A&B Healthcare Week in Review, July 15, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On July 15, 2016, the Food and Drug Administration (FDA) issued a notice entitled, “Prescription Drug User Fee Act; Public Meeting; Request for Comments.” The notice announces a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. As stated in the notice, the current legislative authority for PDUFA expires in September 2017. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary. The public meeting will be held on August 15, 2016, from 9 a.m. ET to 2 p.m. ET. Participants must register for the meeting by August 8, 2016, at http://pdufareauthorization.eventbrite.com. Electronic or written comments must be submitted to the public docket by August 22, 2016.
• On July 14, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, “Provider Cost Report Reimbursement Questionnaire; Medicare Participation Agreement for Physicians and Suppliers.” Section 1842(h) of the Social Security Act permits physicians and suppliers to voluntarily participate in Medicare Part B by agreeing to take assignment on all claims for services to Medicare beneficiaries. The law also requires that the Secretary provide specific benefits to the physicians, suppliers and other persons who choose to participate. Public comments are due by September 13, 2016.
• On July 14, 2016, CMS issued both State and Manufacturer Releases entitled, “Value Based Purchasing, VBP, VBP Arrangements, Medicaid Best Price, Best Price, VBP and Supplemental Rebates, Supplemental Rebates and Managed Care.” The notices inform states and manufacturers on how to seek guidance from CMS on their specific value based purchasing (VBP) arrangement, as well as encourage states to consider entering into VBP arrangements as a means to address, as well as offset, Medicaid’s high cost drug treatments. This guidance also reminds states that they may extend their Medicaid supplemental rebate agreement to some or all of their managed care prescription claims.
• On July 11, 2016, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: “Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S. Hospitals.” Preventing healthcare-associated infections (HAIs) and reducing the emergence and spread of antimicrobial resistance are priorities for the CDC and the Department of Health and Human Services (HHS). Improving antimicrobial drug prescribing in the United States is a critical component of strategies to reduce antimicrobial resistance, and is a key component of the President’s National Strategy for Combating Antibiotic Resistant Bacteria (CARB). Public comments are due by September 12, 2016.
• On July 11, 2016, CMS issued a notice entitled, “Notice of Research Exception under the Genetic Information Nondiscrimination Act; Consumer Experience Survey Data Collection.” Under the Genetic Information Nondiscrimination Act of 2008 (GINA), a plan or issuer may request a genetic test in connection with certain research activities so long as such activities comply with specific requirements, including: (i) the research complies with federal regulations and applicable State or local law or regulations for the protection of human subjects in research; (ii) the request for the participant or beneficiary is made in writing and clearly indicates that compliance with the request is voluntary and that non-compliance will have no effect on eligibility for benefits or premium or contribution amounts; and (iii) no genetic information collected or acquired will be used for underwriting purposes. Public comments are due August 12, 2016.
• On July 11, 2016, National Institutes of Health (NIH) issued a notice entitled, “Palliative Care: Conversations Matter® Phase Two Evaluation.” The Palliative Care: Conversations Matter® initiative, which launched in FY 2014, is now in its second phase. The first phase was focused on providing materials and tools to assist health care providers in having sometimes difficult conversations with children and families about palliative care. The second phase of the campaign, launched in FY 2015, focuses on children, parents, and families. Public comments are due by September 12, 2016.
• On July 8, 2016, the Center for Consumer Information and Insurance Oversight (CCIIO) issued Frequently Asked Questions (FAQs) entitled, “FAQs on the Summary of Benefit and Coverage (SBC) Applicability Date.” The document addresses the applicability date of the SBC template and associated documents that were published on April 6, 2016. For plans and issuers that do not use an annual open enrollment period, this SBC template and associated documents is required beginning on the first day of the first plan year (or, in the individual market, policy year) that begins on or after April 1, 2017.
• On July 12, 2016, HHS issued a notice of proposed rulemaking (NPRM) entitled, “Health and Human Services Grants Regulation.” This NPRM proposes changes to HHS’ adoption of the Office of Management and Budget’s (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (“Uniform Administrative Requirements”) published on December 19, 2014 and the technical amendments published by HHS on January 20, 2016. Public comments are due by August 13, 2016.
