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 (June 11-15, 2018)

Congress

Legislation and Committee Activity

House Prepares for Week of Action on Opioid Bills – The House began a voting marathon last Tuesday on 34 bills designed to address the opioid epidemic. While most are not likely to be contentious, two have previously stirred controversy. House Majority Leader Kevin McCarthy (R-Ca) reserved about a week and a half of floor time to discuss opioid legislation. Additional bills are likely to be considered next week, such as four bill packages, which the House Ways and Means Committee approved with bipartisan support. Read More

The SUPPORT Act – Reps. Greg Walden (R-OR) Kevin Brady (R-TX), Frank Pallone (D-NJ) and Rep. Richard Neal (D-MA) introduced the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act(H.R. 6). This will serve as the legislative package for the majority of House-passed bills to combat the opioid crisis to move over to the Senate. Read More 

Ask For Jobs Corps To Help in Opioid Crisis – On Thursday, House Education and  Workforce Chairwoman, Virginia Foxx (R-NC) asked Labor Secretary Alexander Acosta in a letter to designate Jobs Corps centers as treatment facilities for opioid addicts. Read More

Senate Finance Committee’s HEAL Act, A Critical Step Toward Tackling the Opioid Crisis – The Senate Finance Committee came together this week to advance the bipartisan Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018. HEAL is an important step toward addressing the nation’s opioid crisis through reforming Medicare, Medicaid and family services programs. Read More

House Aims At Campaign-Season Bills Battling Opioid Abuse – The House dove Tuesday into a two-week vote-a-thon on dozens of bills aimed at opioid abuse, as lawmakers try to tackle a crisis that’s killing tens of thousands a year and to score a popular win they can tout for the midterm elections. Read More

Matsui Introduces Legislation in Support of 340B Program – On Wednesday, Rep. Doris Matsui (D-CA) introduced the Stretching Entity Resources for Vulnerable (SERV) Communities Act. The legislation  clarifies the intent of the 340B Program, enhances program integrity, and protects and expands the program to meet the needs of the opioid crisis. Read More

Bipartisan E&C Leaders Request Information from FDA About Efforts to Stop the Importation of Illegal Opioids – Bipartisan Energy and Commerce Committee leaders sent a letter to the Food and Drug Administration (FDA) on Friday regarding its Office of Criminal Investigations (OCI) and ongoing efforts to stop the importation of illegal opioids and other potentially harmful products coming through international mail facilities (IMFs). Read More

Leahy-Grassley CREATES Act to Lower Prescription Drug Prices Clears Judiciary Committee– On Thursday, the Senate Judiciary Committee approved the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act by a strong bipartisan vote of 16 to 5.  The legislation, sponsored by Senator Patrick Leahy (D-VT) and cosponsored by Judiciary Committee Chairman Chuck Grassley (R-IA), would combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block lower-cost generic drugs. Read More

FDA Taking Action to Remove Barriers to Lower Drug Prices – On Wednesday, Senate Health Committee Chairman Lamar Alexander (R-Tenn.), said “smart action” by the Food and Drug Administration would help remove barriers to lower drug prices, as required by the 21st Century Cures Act. Read More

Appropriations Committee Releases the Fiscal Year 2019 Labor, Health and Human Services, Education Funding Bill – On Thursday, The House Appropriations Committee released the draft fiscal year 2019 Labor, Health and Human Services, and Education (LHHS) funding bill, which will be considered in subcommittee today. The legislation includes funding for programs within the Departments of Labor, Health and Human Services,  Education, and other related agencies including the Social Security Administration. In total, the draft bill includes $177.1 billion in discretionary funding, essentially the same as the 2018 enacted level. The bill targets investments in medical research, public health, biodefense, education, and important activities that help promote job readiness. The legislation also includes several provisions to rein in unnecessary regulations and to protect the sanctity of life. Read More

Administration

HHS

HHS Secretary Azar Praises FDA Approval of Generic Drugs for Treating Opioid Dependence– HHS Secretary Alex Azar issued a statement regarding the Food and Drug Administration’s approval of generic versions of Suboxone, a medication used to treat opioid dependence. Read More

The Hill: NIH Outlines Plans for $500M to Combat Opioid Epidemic – Leaders of the National Institutes of Health (NIH) on Tuesday published an outline of how the nation’s medical research agency plans to spend the $500 million Congress gave it to fight the opioid epidemic. Read More

