Knowledge Base Category -

In general, my day-to-day focus as it relates to Medicare Fee-for-Service guidance, is the acute hospital inpatient and outpatient setting. Last week, CMS issued Christmas in July gifts, in the form of 4 final FY 2022 payment rules. While not my day-to-day focus, highlights, and links to information about the final rules are important enough to share with you, our readers, who may be impacted.

FY 2022 Skilled Nursing Facility (SNF) Prospective Payment System (CMS-1746-F)

Major provisions in this final rule are highlighted in a related CMS Fact Sheet (link) and includes:

• FY 2022 Updates to the SNF Payment Rates,
• Methodology for Recalibrating the Patient Driven Patient Model (PDPM) Parity Adjustment,
• Rebase and Revise the SNF Market Basket by using the 2018-based SNF market basket to update the PPS payment rates, instead of the 2014-based SNF market basket,
• Section 134 of the Consolidated Appropriations Act, 2021 – New Blood Clotting Factor Exclusion from SNF Consolidated Billing,
• Changes in the PDPM ICD-10 Code Mappings,
• SNF Quality Reporting Program (SNF QRP) update, and
• SNF Value-Based Purchasing (SNF VBP) Program.

FY 2022 Hospice Payment Rate Update Final Rule (CMS-1745-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

• FY 2022 Routine Annual Rate Setting Changes,
• Other Medicare Hospice Payment Policies,
• Changes to the Hospice Conditions of Participation (CoPs) in response to the COVID-19 Public Health Emergency (PHE),
• Hospice Quality Reporting Program, and
• Home Health Quality Reporting Program.

FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) Final Rule (CMS-1748-F)

Major provisions in this final rule in a related CMS Fact Sheet (link) includes:

• Updates to IRF Payment Rates,
• IRF Quality Reporting Program (IRF QRP) Updates, and
• Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues.

FY 2022 Inpatient Psychiatric Facility (IPF) Prospective Payment System Final Rule (CMS-1750-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

• FY 2022 Updates to the IPF Payment Rates,
• Updates to the IPF Teaching Policy, and
• IPF Quality Reporting Program (IPF QRP) Updates.

Question

In last week’s article about the OPPS and ASC Proposed Rule you indicated that CMS has proposed to remove 258 procedures that were added to the ASC covered procedure list in CY 2021. What procedures are remaining on the ASC list?

Answer

In the CY 2021 Final Rule, the finalized additions to the ASC Covered Procedure List were separated into two tables:

• Table 59 listed procedures added under the standard review process, and
• Table 60 listed procedures added under the second alternative proposal considered for CY 2021.

The procedures proposed for removal from the ASC list for CY 2022 are from Table 60. The procedures listed in Table 59 were not proposed for removal from the ASC list and includes the following CPT/HCPCS codes:

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

Resources:

• CY 2021 OPPS Final Rule and ASC Payment System Final Rule [CMS-1736-FC]: https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppshospital-outpatient-regulations-and-notices/cms-1736-fc
• CY 2022 OPPS and ASC Payment System Proposed Rule {CMS-1753-O]
  Note, see table 45 for procedures proposed for removal from the ASC Covered Procedures List. (link)
• Related MMP Article: CY 2022 OPps and ASC Proposed Rule – Inpatient Only List and ASC Covered Procedure List (link)

Medicare MLN Articles & Transmittals – Recurring Updates

July Quarterly Update for 2021 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule

• Article Release Date: July 2, 2021
• What You Need to Know: This article provides information about changes to the DMEPOS fee schedule that is updated on a quarterly basis. Key points in Change Request 12345 are related to The Coronavirus Aid, Relief, and Economic Security (CAREs) Act, 2020 as it relates to DMEPOS.
• MLN MM12345: (link)

October 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

• Article Release Date: July 15, 2021
• What You Need to Know: This article talks about the ASP methodology, which CMS bases on quarterly data submitted to them by manufacturers.
• MLN MM12342: (link)

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2021

• Article Release Date: July 15, 2021
• What You Need to Know: This article is related to Change Request 12384 which announced the changes that will be included in the October 2021 quarterly release of the edit module for clinical diagnostic laboratory services.
• MLN MM12384: (link)

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.3, Effective October 1, 2021

• Article Release Date: July 14, 2021
• What You Need to Know: Change Request (CR) 12340 provides quarterly updated to the NCCI PTP edits.
• MLN MM12340: (link)

Other Medicare MLN Articles & Transmittals

Section 50 in Chapter 30 of Publication (Pub.) 100-04 Manual Updates: ABNs

• Article Release Date: July 14, 2021
• What You Need to Know: This article alerts providers about key changes being made to Chapter 30, Section 50 of the Medicare Claims Processing Manual related to Advance Beneficiary Notices of Non-coverage (ABNs). One key revision listed is the period of effectiveness of the ABN for repetitive or continuous non-covered care.
• MLN MM12242: (link)

Revised Medicare MLN Articles & Transmittals

National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy – This CR Rescinds and Fully Replaces CR 11783

• Article Release Date: Initial article May 24, 2021 – 2nd Revision July 21, 2021
• What You Need to Know: The revised change request added CPT code C9076 (Breyanz). The implementation date was also revised to September 20, 2021. Breyanz joins a list of other CAR T-cell therapies including Kymriah®, Yescarta®, Tecartus™, and ABECMA®.
• MLN MM12177: (link)

Medicare Coverage Updates

July 12, 2021: National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

July 12, 2021: National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease On June 7, 2021, The FDA approved, using accelerated approval, aducanumab (brand name Aduhelm™) with an indication for the treatment of Alzheimer’s disease. Aducanumab is a monoclonal antibody directed against amyloid beta to reduce amyloid accumulations. CMS has initiated a national coverage determination (NCD) analysis (link) and is requesting public comments to several questions.

