Capitol Hill Healthcare Update

By Adam Higgins and Chris Jones on November 18, 2019 Posted in Uncategorized

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 seen by lawmakers as a blank slate – he has a strong resume as a physician but scant policy experience. However, HELP Chairman Lamar Alexander, R-Tenn., announced he supports Hahn after meeting with the nominee Nov. 6. Meanwhile, Democrats are eager to replace current acting FDA Commissioner Brett Giroir because of concerns over his positions on social issues like abortion.

Still, Hahn is sure to face wide-ranging questions from lawmakers about the mission of the agency he hopes to lead. Senators are also likely to seek commitments from him to focus on certain policy issues.

Given Hahn’s lack of policy track record, senators will want details of his views on regulation of food, drugs and medical devices. Hahn can expect lawmakers to press him on ways the FDA can help to lower prescription drug costs while protecting medical innovation, including Trump’s efforts to allow drug importation. E-cigarettes will be a hot topic, as will cannabis regulation and efforts to stem opioid abuse.

Capitol Hill Healthcare Update

By Chris Jones and Adam Higgins on November 12, 2019 Posted in Uncategorized

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 vote until December – with some House staff fretting the vote could slip to January as leaders wait for CBO forecasts ahead of tough negotiations with moderate and liberal lawmakers.

CBO last month estimated the bill would save Medicare $345 billion over seven years by forcing manufacturers to negotiate prices with the government on 250 drugs and to apply those discounts to private health plans nationwide. Democrats want to redirect those savings to expand Medicare coverage for dental, vision and hearing services, leading to a delay as CBO figures out how much that would cost.

Capitol Hill Healthcare Update

By Chris Jones on October 28, 2019 Posted in Uncategorized

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 to vote on the bill, which would direct the government to negotiate prices with manufacturers on several dozen high-cost drugs, saving an estimated $345 billion over 10 years. The committee separately approved three bills that would expand Medicare coverage to include dental, vision and hearing services, and those provisions are expected to be attached to the drug pricing bill.

Capitol Hill Healthcare Update

By Chris Jones on September 23, 2019 Posted in Uncategorized

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 25 of the highest-cost brand-name drugs that lack generic or biosimilar competition in the Medicare Part D and Part B programs. It also would require manufacturers to cover 30% of the costs of Part D catastrophic coverage, which Medicare currently covers.

Republicans criticized the proposal, focusing on the behind-closed-doors process by which Democratic leaders developed the legislation. But Republicans lack the votes to stop it – or even amend it – in the House, where rules give majority Democrats the power to advance their bill.

Capitol Hill Healthcare Update

By Adam Higgins on September 16, 2019 Posted in Uncategorized

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 fines on companies that failed to participate. The negotiated price – which manufacturers say would be de facto price controls – also would extend to the prices of drugs sold through commercial insurance.

Two House committees plan to vote on Pelosi’s bill in the coming weeks, setting up a potential vote on the House floor by the end of October. In an apparent nod to President Donald Trump’s proposal to base physician-administered drug prices on an index of prices paid in certain European countries, Pelosi would copy that formulation for Medicare Part D drugs, too.

Capitol Hill Healthcare Update

By Chris Jones and Adam Higgins on September 9, 2019 Posted in Healthcare

UPDATE ON DRUG PRICING LEGISLATION AS CONGRESS RECONVENES

Congress reconvenes this week after a monthlong summer recess and begins what likely will be a final push toward overhauling prescription drug prices, but lack of consensus on the underlying policy and the intensifying 2020 presidential campaign will complicate efforts to advance a bill to President Donald Trump’s desk.

House Speaker Nancy Pelosi, D-Calif., is finalizing long-awaited legislation centering on price negotiation for drugs that lack competition, and she could introduce legislation as soon as this week. But the secretive process – even to most members of the Democratic Caucus – is causing frustration. Progressive lawmakers say the speaker’s plan may not go far enough on calling for government negotiation with manufacturers over prices.

Capitol Hill Healthcare Update

By Chris Jones and Adam Higgins on July 22, 2019 Posted in Uncategorized

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 will be included.

Pelosi and Treasury Secretary Steven Mnuchin have been working to permanently lift sequester-imposed budget caps as well as the extend the government’s borrowing authority through July 2012. Mnuchin has warned that without congressional action Washington could reach the debt ceiling shortly after Labor Day.

Democrats want to wrap up a deal this week in advance of the House’s scheduled adjournment Friday, for a monthlong recess.

Capitol Hill Healthcare Update

By Chris Jones and Adam Higgins on July 15, 2019 Posted in Healthcare

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session.

SENATORS RACE TO FINISH DRUG PRICING BILL AS TRUMP PLANS STALL

With only 15 legislative days before a scheduled monthlong recess, Senate leaders are scrambling this week to seek consensus on ambitious legislation to lower prescription drug prices, particularly after major pharmaceutical industry initiatives by the Trump administration were derailed last week.

Senate Finance Committee leaders Charles Grassley, R-Iowa, and Ron Wyden, D-Ore., have been working for months on a package of bills to lower drug prices – and they are hinting a deal is close.

Read more >>

Capitol Hill Healthcare Update

By Chris Jones on June 24, 2019 Posted in Uncategorized

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 go before the end of July.

Although Finance Committee Chairman Chuck Grassley, R-Iowa, and the panel’s top Democrat, Sen. Ron Wyden, D-Ore., are continuing discussions over a drug pricing bill, Grassley said last week that he’s not overly optimistic on reaching consensus. Grassley said he and Wyden have reached agreement on 85% percent of the bill, but that finding agreement on the remaining 15%, he predicts, would be difficult.

The senators have discussed limiting seniors’ out-of-pocket expenses and calling for some changes to Medicare Part B and Part D, but not a wholesale structural overhaul – and not government negotiation of drug prices, which Grassley opposes.

Of the seven Senate Democrats seeking their party’s presidential nomination, all are backing government negotiation of drug pricing – a complicating political factor for Senate Democratic leaders, who might be forced to withhold support for any bill that doesn’t include government negotiation.

McConnell’s July deadline effectively means he’s doubtful drug pricing legislation can achieve bipartisan consensus after Labor Day, when the 2020 presidential campaign will be fully engaged. He also wants to keep the fall Senate schedule clear for budget, spending and debt issues, as lawmakers scramble again to avoid a government shutdown and a possible credit crisis.

Clarity and Transparency: DOJ Issues Updated Corporate Compliance Guide

By BakerHostetler on May 21, 2019 Posted in Uncategorized

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 white collar- or antitrust-oriented – focusing on the program’s design, implementation and practical application. Notably, this Guidance applies to the entire Criminal Division as opposed to only the Fraud Section, to which the prior 2017 guidance applied. In fact, the head of the DOJ’s criminal division, Assistant Attorney General Brian Benczkowski, in a speech at the 2019 Ethics and Compliance Initiative Conference, explained that one of the purposes of the Guidance is to “better harmonize the prior Fraud Section publication with other Department guidance and legal standards.”

Read the full Alert >>