HealthLeaders' regulatory round up series highlights five essential governing updates that cover every aspect of the revenue cycle that leaders need to know. Check back in each month for more updates.
The revenue cycle is complex, detailed, and always changing, so staying on top of regulatory updates and latest best practices requires revenue cycle leaders' constant attention in this ever-changing industry.
In this revenue cycle regulatory roundup, there were an ample number of updates published by CMS and the OIG in February, including public health emergency (PHE) updates and the OIG’s Work Plan.
Guidance was released for rural emergency hospital provisions, conversion process, and conditions of participation.
CMS published a memorandum to state survey agency directors containing guidance on the new rural emergency hospital provider type.
The memo outlines requirements on delivery of care, the conversion process for eligible facilities, survey guidelines, and the conditions of participation that facilities must meet to participate in the Medicare program.
Updated fact sheets were released on COVID-19 PHE waivers.
CMS updated a series of fact sheets about COVID-19 PHE waivers in light of the recent announcement that the Biden administration plans to end the PHE on May 11.
These fact sheets are located on the “Coronavirus Waivers & Flexibilities” webpage and are not dated on the main page but have all been revised as of February 1. They detail which flexibilities will remain after the PHE and which will not. The Hospitals and CAHs, ASCs, and CMHCs fact sheet discusses the end of the Hospital Without Walls program as well as the end of several telehealth flexibilities that were permitted during the PHE.
CMS said in an email that it will continue to provide resources and guidance via its current emergencies webpage as the PHE winds down.
CMS rolls out three new drug pricing models in response to the Biden Administration’s executive order on drug prices.
CMS published a press release to announce that it has selected three new drug pricing models for testing by the CMS Innovation Center in an attempt to help lower prescription drug prices. This action is in response to the Biden Administration’s Executive Order directing HHS to consider additional actions to further drive down prescription drug costs. The three drug models include:
- The Medicare $2 Drug List: Also referred to as the Medicare High-Value Drug List, this model encourages Part D plans to offer a low, fixed copayment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs.
- The Cell & Gene Therapy Access Model: This Medicaid model would have state Medicaid agencies assign CMS to coordinate and administer multi-state outcomes-based agreements with manufacturers for certain cell and gene therapies.
- The Accelerating Clinical Evidence Model: This Part B Model involves having CMS develop payment methods for drugs approved under accelerated approval to encourage timely confirmatory trial completion and improve access to post-market safety and efficacy data.
CMS published a fact sheet and FAQ on these three models. It also published a report regarding the response to the executive order.
A comparison of average sales prices and average manufacturer prices for the third quarter of 2022 was released by the OIG.
The OIG published a report regarding drugs for which the average sales prices (ASP) exceeds the average manufacturer prices (AMP) by 5% or more for two consecutive quarters or three of the previous four quarters.
When this happens, CMS substitutes 103% of the AMP for the ASP-based reimbursement. In the third quarter of 2022, 15 drug codes met this price substitution criteria. Eight additional drug codes exceeded the 5% threshold but were identified as being in short supply. Another 18 drug codes had ASPs exceeding the AMPs by at least 5% in the third quarter of 2022 but didn’t meet other price substitution criteria. The OIG will provide these results to CMS for review.
The OIG made updates to it’s work plan.
The OIG updated its Work Plan with the following new items:
- Bridging Data and Practice: A Resource Guide for Medicare's Enrollment Race and Ethnicity Data
- In-Depth Review of Nursing Home Citations Related to the Use of Antipsychotic Drugs
- Securing Medicaid and Medicare Payments to Providers
Amanda Norris is the Director of Content for HealthLeaders.