This week in Medicare updates—10/13/2021
Correction Notice: FY 2022 Inpatient Psychiatric Facility (IPF) Prospective Payment System (PPS) Final Rule
On October 4, CMS published a Correction Notice in the Federal Register regarding corrections to the FY 2022 IPF PPS final rule, dated August 4, 2021. Due to a technical error in the simulation of IPF payments, the outlier fixed dollar loss threshold amount was originally calculated incorrectly. CMS is correcting that error, other calculations based on the outlier fixed dollar loss threshold amount, and more in this notice.
Dates: This correction is effective October 1, 2021.
Advisory Opinion 21-13
On October 4, the OIG published an Advisory Opinion regarding whether the proposed subsidization of beneficiary cost-sharing obligations for Medicare-covered services provided as part of a clinical trial would be grounds for the imposition of sanctions under civil monetary penalties related to the anti-kickback statute and prohibition of beneficiary inducements. The proposed arrangement involves a clinical trial studying whether the use of PET scans to detect beta amyloid (A𝛽) plaques can help with clinical management of patients with mild cognitive impairment or dementia. The requestors, a professional medical society and a charity supporting research related to Alzheimer’s disease, would pay the coinsurance amounts that Medicare beneficiaries participating in the study would otherwise owe for a Medicare-reimbursable PET A𝛽 scan provided during the study. The professional association would pay the site for the coinsurance in order to remove potential financial obstacles that would prevent beneficiaries from minority communities from participating in the study. The funds the professional association would use to pay for this coinsurance would come from funds donated to the charity expressly for research programs.
The OIG said that while the arrangement would generate prohibited remuneration under the federal anti-kickback statute and the beneficiary inducements CMP, the OIG would not impose administrative sanctions on the requestors for a variety of reasons discussed in the report, such as the coinsurance subsidies being offered specifically to provide a reasonable way to enroll a diverse set of subjects, the arrangement constituting a low risk of overutilization or inappropriate utilization of federal healthcare program items and services, and more.
Comment Request: Medicare Fee-for-Service Prepayment Review of Medical Records; The ESRD Network Peer Mentoring Program; more
On October 5, CMS published a Comment Request in the Federal Register regarding the submission of the following information collections for OMB review:
- Medicare Fee-for-Service Prepayment Review of Medical Records
- The ESRD Network Peer Mentoring Program
- Conditions of Coverage for Portable X-Ray Suppliers and Supporting Regulations
Comments are due to the OMB desk officer by November 4, 2021.
Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for FY 2022
On October 5, CMS published Medicare Claims Processing Transmittal 11039, which rescinds and replaces Transmittal 11019, dated September 27, 2021, to correct the outlier fixed dollar loss threshold amount as discussed in the final rule correction notice. The original transmittal was published regarding changes required due to payment updates and policies finalized in the FY 2022 IPF PPS final rule.
CMS revised MLN Matters 12417 on the same date to accompany the transmittal.
Effective date: October 1, 2021
Implementation date: October 4, 2021
Advisory Opinion 21-14
On October 5, the OIG published an Advisory Opinion regarding whether a proposal to extend an existing discount program for chiropractic patients to include federal healthcare program beneficiaries would be grounds for the imposition of sanctions under civil monetary penalties related to the anti-kickback statute and prohibition of beneficiary inducements. Under the arrangement, the chiropractic clinics would permit federal healthcare program beneficiaries to utilize discounts that are already advertised to the general public for chiropractic services. The clinics have the patients pay the requestor directly at the time of service, then the requestor submits those claims to Medicare on the patients’ behalf. Medicare then sends any reimbursement for those services directly to the patient. To utilize the discounts that beneficiaries with private payors already use, the requestor would provide the discount at the time of service, then submit the claim to Medicare that reflects the discounted amount for the covered service.
The OIG said that while the arrangement would generate prohibited remuneration under the anti-kickback and beneficiary inducements CMP, the OIG would not impose administrative sanctions on the requestor for a variety of reasons discussed in the report.
Medicare Overpaid More Than $636 Million for Neurostimulator Implantation Surgeries
On October 5, the OIG published a Review of whether healthcare providers complied with Medicare requirements for billing neurostimulator implantation surgeries. The OIG reviewed a sample of 124 Medicare claims from CY 2016 and 2017 for services reported by HCPCS codes 61885, 61886, or 63685. It found that more than 40% of providers did not comply with Medicare requirements, as medical records for beneficiaries did not contain sufficient documentation to support the coverage requirements for these surgeries. On the basis of the sample, the OIG estimates that providers received $636 million in unallowable Medicare payments associated with these surgeries and beneficiaries paid $54 million in related unnecessary copays and deductibles.
