New CMS Final Rule Provides Medicare Beneficiaries with Greater Surgical Options and Expands Coverage for Certain Surgical Procedures

The Centers for Medicaid & Medicare Services (CMS) recently released the 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Final Rule, which may be accessed here. Significantly, the Final Rule contains policy changes by CMS that are intended to provide Medicare patients and their physicians greater choices in the outpatient setting at a lower cost. CMS Administrator Seema Verma indicated there would be less micromanagement from the government regarding such decisions.

To accomplish this, CMS will be eliminating the Inpatient Only (IPO) list that contains 1,700 procedures which Medicare requires to be performed in the hospital inpatient setting. CMS will be phasing the IPO list out over the next three years, with the IPO being completely phased out by CY 2024. Phasing the IPO list out will render the services eligible for Medicare reimbursement whether they are furnished in an inpatient or outpatient hospital setting. CMS also anticipates this shift to assist hospitals in handling patient surges due to COVID-19, as the hospitals will be able to provide more treatments in outpatient settings.

Phasing out the IPO list will also provide for lower cost options for beneficiaries, as inpatient treatment is generally more costly than outpatient treatment. As beneficiaries are able to opt for outpatient treatment services rather than inpatient treatment services, they should receive significant cost savings. One example discussed in CMS’ press release for the Final Rule (available here) indicated that a beneficiary who receives thromboendarterectomy (a surgical procedure to remove chronic blood clots from arteries in the lung) could save nearly 25% in deductible costs if the procedure is performed in an outpatient rather than an inpatient setting.

CMS is also adding the following eleven new procedures to the ASC covered procedures list (CPL):

  • CPT code 0266T (Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intraoperative interrogation, programming, and repositioning, when performed)),
  • CPT code 0268T (Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed),
  • CPT code 0404T (Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency), CMS-1736-FC; CMS-1736-IFC 827
  • CPT code 21365 (Open treatment of complicated (eg, comminuted or involving cranial nerve foramina) fracture(s) of malar area, including zygomatic arch and malar tripod; with internal fixation and multiple surgical approaches,
  • CPT code 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft
  • CPT code 27412 (Autologous chondrocyte implantation, knee)
  • CPT code 57282 (Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus))
  • CPT code 57283 (Colpopexy, vaginal; intra-peritoneal approach (uterosacral, levator myorrhaphy)
  • CPT code 57425 (Laparoscopy, surgical, colpopexy (suspension of vaginal apex))
  • CPT code C9764 (Revascularization, endovascular, open or percutaneous, lower extremity artery (ies), except tibial/peroneal; with intravascular lithotripsy, includes angioplasty within the same vessel (s), when performed
  • CPT code C9766 (Revascularization, endovascular, open or percutaneous, lower extremity artery (ies), except tibial/peroneal; with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel (s), when performed.

Lastly, CMS revised the criteria used to add covered surgical procedures to the CPL. CMS will no longer apply the following exclusion criteria to determine what covered surgical procedures to add to the CPL:

  • Generally result in extensive blood loss;
  • Require major or prolonged invasion of body cavities;
  • Directly involve major blood vessels;
  • Are generally emergent or life threatening in nature; or
  • Commonly require systemic thrombolytic therapy.

Note that while CMS will no longer apply these criteria when adding services to the CPL, they expect physicians to look to the criteria as factors in making site-of-service determinations for their beneficiaries. Moving forward, CMS has developed the following new criteria to use when determining whether to add a service to the CPL:

  • The procedures are separately paid under the OPPS; and
  • The procedures are not:
    • Designated as requiring inpatient care under § 419.22(n) as of December 31, 2020;
    • Only able to be reported using a CPT unlisted surgical procedure code; or
    • Otherwise excluded under § 411.15.

Using the revised criteria, CMS will be adding an additional 267 surgical procedures to the CPL in CY 2021.

Please note that the changes in the OPPS and ASC Final Rule are effective January 1, 2021.

For any questions regarding the 2021 OPPS and ASC Final Rule, please contact Jessica Gustafson at, or your regular HLP attorney, or, or call (212) 734-0128 or (248) 996-8510.

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