Capitol Hill Healthcare Update

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.

Read more on BakerHostetler’s Ohio Clock blog >>

Capitol Hill Healthcare Update

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.

Read more on BakerHostetler’s Ohio Clock blog >>

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 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.

Read more on BakerHostetler’s Ohio Clock blog >>

Capitol Hill Healthcare Update

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.

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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.

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.

Read more on BakerHostetler’s Ohio Clock blog >>

Clarity and Transparency: DOJ Issues Updated Corporate Compliance Guide

By Susrut A. CarpenterCarl 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  >>

Capitol Hill Healthcare Update

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Note that because Congress will be in recess for the Memorial Day holiday, the next “Capitol Hill Healthcare Update” will be posted on June 3.

LAWMAKERS QUESTION DEMOCRATS’ STRATEGY ON DRUG PRICING

House Democrats last week combined bipartisan bills designed to lower drug prices with controversial legislation related to the Affordable Care Act, prompting Democratic and Republican lawmakers to question whether party leaders are committed to bipartisan solutions to control drug costs.

By combining the two issues in one bill, the legislation won House approval but on a near-party line vote. Republicans accused Democrats of being more interested in politics than consensus on lowering drug prices.

Read more on BakerHostetler’s Ohio Clock blog >> 

Capitol Hill Healthcare Update

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

HOUSE TO VOTE ON BILL COMBINING ACA, DRUG PRICING PROVISIONS

The House is scheduled to vote on legislation Thursday that would package new funding for state-based marketplaces and enrollment outreach efforts under the Affordable Care Act (ACA), with provisions designed to lower prescription drug prices.

Some of the drug pricing provisions enjoyed bipartisan support when considered earlier this year in the Energy and Commerce Committee and the Judiciary Committee. But House Republicans aren’t expected to support the overall bill because of the ACA funding and provisions that would roll back the Trump administration’s plan to lower insurance premiums for healthier Americans, which Democrats have derided as “junk” insurance plans.

Read more on BakerHostetler’s Ohio Clock blog >>

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 series of hearings and votes on drug pricing legislation, beginning Tuesday and going through at least June. The issue is also on the agenda at a White House meeting Tuesday with House Speaker Nancy Pelosi, D-Calif., Senate Minority Leader Chuck Schumer, D-N.Y., and President Donald Trump.

Senate Finance Committee Chairman Chuck Grassley, R-Iowa, said he’s working with the panel’s top Democrat, Sen. Ron Wyden, D-Ore., on bipartisan drug pricing legislation that he hopes to introduce by mid-June.

Senate HELP Committee Chairman Lamar Alexander, R-Tenn., saidhis committee will take action this summer on a series of bills designed to reduce healthcare costs. Alexander said he favors extending the Trump administration’s proposed regulation requiring negotiated rebates in Medicare Part D plans to be extended to commercial plans. The senator said he hoped to approve several measures that are under his committee’s jurisdiction this summer, combine them with legislation approved by Grassley’s committee and have the package ready for consideration by the full Senate.

In the House, Majority Leader Steny Hoyer, D-Md., said votes on drug pricing bills could be scheduled for next month. Those bills – already approved by the Ways and Means Committee and the Energy and Commerce Committee – include requiring drug manufacturers to publicly justify price increases and launch prices, requiring HHS to disclose rebates negotiated by pharmacy benefits managers and ending “pay-for-delay” patent settlements that critics say block generic competition.

While those bills are mostly bipartisan and in some cases noncontroversial, House Democrats have introduced more sweeping proposals to lower drug prices, such as permitting HHS to negotiate with manufacturers over prices and using the threat of invalidating manufacturers’ patents to force price concessions.

Read more on BakerHostetler’s Ohio Clock Blog>>

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 mandated under the 21st Century Cures Act (Cures Act). Notably, these proposed rules were released shortly before the HHS Office for Civil Rights deadline for comments about potential changes to improve coordinated care. Taken together, recent HHS rulemakings suggest that interoperability is coming, and significant requirements are in store for providers, payors, health information technology developers and players.

The Cures Act charged ONC with the responsibility of implementing many of the provisions designed to advance interoperability, including the provisions addressing information blocking and certification requirements for health information technology (health IT) developers. The ONC rule also contains widespread revisions to the agency’s Health IT Certification Program and the 2015 edition certification criteria to further support access to, exchange of and use of electronic health information. Continue Reading

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