CMS aims to decrease burdens and increase innovation in Medicare parts C and D with new April 2018 guidance

In regulations published on April 16, 2018, the Centers for Medicare & Medicaid Services (CMS) issued two new documents containing guidance primarily on the Medicare Advantage (MA) program and on the Medicare prescription drug benefit program. Taken together, these two documents – a finalized regulation outlining policy changes for Contract Year 2019 (Final Rule) and a 2019 Rate Announcement and Final Call Letter (Final Call Letter) – represent further steps by the Trump administration to reduce regulatory obstacles to better healthcare delivery, to address prescription drug issues, and to improve choices available to Medicare parts C and D plan enrollees. These Final Rules, with limited exceptions, will be applicable January 1, 2019.

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Capitol Hill Healthcare Update

HOUSE PANEL TO QUESTION GOTTLIEB ON FDA BUDGET

Food and Drug Administration (FDA) Commissioner Scott Gottlieb will testify Tuesday before a House appropriations subcommittee on his agency’s fiscal 2019 budget – which includes the largest proposed funding increase in its history.

President Trump earlier this year proposed boosting the FDA’s budget by $473 million – to nearly $3.3 billion. The FDA separately receives an additional $2.5 billion in industry user fees from pharmaceutical and medical technology manufacturers.

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Capitol Hill Healthcare Update

CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS

Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential legislative solutions.

The Senate HELP Committee will hold a hearing Wednesday on bipartisan legislation that, among other things, would give the Food and Drug Administration (FDA) and National Institutes of Health (NIH) flexibility to promote alternative pain treatments, allow nurse practitioners and physician assistants to prescribe medication-assisted treatments, and establish uniform guidelines for local opioid recovery centers.

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Capitol Hill Healthcare Update

CONGRESS WORKS TO PASS BUDGET BEFORE FRIDAY’S SHUTDOWN DEADLINE

House leaders are pushing to schedule a vote this week on a $1.3 trillion budget agreement that would give the Senate enough time to pass it before a Friday deadline when government funding expires.

Without action this week by Congress, the government would shut down for the third time this fiscal year. A series of unresolved policy disagreements – including about healthcare – has prevented lawmakers from reaching an agreement to fund the government through fiscal 2018, which ends Sept. 30.

House leaders say they hope to wrap up discussions today and release legislative text of the budget agreement tonight, setting up a House vote Wednesday. The Senate would follow suit, likely Friday.

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Capitol Hill Healthcare Update

HOUSE VOTE SET FOR UPDATED ‘RIGHT-TO-TRY’ LEGISLATION

The House will vote Tuesday on updated but still controversial legislation that would give terminally ill patients wider access to prescription drugs that haven’t won approval by the Food and Drug Administration.

House Energy and Commerce Committee Chairman Greg Walden, R-Ore., said the “right-to-try” bill would be a modified and more narrow version of legislation introduced earlier by Reps. Brian Fitzpatrick, R-Pa., and Andy Biggs, R-Ariz.

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Capitol Hill Healthcare Update

CONGRESS SCRAMBLES TO COMPLETE BUDGET IN ADVANCE OF DEADLINE

Lawmakers are working overtime – including on key healthcare issues – to wrap up work on a $1.2 trillion omnibus budget bill that would fund the government for the balance of the fiscal year.

Congress last month reached agreement on total spending, but now lawmakers face a March 23 deadline to finalize funding specifics for dozens of departments and agencies and thousands of federal programs. Lawmakers will add $6 billion to crack down on opioid abuse, and medical research at the National Institutes of Health and veterans’ healthcare programs also are expected to receive funding boosts.

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Capitol Hill Healthcare Update

CONGRESS RECONVENES WITH FOCUS ON OPIOID LEGISLATION

Congress reconvenes today after a weeklong recess, and a House subcommittee is scheduled to begin a series of hearings focusing on bipartisan efforts to combat the opioid epidemic, while a Senate committee plans to discuss how technology can curb opioid abuse.

The House Energy and Commerce Health Subcommittee on Wednesday will consider eight bills related to law enforcement and patient safety, including legislation that would authorize new funding for opioid education, loosen restrictions on prescriptions via telemedicine of controlled substances used to treat addiction, and crack down on synthetic opioids. Another bill would call on the Drug Enforcement Administration to develop guidelines to train pharmacists and other healthcare providers on fraudulent or forged prescriptions.

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Capitol Hill Healthcare Update

TRUMP TO RELEASE FISCAL 2019 BUDGET THIS MORNING

The White House this morning is releasing President Trump’s fiscal 2019 budget blueprint, which will include funding requests for HHS, FDA, CMS and dozens of other healthcare-related federal agencies.

The White House says the budget will call for $17 billion for opioid-related spending next year, including for HHS’ efforts to combat the epidemic by expanding access to prevention, treatment and recovery support services as well as support for mental health.

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Capitol Hill Healthcare Update

HEALTHCARE PROVISIONS COULD BE TIED TO BUDGET DEAL TO AVERT GOVERNMENT SHUTDOWN

Congress is expected this week to approve a fifth stopgap budget bill to keep the government open in advance of a Thursday shutdown deadline, and key healthcare provisions could be included in the budget package.

If Congress only extends current funding into March, GOP leaders could include a renewal of the federal community health centers program to attract Democratic votes. That bill also could include a series of expired Medicare programs like the Medicare-Dependent Hospital program, the enhanced Low-Volume Adjustment program, the ambulance add-on payment program and payments for home infusion drugs.

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Capitol Hill Healthcare Update

HEALTHCARE LIKELY TAKES BACK SEAT IN TRUMP’S STATE OF THE UNION ADDRESS

After a tumultuous year on Capitol Hill – with repeated efforts to repeal the Affordable Care Act and stalled attempts to renew the Children’s Health Insurance Program – President Donald Trump isn’t likely to focus on healthcare policy in his State of the Union address Tuesday night.

White House aides previewing the speech this weekend said its major themes will focus on economic growth, infrastructure, immigration and national security. Except for calling for more funding to combat the opioid crisis or highlighting that the ACA’s individual mandate was repealed in last month’s tax cut legislation, the president isn’t expected to address major healthcare policy.

One of Trump’s guests in the gallery is expected to put a “human face on the opioid crisis and [highlight] the heroes involved in that effort,” according to a White House official previewing the speech this weekend to stakeholders.

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