Healthcare Week in Review September 16, 2016

A&B Healthcare Week in Review, September 16, 2016

Healthcare Week in Review

I. Regulations, Notices, & Guidance

  • On September 16, 2016, the National Institutes of Health (NIH) issued a final rule entitled, Clinical Trials Registration and Results Information Submission. The final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric post market surveillances of a device product to ClincialTrials.gov.
  • On September 16, 2016, the NIH issued a notice entitled, NIH Policy on the Dissemination of NIH-Funded Clinical Information. The notice provides an overview of the policy, which establishes the expectation that all investigators conducting clinical trials funded in whole or in part by the NIH will ensure that these trials are registered at ClinicalTrials.gov.
  • On September 16, 2016, the Food and Drug Administration (FDA) issued a draft guidance entitled, S9 Nonclinical Evaluation for Anticancer Pharmaceuticals – Questions and Answers; International Council for Harmonisation. The draft Q&A’s guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both small molecule and biotechnology derive produced, intended to treat patients with cancer.
  • On September 16, 2016, the FDA issued a guidance entitled, Recommendations for Microbial Vectors Used for Gene Therapy. The guidance document provides investigational new drug application (IND) sponsors with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early phase clinical trials.
  • On September 16, 2016, the FDA issued a notice requesting comment entitled, International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4-Methylethcathinone and Eleven Other Substances. The FDA is requesting comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 12 drug substances. Comments are due by September 30, 2016.
  • On September 15, 2016, the FDA issued a guidance entitled, Qualification of Biomarker--Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease. The guidance provides a qualified context of use (COU) for total kidney volume (TKV), measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease (ADPKD) at high risk for a “progressive decline” in renal function. The guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program.
  • On September 14, 2016, the Office of Management and Budget (OMB) received a final rule from the Centers of Medicare & Medicaid Services (CMS) entitled, Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for-Service. The proposed rule would implement provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) related to MIPS and APMs.  Section 101 of MACRA authorizes a new MIPS, which repeals the Medicare sustainable growth rate and improves Medicare payments for physician services.  MACRA consolidates the current programs of the Physician Quality Reporting System, the Value-Based Modifier, and the Electronic Health Records Incentive Program into one program, MIPS, that streamlines and improves on the three distinct incentive programs.  Additionally, MACRA authorizes incentive payments for providers who participate in eligible APMs.

Event Notices

II. Congressional Legislation & Committee Action

U.S. Senate

  • On September 15, 2016, the Senate Homeland Security and Governmental Affairs Committee held a hearing entitled, “The State of Health Insurance Markets.” The witnesses included The Honorable Mary Taylor, Lieutenant Governor and Director, Ohio Department of Insurance (ODI); P. Wieske, Deputy Commissioner, Office of the Commissioner of Insurance State of Wisconsin (OCIW); The Honorable  Nick Gerhart, Commissioner, Iowa Insurance Division (IID); and The Honorable  Mike Kreidler, Commissioner, Office of the Insurance Commissioner State of Washington (OICW).
  • On September 14, 2016, the Senate Special Aging Committee held a hearing entitled, “Maximizing Social Security Benefits.” The witnesses included Mr. Charles Jeszeck, Director, Education, Workforce, and Income Security, U.S. Government Accountability Office; Ms. Virginia P. Reno, Deputy Commissioner For Retirement and Disability Policy, U.S. Social Security Office; Mr. William Meyer, Chief Executive Officer, Social Security Solutions, Inc.; and Ms. Sita Nataraj Slavov, Professor of Public Policy and Visiting Scholar, Schar School of Policy and Government at George Mason University and American Enterprise Institute.
  • On September 14, 2016, the Senate Veterans’ Affairs Committee held a hearing entitled, “The Future of the VA: Examining the Commission on Care Report and VA’s Response.” The witnesses included Honorable Robert A. McDonald, Secretary of Veterans Affairs, U.S. Department of Veteran Affairs; Ms. Nancy M. Schilchting, Chairperson, Commission on Care; Honorable Thomas E. Harvey, Esq.; Mr. Jeff Steele, Assistant Director, Legislative Division, The American Legion; Ms. Joy J. Ilem, National Legislative Direct, Disabled American Veterans; Ms. Lauren Agustine, Senior Legislative Associate, Iraq and Afghanistan Veterans of America; Ms. Rene A. Campos, Deputy Director, Government Relations, Military Officers Association of America; Mr. Carlos Fuentes, Deputy Director, National Legislative Service, Veterans of Foreign Wars; and Mr. Rick Weidman, Executive Director for Policy and Government Affairs, Vietnam Veterans of America.

