FY 2021 OIG Enforcement Outcomes Continue Long-Term Downward Trend

The COVID-19 pandemic continues to take a bite out of the volume of OIG enforcement action. All major metrics were down again in FY 2021, albeit at a less dramatic rate than in FY 2020. That’s one of the principal takeaways from the most recent Semiannual Report to Congress summarizing the agency’s enforcement and program integrity activities from April to September 2021. Here’s a quick look at the key findings and how they fit into the context of long-term enforcement trends.

Long-Term Decline in Enforcement Actions 

OIG fraud recovery had been a solid growth business for nearly two decades. So, when the agency announced a decline in FY 2018 recovery figures, it was more than a bit surprising. Recoveries in FY 2019 rebounded, but exclusions and especially civil actions continued to fall. And in FY 2020, there were steep declines across the board.

FY 2021 OIG Fraud Enforcement by the Numbers

After last year’s decline from $5.04 billion to $3.14 billion, total OIG expected health care fraud investigative recoveries slipped back to $3.00 billion in FY 2021. The agency also expects to recover another $787.29 million from audits. Total criminal actions continued their steady decline, from 809 to 624 in FY 2020 to 532 in FY 2021. Exclusions of individuals and entities followed the same basic three-year trajectory, falling from 2,640 to 2,148 last year and just 1,689 in FY 2021. After actually increasing from 695 to 791 last year, FY 2021 total civil actions fell back again to 689. The decline is somewhat surprising given that the new draconian CMS affiliations exclusions rule is in full force and effect. (For more on the rule, see Laboratory Compliance Advisor, October 28, 2019) 

OIG Enforcement Year-Over-Year Enforcement Action (April – September, FY 2018-2021)

Metric	2021	2020	2019	2018
Expected investigative recoveries	$3.00 billion	$3.14 billion	$5.04 billion	$3.43 billion
Criminal actions	532	624	809	764
Civil actions	689	791	695	813
Exclusions of individuals and entities	1,689	2,148	2,640	2,712

OIG Enforcers Continue to Target Labs

As in most years, labs played more than just a cameo role in the narrative aspects of the 2021 report. OIG also lists enforcement actions involving labs among its top accomplishments for the year, including investigations of COVID-19-related schemes to fraudulently bill Medicare for medically unnecessary testing and medical equipment. The report cites the six-week federal law enforcement action resulting in criminal charges against 138 defendants, including more than 42 doctors, nurses, and other licensed medical professionals, involving over $1.4 billion in alleged losses.

Hints of Future Lab Enforcement Activity

The report also outlines OIG’s enforcement priorities in 2022 and beyond that lab compliance managers should be aware of: Drug Testing Services: In a separate subsection entitled “Opportunities Exist for CMS and Its Medicare Contractors To Strengthen Program Safeguards To Prevent and Detect Improper Payments for Drug Testing Services,” OIG notes that it identified “several weaknesses” in the program safeguards Medicare contractors use to prevent and detect improper payments for drug testing services and promote provider compliance with Medicare requirements. In a previous audit report, OIG called on CMS to work with contractors to determine the feasibility of creating either a National Coverage Determination (NCD) or a series of Local Coverage Determinations (LCDs) to ensure consistency of requirements for drug testing services and implement a system edit or procedure to identify and limit the frequency of drug testing services per beneficiary across all Medicare jurisdictions. Those recommendations went unheeded during the reporting period, the report notes. Automated Chemistry Tests: Billing and payment of lab tests also came up in a separate report listing OIG’s “top unimplemented recommendations” issued by the agency in October. That report echoes the previous recommendation that CMS seek legislative authority to control costs for automated chemistry tests. PAMA market-based price cuts haven’t gone far enough to curb Medicare spending on lab services, OIG suggests. NPI Information on Medicare Advantage Encounter Records: Number 11 on OIG’s list of top unimplemented recommendations is that CMS require Medicare Advantage organizations to submit an ordering provider’s National Provider Identifier (NPI) on encounter records for labs as well as durable medical equipment, prosthetics, orthotics, supplies, imaging and home health services. NPIs are critical for identifying questionable billing patterns, pursuing fraud investigations for ordering and referring providers and assessing whether ordering or referring providers have determined that services were appropriate for patients, OIG notes. The agency adds that NPI requirements should be backed by the development and implementation of “reject edits” that reject encounter records that don’t list the required ordering provider NPI or an NPI that’s not valid and active in the National Plan and Provider Enumeration System registry.

Top 6 HHS Management & Performance Challenges

1. Safeguarding Public Health
2. Ensuring the Financial Integrity of Medicare, Medicaid and Other HHS Programs
3. Delivering Value, Quality and Improved Outcomes in Medicare and Medicaid
4. Protecting the Health and Safety of HHS Beneficiaries
5. Harnessing Data to Improve Health and Well-Being of Individuals
6. Improving Collaboration to Better Serve Our Nation

Source: OIG Semi-Annual Report, April to September 2021