A&B Healthcare Week in Review, July 17, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On July 13, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities.” This proposed rule would revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. According to CMS’ summary, these proposed changes “are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety.” Comments on the proposed rule are due September 11, 2015.
• On July 13, 2015, CMS submitted an information collection request to the Office of Management and Budget (OMB) for review, 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. Agents/brokers will use CMS or third-party systems to enter identifying information and register with the FFM. As a component of registration, agents/ brokers are required to complete online training courses through a CMS or third-party Learning Management System (LMS). Upon completion of their applications and training requirements, agents/brokers will be required to attest to their agreement to adhere to FFM standards and requirements through a CMS or third-party LMS. Comments are due August 12, 2015.
• On July 14, 2015, the Food and Drug Administration (FDA) announced the availability of a draft guidance entitled ‘‘Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.’’ This draft guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). Comments on draft guidance should be submitted by October 13, 2015.
• On July 14, 2015, the FDA announced an opportunity for public comment on a proposed information collection activity entitled “Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach To Monitoring”. The guidance is intended to assist sponsors of clinical investigations in developing strategies for risk-based monitoring and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. Section IV.D ‘‘Monitoring Plan’’ of the guidance recommends that sponsors develop a prospective, detailed monitoring plan that describes the monitoring methods, responsibilities, and requirements for each clinical trial. Comments are due September 14, 2015.
• On July 15, 2015, CMMS announced an extension of the Medicare Prior Authorization for Power Mobility Devices (PMDs) demonstration, which is now scheduled end on August 31, 2018. More information on the announcement may be found here.
• On July 16, 2015, the Centers for Disease Control and Prevention (CDC) issued a notice of proposed rulemaking and request for comments entitled “Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins”. CDC is proposing to add certain influenza virus strains to the list of Department of Health and Human Services (HHS) select agents and toxins. Specifically, CDC is proposing to add the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses, as a non-Tier 1 select agent. We are also proposing to add any influenza viruses that contain the HA from the A/Gs/Gd/ 1/96 lineage that were made transmissible among mammals by respiratory droplets in a laboratory as a Tier 1 select agent. CDC has determined that these influenza viruses have the potential to pose a severe threat to public health and safety. Comments should be received on or before September 14, 2015.
• On July 16, 2015, the Department of Veterans Affairs (VA) published interpretive guidance entitled “Agency Interpretation of Prosthetic Replacement of a Joint”. VA is publishing interpretive guidance for diagnostic codes (DC) 5051 through 5056, which establish rating criteria for prosthetic implant replacements of joints of the musculoskeletal system. The Schedule for Rating Disabilities under these DCs allows for a 1-year, 100-percent disability evaluation upon prosthetic replacement of a joint. This final rule clarifies that VA’s longstanding interpretation of DCs 5051 through 5056 is that a 100-percent evaluation will be in place for a period of one year when the total joint, rather than the partial joint, has been replaced by a prosthetic implant. This final rule is effective July 16, 2015.
• On July 17, 2015, FDA released an information collection activity, entitled “Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act”, for public comment. Comments are due September 15, 2015.
• On July 17, 2015, FDA announced the availability of a draft guidance for industry entitled “Testicular Toxicity: Evaluation During Drug Development; Draft Guidance for Industry”. The draft guidance addresses nonclinical findings that may raise concerns of a drug-related adverse effect on the testes, clinical monitoring of adverse testicular effects early in clinical development, and the design and conduct of a safety clinical trial assessing drug-related testicular toxicity. The draft guidance is intended to assist sponsors developing drugs to identify nonclinical signals of testicular toxicity and to evaluate the potential for such toxicity in humans. Comments are due October 15, 2015.
• On July 17, 2015, HHS released an interim final rule entitled “Health Resources Priority and Allocations System (HRPAS)”. This interim final rule establishes standards and procedures by which HHS may require that certain contracts or orders that promote the national defense be given priority over other contracts or orders. This rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense. This rule will implement HHS’s administration of priorities and allocations actions, and establish the Health Resources Priorities and Allocation System (HRPAS). The HRPAS will cover health resources pursuant to the authority under Section 101(c) of the Defense Production Act as delegated to HHS by Executive Order 13603. Priorities authorities (and other authorities delegated to the Secretary in E.O. 13603, but not covered by this regulation) may be re-delegated by the Secretary. The Secretary retains the authority for allocations. Effective July 17, 2015. Comments must be received by September 15, 2015.
• On July 17, 2015, FDA issued a notice entitled “Market Claims in Direct-to-Consumer Prescription Drug Print Ads”. The Office of Prescription Drug Promotion plans to investigate, through empirical research, the impact of market claims on prescription drug product perceptions with and without quantitative information about product efficacy. This will be investigated in direct-to-consumer (DTC) print advertising for prescription drugs. Comments are due within 60 days.
• On July 17, 2015, FDA announced the availability of a revised draft guidance for industry on lubiprostone capsules entitled "Bioequivalence Recommendations for Lubiprostone." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules.

