This week in Medicare updates—7/14/2021
CY 2022 End Stage Renal Disease Prospective Payment System Proposed Rule
On July 1, CMS published a draft copy of the 2022 ESRD PPS Proposed Rule, which was published in the Federal Register on July 9. Proposals include updates to the outlier policy based on CY 2020 data, the addition of two new products for TPNIES for CY 2022, and changes to the ETC Model to incentivize providers to improve the rates of home dialysis or transplantation among beneficiaries who are dual-eligible for Medicare/Medicaid or beneficiaries who are low-income subsidy recipients. CMS said this makes the ETC Model the first Innovation Center Model to directly address health equity.
CMS estimates payment updates in the rule will increase ESRD payments for freestanding clinics by 1.2% and decrease payments for hospitals by 1.3% compared to CY 2021. The proposed CY 2022 ESRD PPS base rate is $255.55. The rule also includes several requests for information.
Interim Final Rule with Comment: Requirements Related to Surprise Billing - Part 1
On July 1, HHS published a draft copy of an Interim Final Rule with Comment regarding a series of policy changes to protect patients covered under job-based and individual health plans from surprise billing. The rule bans surprise billing for emergency services, bans out-of-network charges for ancillary care at an in-network facility and other out-of-network charges without advance notice, and bans high out-of-network cost-sharing for emergency and non-emergency services. It also requires certain health care providers to supply patients with a one-page notice on certain balance billing information. While the rule does not apply to people with coverage through Medicare, Medicaid, Indian Health Services, VA Health Care, or TRICARE, it reflects a growing trend to protect patients from surprise billing and serves to implement provisions of the Consolidated Appropriations Act, 2021.
Comments are due 60 days after publication in the Federal Register. Most regulations are applicable for plan years beginning on or after January 1, 2022.
July Quarterly Update for 2021 DMEPOS Fee Schedule
On July 1, CMS published Medicare Claims Processing Transmittal 10865 regarding the July quarterly update to the DMEPOS fee schedule. The update includes a notice that CMS will continue the KU modifier fee schedule amounts for wheelchair accessories furnished in connection with specific wheelchair codes effective for dates of service on or after July 1, 2021.
CMS published MLN Matters 12345 on the same date.
Effective date: July 1, 2021
Implementation date: July 6, 2021
Comment Request: Program Integrity II
On July 1, CMS published a Comment Request in the Federal Register regarding the submission of an information collection titled “Program Integrity II” for OMB review. Comments are due to the OMB desk officer by August 2.
Comment Request: Essential Community Provider Data Collection to Support QHP Certification for PYs 2022-2024
On July 1, CMS published a Comment Request in the Federal Register regarding an information collection titled “Essential Community Provider Data Collection to Support QHP Certification for PYs 2022-2024.” Comments are due by August 30.
Comment Request: Transcatheter Valve Therapy (TVT) Registry
On July 2, CMS published a Comment Request in the Federal Register regarding an information collection titled “Transcatheter Valve Therapy (TVT) Registry.” Comments are due by August 31.
Comment Request: Evaluation of the CMS Network of Quality Improvement and Innovation Contractors (NQIIC)
On July 2, CMS published a Comment Request in the Federal Register regarding the submission of an information collection titled “Evaluation of the CMS Network of Quality Improvement and Innovation Contractors (NQIIC)” for OMB review.
Comments are due to the OMB desk officer by August 2.
Corrected ICD-10-CM Files
On July 2, the CDC published corrected versions of the FY 2022 ICD-10-CM Tabular Addenda and the FY 2022 Conversion Table. These corrections were made due to the missing I5A non-ischemic myocardial injury (non-traumatic) code for the addenda.
COVID-19 FAQs on Medicare FFS Billing
On July 2, CMS updated an FAQ regarding the latest guidance on billing for COVID-19. This round of updates included a change to the link and contact email for information on how CMS-HCC risk scores are calculated for ACOs.
CMS continues to update this document on a regular basis. Providers should review frequently for new information.
