Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.

This Week in Health Care Policy (July 16-20, 2018)

Congress

Legislation and Committee Activity

House Passes Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018—On Monday, the house passed H.R. 5333 by a voice vote, which allows the Food and Drug Administration to make scientific determinations for OTC ingredients through an administrative order process. Read More

HELP Committee: Reducing Health Care Costs – On Tuesday, the Senate Health, Education, Labor and Pensions held a hearing on Reducing Health Care Costs: Eliminating Excess Health Care Spending and Improving Quality and Value for Patients. Read More

Modern Healthcare: 4 takeaway questions as the Senate looks at healthcare costs – The Senate health panel on Tuesday grappled with how new policies could curb the ever-increasing costs of the U.S. health system. The lawmakers came away with several questions that likely will recur as the federal government pushes forward with the shift to value-based care. Read More

Energy and Commerce Health Subcommittee Gets Update on Implementation of Landmark Mental Health Reforms Included in 21st Century Cures Act – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), held a hearing to get a status update on the implementation of the landmark mental health reforms included in the 21st Century Cures Act (Cures). Read More

House Energy and Commerce Oversight Subcommittee Examines State Efforts to Increase Transparency in Midst of Skyrocketing Health Care Costs – On Tuesday, the Subcommittee on Oversight and Investigations, chaired by Rep. Gregg Harper (R-MS), held a hearing to examine recently adopted state laws and policies that improve transparency of health care costs for consumers, making information more readily available. Read More

Hearing on Modernizing Stark Law to Ensure the Successful Transition from Volume to Value in the Medicare Program – On Tuesday, the House Ways and Means Health Subcommittee held a hearing on “Modernizing Stark Law to Ensure the Successful Transition from Volume to Value in the Medicare Program.” Read More

Hearing on Combating Fraud in Medicare: A Strategy for Success – On Tuesday, the House Ways and Means Oversight Subcommittee held a hearing on “Combating Fraud in Medicare: A Strategy for Success.” Read More

Appropriations

The Hill: Budget chairs press appropriators on veterans spending – The chairmen of the House and Senate budget committees have weighed in on a debate on how to fund a veterans program that has thrown a wrench into the 2019 appropriations process. Read More

Administration

Bloomberg: Trump Administration Preparing Fix for Obamacare Risk Payments – The Trump administration is preparing a regulation that would allow the resumption of billions of dollars in payments to health insurers in Obamacare. The Office of Management and Budget was sent a rule on Wednesday from the Centers for Medicare and Medicaid Services tied to the risk-adjustment program, which transfers money to insurers who take on sicker customers. Read More

HHS

Politico: Comments roll in on Trump’s drug pricing plan – On Monday, the comment period closes on the plan that President Donald Trump announced two months ago as “the most sweeping effort” in history to lower drug prices. And with the clock ticking, some 2,000 comments had been submitted as of last Friday. Read More

HHS Secretary Azar Directs FDA to Establish Working Group on Drug Importation to Address Price Spikes – On Thursday, as part of the Trump administration’s efforts to lower drug prices and put American patients first, Health and Human Services Secretary Alex Azar requested that FDA Commissioner Scott Gottlieb establish a working group to examine how to safely import prescription drugs from other countries in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities. Read More

HHS Blog: What the Media Is Missing on Drug Pricing – In the past week, two of the world’s largest pharmaceutical companies announced that they will postpone the kind of broad, steep price increases that have characterized America’s market for prescription drugs for far too long. It is hard to imagine, in light of this news, that some in the media are still claiming that the Trump Administration’s plan for reforming drug pricing isn’t delivering. Read More

HHS Blog: Integrating Infectious Disease Prevention and Treatment into the Opioid Response – The opioid crisis in the United States is devastating the lives of millions of Americans. Perhaps overshadowed by the alarming rise in overdoses and deaths is the accompanying numbers of injection-related infectious diseases. Opioid overdose deaths increased fivefold from 1999 to 2016, and new hepatitis C infections more than tripled from 2010 to 2016. Read More

Bloomberg: Drug rebates’ legal protections are on the chopping block – The Trump administration looks like it’s making good on its promise to tweak drug rebate laws that favor pharmacy benefit managers. On Wednesday, HHS’ Office of Inspector General sent a new rule to the White House Office of Management and Budget for review related to legal protections for drug rebates. Read More

CMS

CMS Doubling Down on Health IT; Patients – Americans enjoy the benefits of the best healthcare providers and innovators in the world. Yet, while the volume of care consumed by American patients has not increased dramatically, comparative to similar economies, the cost of care in the United States has accelerated at an alarming pace. Healthcare costs continue to grow faster than the U.S. GDP, making it more difficult with each passing year for CMS to ensure healthcare to not only its beneficiaries of today, but generations of beneficiaries in the future. Read More

Politico: Medicaid looking at ways to help states lower drug cost, Verma says – CMS is exploring options for helping states deal with the rising cost of drugs in their Medicaid programs, Administrator Seema Verma said Tuesday. The agency is open to tying payments to how well drugs perform and paying different prices based on a patient’s disease or condition, Verma said at the POLITICO Pro Summit. The government is also open to paying for a medicine over time. Read More

FDA

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency – On Wednesday, The U.S. Food and Drug Administration  approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Read More

Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs – At the FDA, we’re continuing to look at ways we can foster greater access to the medicines that help keep people healthy. We are considering all options for positively impacting both access and the cost of health care.  Today we are announcing a new effort to establish innovative approaches to increase access to a broader selection of nonprescription drug products for consumers, empowering them to self-treat common conditions and potentially some chronic conditions. Read More

FDA Releases Biosimilar Action Plan – On Wednesday, During a speech given in Washington, DC, FDA Commissioner Scott Gottlieb, MD, announced the release of the long-awaited Biosimilar Action Plan. Read More

News

Modern Healthcare: Appeals court rejects hospitals’ challenge to 340B cuts – On Tuesday a federal appellate court rejected the American Hospital Association’s attempt to block HHS’ $1.6 billion in Medicare 340B reimbursement cuts.

Bloomberg: CVS-Aetna Deal Could Raise Drug Coverage Costs in Some Places – CVS Health Corp.’s proposed acquisition of insurer Aetna Inc. could attract the attention of the Justice Department because it appears likely to reduce competition in at least some of the Medicare prescription drug plan markets in which the two companies currently compete. Read More

States

ABC News: Reversal: Kentucky restoring Medicaid benefits for thousands – Dental and vision care benefits will be restored for hundreds of thousands of Medicaid recipients in a sudden reversal by Kentucky Gov. Matt Bevin’s administration following an outcry over the recent cuts. The coverage had been abruptly cut at the start of July after a federal judge rejected the Republican governor’s plan to overhaul Kentucky’s Medicaid program. Read More

CBS Sacramento: Covered California Premiums To Rise 8.7 Percent In 2019 – Monthly health insurance premiums sold under former President Barack Obama’s health care law will rise by an average of 8.7 percent in 2019, less than the double-digit increases seen in each of the past two years and in other states. Read More

Atlanta Journal: Here’s a look at key contests in Georgia primary runoff – Georgia voters head back to the polls next Tuesday to decide their party’s nominees in some of the state’s top races. Read More

Foley Healthcare Law Today

Our attorneys at Foley pride themselves on having a first-hand understanding of Healthcare’s business and legal challenges. Healthcare Law Today is your go-to resource for information and perspectives on the latest news and developments in Healthcare law and how it relates to and impacts the industry and those with related business interests. For some of the blog’s top stories see below

CMS Recoupment Efforts Stopped by Court While Overpayment Appeals Are Pending – Providers and suppliers who have been assessed overpayments for Medicare services are entitled, by statute, to a stay of recoupment while the provider or supplier’s appeal is pending – but only at the first two levels of administrative appeal. If both appeals are unfavorable to the provider or supplier, the next step is an appeal to the Office of Medicare Hearings and Appeals, where the matter is heard by an Administrative Law Judge (ALJ). Read More 

Medicare’s New Virtual Care Codes: A Monumental Change and Validation of Asynchronous Telemedicine – The Centers for Medicare and Medicaid Services just issued a proposed rule introducing monumental changes to the physician fee schedule, paving the way for asynchronous telemedicine and new technologies through a new set of virtual care codes.  Read More

Looking Ahead 

The House and Senate are in session next week.

The House plans to vote on the following measures to change parts of the Affordable Cart Act:

  • The Protect Medical Innovation Act of 2017 (H.R. 184) which would amend the Internal Revenue Code to repeal the excise tax on the sale of a medical device by the manufacturer, producer, or importer. Read More
  • R. 6199 would repeals provisions of the Internal Revenue Code, as added by the Patient Protection and Affordable Care Act, that limit payments for medications from health savings accounts, medical savings accounts, health flexible spending arrangements, and health reimbursement arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs). The bill also allows the accounts to be used for menstrual care products. Read More
  • R. 6311 amends the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to modify the definition of qualified health plan for purposes of the health insurance premium tax credit and to allow individuals purchasing health insurance in the individual market to purchase a lower premium copper plan. Read More

 On Wednesday, the Senate Health, Education, Labor & Pensions Committee will hold a markup on Patient Right to Know Drug Prices Act (S. 2554), Congenital Heart Futures Reauthorization Act of 2017 (H.R. 1222), Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2018 (S. 2465), and Action for Dental Health Act of 2018 (S. 3016). Read More

Next Thursday, The House Energy and Commerce Health Subcommittee will hold a hearing is entitled, “MACRA and MIPS: An Update on the Merit-based Incentive Payment System.” The hearing will be the fourth bipartisan oversight hearing on the implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015, and builds off of a November 2017 hearing where the subcommittee received a check-up on Alternative Payment Models (APMs), including those that are qualified under MACRA. Read More

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team has a proven track record of helping clients achieve their policy priorities at the federal, state and local levels, with extensive experience advocating on behalf of clients involved in various aspects of government engagement. Our team employs a comprehensive approach to government relations. Our work combines high-level policy development, tactical engagement with policymakers, grassroots, business and public relations strategy and targeted lobbying, along with legal representation of an international law firm, when requested by our clients. Our team maintains strong relationships with key Members of Congress, including those in House and Senate Republican and Democratic leadership, and on key committees. The Foley team is your go-to resource in Washington, D.C., for notable healthcare developments.