Health Law Update

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<img class="alignright size-medium wp-image-4777" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2017/03/hlu-photo-300x200.jpg" alt="" width="300" height="200">Senate GOP Still Talking on Health Bill as Clock Ticks

Senate Republicans continue intra-party discussions on changes to House-passed legislation replacing the Affordable Care Act (ACA), but the lack of consensus is threatening GOP leaders’ pledge to have a bill ready for a vote this month.

Led by Senate Majority Leader Mitch McConnell, key Republican senators held a series of meetings last week to gauge policy options. While the discussions were said to have narrowed some differences, senior staff said senators are not close to resolving the thorny issues that have divided conservative and moderate lawmakers.

The House bill phased out the ACA’s Medicaid expansion after 2020, but Republican senators representing states that added to their Medicaid programs – including Sens. Rob Portman (R-Ohio), Dean Heller (R-Nev.) and Shelly Moore Capito (R-W.Va.) – want to extend it for several more years. A potential solution might be to lengthen the wind-down beyond 2020 but not reduce funding under the per capita cap model as some conservative senators have separately advocated.

Other key disputes focus on state authority to opt out of coverage requirements, boosting federal funding to stabilize insurance markets and reduce premiums, and whether ACA provider taxes will be immediately repealed.

McConnell is facing perhaps his toughest challenge as GOP leader. With only 52 Republicans in the Senate, McConnell barely has room to maneuver, and the defection of more than two Republicans would doom the bill.

McConnell is pressing for a vote before the end of the month, when lawmakers begin a weeklong recess for the Fourth of July. It will be challenging for McConnell to meet that deadline. Once Republicans do largely agree on the underlying policy, the Congressional Budget Office (CBO) must weigh in with a detailed economic analysis of the bill before a Senate vote. Even with GOP leaders last week sharing key provisions with CBO analysts, a formal CBO review of the final legislation could take a week or longer.

House User Fee Bill Advances, but Senate Action Stalled by Health Debate

The House Energy and Commerce Committee last week unanimously approved its Food and Drug Administration (FDA) user fee reauthorization, but action on the Senate version has been stalled because of separate delays in considering the ACA’s replacement.

In an effort to not jeopardize passage of legislation critical to FDA’s core mission of reviewing prescription drugs and medical devices, committee leaders typically support only amendments that enjoy significant bipartisan support. That cross-party alliance was threatened when Rep. Morgan Griffith (R-W.Va.) proposed relaxing off-label restrictions for promoting medical products.

Reps. Frank Pallone (D-N.J.) and Gene Green (D-Texas) – the top Democrats on the full committee and the panel’s health subcommittee – said they would oppose the underlying user fee bill if the off-label language were adopted. Griffith withdrew his amendment rather than force a committee vote.

Another controversial amendment by Rep. Peter Welch (D-Vt.) to permit the importation of prescription drugs from Canada failed on a voice vote.

The committee approved several amendments by both Republicans and Democrats that affect medical devices, including removing a high-risk classification for low-risk device accessories, authorizing the FDA to regulate contrast agents used for medical imaging devices, and establishing a voluntary, post-market pilot program to collect safety data.

The Senate HELP Committee approved its user fee bill last month, but votes by the full House and Senate could be delayed until July as Republicans continue to debate separate healthcare legislation.
Current FDA user fees expire September 30. But if Congress doesn’t renew them before August 1, layoff warning notices would automatically be sent to FDA employees whose jobs are funded by the user fees.

House Committee to Hold CHIP Hearing

The House Energy and Commerce Health Subcommittee on Wednesday will examine several safety net health programs, including the Children’s Health Insurance Program (CHIP) and community health center funding.

The subcommittee’s chairman, Rep. Michael Burgess (R-Texas), said Congress is committed to renewing CHIP but left open the question of for how long and at what federal matching rate.

In addition to CHIP, the subcommittee will also examine Federally Qualified Health Centers and the Community Health Center Fund, which supports grants to outpatient healthcare facilities and is the nation’s largest source of comprehensive primary care for medically underserved populations.

Senate Panel to Hold Hearing on Drug Prices

On Tuesday, the Senate HELP Committee will hold a hearing on prescription drug prices by examining how the overall drug delivery system affects the prices Americans pay for medicine.

