This week in Medicare updates—9/22/2021
Additional Payment Edits for DMEPOS Suppliers of Custom Fabricated and Prefabricated (Custom Fitted) Orthotics, Update to Change Requests 3959, 8390, and 8730
On September 13, CMS published One-Time Notification Transmittal 11002, which rescinds and replaces Transmittal 10896, dated July 21, 2021, to make additional updates to the OR01 and OR02 HCPCS Codes Attachment. The original transmittal was published 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
Medicare Quarterly Provider Compliance Newsletter
On September 13, CMS published the Quarterly Provider Compliance Newsletter, which was backdated to July 2021, regarding two recovery auditor findings and one comprehensive error rate testing (CERT) finding. The recovery auditor findings involved medical necessity and documentation requirements for negative pressure wound therapy and bone marrow or stem cell transplant. The CERT finding involved insufficient documentation and coding errors for glucose testing supplies.
Medicare Vision Services
On September 13, CMS revised an MLN Booklet regarding Medicare policies on vision services. Revisions include language about cataracts, information on coverage of intraocular lenses in ambulatory surgical centers, language about screening for glaucoma, eye, and ear disorders, and more.
Updated Corporate Integrity Agreement Documents
On September 14, the OIG published information on new Corporate Integrity Agreements with the following entity:
Advisory Opinion 21-12
On September 15, the OIG published an Advisory Opinion regarding whether an arrangement in which a critical access hospital (CAH) offers a warranty-like policy for specific joint replacement procedures would be grounds for the imposition of sanctions under the anti-kickback statute or beneficiary inducements CMP. Under this arrangement, the CAH would not bill the patient or patient’s insurer for certain items and services provided to treat complications of joint replacement procedures within 90 days of a qualifying joint replacement procedure. The policy would only apply to qualifying patients whose joint replacement procedures were performed by the CAH’s two orthopedic surgeons.
The OIG said that this arrangement would present a minimal risk of fraud and abuse under the federal anti-kickback statute and, in an exercise of OIG discretion, it would not impose sanctions under the beneficiary inducements CMP. The OIG said the proposed arrangement seems designed to promote quality of care and better outcomes for patients, has built-in safeguards which reduce the risk of the arrangement interfering with or skewing clinical decision-making, and is unlikely to lead to overutilization or inappropriate utilization of items or services reimbursable by federal health care programs. It also said that while the arrangement could result in patient steering, the fact that the requestor is a CAH and the nearest hospital is more than 40 miles away makes it less likely that the arrangement would inappropriately influence a patient’s choice of provider.
Updated OIG Work Plan
On September 15, the OIG updated its Work Plan with the following new item:
Proposed Rule: Repealing the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule
On September 15, CMS published a Proposed Rule in the Federal Register repealing the MCIT and Definition of “Reasonable and Necessary” Final Rule, which had been published in the Federal Register on January 14, 2021, and previously delayed as of March 17, 2021. CMS said it is providing a public comment period to allow time for stakeholders to comment on the proposed repeal, future rulemaking on an expedited coverage pathway that provides access to innovative technologies, and the reasonable and necessary definition.
Comments are due by October 15.
Direct Mailing Notification to the MACs Regarding Clinical Laboratory Fee Schedule (CLFS)
On September 16, CMS published One-Time Notification Transmittal 11001 regarding upcoming mailings the MACs should send out to independent labs and hospitals within their jurisdictions about CLFS changes.
Effective date: September 30, 2021
Implementation date: September 30, 2021
October 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.3
On September 16, CMS published Medicare Claims Processing Transmittal 10996 regarding the regular quarterly updates to the I/OCE.
Effective date: October 1, 2021
Implementation date: October 4, 2021
October 2021 Update of the OPPS
On September 16, CMS published Medicare Claims Processing Transmittal 10997 regarding the October updates to the OPPS. These updates include new COVID-19 vaccine codes, updated dosing for HCPCS code Q0244, a new HCPCS code for endoscopic submucosal dissection, and more.
Effective date: October 1, 2021
Implementation date: October 4, 2021
October 2021 Update of the Ambulatory Surgical Center (ASC) Payment System
On September 17, CMS published Medicare Claims Processing Transmittal 11004 regarding the October updates to the ASC PPS. These include changes to device offsets, three new skin substitute products for the low-cost category, 14 new HCPCS codes for reporting drugs and biologicals in the ASC setting, and more.
CMS published MLN Matters 12451 on the same date to accompany the transmittal.
Effective date: October 1, 2021
Implementation date: October 4, 2021
October Quarterly Update for 2021 DMEPOS Fee Schedule
On September 17, CMS published Medicare Claims Processing Transmittal 11005 regarding the quarterly updates to the DMEPOS fee schedule.
Effective date: October 1, 2021
Implementation date: October 4, 2021
Reinforcement of EMTALA Obligations Specific to Patients Who are Pregnant or are Experiencing Pregnancy Loss
On September 17, CMS published a Memorandum to state survey agency directors regarding EMTALA obligations for patients who are pregnant or are experiencing pregnancy loss. The memo restates existing guidance regarding EMTALA and does not contain new policy. The memo discusses the applicable Medicare Conditions of Participation, specific EMTALA provisions which apply to pregnancy, and hospital obligations.
Effective date: Immediately. This policy should be communicated to all survey and certification staff and managers immediately.