- Legislation Would Prohibit Certain Practices that Block Generics
- Republicans Remain Split on Health Care
- Senators Propose Chronic Care Bill
- MedPAC Recommends Changes to Medicare Part B Drug Reimbursements
Brand-name drug makers would be prohibited from using Food and Drug Administration (FDA) safety programs to deny generic manufacturers access to their products, if a recently proposed bill becomes law.
Generic drug companies and supporters of increased use of generics charge that brand-name firms sometimes use risk evaluation and mitigation strategies (REMS) and similar programs – some of which are self-imposed by manufacturers – that are typically intended to control the distribution of medicines for which there are safety concerns to prevent generic firms from obtaining their products. Without such access, generic firms are unable to show the bioequivalence – or, in the case of biologics, biosimilarity – that is needed for approval by the FDA.
The “Fair Access for Safe and Timely (FAST) Generics Act” (H.R. 2051), from Reps. David McKinley, R-W.V., and Peter Welch, D-Vt., would prohibit brand-name companies from using REMS “in a way that restricts or has the effect of restricting the supply of such covered product to an eligible product developer for development or testing purposes.”
“Our legislation will save consumers billions of dollars by ensuring timely competition in the market and preventing unfair delays for patients seeking more affordable options for their medications,” Welch said.
The Public Sector HealthCare Roundtable signed on to an April 6 letter to McKinley and Welch that states that their legislation “would provide a clear solution to abusive, anticompetitive business practices that increase costs to the American health care system by impeding patient access to generic and biosimilar medicines.”
Eighteen other groups signed on to the letter, including AARP, the Association for Accessible Medicines, America’s Health Insurance Plans, and Public Citizen.
As many as 80 Republicans would have voted against the GOP’s unsuccessful health care reform proposal in the House of Representatives, one of those opponents said at a town hall meeting.
On March 24, GOP leaders of the House of Representatives withdrew the “American Health Care Act” (H.R. 1628) from consideration just before a scheduled vote when it became clear that, despite having a significant majority of the chamber’s members, they lacked the votes needed for passage. This thwarted the fulfillment of one of the Republican Party’s top goals for the past seven years – repeal of the Patient Protection and Affordable Care Act (ACA) – after it seemed since November, when Donald Trump was elected president and Republicans held on to their majorities in both the House and Senate, to be a sure thing.
Given that Democrats were united in opposition to the bill, any more than 21 Republicans voting against it would have most likely resulted in defeat. Trump and GOP congressional leaders said after the vote cancellation that they were close, but Rep. Justin Amash, R-Mich., a libertarian who opposes the ACA but who also heavily criticized the GOP proposal, estimated that 50 to 80 Republicans would have voted against the bill.
“It would have been really embarrassing,” Amash said.
The proposal was also unpopular with the public, with a Quinnipiac survey in late March reporting that it had an approval rating of just 17 percent. An early April Kaiser Family Foundation survey, meanwhile, found that 75 percent of Americans – and 51 percent of Republicans – said they want the Trump administration to “do what they can to make the health care law work.” The Kaiser survey also found that 64 percent of people said it is a “good thing” that Congress did not pass the Republican plan, and 61 percent said that Trump and congressional Republicans are now responsible for the success or failure of the ACA.
This public discontent with Republican actions on health care appears to have contributed to several GOP congressmen in swing districts avoiding town halls.
“Republicans have already squandered a lot of political capital on a bill that went nowhere,” an analyst with the Cook Political Report said, according to USA Today. “The longer the health care issue lingers, the more displeased members of both bases are.”
Though Republicans have held talks in an attempt to revive the effort that was given up for dead on March 24, there appears not to have been much progress toward a deal concerning what some people are referring to as Zombie Trumpcare.
The challenge for Republicans is that they must quell opposition from both moderates, who were concerned about Congressional Budget Office (CBO) and Joint Committee on Taxation (JCT) projections that the proposal would increase the number of people without insurance by 24 million within a decade, and conservatives and libertarians like Amash, who disparaged the bill as “Obamacare Lite.” Any revisions to please one faction are likely to increase opposition in the other one.
Even if a modified proposal were to get through the House, support for the GOP plan is even shakier in the Senate, where Republicans hold only a two-vote majority.
The GOP plan would not repeal all of the ACA because it was structured so that it could be passed using the budget reconciliation process, which is limited to tax and spending-related measures. This procedure does not allow for filibusters and, thus, would require only a simple majority of votes to get through the Senate, rather than a 60-vote supermajority that would otherwise be needed.
A bipartisan group of senators has reintroduced legislation to enhance chronic care management in Medicare.
The Senate Finance Committee Chronic Care Working Group, which includes Finance Committee Chairman Orrin Hatch, R-Utah, Ranking Member Ron Wyden, D-Ore., Sen. Johnny Isakson, R-Ga., and Sen. Mark Warner, D-Va., proposed the “Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act” (S. 870).
The bill would, among other things, expand certain telehealth and home care options; enhance options for the chronically ill within Medicare Advantage; increase payment accuracy for patients with chronic conditions; provide more flexibility to the beneficiary selection process in accountable care organizations, and allow more care coordination in ACOs. (Summary)
“Medicare policy cannot stand idly by while the needs of people in the program shift to managing multiple costly chronic diseases,” Wyden said. “This bill provides new options and tools for seniors and their doctors to coordinate care and makes it less burdensome to stay healthy.”
The group unsuccessfully proposed the same bill during the last session of Congress.
The proposal is based in part on the 327 comments the working group received in response to a December 2015 policy options paper. The Public Sector HealthCare Roundtable submitted comments in January 2016 stating that the options paper “reflects work and analysis that will further the goal of improving care for the millions of vulnerable Medicare beneficiaries managing multiple chronic conditions” and noted that “many of the proposed policies align with the Roundtable’s overarching policy priorities.”
The Medicare Payment Advisory Commission (MedPAC) is recommending that Congress change the way providers are reimbursed for drugs in Medicare Part B.
The approach endorsed by MedPAC in a unanimous vote at its April 6-7 meeting would reduce the amount that Medicare Part B pays for drugs from 6 percent above the average sales price down to 3 percent. In addition, it would require drug manufacturers to submit average sales price data to the Centers for Medicare & Medicaid Services (CMS); to pay a rebate to Medicare when price increases exceed an inflation benchmark; and, beginning in 2022, to negotiate prices with private vendors negotiating on behalf of physicians. It is projected that the proposal would save Medicare as much as $5 billion over five years.
Medicare Part B covers physician visits, so the proposal would only affect payments for drugs administered during those visits. It would not make changes to the Medicare Part D prescription drug benefit.
While all of the commissioners supported the proposal, some indicated that a more aggressive approach to contain drug spending in Medicare might be appropriate, like Commissioner DeBusk, who said, “I don’t know that we’ve gone far enough.”
“I mean, I would describe what we’re doing as a gentle tapping of the brakes on a system that’s designed to go faster and faster,” Brian DeBusk said. “So I see these as very reasonable recommendations.”
The pharmaceutical industry, however, is expected to lobby hard against the recommendations in Congress.
“PhRMA strongly opposes the wide range of new Medicare Part B recommendations approved by MedPAC earlier today,” a Pharmaceutical Research and Manufacturers of America (PhRMA) spokesperson said after the vote. “These recommendations could have a detrimental impact on access for patients who rely on Part B therapies to treat serious and complex conditions. These recommendations ignore the fact that medicines remain a small and stable share of overall spending while providing significant value to patients.”