Medicare Educational Resources

Critical Access Hospital MLN Booklet Revised

JCMS recently revised the MLN Booklet (link) to include changes related to the COVID-19 Public Health Emergency (PHE). Specifically:

• CAH temporary emergency coverage without a qualifying hospital stay due to COVID-19 PHE, and
• Waiving the limitation on number of swing beds (25) and Length of Stay of 96 hours during the COVID-19 PHE.

COVID-19 Updates

Medicare COVID-19 Snapshot Updates

CMS updated their Medicare COVID-19 Data Snapshot slides (link) on June 30, 2021, to provide insight on the Medicare population from January 1, 2020 – April 24, 2021. With this update, data shows that there have been over 4.3 million COVID-19 cases and over 1.2 million COVID-19 hospitalizations.

OIG Fraud Alert: COVID-19 Scams

On July 21, 2021, the OIG updated their Fraud Alert: COVID-19 Scam’s webpage (link). You can find a short YouTube video highlighting 5 things about COVID-19 fraud and tips to protect yourself. For example, “offers to purchase COVID-19 vaccination cards are scams. Valid proof of COVID-19 vaccination can only be provided to individuals by legitimate providers administering vaccines.”

July 19, 2021: COVID-19 PHE Extended

In case you missed it in a recent Wednesday@One article, On July 19, 2021, Xavier Becerra, Secretary of Health and Human Services, renewed the PHE effective July 20, 2021 (link).

Other Updates

CY 2022 Medicare Physician Fee Schedule Proposed Rule

CMS issued this proposed rule on July 13, 2020 (link). Examples of what is being proposed includes:

• Proposals related to telehealth services added during the COVID-19 PHE and a proposal to require use of a new modifier for telehealth services furnished using audio-only communications,
• Proposal to make direct payments to Physician Assistants (PAs) for professional services furnished under Part B beginning January 1, 2022, and
• Proposal to begin the payment penalty phase of the Appropriate Use Criteria (AUC) Program on the later of January 1, 2023, or the January 1 that follows the declared end of the PHE for COVID-19.

You can read additional highlights from the proposed rule in a related CMS Fact Sheet (link).

The Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (link) was released on July 19, 2021.

CMS estimates “that total payments to OPPS providers (including beneficiary cost-sharing and estimated changes in enrollment, utilization, and case-mix) for calendar year (CY) 2022 would be approximately $82.704 billion, an increase of approximately $10.757 billion compared to estimated CY 2021 OPPS payments.”

CMS, in general, plans to use 2019 claims data for rate setting due to the COVID-19 PHE. Examples of specific decreases or increases in claims in CY 2020 cited by CMS includes:

• An approximate 20 percent decrease in the overall volume of outpatient hospital claims,
• An approximate 30 percent decrease in volume in the APCs for hospital emergency department and clinic visits,
• For HCPCS code Q3013 (Telehealth originating site facility fee) in the hospital outpatient claims, the approximate 35,000 services billed in CY 2019 increased to 1.8 million services in the CY 2020.

Inpatient Only Procedure List

Historically, CMS used the following five criteria to assess for removal of a procedure from the Inpatient Only (IPO) list.

• Most outpatient departments are equipped to provide the services to the Medicare population.
• The simplest procedure described by the code may be furnished in most outpatient departments.
• The procedure is related to codes that we have already removed from the IPO list.
• A determination is made that the procedure is being furnished in numerous hospitals on an outpatient basis.
• A determination is made that the procedure can be appropriately and safely furnished in an ASC and is on the list of approved ASC services or has been proposed by us for addition to the ASC list

In a complete one-eighty, CMS has proposed to halt the elimination of the IPO list and, “after clinical review of the services removed from the IPO list in CY 2021,” add the 298 services removed in CY 2021 back to the IPO list beginning in CY 2022. CMS has also proposed to codify the five longstanding criteria for potential removal from the IPO list.

CMS noted that “many commenters, including hospital associations and hospital systems, professional associations, and medical specialty societies, vociferously opposed eliminating the IPO list. These commenters primarily cited patient safety concerns, stating that the IPO list serves as an important programmatic safeguard and maintains a common standard of medical judgment in the Medicare program.”

CMS requests public comments on several questions related to the IPO list. For example, “what information or support would be helpful for providers and physicians in their considerations of site-of-service selections?

Proposed Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2022 and Subsequent Years

Once a surgical procedure has been removed from the IPO List, documentation in the record must support the need for the inpatient admission. CMS reminds providers that “removal of a service from the IPO list has never meant that a beneficiary cannot receive the service as a hospital inpatient – as always, the physician should use his or her complex medical judgment to determine the appropriate setting on a case-by-case basis.”

