This week in Medicare updates—5/4/2022
Proposed Rule: Implementing Certain Provisions of the Consolidated Appropriations Act of 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules
On April 22, CMS published a draft copy of a Proposed Rule to implement sections of the Consolidated Appropriations Act of 2021 that would simplify Medicare enrollment rules and extend coverage of immunosuppressive drugs for certain beneficiaries. Changes include making Medicare coverage effective the month after enrollment for individuals enrolling in the last three months of their initial enrollment period or general enrollment period, and it also allows the Secretary the authority to establish special enrollment periods for exceptional conditions.
The rule also proposes allowing an individual to enroll in Part B beyond the 36-month post-kidney transplant period for the limited purpose of getting Part B coverage for immunosuppressive drugs. This period would be called the Part B Immunosuppressive Drug benefit. Enrollment for it would start in October 2022 and coverage would start as early as January 1, 2023. Both of these policies were mandated by the Consolidated Appropriations Act.
CMS published a Fact Sheet and Press Release on the rule on the same date. The rule was published in the Federal Register on April 27. Comments are due by June 27.
Advisory Opinion No. 22-07
On April 25, the OIG published an Advisory Opinion regarding an arrangement in which certain physicians who are all family members have an ownership interest in a medical device company that manufactures certain upper extremity surgical technologies invented by one of the physicians. The requestors are seeking an opinion as to whether the arrangement constitutes grounds for the imposition of sanctions under the anti-kickback statute.
The OIG determined that while the arrangement implicates the anti-kickback statute, it would not impose sanctions in this case due to a variety of reasons. These include the fact that the arrangement does not exhibit the suspect characteristics sometimes associated with physician-owned entities related to the legitimacy of the entity as a business; the manner in which the company’s future profits would be distributed reduces the risk of harms under the anti-kickback statute; and the physicians involved generate a very limited amount of business for the company. The OIG described additional reasons for its determination within the Opinion.
Revision to Section on NPP Certification/Recertification in the Benefit Policy Manual
On April 27, CMS published Medicare Benefit Policy Transmittal 11386, which rescinds and replaces Transmittal 11296, dated March 25, 2022, to revise the background and policy sections of the business requirements and to revise the IOM with updated information. Changes apply to nurse practitioners documenting scope of practice and their collaborative relationship with a physician in the medical record. The original transmittal was published regarding changes to manual language to incorporate the CY 2022 implementation of the Notice of Admission (NOA), eliminate the Request for Anticipated Payment (RAP) policy, and provide corrections and clarifications regarding who may sign the certification and recertification for home health beneficiaries.
On April 27, CMS revised MLN Matters 12615 to accompany the transmittal.
Effective date: January 1, 2022
Implementation date: May 26, 2022
Medical Record Maintenance & Access Requirements
On April 27, CMS revised an MLN Fact Sheet regarding documentation maintenance and access requirements to add information on medical records to support home health referrals. The changes note that for home health, the certifying physician’s or allowed practitioner’s facility medical record must have information justifying the referral for home health, including documentation of the need for skilled service and homebound status.
Updated List of CMS Recognized PC IOLs and AC IOLs
On April 27, CMS published an updated List of presbyopia-correcting intraocular lenses (PC IOLs) and astigmatism-correcting IOLs (AC IOLs).
Advisory Opinion No. 22-08
On April 27, the OIG published an Advisory Opinion regarding an arrangement in which a federally qualified health center loaned limited-use smartphones to existing patients to provide them with a device capable of running a telehealth application that would enable these patients to receive telehealth services from the requestor. The requestor is asking the OIG whether this arrangement would be grounds for the imposition of sanctions under the anti-kickback statute and prohibition on beneficiary inducements.
The OIG determined that while this arrangement implicates both the anti-kickback statute and prohibition on beneficiary inducements, it would not impose sanctions in this case. The OIG said this arrangement meets the Promotes Access to Care Exception for the beneficiary inducements civil monetary penalty during the PHE, and it presents a low risk of fraud and abuse under the anti-kickback statute.
Advisory Opinion No. 22-09
On April 28, the OIG published an Advisory Opinion regarding an arrangement in which a requestor–who owns a network of clinical laboratories–would enter into contracts with hospitals throughout the country, and the requestor would pay the hospitals on a per-patient-encounter basis to collect, process, and handle specimens that would then be sent to the requestor’s laboratories for testing. The requestor was seeking an opinion as to whether this arrangement would be grounds for the imposition of sanctions under the anti-kickback statute.
The OIG determined that this arrangement would be grounds for the imposition of sanctions, as it does not have sufficient safeguards to reduce the risk of inappropriate steering to the requestor. The OIG said this arrangement warrants careful scrutiny because lab services may be particularly susceptible to the risk of steering and the arrangement involves a “per-click” fee structure.
Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care
On April 28, the OIG published a Report regarding whether Medicare Advantage Organizations (MAO) are appropriately approving or denying services which require prior authorizations. The OIG looked at a stratified random sample of 250 denials of prior authorization requests and 250 payment denials issued by 15 of the largest MAOs in June 2019. It found that 13% of the prior authorization requests the MAOs denied actually met Medicare coverage rules. The two common causes of those denials were MAOs using clinical criteria for medical necessity beyond what Medicare has in its coverage rules and MAOs stating that prior authorization requests did not have sufficient documentation to support approval when the OIG’s reviewers said the documentation provided was more than sufficient to support the request. The OIG also found that 18% of the payment request denials met Medicare coverage rules and MAO billing rules. The OIG attributed most of these denials to human error and system processing error.
The OIG recommends CMS issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in this report, and direct MAOs to take steps to identify and address vulnerabilities that can lead to manual review errors and system errors. CMS agreed with all recommendations.
