status may affect their cost sharing for their current hospital stay as well as coverage for SNF care. 
  • Recommendation 5: The Congress should package payment for self-administered drugs during outpatient observation on a budget-neutral basis within the hospital outpatient prospective payment system.
    
    More information on the meeting may be found here.