WASHINGTON -- Can a federal department choose to ignore recommendations from an advisory committee that was set up by Congress to make those recommendations?
The Department of Health and Human Services (HHS) appears to think so. Its secretary, Alex Azar, announced in a that HHS would not be implementing any of the 10 by the . Instead, Azar said HHS will come up with its own models internally.
Committee member Kavita Patel, MD, a practicing primary care internist at Johns Hopkins Medicine, summed up the letter as follows: "Thank you for all your hard work. We're not interested."
Patel, who spoke only on her own behalf, said she almost quit the committee when she saw the letter.
"I felt defeated ... I think we all did," Patel told 鶹ý.
She never imagined the models would be implemented "as written," but she assumed their basic concepts would be the foundation of new Center for Medicare and Medicaid Innovation (CMMI) payment models.
"I kind of always assumed that CMMI would make modifications,"she said.
Another committee member, Harold Miller, president and CEO of the Center for Healthcare Quality and Payment Reform, told 鶹ý he was also "very disappointed" in Azar's letter.
"I think there are a lot of inaccuracies in it," he said.
Big Misunderstanding?
Azar's letter cited three main "considerations" as the basis for his decision:
- Models must demonstrate the potential for "significant impact" and "robust evaluation"; any limited-scale recommendations are unlikely to be implemented
- Use of proprietary tools or tools that haven't yet been developed in a model are "an obstacle to HHS' testing of that model"
- The department is not interested in developing new payment models that simply incentivize adherence to accepted standards of care
Six of the 10 models the committee recommended were recommended for "limited-scale testing."
"I think there was a misunderstanding that somehow [limited testing] meant limited impact," Miller said, stressing that the committee would never have recommended them if it didn't think they had potential to change care.
Also, the fact that some models use proprietary tools isn't a valid reason for non-implementation, he said.
"If you rejected something on that basis, you'd probably never get anything implemented," he added.
Many of the specific concerns that CMS lists as problems with certain models were the very same concerns that the PTAC itself identified, but the committee felt those problems could be addressed "with some assistance," he said.
"It's not like they failed to meet some kind of standards that CMS has met itself" with its own alternative payment models, Miller added.
Patel agreed, noting that CMS's own models have the same problems with beneficiary selection and risk assessment.
Miller was also angry about Azar's third point about incentivizing care that adheres to commonly accepted standards.
"CMS absolutely should implement models that pay physicians for implementing standards of practice," he fumed. "What else would you want them to do? Pay for models that don't implement standards of practice?"
One reason that standards of care aren't met is because there isn't adequate payment for the right services, he noted.
Finally, the letter suggested that CMS is going to develop models in the same realm as the submitters own proposals, which is hugely frustrating to Miller.
"Congress created a whole process for people to bring in proposals and have them reviewed [by the PTAC] and recommend yes or no, [and the secretary's] response is 'We're not going to do any of this'," he said.
"I personally think that it is a violation of the process that Congress set up," Miller said.
All Is Not Lost
PTAC chairman Jeffrey Bailet appeared more accepting of HHS's rejection. "Our charge is to recommend these models and it's up to CMS and the Secretary to pursue implementation," he told 鶹ý.
The PTAC discussed its concerns with HHS and CMS leadership including Azar, CMS Administrator Seema Verma and Adam Boehler, deputy administrator and director for CMMI, on June 14, the day after Azar sent his letter.
"My perception was that they were interested in trying to address some of the concerns," Miller said. "Exactly what that means is to be determined."
Patel said she was also encouraged by the meeting.
"Adam basically said 'I wasn't here, give me a chance,'" Patel said, noting that he sat and listened to the committee for 3 hours. Boehler officially started at CMS in April.
"He was genuine and earnest, and I took him and Alex and Seema at their word," Patel said.
Another reason that Patel decided to stick with the committee was the continued interest from current physician groups whose applications have yet to be reviewed.
Even if their proposals aren't adopted, receiving advice and insights from the PTAC on designing payment models is still really valuable to them, she said.
Azar's letter was not entirely dismissive of the committee's work. "With PTAC's expert analyses, commentary and recommendations of the proposed new models, HHS can incorporate those ideas when designing payment models," he wrote.
Clock is Ticking
One applicant whose proposal was submitted in December 2016 and voted on in April 2017 is still frustrated with CMMI's process.
None of the recommended proposals have gone forward, said Lawrence Kosinski, MD, MBA, managing partner of the Illinois Gastroenterology Group and president of SonarMD in Chicago, which had submitted a payment model called Project Sonar.
"We've got 2019 right around the corner," he said.
The American Medical Association, , also pointed out that these delays have consequences: "the statute to reform Medicare physician payment provided only six years of bonus payments to facilitate physicians' migration to APMs. We are approaching the three-year mark for the initial implementation and there is still not a robust APM pathway for physicians."
Bailet admitted that there is "disappointment" on the committee and among the stakeholders.
One option is to "throw in the towel... which I'm not ready to do," he said.
Asked if there was any possibility that CMS's decisions could be reversed, Bailet said he didn't want to speak for CMS.
"I'm going to work with them and hope that there's an opportunity to revisit those models and see what's possible," he said. "We know the current situation is unacceptable and we're activated as a committee to try and change that ... and we need a partner on the others side."
PTAC is speaking with CMS and CMMI "in ways that we haven't in the past," Bailet said. "In that regard I'm optimistic that those discussions will yield a different outcome."
In late July, the PTAC will meet again with CMS leadership, including Verma and Boehler, to discuss a path forward.
Patel said she hopes to learn more at that meeting about the priority areas that CMS has expressed interest in such as serious illness and palliative care. "I would like to understand how their priorities might align with the proposals that we recommended."