A&B Healthcare Week in Review

by Alston & Bird
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I. REGULATIONS, NOTICES, & GUIDANCE

Event Notices

  • March 31-April 1, 2016: The Medicaid and CHIP Payment and Access Commission (MACPAC) will convene a series of meetings on March 31st and April 1st, 2016. An agenda is not yet available.
  • April 4, 2016, the Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) Center for Substance Abuse Treatment (CSAT) National Advisory Council will convene a closed teleconference meeting to discuss and evaluate grant applications reviewed by SAMHSA’s Initial Review Groups, and involve an examination of confidential financial and business information as well as personal information concerning the applicants.
  • April 14, 2016, the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. Information about the meeting will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov.  
  • April 20, 2016, HHS Agency for Healthcare Research and Quality (AHRQ) will convene a meeting. The meeting is open to the public and will be available via webcast at www.webconferences.com/ahrq.
  • April 21, 2016, NIH will hold a web conference where the HeLa Genome Data Access working group will report on the evaluation of requests to access HeLa cell genome sequence data. The Clinical Center working group will present their final report to the Advisory Committee to the Director, NIH. Any individual interested in listening to the meeting discussions must call 800-779-9040 and use Participant Passcode 5055308 for access to the meeting.
  • April 25, 2016, the FDA’s Center for Drug Evaluation and Research (CDER), in cosponsorship with the Critical Path Institute (C-Path), will hold a public scientific workshop to discuss the impact of safety biomarkers on drug development. The purpose of the workshop is to discuss the following issues: Application of toxicometrics as a translational safety strategy that integrates nonclinical and clinical safety approaches; uses of rodent and non-rodent nonclinical species in biomarker qualification; and assay validation aspects during biomarker development and qualification.
  • May 16, 2016, the President’s Council on Fitness, Sports, and Nutrition (PCFSN) will hold its annual meeting. The meeting will be open to the public.
  • May 31, 1 &2, 2016, the Office of the National Coordinator for Health IT (ONC) announced its sixth annual meeting will be held at the Walter E. Washington Convention Center in Washington, D.C. The meeting is an opportunity for a wide array of public and private sector partners to discuss ways to leverage health IT to achieve better care, smarter spending, and healthier people.
  • September 12, 13, &14, 2016, FDA will hold a public conference to be held in cosponsorship with the Parenteral Drug Association (PDA), entitled "Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance." The conference will cover current issues affecting the industry as well as explore strategies to facilitate the development and continuous improvement of safe and effective medical products. The conference establishes a unique forum to discuss the foundations, emerging technologies, and innovations in regulatory science, as well as the current quality and compliance areas of concerns. Meeting participants will hear from FDA and industry speakers about the requirements and best practices to consider while implementing robust quality systems in order to deliver the best quality product.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

  • The Senate was adjourned this week and will reconvene on Monday, April 4, 2016.

House of Representatives

  • On March 22, 2016, the House Veterans' Affairs Subcommittee on Health held a hearing entitled, “Choice Consolidation: Leveraging Provider Networks to Increase Veteran Access.” The witnesses included Billy Maynard, President, Health Net Federal Services; David J. McIntyre Jr., President and Chief Executive Officer, TriWest Healthcare Alliance; Baligh Yehia M.D., Assistant Deputy Under Secretary for Health for Community Care, Veterans Health Administration, U.S. Department of Veterans Affairs; Accompanied by: Gene Migliaccio, Deputy Chief Business Officer for Purchased Care, Veterans Health Administration, U.S. Department of Veterans Affairs.
  • On March 22, 2016, the House Appropriations Subcommittee on Defense held a hearing entitled, “Defense Health Program Budget.” The witnesses included Vice Admiral Raquel C. Bono, Director, Defense Health Agency; Lieutenant General Nadja West, Surgeon General, United States Army; Vice Admiral Clinton F. Faison, III, Surgeon General, United States Navy, Lieutenant General Mark A. Ediger, Surgeon General, United States Air Force.
  • On March 22, 2016, the House Small Business Subcommittee on Economic Growth, Tax and Capital Access held a hearing entitled, “Lip Service but Little Else: Failure of the Small Business Health Insurance Tax Credit.” The witnesses included Mr. James R. McTigue, Jr., Director, Strategic Issues, United States Government Accountability Office; Mr. Harold Jackson, Executive Chairman, Buffalo Supply, Inc.; Ms. Holly Wade, Director, Research & Policy Analysis, NFIB Research Foundation.
  • On March 22, 2016, the House Oversight and Government Reform Committee held a hearing entitled, “America's Heroin and Opioid Abuse Epidemic.” The witnesses included Honorable Michael Botticelli, Director Office of National Drug Control Policy, The White House; Mr. Lou Milione, Deputy Assistant Administrator for Diversion Control, Drug Enforcement Administration, U.S. Department of Justice; Ms. Kana Enomoto, Acting Administrator, Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services; Leana S. Wen, M.D., MSc., FAAEM, Health Commissioner, Baltimore City Health Department; Honorable Teresa Jacobs, Mayor of Orange County.
  • On March 22, 2016, the House Judiciary Committee held a full committee markup of H.R.4771, the “Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016”; and H.R.4676, the “Preventing Crimes Against Veterans Act of 2016.”
  • On March 22, 2016, the House Oversight and Government Reform Subcommittee on Health Care, Benefits and Administrative Rules convened a hearing entitled, “Opportunities and Challenges in Advancing Health Information Technology.” The witnesses included Dr. Karen DeSalvo, MD, National Coordinator for Health Information Technology, U.S. Department of Health and Human Services; Ms. Jessica Rich, Director, Bureau of Competition, U.S. Federal Trade Commission; Mr. Matthew Quinn, Federal Managing Director, Intel Healthcare and Life Sciences; Mr. Neil DeCrescenzo, Member, Executive Committee, Healthcare Leadership Council; Mr. Mark Savage, Director of Health IT Policy and Programs, National Partnership for Women & Families.
  • On March 23, 2016, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies convened a hearing entitled “Budget Hearing - Centers for Disease Control and Prevention.” The fiscal year (FY) 2017 President’s Budget request for CDC includes a total funding level of roughly $11.8 billion in discretionary budget authority, mandatory funding, and the Affordable Care Act (ACA) Prevention and Public Health Fund (PPHF). This is an overall increase of $87.3 million above the FY 2016 enacted level. The FY 2017 Budget request builds on priorities outlined in CDC's FY 2016 President's Budget, proposing strategic new investments and identifying targeted reductions that will allow CDC to advance its core public health mission. The sole witness was Dr. Thomas Frieden, Director of CDC.
  • On March 24, 2016, the House Energy & Commerce Committee released a series of slides offering an overview of the Medicaid program, outlining how it has changed over the years, and what to expect in the future as part of the ongoing efforts to educate members, stakeholders, and the public. The slides detail the significant increase in the number of people covered under the program in recent years, and how program spending has grown as well.
  • The House adjourned on the evening of Wednesday, March 23, 2016, and will reconvene Tuesday, April 12, 2016.