Proposed Decision Memo for Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches
On July 2, CMS published a Proposed Decision Memo regarding changes to NCD 240.2.2 (Home Oxygen Use to Treat Cluster Headache) and NCD 240.2 (Home Use of Oxygen). CMS is proposing to remove NCD 240.2.2 to end coverage with evidence development and allow the MACs to make coverage determinations for the use of home oxygen for cluster headaches. CMS did not find sufficient evidence that this treatment universally benefited patients with this condition under the existing NCD. CMS is also proposing to modify NCD 240.2 to expand patient access to oxygen/oxygen equipment in the home and to permit contractors to cover home oxygen and oxygen equipment in treating cluster headaches by changing language to say MACs may determine reasonable and necessary coverage for patients with conditions unrelated to hypoxemia.
Comments on the proposed decision memo are due by August 1.
CMS Announces Director of Center for Medicare
On July 6, CMS published a Press Release to announce that Dr. Meena Seshamani, M.D., Ph.D., will be the new Deputy Administrator and Director of the Center for Medicare. Dr. Seshmani has policy experience as a previous Director of the Office of Health Reform for HHS where she drove strategy and led implementation of the Affordable Care Act. She most recently worked as the Vice President of Clinical Care Transformation at MedStar Health.
Advisory Opinion No. 21-07
On July 7, the OIG published an Advisory Opinion regarding whether the OIG would impose sanctions under the federal anti-kickback statute and prohibition on beneficiary inducements civil monetary penalty due to an arrangement in which a Medigap plan would contract with a preferred hospital organization (PHO) and would have network hospitals under the PHO provide discounts to the Medigap plan on policyholders’ Part A inpatient deductibles. The discount would be established in advance and would be applied uniformly to all policyholders for at least one year. The Medigap plan would then offer a $100 premium credit to policyholders who select a network hospital under the PHO for a Part A covered inpatient stay. This credit would apply to the next premium payment due to the policyholder’s Medigap plan after the inpatient stay. The Medigap plan would also pay the PHO a monthly, percentage-based administrative fee to compensate the PHO for establishing the hospital network and arranging for network hospitals to discount the Part A inpatient deductible.
The OIG determined that all three streams of remuneration in this agreement would implicate the anti-kickback statute, and the premium credit from the Medigap plans to the policyholders would implicate the beneficiary inducements civil monetary penalty. However, the OIG said it would not impose sanctions in this case due to a low risk of fraud and abuse. The OIG said several elements of the arrangement factored into its decision, such as the premium credit reducing the amount a policyholder would owe rather than taking the form of an affirmative payment into the policyholder’s bank account, the universal application of the premium credit, the administrative fee representing a percentage of universal savings rather than revenue generated, and more.
Updated Corporate Integrity Agreement Documents
On July 8, the OIG published information on closed Corporate Integrity Agreements with the following entities:
- ACell, Inc., of Columbia, MD
- Rhine Drug Company and Andy Carter Clements, Jr., of Rhine, GA
- Egbujor, Theophilus and Grace see Friendship Home Health, Inc., of Nashville, TN
- Friendship Home Health, Inc., etc., of Nashville, TN
- Jones, Sheena Atlas Healthcare, Inc., of Hales Corner, WI
- Nacogdoches Memorial Hospital, of Nacogdoches, TX
- Nashville Pharmacy Services, LLC, of Nashville, TN
- Apple Medical and Cardiovascular Group see Portnow, M.D., P.A., Arthur S. D/B/A Apple Medical and Cardiovascular Group, D/B/A Apple Medical Group, and Arthur S. Portnow, M.D., of Sarasota, FL
- Regent Management Services, L.P., of Galveston, TX
- Kindred Healthcare, Inc., see RehabCare Group, Inc., of Louisville, KY
- Rose Radiology Centers, Inc., and Manuel S. Rose, M.D., of Trinity, FL
Updated Provider Self-Disclosure Settlements
On July 8, the OIG published an updated List of Provider Self-Disclosure Settlements with the following organizations:
- On June 2, Casey’s Pond Senior Living, of Colorado, reached a $21,215.43 settlement agreement with the OIG after self-disclosing that it submitted claims for services provided by an unlicensed individual.