Committee Chairman Lamar Alexander (R-Tenn.) last month agreed to hold the hearing in an effort to quell Democrats’ push that drug pricing legislation adverse to the branded pharmaceutical industry be added to the panel’s consideration of the FDA user fee reauthorization.

Witnesses include Dan Mendelson, president of Avalere Health; Allan Coukell, senior director of health programs for The Pew Charitable Trusts; Paul Howard, the director of health policy at the Manhattan Institute; and Gerard Anderson, a professor at Johns Hopkins University School of Medicine.

At last week’s House Energy and Commerce Committee hearing on FDA user fees, Democrats repeatedly called for separate hearings on prescription drug prices. They followed up with a formal letter – signed by every committee Democrat – to Chairman Greg Walden (R-Ore).

During the hearing, Walden said it was important that the committee review the entire healthcare delivery chain, not just the pharmaceutical industry. But he didn’t commit to holding a hearing on drug pricing.

Brady Calls for Subsidies to Stabilize ACA Insurers

In an effort to keep insurance companies participating in the ACA marketplaces and prevent premiums from mushrooming, the chairman of the House Ways and Means Committee said Congress should approve new funding for cost-sharing subsidies.

Rep. Kevin Brady (R-Texas) said Congress must act to stabilize insurance premiums. He made the comment during a hearing last week on the U.S. Department of Health and Human Services (HHS) fiscal 2018 budget with Secretary Tom Price, who repeatedly refused to say whether the Trump administration would continue subsidies to insurers offering plans in the individual market.

Brady didn’t propose a funding level, though some congressional staff said it could ultimately be in the tens of billions of dollars.

Separately, Sens. John Thune (R-S.D.) and Ron Johnson (R-Wis.) also have said Congress may need to act quickly to keep the markets from collapsing. Thune, the No. 3 elected Senate Republican, said Congress also may need to act separately from the ACA replacement legislation to keep insurers in the marketplace.

Bipartisan Bill Would OK Medicare Coverage for Nutrition Therapy

Bipartisan Senate legislation would extend Medicare coverage for nutrition therapy in an effort to reduce the incidence of Type 2 diabetes among seniors.

Medicare covers only nutrition therapy for beneficiaries already diagnosed with diabetes or renal disease. The legislation, introduced by Sens. Gary Peters (D-Mich.) and Shelley Moore Capito (R-W.Va.), would allow for nutrition therapy reimbursement in all cases.

The senators say the coverage amounts to investing in preventive care that will both save taxpayer dollars by reducing Medicare costs for treating diabetes and help at-risk seniors live longer and healthier lives.

Nearly one-third of every Medicare dollar is spent on diabetes-related care – a number the senators say is only likely to increase. The Centers for Disease Control says 30 million Americans have diabetes and 86 million adults have pre-diabetes.

Price to Defend HHS Budget Again This Week

After being grilled by two committees last week, HHS Secretary Tom Price will be on Capitol Hill again this week defending the Trump administration’s fiscal 2018 budget request for federal health programs.

Price will testify before the Senate appropriations subcommittee that finances the HHS budget. The White House’s proposed budget includes more than $11 billion in cuts to HHS, including a $7 billion reduction for the National Institutes of Health, and hundreds of billions of dollars from Medicaid above what is in congressional Republicans’ ACA replacement legislation.

Most of Trump’s proposed HHS spending cuts have so far found little support in Congress, including among key Republicans.

House Scheduled to Vote on Health Bills

The House this week is scheduled to vote on three healthcare bills, including restrictions on malpractice lawsuits and citizenship verification for people receiving tax credits to buy health insurance.

Legislation by Rep. Steve King (R-Iowa) would create a three-year statute of limitations on filing medical malpractice lawsuits where insurance coverage was provided with a federal subsidy or tax benefit.

Rep. Lou Barletta (R-Pa.) introduced legislation that would require citizenship verification before individuals could collect advanced tax credits to buy health insurance.

Finally, the House is scheduled to vote on legislation by Rep. Pat Tiberi (R-Ohio) that would require COBRA health coverage to meet the same requirements as those of other qualified health plans.

Capitol Hill Healthcare Update