For CY 2020, CMS finalized a two-year exemption from site-of-service claim denials, Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO) referrals to RACs, and RAC reviews for “patient status” (that is, site-of-service) for procedures that are removed from the IPO list under the OPPS beginning on January 1, 2020.

For CY 2021, CMS finalized “that procedures removed from the IPO list after January 1, 2021, were indefinitely exempted from site-of-service claims denials under Medicare Part A, eligibility for BFCC-QIO referrals to RACs for noncompliance with the 2-Midngiht rule, and RAC reviews for “patient status” (that is, site-of-service).” This exemption was to remain in place until Medicare claims data indicated a procedure was being performed more than 50 percent of the time in the outpatient setting.

On Monday, July 19th, WPS posted the following notice about spinal neurostimulators prior authorization requests:

For CY 2022, CMS has proposed to “rescind the indefinite exemption and instead apply a 2-year exemption from two midnight medical review activities for services removed from the IPO list on or after January 1, 2021.”

As a provider, keep in mind this exemption is specific to site-of-service claim denials and does not include exemption from medical necessity reviews of services provided based on a National or Local Coverage Determinations (NCDs and LCDs) when applicable.

Proposed Changes to the Ambulatory Surgical Center (ASC) Covered Procedure List (CPL)

CMS is also doing an about face for the ASC CPL. Of the 267 procedures added to the list in CY 2021, CMS has proposed to remove 258 procedures as they do not believe they meet the proposed revisions to the CY 2022 ASC CPL criteria.

CMS notes, “Based on our internal review of preliminary claims submitted to Medicare, we do not believe that ASCs have been furnishing the majority of the 267 procedures finalized in 2021. Because of this, we believe it is unlikely that ASCs have made practice changes in reliance on the policy we adopted in CY 2021. Therefore, we do not anticipate that ASCs would be significantly affected by the removal of these 258 procedures from the ASC CPL.”

A complete list of the 258 procedures can be found in table 45 of the proposed rule.

Proposed Revisions to the CY 2022 ASC CPL Criteria

In CY 2021, CMS revised their policy for adding surgical procedures to the ASC CPL. For CY 2022, they have proposed to revise the requirements for covered surgical procedures to reinstate the specifications established prior to CY 2021. One key proposal would once again define covered surgical procedures as surgical procedures specified by the Secretary and published in the Federal Register and/or via the Internet on the CMS website that are separately paid under the OPPS, that would not be expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure.

Inpatient, outpatient or ASC, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed.

While this article highlights a couple of topics in the proposed rule, I encourage you to review the entire document for other key proposals such as the proposed increase in civil monetary penalties (CMP) for hospital noncompliance with the Price Transparency requirements. You can also read more about what is being proposed in a related CMS Fact Sheet (link).

Welcome to the second monthly edition of MMP’s P.A.R. Pro Tips. For those new to the Wednesday@One, MMP has collaborated with RealTime Medicare Data (RTMD), to develop a proprietary Protection Assessment Report (P.A.R.). This report is a combination of current Medicare Fee-for-Service review targets with hospital specific Medicare Fee-For-Service paid claims data. As a bonus to our Wednesday@One readers, we have begun to provide useful “Did You Know” information that we come across in our ongoing review of key websites (i.e., Medicare Administrative Contractors (MACs), OIG, Recovery Auditors, etc.)

Did You Know?

The Prior Authorization for Certain Hospital OPD Services was implemented effective July 1, 2020. On July 1, 2021, two additional services were added to the list of services requiring prior authorization (Spinal Neurostimlators and Cervical Fusion with Disc Removal). The full list of HCPCS codes requiring prior authorization is available on the CMS webpage dedicated to this process (link).

Pro Tip: MAC Education

MACs nationwide have been providing education to providers regarding this program and more specifically the two new services that have been added to the list of services requiring prior authorization. Following is a sampling of information available for hospital outpatient departments:

CGS (Jurisdiction 15)

CGS’ OPD Prior Authorization webpage (link) walks providers through the process of submitting a prior authorization request, outlines medical record documentation requirements to meet coverage criteria, provides a detailed exemption process timeline, and information about claims submission and appeals. There are also several “NOTES” included throughout this webpage, for example:

“Although other providers, such as a physician/staff may submit a PAR on the hospital OPD’s behalf, departmental collaboration is crucial.”

“A PAR is valid for one claim/date of service.” Unlike MMP’s Protection Assessment Report (P.A.R.), the PAR related to this CMS program is an acronym for Prior Authorization Request.

First Coast Service Options, Inc. (Jurisdiction N)

In late June, First Coast modified their article Vein ablation and related services (link). This article includes:

• Clinical definitions of veins, varicose veins, endovenous ablation, and chronic venous insufficiency,
• Applicable HCPCS codes,
• Documentation requirements,
• Best practice/documentation feedback/tips and help,
• Billing and coding alerts, and
• References, including links to applicable Local Coverage Determination (LCD) and related Local Coverage Article (LCA).

First Coast also released an updated Prior Authorization (PA) program Q&A document (link) on July 15th.

National Government Services (NGS Jurisdiction K)

On July 7, 2021, NGS posted an Outpatient Department Prior Authorization for Implanted Neurostimulators Alert (link). The alert begins by reminding providers that HCPCS 63650 is the only code that needs to be prior authorized for trial and permanent placement. The alert goes on to provide documentation requirements and links to related content.

