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May 2021 Medicare Transmittals and Other Updates
Published on Jun 02, 2021
20210602

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.”

Beth Cobb

Prior Authorization for Certain Hospital Outpatient Department (OPD) Services Updates for July 1, 2021
Published on Jun 02, 2021
20210602

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.

April 2021 Medicare Transmittals and Other Updates
Published on Apr 28, 2021
20210428

Medicare MLN Articles & Transmittals – Recurring Updates

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.2, Effective July 1, 2021

  • Article Release Date: March 31, 2021
  • What You Need to Know: NCCI edits were developed to promote national correct coding methodologies and to control improper coding that leads to inappropriate payment in Part B claims. This article alerts providers about the quarterly updates to the NCCI PTP edits in Change Request (CR) 12226 effective July 1, 2021. CMS includes the following bolded statement in the CR, “the edits previously contained in the Mutually Exclusive edit file are NOT being deleted but are being moved to the Column One/Column Two Correct Coding edit file.”
  • MLN MM12226: link

April 2021 Update of the Ambulatory Surgical Center (ASC) Payment System

  • Article Release Date: April 1, 2021
  • What You Need to Know: Billing instructions for various payment policies CMS made in the April 2021 ACS payment system update are referenced in this article.
  • MLN MM12183: link

Other Medicare MLN Articles&Transmittals

Updated to the Payment for Grandfathered Tribal Federally Qualified Health Centers (FQHCs) for Calendar Year (CY) 2021

  • Article Release Date: March 31, 2021
  • What You Need to Know: This article is for FQHCs billing MACs for services provided to Medicare patients.
  • MLN MM12202: link

Revised Medicare MLN Articles&Transmittals

Penalty for Delayed Request for Anticipated (RAP) Submission – Implementation

  • Article Release Date: July 31, 2020 – Most recent revision April 1, 2021
  • What You Need to Know: This is the third revision to the original July 31, 2020 MLN article. Information in the article is for Home Health Agencies (HHA) who bill MACs for services provided. The April 1, 2021 revision reflects the revised CR 11855. The revised CR changes the principal diagnosis code reporting instructions in Chapter 10, Section 40.1 and the service date reporting instructions in Chapter 10, Section 40.2 of the Medicare Claims Processing Manual. The changes make sure claims successfully match their corresponding RAP. Changes in the text of the document are in red print.
  • MLN MM11855: link

Common Working File (CWF) Edits for Medicare Telehealth Services and Manual Update

  • Article Release Date: March 18, 2021 – Revised April 6, 2021
  • What You Need to Know: This article reflects a revised Change Request CR 12068. The substance of the article did not change.
  • MLN MM12068: link

Medicare Coverage Updates

April 13, 2021: Final Decision Memo for AlloMap® Molecular Expression Testing for Detection of Reject of Cardiac Allografts

CMS indicates in the background section of this Decision Memo (link), that the “AlloMap is intended to give physicians information on the risk of acute cellular rejection in their patients following heart transplant.” CMS received a request in January of 2013 to non-cover this assay as the requester felt this particular assay “does not perform adequately,” has “poor sensitivity,” and “no intrinsic predictive capability.” A national coverage analysis was issued October 16, 2020. CMS received three comments. CMS did not issue a National Coverage Determination for this testing and notes in the Final Decision Memo that, “in the absence of an NCD, coverage determinations for AlloMap® Molecular Expression Testing for Detection of Rejection of Cardiac Allografts…will continue to be made by the local Medicare Administrative Contractors (MACs).”

April 13, 2021: Final Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds

CMS indicates in this Decision Memo (link) that they “will cover autologous platelet-rich plasma (PRP) for the treatment of chronic non-healing diabetic wounds under section 1862(a)(1)(A) of the Social Security Act (the Act) for a duration of 20 weeks, when prepared by devices whose FDA cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers. Coverage of autologous PRP for the treatment of chronic non-healing diabetic wounds beyond 20 weeks will be determined by local Medicare Administrative Contractors (MACs). Coverage of autologous PRP for the treatment of all other chronic non-healing wounds will be determined by local Medicare Administrative Contractors (MACs) under section 1862(a)(1)(A) of the Act.”

April 13, 2021: National Coverage Analysis (NCA) Tracking Sheet for Transvenous (Catheter) Pulmonary Embolectomy

Currently, this procedure is non-covered. CMS internally generated this NCA reconsideration (link) based on stakeholder feedback and have had several requests for this NCD to be removed. The public comment period is from April 13, 2021 through May 13, 2021. The proposed decision memo due date is October 13, 2021.