Event Notices

• September 22, 2015: FDA is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Huntington’s disease and Parkinson’s disease. Patient-Focused Drug Development is part of FDA’s performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of Huntington’s disease and Parkinson’s disease on daily life and patient views on treatment approaches. Although these are both neurological diseases, since they are quite distinct, FDA will structure this public meeting into two distinct sessions. The morning session, scheduled from 9 a.m. to 1 p.m., will be devoted to hearing patient perspectives on the impact of Huntington’s disease on daily life and their views on currently available treatment approaches. The afternoon session, scheduled from 1 p.m. to 5 p.m., will be devoted to obtaining patient perspectives on the impact of Parkinson’s disease on daily life and patient views on currently available treatment approaches. The meetings will take place at FDA’s White Oak Campus in Silver Spring, Maryland. More information may be found here.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On July 16, 2015, the Senate Finance Committee convened a hearing entitled “Reviewing HealthCare.gov Controls”. The sole witness for the hearing was Seto J. Bagdoyan, Director, Audit Services, Forensic and Investigative Service, United States Government Accountability Office (GAO). During the hearing members discussed the results of a recently-released GAO report entitled “Patient Protection and Affordable Care Act [ACA]: Observations on 18 Undercover Tests of Enrollment Controls for Health-Care Coverage and Consumer Subsidies Provided under the Act”. [See next section for more information]. During the hearing Chairman Orrin Hatch (R-UT) expressed concern with the results of the GAO study, stating that the federal Exchange appears to have “failed spectacularly” in a display of “mind-boggling incompetence”. He criticized the Administration for failing to address fraud and integrity concerns associated with the federal Marketplace. Hatch also suggested that HHS has focused its resources on bolstering Marketplace enrollment, often at the expense of program integrity. Ranking Member Ron Wyden (D-OR) argued that is important to recall that the GAO report under discussion does not demonstrate any real-world fraud taking place. More information on the hearing may be found here.
• On July 15, 2015, the Senate Special Aging Committee convened a hearing entitled “Diabetes Research: Improving Lives on the Path to a Cure”. Witnesses for the hearing included Habib Zaghouani, PhD, J. Lavenia Edwards Chair In Pediatrics, Department Of Molecular Microbiology And Immunology, Neurology And Child Health, University of Missouri School of Medicine; Griffin Rodgers, MD, Director Of The National Institute Of Diabetes And Digestive And Kidney Disease (NIDKK) at the National Institutes of Health (NIH); Bob Amato, Former Runner And Coach, Member Of Athletic Hall Of Fame At Providence College; Kate Hall, Recent High-School Graduate And Track And Field Athlete; Amelia Cooper, Age 15, Diagnosed With Type 1 Diabetes At The Age 12; Isabelle Levesque, Age 10, Diagnosed With Type 1 Diabetes At Age 2. During the hearing Amato, Cooper, Levesque, and Hall discussed their experiences living with diabetes, and the importance of continuous glucose monitoring technology in managing their condition. During the hearing Chairwoman Susan Collins (R-ME) discussed the significant costs associated with treating diabetes, and the financial toll the disease takes on individuals, the health system, and the Medicare program. She said she is concerned that Medicare beneficiaries are being denied coverage for CGM, and discussed legislation she has introduced with Senator Jeanne Shaheen (D-NH) which would mandate Medicare coverage for CGM (the Medicare CGM Access Act of 2015, S. 804). More information on the hearing may be found here.
• On July 14, 2015, the Senate Committee on Commerce, Science, and Transportation Subcommittee on Space, Science, and Competitiveness convened a hearing entitled “Unlocking the Cures for America’s Most Deadly Diseases”. Witnesses for the hearing included Dr. Tom Coburn, Former United States Senator (R-OK); Mr. Christopher Frangione, Vice President, Prize Development, XPRIZE; Mr. Peter Huber, Senior Fellow, Manhattan Institute; and Dr. Keith Yamamoto, Vice Chancellor for Research, University of California, San Francisco. More information may be found here.