Noridian (Jurisdiction E)

Noridian has created a Prior Authorization Lookup Tool to help providers determine which HCPSC codes require a prior authorization (link). They are also providing Prior Authorization for Certain Hospital Outpatient Department (OPD) Services webinars (link). One is scheduled for today July 21, 2021, and another one is scheduled for August 12, 2021.

Novitas Solutions Jurisdiction (Jurisdiction H)

On the Novitas webpage that is dedicated to this program (link), you will find the following:

• Program background information,
• Quick links to key documents,
• General information,
• Upcoming Education events,
• Links to all applicable LCDs and LCAs,
• Information about expedited requests, and
• Contact Information.

Palmetto GBA (Jurisdiction J)

Palmetto has made available a Cervical Disc Spinal Fusion and Spinal Cord Stimulator On-Demand Webcast (link). On July 15th, Palmetto also posted an article detailing the Prior Authorization Exemption Process (link).

WPS (Jurisdiction 5)

On Monday, July 19th, WPS posted the following notice about spinal neurostimulators prior authorization requests:

“Providers who perform and bill CPT code 63650 (percutaneous implantation of neurostimulator electrode array, epidural) must remember to request prior authorization (PA) for both the trial and permanent placement.

Providers should submit a PA for the trial placement only if the plan is to perform the procedure in a hospital outpatient department (HOPD). Providers should submit one prior authorization request (PAR) when both the trial and the permanent placement will be in the same HOPD. WPS will only assign one Unique Tracking Number (UTN) that the provider should use to bill for both claims.

If the trial and permanent placement are to occur at two separate HOPDs, then the provider will need two separate UTNs as each HOPD has their own Provider Transaction Access Number (PTAN) and National Provider Identifier (NPI).”

What Can You Do?

For those involved in the Prior Authorization process at your hospital, be sure and check out available resources on your MAC specific webpage. CMS’s Review Contractor Directory – Interactive Map (link) among other Medicare Contractors, provides links to your state specific MAC.

Medicare MLN Articles & Transmittals – Recurring Updates

Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Codes 0240U, 0231U and 87637

• Article Release Date: June 11, 2021
• What You Need to Know: The FDA has issued Emergency Use Authorizations (EUAs) for the COVID-19 tests represented by these three HCPCS codes. “For Medicare to recognize these tests performed under a CLIA certificate of waiver or a CLIA certificate for provider-performed microscopy procedures, you must add the modifier QW.”
• MLN MM12318: (link)

July 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: June 14, 2021
• What You Need to Know: This article provides a summary of changes to and billing instructions for payment policies to be implemented by CMS on July 1, 2021.
• MLN MM12316: (link)

July 2021 Update of the Ambulatory Surgical Center [ASC] Payment System

• Article Release Date: June 25, 2021
• What You Need to Know: For the July 2021 Update there are 8 new CPT Category III codes, a new device pass through code, new HCPCS codes for drugs and biologicals, a change to a skin substitute HCPCS code from the low to the high-cost skin substitute group and a new technology HCPCS code as been established to describe the technology associated with vaginal colpopexy by sacrospinous ligation fixation.
• MLN MM12341: (link)

Revised Medicare MLN Articles & Transmittals

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – July 2021 Update

• Article Release Date: February 23, 2021 – Most recent revision June 3, 2021
• What You Need to Know: In the third iteration of this MLN article, important information about the use of the QW modifier was added in red print on page 10 of this document.
• MLN MM12131: (link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – July 2021

• Article Release Date: May 18, 2021 – Revised June 3, 2021
• What You Need to Know: This article was revised to reflect NCD specific changes made in a revised Change Request (CR) 12124.
• MLN MM12124: (link)

July 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

• Article Release Date: April 27, 2021 – Revised June 8, 2021
• What You Need to Know: This article was revised to reflect a revised CR 12244 which added language about Section 405 of the Consolidated Appropriates Act, 2021.
• MLN MM12244: (link)

Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Amount

• Article Release Date: May 24, 2021 – Revised June 15, 2021
• What You Need to Know: This article was revised due to a revised Change Request (CR) 12885 which included the addition of new codes to the national HCPCS file.
• MLN MM12285: (link)

Medicare Coverage Updates

June 10, 2021: NGS Reminder Regarding General Anesthesia, Conscious Sedation and Facet Joint Interventions

NGS posted a reminder regarding the recent revision to Local Coverage Determination (LCD) (L35936) “Facet Joint Interventions for Pain Management” and Local Coverage Article (LCA) (A57826) “Billing and Coding: Facet Joint Interventions for Pain Management.” As of April 25, 2021, one Limitation of LCD L359356 (link) indicates that “general anesthesia is considered not reasonable and necessary for facet joint interventions.” Neither conscious sedation nor monitored anesthesia care (MAC) is routinely necessary for intraarticular facet joint injections or medial branch blocks are not routinely reimbursable. Individual consideration may be given on redetermination (appeal) for payment in rare, unique circumstances if the medical necessity of sedation is unequivocal and clearly documented in the medical record. Frequent reporting of these services together may trigger focused medical review.”

