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" />Delayed Senate Health Vote Boon to GOP or Just Prolonging the Inevitable?

Senate Majority Leader Mitch McConnell’s announcement that he would delay a key procedural vote scheduled for this week on the Republicans’ healthcare overhaul gave the GOP yet more time to find a legislative solution that can pass the Senate.

But given McConnell’s inability so far to cobble together a majority to repeal the Affordable Care Act, the delay may just be prolonging what’s turning into a political nightmare for the GOP. Despite congressional majorities in the House and Senate, Republicans can’t rally around a plan to overturn a law they have campaigned against for seven years.

McConnell was forced to push back a vote on whether to begin debating the GOP health bill, the Better Care Reconciliation Act, after Sen. John McCain underwent surgery for a blood clot Saturday. McCain won't be back in Washington for at least another week. 

McConnell needs McCain's vote on the so-called “motion to proceed.” Of the 52 Senate Republicans, two have already said they would oppose that motion. One more GOP “no” vote or a Republican not voting, and the party’s bill would effectively die before it could even be debated or voted on.

Sens. Rand Paul (R-Ky.) and Susan Collins (R-Maine) have said they would vote to block consideration of the Republicans’ health bill.

McConnell had earlier announced the Senate would remain in session for the first two weeks of August, rather than adjourning as planned on July 28 for a recess that would last until after Labor Day. Some Republican staff were hopeful the delay in considering the health bill and the shortened August recess could give McConnell additional time to craft a political solution that has so far eluded the renowned legislative dealmaker.

But others were openly pessimistic, lamenting the political consequences of failing to address a law Republicans have told their voters they would repeal as well as the opportunity cost of the legislative time lost during the debate on the ACA.

McConnell’s challenge remains balancing the demands of conservatives who want to wipe out as much of the ACA as possible and those of more moderate Republicans who want to protect states that have expanded their Medicaid programs and Americans whose insurance covers pre-existing conditions.

Senate Health Bill Delay May Spur Action on User Fee Renewal

The House last week approved by voice vote a five-year renewal of FDA user fees for pharmaceutical and medical technology manufacturers, potentially setting up action in the Senate for later this month.

With Senate votes delayed on Republicans’ plans to repeal the Affordable Care Act, the user fee reauthorization could see accelerated floor time in the Senate. Senate leaders as of Monday had not announced a timetable for considering the House-passed legislation.

Although the user fee bill is largely non-controversial, Senate leaders had hoped to approve it after voting on the ACA bill. GOP leaders feared the user fee package could become collateral partisan damage from the ACA debate.

During the past several weeks, key House and Senate staff worked to pre-negotiate several policy issues to allow the House and Senate to vote on a single bill rather than establishing a formal conference committee between the two chambers. The latter process could have made the bill subject to more procedural hurdles and an attractive political target to which lawmakers could attach controversial provisions, such as on drug pricing.

The user fees for pharmaceutical and medical technology manufacturers expire September 30. Without congressional action by August 1, mandatory notices will be sent to FDA staff whose jobs are tied to user fee funding, warning of potential layoffs if Congress fails to renew the program. Lawmakers in both parties say they want to avoid triggering those notices.

House Hearing This Week on 340B Drug Program

The House Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing Tuesday on the Health Resources and Services Administration’s (HRSA’s) oversight of the 340B prescription drug discount program.

This will be the second committee hearing looking into HRSA’s management of the program, which has come under bipartisan criticism in recent years. Witnesses include Krista Pedley, director of HRSA’s Office of Pharmacy Affairs; Debbie Draper, director of health care at the Government Accountability Office; and Erin Bliss of HHS’ inspector general office.

Separately, the Centers for Medicare &amp; Medicaid Services (CMS) proposed last week to reduce the reimbursement rate for Medicare Part B payments to hospitals for drugs covered by the 340B program. The move was designed to reflect the discounted rate hospitals pay for those drugs.

The subcommittee has been critical of what it says is HRSA’s lax oversight of the discount program while the program has mushroomed in recent years. The number of 340B covered entities has grown from 3,200 in 2011 to 12,148 as of last October, and the number of hospitals participating in the program has increased from 591 in 2005 to 2,871 as of this month.

Despite the size of the program – entities saved $4.5 billion in drug costs in fiscal 2014 – the GAO and other offices have criticized HRSA for failing to adequately supervise the program, including infrequent audits of participating entities.

Hatch, Grassley Question CMS on Meaningful Use Overpayments

The Department of Health and Human Services’ (HHS’) inspector general in June announced that CMS had overpaid physicians for electronic health record incentive payments by more than $700 million, and two key senators want to know what the agency is doing about it.

Finance Committee Chairman Orrin Hatch (R-Utah) and Judiciary Committee Chairman Chuck Grassley (R-Iowa) want to know if CMS is “capable of recovering taxpayer money that should not have been spent.” In a letter to CMS Administrator Seema Verma, the senators want to know what the agency is doing about the excess payments from 2011 to 2014 and what it is doing to prevent future over-payments.

HHS’ inspector general found physicians had failed to demonstrate meaningful use of electronic records, and that CMS made inappropriate incentive payments to doctors who switched between Medicare and Medicaid.

House Panel Approves Medicare Reimbursement for Telehealth

The House Ways and Means Committee last week approved bipartisan legislation that would allow for Medicare to reimburse for monthly telemedicine visits at home for end-stage renal disease patients.

Introduced by committee Chairman Kevin Brady (R-Texas) and the panel’s top Democrat, Rep. Richard Neal (D-Mass.), the legislation would make several changes to the home infusion and dialysis benefits under Medicare Part B.

Separately, the committee also approved legislation that would make permanent Medicare Advantage special needs plans for beneficiaries who are institutionalized. Introduced by Health Subcommittee Chairman Pat Tiberi (R-Ohio), the bill would authorize for five years special needs plans for beneficiaries who are dually eligible for Medicare and Medicaid and special needs plans for those with chronic conditions.

Capitol Hill Healthcare Update