Regulatory roundup: CMS final rule targets fraudulent billing in MSSP; OIG calls for additional oversight of remote patient monitoring in Medicare; and more

RISE summarizes recent regulatory-related headlines.

CMS final rule targets fraudulent billing in Medicare Shared Savings Program

The Centers for Medicare & Medicaid Services (CMS) on Tuesday issued a final rule that aims to help address “significant, anomalous, and highly suspect (SAHS) billing activity” within accountable care organizations (ACOs) reconciliation.

The final rule provisions were made in response to a suspicious increase in urinary catheter billings, which CMS identified in early 2023 and attributed to a small group of durable medical equipment supply companies. Medicare beneficiaries didn’t receive catheters and weren’t billed directly, physicians didn’t order the supplies, and the supplies weren’t needed, according to CMS. Once CMS identified the problem, the agency stopped payment on nearly all these claims and began investigating suspect suppliers. CMS has since revoked the Medicare enrollment of the top 15 billers of the suspicious catheter claims.

RELATED: WaPo: Feds investigating an alleged $2B Medicare fraud scam involving catheters

The suspicious billing could have led to reduced shared savings or even shared losses for ACOs in the Medicare Shared Savings Program. The final rule mitigates this risk by excluding payments for the suspicious codes (A4352 (Intermittent urinary catheter; Coude (curved) tip, with or without coating (Teflon, silicone, silicone elastomeric, or hydrophilic, etc.), and A4353 (Intermittent urinary catheter, with insertion supplies) from the 2023 performance year.

The National Association of ACOs (NAACOS) applauded the final rule. In a statement, Clif Gaus, Sc.D., president and CEO of NAACOS, said CMS’ decision to hold ACOs harmless for the suspicious billings ensures that clinicians, hospitals, other health care providers, and ACOs are not unfairly held responsible for this spending.

The final rule will be published in the Federal Register on Friday and takes effect on October 15. For more information, click here for the CMS fact sheet.

KFF: After unwinding, Medicaid enrollment is 10M higher than pre-pandemic levels

A new KFF analysis of the outcomes of the Medicaid unwinding finds that more than 25 million people were disenrolled from Medicaid and over 56 million had their coverage renewed.

Despite these millions of disenrollments, 10 million more people are currently enrolled in Medicaid and the Children’s Health Insurance Program (CHIP) nationally than at the start of the pandemic, researchers found. Most states ended the unwinding with higher total Medicaid and CHIP enrollment than they began with in February 2020, including seven states where enrollment levels were at least 30 percent higher.

States kept people continuously enrolled in Medicaid during the COVID-19 pandemic, in exchange for enhanced federal funding, leading to record growth in Medicaid enrollment. After the continuous enrollment policy ended on March 31, 2023, and under the process referred to as “unwinding,” states were required to complete eligibility renewals for all Medicaid enrollees.

During the unwinding period, many states took steps to improve their renewal systems, leading to fewer people getting dropped even though they remain eligible. Five states—Missouri, Nebraska, North Carolina, Oklahoma, and South Dakota—have also adopted Medicaid expansion since the onset of the pandemic, and several states expanded eligibility for other groups, including children. The net effect is that Medicaid enrollment is higher than it was before the pandemic.

However, the KFF analysis found that enrollment among children has nearly returned to pre-pandemic levels (at only five percent higher). Twelve states saw drops in child enrollment and three states saw enrollment fall for both children and adults relative to pre-pandemic levels.

Because Medicaid eligibility levels are more generous for children, researchers said these drops in child enrollment—coupled with an increase in the 2023 child uninsured rate—suggest some children may have lost coverage despite being eligible.

Overall, 31 percent of people whose Medicaid coverage was redetermined during the unwinding were disenrolled, with wide differences across states. Five states had disenrollment rates of more than 50 percent (Montana, Utah, Idaho, Oklahoma, and Texas), while five states had rates under 20 percent (North Carolina, Maine, Oregon, California, and Connecticut).

