Washington DC iStock_000074771283_FullUpton Acknowledges ‘Cures’ Stalled

House Energy and Commerce Committee Chairman Fred Upton (R-MI) acknowledged publicly last week what has been widely suspected on Capitol Hill – his “21st Century Cures” medical innovation legislation will not pass Congress before the November elections. Upton had hoped to push through even a scaled-back version. But lack of consensus over how to pay for new National Institutes of Health (NIH) and Cancer Moonshot funding as well as limited legislative time available this month in the Senate conspired to sink Cures before the elections. One senior Republican committee member last week said the House may vote in September on its version of the bill, with the Senate voting after the election. But even that plan may not happen as lawmakers rush to exit Washington and campaign for re-election.

Congress Looks To Avoid Shutdown, Fund Zika Efforts 

The congressional leadership in both parties met with President Obama Monday to try to hammer out an agreement that keeps the government funded beyond the Sept. 30 expiration of the 2016 fiscal year.

A sticking point has been funding to combat the spread of the Zika virus. Lawmakers are expected to agree on a stopgap budget bill that would keep the government open until mid-December, when Congress will reconvene for a post-election lame duck voting session.

Lawmakers Praise MACRA ‘Flexibility’

Bipartisan healthcare leaders in the House last week praised CMS’s announcement that it would allow physicians more flexibility in complying with new MACRA reporting data next year. By providing flexibility for doctors and other healthcare providers, the CMS announcement will allow doctors to prioritize patient care instead of focusing on burdensome paperwork, according to a joint statement by Ways and Means Committee Chairman Kevin Brady (R-TX) and Energy and Commerce Committee Chairman Fred Upton (R-MI). The top Democrats on those committees also issued positive statements. CMS Acting administrator Andy Slavitt outlined four options for doctors to comply with MACRA in a blog post last week.

Lawmakers Urge Hearings on Device Safety Issues

Two House lawmakers are calling on a key healthcare committee to examine an FDA “struggling” to protect patient health and safety. “Congress cannot ignore the voices of those harmed by unsafe medical devices,” according to a draft letter by Reps. Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY), both long-time critics of the medical technology industry and the FDA’s device center. The letter is addressed to House Energy and Commerce Committee Chairman Fred Upton (R-MI). It is not expected that Upton’s panel will hold such a hearing before Congress adjourns this year.

Hatch: Drug Prices ‘Major Issue’ In 2017

One of the pharmaceutical industry’s champions on Capitol Hill, Sen. Orrin Hatch (R-UT), acknowledged last week that drug prices will be a “major issue” the new Congress debates in 2017. Hatch, chairman of the Senate Finance Committee, made the comment as Mylan Pharmaceuticals’ pricing for EpiPen sparked a new round of bipartisan industry criticism over drug pricing. Congress next year will debate the pharmaceutical industry’s user fee authorization, which expires next September and could become an attractive target for drug-pricing provisions adverse to the industry.

Votes Scheduled on Public Health Bills 

The House Energy and Commerce Committee this week is scheduled to vote on a series of public health bills, including legislation that would boost research for sickle cell disease, evaluate diabetes’ impact on healthcare costs, and seek to improve treatments for those suffering from an inherited blood disorder. Each of the bills is non-controversial and was approved last week by the panel’s health subcommittee.

One bill, by Rep. Pete Olson (R-TX), would establish a National Diabetes Clinical Care Commission within the U.S. Department of Health and Human Services to develop strategies to boost clinical care for individuals with diabetes, pre-diabetes and chronic conditions caused by the disease.

Ryan Says No To ACA Tinkering

With Aetna the latest insurer to curtail selling policies on the Affordable Care Act exchanges, congressional Republicans are continuing their election-year focus on the need to repeal the law, not try to make it better. “No amount of tinkering around the margins is going to salvage Obamacare from collapsing under its own weight,” House Speaker Paul Ryan (R-WI) told reporters last week. “It basically doesn’t even feel like you have insurance anymore because your deductibles are so high, not to mention double-digit premium increases that families are getting socked with.” Separately, the two committees in the Republican-controlled House will hold hearings this week examining premium increases from ACA marketplace insurers.

Part B Demo Could Complicate ‘Cures’ Passage

A scaled-down version of the medical innovation legislation known as “21st Century Cures” would increase spending on NIH, the Cancer Moonshot program and other initiatives by about $6 billion over 10 years. Blocking CMS’s controversial plan to overhaul drug reimbursements under Medicare Part B carries a bigger price tag – more than $30 billion. Increasingly, the pharmaceutical industry sees blocking the near-nationwide Part B demo as its highest legislative priority. Even manufacturers with a portfolio heavy with Part D drugs see killing the pilot as a priority as Democratic lawmakers and some consumer groups say CMS’s next demo should target Part D drugs.

To avoid increasing the deficit – and to comply with Congress’ budget rules – lawmakers must offset spending increases with reductions in current spending. So killing the CMS pilot would come with a hefty price tag, including offsets that likely would impact the drug industry. Rather than helping to offset Cures’ new spending – which the industry believes is of limited near-term benefit – PhRMA lobbyists want to target offsets toward overturning the Part B pilot and the Center for Medicare and Medicaid Innovation’s ability to develop a Part D demo. Congress won’t move to block the demo before October, when lawmakers will adjourn for the elections. But it could be considered in a post-election lame-duck voting session in December.

House Panel Examines Part A

The House Ways and Means Health Subcommittee last week held a hearing to examine the evolution of quality in Medicare Part A, specifically whether existing Medicare policies are giving hospitals enough incentives to deliver high-quality, cost-efficient care. “Breaking down barriers to innovation in Medicare will improve the program for beneficiaries and ensure limited taxpayer dollars are being spent efficiently,” subcommittee Chairman Pat Tiberi (R-OH) said.

Mylan Faces House Hearing

House Oversight and Government Reform Chairman Jason Chaffetz (R-UT) said his panel will likely hold a hearing examining Mylan Pharmaceuticals’ price increases for its EpiPen emergency allergy treatment. Senate Judiciary Committee Chairman Chuck Grassley (R-IA) also said the company’s responses to his recent requests for information on the price increases were insufficient, increasing the possibility that Grassley’s committee may hold hearings, too.