United States: Health Care Policy Newsletter - 21 May 2018

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.

Health Care Policy Review (May 14-18, 2018)

CONGRESS

Legislation and Committee Activity

House Opioid Vote – Rep. Greg Walden (R-OR), said Thursday he has fulfilled his commitment to advance legislation to combat the opioid crisis to the House by Memorial Day. The House Energy and Commerce Committee, where Walden serves as Chairman, advanced 32 more bills Thursday — for a total of 57 measures sent to the full House to address the opioid crisis in Oregon and across the country. Read More

A Sustainable Solution To The Evolving Opioid Crisis: Revitalizing The Office Of National Drug Control Policy Hearing – On Thursday, the House Oversight Committee held a hearing to discuss the revitalization of the Office of National Drug Control Policy to address the nationwide opioid epidemic. Read More

Ways & Means Opioid Markup – On Wednesday, the House Ways and Means Committee held a markup and today advanced seven bipartisan bills aimed at addressing the opioid crisis. Read More

On Tuesday, Reps. Mike Bishop (R-MI) and Bill Pascrell (D-NJ) introduced the Securing the International Mail Against Opioids Act of 2018 (H.R. 5788) which will impose new requirements on the Postal Service and Customs and Border Protection (CBP) to address the opioids epidemic by securing the international mail. Read More

On Thursday, Sens. Shelley Moore Capito (R-WV) and Catherine Cortez Masto (D-NV) introduced the Opioid Addiction Recovery Fraud Prevention Act of 2018 (S.2842) which would prohibit the marketing of "bogus" opioid treatment programs or products. Read More

On Monday, Sen. John Thune (R-SD) introduced the Fighting Opioid Abuse in Transportation Act (S. 2848) which would improve Department of Transportation controlled substances and alcohol testing. Read More

The Hill: GOP chairman plans hearings on Trump drug pricing proposals – House Ways and Means Committee Chairman Kevin Brady (R-Texas) said Tuesday that he plans to conduct hearings on some of President Trump's new proposals to bring down drug prices. Brady said it is too early to tell if the committee will move legislation on the issue, but said he wanted to consider the ideas. Read More

The Hill: Overnight Health Care —ObamaCare premium wars are back – But they're looking different than in years past. During the Obama administration, Republicans railed against Obamacare's premium hikes while pledging to repeal and replace the law. But that repeal push ended in failure last year, Democrats say the political winds have shifted in their favor. Read More

NIH Director Testifies at Appropriations Hearing – On Thursday, NIH Director Francis Collins testified before the Senate Appropriations Labor-HHS-Education Subcommittee on the proposed 2019 fiscal budget for the National institutes of Health. Read More

Modern Healthcare: Senate committee turns 340B spotlight on drugmakers – Lawmakers turned their sharp scrutiny of the 340B program on drugmakers Tuesday, questioning why states and providers don't know the ceiling prices within the drug discount program. Read More

Senator Murray Highlights Importance of Funding Health Research, Criticizes Trump Proposal to Undermine Investments in Bipartisan Budget Deal – On Wednesday, U.S. Senator Patty Murray (D-WA), top Democrat on the Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee (LHHS), highlighted the importance of continuing to invest in groundbreaking, lifesaving medical research during a committee hearing on medical research funding. Read More

Politico: McConnell threatens to kill August recess – Senate Majority Leader Mitch McConnell is seriously considering scrapping some or all of the August recess this year, according to senators and aides. The GOP leader told Republican chairmen on Wednesday that he would speak to Senate Minority Leader Chuck Schumer (D-N.Y.) about whether Democrats are willing to cooperate at all on spending bills and President Donald Trump's nominations in order to avoid scuttling this year's four-week break. Read More

Senators Send Letter to Request CMS Administrator at Hearing – On Monday, the Senate Homeland Security and Governmental Affairs Committee sent a letter to CMS Administration, Seema Verma, asking her to testify at a hearing in mid-June and noting if Verma does not confirm her appearance, the panel may be forced to seek alternative means to compel her to testify. Read More

ADMINISTRATION

HHS

Health Information Technology: Certification and Interoperability Enhancements – Last week, the federal government released its Spring unified agenda, included was a proposed rule to update the ONC Health IT Certification Program (Program) by implementing certain provisions of the 21st Century Cures Act. Thisincludes conditions and maintenance of certification requirements for health information technology (IT) developers, the voluntary certification of health IT for use by pediatric healthcare providers, health information network voluntary attestation to the adoption of a trusted exchange framework and common agreement in support of network-to-network exchange, and reasonable and necessary activities that do not constitute information blocking. The rulemaking would also modify the Program through other complementary means to advance health IT certification and interoperability. Read More

HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs – Notice of the Department of Health and Human Services announces a blueprint to improve the affordability and accessibility of prescription drugs and a request for information on proposed policies. The agency requests information on the impacts of federal drug rebate programs and Affordable Care Act taxes and rebates on competition. Comments on any other policies that may impact drug list prices, net prices, and out-of-pocket drug spending are also requested. Comments are due July 16, 2018. Read More

