This week in Medicare updates—3/23/2022

March 23, 2022

Medicare Insider

Updated OIG Work Plan

On March 15, the OIG updated its Work Plan with the following new items:

Quarterly Update to the End-Stage Renal Disease Prospective Payment System (ESRD PPS)

On March 15, CMS published Medicare Claims Processing Transmittal 11295, which rescinds and replaces Transmittal 11278, dated February 24, 2022, to revise both the background and policy sections. The original transmittal was issued regarding implementation of the transitional drug add-on payment adjustment (TDAPA) for HCPCS code J0879 effective April 1, 2022.

Effective date: April 1, 2022

Implementation date: April 4, 2022

Comment Request: Reform of Requirements for Long-Term Care Facilities; Medicare Authorization to Disclose Personal Health Information; more

On March 15, CMS published a Comment Request in the Federal Register regarding the following information collections:

Reform of Requirements for Long-Term Care Facilities
Medicare Authorization to Disclose Personal Health Information

Comments are due by May 16.

Advisory Opinion No. 22-05

On March 16, the OIG published an Advisory Opinion regarding whether the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial would be grounds for the imposition of sanctions under civil monetary penalties or exclusion authorities related to the anti-kickback statute and prohibition on beneficiary inducements. Under this arrangement, the Requestor–a manufacturer of an investigational therapy in which a patient’s own cells are used to treat ischemic systolic heart failure–would pay cost-sharing obligations that Medicare beneficiaries participating in the study would otherwise owe for Medicare-reimbursable items and services provided during the study. The requestor would directly pay the institution to whom the beneficiary would otherwise owe the cost-sharing amount, meaning beneficiaries would incur no out-of-pocket costs for participating in the study. The requestor stated that cost-sharing obligations would otherwise cost beneficiaries more than $1,300, which may be cost-prohibitive for the Medicare beneficiaries participating in the study.

The OIG said that while this arrangement would implicate the anti-kickback statute and prohibition on beneficiary inducements, it would not impose sanctions in this case for a variety of reasons, including that the proposed arrangement appears to be a reasonable way of promoting enrollment in a study that may otherwise be cost-prohibitive for beneficiaries, the arrangement poses a low risk of overutilization or inappropriate utilization of services, the arrangement is distinguishable from problematic seeding arrangements in a variety of ways, and more. The full rationale is provided in the Opinion.

New COVID-19 Enforcement Action

On March 17, the OIG published a new COVID-19 Enforcement Action with the following entity:

On January 14, John Pierce, MD, of San Francisco, CA, reached a $18,846.61 settlement agreement with the OIG to resolve allegations that he attested in the Provider Relief Fund Portal that he was eligible to receive Provider Relief Fund payments for providing diagnoses, testing, or care for individuals with possible or actual cases of COVID-19 when he did not actually provide these services.

Updated Civil Monetary Penalties and Affirmative Exclusions

On March 17, the OIG published an updated List of Civil Monetary Penalties and Affirmative Exclusions, including:

On February 7, Physicians Toxicology Laboratory (PTL), of Tampa, FL, reached a $386,482.24 settlement agreement with the OIG to resolve allegations that PTL submitted claims to Medicare for specimen validity testing (SVT) in conjunction with claims for urine drug testing when SVT was a non-covered service.
On February 8, Alternative Consulting Enterprises, Supportive Concepts for Families, and Imperium, of PA, reached a $111,019.44 settlement agreement with the OIG to resolve allegations that they submitted claims for psychotherapy services as if provided by a psychiatrist when they were not.
On February 17, Isis Moneer Mary Abraham, of Roanoke, VA, agreed to a three-year exclusion after she improperly retained and aggregated unused Xolair from prior subcutaneous administrations and then improperly submitted claims to Medicare and Medicaid for the use of that Xolair when it should have been discarded.
On February 18, Interventional Pain Center, of Fayetteville, NC, reached a $38,104.70 settlement agreement with the OIG to resolve allegations that it submitted claims to Medicare for specimen validity testing (SVT) in conjunction with claims for urine drug testing when SVT was a non-covered service.

Telehealth Was Critical for Providing Services to Medicare Beneficiaries During the First Year of the COVID-19 Pandemic

On March 17, the OIG published a Data Brief regarding the use of telehealth during the first year of the COVID-19 PHE. The OIG found that 43% of Medicare beneficiaries (more than 28 million people) used telehealth during the first year of the pandemic, and it was most commonly used for office visits. Beneficiaries used 88 times more telehealth services during the first year of the pandemic than they did the previous year. Despite the high usage of telehealth, it still accounted for just 12% of all services used by beneficiaries for the first year of the pandemic. Beneficiaries used telehealth for a larger share of all behavioral health services than any other type of service. The OIG said CMS, Congress, and other stakeholders should use this data as they consider making changes to telehealth in Medicare.