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<img class="alignright size-full wp-image-5514" src="https://ohioclockblog.bakerhostetlerblogs.com/wp-content/uploads/sites/27/2018/09/1200x630Washington-DC-iStock_000074771283_Blog-image_lt-blue-e1538404502735.jpg" alt="" width="476" height="250">Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: Azar testifies before three committees on HHS’ budget; a series of Senate bills targeting pharma introduced; medical device tax repeal legislation introduced – but only in the Senate; outpatient physicians plan to lobby on Part B reimbursements; and more.

AZAR ON THE HILL THIS WEEK AS TRUMP’S BUDGET RELEASED

[caption id="attachment_5836" align="alignleft" width="114"]<img class="wp-image-5836 size-full" src="https://ohioclockblog.bakerhostetlerblogs.com/wp-content/uploads/sites/27/2019/03/AlexAzar.jpg" alt="" width="114" height="160"> Alex M. Azar II, HHS Secretary[/caption]

HHS Secretary Alex Azar will testify before three congressional committees this week to defend President Donald Trump’s fiscal 2020 budget for his department.

The budget, which is being released today, covers spending proposals beginning Oct. 1, when the 2020 federal fiscal year starts. White House officials have signaled the budget is expected to include cuts to most domestic programs, including healthcare, while boosting defense spending.

Congress is under no obligation to approve the president’s budget – and lawmakers never do, regardless of who’s in the White House. Instead it’s mostly a starting point for later spending negotiations.

Azar will testify <a href="https://energycommerce.house.gov/newsroom/press-releases/health-subcommittee-to-hold-hearing-with-secretary-azar-on-president-trump-s">Tuesday</a> before the House Energy and Commerce Health Subcommittee, <a href="https://appropriations.house.gov/legislation/hearings/department-of-health-and-human-services-budget-request-for-fy-2020">Wednesday</a> before the House Appropriations subcommittee that approves HHS’ budget, and <a href="https://www.finance.senate.gov/hearings/the-presidents-fiscal-year-2020-budget">Thursday</a> before the Senate Finance Committee.

In addition to healthcare policy and funding issues, Azar is likely to be questioned by lawmakers about the replacement for FDA Commissioner Scott Gottlieb, who announced last week that he is stepping down at the end of the month.

BIPARTISAN SENATE BILL TO REPEAL MEDICAL TAX DEVICE INTRODUCED

A bipartisan group of 20 senators last week <a href="https://www.toomey.senate.gov/?p=op_ed&amp;id=2366">introduced legislation</a> to repeal the medical device excise tax.

Introduced by Sens. <a href="https://www.toomey.senate.gov/">Pat Toomey</a>, R-Penn., and <a href="https://www.klobuchar.senate.gov/public/">Amy Klobuchar</a>, D-Minn., the bill would permanently repeal the 2.3 percent tax on the sales of medical devices. The tax, enacted as part of the Affordable Care Act, first took effect in 2013 but has been suspended since 2016.

It’s scheduled to come back online in 2020 unless Congress acts to further delay it.

Companion legislation by Reps. <a href="https://kind.house.gov/">Ron Kind</a>, D-Wis., and <a href="https://walorski.house.gov/">Jackie Walorski</a>, R-Ind., is expected to be introduced in the House, but the timetable has slipped as the authors seek to gain more co-sponsors.

HOUSE SUBCOMMITTEE TO CONSIDER DRUG-PRICING BILLS

A key House healthcare panel will hold a <a href="https://energycommerce.house.gov/committee-activity/hearings/hearing-on-lowering-the-cost-of-prescription-drugs-reducing-barriers-to">hearing</a> Wednesday examining legislation designed to lower the cost of prescription drugs by reducing barriers to market competition.

The Energy and Commerce Subcommittee on Health is scheduled to consider several bills that aim to speed approval of generic drugs. The panel, on which Rep. <a href="https://eshoo.house.gov/">Anna Eshoo</a>, D-Calif., serves as chairwoman, is not expected to vote on any of the bills this week.