NPR: Trump Administration's 3 Biggest Ideas For Lowering Drug Prices – Azar was making the point that in the area of drug prices, the head of HHS — which runs the Medicare and Medicaid programs and buys about $130 billion in prescription drugs each year — can make a lot of changes in the pharmaceutical market. And he doesn't need congressional approval to do it. Read More

Bloomberg: Trump Administration to Propose New Curbs on Abortion – The Trump administration will propose new rules to bar Planned Parenthood and other health-care providers from performing abortions at facilities that receive federal family planning funds, an administration official said on Thursday night. Read More

CMS

The Hill: Overnight Health Care —Trump official won't OK lifetime limits on Medicaid – Verma once again made it clear that the Trump administration isn't giving conservative states a blank check for changes to Medicaid. During an event hosted by The Washington Post, Verma said the administration will not approve any requests by states to impose lifetime limits. Read More

Modern Healthcare: Medicaid payment for opioid treatment embroiled in politics over loosening restrictions – In Cincinnati, wait times for opioid addicts seeking residential treatment have dropped as the city's providers are banding together to manage the barrage of cases across different settings. In January, Mercy Health partnered with 10 outpatient treatment centers. The hospital offers short-term detox stays for patients, then the clinics take over and manage the long-term treatment, nearly on demand. After they have stabilized, patients can decide whether they want residential treatment or outpatient care. Read More

Pharmacy Gag Clauses – On Thursday, CMS sent a letter to plans that participate in Medicare Part D advising them to drop "gag clauses" that some health plans and pharmacy benefit managers include in their contracts with pharmacies. Read More

FDA

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults – The U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD. Read More

Modern Healthcare: FDA calls out drugmakers to promote greater generic competition – The U.S. Food and Drug Administration on Thursday called out 39 drugmakers for potentially blocking access to their drug samples in an effort to delay generic competition. Read More

Veteran Affairs

Nextgov: VA Signs $10 Billion Health Records Contract With Cerner – The Veterans Affairs Department inked a 10-year, $10 billion contract Thursday with Cerner Corp. to adopt the same commercial electronic health records system as the Pentagon. Read More

STATES

The Hill: Court rules Dem states can intervene in ObamaCare lawsuit – A federal judge granted a request from states looking to defend ObamaCare in a lawsuit filed in Texas. California Attorney General Xavier Becerra, and 16 other state attorneys general in Democratic states were granted the right to intervene in the lawsuit that seeks to dismantle the Affordable Care Act (ACA). Read More

Vermont Drug Importation Program Will Need Federal Approval – Vermont is attempting to create a first-in-the-nation program to allow the wholesale importation of prescription drugs from Canada, but first the state needs approval from skeptical White House officials. Republican Gov. Phil Scott signed a bill Wednesday that passed with overwhelming support from Vermont's three political parties. Read More

LePage administration responds to Medicaid lawsuit, blames Legislature for not funding expansion – The DHHS says in a court filing that without the funds it 'lacks legal authority' to spend on expansion, but the plaintiffs point to unexpended funds in the state's Medicaid account and say the voter-approved law is being violated. Read More

SF Gate: Covered California premiums projected to rise 11 percent in 2019 – The cost of health insurance continues to climb in California. Estimates released Thursday by Covered California, the state insurance marketplace, project that premiums in the individual market will rise 11 percent next year, while enrollment in the exchange — which is larger than any other state's — will drop 12 percent. Read More

Primaries

NY Times: 3 Key Takeaways From Tuesday Night – Four states held primary elections on Tuesday, but one loomed the largest by far: Pennsylvania. In a state that has emerged as one of the most important battlegrounds of 2018, Democrats settled a cluster of chaotic nomination fights — and Republicans, despite being on the defensive, sent a signal of strong support for President Trump. Read More

On May 22, Arkansas, Georgia, Kentucky, and Texas 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. For some of the blog's top stories – Read More https://www.healthcarelawtoday.com/

THE WEEK AHEAD

The House and Senate are both in session next week.

Washington Examiner: House to vote on 'right to try' bill next week – The House will vote this week on the Right to Try Act (S. 204), which would give terminally ill patients access to possibly life-saving experimental medicine. House Majority Leader Kevin McCarthy (R-CA) made the announcement Thursday morning, which comes nearly two months after the House passed a different version of right to try, but could not get it through the Senate. The Senate unanimously passed its version of the bill in August. That version was introduced by Sen. Ron Johnson (R-WI) and Sen. Joe Donnelly (D-IN) and is the one the House is now poised to vote on. Read More

On May 22, Senate Health, Education, Labor and Pensions (HELP) Committee will hold a hearing on the Healthcare Workforce Issues. Read More

On May 22, Senate Commerce, Science and Transportation Committee plans to mark up, the Fighting Opioid Abuse in Transportation Act (S. 2848). Read More

On May 22, Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies will hold a markup on Agriculture-FDA-Rural Development Appropriations. Read More

On May 23, Senate Appropriations Subcommittee on Interior, Environment and Related Agencies will hold a hearing on Indian Health Service Budget. Read More

On May 23, Senate HELP Committee will hold a markup on the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (S.2852). Read More

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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