This week in Medicare updates—12/2/2020

December 2, 2020
Medicare Insider

Final Rule: Modernizing and Clarifying the Physician Self-Referral Regulations

On November 20, CMS published a draft copy of a Final Rule regarding changes to the physician self-referral law (aka Stark Law). While the law has been updated a handful of times since it was enacted in 1989, this update is the first that addresses conflicts that arose as Medicare shifted toward a value-based healthcare payment system. The rule creates value-based exceptions to Stark Law that will allow physicians and providers to participate in value-based arrangements without fear of violating the law. It also contains clarifications on what type of compensation meets the fair market value requirement, allows for donations of certain cybersecurity technology, provides clarity and guidance on a wide range of other technical compliance requirements, and more. 

CMS published a Fact Sheet and Press Release on the rule on the same date. The OIG also published a draft copy of a corollary final rule on revisions to safe harbors under the anti-kickback statute and a Fact Sheet on the rule on the same date. The rules are expected to be published in the Federal Register on December 2.

Dates: These regulations are effective on January 19, 2021, except for amendment number 3 (which further amends section 411.352[i]), which is effective January 1, 2022.


Interim Final Rule with Comment: Most Favored Nation (MFN) Model

On November 20, CMS published a draft copy of the Most Favored Nation Model Interim Final Rule with Comment, which was published in the Federal Register on November 27. The MFN Model, a new Medicare payment model, tests whether aligning payment for Part B drugs and biologicals with international prices while also removing incentives to use higher cost drugs can help control Part B spending without decreasing quality of care for beneficiaries. This will work by lowering payment for a select cohort of high-cost Part B drugs to no higher than the lower price that drug manufacturers receive in similar countries. It will also pay providers a flat add-on amount instead of a percentage of each drug’s cost for each dose of an MFN drug. Beneficiaries will pay lower coinsurance for high-cost Part B drugs and will not pay coinsurance on add-on payments.

Participation is required by Medicare providers and suppliers that receive separate Part B FFS payment for the model’s included drugs, except for cancer hospitals, children’s hospitals, CAHs, rural health centers, federally qualified health centers, and Indian Health Service facilities. Some temporary exclusions also apply to participants in certain Innovation Center models. The model is a 7-year model and will start on January 1, 2021--a few weeks before the close of the comment period on the model. 

CMS published a Fact Sheet, Press Release, ASPE reports on rises in Part B spending and comparisons between Part B and international drug pricing, and a webpage about the model on the same date. Comments are due no later than 5 p.m. on January 26, 2021.

Effective date: These regulations are effective November 27, 2020.


Final Rule: Organ Procurement Organizations (OPO) Conditions for Coverage (CFC): Revisions to the Outcome Measure Requirements for Organ Procurement Organizations

On November 20, CMS published a draft copy of a Final Rule regarding revisions to the OPO CFCs which increase donation rates and organ transplantation rates by revising outcome measures and increasing competition for open donation service areas. The rule changes the donation rate measure to define a donor as a deceased individual from whom at least one vascularized organ is transplanted or for whom a pancreas is procured and used for research of islet cell transplantation. It also changes the transplantation rate measure to the number of organs from an OPO’s donation service area as a percentage of inpatient deaths among patients up to 75 years old with a primary cause of death consistent with organ donation. The rule also changes the performance benchmark, implements 12-month review periods, develops performance tiers, and more. 

CMS will implement the new performance measures on August 1, 2022. Regulations are effective 60 days after publication in the Federal Register. CMS published a Fact Sheet and Press Release on the rule.


Implementation of Changes in the End-Stage Renal Disease (ESRD) PPS and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facility for CY 2021

On November 23, CMS published Medicare Benefit Policy Transmittal 10490, which rescinds and replaces Transmittal 10451, dated November 6, to revise the CY 2021 AKI dialysis payment rate for renal dialysis services reported in the policy section of this CR.

