WASHINGTON — New rules for some of Medicare‘s accountable care organizations (ACOs), an approval for the first RNA interference agent, and a challenge to states to loosen their scope-of-practice rules were all part of the mix in the nation’s capital this week during what is usually a quiet time of the year.
The Centers for Medicare & Medicaid Services (CMS) announced a radical overhaul to Medicare Shared Savings Accountable Care Organizations (MSS ACOs) on Thursday, demanding participants take more risk, more quickly, under a new draft rule.
New ACO participants will be allowed to stay in an “upside-only” risk model for a maximum of 2 years under the proposed rule. Participants who have previous experience in upside-only MSS ACOs will have a 1-year glide path before they must move to two-sided risk arrangements.
In 2018, about 460 of the 561 MSS ACOs (82%) were in one-sided, non-risk bearing models, according to a CMS press release.
“After 6 years, we believe the time has come to put accountability into the accountable care organizations,” said CMS Administrator Seema Verma on a press call Thursday.
Patisiran Wins Two Firsts with FDA Approval
The FDA said Friday it had approved patisiran (Onpattro) to treat polyneuropathy associated with hereditary transthyretin (hATTR) amyloidosis, caused by a gene mutation that leads to amyloid deposits in nerves and tissues.
In the phase III APOLLO trial, patisiran slowed peripheral neuropathy progression in patients with hATTR amyloidosis, improving neurological impairment and clinical manifestations by over 18 months.
HHS Urges States to Ease Scope-of-Practice Rules
States should consider relaxing restrictions on scope of practice and lessening Certificate of Need requirements in order to broaden the free market for healthcare, Health and Human Services (HHS) Secretary Alex Azar told state lawmakers meeting in New Orleans on Thursday.
“I would urge all of you to take a look at how state and local regulations can be impeding healthcare competition, raising costs for American patients, and depriving them of choices,” Azar said at a meeting of the American Legislative Exchange Council, a group of conservative state legislators. “Regulations like Certificates of Need and scope of practice can have a legitimate purpose. But too often, these rules can be a significant barrier to new competition and lower-cost market disruptors.”
“Fundamentally, when we wonder why American healthcare costs so much, why patients feel so disempowered, so often the answer is that government rules are standing in the way of necessary innovation,” Azar said. “As we undertake our efforts to free up competition from the federal level, we hope all of you will examine what can be done in the states.”
An FDA advisory committee voted 17-1 Wednesday to recommend approval of omadacycline, a next-generation tetracycline-class antibiotic, for treatment of acute bacterial skin and skin structure infections.
The Antimicrobial Drugs Advisory Committee also voted 14-4 in favor of approving the drug, made by Boston-based Paratek Pharmaceuticals, for the treatment of community-acquired bacterial pneumonia. Both votes were responding to questions of whether the company had shown that the drug was safe and effective in the particular indication.
“Studies showed clear evidence of meeting non-inferiority [criteria], and this is an area where we are glad to have new treatments,” said panel member Barbara Gripshover, MD, an associate professor of medicine at Case Western Reserve University. However, she said there didn’t appear to be enough evidence to use the drug to treat patients with bacteremia, since they usually need at least 2 weeks of treatment and the drug‘s clinical trials didn’t last that long.
On Tuesday, the same committee also voted solidly in favor of amikacin liposome inhalation suspension as a last resort for treating non-tuberculous mycobacterial lung infections — even though panel members were skeptical of the surrogate endpoint used to demonstrate efficacy.
CMS Proposes Rule for 2018 Risk Adjustment Payments
CMS continued its push to reinstate risk adjustment payments to health insurance plans, releasing a proposed rule to issue risk adjustment payments for the 2018 plan year.
Last month, the agency posted a final rule to reinstate the risk adjustment payments for the 2017 plan year. “The rule proposed today would allow the program to continue for the 2018 benefit year,” the agency said Wednesday in a press release.
The risk adjustment payments reimburse health insurers who sell individual or small-group policies both inside and outside the Affordable Care Act’s health insurance exchanges. Health plans whose enrollees are healthier than average pay into the risk adjustment program, which then spreads the funds among plans with less healthy enrollees. The agency stopped the payments in early July due to an adverse federal court decision.
The House continues its August recess. The Senate is scheduled to reconvene but does not have any healthcare-related hearings planned.
On Monday afternoon, the White House will host a health information technology developer conference; part of the event will be livestreamed here.
On Thursday, the Bipartisan Policy Center will host an event on integrating behavioral and clinical healthcare.