National Coverage Determination (NCD) 20.9.1 Ventricular Assist Devices (VADs)

• Article Release Date: June 11, 2021
• What You Need to Know: Effective December 1, 2020, CMS covers VADs under certain criteria. Change Request (CR) 12290 revises NCD 20.9 in the Medicare NCD Manual and Chapter 32, Section 320 of the Medicare Claims Processing Manual.
• MLN MM12290: (link)

July 2, 2021: Proposed Decision Memo for Home Use of Oxygen and Home Oxygen Use to Treat Cluster Headaches

CMS issued Proposed Decision Memo CAG-00296R2 (link). Two changes being proposed includes:

• Remove NCD 240.2.2 of the Medicare NCD Manual, ending coverage with evidence development, and allow the Medicare Administrative Contractors (MACs) to make coverage determinations regarding the use of home oxygen and oxygen equipment for cluster headaches (CH), and
• Modify NCD 240.2 Home Use of Oxygen to expand patient access to oxygen and oxygen equipment in the home, and to permit MACs to cover the use of home oxygen and equipment in order to treat CH and other acute conditions.

You can submit comments through August 1, 2021. The related National Coverage Analysis (NCA) Tracking Sheet for this Decision Memo CAG-00296R2 (link) will enable you to follow the progress of this proposal.

Medicare Educational Resources

Revised MLN Fact Sheet: Medicare Disproportionate Share Hospital

CMS issued a revised edition of the Medicare Disproportionate Share Hospital MLN Fact Sheet (link). Specifically, the Fact Sheet includes information about how CMS calculates uncompensated care payments for FY 2021 and FY 2022.

Revised MLN Fact Sheet: Medicare Billing for Cardiac Device Credits

This revised Fact Sheet (link) includes the following two changes highlighted in dark red font in the text:

• When a hospital gets a replaced device credit 50% or greater than the device’s cost, report the amount in the claim’s FD code value portion.
• Beginning in 2020, Medicare applies a device offset cap to the Ambulatory Payment Classification (APC) claims that require implantable devices and have significant device offset (greater than 30%) based on the FD value code’s listed credit amount.”

MLN Educational Tool: Medicare Preventive Services Revised

CMS updated this Education Tool (link) in May. Information available in this tool includes:

• Link to National Coverage Determination (NCD) services webpage when applicable to a service,
• HCPCS and CPT codes,
• Prolonger Prevention Services information,
• ICD-10-CM diagnosis codes,
• Billing for telehealth during COVID-19,
• Coverage Requirement,
• Frequency Requirements,
• Patient liability, and
• Telehealth eligibility.

COVID-19 Updates

June 3, 2021: Myths and Facts about COVID-19 Vaccines

The CDC developed this webpage (link) to help stop common myths and rumors such as:

• The COVID-19 vaccine can make you be magnetic,
• The COVID-19 vaccine will alter my DNA, or
• The COVID-19 vaccine will make me sick with COVID-19.

June 9, 2021: Medicare to Increase Payment for Medicare Vaccination Administration in the Home

In a Special Edition MLN Connects, CMS announced additional payment for administering in-home COVID-19 vaccinations to Medicare beneficiaries (link). A related infographic (link) was also updated to include this information.

June 17, 2021: CMS MLN Connects – Emergency Use Authorization (EUA) for Monoclonal Antibody Updates

CMS noted that on May 26, 2021, the FDA released an EUA for the COVID-19 monoclonal antibody product sotrovimab. Coinciding with the FDA release, CMS created new HCPCS codes also effective May 26th for sotrovimab. This drug can be administered in health care setting and the home. The following is an excerpt from the MLN Connects newsletter:

Q0247

• Long descriptor: Injection, sotrovimab, 500 mg
• Short descriptor: Sotrovimab
• Price: The government won’t provide this drug for free; visit the COVID-19 Vaccines and Monoclonal Antibodies webpage for pricing information (available soon)

M0247

• Long Descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring
• Short Descriptor: Sotrovimab infusion
• Price: $450.00 per infusion

M0248

• Long Descriptor: Intravenous infusion, sotrovimab, includes infusion and post administration monitoring in the home or residence; this includes a beneficiary’s home that has been made provider-based to the hospital during the COVID-19 public health emergency
• Short Descriptor: Sotrovimab inf, home admin
• Price: $750.00 per infusion

On June 3rd, the FDA released a revised EUA for Regnereon’s COVID-19 monoclonal antibody combination product casirivimab and imdevimab. Updates includes new dosing regimen and allows a new route of administration. “In response to this change, CMS created a new HCPCS code, effective June 3, and updated the short and long code descriptors. This information is detailed in the MLN Connects newsletter (link).

Other Medicare Updates

July 1, 2021: Interim Final Rule Banning Surprise Billing and Certain Out-of-Network Charges

HHS issued the interim final rule, “Requirements Related to Surprise Billing: Part 1,” that will restrict surprise billing for insured patients that receive emergency care, non-emergency care from out-of-network providers at their in-network facility, and air ambulance services from out-of-network providers. One way this helps patient, as noted in a Related CMS Fact Sheet (link), is that “if your health plan provides or covers any benefits for emergency services, this rule requires emergency services to be covered:

• Without any prior authorization (meaning you no not need to get approval beforehand).
• Regardless of whether a provider or facility is in-network.”

