This week in Medicare updates—5/26/2021
Medicare Mental Health
On May 17, CMS updated an MLN Booklet on mental health services covered by Medicare. Changes include a new outpatient psychiatric services medical records checklist, acute care hospital information, and updates to CPT codes in table 9.
ICD-10 and Other Coding Revisions to NCDs--July 2021
On May 17, CMS published One-Time Notification Transmittal 10804, which rescinds and replaces Transmittal 10624, dated March 23, 2021, to make several changes to BR 12124.2, NCD 90.2, Next Generation Sequencing (NGS), such as retaining previously deleted codes for a year then deleting following provider education, adding three CPT codes, and more. The correction also adds BR 12124.2.1 and revises the attachment NCD 90.2 NGS spreadsheet. The original transmittal was issued regarding the regular ICD-10 conversions and coding updates specific to NCDs.
CMS revised MLN Matters 12124 on the same date to accompany the transmittal.
Effective date: July 1, 2021 - Unless otherwise indicated in business requirements
Implementation date: July 6, 2021
Advisory Opinions No. 21-03, No. 21-04, and No. 21-05
On May 17, 19, and 20, the OIG published three Advisory Opinions, (Advisory Opinion No. 21-03, Advisory Opinion No. 21-04, and Advisory Opinion No. 21-05) regarding whether the OIG would impose sanctions under the federal anti-kickback statute and prohibition on beneficiary inducements civil monetary penalty due to arrangements in which Medigap plans would contract with a preferred hospital organization (PHO) and would have network hospitals under the PHO provide discounts to the Medigap plans 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 plans 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 plans 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 these agreements 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 these three cases due to a low risk of fraud and abuse. The OIG said several elements of the arrangements 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.
CMS Needs to Strengthen Regulatory Requirements for Medicare Part B Outpatient Cardiac and Pulmonary Rehabilitation Services to Ensure Providers Fully Meet Coverage Requirements
On May 17, the OIG published a Review of whether CMS regulatory requirements contained sufficient information to ensure that claims for outpatient cardiac and pulmonary rehab services complied with Medicare coverage requirements. The OIG originally conducted the review in an effort to look into the third highest-paid provider in the country for these services. During the course of that review, the OIG found that although the provider generally complied with Medicare coverage requirements for those services, it did not meet the intent of the requirements. The OIG then shifted its audit from the provider to CMS. It found that Medicare’s coverage requirements lacked details related to what patient-specific information to include in a beneficiary’s medical record and how that information should relate to individualized treatment. Information missing from the sample claims included individualized treatment plans that were incomplete or missing essential content, documentation that did not show that an adequate psychosocial assessment was performed, and treatment plans that did not indicate that education and counseling services were tailored to the beneficiary’s specific needs.
The OIG determined that $2.7 million in Medicare payments in this select audit were for services that may not have met the intent of Medicare coverage requirements. The OIG recommends CMS revise its regulations to provide sufficient guidance ensuring that providers meet coverage requirements for these services. CMS stated that it updated subregulatory guidance in two of its manuals in March 2021 to more closely reflect regulatory text, and it said it will consider the OIG’s recommendation when determining next steps regarding regulations on outpatient cardiac and pulmonary rehab services.
Updated OIG Work Plan
On May 17, the OIG updated its Work Plan with the following new items:
- Medicare-Related Capital Costs Reported by New Hospitals
- Audits of Medicare Payments for Spinal Pain Management Services
- Meeting the Challenges Presented by COVID-19: Nursing Homes
- Impact of Expanding the Hospital Transfer Payment Policy for Early Discharges to Postacute Care
Comparison of Average Sales Prices (ASP) and Average Manufacturer Prices (AMP): Results for the Fourth Quarter of 2020
On May 18, the OIG published a Report regarding drugs for which the ASP exceeds the AMP by 5% or more for two consecutive quarters or three of the previous four quarters. When this happens, CMS substitutes 103% of the AMP for the ASP-based reimbursement. In the fourth quarter of 2020, five drug codes met this price substitution criteria. Three additional codes exceeded the 5% threshold but were identified as being in short supply. Another eight codes exceeded the 5% threshold but did not meet other CMS criteria for price substitution. The OIG will provide these results to CMS for review.
