Capitol Hill Healthcare Update

HOUSE PANEL TO EXAMINE POTENTIAL CHANGES TO STARK LAW

Senior Health and Human Services (HHS) officials are scheduled to testify this week before a House subcommittee examining whether laws governing physician self-referral are an impediment to coordinated care.

HHS Deputy Secretary Eric Hargan and Deputy General Counsel Kelly Cleary are scheduled to testify Tuesday before the House Ways and Means Health Subcommittee.

Subcommittee Chairman Peter Roskam (R-Ill.) has said the physician self-referral law, or “Stark Law,” impedes value-based reforms that reward better outcomes and higher-value care.

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Capitol Hill Healthcare Update

LAWMAKERS COOL TO TRUMP PLAN ON HHS, GOVERNMENT REORGANIZATION

The response from lawmakers on Capitol Hill to the White House plan to reorganize the federal government – including proposed changes to multiple healthcare agencies – ranged from lukewarm to outright opposition.

President Donald J. Trump’s plan would rebrand Health and Human Services (HHS) as the “Department of Health and Public Welfare.” It would consolidate certain welfare and nutrition assistance programs, now run by the Agriculture Department, into the new department.

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Capitol Hill Healthcare Update

HOUSE OKs DOZENS OF OPIOID-RELATED BILLS; MORE VOTES SCHEDULED

The House last week approved 38 bills that lawmakers hope will stem the opioid epidemic, and it scheduled votes this week on at least a dozen more.

Most bills were noncontroversial, and others thought to be contentious – like giving the Postal Service more tools to track foreign mail shipments into the United States – easily won House approval.

House Republicans plan more votes on opioid bills this week. Then GOP leaders will package the individual bills into one comprehensive measure to send to the Senate.

Meanwhile, the Senate Finance Committee last week approved a combined package with 22 provisions that aim to crack down on opioid abuse and expand access to treatment. The bill would expand telehealth coverage, standardize electronic prior authorizations and remove Medicaid lifetime limits for substance abuse treatment.

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Capitol Hill Healthcare Update

HOUSE TO VOTE ON DOZENS OF OPIOID BILLS WHILE SENATE READIES COMPREHENSIVE MEASURE

The House this week will begin considering some of the 70 different opioid bills that have been approved by eight different committees, focusing on prescribing, enforcement, and Medicare and Medicaid coverage of treatment options.

House Majority Leader Kevin McCarthy (R-Calif.) announced last week that several dozen noncontroversial bills will be considered either by voice vote or under expedited procedures that require supermajorities to pass but allow House leaders to move them quickly. Other bills – like relaxing health privacy rules for drug abuse treatment records and allowing Medicaid to cover in-patient drug rehab costs – will be debated on the House floor, with opportunities for amendments.

Bills receiving votes this week include establishing a new category of synthetic opioids and other drugs under the Controlled Substances Act, allowing low-income housing vouchers to be used to aid recovering addicts, and increasing the tracking of parcels and mail into the United States.

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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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