The proposed federal regulations to implement the MACRA health care reforms are too complex, too onerous on small and solo practices, lack opportunities for many to participate in alternative payment models, and should be delayed for a full year, at least.

That was the message that emerged from hundreds of comments regarding the proposed rule that were submitted by physician organizations and other stakeholders.

“The intent of [the Medicare Access and CHIP Reauthorization Act of 2015] was not to merely move the current incentive program into [the Merit-based Incentive Payment System], but to improve and simplify these programs into a single more unified approach,” the American Medical Association said in its comments , noting that “numerous changes” will be needed in the way cost and quality are measured.

AMA also called for a better, faster way for physicians to develop alternative payment models. “We strongly urge CMS to vigorously pursue this objective and establish a much more progressive and welcoming environment for the development and implementation of specialty-defined APMs than proposed in the [proposed rule].”

AMA also suggested that CMS provide more flexibility for solo and small practices, align the four components of MIPS so it operates as a single program, simplifying and lowering the financial risk for advanced APMs, and providing more timely feedback to physicians.

The organization also called for CMS to “create an initial transitional performance period from July 1, 2017, to December 31, 2017, to ensure the successful and appropriate implementation of the MACRA program. In future years, for all reporting requirements, CMS should allow physicians to select periods of less than a full calendar year to provide flexibility.”

In its comments , the American Medical Group Association questioned whether the proposed rule actually would lead to improved quality of care and reward value.

In the proposed rule, “CMS will measure and score quality and resource use or spending separately,” AMGA wrote in its comments. “CMS will not measure outcomes in relation to spending. CMS will not measure for value. If value is left unaddressed in the final rule, it will be difficult at best for the agency to meet MACRA and the [HHS] secretary’s overarching goals.”

While expressing support for MACRA conceptually, officials with the American Academy of Family Physicians wrote that they “see a strong and definite need and opportunity for CMS to step back and reconsider the approach to this proposed rule which we view as overly complex and burdensome to our members and indeed for all physicians. Given the significant complexity of the rule, we strongly encourage CMS to issue an interim final rule with comment period rather than to issue a final rule.”

Specifically, AAFP criticized the proposed rule for allowing small and solo practices to form “virtual groups” in order to earn bonuses, despite it being mandated by law.

Solo and small group practices who participate in MIPS to should “be eligible for positive payment updates if their performance yields such payments, but would be exempt from any negative payment update until such a time that the virtual group option is available,” AAFP officials wrote.

They also called for medical home delivery models to be included in APMs, in an effort to improve on the limited opportunities for family practices in particular to participate in alternative payment models.

The American College of Physicians also called for safe harbors for small and solo practices until virtual group options can be established.

ACP, like other groups, questioned that medical homes are not recognized as alternative payment models and argued that Congress intended medical homes to qualify as APMs “without bearing more than nominal financial risk.”

Despite the flexible approach to the overall quality payment program, CMS has “created a degree of complexity” and must “continue to seek ways to further streamline and simplify” the move to quality payments, according to comments from the American College of Cardiology.

The ACC also expressed concerns that the reporting requirements under MIPS and some of the APMs will limit the ability for cardiologists to report the most meaningful measures, particularly if they are part of a multi-specialty group, and suggested changes in scoring methodology or to allow more than one data file to be submitted in multi-specialty situations.

It also expressed concerns that the rule as proposed could adversely effect small practices, rural practices, and practices in health professional shortage areas, and “in the absence of other solutions such as virtual groups in 2017, CMS should monitor policies and provide effective practice assistance to these practices.”

The proposed rule provides no support for small practices, according to the American Gastroenterological Association .

“Upon release of the proposed rule, we were disappointed to see that not only will APMs be essentially closed off to small practices in the first years of implementation, but the MIPS program will significantly harm practices with less than 25 eligible clinicians,” AGA noted, citing data presented by CMS that 87% of solo practitioners will receive a negative adjustment with an aggregate negative impact of $300 million and for all practices with less than 25 eligible clinicians, the aggregate negative adjustment will total $649 million.

“Any system in which smaller practices are so heavily disadvantaged is unacceptable,” AGA said. CMS has previously stated that the regulatory impact statement would likely change and reflect a smaller impact for small and solo practices once more updated information can be modeled when the rule is final.

Additionally, AGA expressed concern over the limited engagement in APMs that will be possible under the proposed rule. “Given the importance of APM participation to both the practice and reimbursement of Medicare physicians, access to advanced APMs should be provided to all physicians.”

The association also expressed concern that the definition of APM is not broad enough and suggested that it be widened in scope so that it can capture payment models that have been created using the AGA’s Roadmap to the Future of GI Practice . It recommended a number of models be classified as APMs, including the colonoscopy bundled payment, gastroesophageal reflux disease episode payment, obesity bundled payment, Project Sonar (a chronic disease management program for IBD), and the Medical Home Neighbor.

The American College of Rheumatology called for a delay in the implementation of any final MACRA regulations, noting in its comments that with requirements set to begin in 2017, the current implementation schedule “does not provide enough time for providers to implement the required changes,” though ACR does not recommend a specific start time.

ACR also questioned how the criteria for APMs was set up, noting expressly that Physician Focused Payment Models may not meet the APM requirements. The group is seeking clarification on whether these models will qualify as an APM.

“Medical home APMs should also permit specialty physicians to participate, including small group and multispeciality groups, in keeping with the need for APMs to be flexible with their criteria and the role of specialty physicians in providing chronic care.

The American Academy of Dermatology Association echoed a number of concerns voiced across the medical profession and is calling for a delay in the implementation of MACRA’s regulations.

In particular, AADA noted that the regulations are not friendly for small and solo practices in general and little is contained within the proposal to “meaningfully engage specialist physicians in APMs.”

The association also is calling for broader mechanisms to allow for the development and recognition of APMs, including recognizing specialty-focused medical homes.

The group also is calling for pilot programs to test the validity of the measures that will form the basis of quality payment incentives and penalties.

In an effort to protect small and solo practices, AADA is calling for an exemption from MIPS or APM requirements until a virtual group option is developed, tested, and is fully operational.

The American Psychiatric Association echoed a number of broad concerns raised across the physician spectrum, including calling for a to the first year of implementation to July 1, 2017, and lasting through Dec. 31, 2017, as well as enabling the formation of virtual groups at the onset of implementation in its comments .

But APA also noted that mental health presents a variety of unique issues that need to be addressed.

For example, the association notes that psychiatrists work across a number of practice settings, including academic health centers, hospitals, clinics, nursing homes, and private practices, as well as offering services via telemedicine.

“This makes it difficult for psychiatrists to capture all the work they do, because of the combination of settings that utilize multiple, and potentially differing reporting programs and methods,” APA noted.

It added that psychiatrists generally have limited time and resources that can be devoted to Medicare quality reporting, which would make participation in MIPS and APMs more challenging, particularly because many operate in small or solo practices that do not own electronic health record systems, which would complicate reporting requirements to qualify for MIPS or APMs.

In addition to concerns with reporting in general, APA said that psychiatrists “also have limited choices in outcome quality measures.”

gtwachtman@frontlinemedcom.com

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