Meanwhile, in a recent informational bulletin,  the Centers for Medicare & Medicaid Services (CMS) gave states two years to correct any issues found with their Medicaid and CHIP renewals.

The bulletin gives states until the end of this December to evaluate compliance. States that find they have deficiencies must submit updates to their assessments every six months until CMS confirms compliance with all requirements. States that have identified problems must demonstrate compliance with all renewal requirements by December 31, 2026.

OIG calls for additional oversight of remote patient monitoring in Medicare

A new Office of Inspector General (OIG) report finds that remote patient monitoring in Medicare increased dramatically from 2019 to 2022. Indeed, roughly 43 percent of enrollees who received remote patient monitoring did not receive all three components of it, which raises questions about whether providers use monitoring as intended. In addition to potential fraud concerns, OIG said Medicare doesn’t have the information it needs for oversight, such as who ordered the monitored for the enrollee.

To strengthen oversight, OIG recommends that CMS take five steps:

  • Implement additional safeguards to ensure that remote patient monitoring is used and billed appropriately in Medicare
  • Require that providers order remote patient monitoring and include the ordering provider information on claims and encounter data for remote patient monitoring
  • Develop methods to identify what health data are being monitored
  • Conduct provider education about billing of remote patient monitoring
  • Identify and monitor companies that bill for remote patient monitoring

Seven people charged with over $40M in Medicare and Medicaid fraud

The United States Attorney’s Office for the District of Colorado announced this week that seven people were indicted by a federal grand jury on charges related to defrauding Medicare and Colorado Medicaid.

Those individuals are Ronald King, 51, formerly of Berlin, N.H, who now lives in Bangor, Maine; Victor Roiter, 55, of Sunny Isles Beach, Fla.; Tina Wellman, 51, of Mayfield, N.Y.; Adam Shorr, 55, of Dunedin, Fla.; Robert O’Sullivan, 55, of Lake Sherwood, Calif.; Bradley Edson, 66, of Mesa, Ariz.; and John Gautereaux, 59, of Temecula, Calif.

King, Roiter, Wellman, and Shorr allegedly conspired to defraud Medicare and Colorado Medicaid through several means, including by paying kickbacks and bribes to purported marketing companies for referrals for fraudulent and medically unnecessary genetic testing. These referrals in turn led to more than $40 million in false and fraudulent claims paid by Medicare and Colorado Medicaid to laboratories in Colorado for the genetic testing claims. The indictment alleges that all seven defendants participated in a conspiracy to offer and pay illegal bribes and kickbacks in connection with health care benefit programs, including Medicare, Colorado Medicaid, and private health insurance plans. 

The defendants agreed to pay kickbacks and bribes to individuals and entities they identified as “marketers” to solicit patients, including elderly Medicare beneficiaries, to participate in unnecessary genetic testing and to obtain doctors’ signatures on testing order forms for these patients. Many of those who received kickbacks used call centers to target elderly Medicare beneficiaries.

OIG: Pennsylvania MA plan received $4.2M in overpayments for 2018 and 2019

A new OIG audit found that HealthAssurance Pennsylvania Inc., a Medicare Advantage health plan administered by Aetna, a CVS Health company, received at least $4.2 million in overpayments for 2018 and 2019. The payments were for nine groups of high-risk diagnosis codes that were submitted to CMS’ risk adjustment program but did not comply with federal requirement.

The audit sampled 269 unique enrollee-years and focused on payments for 2018 and 2019 associated with codes for acute stroke, acute myocardial Infarction, embolism, sepsis, pressure ulcer, lung cancer, breast cancer, colon cancer, and prostate cancer. The payments totaled $966,561.

OIG auditors found that for 222 of the 269 sampled enrollee-years, the medical records did not support the diagnosis codes and resulted in $657,744 in overpayments. Based on the sample results, OIG estimated that HealthAssurance received at least $4.2 million in overpayments for 2018 and 2019. OIG recommends that CVS Health refund the $4.2 million, identify similar instances of noncompliance for those diagnosis codes before or after the audit period, and refund any resulting overpayments and continue to examine its compliance procedures and take necessary steps for improvement.