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

I. REGULATIONS, NOTICES, & GUIDANCE

• On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph: Fixed-Combination and Co-Packaged Drugs.” FDA is reopening the comment period for the proposed rule. The proposed rule would revise FDA’s regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. Public comments are due May 15, 2016.
• On April 15, 2016, FDA issued a draft guidance entitled, “Draft Guidance for Industry: Facility Definition under the Federal Food, Drug, and Cosmetic Act.” Pharmacies located within a hospital or standalone pharmacies that are part of a health system frequently provide compounded drug products for administration within the hospital or health system. This guidance describes how FDA intends to apply the Federal Food, Drug, and Cosmetic Act to drugs compounded by licensed pharmacists or physicians in state-licensed hospital or health system pharmacies. Public comments are due July 15, 2016.
• On April 15, 2016, FDA issued a guidance entitled, “Prescription Requirement the Federal Food, Drug, and Cosmetic Act.” This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use. Public comments are due May 15, 2016.
• On April 11, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an informational bulletin entitled, “State Medicaid Payment Approaches to Improve Access to Long-Acting Reversible Contraception.” This informational bulletin describes emerging payment approaches several state Medicaid agencies have used to optimize access and use of long-acting reversible contraception (LARC).
• On April 11, 2016, CMS issued an informational collection request (ICR) entitled, “Medicaid Drug Use Review (DUR) Program; Medicaid Statistical Information System (MSIS) and Transformed – Medicaid Statistical Information System (T-MSIS).” States must provide for a review of drug therapy before each prescription is filled or delivered to a Medicaid patient. This review includes screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Pharmacists must make a reasonable effort to obtain, record, and maintain Medicaid patient profiles. Public comments are due May 11, 2016.
• On April 14, 2016, FDA issued a notice entitled, “Pharmaceutical Distribution Supply Chain Pilot Projects.” FDA is seeking information regarding issues related to utilizing the product identifier for product tracking, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from public comments will assist with the design and development of the pilot projects that FDA establishes under the DSCSA.
• On April 11, 2016, FDA issued an ICR entitled, “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens.” FDA's investigational device regulations are intended to encourage the development of new, useful devices in a manner that is consistent with public health, safety, and compliant with ethical standards. Investigators should have freedom to pursue the least burdensome means of accomplishing this goal. However, to ensure that the balance is maintained between product development and the protection of public health, safety, and ethical standards, FDA has established human subject protection regulations addressing requirements for informed consent and institutional review board (IRB) review that apply to all FDA-regulated clinical investigations involving human subjects. Public comments are due May 12, 2016.
• On April 11, 2016, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, “Emergency Funding for Puerto Rico Department of Health, Zika virus Outbreak.” CDC is providing $3.7 million in urgent funding through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement to the Puerto Rico Department of Health (PRDOH) to combat the current outbreak of Zika virus.
• On April 11, 2016, the Internal Revenue Services (IRS) issued a data table entitled, “26 CFR 601.105: Examination of returns and claims for refund, credit, or abatement; determination of correct tax liability. (Also §§ 36B, 5000A; 1.36B-2T, 1.36B-3, 1.5000A-3.)” This revenue procedure provides indexing adjustments for certain provisions under sections 36B and 5000A of the Internal Revenue Code. In particular, it updates the Applicable Percentage Table in §36B (b)(3)(A)(i) to provide the Applicable Percentage Table for 2017. This table is used to calculate an individual’s premium tax credit. This revenue procedure also updates the required contribution percentage in § 36B(c)(2)(C)(i)(II) for plan years beginning after calendar year 2016.