- On June 8, ProHEALTH Care Associates, of New York, reached a $50,000 settlement agreement with the OIG after self-disclosing that it paid remuneration to health care providers, their immediate family members, and/or their office staff in the form of cost-sharing write-offs, gifts, and/or meals.
- On June 24, Hospice of Limestone County, of Alabama, reached a $500,000 settlement agreement with the OIG after self-disclosing that it submitted claims to Medicare for hospice services that lacked recertifications of terminal illness.
- On June 25, RiverKids Pediatric Home Health, of Texas, reached a $66,594.90 settlement agreement with the OIG after self-disclosing that it employed an individual it knew or should have known was excluded from participation in federal health care services.
COVID-19 Accelerated and Advance Payments: Updated FAQs
On July 8, CMS published an Updated FAQ, dated June 24, 2021, regarding recoupment of COVID-19 Accelerated and Advance Payments. CMS did not highlight which information in the FAQs was updated, so the document should be reviewed in its entirety.
Advisory Opinion No. 21-08
On July 8, the OIG published an Advisory Opinion regarding whether the OIG would impose sanctions under the federal anti-kickback statute and prohibition on beneficiary inducements civil monetary penalty due to an arrangement in which a pharmaceutical manufacturer would provide financial assistance for travel, lodging, and meals to certain patients who are potentially eligible for treatment with the manufacturer’s drug. This drug is an FDA-approved gene therapy used to treat individuals with a rare, inherited retinal disease. It is the only pharmacologic treatment currently available for these patients and is administered in the hospital outpatient setting via surgical injection in the eye at least six days apart. As part of the treatment, patients must avoid air travel or travel to high elevations until any air bubbles formed during the treatment dissipate, which can take a week or longer. The treatment is currently only provided in 10 centers nationwide, and therefore the arrangement in this opinion would offer financial assistance to certain patients and one caregiver for transportation, lodging, and meals associated with an initial consultation, administration appointments, and one follow-up appointment. This arrangement would only be provided for patients who meet travel distance and household income requirements.
The OIG stated that while the arrangement implicates the beneficiary inducements CMP, it meets the Promotes Access to Care exception and therefore the OIG would not impose sanctions under that CMP. The arrangement also implicates the anti-kickback statute; however, the OIG said this specific arrangement presents a low risk of fraud and abuse for reasons explained in the opinion and it would not impose sanctions in this case.
Updated List of Excluded Individuals and Entities (LEIE)
On July 9, the OIG updated its LEIE with an updated LEIE database for download and lists of June 2021 exclusions, reinstatements, and profile corrections.
Medicare Payments for Transitional Care Management (TCM) Services Generally Complied with Federal Requirements, but Some Overpayments were Made
On July 9, the OIG published a Review of whether payments made to physicians and qualifying nonphysician-practitioners for TCM services during CYs 2015-2016 complied with federal requirements. The OIG said it conducted the audit because TCM services are relatively new and have multiple billing restrictions for how and when the services can be billed. The audit covered $249.5 million in payments, and the OIG found a high rate of compliance, as only $1.7 million of that total were identified as overpayments. The overpayments resulted from instances in which multiple physicians billed for TCM services for a beneficiary’s same 30-day TCM service period. Overpayments also resulted from instances where physicians billed on different dates for TCM and restricted overlapping care management services provided during the same 30-day TCM service period for the same beneficiary. The OIG said CMS did not have controls in place to prevent and detect multiple TCM services provided to beneficiaries and to identify instances of overlapping care management.
The OIG recommends CMS notify appropriate providers so the providers can exercise reasonable diligence to identify, report, and return any overpayments in accordance with the 60-day rule, and it recommends CMS implement claims processing control, including system edits, to prevent and detect overpayments. CMS concurred with both recommendations, noted that it changed some payment policies since the audit period, and said it would evaluate opportunities to implement claims processing controls or system edits relevant to TCM services.
Correction: Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes to Episode Definition and Pricing Final Rule
On July 9, CMS published a Correction in the Federal Register regarding two changes to the Comprehensive Care for Joint Replacement Model Final Rule, dated May 3, 2021. The changes apply to two typos in quality measures numbers where the numbers should have been preceded by a greater than or equal to symbol but did not have that symbol in the original document.