Delay of Effective Date: Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule
On May 18, CMS published a Final Rule in the Federal Register regarding implementation of the MCIT and Definition of “Reasonable and Necessary” Final Rule. The rule had been published January 14, 2021 and previously delayed as of March 17, 2021. This new final rule delays implementation of the MCIT rule further until December 15, 2021. CMS opened a public comment period in March when the rule was first delayed and received approximately 215 comments during that period. CMS summarized responses to those comments in this final rule. CMS said by delaying implementation of the rule until at least December, it hopes to have time to address issues raised by stakeholders, especially as it pertains to Medicare patient protections, evidence criteria, and lack of coordination between coverage, coding, and payment.
Dates: As of May 14, the effective date of the MCIT and Definition of “Reasonable and Necessary” Final Rule is further delayed until December 15, 2021.
Comment Request: Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory; Medicare Fee-for-Service Prepayment Review of Medical Records; more
On May 18, CMS published a Comment Request in the Federal Register regarding the following information collections:
- Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory
- Fee-for-Service Improper Payment Rate Measurement in Medicaid and CHIP
- Medicaid and CHIP Managed Care Payments and Related Information
- Payment Error Rate Measurement - State Medicaid and CHIP Eligibility
- Medicare Fee-for-Service Prepayment Review of Medical Records
- Annual Report on Home and Community Based Services Waivers and Supporting Regulations
Comments are due by July 19.
NCA for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)
On May 18, CMS published a Tracking Sheet regarding an NCA to reconsider the NCD for Screening for Lung Cancer with LDCT. The US Preventive Services Task Force recently published updated recommendations on screening people at high risk for lung cancer with LDCT based on age and smoking history. Due to this update, CMS is being asked to reconsider coverage requirements in the NCD.
By issuing the tracking sheet, CMS initiates a 30-day public comment period on the NCA. Comments are due by June 17.
Hospice Provider Compliance Audit: Ambercare Hospice, Inc.
On May 18, the OIG published a Review of whether Ambercare Hospice, Inc., complied with Medicare requirements for hospice services. The OIG found that Ambercare did not comply with Medicare requirements for 52 of the 100 claims reviewed in the sample. Errors involved claims for which the clinical record did not support the beneficiary’s terminal diagnosis. The OIG estimates that Ambercare received at least $24.6 million in Medicare reimbursement for noncompliant hospice services.
In response to the OIG’s draft report, Ambercare argued that all but four claims were compliant. It said the OIG’s medical review contractor did not apply the correct standard to determine whether the clinical record supported the beneficiary’s terminal diagnosis or eligibility to receive services. It also said that while the independent medical review contractor found documentation did not satisfy LCD criteria, Ambercare does not believe LCD guidelines are mandatory. After reviewing Ambercare’s comments, the OIG maintained its original findings. The OIG recommends Ambercare refund the federal government for the portion of the $24.6 million within the 4-year claims reopening period; identify, report, and return any overpayments within the 60-day rule; and strengthen its procedures to ensure hospice services comply with Medicare requirements.
Hospice Provider Compliance Audit: Alive Hospice, Inc.
On May 18, the OIG published a Review of whether Alive Hospice, Inc., complied with Medicare requirements for hospice services. The OIG found that Alive did not comply with Medicare requirements for 24 of the 100 claims reviewed in the sample. Errors involved 16 claims for which the clinical record did not support the beneficiary’s terminal diagnosis and eight claims for which the clinical record did not support the level of care claimed for Medicare reimbursement. The OIG estimates that Alive received at least $7.3 million in Medicare reimbursement for noncompliant hospice services.
In response to the OIG’s draft report, Alive argued that all but two claims were compliant. It said the OIG’s medical review contractor failed to view the medical record as a whole and prioritized the medical reviewer’s judgment above that of the certifying physician. Alive stated the review contractor applied criteria and rules that are not applicable and not appropriate for reviewing hospice eligibility and level of care. It found issue with the fact that the independent medical review contractor used LCD criteria to determine whether documentation was sufficient, and Alive said LCD guidelines are not mandatory and failure to meet those guidelines cannot support a claim denial. After reviewing Alive’s comments, the OIG maintained its original findings. The OIG recommends Alive refund the federal government for the portion of the $7.3 million within the 4-year claims reopening period; identify, report, and return any overpayments within the 60-day rule; and strengthen its procedures to ensure hospice services comply with Medicare requirements.
Updated Corporate Integrity Agreement Documents
On May 20, the OIG published information on a new Corporate Integrity Agreement with the following entity:
Hospice Provider Compliance Audit: Franciscan Hospice, Inc.