• On July 15, 2016, the Department of Veterans Affairs (VA) issued a final rule entitled, “Prescriptions in Alaska and U.S. Territories and Possessions.” The VA is removing its medical regulation that governs medications provided in Alaska and territories and possessions of the United States because this regulation is otherwise subsumed by another VA medical regulation related to provision of medications that are prescribed by non-VA providers.
• On July 14, 2016, OMB received a final rule for review entitled, “Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2017 Rates.” According to OMB, this annual final rule revises the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This rule implements changes arising from the continuing experience with these systems.
• On July 12, 2016, the Health Resources and Services Administration (HRSA) issued a chart entitled, “Program Integrity: FY16 Audit Results.” HRSA recommends manufacturers do not contact audited entities regarding sanctions until a corrective action plan has been approved by HRSA and posted on this website.
• On July 12, 2016, CMS issued a transmittal entitled, “Notice of New Interest Rate for Medicare Overpayments and Underpayments -4th Qtr Notification for FY 2016.” Medicare Regulation 42 CFR Section 405.378 provides for the charging and payment of interest on overpayments and underpayments to Medicare providers. The Secretary of Treasury certifies an interest rate quarterly. Treasury utilizes the most comprehensive data available on consumer interest rates to determine the certified rate. Interest is assessed on delinquent debts in order to protect the Medicare Trust Funds.
• On July 14, 2016, CMS issued a notice entitled, “Medicare Program: Requirements and Registration for the MIPS Mobile Challenge; Deadline Extension.” This notice launches a challenge related to the new Merit-based Incentive Payment System (MIPS) program, which will assist CMS in accelerating the transition from the traditional fee-for-service payment model to a system that rewards health care providers for providing better care, not just more care. This challenge will address one of the most important aspects of the programs, which is educating and providing outreach to the potential hundreds of thousands of MIPS eligible clinicians.
• On July 14, 2016, FDA issued a draft guidance entitled, “Draft Guidance for Industry and Food and Drug Administration Staff: Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.” This draft guidance is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product with an accompanying IVD companion diagnostic, a process referred to as codevelopment. This draft guidance is also intended to assist FDA staff participating in the review of such IVD companion diagnostics or their associated therapeutic products. Public comments are due October 15, 2016.
• On July 14, 2016, NIH issued a notice entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: The Study of the Global Cancer Project Map.” This is a new information collection request for the Study of the Global Cancer Project Map (GCPM) for three years. Information will be collected from health care professionals and researchers in an effort to catalog international efforts related to cancer research, care, and outreach by integrating cancer control program and research project information from various organizations worldwide. Public comments are due on September 15, 2016.
• On July 14, 2016, HRSA issued a notice entitled, “Requests for Nominations: Council on Graduate Medical Education.” HRSA is requesting nominations to fill vacancies on the Council on Graduate Medical Education (COGME). The agency will receive nominations on a continuous basis.
• On July 15, 2016, NIH issued a notice entitled, “Request for Data and Information on Technologies Used to Identify Substances with the Potential to Cause Acute Systemic Toxicity.” NIH requests data and information on approaches and/or technologies currently used to identify substances with the potential to cause acute systemic toxicity when swallowed, inhaled, or absorbed through the skin. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce acute systemic toxicity. Public comments are due September 2, 2016.
• On July 15, 2016, FDA issued a notice entitled, “Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Act (CLIA) of 1988 Waiver Applications.” Congress passed the CLIA in 1988 to establish quality standards for all laboratory testing. The purpose was to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test took place. CLIA requires that clinical laboratories obtain a certificate from the Secretary of HHS, before accepting materials derived from the human body for laboratory tests. Public comments are due by August 18, 2016.

