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="hlu photo" width="300" height="200">No vote this week, but GOP leaders vow action on health bill

Although House Republicans made progress on bridging ideological differences over how to replace the Affordable Care Act (ACA), GOP leaders say not to expect a vote this week as Congress faces a more immediate deadline: The government runs out of money Friday.

Reconvening after a two-week recess, lawmakers are grappling with how to fund competing budget priorities for the remainder of fiscal 2017, including $3 billion for a partial wall along the Mexican border sought by President Trump. GOP lawmakers say they likely will approve a short-term spending bill to keep the government open for another week as underlying budget negotiations continue.

The healthcare discussions are expected to continue, too, as lawmakers learn more about negotiations between House conservatives and moderates during the recess. Rep. Tom MacArthur (R-N.J.), a leader of the moderate Tuesday Group, said last week he reached an agreement on insurance market provisions with Rep. Mark Meadows (R-N.C.), the chairman of the conservative House Freedom Caucus.

The MacArthur-Meadows plan would ensure post-ACA coverage includes pre-existing conditions while also keeping essential health benefits part of a federal standard. Under that plan, states could seek waivers from some federal standards, but no state could waive requirements that young adults be included on their parents’ insurance policies, nor rules to prevent denial of coverage based on pre-existing conditions or gender.

The MacArthur-Meadows outline hasn’t been translated into legislative text nor vetted with a wider group of GOP lawmakers, so it’s unclear whether it could break the Republicans’ intra-party logjam that has stalled passage of a bill replacing the ACA. The White House had been pushing for a vote, hoping to trigger House action before Saturday, which marks the end of Trump’s first 100 days in office. But after canceling a vote in late March on the American Health Care Act, senior congressional staff say a new vote won’t be scheduled until leaders are certain they can pass the bill.

Despite the continued uncertainty on a path forward, GOP leaders say privately they are confident they will eventually secure the votes needed for House approval. Too much of their follow-on agenda, including tax reform, is predicated on replacing the ACA and repealing the law’s tax provisions, they say.

Gottlieb vote set for Wednesday

The Senate HELP Committee on Wednesday is scheduled to vote to advance President Trump’s nominee to lead the FDA. Dr. Scott Gottlieb is likely to win committee approval and has the strong backing of committee Chairman Lamar Alexander (R-Tenn.). Democrats on the panel have said Gottlieb is too close to the pharmaceutical industry that he would oversee at the agency, and it’s possible all committee Democrats may vote against his nomination. If Gottlieb wins committee approval, leadership aides say they hope to schedule a Senate confirmation vote before the Memorial Day recess next month.

Republican introduces REMS bill to address drug prices

A House Republican introduced legislation that would end what he said was brand-name pharmaceutical manufacturers’ “manipulation” of an FDA safety program to block competition and thwart lower drug prices. The legislation would compel brand-name companies to make their products available to generic drug makers, including drugs covered by the FDA-mandated safety program Risk Evaluation and Mitigation Strategies (REMS). Critics say innovator manufacturers use REMS to block access to drugs that generic companies need for bioequivalence testing. The House legislation has been introduced before, including in the Senate, but failed to gain traction, as brand-name companies say it would unfairly force them to sell drugs to generic manufacturers, including some that lack the capability of safeguarding high-risk REMS treatments.

What’s notable about the House legislation is its new Republican lead sponsor, Rep. David McKinley (R-W.Va.). McKinley is a member of the Energy and Commerce Committee, which has legislative jurisdiction over the FDA. Other Republicans have supported previous efforts to relax REMS safety standards and force drug companies to sell their products to generics, but McKinley is the first GOP lawmaker on a relevant healthcare committee to lead the effort. McKinley’s West Virginia district includes Morgantown, where generic manufacturer Mylan Pharmaceuticals has its corporate headquarters.

Bipartisan step therapy bill introduced in house

New legislation introduced in the House would regulate insurers’ “step therapy” protocols, giving doctors greater say in the treatments they prescribe for their patients. Introduced 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. It also outlines several conditions under which exceptions to step therapy requirements would be automatically granted.

The lawmakers said step therapy is “a one-size-fits-all policy” that ignores patients’ medical histories, overlooks doctors’ recommendations and can lead to unnecessary breaks in treatment. The legislation is designed to ensure that a patient’s healthcare provider, not an insurance company, makes treatment decisions, they said.

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

Insurers increasingly use step therapy as a cost-containment tool, but in some cases it can have the opposite effect. Patients are often required to try and fail on two or more drugs before a health plan or PBM approves coverage for the medicine originally prescribed. Some plans and PBMs even require patients to first try medicines with black-box warnings.

The bill would only affect employer-sponsored health plans governed under federal law and would not preempt state laws – though several states have enacted similar legislation in recent years.

Grassley questions insurer over brand drug “penalties”

One of the leading Republican voices in Congress on the issue of drug prices is asking CareFirst BlueCross BlueShield why it’s charging patients a penalty for certain brand name drugs. CareFirst, one of the largest insurers in the mid-Atlantic, is up-charging patients whose doctors are prescribing brand name drugs when generics are available. Sen. Chuck Grassley (R-Iowa) wants to know why.

Grassley, in a letter to CareFirst, questioned why the insurer is charging a penalty – equal to the difference between a brand drug’s price and a generic’s price – when a physician has found the brand drug to be medically necessary. Grassley, who is chairman of the Judiciary Committee, said he is looking into whether the practice is commonplace among plans and whether it violates a federal law that requires insurers to waive cost sharing when a physician prescribes a brand drug for medical reasons.

Senate bill would expand telehealth

Bipartisan legislation introduced in the Senate would require the Centers for Medicare &amp; Medicaid Services to test whether telehealth and remote monitoring services can help providers boost health outcomes. The bill was introduced by Sens. Cory Gardner (R-Col.) and Gary Peters (D-Mich.), who said greater use of telehealth services would expand access to healthcare in both rural and urban areas. The legislation would require the U.S. Department of Health and Human Services to allow eligible hospitals to test telehealth services through the Center for Medicare &amp; Medicaid Innovation (CMMI). It would also direct CMMI to order an independent evaluation to assess telehealth models in Medicare Parts A and B. If the telehealth model meets criteria for savings and health outcomes, it would win wider Medicare reimbursement eligibility.

Chronic care legislation introduced in Senate

A bipartisan group of senators introduced legislation that would overhaul how Medicare pays for patients with chronic illnesses. The legislation was spearheaded by the Senate Finance Committee, which undertook a yearlong effort to consider how to improve health outcomes for the more than two-thirds of Medicare beneficiaries living with chronic diseases. The bill would expand the Independence at Home program, which allows seniors with multiple, complex and expensive chronic conditions to receive specialized care at home from a team of healthcare providers. The bill would also allow Medicare Advantage plans to tailor coordination and benefits to specific patient groups, and it would promote the wider use of telehealth services.

For Accountable Care Organizations, the bill would allow certain ACOs to use funds to help patients afford primary care services needed to manage chronic conditions.

The bill is sponsored by the committee chairman, Sen. Orrin Hatch (R-Utah), and the panel’s top Democrat, Sen. Ron Wyden (D-Ore).

Capitol Hill Healthcare Update