Among the bills the subcommittee is expected to consider is <a href="https://www.congress.gov/bill/116th-congress/house-bill/965?q=%7B%22search%22%3A%5B%22HR965%22%5D%7D&amp;s=5&amp;r=1">legislation</a> by Rep. <a href="https://cicilline.house.gov/">David Cicilline</a>, D-R.I., that would allow generic manufacturers to gain access to drugs protected by <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609365.htm">FDA’s risk evaluation and mitigation strategy safety program</a>. The legislation is a priority for full committee Chairman <a href="https://pallone.house.gov/">Frank Pallone</a>, D-N.J., and its <a href="https://www.congress.gov/bill/116th-congress/senate-bill/340?q=%7B%22search%22%3A%5B%22s340%22%5D%7D&amp;r=1&amp;s=6">Senate version</a> is being pushed by Finance Committee Chairman <a href="https://www.grassley.senate.gov/">Chuck Grassley</a>, R-Iowa.

SENATE BILLS TARGET PHARMA, INCLUDING PATENTS FOR BIOLOGICS

A group of bipartisan senators last week <a href="https://www.aging.senate.gov/press-releases/bipartisan-group-of-senators-launch-effort-to-stop-patent-gaming-and-increase-access-to-lower-cost-drugs">introduced legislation</a> that would require manufacturers of biologic drugs to disclose their patents and create a searchable online patent database.

Bill sponsors include Sens. <a href="https://www.collins.senate.gov/">Susan Collins</a>, R-Maine; <a href="https://www.kaine.senate.gov/">Tim Kaine</a>, D-Va.; <a href="https://www.portman.senate.gov/public/">Rob Portman</a>, R-Ohio; <a href="https://www.shaheen.senate.gov/">Jeanne Shaheen</a>, D-N.H.; <a href="https://www.braun.senate.gov/">Mike Braun</a>, R-Ind.; and <a href="https://www.stabenow.senate.gov/">Debbie Stabenow</a>, D-Mich.

The senators said <a href="https://www.collins.senate.gov/sites/default/files/Biologic%20Patent%20Transparency%20Act%20One%20Pager%20for%20Release.pdf">their bill</a> would make it easier for competing drug companies to evaluate and plan for the development of biosimilars.

[caption id="attachment_5373" align="alignleft" width="150"]<img class="wp-image-5373 size-thumbnail" src="https://ohioclockblog.bakerhostetlerblogs.com/wp-content/uploads/sites/27/2018/07/Official-Collins-150x150.jpg" alt="" width="150" height="150"> Sen. Susan Collins, R-Maine[/caption]

Separately, Collins is working on bipartisan legislation with Sen. <a href="https://www.casey.senate.gov/">Bob Casey</a>, D-Penn., that would require rebates from drugs’ list prices to directly flow to consumers as well as cap beneficiaries’ out-of-pocket costs in Medicare Part D.

Collins is chairwoman of the Senate Aging Committee, which held two hearings last week on drug prices. A third hearing is planned in the coming weeks with Trump administration officials as witnesses. Casey is the top Democrat on the committee.

Meanwhile, Braun <a href="https://www.braun.senate.gov/braun-introduces-3-bills-lower-prescription-drug-costs">introduced legislation</a> last week that would upend the drug-supply chain by extending to commercial plans an HHS <a href="https://www.federalregister.gov/documents/2019/02/06/2019-01026/fraud-and-abuse-removal-of-safe-harbor-protection-for-rebates-involving-prescription-pharmaceuticals">proposal</a> to eliminate the rebates that pharmaceutical manufacturers pay to pharmacy benefit managers as the intermediaries between drugmakers and insurers.

Another Braun bill would create a six-month FDA expedited drug approval process for treatments already approved by European Union member companies, Israel, Australia, Canada or Japan.

LAWMAKERS CALL ON FDA TO ACT AFTER MEDICAL DEVICE STERILIZATION PLANT CLOSED

A bipartisan group of lawmakers from Minnesota – home to one of the nation’s highest concentrations of medical device manufacturers – is calling on FDA to avoid potential disruptions to medical device and pharmaceutical supplies after a sterilization plant in Illinois was <a href="https://www.chicagotribune.com/news/local/breaking/ct-met-sterigenics-epa-ethylene-oxide-testing-20190307-story.html">closed</a>.

