United States: Capitol Hill Healthcare Update- June 11, 2018

HOUSE TO VOTE ON DOZENS OF OPIOID BILLS WHILE SENATE READIES COMPREHENSIVE MEASURE

The House this week will begin considering some of the 70 different opioid bills that have been approved by eight different committees, focusing on prescribing, enforcement, and Medicare and Medicaid coverage of treatment options.

House Majority Leader Kevin McCarthy (R-Calif.) announced last week that several dozen noncontroversial bills will be considered either by voice vote or under expedited procedures that require supermajorities to pass but allow House leaders to move them quickly. Other bills – like relaxing health privacy rules for drug abuse treatment records and allowing Medicaid to cover in-patient drug rehab costs – will be debated on the House floor, with opportunities for amendments.

Bills receiving votes this week include establishing a new category of synthetic opioids and other drugs under the Controlled Substances Act, allowing low-income housing vouchers to be used to aid recovering addicts, and increasing the tracking of parcels and mail into the United States.

Voting in the House is likely to continue into next week, McCarthy says. The plan then is to package individual legislation that won House approval into one comprehensive bill.

Meanwhile, on Tuesday, the Senate Finance Committee will vote on a combined opioid response package that aims to crack down on abuse and expand access to treatment. The committee bill would expand telehealth coverage, standardize electronic prior authorizations, remove Medicaid lifetime limits for substance abuse treatment, and expand payment disclosures by pharmaceutical and medical device manufacturers.

AZAR TO TESTIFY BEFORE SENATE PANEL ON TRUMP'S PLAN TO LOWER DRUG PRICES

Health and Human Services (HHS) Secretary Alex Azar will be the sole witness at a Senate hearing Tuesday on the White House's plan to lower prescription drug costs.

Few details have been released in the month since Azar and President Donald Trump released their blueprint to reduce prescription drug prices, "American Patients First." While most senators are likely to question Azar on details of potential HHS regulatory actions, guidance documents and demonstration projects referenced in the plan, the secretary also is likely to be criticized by lawmakers – mostly Democrats – who say it doesn't go far enough.

This will be the Senate Health, Education, Labor & Pensions (HELP) Committee's fourth hearing on drug costs. Meanwhile, the Senate Judiciary Committee plans to vote Thursday on legislation designed to speed generic manufacturers' access to brand-name drugs in the Food and Drug Administration's (FDA's) risk evaluation and mitigation strategy safety program for high-risk medicines.

SENATE PANEL TO HEAR FROM OFFICIAL WHO OVERSEES 340B PROGRAM

The director of the agency responsible for oversight of the 340B prescription drug discount program will testify at a Senate hearing next week.

Capt. Krista Pedley, director of the Health Resources and Services Administration (HRSA), will testify June 19 before the Senate HELP Committee.

Pedley's agency has been criticized by committee chairman Lamar Alexander (R-Tenn.) for oversight failures, including not auditing hospitals participating in the program. HRSA's defenders say the agency is woefully underfunded – with fewer than two dozen full-time employees – to adequately supervise the program.

In a report released last year, the House Energy and Commerce Committee found that discounted drug purchases made by 340B-covered entities totaled more than $16 billion in 2016, a more than 30 percent increase in one year, and that more than 12,000 covered entities participate in the program.

SECOND SENATE BILL INTRODUCED TO EXPAND 'SUNSHINE' REPORTING

Sen. Claire McCaskill (D-Mo.) last week introduced legislation that would expand current physician payment reporting requirements by pharmaceutical manufacturers and medical device companies.

McCaskill's bill would capture payments made to professional medical societies; patient, consumer and disease-specific advocacy groups; copay and patient financial assistance groups; providers of continuing medical education; and entities that produce marketing materials and social media advertising.

McCaskill's bill is the second in as many weeks introduced to amend the Physician Payment Sunshine Act. Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) – who authored that 2010 reporting law – introduced legislation in late May that would require drug and device companies to report payments to nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives.

Both McCaskill and Grassley said the opioid epidemic justified expanding the reporting requirements. McCaskill, the top Democrat on the Homeland Security and Government Affairs Committee, released a report in February saying that opioid manufacturers made nearly $9 million in payments to 14 patient advocacy groups and professional societies active in chronic pain and other opioid-related issues between 2012 and 2017. When he introduced his bill, Grassley said nurse practitioners were among the top prescribers of opioids.

On Tuesday, the Senate Finance Committee is scheduled to vote on an opioid-related bill that includes Grassley's legislation. Next steps for McCaskill's bill aren't clear.

GOP LEADERS: HOUSE TO VOTE IN JULY ON REPEALING MEDICAL DEVICE TAX

The House will vote next month on stand-alone legislation to repeal the 2.3 percent excise tax on medical devices, Republicans leaders said last week.

Majority Leader Kevin McCarthy (R-Calif.) and Majority Whip Steve Scalise (R-La.) told medical technology executives during meetings on Capitol Hill that the House would vote on the bill authored by Rep. Erik Paulsen (R-Minn.). Organized by the trade group AdvaMed, the company executives also lobbied lawmakers for coverage and payment reforms.

Repealing the device tax has generated bipartisan support since it was first included as a revenue source for the Affordable Care Act. Industry advocates hope to maximize the House vote to put pressure on the Senate to act.

Still, it's unlikely Congress takes final action on the device tax until after the November midterm congressional elections.

