United States: Capitol Hill Healthcare Update – November 2017

CONGRESS RECONVENES WITH DAUNTING HEALTHCARE TO-DO LIST

Lawmakers returning to Capitol Hill this week after the Thanksgiving recess face a daunting series of tax and budget deadlines that will set the stage for how Congress addresses year-end healthcare priorities.

That healthcare to-do list includes renewing the Children's Health Insurance Program (CHIP), which expired in September. CMS has allocated $607 million in October and this month to help shore up the program in 14 states and territories. More states will run out of CHIP funding beginning in January if Congress doesn't act.

Other healthcare priorities include funding for community health centers, Affordable Care Act (ACA) subsidies for insurers and provider taxes, and a series of expiring Medicare payment policies.

Alex Azar, President Donald Trump's nominee to be health and human services (HHS) secretary, will receive a Senate Health, Education, Labor & Pensions (HELP) Committee hearing this week, but it's not clear that the Finance Committee will vote on Azar's nomination before the end of the year. The Finance Committee, which has jurisdiction over Azar's nomination, is likely to be distracted if not consumed in December by Republicans' focus on passing tax reform.

Some healthcare policies, like renewing CHIP, enjoy bipartisan support in both the House and Senate. But congressional leaders may need to package popular programs such as CHIP with other policies that could have trouble winning approval on their own.

Congress' No. 1 priority is avoiding a government shutdown. Funding expires Dec. 8, and leaders this week are likely to confirm their intention to advance a short-term budget bill to keep the government open until Christmas. Lawmakers hope that will give them time in December to resolve budget issues and a host of other critical policies, including the tax bill, disaster spending for the three hurricanes and California wildfires, National Security Agency surveillance authority, and Trump's demand for a $1.6 billion down payment on funding for a wall along the U.S.-Mexican border.

DEMOCRATS PLEDGE TO QUESTION HHS PICK ON DRUG PRICES

On Wednesday, the Senate HELP Committee will hold a hearing on Alex Azar, as Democrats pledge to sharply question the former Eli Lilly executive about his role in setting the company's prescription drug prices.

Although the committee oversees parts of HHS, it doesn't have jurisdiction over Azar's nomination, so it will be considered a courtesy hearing. Still, committee Democrats said they're ready to take on Azar over drug prices, including highlighting Trump's frequent criticism of the industry but the lack thus far of new administration policies.

Sen. Bernie Sanders (I-Vt.), a member of the HELP Committee, already announced his opposition to Azar. Sen. Elizabeth Warren (D-Mass.), who also serves on the HELP Committee, said she will sharply question Azar regarding his role in setting prices at Lilly.

Azar enjoys wide support among Republicans on Capitol Hill, and absent an unforeseen development, he is expected to win confirmation. But because of the focus on the GOP's tax plan, a Senate vote may not take place until January. Azar previously was general counsel and deputy secretary at HHS during the George W. Bush administration – positions for which he twice received unanimous Senate confirmation.

FDA, NIH HIGHLIGHT HEARING ON 21ST CENTURY CURES IMPLEMENTATION

FDA Commissioner Scott Gottlieb and National Institutes of Health (NIH) Director Francis Collins will headline a House hearing Thursday on the status of a 2016 law designed to speed the discovery and development of new medical treatments.

The House Energy and Commerce Subcommittee on Health will hold the hearing on the implementation of the 21st Century Cures Act, which Congress approved last December. The law boosted funding for NIH and created a precision medicine initiative and a project to study the brain and diseases such as Alzheimer's.

Subcommittee Chairman Michael Burgess (R-Texas) pledged that the panel will work closely with federal healthcare agencies to ensure the law is properly implemented. Thursday's hearing will mark the subcommittee's second look this year at Cures Act implementation.

KEY SENATOR LINKS ACA's INDIVIDUAL MANDATE, COST-SHARING

A Republican senator said she could support repealing the ACA's individual mandate as part of the GOP's sweeping tax overhaul if lawmakers also guarantee continued funding for the health law's subsidies for insurers.

Sen. Lisa Murkowski (R-Alaska) wrote in an op-ed last week that she supports using the tax bill to overturn the individual mandate if Congress also adopts the insurers' cost-sharing subsidies. In comments to Maine media last week, Sen. Susan Collins (R-Maine) seemed more open to the idea of repealing the mandate, and she too wanted to link the issue with the insurance stabilization legislation drafted by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.).

The Congressional Budget Office said repealing the individual mandate would reduce government spending by $338 billion over 10 years – creating an easier path for Republicans to make the numbers work on their tax bill.

The Alexander-Murray legislation can't be included in the tax bill because of Senate rules. But Murkowski said she wants a commitment from Senate GOP leaders that it would be voted on separately. Alexander and Murray's bill would continue the insurer subsidies, which are designed to hold down premiums for individual ACA policies, and in return states would gain flexibility from HHS in creating ACA plan coverage.

TOP DEMOCRAT ON HOUSE HEALTH PANEL TO RETIRE

Rep. Gene Green (D-Texas), the ranking Democrat on the Energy and Commerce's Health Subcommittee, announced last week that he won't seek re-election in 2018.

Green was first elected to Congress in 1992 from a Houston-area district. He previously served in the Texas legislature for 20 years.

In recent years, Green has used his position on the subcommittee to try to thwart House Republicans' efforts to dismantle the ACA. He also has advocated for increasing federal funding for community health centers and incentivizing the development of new antibiotics and antifungals aimed at treating life-threatening infections.

