Introduction
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “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
Congress
Challenges and Solutions in the Opioid Abuse Crisis – On Tuesday, the House Judiciary Committee held a hearing on the Challenges and Solutions in the Opioid Abuse Crisis. Read More
25 Opioid Bills Advance – On Wednesday, the House Energy and Commerce Committee advanced 25 bills through committee markup to combat the opioid crisis. Read More
The Overdose Prevention and Patient Safety Act – On Wednesday, the House Energy and Commerce Subcommittee on Health held a hearing to examine a discussion draft the Overdose Prevention and Patient Safety Act (H.R. 3545) that would permit substance use disorder (SUD) treatment records, currently governed under 42 CFR Part 2 (often called “Part 2”) to be shared in accordance with HIPAA. The bill would also increase the penalties in the event of disclosure, add breach notification requirements, and provide discrimination prohibitions to protect people seeking and receiving SUD treatment. Read More
HHS Budget Hearing – On Thursday, the Department of Health and Human Services Secretary Alex Azar testified at the Senate Appropriations Labor, HHS, and Education subcommittee on HHS’ fiscal 2019 budget request. Read More
Military Times: Lawmakers advance VA health care overhaul, medical marijuana research for vets – On Tuesday, House lawmakers advanced plans to increase veterans’ access to private-sector doctors, expand caregiver stipends to more former military families and increase medical marijuana research for veterans care in a flurry of votes before the House Veterans’ Affairs Committee. Read More
Politico: Opioid distributors blame pharmacies, docs for crisis – Five of the nation’s top opioid distributors on Tuesday told a House panel that responsibility for the opioid crisis rests with bad actors at pharmacies and doctors who wrote too many prescriptions, not with their companies. Read More
NPR: Farm Bill Could Undo Part Of The Affordable Care Act – Although the GOP repeal-and-replace mantra seems to have quieted, some Republican lawmakers continue efforts to get around the sweeping federal health law’s requirements. Sometimes that happens in surprising places. Like the farm bill. Read More
Washington Times: Sen. Lamar Alexander: Obamacare stabilization effort is dead – Senate Health Committee Chairman Lamar Alexander says legislative efforts to stabilize the Obamacare markets this year are dead and that it’s up to states and the Trump administration to provide relief from rising insurance rates. Read More
Affordable Prescription Drug Task Force Lays Out Priorities for Trump to Lower Prescription Drug Prices – In anticipation that President Donald Trump will belatedly present at 2:00pm Friday, May 11, his plans to address the soaring cost of prescription drugs, the Affordable Prescription Drug Task Force released a list of key provisions that any effective plan should include. Read More
Kaiser Health Tracking Poll: Preview of the Role of Health Care in the 2018 Midterm Campaigns – At the beginning of the 2018 primary season, congressional candidates’ positions on President Trump are weighing greater on most voters’ minds than any issue – including health care. Read More
Legislation
On Monday, the Senate passed the Improving Access to Behavioral Health Information Technology Act (S. 1732) which would expand an existing incentive payment program to include behavioral health providers, which the bill defined as psychiatric hospitals, community mental health centers, clinical psychologists, and hospitals or mental health providers that participate in state plans. Read More
On May 9, Rep. Peter Roskam (R-IL) introduced a bill (H.R. 5725) to direct the Secretary of Health and Human Services to submit to Congress a report on the extent to which Medicare Advantage plans offered under part C of the Medicare program include supplemental health care benefits designed to treat or prevent substance use disorders. Read More
On May 7, Rep. Mike Kelly introduced the Protecting Seniors From Opioid Abuse Act (H.R. 5684) to amend title XVIII of the Social Security Act to expand eligibility for medication therapy management programs established under part D of the Medicare program to include certain individuals who are at risk for prescription drug abuse. Read More
On May 7, Rep. Richard Hudson (R-NC) introduced the SOUND Disposal and Packaging Act (H.R. 5687) to amend the Federal Food, Drug, and Cosmetic Act to require improved packaging and disposal methods with respect to certain drugs, and for other purposes. Read More
Administration
Politico: Trump’s ‘America First’ agenda on drug pricing could backfire around the world – President Donald Trump wants Americans to get lower prices for medicines — and the rest of the world may pay for it. His “America First” message on drugs at home, coupled with pro-pharmaceutical industry policies abroad, could lead to higher costs for patients around the world — without making drugs more affordable for those in the U.S. Trump on Friday plans to deliver his long-promised speech on how to lower drug costs, addressing an industry he has in the past accused of “getting away with murder.” Global health officials worry he will also target practices that keep medicines affordable in other countries. Read More
4 Takeaways From Trump’s Plan To Rescind CHIP Funding – President Donald Trump wants to employ a rarely used budget maneuver called “rescission” to eliminate $15 billion in federal spending, including $7 billion from the popular Children’s Health Insurance Program (CHIP). Read More
Trump lays out his vision for lower drug prices – On Friday, The Trump administration has released a 44-page plan aimed at lowering drug costs. Read More
HHS
Patients pave the way for interoperability – Healthcare data, once confined to a single hospital or system, are increasingly moving more freely outside the constraints of an electronic health record system, giving patients added control over their care and arming providers with the information they need to close gaps in care. Read More
CMS