The OIG recommends CMS and the MACs recover the potential overpayments within the four-year reopening period, instruct the providers with incorrectly billed claims to refund coinsurance amounts collected from affected beneficiaries within the four-year reopening period, find and recover any similar overpayments, and notify providers with potential overpayments so those providers can identify and return any overpayments in accordance with the 60-day rule. The OIG also recommends CMS conduct provider outreach and education regarding Medicare coverage requirements for neurostimulator implantation surgeries and require prior authorization for neurostimulator implantation surgeries for Parkinson’s disease and seizure disorders. CMS concurred with most recommendations but said its prior authorization authority does not extend to inpatient services, such as implantation surgeries for Parkinson’s disease and seizure disorders.
Laboratory Tests Subject to Exceptions from Laboratory DOS Policy
On October 6, CMS published an updated Download Link for the latest list of laboratory tests subject to exceptions to the Laboratory DOS Policy defined at 42 CFR §414.510(b)(5) to reflect the October updates.
Updated Civil Monetary Penalties and Affirmative Exclusions
On October 6, the OIG published an updated List of Civil Monetary Penalties and Affirmative Exclusions, including:
- On September 9, Oasis Healthcare, Inc., and Quizena Walker, of Stafford, Texas, reached a $15,123.72 settlement agreement with the OIG to resolve allegations that Oasis and Walker falsely attested that they were eligible to receive Provider Relief Fund payments through the CARES Act when Oasis’s Medicare billing privileges were revoked at the time it made the attestation.
- On September 9, McAllen Nursing and Rehab Center, of McAllen, Texas, reached a $91,194.87 settlement agreement with the OIG to resolve allegations that it employed an individual who was excluded from participating in any federal healthcare program.
- On September 9, Colonial Manor Advanced Rehab and Healthcare, of Arlington, Texas, reached a $247,647.94 settlement agreement with the OIG to resolve allegations that it employed an individual who was excluded from participating in federal healthcare programs.
- On September 9, 441 Urgent Care Center, LLC, of Summerfield, Florida, reached a $165,608.78 settlement agreement with the OIG to resolve allegations that it falsely attested that it was eligible to receive Provider Relief Fund payments through the CARES Act when its Medicare billing privileges were revoked at the time it made the attestation.
Updated Provider Self-Disclosure Settlements
On October 6, the OIG published an updated List of Provider Self-Disclosure Settlements with the following organizations:
- On September 1, The Eye Institute, Inc., of Oklahoma, reached a $204,484.16 settlement agreement with the OIG to resolve allegations that it submitted claims to federal healthcare programs for services not provided as claimed due to improper coding and billing.
- On September 1, Parkview Orthopaedic Group, of Illinois, reached a $72,752.37 settlement agreement with the OIG to resolve allegations that it submitted claims to federal healthcare programs for services it knew or should have known were not rendered.
- On September 8, Consulate Health Care of Port Charlotte, of Florida, reached a $14,817.24 settlement agreement with the OIG to resolve allegations that it submitted claims to federal healthcare programs for services provided by an unlicensed individual.
- On September 9, IvyRehab Physical Therapy, of New York, reached a $155,833.50 settlement agreement with the OIG to resolve allegations that it paid improper remuneration to beneficiaries in the form of waived copayments for services and also billed for codes 97110, 97112, and 97530 when those services were provided by unlicensed physical therapy aides.
- On September 28, Eskenazi Health and Midtown Community Mental Health Clinic, of Indiana, reached a $901,724.01 settlement agreement with the OIG to resolve allegations that it submitted outpatient hospital claims to Medicare and Medicaid at hospital rates for services provided at off-site locations which failed to meet applicable provider-based requirements.
- On September 29, Ability Plus Home Healthcare, of Michigan, reached a $47,082.60 settlement agreement with the OIG to resolve allegations that it billed Medicare for services provided by a nurse who did not have an active nursing license.
The OIG also reached new settlements with facilities that employed individuals they knew or should have known were excluded from federal healthcare programs, including:
- The Cornerstone of Recovery
- South County Nursing and Rehabilitation Center
- Central Maine Medical Center
- Risk Optometric Associates
COVID-19 FAQs on Medicare Fee-for-Service Billing
On October 6, CMS updated an FAQ regarding the latest guidance on billing for COVID-19. This round of updates included guidance on whether the revised definition of direct supervision to include virtual presence applies to physical therapists and occupational therapists providing direct supervision of their therapist assistants in private practices.
Updated COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers
On October 7, CMS updated the blanket waivers for health care providers Fact Sheet regarding waived eligibility requirements for Medicare-Dependent, small rural hospitals (MDH). For the duration of the PHE, CMS will waive the eligibility requirements at 42 CFR §412.108(a)(1)(ii) and §412.108(a)(1)(iv)(C) on number of beds and percentage of inpatient days/discharges attributable to individuals with Part A. This allows MDHs to help meet the needs of their communities during the pandemic.
Updated List of Excluded Individuals and Entities (LEIE)
On October 7, the OIG updated its LEIE with an updated LEIE database for download and lists of September 2021 exclusions, reinstatements, and profile corrections.
Updated Corporate Integrity Agreement Documents
On October 7, the OIG published information on a new Corporate Integrity Agreement with the following entity: