United States: Capitol Hill Healthcare Update - July 31, 2017

Editor's Note – The next Capitol Hill Healthcare Update will be published after Labor Day when Congress reconvenes following its August recess.

Republicans Contemplate Next Steps Amid ACA Flameout

Congressional Republicans and President Donald Trump face a series of key questions about how or whether to fortify the Affordable Care Act – particularly in the law's beleaguered individual exchanges – after the Senate last week failed to advance legislation overhauling the healthcare law.

When Sen. John McCain (R-Ariz.) cast the deciding vote against a slimmed-down bill eliminating parts of the ACA, it marked an extraordinary political flameout for Republicans, who have singularly campaigned against the ACA for the past seven years. Deep ideological divides among congressional Republicans and Trump's thorough inability to forge consensus between moderate and conservative lawmakers ultimately sank the GOP's bill – and likely imperils future party-line efforts to make changes to the healthcare law.

After the vote, Senate HELP Committee Chairman Lamar Alexander (R-Tenn.) said his panel would hold bipartisan hearings on next steps, and he identified the cost-sharing subsidies in the individual exchanges as a critical first step. Trump appeared to signal he would withhold future monthly payments the government is making, calling them in a tweet Saturday "bailouts" for insurers. He also tweeted this morning that insurance companies should feel the "hurt" of the ACA.

While there are bipartisan clusters of lawmakers in the House and Senate talking about fixes to the ACA, there isn't currently a majority in either chamber to advance legislation. It's not just Republicans who are in a policy and political straightjacket over healthcare. Democrats are split, too, with some calling for narrow fixes to the ACA and others pulled by the party's liberal activists pushing for a single-payer, government-run system.

Even if bipartisan fairy dust is sprinkled over Washington when lawmakers return from their summer break after Labor Day, Congress will have other legislative priorities in the fall.

Before the 2017 fiscal year expires on Sept. 30, Congress must approve a stopgap budget to keep the government open, and Trump administration officials want lawmakers to raise the government's debt ceiling before the end of September. On the healthcare front, both FDA user fees and the Children's Health Insurance Program (CHIP) will expire unless renewed by Congress in September.

Providers are also contemplating ACA next steps. Several iterations of Republicans' bills in recent months would have ended or suspended the medical device industry's 2.3 percent excise tax, which is scheduled to come back online Jan. 1 after a two-year hiatus. Technology manufacturers now will look to other legislative vehicles, like tax reform, to carry device tax repeal.

Insurers say they need clarity on cost-sharing subsidies or more companies will flee the individual markets. Already consumers in 974 counties nationwide don't have choices in health insurance because only one insurer is offering coverage, and there are no insurance options available in dozens of other counties.

White House Budget Director Mick Mulvaney on Sunday said the Senate should hold a re-vote on its ACA bill and not consider any other legislation until it passes. But the Senate isn't likely to oblige. McCain is returning to Arizona this week to continue treatment for brain cancer, and Republicans currently don't have consensus on healthcare policy – and therefore don't have the votes – to pass anything substantive related to the law they have opposed since it was enacted in 2010.

Senator Introduces Medical Device Cyber Bill

Saying medical device manufacturers don't follow best practices when it comes to cyber security, a senator introduced legislation last week that would create a series of reporting and certification requirements for medical technology companies.

Introduced by Sen. Richard Blumenthal (D-Conn.), the legislation would create a cyber report card for medical devices and require manufacturers to obtain consent from healthcare providers before remotely accessing a device. The bill would not require device manufacturers to seek a new 510(k) approval from the FDA for software updates related to cybersecurity.

The senator said that while some manufacturers offer prompt cybersecurity updates, others fail to follow cyber best practices. Blumenthal is not a member of the Senate HELP Committee, which has legislative jurisdiction over healthcare policy.

More Drug Manufacturers, Distributors Targeted in Senate Opioid Probe

A Democratic senator is adding four pharmaceutical manufacturers and three drug distributors to her investigation into the underlying causes of the opioid crisis.

Sen. Claire McCaskill (D-Mo.) wants to know whether stakeholders were aware of and reported diversion of prescribed opioids for illicit use. McCaskill sent letters to drug manufacturers Allergan, Endo, Mallinckrodt and Teva, and to opioid distributors AmerisourceBergen, Cardinal Health and McKesson.

McCaskill is the top Democrat on the Homeland Security and Governmental Affairs Committee. She is leading the opioid examination for the most part independently of Committee Chairman Ron Johnson (R-Wis.). But cracking down on opioid abuse is also priority for Johnson, whose nephew died of a heroin overdose after earlier abusing opioids following a sports injury.

The attorney general from McCaskill's home state of Missouri, Josh Hawley, filed suit against three pharmaceutical companies in June for allegedly violating the state's Medicaid fraud and consumer-protection statutes by "misrepresenting the truth" about opioids. He said that in 2015, 500 Missouri residents died of opioid overdoses or complications and 300 more died from heroin abuse.

House OKs Medicare Payment Change

The House last week approved legislation that would make a series of changes to Medicare payment policies, including extending coverage for at-home end-stage renal disease treatment.

The bill won House approval on a voice vote and now moves to the Senate for consideration. It was introduced by House Ways and Means Committee Chairman Kevin Brady (R-Texas).

The medical innovation law 21st Century Cures, which Congress approved last year, changes the way Medicare reimburses for the acquisition of home infusion drugs. Brady's bill would create a payment structure for home infusion.

It also would expand a Medicare telehealth program for people with end-stage renal disease, codify recent changes to physician self-referral rules and make it easier for Medicare beneficiaries to get customized orthotics and prosthetics.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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