This rule will take effect on January 1, 2022. CMS is excepting written comments through 5 p.m. 60 days after the rule is displayed in the Federal Register. At the time of this article, the interim final rule had not been published in the Federal Register. You can learn more about the interim rule requirements in another CMS Fact Sheet (link).

MMP and RealTime Medicare Data (RTMD) have collaborated to highlight Health Awareness Month topics throughout the year with an infographic spotlight on Medicare Fee-for-Service (FFS) paid claims data comparatives and a related article. June is Cataract Awareness Month. The American Academy of Ophthalmology notes that “cataract is one of blindness in the United States. If not treated, cataracts can lead to blindness. In addition, the longer cataracts are left untreated, the more difficult it can be to successfully remove the cataract and restore vision. During Cataract Awareness Month in June, the American Academy of Ophthalmology reminds the public that early detection and treatment of cataracts is critical to preserving sight.”

Did You Know?

According to Medicare.gov (link) the average amount that a patient pays for extracapsular lens removal with insertion of intraocular lens prosthesis (CPT 66984) is $316 in the Ambulatory Surgery Center (ASC) setting and $524 in a Hospital Outpatient Department.

Several Medicare Administrative Contractors (MACs) have Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) related to cataract removal.

Why Does this Matter?

The CERT, Recovery Auditors and a two of the MACs are reviewing cataract procedure records. Reviews include the ASC and Hospital Outpatient Department Settings.

Comprehensive Error Rate Testing (CERT)

In the 2020 Medicare Fee-for-Service Supplemental Improper Payment Data (link), the CERT review contractor indicates they reviewed 209 Part B claims and identified a 6% improper payment rate that equates to a projected improper payment amount of $111,696,441.

Recovery Auditors

There are currently three approved RAC issues related to cataracts:

• Issue 0002: Cataract Removal: Medical Necessity & Documentation Requirements,
• Issue 0083: Cataract Removal: Excessive Units (partial), and
• Issue 0084: Cataract Removal: Partial Payment.

Provider Types they have been approved to review includes ASC, Outpatient Hospitals and specific to Issue 0083 and 0084 Professional Services.

CGS MAC for Jurisdiction 15 (J15)

Prior to CMS temporarily pausing the Targeted Probe and Educate (TPE) Program, reviewing Medicare Part A claims for cataract removal was part of CGS’, the MAC for Kentucky and Ohio, list of review topics. A Cataract Extraction with IOL ADR Checklist (link) is available on the CGS website.

Palmetto GBA JJ and JM

Palmetto GBA, the MAC for Jurisdictions J (Alabama, Georgia, and Tennessee) and M (North and South Carolina, Virginia and West Virginia) recently published service-specific post payment probe review results of CPT 66984, Extracapsular Cataract Removal with insertion for both Jurisdictions. Both articles include state specific findings, reasons for claims denials and recommendations to prevent future denials.

• April 14, 2021, Palmetto GBA JJ Part B results (link): 680 claims were reviewed, with 110 (16.17%) claims being completely or partially denied. The charge denial rate of 15.65% equated to $59,466.77 in denials.
• May 11, 2021, Palmetto GBA, JM Part B results (link): 2,508 claims were reviewed, with 128 (5.1%) claims being completely or partially denied. The charge denial rate of 5.13% equated to $76,598.10 in denials.

Based on their findings, Palmetto plans to continue post-payment reviews of CPT 66984 in both Jurisdictions.

What You Can Do About It?

• Identify whether there is an applicable LCD and LCA for your MAC jurisdiction.
• Read Palmetto GBA’s Cataract Removal article (link) which provides conditions or circumstances when lens extraction is considered medically necessary and therefore covered by Medicare.
• Share this information with Providers performing these procedures at your facility.
• Review a sample of your cataract claims for documentation supporting the medical necessity of the service.

Resource

• CMS MLN Matters SE1319: Cataract Removal, Part B: (link)

For most students, the school year has come to an end. However, for those of you that are involved in the Prior Authorization for Certain Hospital Outpatient Department (ODP) process at your hospital, there is some essential summer reading requirements that you need to complete in the next couple of weeks. p>

Background

This program was finalized in the Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) Final Rule and is specific to the Hospital Outpatient Department setting. Effective July 1, 2020, a Prior Authorization was required for the following five procedures:

• Blepharoplasty
• Botulinum toxin injections
• Panniculectomy
• Rhinoplasty
• Vein ablation

CMS believes this program will be an effective tool in controlling unnecessary increases in volume by ensuring payments are only being made for medically necessary services. You will find additional resource information and updates on the CMS webpage created for this program (link) .

2021 Program Updates

Two New Procedures to Require Prior Authorization

CMS has added Implanted Spinal Neurostimulators and Cervical Fusion with Disc Removal to this process, effective July 1, 2021. These two services are not replacing, but are being added to the list of procedures currently requiring prior authorization.

Note: MACs will begin accepting Prior Authorization Requests (PARs) for these two new services on June 17, 2021, for services rendered on or after July 1, 2021.

