Regulatory Editor

The Trump administration is leaving its mark on Medicare, most recently with the announcement that the Centers for Medicare & Medicaid Services will peel back some of the mandates around a joint replacement bundled care program. CMS struck a novel tone in its announcement, which said that the agency "expects to increase opportunities for providers to participate in voluntary initiatives rather than large, mandatory episode payment model efforts" moving forward.

CMS said it would trim 33 geographic areas from the total of 67 in which participation in the joint replacement program was mandatory. However, the agency also said that providers in the remaining areas would not be forced to take part, adding that participation was likewise optional for "all low-volume and rural hospitals" in the geographic areas spelled out in the initial rule. Beyond this, CMS will cancel outright two other payment models, including the cardiac rehabilitation model, that would have gone into force as of January 2018.

CMS administrator Seema Verma said the change in the models "allows CMS to test and evaluate improvements in care processes" that would "ease burdens on hospitals." Verma said stakeholders have sought more input on the design of the payment models promulgated by the Center for Medicare & Medicaid Innovation, and that the agency will test "other episode-based models that will bring about innovation and provide better care for Medicare beneficiaries."

The unveiling of the Comprehensive Care for Joint Replacement (CJR) program was accompanied by a claim that the program could shave as much as $153 million from the taxpayer's Medicare tab over five years. Under the initial program conditions, hospitals would disburse fees to providers, but administering the program promised to be complicated for providers and for Medicare administrative contractors given that reconciliation would be specific to beneficiaries as a way of avoiding conflict with other incentive payment programs already in place. (See BioWorld Medtech, July 14, 2015.)

In the interim, the program's emphasis on hip and knee replacement surgeries was expanded to include services rendered in treatment of heart attack, including coronary artery bypass, and those provided to beneficiaries for fractures of the hip and the femur. The program would have used the traditional 90-day set point for defining an episode of care, but the rates paid in these programs would have been adjusted for patient severity. (See BioWorld MedTech, July 28, 2016.)

The political part of the problem for these programs was that Rep. Tom Price (R-Ga.) was tabbed as the Secretary of Health and Human Services for the Trump administration. Price had previously voiced his opposition to the CJR program, and had floated legislation that would have brought the CJR program to a halt in December 2016. (See BioWorld MedTech, Dec. 22, 2016.)

Much of the reaction to the news was tempered. Mary Norine Walsh, President of the American College of Cardiology, did not explicitly cheer the drawback of the CJR program other than to say that the ACC "will continue to work with CMS on opportunities to participate meaningfully" in advanced alternative Medicare payment models. Walsh offered little in the way of direct criticism of the program, stating that the move toward value-based care requires that CMS and providers "work together to find solutions."

However, Walsh's immediate predecessor at ACC, Richard Chazal, said in December 2016 that the addition of the cardiology care modules to the CJR presented cardiologists with "a challenging step." The association's comments upon release of the cardiology care track included the recommendation that CMS "proceed with great caution" with implementation of the program, and that among the association's concerns were accurate beneficiary attribution and the use of valid quality and cost measurements.

Chazal: 'a confusing time' in Medicare

Chazal told BioWorld MedTech, "I think there were a lot of implications" about the initial cardiac bundled care program under CJR, one of which was that it seemed to require that providers modify a number of processes in order to fit in with the goals of the program.

"Hold[ing] institutions responsible for the initial care and the significant follow-up care presents real challenges," Chazal said, particularly as the patient migrates to other care settings. He noted that his home institution (Chazal is the medical director of the Heart and Vascular Institute for Lee Health in Ft. Myers, Fl.) handles a substantial number of patients who keep only a winter home in Florida. The dilemma at times is that a patient admitted at Lee Health becomes that physician's and institution's responsibility even after they return home to that other state.

Chazal said the ACC is not prepared to comment on specific changes to any successor program, but he said the regulatory churn at CMS is making itself felt. "I think for providers and for patients, it's a confusing time and it can be difficult to navigate." He noted that providers are "spending a lot of time and effort to make certain they are keeping pace with technology and health care delivery," but that patients are also asking what the implications are for them, including whether any such program affects physician selection.

SCAI saw DES utilization as a concern

The Society for Cardiovascular Angiography and Interventions (SCAI) said in an April 21, 2017, letter to Price that the association "applauds the proposed delay" then floated by the administration. SCAI President-elect Ken Rosenfeld said the program ought to be voluntary and that the proposed delay would give providers time to "make any infrastructure changes that may be necessary" to take part.

Rosenfeld suggested that CMS add CPT code 92941 to the Medicare inpatient-only list as a means of ensuring that infarct patients would not be "relegated to outpatient/observation status by facilities seeking to avoid inclusion" in the bundled payment program. He said CMS should exclude infarct cases from the program when percutaneous coronary intervention has not been performed with the 92941 code in part because "rampant troponin testing" has led to many infarct patients not being treated by cardiology or by catheterization. Rosenfeld also took a swipe at the 90-day care episode, stating that SCAI member experience suggests that the notion that post-30 day expenses are significant is "not aligned with SCAI members' real-world experience."

In addition, Rosenfeld cited concerns that the bundled payment program could discourage the use of drug-eluting stents because CMS had indicated that the additional cost for DES units has already been taken into account. SCAI members disagree, Rosenfeld said, suggesting that the agency benchmark utilization mixes for "any facility subject to or engaging (should it become voluntary) in the" CJR program.

Device makers want to take part

Don May, executive VP for payment and health care delivery policy at the Advanced Medical Technology Association, told BioWorld MedTech that the association is still examining the proposed changes to the CJR program, and that AdvaMed had not previously commented on these programs. Nonetheless, he said that such programs, "if done right and implemented correctly, have the potential to lower costs and improve quality of care by placing a premium on quality and efficiency, and improving provider coordination and collaboration."

AdvaMed members, May said, "want the option to be official collaborators in these payment models," which he said "would allow them to be official partners, and even potentially assume some of the financial risks and rewards of bundling programs, along with physicians and hospitals." He pointed out that some AdvaMed members that are affected by bundling "are also seeking to partner with hospital customers to better manage post-acute care, where most of the variation in Medicare spending currently exists."

No Comments