WASHINGTON -- The Obama administration is aware of the backlash to a proposed new Medicare Part B demonstration project and says it is willing to adjust its plan.
CMS Open to Changes in Part B Proposal, Official Says
The Centers for Medicare & Medicaid Services (CMS) is open to revising its proposal to change the way physicians are paid for drugs administered under Medicare's Part B program, an agency official said Wednesday.
"The proposal was to remove financial considerations from the prescribing of medicine," CMS chief medical officer Patrick Conway, MD, told reporters at a briefing sponsored by the Alliance for Health Reform, Health Affairs, and the Jayne Koskinas Ted Giovanis Foundation for Health and Policy. "That being said, if the proposal doesn't hit that point and we need to adjust it, we'd be open to that."
The current CMS plan would replace the current Medicare reimbursement -- the average sales price of the drug plus a 6% add-on fee to cover costs -- with a rate of the average sales price (ASP) plus 2.5%, plus a flat fee of $16.80 per drug per day. The flat fee would be adjusted at the beginning of each year. However, some specialists (especially oncologists) objected that this would amount to a hefty pay cut.
Novel Opioid Not Abuse-Deterrent, FDA Panel Says
At a joint FDA advisory committee meeting Thursday, members voted that an immediate-release version of a hydrocodone/acetaminophen combination product could be approved, but it shouldn't get abuse-deterrent labeling.
Panelists voted 16-4 that benzhydrocodone/acetaminophen (6.67 mg/325 mg), or KP201 (Apadaz), proved bioequivalence to similar products on the market, but voted 18-2 that evidence to demonstrate abuse deterrence -- focused mostly on preventing the drug from being snorted -- were lacking.
"I think we would like to see an abuse-deterrent product for immediate release that really has an effect, but we have to remain critical," said panelist Tobias Gerhard, PhD, of Rutgers University. "We haven't seen the evidence that this product makes a difference compared to available immediate-release products."
CMS Panel Offers Plan for New Medicare Payment Models
A new advisory panel to the Centers for Medicare and Medicaid Services (CMS) offered a draft blueprint for evaluating certain alternative payment models under the agency's new reimbursement framework at a Wednesday meeting. The panel also gathered feedback from stakeholders on its proposed process.
CMS staff joined the Physician-Focused Payment Model Technical Advisory Committee (P-TAC) meeting, presenting a proposed rule for its new reimbursement framework, released last week, including draft criteria for new alternative payment models.
A physician-focused payment model, or PFPM, is defined by last year's MACRA legislation as an "alternative payment model (APM) wherein Medicare is a payer, which includes physician group practices or individual physicians as APM entities," and its primary focus is improving the cost and quality of physician services.
FDA Regulates E-Cigarettes, Hookahs
The FDA released its long-awaited final "deeming" regulations on noncigarette tobacco products Thursday, giving the agency authority over e-cigarettes, cigars, little cigars, pipe tobacco, hookah pipes, and other tobacco products.
The action will subject all manufacturers, importers and/or retailers of e-cigarettes and the other newly regulated products to the same regulatory restrictions as traditional cigarettes, and bar sales of these products to minors.
Moreover, starting in 90 days, photo IDs will be required to purchase e-cigarettes, hookahs, and the other products, and sale of the products in vending machines and distribution of free samples will be prohibited. Advertising and marketing of the products will be greatly restricted as well.
ABIM Announces New Certification Exam Option
Internists will have a new option for board certification starting in 2018, the American Board of Internal Medicine (ABIM) announced Thursday.
"In an effort to provide options and alternatives to the once-every-10-year exam, beginning in January of 2018, ABIM will offer two assessment options," Richard Baron, MD, president and CEO of ABIM, said here at the annual meeting of the American College of Physicians. "One will continue to be the long-form assessment taken every 10 years ... but the new track is a more frequent assessment, with fewer questions, completed outside a testing center."
The frequency of the shorter exam will be more often than every 10 years but no more than annually, according to an ABIM press release. As to the exact interval, that is something "we need to be discussing with all of you about what feels right," Baron told the audience. ABIM will also be using some version of remote proctoring, "which is another term for the ability to verify that the person doing the assessment is the person we think it is, and the resources they're accessing are the same resources anybody taking it is accessing," he added.
Next Week
On Wednesday, the FDA's Vaccines and Related Biological Products Advisory Committee will hear updates of the research program in the Laboratory of Bacterial Polysaccharides.
And the House Energy & Commerce Committee will discuss healthcare solutions for expanding patient choice and plan innovation.
On Thursday, the House Committee on Veterans' Affairs will review efforts to prevent veteran suicide.
And Health Affairs will hold a discussion to explore value based payments.
On Friday, a House Subcommittee for the Committee on Energy and Commerce will address concussions in youth sports.
D.C. Week: CMS Open to Changes in Part B Proposal
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