House of Representatives

• On July 14, 2015, the House Energy & Commerce Subcommittee on Oversight and Investigations convened a hearing entitled “Medicare Part D: Measures Needed to Strengthen Program Integrity”. Witnesses for the hearing included Ann Maxwell, Assistant Inspector General, Evaluation and Inspections, Office of Inspector General (OIG), U.S. Department of Health and Human Services (HHS); and Shantanu Agrawal, M.D., Deputy Administrator and Director, CMS Center for Program Integrity. During the hearing Subcommittee Chairman Tim Murphy (R-PA) expressed concern that CMS has failed to adopt a number of OIG recommendations to strengthen Part D program integrity over the last several years. He claimed that CMS’s failure to implement these recommendations has led to trends of questionable billing associated with pharmacies, prescribers, and beneficiaries. “Now it is incumbent upon CMS to take action and actually prevent fraud and abuse before it reaches a level that requires a nationwide takedown,” Murphy said. “The Committee is concerned that it continues to hold hearings like this one today where we see steps not taken and tools not utilized to protect the integrity of these programs as well as our taxpayers’ dollars.” OIG’s Ann Maxwell discussed the results of two OIG reports, entitled Ensuring the Integrity of Medicare Part D (OEI-03-15-00180), and Questionable Billing and Geographic Hotspots Point to Potential Fraud and Abuse in Medicare Part D[1] (OEI-02-15-00190). More information may be found here.
• On July 14, 2015, the House Veterans’ Affairs Health Subcommittee convened a hearing to review veterans’ health legislation. Bills under consideration included:
  • HR 272 — Medal of Honor Priority Care Act
  • HR 353 — Veterans' Access to Hearing Health Act
  • HR 359 — Veterans Dog Training Therapy Act
  • HR 421 — Classified Veterans Access to Care Act
  • HR 423 — Newborn Care Improvement Act
  • HR 1356 — Women Veterans Access to Quality Care Act
  • HR 1688 — A bill to amend the Veterans Access, Choice, and Accountability Act of 2014 to designate 20 graduate medical education residency positions specifically for the study of optometry.
  • HR 1862 — Veterans' Credit Protection Act
  • HR 2464 — A bill to amend title 38, United States Code, to improve the accountability of the Secretary of Veterans Affairs to the Inspector General of the Department of Veterans Affairs.
  • HR 2914 — Build a Better VA Act
  • HR 2915 — Female Veteran Suicide Prevention Act
  • Draft Bill — Draft Bill on VA medical facility construction
  • HR 3016 — A bill to amend title 38, United States Code, to clarify the role of podiatrists in the Department of Veterans Affairs.
    
    More information on the hearing may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On July 16, 2015, GAO released a report entitled “Patient Protection and Affordable Care Act: Observations on 18 Undercover Tests of Enrollment Controls for Health-Care Coverage and Consumer Subsidies Provided under the Act”. To assess the enrollment controls of the federal Health Insurance Marketplace (Marketplace), GAO performed 18 undercover tests, 12 of which focused on phone or online applications. During these tests, the Marketplace approved subsidized coverage under the Affordable Care Act (ACA) for 11 of the 12 fictitious GAO applicants for 2014. The GAO applicants obtained a total of about $30,000 in annual advance premium tax credits, plus eligibility for lower costs due at time of service. For 7 of the 11 successful fictitious applicants, GAO intentionally did not submit all required verification documentation to the Marketplace, but the Marketplace did not cancel subsidized coverage for these applicants. Other observations included:
  • The Marketplace did not accurately record all inconsistencies.
  • Under PPACA, filing a federal income-tax return is a key control element, designed to ensure that premium subsidies granted at time of application are appropriate based on reported applicant earnings during the coverage year. GAO, however, found errors in information reported by the Marketplace for tax filing purposes for 3 of its 11 fictitious enrollees, such as incorrect coverage periods and subsidy amounts.
  • The Marketplace automatically reenrolled coverage for all 11 fictitious enrollees for 2015.
    