On May 20, the OIG published a Review of whether Franciscan Hospice complied with Medicare requirements for hospice services. The OIG found that Franciscan did not comply with Medicare requirements for 21 of the 100 claims reviewed in the sample. Errors involved 19 claims for which the clinical record did not support the beneficiary’s terminal diagnosis and two claims for which there was no documentation to support the hospice services billed to Medicare. The OIG estimates that Franciscan received at least $13 million in Medicare reimbursement for noncompliant hospice services.
In response to the OIG’s draft report, Franciscan disagreed with the OIG’s determination for 12 of the 19 claims for which the OIG said documentation did not support a terminal diagnosis. It said the physician’s clinical judgment is fundamental in determining the terminal prognosis and is based on the beneficiary’s full clinical picture. Franciscan also disagreed with the medical review contractor’s use of LCDs as a checklist of hospice eligibility. After reviewing Franciscan’s comments, the OIG maintained its original findings. The OIG recommends Franciscan refund the federal government for the portion of the $13 million within the 4-year claims reopening period; identify, report, and return any overpayments within the 60-day rule; and strengthen its procedures to ensure hospice services comply with Medicare requirements.
Comment Request: Disclosures Required of Certain Hospitals and Critical Access Hospitals Regarding Physician Ownership; Evaluation of Risk Adjustment Data Validation (RADV) Appeals and Health Insurance Exchange Outreach Training Sessions; more
On May 20, CMS published a Comment Request in the Federal Register regarding the submission of the following information collections for OMB review:
- Medicaid Eligibility and Enrollment (EE) Implementation Advanced Planning Document (IAPD) Template
- Disclosures Required of Certain Hospitals and Critical Access Hospitals Regarding Physician Ownership
- Evaluation of Risk Adjustment Data Validation (RADV) Appeals and Health Insurance Exchange Outreach Training Sessions
Comments are due to the OMB desk officer by June 21.
Replacing Home Health Requests for Anticipated Payment (RAPs) with a Notice of Admission (NOA) -- Implementation
On May 20, CMS published One-Time Notification Transmittal 10795 regarding the implementation of the one-time Notice of Admission submission instead of submitting a RAP for every home health period of care.
Effective date: January 1, 2022 - Claims from dates on or after this date
Implementation date: October 4, 2021 - for FISS & CWF requirements, design and coding; January 3, 2022 - for FISS and CWF additional coding, testing and implementation, and for all HIGLAS changes; April 4, 2022 - for CWF changes to HICR under BR 12227.6
Addition of the Shared System CWF to the BRs for the HCPCS Codes U0002QW and 87635QW Mentioned in Change Request 11765
On May 20, CMS published One-Time Notification Transmittal 10798 regarding a revision to Change Request 11765, dated April 24, 2020, to add the CWF to the business requirements of that transmittal. Change request 11765 added the QW modifier to COVID-19 testing codes U0002 and 87635.
CMS published MLN Matters 12294 on the same date.
Effective date: March 20, 2020
Implementation date: July 6, 2021 - fast tracked May 10, 2021
Additional Payment Edits for DMEPOS Suppliers of Custom Fabricated and Prefabricated (Custom Fitted) Orthotics, Update to Change Requests 3959, 8390, and 8730
On May 20, CMS published One-Time Notification Transmittal 10801 regarding the addition of HCPCS codes which require the use of a licensed/certified orthotist or prosthetist for furnishing orthotics or prosthetics under two additional product and service codes: OR01 (orthoses: custom fabricated) and OR02 (prefabricated [custom fitted]).
Effective date: October 1, 2021
Implementation date: October 4, 2021
National Coverage Determination (NCD) Removal
On May 20, CMS published Medicare National Coverage Determinations Transmittal 10797 regarding the removal of six NCDs from the NCD manual. These NCDs include:
- NCD 20.5 Extracorporeal Immunoadsorption (ECI) Using Protein A Columns
- NCD 30.4 Electrosleep Therapy
- NCD 100.9 Implantation of Gastrointestinal Reflux Devices
- NCD 110.19 Abarelix for the Treatment of Prostate Cancer
- NCD 220.2.1 Magnetic Resonance Spectroscopy
- NCD 220.6.16 FDG PET for Inflammation and Infection
The transmittal also made a change to NCD 220.6 Positron Emission Tomography (PET) Scans regarding coverage of FDG PET for Infection and Inflammation.
Effective date: January 1, 2021; October 1, 2021
Implementation date: June 22, 2021; October 4, 2021
NCD 110.24: Chimeric Antigen Receptor (CAR) T-Cell Therapy
On May 20, CMS published Medicare National Coverage Determination Transmittal 10796 and Medicare Claims Processing Transmittal 10796 which rescind and replace Change Request 11783. The transmittals were issued regarding coverage of autologous treatment for cancer with T-cells expressing at least one CAR when administered at healthcare facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies and when use meets specified FDA conditions.
