FDA NOMINATION HEARING DRIVES THE WEEK IN HEALTH POLICY President Trump’s nominee to lead the Food and Drug Administration, Dr. Stephen Hahn, will appear Wednesday before the Senate Health, Education, Labor and Pensions Committee for a hearing on his nomination. Hahn, an oncologist and chief medical executive at MD Anderson Cancer Center in Houston, is … Continue Reading
COMPREHENSIVE DRUG BILL STALLS WHILE HOUSE PUSHES SMALLER MEASURES House Democrats are planning to take up more narrow bills addressing prescription drug costs while their broad legislation is delayed as the Congressional Budget Office (CBO) works on estimating its budgetary impacts. Majority Leader Steny Hoyer, D-Md., said the Democrats’ bill now won’t receive a floor … Continue Reading
DEMOCRATS PRESS FOR PRE-THANKSGIVING VOTE ON DRUG PRICING BILL The House Ways and Means Committee last week approved an amended version of legislation that would overhaul how Medicare and private insurers reimburse for prescription drugs, setting up what Democrats hope will be a pre-Thanksgiving vote on the House floor. It was the third House committee … Continue Reading
PELOSI INTRODUCES DRUG PRICING BILL WHILE TRUMP PUSHES SENATE VERSION House Democrats introduced legislation last week to lower prescription drug prices – including allowing Medicare to negotiate prices with manufacturers – and set an aggressive timeline to approve the bill by Halloween. The legislation would allow the government to negotiate prices annually for at least … Continue Reading
PELOSI DRUG PRICE PLAN EXPECTED THIS WEEK House Speaker Nancy Pelosi, D-Calif., is expected to release her long-awaited plan this week to address prescription drug costs, according to congressional staff. A draft summary of the proposal that circulated last week would allow the government to negotiate prices with manufacturers on 250 drugs and impose sweeping … Continue Reading
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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