• On April 11, 2016, FDA issued a guidance entitled, “Guidance: Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry.” The recommendations in this guidance apply broadly to the development of drug and biologic products. Accordingly, this guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides a set of principles for using a systems approach to minimize medication errors relating to product design and container closure design and thus enhance patient safety. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drugs and biologic products regulated by the Center for Drug Evaluation and Research (CDER), which are referred to collectively in this guidance as products. The guidance also provides examples of product designs that have resulted in postmarketing medication errors.
• On April 12, 2016, the Agency for Healthcare Research and Quality (AHRQ) issued an ICR entitled, “AHRQ ACTION III – Measurement for Performance Improvement in Physician Practices.” This two-year project is a first step towards fully understanding measurement for performance improvement in medical groups. This research will look at the current landscape to better understand how medical groups are using measurement internally to improve performance and what that means to them, and how internal measurement relates to external measurement obligations and identifying where the gaps are. Public comments are due by June 12, 2016.
• On April 14, 2016, FDA issued an ICR entitled, “Center for Devices and Radiological Health Appeals Processes.” The guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes” describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH) employees. FDA is seeking approval for the new reporting burden associated with requests for additional review of decisions and actions by CDRH employees as described in the guidance. Public comments are due by May 14, 2016.
• On April 14, 2016, FDA issued a draft guidance entitled, “Guidance for Industry: Data Integrity and Compliance With Current Good Manufacturing Practice.” The purpose of the draft guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The draft guidance is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements. Public comments are due by May 14, 2016.
• On April 14, 2016, CMS issued an ICR entitled, “Prepaid Health Plan Cost Report; Social Security Office (SSO) Report of State Buy-in Problem.” The purpose of the state buy-in’ program is to assure that Medicaid is the payer of last resort by permitting a state to provide Medicare protection to certain groups of needy individuals, as part of the state’s total assistance plan. State buy-in also has the effect of transferring some medical costs for this population from the Medicaid program, which is partially state funded to the Medicare program, which is funded by the federal government and individual premiums. The CMS- 1957, “SSO Report of State Buy-In Problem” is used to report buy-in problems cases. Public comments are due May 14, 2016.
• On April 14, 2016, the Health Resources and Services Administration (HRSA) issued a request for nominations entitled, “Requests for Nominations: Advisory Committee on Heritable Disorders in Newborns and Children.” HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children. The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of Health and Human Services. HRSA is seeking nominations of qualified candidates to fill three positions on the Committee. Nominations are due May 14, 2016.
• On April 12, 2016, CMS issued a summary of changes entitled, “Notice of New Interest Rate for Medicare Overpayments and Underpayments - 3rd 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. The Medicare contractors shall implement an interest rate of 10 percent effective April 19, 2016 for Medicare overpayments and underpayments.
• On April 15, 2016, AHRQ issued a notice entitled, “Making It Easier for Patients to Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures.” This proposed information collection was previously published in the Federal Register on February 10, 2016 and allowed 60 days for public comment. AHRQ received no substantive comments of the public. The purpose of this notice is to allow an additional 30 days for public comment. Public comments are due May 10, 2016.
• On April 15, 2016, FDA issued a final order entitled, “Cardiovascular Devices: External Pacemaker Pulse Generator Devices; Pacing System Analyzers; Reclassifications.” The final order reclassifies external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently post-amendments class III devices, into that new classification regulation.

