Response to 60-day comments

CMS Response to Public Comments Received for CMS-10711

The Centers for Medicare and Medicaid Services (CMS) received comments from

Philips health technology company and Medical Device Manufacturers Association (MDMA) related to CMS-10711. This is the reconciliation of the comments.

Comment:

CMS received comments from Philips and MDMA. Both commenters mentioned that CMS has not established a valid rationale for the prior authorization program, that the Social Security Act (the Act) does not direct CMS to implement prior authorization as a method to control costs, and that CMS has other options to monitor utilization and identify practitioners who may provide services that are not reasonable and medically necessary. Both commenters also noted concerns about the agency’s process for determining the need for prior authorization for specific services and increased volume as a result of providers migrating from the inpatient to the outpatient setting.

Response:

Section 1833(t)(2)(F) of the Act gives CMS discretion to determine appropriate methods to control unnecessary increases in the volume of covered hospital outpatient department (OPD) services. We carefully considered all available program integrity options to control unnecessary increases in volume and selected the prior authorization process, which has already been shown to be an effective tool for controlling unnecessary utilization of Durable Medical Equipment and other services. As part of our responsibility to protect the Medicare Trust Funds, we continue our routine analysis of data associated with the Medicare program. CMS previously explained in the hospital outpatient prospective payment and ambulatory surgical center payment systems final rules that the increases in volume associated with certain OPD services are unnecessary because the data shows that the volume of utilization of these services far exceeds what would be expected in light of the average rate-of-increase in the number of Medicare beneficiaries and we also did not identify other legitimate factors that might contribute to the sustained increases in volume. We believe that we have structured the prior authorization processes to effectively account for concerns associated with processing timeframes, patient care, and other administrative concerns. Through the prior authorization process, we are best able to identify problems before they occur and control unnecessary increases in volume while ensuring that beneficiaries receive services that are medically necessary.

Comment:

Both commenters noted that CMS has not shared the volume increase analyses for the procedures that have been added to the OPD program list since its inception.

Response:

On September 15, 2023, CMS posted prior authorization and pre-claim review program stats on the prior authorization and pre-claim review initiatives website. The stats show the total number of prior authorization requests received and reviewed, the number of requests affirmed or non-affirmed, appeals and accuracy rates. CMS continues to analyze data associated with the services that require prior authorization and hopes to share additional data in the future.

Comment:

Both commenters suggested that CMS should align prior authorization processing time with other federal programs. Commenters conveyed that under the prior authorization program, Medicare Administrative Contractors (MACs) are required to process most prior authorization requests within ten business days. However, Medicare Advantage plans and other federally funded programs are instructed to process most prior authorization requests within seven calendar days. Both commenters encourage CMS to align the prior authorization timelines with Medicare Advantage to provide consistency of access among all Medicare beneficiaries and process prior authorization requests within seven calendar days.

Response:

CMS is considering aligning the prior authorization processing timeframes with other impacted payers, as noted in the CMS Interoperability and Prior Authorization Final Rule CMS-0057-F.

Comment:

Both commenters noted that CMS should consider the impact of prior authorization on underserved communities. Commenters are concerned that “utilization management policies and procedures, including prior authorization, may have a disproportionate impact on underserved populations and may delay or deny access to certain services.” Commenters encouraged CMS to evaluate the role that prior authorization could play in exacerbating disparities in access to care for underserved communities.

Response:

Although specific data is not available to determine the actual impacts on underserved communities, CMS believes that beneficiaries who meet Medicare requirements for services under prior authorization will receive decisions on their prior authorization requests in a timely manner to obtain their medically necessary procedures. Also, CMS allows multiple methods to submit prior authorization requests to the MACs (e.g., electronic, fax, mail) to account for differences in the utilization of technology among different providers. Additionally, while the OPD services that require prior authorization are generally not emergent, if it is determined that a delay could seriously jeopardize the beneficiary’s life, health, or ability to regain maximum function, a provider can submit a request for an expedited review. CMS will continue to monitor to ensure that this OPD prior authorization program does not have a disproportionate impact on underserved populations and work to advance health equity by operationalizing policies and programs that support health for all beneficiaries.