February 26, 2021: Exemption(s)

CMS noted that “MACs are in the process of identifying those hospital OPDs that will be exempt from the prior authorization process. Starting February 1, 2021 MACs began calculating the affirmation rate of initial prior authorization requests submitted. Hospital OPD providers who met the affirmation rate threshold of 90% or greater will receive a written Notice of Exemption no later than March 1, 2021. Those hospital OPDs will be exempt from submitting prior authorization requests for dates of service beginning May 1, 2021.”

CMS’ Prior Authorization Program Operational Guide was updated on May 13, 2020. Updates are highlighted in red. There are a couple of specific updates to hospitals exempted from having to submit a Prior Authorization Request (PAR):

• The exemption will include PARs for the two new services being added to the program effective July 1, 2021.
• A word of caution, if you have been exempted from this process, you must continue to ensure documentation supports medical necessity of the procedure being performed. CMS has advised that they will be sending post-payment Additional Documentation Requests (ADRs) for a 10-claim sample from the time period you were exempted to determine compliance. Note, the sample may include claims for the two new services (cervical fusion with disc removal and implanted spinal neurostimulators).

May 13, 2021: Change to Implanted Spinal Neurostimulators

“CMS is temporarily removing CPT codes 63685 and 63688 from the list of OPD services that require prior authorization. The only service that will require prior authorization for implanted spinal neurostimulators is CPT code 63650. Providers who plan to perform both the trial and permanent implantation procedures using CPT code 63650 in the OPD will only require prior authorization for the trial procedure. When the trial is rendered in a setting other than the OPD, providers will need to request prior authorization for CPT code 63650 as part of the permanent implantation procedure in the hospital OPD.”

CMS has added the following paragraph to the program Operational Guide related to when a PAR is required:

“Providers who plan to perform both the trial and permanent implantation procedures using CPT 63650 in the hospital OPD will only be required to submit a PAR for the trial procedure. To avoid a claim denial, providers must place the Unique Tracking Number (UTN) received for the trial procedure on the claim submitted for the permanent implantation procedure. When the trial is rendered in a setting other than hospital OPD, providers will need to request PA for CPT 63650 as part of the permanent implantation procedure in the hospital OPD.”

May 14, 2021: MAC Educating Providers

CMS released Change Request (CR) 12214 (link) to instruct Medicare Administrative Contractors (MACs) to provide education regarding the prior authorization (PA) process for cervical fusion with disc removal and implanted spinal neurostimulators in the hospital OPD setting. One part of this education will be MACs sending introductory letters detailing the July 1, 2021 updates and general “What You Need to Know” information to physicians and providers. Templates of these letters are included in this CR.

Cervical Fusion with Disc Removal and Implanted Spinal Neurostimulators by the Numbers

In an effort to quantify the volume and payment related to the two new procedures, I worked with RealTime Medicare Data (RTMD). For those who may be new readers of our newsletter, RTMD’s current data base consists of Medicare Fee-for-Service paid claims data for hospital inpatient discharges, outpatient hospital services, and CMS 1500 professional services for 48 states and territories. The following data is specific to U.S. states for calendar years (CY) 2019 and 2020. Since COVID-19 had an impact on planned surgical procedures, I believe it is important to view both years of data

Cervical Fusion with Disc Removal

CY2019

• Procedure Volume: 20,203
• Paid Claims Amount: $163,592,946.40

CY2020

• Procedure Volume: 17,569
• Paid Claims Amount: $164,226,275.35

Implanted Spinal Neurostimulators

CY2019

• Procedure Volume: 27,056
• Paid Claims Amount: $43,991,713.02

CY2020

• Procedure Volume: 19,853
• Paid Claims Amount: $34,603,818.02

Moving Forward

This is where the urgent summer reading comes in. For those actively involved in this process, I encourage you:

• To read CMS’ OPD Operational Guide and Frequently Asked Questions, both of which were last updated on May 13, 2021,
• Review your MACs website for education offering related to updates to this program. You will find contact information for all of the MACs in the OPD Operational Guide.
• Make sure your Physicians performing these procedures are aware of the documentation requirements supporting medical necessity of the procedure. In addition to MAC contact information, the OPD Operational Guide includes “Required Documentation” for each of the procedure.
• Finally, if you are currently exempt from the PAR process, be on the lookout for ADR requests from your MAC in the not too distant future.

Medicare MLN Articles & Transmittals – Recurring Updates

July 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

• Article Release Date: April 27, 2021
• What You Need to Know: This article includes quarterly updates effective July 1, 2021 for ASP and Not Otherwise Classified (NOC) drug pricing files for Medicare Part B drugs.
• MLN MM12244: (link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – July 2021

• Article Release Date: May 18, 2021
• What You Need to Know: You will find information about updated ICD-10 conversions and coding updates specific to NCDs as a result of newly available code, coding revisions to NCDs released separately and coding feedback received.
• MLN MM12124: (link)

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – July 2021 Update

• Article Release Date: May 21, 2021
• What You Need to Know: July 2021 updates to the 2021 MPFS are detailed in this MLN article.
• MLN MM12289: (link)

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update

• Article Release Date: May 21, 2021
• What You Need to Know: MACs perform updates to the RARC and CARC based on the code update schedule and occur around March 1, July 1, and November 1.
• MLN MM12220: (link)

