This week in Medicare updates—12/15/2021
Advisory Opinion 21-19
On December 6, the OIG published an Advisory Opinion regarding whether a pharmaceutical manufacturer providing free eye drops to mitigate the side effects for patients using one of the company’s products would be grounds for the imposition of sanctions under civil monetary penalties related to the anti-kickback statute and prohibition on beneficiary inducements. The eye drops are a non-prescription product that are typically not reimbursable by federal health care programs and would be provided to all patients who have been prescribed the product for an on-label indication, are enrolled in the REMS, and are enrolled in the requestor’s free eye drop program regardless of the patient’s insurer.
The OIG said that the arrangement would generate prohibited remuneration under the federal anti-kickback statute but would not implicate the beneficiary inducements CMP. The OIG also said that it would not impose sanctions under the anti-kickback statute in this case because the FDA-approved Product label, medication guide, and REMS patient guide all recommend that patients use eye drops with the product to mitigate a known safety risk; the eye drops are low cost and receiving them for free should not lead to overutilization or inappropriate utilization; and a variety of other details about the arrangement indicate it would present a low risk of fraud or abuse.
Medicare Improperly Paid Physicians for Spinal Facet-Joint Denervation Sessions
On December 6, the OIG published a Review of whether Medicare paid physicians for selected facet-joint denervation sessions in accordance with Medicare requirements. The OIG found that Medicare did not pay physicians for selected facet-joint denervation sessions in accordance with Medicare requirements. These improper payments centered around Medicare paying for facet-joint denervation sessions above the MAC coverage limitations for these procedures. The OIG cited an example where a MAC had a coverage limitation for two facet-joint denervation sessions during a 12-month period. The beneficiary in the example had eight facet-joint denervation sessions between January 23, 2019 - January 22, 2020, and Medicare paid for all eight sessions instead of just the first two sessions. The OIG said overpayments for these procedures totaled $9.5 million during the audit period and occurred because CMS oversight was not adequate to prevent or detect improper payments for these procedures.
The OIG recommends CMS direct the MACs to recover the $9.5 million in improper payments and notify physicians so that they can identify and return any similar overpayments. The OIG also recommends CMS assess the effectiveness of oversight mechanisms for preventing or detecting improper payments for facet-joint denervation sessions and included two procedural recommendations for CMS to direct the MACs to review claims for denervation sessions after the audit period to recover any improper payments. CMS concurred with the OIG recommendations.
Evidence-Based Best Practices for Hospitals in Managing Obstetric Emergencies and Other Key Contributors to Maternal Health Disparities
On December 7, CMS published a Memorandum to state survey agency directors regarding the Condition of Participation for Quality Assessment and Performance Improvement Program (§482.21) which requires that hospitals develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. CMS noted that The Joint Commission released new elements of performance focused on improving quality and safety in maternity care. Effective October 1, 2021, CMS adopted a new structural quality measure for the Inpatient Quality Reporting Program asking hospitals to attest to whether they participate in statewide/national maternal safety quality collaboratives and whether they have implemented patient safety practices or bundles to improve maternal outcomes. CMS said it is encouraging hospitals to consider implementing evidence-based best practices for managing obstetric emergencies and addressing maternal health disparities.
Effective date: This is an advisory memo only.
Updated Corporate Integrity Agreement Documents
On December 9, the OIG published information on a new Corporate Integrity Agreement with the following entity:
The OIG also published information on closed cases with the following entities:
- Northwest ENT Associates, P.C., of Marietta, GA
- Shire North American Group, Inc., and Shire Pharmaceuticals, LLC, of Wayne, PA
- The University of Missouri Health System, of Columbia, MO
- Westlake Convalescent Hospital, of Los Angeles, CA
- Hospice of Citrus and The Nature Coast, Inc., of Lecanto, FL
Updated Civil Monetary Penalties and Affirmative Exclusions
On December 9, the OIG published an updated List of Civil Monetary Penalties and Affirmative Exclusions, including:
- On November 2, Dr. Jung Gook Lim and Nothern Virginia Neurology and Headache, of Virginia, reached a $468,828 settlement agreement with the OIG to resolve allegations that Dr. Lim submitted claims to Medicare for medically unnecessary nerve conduction studies and autonomic nervous system tests performed on the same date of service for the same patient as nerve conduction studies.
- On November 9, Med First Immediate & Family Care PA, of North Carolina, reached a $58,699 settlement agreement with the OIG to resolve allegations that Med First submitted claims to Medicare for specimen validity testing in conjunction with urine drug testing when specimen validity testing was a non-covered service.