Event Notices

• July 20, 2016, CMS will host a third Special Open Door Forum (ODF) call to allow home health agencies, physicians, and other interested parties to learn about the Pre-Claim Review Demonstration for Home Health Services. Two of CMS’ Medicare Administrative Contractors (MACs), Palmetto GBA and CGS, will be available for questions. Palmetto GBA will present on their activities to ready for the demonstration launch in Illinois, and provide an overview of their Web portal submission tool.
• July 25, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced a teleconference meeting with the Center for Substance Abuse Prevention (CSAP) National Advisory Council.
• July 29, 2016, HHS announced a public teleconference with the National Preparedness and Response Science Board (NPRSB).
• August 8, 9, &10, 2016, CDC announced a closed meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP).
• August 9 &10, 2016, CDC announced a public meeting with the National Institute for Occupational Safety and Health (NIOSH), Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board).
• August 24, 2016, SAMHSA announced open and closed sessions with the Center for Mental Health Services (CMHS) National Advisory Council (NAC).
• August 30 &31, 2016, CDC announced a closed meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP).
• October 27 &28, 2016, FDA announced a public workshop entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in the prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a nongovernmental organization.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On July 12, 2016, the Senate Finance Committee convened a hearing entitled, “Examining the Stark Law: Current Issues and Opportunities.” The witnesses included Mr. Troy A. Barsky, Partner, Crowell & Moring LLP; Dr. Ronald A. Paulus, President And Chief Executive Officer, Mission Health; and Mr. Peter Mancino, Deputy General Counsel, The Johns Hopkins Health System Corporation.
• On July 13, 2016, the Senate Finance Committee convened a hearing entitled, “Medicare Access and CHIP Reauthorization Act of 2015: Ensuring Successful Implementation of Physician Payment Reforms.” The sole witness was Mr. Andrew M. Slavitt, Acting Administrator of CMS.
• On July 13, 2016, the Senate Finance Subcommittee on Health Care convened a hearing entitled, “Alzheimer’s Disease: The Struggle for Families, a Looming Crisis for Medicare.” The witnesses included Dr. Ronald C. Peterson, Chair, Advisory Council on Alzheimer’s Research, Care, and Services for the National Alzheimer’s Project Act; Dr. Henry L. Paulson, Director, University Of Michigan Alzheimer’s Disease Center; and Ms. Connie Bastek-Karasow, Caregiver.

House of Representatives

• On July 12, 2016, the House Ways and Means Committee convened a hearing entitled, “Rising Health Insurance Premiums Under the Affordable Care Act.” The witnesses included Joel White, President, Council for Affordable Health Coverage (CAHC); Christopher Condeluci, Principal, CC Law & Policy PLLC; Tom Harte, President, Landmark Benefits; Peter Lee, Executive Director, Covered California.
• On July 12, 2016, the House Energy and Commerce Subcommittee on Health convened a hearing on “Strengthening our National Trauma System," including a discussion on H.R. 4365, the "Protecting Patient Access to Emergency Medications Act of 2016"; and a discussion draft to amend the Public Health Service Act to facilitate assignment of military trauma care providers to civilian trauma centers in order to maintain military trauma readiness and to support such centers. The witnesses included Ms. Jorie Klein BSN, RN, Director, Trauma Program, Rees-Jones Trauma Center at Parkland; Dr. Craig Manifold DO, FACEP, Committee Chair, American College of Emergency Physicians; Dr. David Marcozzi MD, University of Maryland Department of Emergency Medicine; Dr. Brent Myers MD, MPH, FACEP, President-Elect, National Association of EMS Physicians; and Dr. C. William Schwab MD, FACS, Professor of Surgery, Penn Presbyterian Medical Center.
• On July 13, 2016, the House Ways and Means Committee convened a markup of several pieces of health, tax, and Social Security legislation , including: H.R. 5659, “Expanding Seniors Receiving Dialysis Choice Act of 2016.”; and H.R. 5713, “Sustaining Healthcare Integrity and Fair Treatment Act of 2016.”
• On July 13 & 14, 2016, the House Appropriations Committee held a markup of the FY 2017 Labor, Health and Human Services, and Education bill. The Committee approved the draft FY 2017 Labor-HHS-Education spending bill by a 31-19 vote.
• On July 13, 2016, the House Oversight and Government Reform Subcommittee on Health Care, Benefits and Administrative Rules convened a hearing entitled, “From Premium Increases to Failing Co-Ops: An Obamacare Checkup.” The witnesses included Mr. Kevin Counihan, Deputy Administrator and Director, Center for Consumer Information and Insurance Oversight (CCIIO), CMS; and Ms. Linda Blumberg, Senior Fellow, Urban Institute.

