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Capitol Hill Healthcare Update

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. MAJOR HEALTH POLICY UNLIKELY IN POTENTIAL DEBT-SPENDING DEAL As House Speaker Nancy Pelosi, D-Calif., and the Trump administration edge closer to a sweeping agreement to avoid a government shutdown and debt default, it’s increasingly unlikely major healthcare provisions … Continue Reading

Capitol Hill Healthcare Update

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. McCONNELL WANTS BIPARTISAN DEAL ON DRUG PRICES BY JULY To schedule time for debate in the Senate on legislation to lower prescription drug prices, Majority Leader Mitch McConnell, R-Ky., wants a bill that’s thoroughly bipartisan and ready to … Continue Reading

Clarity and Transparency: DOJ Issues Updated Corporate Compliance Guide

By Susrut A. Carpenter, Carl W. Hittinger and George A. Stamboulidis On April 30, 2019, the Criminal Division of the U.S. Department of Justice (“DOJ”) released a new corporate compliance guidance document for prosecutors titled “Evaluation of Corporate Compliance Programs” (“Guidance”). The Guidance sheds light on how the DOJ evaluates the effectiveness of a company’s compliance program – whether … Continue Reading

Capitol Hill Healthcare Update

Here is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. DRUG PRICES: CONGRESS RETURNS, PICKS UP WHERE LAWMAKERS LEFT OFF Congress reconvenes today after a two-week spring recess, with lawmakers in both parties continuing their focus on prescription drug prices. House and Senate committees are planning a … Continue Reading

Two rules both alike in dignity: CMS and ONC release proposed rules to advance interoperability

On Feb. 11, 2019, two Department of Health and Human Services (HHS) agencies, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS), released their long-awaited proposed rules designed to further HHS’ goal of promoting electronic health information interoperability and implementing many of the provisions … Continue Reading

PE Investment in Physician Practice Management ‒ What’s to Come in 2019?

Private equity (PE) investors entered the physician practice management (PPM) market in 2011, and eight years later the PPM sector continues to be a ripe middle market for PE investors looking to diversify their portfolios. However, as the healthcare market continues to change in light of increasing vertical integration between payors and providers and disruption … Continue Reading

Capitol Hill Healthcare Update

This week’s “Capitol Hill Healthcare Update” includes the latest on a pending Senate vote on opioid legislation as Congress races to enact a response to the crisis before the November election; the Senate votes to expand Sunshine Act disclosure requirements; and a key House Republican backs requiring drug manufacturers to include prices in their ads; … Continue Reading

Capitol Hill Healthcare Update

This week’s “Capitol Hill Healthcare Update” includes the latest on a series of healthcare bills scheduled for House votes, including one to repeal the medical device tax; Food and Drug Administration (FDA) Commissioner Scott Gottlieb and National Institutes of Health (NIH) Director Francis Collins’ scheduled testimony on before a House committee; reaction from congressional leaders … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 – … Continue Reading

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 … Continue Reading

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 … Continue Reading

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 … Continue Reading
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