HealthCare Roundtable e-News – May 26, 2017

GOP Proposal Would Result in 23 Million More People Without Insurance: CBO

The Republican health care proposal that passed the House of Representatives in early May would result in the number of Americans who have no health insurance increasing by 14 million next year and by 23 million in 2026, according to the Congressional Budget Office (CBO).

The House on May 4 narrowly passed its replacement for the Patient Protection and Affordable Care Act (ACA), the “American Health Care Act” (H.R. 1628) The proposal would, among other things, eliminate or make major changes to the ACA’s individual and employer mandates, Medicaid expansion, subsidies for the purchase of health insurance in the exchanges created by the ACA, prohibition on setting premiums based on a person’s health status, and requirement that policies cover certain “essential health benefits.”

The legislation would reduce planned Medicaid spending by $880 billion over 10 years, and CBO concluded that this, alone, would lead to 14 million fewer people having insurance in 2026. Also in that year, about 6 million fewer people would obtain individual coverage through the exchanges.

“Fewer people would enroll in the nongroup market because the penalty for not having insurance would be eliminated and, starting in 2020, because the average subsidy for coverage in that market would be substantially lower for most people currently eligible for subsidies,” CBO stated. “Also, more employers would offer coverage to their employees because the available nongroup coverage would tend to have higher out-of-pocket premiums for people currently eligible for subsidies and because the plans would tend to provide fewer benefits.”

The bill, CBO estimated, would reduce federal deficits by about $119 billion over a decade. This is about 1.3 percent of the combined $8.6 trillion in projected deficits during that time.

Health and Human Services Secretary Tom Price rejected the conclusions reached by CBO.

“The CBO was wrong when they analyzed Obamacare’s effect on cost and coverage, and they are wrong again,” Price said. “In reality, Americans are paying more for fewer health care choices because of Obamacare, and that’s why the Trump administration is committed to reforming healthcare.”

Republican leaders of the House Energy and Commerce Committee, who helped to develop the legislation, though, focused on the agency’s projections that, under the legislation, “nongroup insurance markets would continue to be stable in many parts of the country” and, while premiums in the individual market would increase during the first two years after the law’s enactment, they could then decrease in states that sought a waiver to lift requirements regarding essential health benefits (EHBs).

“CBO continues to find that through our patient-focused bill, premiums will go down and that our reforms will help stabilize the market,” Energy and Commerce Committee Chairman Greg Walden, R-Ore., and Health Subcommittee Chairman Michael Burgess, R-Texas, said.

Democrats, meanwhile, pointed to CBO’s projections as confirmation of their criticisms of the proposal.

“If House Republicans have their way, many Americans with pre-existing conditions will be pushed off their insurance and forced into high risk pools with soaring costs and frightening limits on the care they need,” House Minority Leader Nancy Pelosi, D-Calif., said. “Some Americans with pre-existing conditions would no longer be able to afford coverage of any kind. Trumpcare would also gut the essential health benefits for millions of Americans, meaning huge cost increases for basic coverage like maternity care, addiction and mental health treatment, and emergency services. Under Trumpcare, after an illness or injury, many Americans will find they’ve been paying for health coverage that doesn’t cover much at all. Trumpcare is a billionaire’s tax cut disguised as a health care bill: one of the largest transfers of wealth from working families to the rich in our history.”

The bill would cut taxes by $883 billion over 10 years. The Tax Policy Center concluded that more than 90 percent of the benefits of those cuts would go to households with annual incomes of more than $100,000, and more than 70 percent would go to those with $200,000 or more in income.

The legislation now awaits action by the Senate. Republicans in that chamber, however, are drafting their own proposal that will likely be very different from the House bill, given that the GOP has only a two-seat majority and several Republican senators have already announced their opposition to the House proposal. Even if Senate Republicans are able to write a bill that wins over nearly its entire caucus, that legislation would have to go back to the House for another vote, and the changes made by the upper chamber could upset the delicate balance that was crafted to get the bill through the House the first time.

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FDA to Implement Measures to Enhance Generic Drug Competition

The Food and Drug Administration (FDA) is making procedural changes aimed at increasing generic drug competition, the head of the agency told members of Congress.

The prices of some generic drugs have increased sharply in recent years, prompting calls from consumer advocates and some lawmakers for a legislative or regulatory response. The increases have been especially high for drugs that, while off patent, have only a single generic manufacturer.

During a May 25 hearing held by a House Appropriations Committee subcommittee, Bloomberg BNA reported, FDA Commissioner Scott Gottlieb noted several actions that the agency will take to address this and other issues related to the development and approval of generic drugs, including:

  • Publishing a list of drugs that are off patent but have no generic competition
  • Increasing communications with generic drug makers
  • Examining whether the FDA can act when brand name drug manufacturers use certain safety rules known as risk evaluation mitigation strategies (REMS) to prevent generic companies from obtaining their products

“Simply put, too many patients are priced out of the medicines they need,” Gottlieb said. “While the FDA does not have a direct role in drug pricing, we can take steps to facilitate entry of lower-cost alternatives to the market, and increase competition.”

The Senate is considering legislation that includes provisions aimed at increasing generic drug competition by setting a limit of no more than eight months for FDA action on drug applications in cases where there is inadequate generic competition and implementing other measures intended to speed generic drugs to market when competition is lacking. In addition, bills have been introduced in both the House and Senate that seek to prevent brand name companies from abusing REMS. The Public Sector HealthCare Roundtable is supporting the proposal.

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Panel OKs Biosimilar Application

A Food and Drug Administration (FDA) panel voted to recommend approval of what would be the sixth biosimilar to be sold in the United States.

Biologic drugs are highly advanced medicines derived from biological, rather than chemical, processes. They are among the most innovative of drug treatments and, as such, are also among the most expensive, potentially costing tens, even hundreds, of thousands of dollars each year for a single patient. Generic biopharmaceuticals are expected to offer lower-cost alternatives to brand-name products, as generic versions of traditional drugs do.

The FDA’s Oncologic Drugs Advisory Committee voted 14-1 on May 25 in support of approving an epoeitin alfa biosimilar that is manufactured by Hospira, a subsidiary of Pfizer. The reference product is Epogen from Amgen. The drug treats anemia in patients with cancer, HIV and certain other conditions.

Regulatory Focus reported that advisory committee members expressed few concerns about the biosimilar application, “breezing through questions about the analytical comparability of the two products and whether there were any clinically meaningful differences.” The one member who voted in opposition expressed support for two of the biosimilar’s four proposed indications, but said he had “residual concerns about lack of immunogenicity and basic safety data in patients with HIV and cancer.”

The biosimilar now awaits formal approval by the FDA.

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