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update

• Change Request Release Date: May 21, 2021
• What You Need to Know: This recurring transmittal is a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. Two NCDs specific to this update are NCD 30.3.3 Acupuncture for Chronic Low-Back Pain (cLBP), and NCD 20.33 Transcatheter Mitral Valve Repair/Transcatheter Edge-to-Edge Repair (TMVR/TEER).
• Change Request (CR) 12279: (link)

Other Medicare MLN Articles & Transmittals

New Waived Tests

• Article Release Date: April 27, 2021
• What You Need to Know: This article highlights newly FDA approved Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests.
• MLN MM12204: (link)

Waiver of Coinsurance and Deductible for Hepatitis B Preventive Service Vaccine Code, Section 4104 of the Patient Protection and Affordable Health Care Act (the Affordable Care Act), Removal of Barriers to Preventive Services in Medicare

• Article Release Date: May 11, 2021
• What You Need to Know: The Hepatitis B vaccine (HCPCS 90739) has been added to the preventive services recommended by the U.S. Preventive Services Task Force. Consequently, coinsurance and deductibles won’t apply for this code. Medicare will make a reasonable cost reimbursement for Types of Bill (TOB) 012X, 013X, 022X, and 034X.
• MLN MM12230: (link)

Addition of the Shared System CWF to the Business Requirements for the Healthcare Common Procedure Coding System (HCPCS) Codes U0002QW and 87635QW Mentioned in Change Request 11765

• Article Release Date: May 20, 2021
• What You Need to Know: For labs billing MACs for COVID-19 testing services, this article informs you about a revision to CR 11765 that requires changes to Medicare Common Working File (CWF) for:
• o HCPCS U0002QW [2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC], and
• o 87635 [Infectious agent detection by nucleic acid (DNC or RNA0; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique].
• MLN MM12294: (link)

Other Medicare Updates

New CMS Hospital Star Ratings

On April 28th, CMS updated the Hospital Compare Overall Hospital Quality Ratings (link). Hospital specific scores are based on performance for 5 measure groups (Mortality, Safety of Care, Readmission, Patient Experience and Timely & Effective Care). April 2021 results:

• 455 hospitals received the highest rating of 5 stars,
• 1,018 hospitals received 3 stars, and
• 204 hospitals received a 1 star rating.

Clinical Diagnostic Laboratory Resources about the Private Payor Rate-Based CLFS

CMS posted the following information in the Thursday April 29, 2021 edition of MLN Connects (link): “If you’re a laboratory, including an independent laboratory, a physician office laboratory, or hospital outreach laboratory that meets the definition of an applicable laboratory under the Clinical Laboratory Fee Schedule (CLFS), you must report information, including laboratory test HCPCS codes, associated private payor rates, and volume data.” You can find links to updated resources and the data collection and reporting timeline in the MLN Connects post.

April 29, 2021: CJR Three-Year Extension Final Rule

CMS released the Comprehensive Care for Joint Replacement Model Final Rule which extends the model through December 31, 2021 by adding an additional 3 performance years (PYs). This final rule also revises the episode of care definition, the target price calculation, the reconciliation process, the beneficiary notice requirements and the appeals process. The episode of care definition was revised to include outpatient Total Knee and Total Hip Arthroplasty (TKA/THA) procedures. You can read more about this Model on the CJR CMS webpage (link).

May 7, 2021: Advance Copy of Hospital Interpretive Guidelines for Admission, Discharge and Transfer Notification Requirements

CMS issued a memorandum (link) to State Survey Agency Directors providing an advance copy of the hospital interpretive guidelines for the admission, discharge, and transfer notification requirements outlined in the Interoperability and Patient Access final rule. This guidance is for Hospitals, Psychiatric Hospitals and Critical Access Hospitals and it will also be published in an updated Appendix A of the State Operations Manual.

May 2021: United Healthcare Sepsis Claims Review Change Effective July 1, 2021

While this article focuses on Medicare updates, I believe it is important for Clinical Documentation Integrity Specialists and Utilization Review staff to be aware of this notice. United Healthcare (UHC) has announced (link) that “effective July 1, 2021, Medicare Advantage and commercial claims for sepsis-related treatment may be reviewed on a pre-payment or post payment basis.” UHC will use their Sepsis Clinical Guidelines which includes using Sepsis-3.

May 10, 2021: University of Miami to Pay $22 Million to Settle Claims Involving Medically Unnecessary Laboratory Tests and Fraudulent Billing Practices

This Department of Justice release (link) indicates that the University of Miami (UM):

• Knowingly engaged in improper billing relating to its Hospital Facilities,
• Billed federal health care programs for medically unnecessary laboratory tests for patients who received kidney transplants at the Miami Transplant Institute (MTI) – a transplant program operate by UM and Jackson Memorial Hospital (JMH) and
• Caused JMH to submit inflated claims for reimbursement for pre-transplant laboratory testing conducted at the MTI.

This settlement resolves allegations made in three lawsuits filed under the qui tam (whistleblower) provisions of the False Claims Act.

May 18, 2021: CMS Delays Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule

MMP first wrote about this Proposed Rule in October 2020 (link). CMS published a notice further delaying this final rule until December 15, 2021 (link). They note this additional time provides “an opportunity to address all of the issues raised by stakeholders, especially Medicare patient protections, evidence criteria and lack of coordination between coverage, coding and payment.”