TWO COMMITTEES TO PROBE OPIOID ABUSE THIS WEEK

Two committees will hold hearings this week on opioids, and Congress' watchdog says lawmakers need to ensure CMS provides greater oversight of Medicare Part D opioid prescriptions.

The House Oversight and Government Reform Committee will hold a field hearing Tuesday at Johns Hopkins Hospital in Baltimore. New Jersey Gov. Chris Christie, who led Trump's opioid task force, is scheduled to testify along with local officials.

On Thursday, the Senate HELP Committee will hold an opioid hearing with state and local officials. Scheduled witnesses included Dr. Omar Abubaker, professor at Virginia Commonwealth University; Rebecca Boss, director of the Rhode Island Department of Behavioral Healthcare; Andrea Magermans, managing director of the Wisconsin Prescription Drug Monitoring Program; and John Tilley, secretary of the Kentucky justice and public safety department.

To curb prescription opioid abuse among older adults, the Government Accountability Office (GAO) earlier this month said CMS should expand oversight of the Part D prescription drug program. GAO also called on Congress to ensure CMS had the tools and authority to crack down on opioid abuse within Part D.

LAWMAKERS WANT BRIEFING ON MEDICAL DEVICE PRICE CONTROLS IN INDIA

A bipartisan group of House lawmakers is calling on U.S. trade representative Robert Lighthizer to brief Congress on his efforts to address price controls on medical devices in India.

In February, India exercised a rarely invoked legal provision that allowed it to cut prices of prescription drugs, and for the first time, the New Delhi government expanded that authority to medical devices.

In a letter to Lighthizer, the lawmakers wrote that artificially reducing prices stifles innovation and forces some manufacturers to sell at a loss. The letter was penned by Reps. Jack Walorski (R-Ind.), Ron Kind (D-Wis.), Erik Paulsen (R-Minn.), Jim Banks (R-IN), Luke Messer (R-Ind.) and Jim Himes (D-Conn.).

HOUSE PANEL TARGETS MEDICARE 'EXTENDER' PAYMENTS

The House Ways and Means Committee last week announced it had reached bipartisan agreement to renew several so-called Medicare extenders, payment provisions that either have expired or soon will expire.

Committee Chairman Kevin Brady (R-Texas) said the agreement calls for two-year extensions of the Medicare Dependent Hospital Program, the Low-Volume Adjustment Program and the Medicare geographic payment cost index for physician payments. The committee also agreed to temporary funding increases for ambulance services and rural home health services and a permanent repeal of caps on outpatient therapies such as physical therapy.

The panel also identified a number of offsets to pay for the new programs, including allowing Medicare Advantage plans to pay for telemedicine, which budget scorekeepers estimate would save the government money. Other pay-fors include reducing payments for nonemergency transportation related to end-stage renal dialysis and making changes to skilled nursing and home health reimbursements.

Separately, the Senate Finance Committee outlined its list of priorities for Medicare extenders, and the House Energy and Commerce Committee also has some jurisdiction over specific Medicare programs. A final extender list will likely be packaged with other year-end legislation Congress hopes to pass next month.

BIPARTISAN BILL SEEKS TO BLOCK PROPOSED 340B CUTS.

Bipartisan legislation introduced in the House this month would overturn a proposed CMS rule that would reduce payments to hospitals that participate in the 340B drug discount program.

The legislation – introduced by Reps. David McKinley (R-W.Va.) and Mike Thompson (D-Calif.) – is just the latest signal of opposition to the CMS plan. In September, 228 House lawmakers wrote to CMS administrator Seema Verma and called on her to scrap the proposed rule; 57 senators signed a similar letter.

Scheduled to take effect Jan. 1, the rule would reduce payments for physician-administered 340B drugs by more than 28 percent, effectively reducing hospital and outpatient clinic payments by $1.6 billion. Hospitals are suing to try to block the rule.

Several congressional committees in recent years have raised concerns about the growth of the 340B program, including whether its covered entities are appropriately passing along drug savings to patients. Some lawmakers have also said it encourages a shift in site of care from physician offices to hospital outpatient settings, increasing overall healthcare costs.

PATIENT GROUPS TO LOBBY THIS WEEK FOR HOUSE STEP THERAPY BILL

Several patient advocacy groups will be on Capitol Hill this week lobbying House members to support bipartisan legislation that would regulate insurers' step therapy protocols by giving doctors greater say in the treatments they prescribe for their patients.

The National Psoriasis Foundation, the American Academy of Dermatology, the American Medical Association and the American Association of Clinical Endocrinologists will lead the effort to raise visibility into the legislation, which has 28 bipartisan co-sponsors in the House.

Introduced in April by Reps. Brad Wenstrup (R-Ohio) and Raul Ruiz (D-Calif.), the legislation would require health plans to establish a clear process under which physicians could request exceptions to step therapy protocols and require plans to respond to physician requests in a timely manner. The bill would affect only employer-sponsored health plans governed under federal law and would not pre-empt state laws – though several states have enacted similar legislation in recent years.

Wenstrup is a former podiatric surgeon, and Ruiz is a former emergency room physician.

WALDEN ASKS HHS TO LEAD DEVELOPMENT ON CYBER PROTECTION

The chairman of the House Energy and Commerce Committee is calling on HHS to lead on strengthening the cybersecurity of medical technology by focusing on the security of medical device components.

Rep. Greg Walden (R-Ore.) called on HHS Acting Secretary Eric Hargan to convene a sectorwide effort to develop a plan of action by creating a so-called software bill of materials for medical technologies – a catalog of the types of third-party hardware and software included in each medical device.

Under Walden's chairmanship, the committee has held several oversight hearings on HHS' role in healthcare cybersecurity and responses to recent outbreaks.

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