    For an additional six applicants, GAO sought to test the extent to which, if any, in-person assisters would encourage applicants to misstate income in order to qualify for income-based subsidies during coverage year 2014. However, GAO was unable to obtain in-person assistance in 5 of the 6 undercover attempts.
• On July 17, 2015, the Medicare Payment Advisory Commission (MedPAC) published the June 2015 edition of MedPAC’s Data Book, entitled “Health Care Spending and the Medicare Program”. The MedPAC Data Book provides information on national health care and Medicare spending as well as Medicare beneficiary demographics, dual-eligible beneficiaries, quality of care in the Medicare program, and Medicare beneficiary and other payer liability. It also examines provider settings—such as hospitals and post-acute care—and presents data on Medicare spending, beneficiaries’ access to care in the setting (measured by the number of beneficiaries using the service, number of providers, volume of services, length of stay, or through direct surveys), and the sector’s Medicare profit margins, if applicable. In addition, it covers the Medicare Advantage program and prescription drug coverage for Medicare beneficiaries, including Part D.
• On July 15, 20015, the HHS Office of Inspector General (OIG) released a report entitled “The Fraud Prevention System Increased Recovery and Prevention of Improper Medicare Payments, But Updated Procedures Would Improve Reported Savings”. OIG found that in the third implementation year of the FPS in calendar year (CY) 2014, the Department complied with the requirements of the Small Jobs Act of 2010 (the Act) for reporting actual and projected savings in the Medicare Fee-for-Service program and the return on investment from the use of predictive analytics technologies. In addition, in CY 2014, the Department’s use of the FPS generated a positive return on investment, and the Department continues to provide oversight, management, and control of selecting and developing new models, enhancing existing models, and implementing system changes to improve the FPS. To help identify and better report FPS savings, OIG recommended that the Department provide its contractors with improved written instructions on how to attribute the FPS savings accurately and better document the contribution of the FPS leads toward achieving administrative actions.
• On July 15, 2015, Avalere released a new analysis which finds that the average provider networks for plans offered on the health insurance exchanges created by the ACA include 34 percent fewer providers than the average commercial plan offered outside the exchange. The new data quantifies anecdotal reports that exchange networks contain fewer providers than traditional commercial plans. “Plans continue to test new benefit designs in the exchange market,” said Dan Mendelson, CEO at Avalere. “Given the new requirements put in place by the ACA, network design is one way plans can drive value-based care and keep premiums low.”

IV. OTHER HEALTH POLICY NEWS

• On July 16, 2015, Alaska Governor Bill Walker (I) issued a letter to the Legislative Budget and Audit Committee giving members notice of his intention to accept additional federal and Mental Health Trust Fund Authority funds to expand Medicaid in Alaska. A Department of Health and Social Services press release may be found here. “The Department…stands ready to implement Medicaid expansion,” it reads. “DHSS staff have been working diligently to prepare for Medicaid expansion,” Health and Social Services Commissioner Valerie Davidson said. “The new Medicaid claims payment system that had a rocky start two years ago is now working, and the new eligibility and enrollment system is being modified to automate and streamline the process for review and approval of applications.” Nearly 42,000 Alaskans will be eligible for expansion. Approximately 21,000 Alaskans are expected to enroll in the first year.
• On July 15, 2015, America’s Health Insurance Plans’(AHIP) Board of Directors unanimously elected former CMS Administrator Marilyn Tavenner as AHIP President and CEO. A statement from AHIP Board Chair Mark Ganz on her appointment may be found here.