Event Notices

• May 3, 2016, the Department of Health and Human Services (HHS) Presidential Commission for the Study of Bioethical Issues will conduct a meeting to reflect on the past, present, and future impact of national bioethics advisory bodies. Topics will include the history of national bioethics advisory bodies and their contributions to health policy, perspectives about similar bodies elsewhere, and discussion about what the future holds for groups like the Commission.
• May 3&4, 2016, the National Institutes of Health (NIH) will hold a meeting with the National Advisory Council on Drug Abuse. The May 4th portion of the meeting will be open to the public for announcements and reports of administrative, legislative, and program developments in the drug abuse field.
• May 6, 2016, FDA will convene a regional public meeting entitled "U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)." The meeting will take place on the FDA campus and also be broadcast on the Internet. The goal of this meeting is to provide information and receive comments on the ICH, as well as information related to the upcoming ICH meetings in Lisbon, Portugal, in June 2016.
• May 6, 2016, HHS will hold an informal Stakeholder Listening Session in preparation for the 69th World Health Assembly. The Stakeholder Listening Session will help the HHS Office of Global Affairs prepare the U.S. delegation for the World Health Assembly by taking full advantage of the knowledge, ideas, feedback, and suggestions from all communities interested in and affected by agenda items to be discussed at the 69th World Health Assembly.
• May 9, 2016, the Department of Veterans Affairs (VA) Subcommittees of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board will convene a meeting entitled, “Research Career Scientists & Promotions.”
• June 2&3, 2016, FDA will convene an advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
• June 9, 2016, FDA will convene a meeting with the Antimicrobial Drugs Advisory Committee. The Committee will provide advice and recommendations to the Agency on FDA’s regulatory issues.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On April 14, 2016, the Senate Homeland Security and Governmental Affairs Committee convened a hearing entitled, “The Federal Perspective on the State of Our Nation's Biodefense.” The witnesses included Richard J. Hatchett, M.D. Acting Director, Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services; Stephen C. Redd, M.D., Director, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention; Kevin Shea, Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture; Aaron M. Firoved, Ph.D., Director, National Biosurveillance Integration Center, Office of Health Affairs, U.S. Department of Homeland Security; and Christopher P. Currie, Director, Homeland Security and Justice, U.S. Government Accountability Office.

House of Representatives

• On April 14, 2016, the House Ways and Means Committee convened a hearing entitled, “Tax Treatment of Health Care.” The hearing examined how the tax code affects our health care system. Members also discussed ways to lower health care costs, improve choice and access, and ensure the tax code treats all Americans fairly. The witnesses included Joseph Antos, Scholar, American Enterprise Institute (AEI); Avik Roy, Senior Fellow, the Manhattan Institute; and Steven Kreisberg, Director of Research, American Federation of State, County & Municipal Employees (AFSCME).
• On April 14, 2016, the House Education and the Workforce Subcommittee on Health, Employment, Labor and Pensions convened a hearing entitled, “Innovations in Health Care: Exploring Free-Market Solutions for a Healthy Workforce.” The witnesses included Ms. Sabrina Corlette, J.D, Senior Research Professor, Center on Health Insurance Reforms, Georgetown University’s Health Policy Institute; Ms. Tresia Franklin, Director, Total Rewards and Employee Relations, Hallmark Cards, Inc.; Ms. Amy McDonough, Vice President and General Manager of Corporate Wellness, Fitbit; and Mr. John Zern, Executive Vice President and Global Health Leader, Aon.
• On April 15, 2016, the House Energy and Commerce Subcommittee on Oversight and Investigations convened a hearing entitled, “Unlawful Reinsurance Payments: CMS Diverting $3.5 Billion from Taxpayers to Pay Insurance Companies.” The sole witness was Andy Slavitt, Acting Administrator of CMS.
• On April 14, 2016, Congressman Jim Renacci (R-OH) and Congressman Bill Pascrell (D-NJ) sent a letter to Acting Administrator of CMS, Andy Slavitt. They expressed concerns with the hospital star rating system that CMS plans to publicly release in April 2016. “While we strongly support public reporting of provider quality data, we urge you to ensure that this data adequately accounts for hospital patient mixes that include higher proportions of patients with multiple complex chronic health conditions and lower socioeconomic status. We also request that you provide hospitals with more details on the methodology used to determine their star ratings,” the letter stated.
• On April 14, 2016, the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies approved by voice vote for full committee action a bill that would increase funding for the FDA in fiscal year 2017. The bill would give the FDA $2.7 billion in discretionary funding, an increase of $33 million over the FY 2016 enacted level. Total funding for the FDA, including revenue from industry-paid user fees, would be $4.78 billion, which would be $97.4 million above FY 2016. The bill now goes to the full Appropriations Committee, which will mark up the bill on April 19, 2016.