CMS Announces Agency’s First Rural Health Strategy – On Monday, the Centers for Medicare & Medicaid Services (CMS) released the agency’s first Rural Health Strategy intended to provide a proactive approach on healthcare issues to ensure that the nearly one in five individuals who live in rural America have access to high quality, affordable healthcare. Read More
Verma draws the line on Medicaid limits, ACO risk contracts – CMS Administrator Seema Verma offered hospital executives on Monday good and bad news on Medicaid coverage limits and accountable care organizations’ risk contracts. Read More
Judges mull reviving hospitals’ challenge to 340B Medicare cuts – A panel of federal appellate judges on Friday considered reviving the American Hospital Association’s challenge to Medicare 340B reimbursement cuts, questioning whether the changes were made properly. Although the Trump administration claimed that the CMS has the authority to adjust Medicare drug reimbursements for 340B hospitals through rulemaking, the three judges for the U.S. Court of Appeals for the District of Columbia Circuit found inconsistencies in the government’s argument. Read More
FDA
FDA on the hunt for its own EHR system – The Food and Drug Administration is looking for a “large electronic medical record system” to conduct research about adverse drug reactions. The FDA’s Bioinformatics and Biostatistics Division will use the EHR to look into the “safety and surveillance of FDA regulated products,” according to the request for quote the agency posted earlier this week. Specifically, researchers will analyze VA data to look for adverse side effects from medications. It will use the EHR to develop “novel data mining and data visualization” to apply to the data. Read More
Emerging issues of misuse and abuse of OTC loperamide challenge FDA to address a new turn in the opioid addiction crisis, while maintaining access for patients – Food and Drug Administration Commissioner Scott Gottlieb writes a blog post on the opioid epidemic and new patterns of abuse and misuse of different drugs. Read More
Spring Unified Agenda: FDA’s Anticipated Upcoming Regulatory Work – On Wednesday, the federal government published the Spring 2018 “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), which provides federal agencies with the opportunity to update the American public on the government’s regulatory priorities. Read More
DEA
DEA Must Divulge National Data In Opioid MDL, Judge Rules – The U.S. Drug Enforcement Administration (DEA) must disclose nationwide data on opioid sales as part of multidistrict litigation over the opioid crisis, an Ohio federal judge ruled Tuesday, saying it will expand on state information that has been “extremely informative” for plaintiffs’ lawyers. Read More
States
Modern Healthcare: Illinois wins Medicaid flexibility under Trump – Illinois Gov. Bruce Rauner has received federal approval to use $2 billion in Medicaid funding differently, a longtime goal that his predecessor Pat Quinn originally sought. Read More
The Hill: New Hampshire wins approval for Medicaid work requirements – Medicaid beneficiaries in New Hampshire will have to work, attend school or perform community service to be eligible for benefits under a new waiver approved by the Trump administration. Under the program, adults aged 19 to 64 will be required to participate in 100 hours per month of “community engagement activities,” such as employment, education, job skills training or community service. Read More
Oklahoma legislation will require Medicaid recipients to work before they can receive benefits – A piece of Oklahoma legislation will require able-bodied Medicaid recipients to work in order to receive benefits. Monday, Governor Mary Fallin signed legislation that would direct the Health Care Authority to apply for a waiver that institutes work requirements for Medicaid. Read More
Primaries
This week, Indiana, North Carolina, Ohio, and West Virginia all held their state primary elections. See below and Read More:
In West Virginia, state Attorney General Patrick Morrisey won the Senate Republican primary and will face Senator Joe Manchin (D-WV) in November.
Businessman and former state Rep. Mike Braun won Indiana’s GOP Senate primary and will challenge Senator Joe Donnelly (D-IN) who ran unopposed.
In Ohio, Rep. Jim Renacci (R-OH) won the Republican Senate primary. He will face Democratic Senator Sherrod Brown (D-OH), who ran unopposed.
Rep. Robert Pittenger (R-NC) became the first incumbent this year to lose a primary challenge, conceding to pastor Mark Harris in the 9th District primary. He is expected to take on Democrat Dan McCready, an Iraq War veteran.
On May 15, Idaho, Nebraska, Oregon, and Pennsylvania will head to the polls. Read More
Foley Health Care Law Today
Our attorneys at Foley pride themselves on having a first-hand understanding of health care’s business and legal challenges. Health Care Law Today is your go-to resource for information and perspectives on the latest news and developments in health care law and how it relates to and impacts the industry and those with related business interests. See below for some of the blog’s top stories:
Scientific Research Misconduct vs. Fraud: How to Tell the Difference – For years, misconduct in scientific research was policed primarily by the Office of Research Integrity (ORI) at the U.S. Department of Health and Human Services.1 After a lengthy and confidential review, an institution suspected of producing false or fraudulent research was either cleared of the charges or required to issue retractions and pay back any federal grants that had been tainted by misconduct. Read More
The Week Ahead
The House and Senate are in session this week. The House is set to vote on the sweeping farm bill next week, according to the majority leader, but Republicans are divided on its outlook. President Donald Trump released his plans to combat drug pricing on Friday.
On Tuesday, the Senate Health, Education, Labor and Pensions Committee will hold a hearing on the Oversight 340B Drug Pricing Program. Ready More Read More
On Thursday, the House Veterans’ Affairs Subcommittee on Oversight and Investigations will hold a hearing on VA Health research. Read more Read More
On Thursday, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies will hold a hearing on NIH Budget. Read More 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, DC for notable health care developments.
