- Senate GOP Aiming for Health Care Vote Before July
- Proposal Would Require Drug Makers to Justify Big Price Increases
- FDA Releases Guidance for Expedited Review of Generic Drug Applications
- Per Capita Health Care Spending in U.S. Exceeded $8,000 in 2014: CMS
Republicans in the Senate are reportedly aiming to vote on a health care bill during the week of June 26.
The House of Representatives on May 4 narrowly passed the “American Health Care Act” (H.R. 1628), which 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 state-level exchanges, prohibition on setting premiums based on a person’s health status, and requirement that policies cover certain “essential health benefits,” all while cutting taxes by $883 billion over 10 years. Although Republicans have majorities in both chambers, the House bill has little support in the Senate, and GOP senators have been developing their own proposal.
A working group of Republican senators has been crafting a plan and, not surprisingly, have had difficulty trying to satisfy both moderates and conservatives in the party. Since Republicans have only a two-seat majority in the 100-member Senate, they will need near-unanimous support within their party to pass the bill. (Republicans plan to use a procedural maneuver that will avoid the possibility of a Democratic filibuster and require only a simple majority for passage.)
“We have 52 Republican senators all wanting to get to yes to find a solution, and I believe we’re going to vote before the July 4th recess,” Sen. John Barrasso, R-Wyo., a member of the Senate leadership, said on CNBC.
After the Independence Day recess, Congress will also be out for most of August before returning to Washington, D.C., after Labor Day. This leaves limited time to pass a health care bill, in addition to addressing legislative necessities, such as spending bills and an increase in the debt limit, and other GOP priorities, including tax reform.
Senate Republicans so far have conducted all of their health care discussions in private, and it appears that they will not hold any committee hearings on the legislation. To protest this, Democrats are employing procedural tactics to slow down all of the Senate’s business.
“If Republicans won’t relent and debate their health care bill in the open for the American people to see, then they shouldn’t expect business as usual in the Senate,” Senate Minority Leader Charles Schumer, D-N.Y., said. “Republicans are drafting this bill in secret because they’re ashamed of it, plain and simple.”
Even some rank-and-file Republican senators have expressed concern about the process.
“None of us have actually seen language,” Sen. Lisa Murkowski, R-Alaska, told Vox. “My constituents expect me to know, and if we had utilized the process that goes through a committee, I would be able to answer … my constituents’ questions.”
Senate Majority Leader Mitch McConnell, R-Ky., though, said, “I think we’ll have ample opportunity to read and amend the bill.”
President Donald Trump, meanwhile, reportedly told 15 Republican senators during a June 13 lunch meeting that the House bill – which he had called a “great plan” and for which he held a Rose Garden celebration to celebrate its passage through a single chamber of Congress – was “mean.”
“We need to be more generous,” Trump was reported to have said.
Once complete, the Senate bill is to be submitted to the Congressional Budget Office (CBO) for an analysis of how it would affect insurance coverage and government spending. CBO concluded that the House bill would result in the number of Americans who have no health insurance increasing by 14 million next year and by 23 million in 2026. The agency also estimated that the bill would reduce federal deficits by $119 billion over a decade – about 1.3 percent of the combined $8.6 trillion in projected deficits during that time.
Even if Senate Republicans are able to pass a bill, 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 put together to get the bill through the House the first time.
A senior Democratic senator has proposed a bill that would require drug manufacturers to explain the reasons behind sharp price increases.
The “Stopping the Pharmaceutical Industry from Keeping Drugs Expensive Act” from Senate Finance Committee Ranking Democrat Ron Wyden of Oregon would direct the Department of Health and Human Services (HHS) to notify a manufacturer when the price of a drug exceeds certain thresholds, for example, doubling within the previous year. The drug maker would have 180 days from that point to submit to HHS “all relevant information and supporting documentation necessary to justify the increase in the wholesale acquisition cost of the applicable drug.” HHS would then post the justification information online. (Summary)
“Americans are sick and tired of seeing the cost of their prescription drugs race past their paychecks,” Wyden said. “Drug companies that increase their prices by double or even triple digits every year ought to be accountable to American families and taxpayers.”
Wyden’s proposal has three original cosponsors, all of whom are Democrats. Given that Republicans control the Senate and generally oppose government involvement in company pricing decisions, the legislation is unlikely to advance.
Wyden also reintroduced the “Reducing Existing Costs Associated with Pharmaceuticals (RxCAP) for Seniors Act”, which would eliminate cost-sharing for Medicare Part D (prescription drug benefit) beneficiaries whose out-of-pocket costs exceed $7,500. Wyden unsuccessfully introduced the same bill last year.
The Food and Drug Administration (FDA) released draft guidance on how generic drug manufacturers can qualify for expedited review of their applications.
In response to the sharp increases in the prices of some generic drugs, the FDA is offering an expedited review process for approval of certain generic drugs that meet the criteria for being a “priority” submission, as in the case of a drug shortage.
The non-binding guidance advises that, in order for expedited review to be granted, a company must submit “pre-submission facility correspondence” (PFC) two to three months before the regular application for approval is submitted. The PFC would provide the FDA with information about the manufacturing process and testing facility, relevant bioequivalence and clinical studies, and other factors to give the agency “the opportunity to determine whether facility inspections will be needed, and when they are, to initiate inspection planning earlier in the review of the [application], enabling FDA to meet the shorter review timeframe.”
The FDA’s regulations and guidance are separate from legislative attempts to speed the approval of generic drug applications, such as the “Lower Drug Costs Through Competition Act” (H.R. 749), which would seek to promote the development of generic drugs when there is no competition for an existing generic or there is a shortage by awarding manufacturers who develop a generic in such situations a “priority review voucher” that would enable them to jump to the front of the FDA’s review line. The proposal would also require the FDA to act on generic applications within 180 days when there is a drug shortage or not enough manufacturers to sustain competition.
As of the end of 2016, the FDA had a backlog of 2,358 generic drug applications. That was down from 2,962 a year earlier.
Per capita health care spending in the United States in 2014 averaged $8,045, but averages within states varied by thousands of dollars, according to the Centers for Medicare & Medicaid Services (CMS).
Alaska had the highest per capita spending at $11,064, while Utah had the lowest at $5,982. Alaska also tied for the highest average annual percentage increase in per capita health care spending between 1991 and 2014 at 6.6 percent. Vermont also came in at 6.6 percent, while spending in New Hampshire during that time increased by 6.1 percent.
“The health sector experienced substantial change during the period 201014,” a Health Affairs article about the data written by representatives of CMS’ Office of the Actuary stated. “Concurrent with the lagged impact of a severe recession and extended modest recovery, the enactment and implementation of comprehensive health reform legislation affected not only coverage for health care but also its financing and delivery. Additionally, the baby-boom generation began to enroll in Medicare – a notable demographic shift both for the nation as a whole and for the Medicare population itself.”
Between 2013 and 2014, national per capita spending increased by 4.4 percent. This was higher than the 2.8 percent average annual increase during the post-Great Recession years of 2010-13 but lower than the 5.2 percent annual growth from 2004-09.