United States: Capitol Hill Healthcare Update – April 23, 2018

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 White House on Sunday announced it was postponing this week's event, saying it would be rescheduled for the "near future." A senior White House aide last week said the announcement is now tentatively scheduled for May 8 but could be delayed further because of President Donald Trump's official and political travel scheduled for next month.

HHS said in a statement Friday that Azar, 50, had been diagnosed with diverticulitis and likely wouldn't return to Washington until later this week.

The White House plan was expected to include a mix of policies already enacted by the administration, including the Food and Drug Administration (FDA) speeding approvals of certain applications for generic drugs, as well as requests for information from providers and voluntary demonstration projects. Other initiatives that have been discussed include ensuring that prescription drug rebates negotiated by distributors are passed to beneficiaries, transferring some Medicare Part B drugs to Part D and potential changes to the Part B reimbursement formula.

While some proposals may require congressional approval, the bulk of the plan is expected to rely on steps the administration can take unilaterally.

GOTTLIEB TO APPEAR BEFORE SENATE PANEL ON FDA BUDGET

FDA Commissioner Scott Gottlieb will testify Tuesday before a Senate appropriations subcommittee on his agency's fiscal 2019 budget.

Gottlieb testified last week before a House spending committee, which warned that Congress may not be able to approve the Trump administration's proposed budget increase for the agency.

The White House wants Congress to boost the FDA's budget by $473 million to nearly $5.8 billion. Just over half, or $2.8 billion, of the FDA's budget is approved by Congress, with the balance generated from industry user fees.

Neither the House nor the Senate appropriations committees have released their proposed FDA spending plans for fiscal 2019, which begins Oct. 1.

BIPARTISAN SENATORS WANT OPIOID MANUFACTURERS' CEOs TO TESTIFY

Senior executives whose drug companies manufacturer opioids should testify before Congress, two leading senators said last week.

Sen. Ron Wyden, D-Ore., said during a Finance Committee hearing that CEOs need to be held "accountable for their role in creating a public health calamity that is killing tens of thousands of Americans." Wyden is the top Democrat on the committee, which held a hearing last week on how changes to Medicare and Medicaid reimbursement policies could help curb the opioid crisis among those beneficiaries.

Senate Majority Whip John Cornyn – the No. 2 Republican in the Senate – said last week that it would "be a good idea" for drug company executives to testify before Congress on the opioid epidemic.

The House Energy and Commerce investigations subcommittee is holding a hearing May 8 with the CEOs of five leading pharmaceutical distributors. No drug manufacturing executives have been called to testify before Congress.

Meanwhile, lawmakers are continuing their wide-ranging focus on the opioid crisis with several hearings and votes this week in the both the House and the Senate. The Senate Health, Education, Labor and Pensions Committee will vote on Tuesday on several bipartisan bills, including one to provide the FDA with flexibility to promote alternative pain treatments, allow nurse practitioners and physician assistants to prescribe medication-assisted treatments, and establish uniform guidelines for local opioid recovery centers. On Wednesday, the House Ways and Means Committee is scheduled to hold a hearing on stopping the flow of synthetic opioids.

Also on Wednesday, the House Energy and Commerce Committee is scheduled to vote on as many as 60 different opioid response measures. Committee Chairman Greg Walden, R-Ore., has pledged to consolidate the legislation into one bill that can be scheduled for a House vote before Memorial Day.

Sen. Bernie Sanders, I-Vt., last week introduced legislation that would fine opioid manufacturers up to 25 percent of the profits generated from painkiller products for deceptive advertising and also establish criminal liability for top drug company executives found to have contributed to the epidemic.

HOUSE PANEL TO HOLD HEARING ON INNOVATION AMONG PHYSICIANS

The House Ways and Means Health Subcommittee will hold a hearing on Thursday on innovations and new technologies used by physician practices.

Subcommittee Chairman Peter Roskam, R-Ill., said the hearing on private sector innovative practices would be used to inform lawmakers on ways to modernize Medicare.

Witnesses include officials from Aledale Inc., a Maryland-based consultancy for primary care physicians; CliniSync, an Ohio-based nonprofit health information exchange; Zocdoc, an online medical scheduling service; Zipnosis, a Minnesota-based telemedicine services provider; and DuPaige Medical Group, an independent multispecialty physician group in Illinois.

HOUSE DEMOCRAT WANTS COMMITTEE REVIEW OF DRUG PRICES

The top Democrat on the Joint Economic Committee wants the panel to investigate anti-competitive practices in the prescription drug market.

In a letter last week to committee Chairman Erik Paulsen, R-Minn., Rep. Carolyn Maloney, D-N.Y., wrote that a hearing would help lawmakers understand the extent of anti-competitive practices and that "artificial inflation of the prescription drug market violates both consumer rights and the principles of free-market capitalism."

Maloney is the former chairwoman of the committee, which was created by Congress to review economic conditions and to recommend improvements in economic policy.

It's unlikely the committee under Paulsen's leadership would hold such a hearing. But it's an additional indication that congressional Democrats continue to see political advantage in pressing the issue of prescription drug prices.

MEDTECH CAUCUS TO HOLD BRIEFING FOR CONGRESSIONAL STAFF

The House Medical Technology Caucus today will hold its first congressional staff briefing of the year, focusing on emerging federal policy issues faced by the medical device industry.

The bipartisan caucus is co-chaired by Rep. Erik Paulsen, R-Minn., and Rep. Anna Eshoo, D-Calif. Caucus briefings aim to educate Capitol Hill staff on the FDA's role as primary industry regulator of medical devices, the growing challenges posed by the Centers for Medicare & Medicaid reimbursement and coverage processes, and the outlook for investment in new and innovative medtech firms.

AdvaMed, the Medical Device Manufacturers Association and the Medical Imagining Technology Alliance are co-hosting the event.

Speakers include Ryan Drant of Questa Capital, a healthcare venture capital firm; Phil Desjardins, a vice president of global regulatory policy at Johnson & Johnson; and Marjorie Kanof of Health Policy Alternatives, which offers technical analysis of federal legislative and regulatory proposals.

COMMITTEE SEEKS FEEDBACK ON CYBER CHALLENGES OF LEGACY HEALTH TECH

The House Energy and Commerce Committee last week announced it was seeking industry feedback on legacy health technology, including its susceptibility to cybersecurity challenges.

The committee has held several hearings on cyber issues facing healthcare treatment and diagnostic technologies. Chairman Greg Walden, R-Ore., said the use of legacy technologies, which are generally less protected from cyber threats than their modern counterparts, continues to be a root cause of many cyber incidents.

The committee says it wants to better understand the vulnerability identification and management by healthcare stakeholders with legacy technologies. It requests "information regarding legacy technology challenges, opportunities, considerations, and suggestions in the health care sector" by May 31.

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