III. REPORTS, STUDIES, & ANALYSES

• On July 13, 2016. CMS Office of the Actuary (OACT) released a report entitled, “2015-2025 Projections of National Health Expenditures.” According to the report, total health care spending growth is expected to average 5.8 percent annually over 2015-2025. The report also projected that national health spending growth remains lower than the average over previous two decades before 2008 (nearly 8 percent).
• On July 11, 2016, the Congressional Budget Office (CBO) released a Cost Estimate of S. 2967, National Biodefense Strategy Act of 2016. CBO estimates that enacting S. 2967 would cost less than $500,000 annually and about $2 million over the 2017-2021 period. CBO also estimates that enacting S. 2967 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
• On July 12, 2016, CBO released The 2016 Long-Term Budget Outlook. According to the report, if current laws remained generally unchanged, the United States would face steadily increasing federal budget deficits and debt over the next 30 years—reaching the highest level of debt relative to GDP ever experienced in this country.
• On July 12, 2016, CBO released a Cost Estimate of S. 1622, FDA Device Accountability Act of 2016. CBO estimates that implementing S. 1622 would cost $7 million over the 2017-2021 period, subject to the availability of appropriated funds. CBO also estimates that enacting S. 1622 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
• On July 13, 2016, the Government Accountability Office (GAO) released a report entitled, “Electronic Health Records: VA's Efforts Raise Concerns about Interoperability Goals and Measures, Duplication with DOD, and Future Plans.” GAO found that even as the Department of Veterans Affairs (VA) has undertaken numerous initiatives with the Department of Defense (DOD) that were intended to advance the ability of the two departments to share electronic health records, the departments have not identified outcome-oriented goals and metrics to clearly define what they aim to achieve from their interoperability efforts. GAO has recommended that VA address challenges associated with interoperability, develop goals and metrics to determine the extent to which the modernized systems are achieving interoperability, and address shortcomings with planning. VA generally agreed with GAO's recommendations.

IV. OTHER HEALTH POLICY NEWS

• On July 11, 2016, the Journal of the American Medical Association (JAMA) released a scholarly article entitled, “United States Health Care Reform: Progress to Date and Next Steps,” which was authored by President Obama. The article examines the passage of the ACA and proposes improvements to the health care system. President Obama wrote that a “public option” should be made available in rural areas where competition is limited.
• On July 15, 2016, the Medicare Payment Advisory Commission (MedPAC) issued its June 2016 Databook. The annual document is a chart book that provides tables and graphs describing the Medicare program, Medicare beneficiaries and their utilization of health care services, and Medicare’s payment systems.
• On July 12, 2016, CMS issued a data brief entitled, “Data Brief: 2016 Median Marketplace Deductible $850, with Seven Health Services Covered Before the Deductible on Average.” According to the document, median individual deductible is $850 for Healthcare.gov Marketplace policies, and consumers’ plans have an average of seven covered services before the deductible. “This report shows that Marketplace plans are providing consumers with real financial protections and access to important health services,” said Health Insurance Marketplace CEO Kevin Counihan. “As with premiums, Marketplace deductibles and out-of-pocket costs in Marketplace plans are often lower than advertised thanks to the financial help available. And most plans cover common health services, like primary care visits and generic drugs, with no or low cost-sharing before consumers meet their deductibles.”