Bloomberg: Trump Health Chief Renews Call to End Key Drug-Pricing Tactic – U.S. Health and Human Services Secretary Alex Azar told lawmakers that it may be time to eliminate the complex system of rebates that drug companies and pharmacy-benefit managers use to negotiate and set prices. Read More

HHS Secretary Azar Meets with Kidney Disease and Rare Disease Advocates – On Wednesday, Secretary Alex Azar met with representatives from Kidney Care Partners, an umbrella organization representing kidney-disease nonprofits and companies,  the National Organization for Rare Disorders. Read More

Bloomberg: Azar Weighs In On Medicare Payment Models – On Wednesday, HHS Secretary Alex Azar has responded to medical professionals and others who submitted ideas to a federal advisory committee for alternative payment models for doctors that want to get out of Medicare’s fee-for-service payment system. Read More

CMS

CMS Leverages Medicaid Program To Combat the Opioid Crisis – On Monday, CMS released guidance aimed at building on our commitment to partner with states to ensure that they have flexibilities and the tools necessary to combat the opioid crisis.  This new guidance provides information to states on the tools available to them, describes the types of approaches they can use to combat this crisis, ensures states know what resources are available, and articulates promising practices for addressing the needs of beneficiaries facing opioid addiction. Read More

Modern Healthcare: Hospital Star-Ratings Release Delayed by CMS – CMS will not update the hospital quality star ratings on Hospital Compare next month as it continues to evaluate concerns from stakeholders on methodology changes, the agency told hospitals on Tuesday. Read More

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D., On FDA’s Efforts To Foster Discovery And Development of New Tools To Fight Antimicrobial-Resistant Infections – The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. According to our colleagues at the Centers for Disease Control and Prevention, each year in the U.S. at least 2 million people become infected with bacteria that are resistant to antibiotics and 23,000 people die each year as a direct result of these infections. Read More

States

Modern Healthcare: Kentucky’s Medicaid Work Requirement Faces Reckoning In Court – In a case with major national implications, the Trump administration and advocacy groups are set to argue in federal court Friday over whether the HHS secretary has the legal authority to allow Kentucky to establish a work requirement and other tough new conditions on people receiving Medicaid coverage. Read More

US News: New Mexico’s Opioid Case to Be Heard in New Mexico Court – The New Mexico Attorney General’s Office says the state’s lawsuit against major opioid manufacturers will be heard by a state court in New Mexico where it was originally filed, not in a federal court in Ohio. Read More

Vox: Maine’s Governor Blocked Medicaid Expansion for Years – Maine voters overwhelmingly supported Medicaid expansion last November, but it still hasn’t happened yet. And it may just be their vote to choose the next governor that finally finishes the job. Read More

Primaries

CBS News: Key Takeaways from Tuesday Night’s Primaries – Tuesday night’s primaries in Virginia, South Carolina, Maine, Nevada and North Carolina continued some key trends in the 2018 midterm election cycle. It was generally a good night for some of the Republicans who stick with President Trump — and not so good for some of the others who have criticized him in the past. It was also a good night for women running on campaigns opposed to Mr. Trump, in a cycle that has more female candidates than ever before. Read More

Next week, voters in Washington, DC will head to the polls. Read More

Looking Ahead

The House and Senate are in session next week.

This week, the House plans to take up almost two dozen opioid measures on topics including Medicare/Medicaid, inpatient treatment and patient privacy.

On Tuesday, the Senate HELP Committee will hold a hearing on the Effective Administration of the 340B Drug Pricing Program. Read More

On Tuesday, The House Homeland Security Subcommittee on Oversight and Management Efficiency Committee will hold a field hearing in Harrisburg, PA on DHS/State and Local Opioid Coordination. Read More

On Tuesday, the Senate Special Aging Committee will hold a hearing on Alzheimer’s. Read More

On Wednesday, the Senate HELP committee will mark up the PREEMIE Act (S. 3029) a bipartisan bill to reauthorize until 2023 the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act. Without a new reauthorization, programs at the Centers for Disease Control and Prevention to research and collect data on premature infants, as well as treatment programs at the Health Resources and Services Administration, will expire Sept. 30. Read More