On November 23, CMS revised MLN Matters 12011 to accompany the transmittal. 

Effective date: January 1, 2021

Implementation date: January 4, 2021


Updated COVID-19 Fraud Alert

On November 23, the OIG updated a Fraud Alert pertaining to fraud schemes related to the COVID-19 PHE. These schemes involve social media hacking, illegitimate grant money offers, exchanging COVID-19 tests for Medicare information, medical labs targeting retirement communities claiming to offer COVID-19 tests then drawing blood and billing for medically unnecessary services, and more. 


Provider Enrollment Application Fee Amount for CY 2021

On November 23, CMS published a Notice in the Federal Register to announce the CY 2021 application fee for institutional providers enrolling in Medicare, Medicaid, or the Children’s Health Insurance Program will be $599. This applies to initial enrollment, revalidating enrollment, or new Medicare practice location enrollment applications. 

Dates: The application fee announced in this notice is effective on January 1, 2021.


Medicare Accelerated and Advance Payments Program COVID-19 PHE Payment Data

On November 23, CMS updated a Document containing over 1400 pages of data on the accelerated and advanced payments provided during the COVID-19 PHE through November 18. Payments so far have totaled over $107 billion, most of which (92.07%) was made via accelerated payments. The payments come from the Federal Hospital Insurance Trust Fund (63%) and the Federal Supplementary Insurance Trust Fund (37%). The document contains a summary of payments made by provider and supplier type and a listing of all providers and suppliers by name who received payments as well as the amount they received through the program.


Clarifying the Use of As-Needed/PRN Orders for DMEPOS

On November 25, CMS published Medicare Program Integrity Transmittal 10492 regarding changes to the manual to remove frequency from the standard written order for DMEPOS as a result of a recent regulatory change.

Effective date: January 1, 2020 - The effective date is 1-1-2020 to align with the effective date of CMS regulation 1713-F

Implementation date: December 29, 2020


CMS Announces Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge

On November 25, CMS published a Press Release regarding steps CMS is taking to increase the health care system’s capacity to care for patients outside of a traditional hospital due to the rise in COVID-19 hospitalizations nationwide. CMS is introducing the Acute Hospital Care At Home program, which creates regulatory flexibilities to allow eligible patients to be treated at home. Hospitals will have to have appropriate screening protocols for both medical and non-medical factors before instituting care at home, including an in-person physician evaluation. An RN will evaluate each patient once daily either in person or remotely, and twice daily in-person visits by RNs or mobile integrated health paramedics will be required. CMS has approved six hospitals thus far for this program.

CMS is also updating regulatory flexibilities for ambulatory surgical centers (ASC) to only require nurses to be present at ASCs when a patient is in the facility. The ASC provisions are also discussed in a separate memorandum.

CMS published feedback from hospitals participating in the Acute Hospital Care At Home program, a webpage on the Acute Hospital Care At Home program, a memo on ASC provisions, and FAQs on Hospital Without Walls for ASCs and the Acute Hospital Care At Home program


Guidance for Processing Attestation Statements from Ambulatory Surgical Centers (ASC) Temporarily Enrolling as Hospitals During the COVID-19 PHE

On November 25, CMS revised a Memorandum to state survey agency directors regarding how ASCs can temporarily enroll as a hospital during the COVID-19 public health emergency (PHE). CMS added information given the continuing surge in COVID-19 cases to note that CMS is waiving the requirement at 42 CFR §482.23(b)(1) to only require ASCs enrolled as hospitals to provide 24-hour nursing services when there is a patient in the facility. This will allow ASCs enrolled as hospitals to provide nursing services on demand with a 24/7 on-call service. This waiver does not supersede state requirements for licensure. CMS updated the COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers on November 27 to reflect this change. 

Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/regional office training coordinators immediately. This guidance will cease to be in effect when the Secretary determines there is no longer a PHE due to COVID-19.