III. REPORTS, STUDIES, & ANALYSES

  • On March 22, 2016, the Government Accountability Office (GAO) released a report entitled, “Small Employer Health Tax Credit: Limited Use Continues Due to Multiple Reasons.” GAO found that the cost and complexity involved in claiming the tax credit was significant, deterring small employers from claiming it. Many small businesses have also reported that they were unaware of the credit. Even so, the Internal Revenue Service (IRS) had been taking steps since April 2010 to raise awareness about the credit and reduce the burden on taxpayers by offering tools to help taxpayers determine eligibility for the credit. Congress and the administration have proposed a number of changes to the credit. These include expanding the size of eligible employers, altering the phase out rules, and allowing the credit to be claimed in more than two consecutive years.
  • On March 23, 2016, the HHS Office of Inspector General (OIG) released a report entitled, “The Medicare Contractors for Jurisdiction E Overpaid Claims for Replaced Cardiac Medical Devices When Hospitals Had Not Reported Manufacturer Credits.” OIG found that the hospitals' incorrect billing of these claims resulted in overpayments of $2.1 million that the hospitals had not identified, refunded, or adjusted by the beginning of the OIG audit. The Medicare contractors overpaid the hospitals because they had no specific controls to ensure that hospitals complied with Medicare requirements for reporting manufacturer credits.
  • On March 23, 2016, the GAO released a report entitled, “Healthcare.gov: Actions Needed to Enhance Information Security and Privacy Controls.” GAO identified weaknesses in technical controls protecting the data flowing through the data hub. These included insufficiently restricted administrator privileges for data hub systems; inconsistent application of security patches; and insecure configuration of an administrative network. GAO also identified additional weaknesses in technical controls that could place sensitive information at risk of unauthorized disclosure, modification, or loss.
  • On March 22, 2016, the Congressional Budget Office (CBO) release a report entitled, “H.R. 4723, Protecting Taxpayers by Recovering Improper Obamacare Subsidy Overpayments Act.” H.R. 4723 would amend the Internal Revenue Code to provide for the recovery of overpayments resulting from certain federally subsidized health insurance. The staff of the Joint Committee on Taxation (JCT) estimates that relative to CBO’s January 2016 baseline, the legislation would decrease outlays by $45.8 billion and increase revenues by $15.8 billion over the 2016-2026 period. JCT therefore estimates that the legislation would reduce federal budget deficits by $61.6 billion over the 2016-2026 period. The change in revenues includes a reduction of about $718 million over the 2016-2026 period that would result from changes in off-budget revenues (from Social Security payroll taxes).
  • On March 22, 2016, HHS released a report entitled, “Health Care Spending Growth and Federal Policy.” The report found that that Medicare spent $473.1 billion less on personal health care expenditures between 2009 and 2014 than would have been spent if the 2000-2008 average growth rate had continued through 2014. In addition, if trends continue through 2015, that amount could grow to a projected $648.6 billion.
  • On March 24, 2016, CBO released a report entitled, “Cost Estimate of S. 1916, Rural Health Care Connectivity Act of 2015.” CBO estimates that enacting S. 1916 would increase direct spending by $197 million over the 2017-2026 period and result in increased revenue collections of $215 million over the same period, resulting in an estimated net reduction in the deficit of $18 million. CBO estimates that implementing the bill would have no significant discretionary costs. Pay-as-you-go procedures apply because enacting the legislation would affect direct spending and revenues. Additionally, CBO estimates that enacting the legislation would not increase net direct spending or on-budget deficits by more than $5 billion in one or more of the four consecutive 10-year periods beginning in 2027.
  • On March 24, 2016, CBO released a report entitled, “Report: Federal Subsidies for Health Insurance Coverage for People Under Age 65: 2016 to 2026.” In 2016, the federal government subsidizes health insurance for people under age 65 will total more than $600 billion, CBO and JCT estimate. By CBO and JCT’s estimates, an average of about 244 million noninstitutionalized residents of the United States under age 65 will have health insurance in any given month in 2016. Almost two-thirds of them will obtain coverage through an employer, and about a quarter will be enrolled in Medicaid or CHIP.
  • On March 24, 2016, CBO released a report entitled, “Cost Estimate of H.R. 4725, Common Sense Savings Act of 2016.” H.R. 4725 would make changes to Medicaid and CHIP that would reduce the federal medical assistance percentages (FMAPs) for certain enrolled individuals. CBO estimates that enacting the legislation would reduce federal deficits by $29.6 billion over the 2016-2026 period. That total consists of $29.4 billion in on-budget savings and $0.2 billion in off-budget savings. Pay-as-you-go procedures apply because enacting the legislation would affect direct spending and revenues. Additionally, CBO estimates that enacting the legislation would not increase net direct spending or on-budget deficits by more than $5 billion in any of the four consecutive 10-year periods beginning in 2027.
  • On March 24, 2016, CBO released a report entitled, “Updated Budget Projections: 2016 to 2026.” CBO projects a $534 billion deficit in fiscal year 2016, about $100 billion more than in 2015. If current laws generally remained unchanged, the deficit would increase from 2.9 percent to 4.9 percent of GDP over the next decade.

IV. OTHER HEALTH POLICY NEWS

  • On March 22, 2016, HHS Secretary Sylvia M. Burwell announced the CMS Office of the Actuary had certified that expansion of the Diabetes Prevention Program, a model funded by the ACA, would reduce net Medicare spending. The expansion was also determined to improve the quality of patient care without limiting coverage or benefits. This is the first time that a preventive service model from the CMS Innovation Center has become eligible for expansion into the Medicare program. "This program has been shown to reduce health care costs and help prevent diabetes, and is one that Medicare, employers and private insurers can use to help 86 million Americans live healthier,” said HHS Secretary Sylvia M. Burwell. “The Affordable Care Act gave Medicare the tools to support this groundbreaking effort and to expand this program more broadly. Today’s announcement is a milestone for prevention and America’s health.”
  • On March 24, 2016, CMS announced that the Agency will test whether a new payment model for nursing facilities and practitioners will further reduce avoidable hospitalizations, lower combined Medicare and Medicaid spending, and improve the quality of care received by nursing facility residents. This next phase of the Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents seeks to reduce avoidable hospitalizations among beneficiaries eligible for Medicare and/or Medicaid by providing new payments to practitioners for engagement in multidisciplinary care planning activities. In addition, the participating skilled nursing facilities will receive payment to provide additional treatment for common medical conditions that often lead to avoidable hospitalizations. This new four-year payment phase of the Initiative, slated to begin fall 2016, will be implemented through cooperative agreements with six ECCPs.
  • On March 24, 2016, CMS released a discussion paper in advance of the March 31, 2016, HHS-Operated Risk Adjustment Methodology Meeting. “CMS has implemented a risk adjustment program to mitigate the effects of risk selection on health insurance premiums for non-grandfathered plans in the individual and small group markets,” the paper concludes. “The risk adjustment program, supports market stability by pooling risk and transferring funds from plans with more low-risk (i.e., healthier and lower cost) enrollees to those plans with more high-risk (i.e., less healthy and higher cost) enrollees.” HHS is holding a public hearing on March 31, 2016 to discuss the proposed ideas.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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