Healthcare Week in Review June 24, 2016

A&B Healthcare Week in Review, June 24, 2016

Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE

Event Notices

  • June 28&29, 2016, FDA announced a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee.
  • July 14&15, 2016, the Centers for Disease Control and Prevention (CDC) announced a meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). The agenda will include updates on CDC’s activities for prevention of healthcare associated infections (HAIs), updates on antimicrobial stewardship, an update on Draft Guideline for Prevention of Infections in Healthcare Personnel, and an update from the workgroup for considerations on endoscope reprocessing.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

  • On June 23, 2016, the Senate Special Committee on Aging convened a hearing entitled, “The Right Care at the Right Time: Ensuring Person-Centered Care for Individuals with Serious Illness.” The witnesses included Dr. Atul Gawande, Executive Director, Ariadne Labs; Dr. Katherine Pope, Spectrum Medical Group; Co-Founder, Hospice of Southern Maine; Dr. Kate Lally, Chief of Palliative Care, Care New England Health System; Amy Berman, Senior Program Officer, The John A. Hartford Foundation.
  • On June 21, 2016, Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights convened a hearing entitled, “The CREATES Act: Ending Regulatory Abuse, Protecting Consumers, and Ensuring Drug Price Competition.” The witnesses included Mr. Alden Abbott, Deputy Director of the Edwin Meese III Center for Legal and Judicial Studies and John, Barbara, and Victoria Rumpel Senior Legal Fellow at the Heritage Foundation; Professor Robin Feldman, Harry & Lillian Hastings Professor Of Law and Director of The Institute For Innovation Law at UC Hastings College Of Law; Mr. Peter O. Safir, Senior Counsel at Covington & Burling; Ms. Beth Zelnick-Kaufman, Assistant General Counsel for Amneal Pharmaceuticals; Mr. George Slover, Senior Policy Counsel for Consumers Union; and Dr. Nitin Damle, President of the American College of Physicians.
  • On June 22, 2016, the Senate Veterans' Affairs Committee convened a hearing entitled, “Examining the Progress and Challenges in Modernizing Information Technology at the Department of Veterans Affairs.” The witnesses included Dr. David J. Shulkin, Under Secretary For Health, Department of Veterans Affairs; Valerie C. Melvin, Director Of Information Management, U.S. Government Accountability Office.

House of Representatives

  • On June 22, 2016, House Republicans released a Health Care White Paper entitled, “A Better Way: Our Vision for a Confident America.” The proposal is built on five principles: (1) Repeal the ACA; (2) Provide all Americans with more choices, lower costs, and greater flexibility; (3) Protect the nation’s most vulnerable; (4) Spur innovation in health care; and (5) Protect and preserve Medicare.
  • On June 21, 2016, the House passed by voice vote H.R. 5860, the Small Business Healthcare Relief Act, which was introduced by Rep. Mike Thompson (D-CA) and Rep. Charles W. Boustany (R-LA). H.R. 5860 would allow small businesses to use pre-tax dollars for assistance to employees purchasing policies in the individual market and except certain health reimbursement arrangements from group health plan requirements.
  • On June 21, 2016, Rep. Michael Burgess (R-TX) and Rep. Gene Green (D-TX) introduced bipartisan legislation aimed at making health care more affordable by promoting greater transparency around the costs of health care services for patients. The Health Care Price Transparency Promotion Act of 2016 calls upon the states to establish and maintain laws requiring disclosure of information on hospital charges, to make such information available to the public, and to provide individuals with information about estimated out-of-pocket costs for health care services.
  • On June 23, 2016, the House approved the Military Construction and Veterans Affairs and Zika Response Appropriations Act final Conference Report that includes a $1.1 billion plan to fight the Zika virus. The bill passed by a 239-171 vote. The legislation now needs to be approved by the Senate, before heading to the President’s desk for final approval.