III. REPORTS, STUDIES, & ANALYSES

• On April 12, 2016, the Office of the Inspector General (OIG) released a report entitled, “April 2016 Compendium of Unimplemented Recommendations.” The 2016 edition of OIG's Compendium of Unimplemented Recommendations focuses on the top 25 unimplemented recommendations that, on the basis of OIG's professional opinion, would most positively impact HHS programs in terms of cost savings and/or quality improvements and should, therefore, be prioritized for implementation. The April 2016 edition includes unimplemented recommendations on Medicare, Medicaid, ACA Marketplaces, and Health Information Technology.
• On April 12, 2016, HHS released a report entitled, “Marketplace Premiums After Shopping, Switching, and Premium Tax Credits, 2015-2016.” Health insurance rate information becomes available each spring as issuers file proposed rates with federal and state regulators. Rates then undergo review before being finalized in the fall, prior to the annual Health Insurance Marketplace Open Enrollment Period. The report notes that neither the proposed nor final rates offered by any individual issuer provide a reliable basis for predicting what typical Marketplace consumers will pay in the following year. HHS says that consumers’ actual health insurance premiums will be lower because public rate review can bring down proposed increases, shopping gives all consumers a chance to find the best deal, and tax credits reduce the cost of coverage for the vast majority of Marketplace consumers. Among the roughly 85 percent of HealthCare.gov consumers with premium tax credits, the average monthly net premium increased just $4, or 4%, from 2015 to 2016.
• On April 13, 2016, the Government Accountability Office (GAO) released a report entitled, “Medicare: Opportunities Exist to Recover Potential Overpayments to Providers with Criminal Backgrounds.” GAO found that there are opportunities for CMS to recover about $1.3 million in potential overpayments to 16 out of 66 potentially ineligible providers with criminal backgrounds who were enrolled in Medicare before CMS implemented more extensive background-check processes in April 2014. As a result, GAO found that CMS missed an opportunity to revoke these ineligible providers sooner. Instead, GAO said that CMS officials used other information that it identified, such as reported dates of medical-license suspensions, OIG exclusion dates, and deactivation dates--which were subsequent to the original felony conviction/offense date--to determine the date to remove the providers from Medicare.
• On April 14, 2016, OIG released a report entitled, “The Medicaid Program Could Have Achieved Savings if Oregon Had Applied Medical Loss Ratio (MLR) Standards Similar to Those Established by the Affordable Care Act.” The objective of this review was to determine potential Medicaid program savings if the Oregon Health Authority, Division of Medical Assistance Programs (State agency), had required its Medicaid coordinated-care organization (CCO) plans to meet MLR standards for its non-expansion population similar to those standards established by the ACA. OIG recommended that the State agency incorporate MLR standards into its contracts with Medicaid CCO plans for its non-expansion population.
• On April 14, 2016, the IMS Institute released a report entitled, “Medicine Use and Spending in the U.S.: Review of 2015 and Outlook to 2020.” While net growth slowed as pharmaceutical companies offered more rebates and patient assistance programs to help cover the costs, spending will continue to rise at a steady mid-single-digit rate through 2020, when it's expected to hit $610 million to $640 million, according to the report.

IV. OTHER HEALTH POLICY NEWS

• On April 11, 2016, CMS announced a multi-payer initiative to improve primary care. The Comprehensive Primary Care Plus (CPC+) model will be implemented in up to 20 regions and can accommodate up to 5,000 practices, which would encompass more than 20,000 doctors and clinicians and the 25 million people they serve. The initiative is designed to provide doctors the freedom to care for their patients the way they think will deliver the best outcomes and to pay them for achieving results and improving care. “Strengthening primary care is critical to an effective health care system,” said Dr. Patrick Conway, CMS deputy administrator and chief medical officer. “By supporting primary care doctors and clinicians to spend time with patients, serve patients’ needs outside of the office visit, and better coordinate care with specialists we can continue to build a health care system that results in healthier people and smarter spending of our health care dollars. The Comprehensive Primary Care Plus model represents the future of health care that we’re striving towards.”