BILL: AUTOMATIC PAYMENT COVERAGE FOR BREAKTHROUGH TECHNOLOGIES

Bipartisan legislation introduced last week in the House would create temporary automatic coverage for medical devices approved under the FDA breakthrough pathway designation.

Introduced by Reps. Suzan DelBene (D-Wash.) and Jackie Walorski (R-Ind.), the measure requires the Centers for Medicare & Medicaid Services (CMS) to provide immediate transitional coverage for three years for any new device or diagnostic the FDA designated as a breakthrough technology.

Medical services and technology also would be eligible for new technology add-on payments (NTAPs) and outpatient pass-through payments. NTAPs would increase to 80 percent, up from the current 50 percent, and pass-through payments at 100 percent would apply for services provided in an outpatient setting.

Under the bill, new technologies denied NTAP coverage could for the first time appeal an adverse ruling and CMS would be required to respond within 90 days.

While bill supporters are focused on increasing bipartisan co-sponsors, its future in the House is unclear. Because the legislation would automatically cover new breakthrough devices and boost NTAPs, it would increase Medicare expenses, which means it would also require corresponding offsets.

HOUSE OKs RESCINDING 'UNUSED FUNDING' FROM CHIP, CMMI

The House last week narrowly approved a $14.8 billion appropriations rescissions bill, eliminating previously approved but unused funding from the Children's Health Insurance Program (CHIP) and CMS' Center for Medicare and Medicaid Innovation.

The measure won House approval 210-206. No Democrat voted for the bill, while 19 Republicans broke with party leaders to oppose the measure.

Under budget rules, the Senate has until June 22 to approve the bill with a simple majority, less than the usual 60 votes required to approve appropriations bills. Trump administration officials are pushing hard for the bill, but its future in the Senate is unclear.

The effort is the first major cost-cutting legislation advanced by this Congress, but it would do little to impact the deficit or debt. Under budget scoring rules, the bill would produce only $1 billion in savings because spending scorekeepers ruled the unused funding would never have been spent anyway.

Many House Republicans had objected to voting on the bill, saying the optics of cutting $7 billion from CHIP while reducing the deficit by only $1 billion combined to make for bad politics in an election year. House GOP leaders did make changes to the bill, including to CHIP, and dropped proposed recessions from programs to fight the Ebola virus as well as to aid Hurricane Sandy recovery efforts.

HOUSE OVERSIGHT PANEL TO HOLD HEARING ON BIOPREPAREDNESS

The House Energy and Commerce Oversight and Investigations Subcommittee will hold a hearing Friday assessing the country's readiness to respond to a biological threat.

Rep. Gregg Harper (R-Miss.), the subcommittee's chairman, said the hearing will gauge the country's responsiveness to not only threats from an external attack but also a disease outbreak.

Witnesses include Rick Right, director of the Biomedical Advanced Research and Development Authority and deputy assistant HHS secretary for preparedness and response; Dr. Anne Schuchat, acting director of the Centers for Disease Control and Prevention; Dr. Anthony Fauci, director of the National Institutes of Health's Institute of Allergy and Infectious Diseases; and Anna Abram, deputy FDA commissioner for policy planning.

Separately last week, the panel's Health Subcommittee held a legislative hearing to review a bipartisan draft bill that would renew the Pandemic and All-Hazards Preparedness Act, which would authorize key biodefense programs for five years. That bill, however, does not include any regulatory or reimbursement incentives for pharmaceutical manufacturers to focus on developing new antibiotics, which lawmakers in both parties had identified as a key weakness in the country's biopreparedness.

SCHUMER: LET'S DEBATE DRUG PRICES, HEALTH COSTS IN AUGUST

After Senate Republicans canceled most of the planned August recess, Democratic Leader Chuck Schumer (D-N.Y.) said lawmakers should spend the time debating healthcare legislation.

Senate Republican Leader Mitch McConnell (R-Ky.) last week announced he was revoking three of the chamber's planned four weeks of recess in August, when lawmakers traditionally travel overseas or just go on vacation. McConnell said he needed to use the time because of Democrats' ongoing obstruction in advancing Trump administration judicial nominations. But Democrats believe McConnell's real motivation is to keep vulnerable Democratic senators seeking re-election this year off the campaign trail.

Schumer called on McConnell to schedule votes on five initiatives supported by Democrats, including proposals to address prescription drug prices by allowing Medicare to negotiate directly with drug manufacturers, allowing people to enroll in Medicare before they reach the age of 65 and encouraging states to expand Medicaid.

Senate Republicans are unlikely to accommodate Schumer's requests.

GOP SENATORS CALL ON HHS TO EXPAND SHORT-TERM HEALTH PLANS

Thirty-five Senate Republicans are calling on the Trump administration to extend contract terms for so-called "short-term limited duration" health plans for up to 12 months and to allow those plans to renew automatically.

Led by Sen. Ron Johnson (R-Wis.), the senators sent a letter to Secretary Azar saying the policy would allow options for enrollees who face increasing premiums or who have an unexpected gap in coverage. The letter also went to Treasury Secretary Steve Mnuchin and Labor Secretary Alexander Acosta.

For nearly 20 years, Republican and Democratic administrations accepted that short-term limited duration health plans could offer contract terms of up to 12 months. That changed in 2016, when the Obama administration decided to "arbitrarily prohibit" plans from offering contract terms longer than three months and blocked guaranteed renewal, the Republican senators wrote.

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