- On November 16, Advanced Spine & Pain Center, PA, of North Carolina, reached a $35,238.82 settlement agreement with the OIG to resolve allegations that it submitted claims to Medicare for specimen validity testing in conjunction with urine drug testing when specimen validity testing was a non-covered service.
- On November 19, Keystone Laboratories, Inc., of North Carolina, reached a $24,443.70 settlement agreement with the OIG to resolve allegations that it submitted claims to Medicare for specimen validity testing in conjunction with urine drug testing when specimen validity testing was a non-covered service.
Updated Provider Self-Disclosure Settlements
On December 9, the OIG published an updated List of Provider Self-Disclosure Settlements with the following organizations:
- On November 3, Neighborhood Healthcare, of California, reached a $40,460.34 settlement agreement with the OIG to resolve allegations that it submitted multiple claims for dental services performed by a dentist that were provided on a single date of service.
- On November 5, Visiting Nurse Association and Hospice of Vermont and New Hampshire reached a $2,389,706.26 settlement agreement with the OIG to resolve allegations that it submitted claims for home health services based on orders signed by a qualified clinician but not cosigned by a physician or allowed practitioner.
- On November 17, Patient First Maryland Medical Group, of Maryland, reached a $10,000 settlement agreement with the OIG to resolve allegations that it employed an individual it knew or should have known was excluded from participation in federal health care programs.
Updated List of Excluded Individuals and Entities (LEIE)
On December 9, the OIG updated its LEIE with an updated LEIE database for download and lists of November 2021 exclusions, reinstatements, and profile corrections.
Medicare Could Have Saved Approximately $993 Million in 2017 and 2018 if it had Implemented an Inpatient Rehabilitation Facility Transfer Payment Policy for Early Discharges to Home Health Agencies (HHA)
On December 10, the OIG published a Review of how much Medicare could have saved in CYs 2017 and 2018 if it had expanded the IRF transfer payment policy to include early discharges to home health care. The OIG looked at claims where the length of stay was more than three days but less than the case-mix group average length of stay and claims where the length of stay matched an actual HHA date of service that was within three days of the IRF discharge date. The OIG calculated the savings CMS would have realized for these claims if the transfer payment policy covered discharges to home health and found that Medicare could have saved $993 million during the audit period if it had expanded its IRF transfer payment policy to apply to early discharges to home health. The OIG recommends CMS take the necessary steps to establish an IRF transfer payment policy for early discharges to home health. CMS said it will continue the recommendation when determining next steps for the IRF prospective payment system, but any changes will have to go through the notice-and-comment rulemaking process.
January 2022 Update of the Hospital Outpatient Prospective Payment System (OPPS)
On December 10, CMS published Medicare Claims Processing Transmittal 11150 regarding the January 2022 update of the OPPS. Changes include new COVID-19 CPT codes for vaccines and vaccine administration, 21 new proprietary laboratory analyses codes, changes to device offsets, and more.
Effective date: January 1, 2022
Implementation date: January 3, 2022
January 2022 Integrated Outpatient Code Editor (I/OCE) Specifications Version 23.0
On December 10, CMS published Medicare Claims Processing Transmittal 11149 regarding the January 2022 quarterly update to the I/OCE.
Effective date: January 1, 2022
Implementation date: January 3, 2022
CY 2022 Annual Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment
On December 10, CMS published Medicare Claims Processing Transmittal 11151 regarding the CY 2022 updates to the CLFS. Updates include changes to fees for pap smear tests, a new code for a multianalyte assay with algorithmic analyses (MAAA), and more.
Effective date: January 1, 2022
Implementation date: January 3, 2022
Notification of Enforcement Discretion: Interoperability and Patient Access for Medicare Advantage Organizations and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies, and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers
On December 10, CMS published a Notification of Enforcement Discretion in the Federal Register to announce it is exercising discretion in how it enforces the payer-to-payer data exchange provisions. CMS said it does not expect to enforce compliance with these provisions until it is able to address certain implementation challenges.
Dates: The notification of enforcement discretion is effective on December 10, 2021.
Application From The Joint Commission for Continued Approval of its Hospital Accreditation Program
On December 10, CMS published a Proposed Notice in the Federal Register to announce it has received an application from The Joint Commission for continued recognition as a national accrediting organization for hospitals that wish to participate in Medicare or Medicaid.
Comments are due by January 10, 2022.