The Sterigenics plant in Willowbrook, Ill., was shuttered after monitoring equipment detected <a href="https://abc7chicago.com/health/willowbrook-sterigenics-plant-shut-down-friday-night/5141207/">unhealthy levels of ethylene oxide</a>, which is used to sterilize medical technology and prescription drugs. The facility is one of the nation’s principal sterilization sources for medical treatments. FDA officials have <a href="https://www.medicaldesignandoutsourcing.com/fda-warns-of-potential-medical-device-shortage-following-sterigenics-plant-shutdown/">said</a> more than 100 medtech manufacturers nationwide and hundreds of devices may be affected by the shutdown.

In a letter to FDA Commissioner Scott Gottlieb, the Minnesota congressional delegation – led by Reps. <a href="https://emmer.house.gov/">Tom Emmer</a>, R-Minn., and <a href="https://emmer.house.gov/">Dean Phillips</a>, D-Minn. – called on FDA to “immediately take any and all action needed” to avoid supply-chain disruptions.

Device manufacturers that relied on the Illinois plant have as little as one or two months of sterilized devices available, the lawmakers wrote, creating potential disruption in the supply chain unless new sterilization sources become available.

GOP DOCTORS CAUCUS APPLAUDS PART D REBATE PLAN

A group of former physicians now serving in the House last week <a href="https://roe.house.gov/news/documentsingle.aspx?DocumentID=398457">praised</a> HHS’ <a href="https://www.federalregister.gov/documents/2019/02/06/2019-01026/fraud-and-abuse-removal-of-safe-harbor-protection-for-rebates-involving-prescription-pharmaceuticals">proposal</a> to eliminate rebates that pharmaceutical manufacturers pay to middlemen pharmacy benefit managers.

The GOP Doctors Caucus – comprising 16 physicians-turned-lawmakers – praised the Trump administration plan, saying it would lower patients’ out-of-pocket costs and inject transparency into the drug-delivery system.

“These reforms will replace the current system of middleman kickbacks with transparent, point-of-sale discounts that will lower the cost of prescriptions for Part D enrollees,” said Rep. <a href="https://roe.house.gov/">Phil Roe</a>, R-Tenn., chairman of the caucus. Roe is a former primary care doctor.

BRAIN INJURY TASK FORCE HOSTS ANNUAL CAPITOL HILL BRIEFING 

[caption id="attachment_5835" align="alignleft" width="106"]<img class="wp-image-5835 size-full" src="https://ohioclockblog.bakerhostetlerblogs.com/wp-content/uploads/sites/27/2019/03/BillPascrell.jpg" alt="" width="106" height="160"> Bill Pascrell, D-N.J.[/caption]

Medical device and prescription drug manufacturers Wednesday will display their latest technology to treat brain injuries as part of activities around the 2019 Brain Injury Awareness Day on Capitol Hill.

The daylong events, hosted by the <a href="https://pascrell.house.gov/issues/brain-injury-task-force/">Congressional Brain Injury Task Force</a>, includes an awareness fair for manufacturers and a briefing for congressional staff on living with brain injuries.

Traumatic brain injury is a major cause of death and disability in the United States, contributing to as much as 30 percent of all injury deaths, according to the <a href="https://www.cdc.gov/traumaticbraininjury/get_the_facts.html">Centers for Disease Control and Prevention</a>.

Founded by Rep. <a href="https://pascrell.house.gov/">Bill Pascrell</a>, D-N.J., the task force seeks to raise awareness of and policies that support patients with brain injuries.

 OUTPATIENT PHYSICIANS GROUP PLANS HILL STAFF BRIEFING ON PART B

 An alliance of patient and provider groups will be leading a discussion on Medicare Part B reimbursement issues for congressional staff at a Hill briefing next week.

The briefing by <a href="http://www.partbaccess.org/">Part B Access for Seniors and Physicians (ASP) Coalition</a> on March 19 will offer an overview of the services offered in outpatient settings as well as reimbursement issues for drugs administered in hospital outpatient departments or physician offices, or at dialysis centers.

The group is <a href="http://partbaccess.org/threats/">lobbying against</a> the Trump administration’s proposal to link Part B reimbursements to an international index of drug costs in foreign countries where governments set prices as well as against the administration’s plan to mandate step therapy for Part B drugs in Medicare Advantage plans.

The coalition comprises patient groups like the U.S. Pain Foundation and the Lupus and Allied Diseases Association, and specialty physician groups like the American Association of Clinical Urologists and the U.S. Oncology Network.