The OIG published a Video about these types of Medicare Advantage denials on the same date.
Ambulance Payment Policy if Patient Dies After Dispatch but Before Arrival Added to Manual
On April 28, CMS published Medicare Claims Processing Transmittal 11365 regarding changes to the manual for billing processes when a patient dies before the ambulance arrives or when the patient dies after being loaded on the ambulance.
CMS published MLN Matters 12707 on the same date to accompany the transmittal.
Effective date: May 31, 2022
Implementation date: May 31, 2022
Section 127 of the Consolidated Appropriations Act: Graduate Medical Education (GME) Payment for Rural Track Programs
On April 28, CMS published One-Time Notification Transmittal 11366 regarding implementation of legislative changes for GME and indirect medical education (IME) payments to urban and rural teaching hospitals. The transmittal provides guidance to hospitals and instructions to the MACs on how to review and implement requests to increase hospitals’ IME and direct GME rates due to participating in new Rural Training Programs and/or adding clinical participating sites to existing RTPs.
CMS published MLN Matters 12709 on the same date to accompany the transmittal.
Effective date: October 1, 2022
Implementation date: MACs shall follow regular interim rate adjustment schedule after 10/1/2022
Implementation of the Award for the Jurisdiction K (J-K) Part A and Part B MAC (JK A/B MAC)
On April 28, CMS published One-Time Notification Transmittal 11390 to announce that NGS was awarded the Jurisdiction K workload via the competition procurement. NGS is the incumbent contractor for this workload.
Effective date: May 1, 2022 - Part A and Part B
Implementation date: May 1, 2022 - Part A and Part B
Medicare Summary Notice (MSN) Created with Wrong Beneficiary Data - Update Beneficiary Data Streamlining Logic
On April 29, CMS published One-Time Notification Transmittal 11376 regarding an issue where MSNs are being created for the wrong beneficiary when there is a Medicare Beneficiary Identifier or Health Insurance Claim Number mismatch to the name submitted on the claim. The transmittal provides instructions for the MCS to ensure the systems are fixed to resolve this problem.
Effective date: October 1, 2022
Implementation date: October 3, 2022
Updating Reason Code 32287 Edit in the FISS to Allow Processing of Claims Containing COVID-19 Vaccine and Other Vaccines When Billed on the Same Claim
On April 29, CMS published One-Time Notification Transmittal 11377 regarding a revision to FISS reason code 32287 to allow claims to process when COVID-19 vaccines are billed on the same claim as flu or PPV vaccines.
Effective date: October 1, 2022 - Claims received on or after this date
Implementation date: October 3, 2022
Changes to Beneficiary Coinsurance for Additional Procedures Furnished During the Same Clinical Encounter as Certain Colorectal Cancer Screening Tests
On April 29, CMS published One-Time Notification Transmittal 11374 regarding the implementation of a gradual reduction in coinsurance for certain colorectal cancer screening procedures as mandated by the Consolidated Appropriations Act of 2021. The transmittal contains a schedule of which codes this reduction will apply to and how much coinsurance will be reduced by for certain years.
CMS published MLN Matters 12656 on the same date to accompany the transmittal.
Effective date: January 1, 2022
Implementation date: October 3, 2022 - Coding; January 3, 2023 - Testing and Full Implementation
NCD 210.14 Reconsideration - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)
On April 29, CMS published Medicare National Coverage Determinations Transmittal 11388 and Medicare Claims Processing Transmittal 11388 regarding implementation of the revised NCD 210.14 - Screening for Lung Cancer with LDCT. CMS is expanding beneficiary eligibility for this screening by lowering the minimum age from 55 down to 50 years and reducing the smoking history requirement to at least 20 pack-years. Changes also include simplified requirements for counseling and shared decision-making visit, a removal of the restriction on who must furnish that visit, and more.
Effective date: February 10, 2022
Implementation date: October 3, 2022
ICD-10 and Other Coding Revisions to NCDs – July 2022
On April 29, CMS published One-Time Notification Transmittal 11391, which rescinds and replaces Transmittal 11342, to replace two spreadsheets: NCD 160.18 (Vagus Nerve Stimulation) and NCD 110.24 (CAR T-Cell Therapy). The original transmittal was published regarding the regular updates of ICD-10 conversions and other coding updates specific to NCDs.
CMS revised MLN Matters 12606 on the same date to accompany the transmittal.
Effective date: July 1, 2022 - unless otherwise specified in the individual requirements
Implementation date: March 12, 2022 - A/B MACs local edits; July 5, 2022 - Shared Systems edits
Final Rule: Contract Year (CY) 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Program
On April 29, CMS published a draft copy of a Final Rule regarding changes to Medicare Advantage (MA) and Part D for CY 2023. CMS finalized a policy that requires Part D plans to apply all price concessions they receive from network pharmacies to the point of sale so beneficiaries can share in savings. It also finalized changes to marketing and communications oversight to help detect and prevent deceptive marketing tactics used to enroll beneficiaries in MA and Part D plans; reinstated medical loss ratio (MLR) reporting requirements that were in effect for contract years 2014-2017; specified how the maximum out-of-pocket limit is calculated for dually eligible beneficiaries, and more.
CMS published a Fact Sheet and a Press Release on the rule on the same date. The rule is scheduled to be published in the Federal Register on May 9.
Effective dates: These regulations are effective on June 28, 2022, except for amendatory instructions 27 and 36 (regarding the definition of “negotiated price” at §§423.100 and 423.2305), which are effective January 1, 2024.
Applicability dates: The applicability date of the provisions in this rule is January 1, 2023, except as explained in the supplementary information.