Effective date: August 7, 2019
Implementation date: July 23, 2021
NCD 210.3: Screening for Colorectal Cancer (CRC) - Blood-Based Biomarker Tests
On May 20, CMS published Medicare National Coverage Determinations Transmittal 10818 and Medicare Claims Processing Transmittal 10818 regarding the establishment of coverage for blood-based biomarker tests as an appropriate CRC screening test once every three years when performed in a CLIA-certified lab and when certain patient and test requirements are met.
Effective date: January 19, 2021
Implementation date: October 4, 2021
Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment
On May 20, CMS published Medicare Claims Processing Transmittal 10810 regarding the quarterly updates to the CLFS. Changes include seven new PLA codes and two additional new codes effective April 1, 2021.
Effective date: July 1, 2021
Implementation date: July 6, 2021
Second General Update to Chapter 10 of the Program Integrity Manual
On May 20, CMS published Medicare Program Integrity Transmittal 10800 regarding a significant amount of technical, editorial, and organizational changes to sections 10.2.2, 10.2.3, and 10.3.2 in chapter 10 of the Program Integrity Manual.
Effective date: June 22, 2021
Implementation date: June 22, 2021
Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July 2021 Update
On May 20, CMS published Medicare Claims Processing Transmittal 10793 regarding the regular quarterly updates to the MPFSDB. Updates include changes to bilateral surgery indicators for two codes, a variety of new codes, a change to a short descriptor for code 0493T, and more.
CMS published MLN Matters 12289 on the same date.
Effective date: July 1, 2021
Implementation date: July 6, 2021
Sleep Management, LLC: Audit of Claims for Monthly Rental of Noninvasive Home Ventilators
On May 21, the OIG published a Review of whether Medicare claims submitted by Sleep Management for the monthly rental of noninvasive home ventilators (NHV) complied with Medicare requirements. The OIG found that 98 of the 100 claim lines reviewed did not comply with Medicare requirements, as Sleep Management did not follow its policies and procedures to ensure it obtained sufficient documentation to support the medical necessity of the NHV or discontinued service for lack of beneficiary usage. The OIG estimates that Sleep Management received at least $29.1 million in overpayments for these services.
The OIG recommends Sleep Management refund the portion of the $29.1 million in overpayments within the 4-year claims reopening period; identify, report, and return any overpayments within the 60-day rule; and follow existing policies and procedures to ensure it complies with Medicare requirements. Sleep Management disagreed with the OIG’s findings and recommendations for a number of reasons listed in the report. Those issues involved concerns about the medical reviewer’s independence, clinical standards not required by CMS, and more. The OIG maintained its original findings and recommendations are valid, although it did remove one finding in an attempt to avoid potential confusion.
Comment Request: Survey of Retail Prices; Outcome and Assessment Information Set (OASIS) OASIS-D
On May 21, CMS published a Comment Request in the Federal Register regarding the following information collections:
- Survey of Retail Prices
- Outcome and Assessment Information Set (OASIS) OASIS-D
Comments are due by July 20.
Primary Care First (PCF) and Serious Illness Patient (SIP) Models: Part 3: IURs and Edits for Non-Sequential Claims
On May 21, CMS published Demonstrations Transmittal 10820, which rescinds and replaces Transmittal 10746, dated April 27, 2021, to revise business requirement 11911.1.4.1, adding the CARC information to the instruction. This business requirement had previously been edited in the April version of the transmittal. The original transmittal was published in preparation for the implementation of the PCF and SIP Models to address processing certain HCPCS codes under fee-for-service rules for SIP beneficiaries when there is no paid claim line of HCPCS code G2020.
Effective date: April 1, 2021
Implementation date: April 5, 2021
Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update
On May 21, CMS published Medicare Claims Processing Transmittal 10814 regarding updates to the RARC and CARC lists and instructions to the VMS and FISS to update the MREP and PC Print.
Effective date: October 1, 2021
Implementation date: October 4, 2021
ICD-10 and Other Coding Revisions to National Coverage Determinations (NCD) -- October 2021
On May 21, CMS published One-Time Notification Transmittal 10817 regarding the regular coding updates specific to NCDs.
Effective date: October 1, 2021 - or as specified in individual business requirements
Implementation date: October 4, 2021