III. REPORTS, STUDIES, & ANALYSES

  • On June 22, 2016, the Board of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds released the 2016 Medicare Trustees Report. According to the report, the ACA requires the Independent Payment Advisory Board (IPAB) to submit proposals to the President the year following a determination that the projected rate of growth in Medicare spending per beneficiary exceeds a target growth rate. Since 2013, the Chief Actuary at CMS has been required to determine the projected and target growth rates. If the Chief Actuary makes a determination that the projected Medicare per capita growth rate exceeds the per capita target growth rate in the implementation year, the Chief Actuary is required to establish a savings target for that year. As in prior years, the 2016 determination is that the target growth rate has not been exceeded and IPAB has not been triggered.
  • On June 20, 2016, the Government Accountability Office (GAO) released a report entitled, “Federal Autism Activities: Agencies Are Encouraging Early Identification and Providing Services, and Recent Actions Could Improve Coordination.” GAO found that specific actions were taken to help respond to the individual intervention needs of children with autism. GAO identified about 8,200 young children with autism in five states enrolled in Medicaid or CHIP and found that speech, language, and audiology services were the most common overall; however, the types of services commonly received varied, depending on the age of the child.
  • On June 22, 2016, HHS Office of the Inspector General (OIG) released a report entitled, “Nationwide Analysis of Common Characteristics in OIG Home Health Fraud Cases.” OIG identified a substantial number of providers-over 500 HHAs and over 4,500 physicians-that were outliers in comparison to their peers nationally with respect to multiple characteristics commonly found in OIG-investigated cases of home health fraud. OIG simultaneously released a report entitled, “Alert: Improper Arrangements and Conduct Involving Home Health Agencies and Physicians.” OIG found that home health services are vulnerable to fraud, waste, and abuse. The federal government has obtained criminal convictions and reached civil settlements with several HHAs, individual physicians, and heads of home-visiting physician companies that defrauded Medicare by, among other conduct, making (or accepting) payments for patient referrals, falsely certifying patients as homebound, and billing for medically unnecessary services or for services that were not rendered.
  • On June 22, 2016, OIG released a report entitled, “High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns.” OIG found that Medicare spending for Part D drugs has continued to rise by more than $10 billion a year. OIG also found that in particular, compounded topical drugs rose more than 3,400 percent since 2006. OIG will continue to conduct investigations and reviews to help address the ongoing problems created by opioid abuse and the emerging problems linked to compounded drugs.
  • On June 21, 2016, GAO released a report entitled, “Controlled Substances: DEA Should Take Additional Actions to Reduce Risks in Monitoring the Continued Eligibility of Its Registrants.” The Drug Enforcement Administration (DEA) has established controls for determining registrant eligibility to handle and prescribe controlled substances. However, GAO found limitations in DEA's controls to help ensure that individual registrants are and remain eligible and do not present issues that may increase the risk of illicit diversion. GAO is making five recommendations to DEA to help ensure practitioners are and remain eligible and that those who pose an increased risk of illicit diversion are identified. DEA stated it appreciated the intent of GAO's recommendations, but raised concerns about its legal authority to take some of the actions. GAO's recommendations include having DEA seek legal authority as needed, and remain valid.

IV. OTHER HEALTH POLICY NEWS

  • On June 20, 2016, HHS announced a major initiative to help small practices prepare for the Quality Payment Program. HHS will award $20 million to fund on-the-ground training and education for Medicare clinicians in individual or small group practices of 15 clinicians or fewer. These funds will help provide hands-on training tailored to small practices, especially those that practice in historically under-resourced areas including rural areas, health professional shortage areas, and medically underserved areas.
  • On June 20, 2016, the U.S. Supreme Court ruled to affirm a lower court ruling allowing the U.S. Patent and Trademark Office's Patent Trial and Appeal Board to continue using a broader standard than federal courts when it comes to interpreting patent claims in Cuozzo Speed Technologies v. Lee. The decision could reportedly make it harder for pharmaceutical manufacturers of brand-name drugs to protect their patents.
  • On June 23, 2016, the American Enterprise Institute (AEI) and the Schaeffer Initiative for Innovation in Health Policy, a collaboration between the USC Leonard D. Schaeffer Center for Health Policy & Economics and the Brookings Institution, convened a session entitled, “The 2016 Medicare Trustees Report: One year closer to Independent Payment Advisory Board (IPAB) cuts?” The discussion focused on the new 2016 Medicare Trustees Report (2016 Report) released on June 22, 2016. Medicare’s Chief Actuary Paul Spitalnic summarized the key findings, which was followed by a panel of experts who discussed the potential consequences of the report on policy actions that might be taken to improve the program's fiscal condition.
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