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September 2021 Medicare Rules, Regulations & Enforcement Updates

Published on 

Wednesday, September 22, 2021

September 9, 2021: Outpatient Clinic Visit Services at Excepted Off-Campus Provider-Based Departments: Payment Update

CMS included the following updated information in the Thursday September 9, 2021 edition of MLN Connects (link):

“By November 1, 2021, CMS will begin reprocessing claims for outpatient clinic visit services provided at excepted off-campus Provider-Based Departments (PBDs) so they’re paid at the same rate as non-excepted off-campus PBDs for those services under the Physician Fee Schedule (PFS). This affects certain claims with dates of service between January 1 - December 31, 2019. You don’t need to do anything; we’ll reprocess all affected claims. You must refund the coinsurance difference to patients (or payers) who paid the higher coinsurance rates based on new remittance advice information.


  • November 21, 2018: The Calendar Year (CY) 2019 Outpatient Prospective Payment System (OPPS) Rule (link) finalized payment for certain outpatient clinic visit services provided at excepted off-campus PBDs at the same rate that we pay non-excepted off-campus PBDs for those services under the PFS. Previously, CMS and Medicare patients often paid more for the same type of clinic visit in the hospital outpatient setting than in the physician office setting.
  • In 2019: We reduced payment to 70% of the full OPPS rate in off-campus PBDs. In 2020, this rate changed to 40%.
  • September 17, 2019: The U.S. District Court for the District of Columbia declared invalid the CY 2019 payment rule that provided for the reduction for clinic visits provided at excepted off-campus PBDs.
  • January 1 – July 2020: We reprocessed CY 2019 claims paid at the reduced payment rate of 70% to restore the 100% payment rate in accordance with the district court decision.
  • July 17, 2020: The U.S. Court of Appeals for the D.C. Circuit reversed the district court ruling, upholding our volume control site-neutrality payment policy for off-campus outpatient hospital clinic visits.”
September 13, 2021: Proposal to Fully Repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule

On September 1, 2020, the CMS released the Proposed Rule Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Proposed Rule (CMS-3372-P). At that time, then Medicare HHS Secretary Alex Azar stated in a related press release that “this new proposal would give Medicare beneficiaries faster access to the latest lifesaving technologies and provider more support for breakthrough innovations by finally delivering Medicare reimbursement at the same time as FDA approval.” A Final Rule was published in the Federal Register on January 14, 2021, with a stated effective date of March 14, 2021. The effective date has since been delayed until December 15, 2021.

On Wednesday September 15, 2021, the CMS issued a Notice of Proposed Rule Making to fully repeal this final rule. (link). The repeal includes a public comment period through October 15, 2021. CMS’s intent is “to conduct future rulemaking to explore an expedited coverage pathway for innovative technologies (balanced with evidence development to ensure beneficial health outcomes for beneficiaries) and a regulatory definition of the Reasonable and Necessary standard for Medicare coverage.”

September 15, 2021: Department of Justice News: Orlando Cardiologist Pays $6.75 Million to Resolve Allegations

In a recent announcement (link), the DOJ indicated that an Orlando Cardiologist paid $6.75 million to resolve allegations that he performed medically unnecessary ablations and vein stent procedures. Specific allegations included:

  • Ablations and stent procedures were performed on veins that did not qualify for treatment under accepted standards of medical practice,
  • Dr. Pal made misrepresentations in patient records to justify the procedures, including overstating the degree of reflux and diameter of veins, and falsely documenting patient symptoms, and
  • In many instances, the ablations were performed either exclusively or primarily by one or more ultrasound technicians outside their scope of practice.”
September 17, 2021: DOJ News – National Healthcare Fraud Enforcement Action

The DOJ announced (link) criminal charges against 138 defendants, including 42 doctors, nurses, and other licensed medical professionals in 31 federal districts across the U.S. for alleged participation in health care fraud schemes resulting in approximately $1.4 billion in alleged losses. Specifically, charges targeted approximately $1.1 billion in fraud committed using telemedicine, $29 million in COVID-19 health care fraud, $133 million connected to substance abuse treatment facilities, and $160 million connected to other health care fraud and illegal opioid distribution schemes.

Article Author: Beth Cobb, RN, BSN, ACM, CCDS
Beth Cobb, RN, BSN, ACM, CCDS, is the Manager of Clinical Analytics at Medical Management Plus, Inc. Beth has over twenty-five years of experience in healthcare including eleven years in Case Management at a large multi-facility health system. In her current position, Beth is a principle writer for MMP’s Wednesday@One weekly e-newsletter, an active member of our HIPAA Compliance Committee, MMP’s Education Department Program Director and co-developer of MMP’s proprietary Compliance Protection Assessment Tool.

This material was compiled to share information.  MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.