House of Representatives

  • On September 14, 2016, the House Oversight and Government Reform Committee held a hearing entitled, “Examining the Affordable Care Act’s Premium Increases.” The witnesses included Mr. Chris Carlson, Principal, Oliver Wyman; Mr. Kurt Giesa, Partner, Head of Actuarial Healthcare Practice, Oliver Wyman; Mr. Al Redmer, Jr., Commissioner, Maryland Insurance Administration; Dr. Mandy Cohen, M.D., MPH, Chief Operating Office and Chief of Staff, Office of the Administrator, U.S. Department of Health and Human Services (HHS); and Mr. Topher Spiro, Vice President, Health Policy, Center for American Progress.
  • On September 14, 2016, the House Energy and Commerce Health and Oversight and Investigations Subcommittees held a joint hearing entitled, “Affordable Care Act Outlook and Oversight.” The witnesses included Mr. Chris Carlson, Principal, Oliver Wyman; Mr. Kurt Giesa, Partner, Head of Actuarial Healthcare Practice, Oliver Wyman; Mr. Al Redmer, Jr., Commissioner, Maryland Insurance Administration; Dr. Mandy Cohen, M.D., MPH, Chief Operating Office and Chief of Staff, Office of the Administrator, U.S. Department of Health and Human Services (HHS); and Mr. Topher Spiro, Vice President, Health Policy, Center for American Progress.
  • On September 14, 2016, the House Ways and Means Health Subcommittee held a hearing entitled, “Spurring Health Care Innovation.” The witnesses included Mr. Michael Gallup, President, TeleTracking Technologies; Mr. Jared Short, Chief Operating Office, Cambia Health Solutions; Mr. Paul Black, Chief Executive Officer, Allscripts; and Mr. Greg Long, Chief Medical Officer, Senior Vice President, Systems of Care, Thedacare.

III. Reports, Studies, & Analyses 

IV. Other Health Policy News

  • On September 15, 2016, CMS released a Pre-claim Review Demonstration for Home Health Services Frequently Asked Questions. The FAQs address questions related to whether certain branch locations and HHAs are included in the demonstration given their location/populations served, the requirement to include an NPI on claims, the preferred timing of RAP submissions, PCR review submission processes, and how to manage uncooperative certifying physicians.
  • On September 15, 2016, U.S. Senators Tammy Baldwin (D-WI) and John McCain (R-AZ) and U.S. Representative Jan Schakowsky (D-IL) introduced the Fair Drug Pricing Act. The legislation would impose new transparency requirements on drug manufactures whose products are facing specified increase in price.
  • On September 13, 2016, CMS released a blog post by Principal Deputy Administrator and Chief Medical Officer, Patrick Conway, M.D. The blog post provides data, which shows that efforts made by CMS to lower hospital readmission has worked. The data shows that all states, but one have seen Medicare 30-day readmission rates fall; in 43 states, readmission rates fell by more than 5%; and in 11 states, readmission rates fell by more than 10%.
  • On September 12, 2016, more than a dozen House Energy and Commerce Committee Republicans sent a letter to HHS questioning what they see, as the misclassification of the EpiPen in the Medicaid Drug Rebate Program. The authors requested that the OIG open an independent inquiry into CMS’ oversight of the program.
  • On September 12, 2016, leaders of the House Ways and Means Committee, House Energy and Commerce Committee, and the Senate Finance Committee sent a letter to CMS and Acting Administrator Andrew Slavitt, expressing concerns about fraudulent Medicare spending despite the Agency’s recent efforts to prevent improper payments before they are sent out the door.
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