Capitol Hill Healthcare Update

RYAN SAYS POTENTIAL COMPROMISE COMING ON RISK EVALUATION AND MITIGATION STRATEGY DRUGS

House Speaker Paul Ryan, R-Wis., last week said congressional leaders are trying to hammer out compromise legislation that would make it easier for generic manufacturers to obtain branded drugs that are protected under a Food and Drug Administration (FDA) safety program.

Ryan made the comment about the FDA’s Risk Evaluation and Mitigation Strategies (REMS) safety program during BakerHostetler’s 29th annual Legislative Seminar last week. Ryan didn’t offer specifics but said leaders on the House Energy and Commerce and Judiciary committees were working on compromise language that would speed generic manufacturers’ access to those drugs for bioequivalence testing.

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Proposed IPPS Rule Changes

The Centers for Medicare & Medicaid Services (CMS) recently released its proposed rules for the Hospital Inpatient Prospective Payment System (IPPS) for fiscal year (FY) 2019. As discussed below, the proposed rule focuses on promoting interoperability to reduce administrative burdens, increase efficiency and improve patient access while providing high-quality patient care. Comments on the proposed rule are due June 25, 2018.

Electronic Health Records (EHR) Program Update

CMS proposed significant changes to the Medicare and Medicaid Electronic Health Record (EHR) Programs. For starters, it renamed the program to Promoting Interoperability (PI) Programs to better reflect its focus on interoperability and improving patient access to health information. To maintain alignment across programs, CMS noted that the name change applies to the Merit-Based Incentive Payment System Advancing Care Information performance category.

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Capitol Hill Healthcare Update

LAWMAKERS PRAISE, CRITICIZE TRUMP PLAN ON DRUG PRICES

On Capitol Hill, reaction to President Donald Trump’s “American Patients First” plan to bring down prescription drug prices fell predictably along partisan lines: Republicans generally praised it, while Democrats criticized it for not going nearly far enough.

Republicans weren’t effusive in their support, but House Ways and Means Committee Chairman Kevin Brady, R-Texas, praised Trump for “leading the charge” to lower drug prices. House Energy and Commerce Committee Chairman Greg Walden, R-Ore., “applauded” Trump for “working to lower the cost of important medications.”

After Trump backed away from proposing that Medicare negotiate prices with drug companies – something he campaigned on in 2016 – Democrats sharply criticized the president. “I think very expensive champagne will be popping in drug company boardrooms across the country tonight,” said Rep. Elijah Cummings, the top Democrat on the House Oversight and Government Reform Committee.

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Capitol Hill Healthcare Update

GOP LAWMAKERS: EUROPE, CANADA ‘FREE RIDING’ ON US DRUG INNOVATION

More than two dozen House Republicans last week called on President Donald Trump to leverage upcoming trade negotiations to stop other nations from “free riding” on U.S. pharmaceutical innovations.

In a letter to Trump, Rep. Sean Duffy, R-Wis., wrote that foreign government price controls, market access barriers and theft of intellectual property undermine U.S. companies and place an unfair burden on American patients. The letter, which was signed by 27 House Republicans, singled out Germany, France, Japan, Australia and Canada as countries whose policies effectively force U.S. patients to shoulder a disproportionate share of research and development costs.

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Capitol Hill Healthcare Update

AZAR ILLNESS DELAYS WHITE HOUSE ANNOUNCEMENT ON DRUG PRICING INITIATIVE

Health & Human Services (HHS) Secretary Alex Azar is recovering at his home in Indianapolis following his second hospitalization in less than a week to treat a bowel condition, delaying a scheduled Trump administration announcement this week on initiatives to control prescription drug prices.

The White House on Sunday announced it was postponing this week’s event, saying it would be rescheduled for the “near future.” A senior White House aide last week said the announcement is now tentatively scheduled for May 8 but could be delayed further because of President Donald Trump’s official and political travel scheduled for next month.
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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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