Medicare Educational Resources

New MLN Booklet: How to Use the Medicaid National Correct Coding Initiative (NCCI) Tools

CMS has issued a new Medicare Learning Network booklet titled How to Use the Medicaid National Correct Coding Initiative (NCCI) Tools (link). This publication is aimed at helping providers learn to navigate the CMS Medicaid NCCI webpages, work with Medicaid Procedure-to-Procedure edits, and manually unlikely edits. CMS notes that the Medicare NCCI Program has significant differences from the Medicaid NCCI initiative and provides related links to the Medicaid NCCI Initiative and Medicare NCCI Program.

Revised MLN Booklet: Behavioral Health Integration Services

CMS has issued a revised version of the Behavioral Health Integration Services MLN Booklet (link) to add CY 2021 MPFS Final Rule CMS-1734-F Updates and add new HCPCS code G2214 (Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional).

CMS’ Diagnosis Coding: Using ICD-10-CM and ICD-10-PCS Web-Based Training Courses Revised

CMS has updated their ICD-10-CM and PCS web-based training courses. These courses can help you learn how to identify structure and format, recognize features and find codes. You can access both revised courses on the CMS MLN Web-Based Training webpage at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/WebBasedTraining.

Revised MLN Booklet: Medicare Billing: Form CMS-1450 and the 837 Institutional

In mid-April, CMS published a revised version of this MLN Booklet (link. In the revised version, CMS updated MSP information in the Medicare Claims Submission section of the booklet and added a new Where to Submit FFS Claims section.

Medicare Wellness Visits Educational Tool Revised

CMS noted in the April 22, 2021 edition of MLN Connects (link) that their Medicare Wellness Visit Education Tool has been revised. Providers can use this tool to learn about the annual wellness visit (AWV) and Initial preventive physical exam (IPPE).

Other Medicare Updates

April 8, 2021: CMS Issues FY 2022 Proposed Rules

In a Special Edition MLN Connects (link), CMS issued Proposed Rules for:

  • SNF Prospective Payment System: FY 2022 Proposed Rule
  • Hospice Payment Rate Update for FY 2022,
  • IRF Prospective Payment System: FY 2022 Proposed Rule, and
  • IPF: Proposed Medicare Payment&Quality Reporting Updates.

Links to each proposed rule and a related Fact Sheet are available in this announcement. CMS is accepting comments on all four proposed rules until June 7, 2021.

Beth Cobb

March 2021 Medicare Transmittals and Other Updates
Published on Mar 31, 2021
20210331

MEDICARE MLN ARTICLES & TRANSMITTALS – RECURRING UPDATES

April 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.1

  • Article Release Date: March 8, 2021
  • What You Need to Know: Included in this MLN article are changes to the April 2021 version of the I/OCE instructions and specifications for the I/OCE that Medicare uses under the OPPS and non-OPPS for hospital outpatient departments, community mental health centers, all non-OPPS providers, limited services when provided in a home health agency not under the HH PPS, and for a hospice patient for treating a non-terminal illness.
  • MLN MM12187: https://www.cms.gov/files/document/mm12187.pdf

Clinical Laboratory Fee Schedule – Medicare Travel Allowance Fees for Collection of Specimens

  • Article Release Date: March 9, 2021
  • What You Need to Know: Changes to CY 2021 travel allowances bill per mileage basis (HCPCS P9603) and on a flat rate basis (HCPCS P9604) are included in this article. Note, “Medicare Part B allows payment for a specimen collection fee and travel allowance, when medically necessary, for a laboratory technician to draw a specimen from either a nursing home patient or homebound patient under Section 1833(h)(3) of the Act. Payment for these services is made based on the Clinical Laboratory Fee Schedule (CLFS).”
  • MLN MM12140: https://www.cms.gov/files/document/mm12140.pdf

April 2021 Update to the Fiscal Year (FY) 2021 Inpatient Prospective Payment System

  • Article Release Date: March 9, 2021
  • What You Need to Know: This MLN Article provides notice of changes that CMS is making for the April 2021 update of the FY 2021 Inpatient Prospective Payment System (IPPS). CMS notes that MACs will be reprocessing certain claims as explained in this article.
  • MLN MM12062: https://www.cms.gov/files/document/mm12062.pdf

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

  • Article Release Date: March 8, 2021
  • What You Need to Know: Related CR 12175 describes changes to and billing instructions for various payment policies implemented in the April 2021 Outpatient Prospective Payment System (OPPS) update. The April 2021 Integrated Outpatient Code Editor (I/OCE) will reflect the HCPCS, Ambulatory Payment Classification (APC), HCPCS Modifier, and Revenue Code additions, changes, and deletions identified in CR 12175.
  • MLN MM 12175: https://www.cms.gov/files/document/mm12175.pdf

Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

  • Article Release Date: March 10, 2021
  • What You Need to Know: Quarterly updates to the Clinical Laboratory Fee Schedule (CLFS) are detailed in this MLN article, including a table of new codes effective April 1, 2021.
  • MLN Article MM12178: https://www.cms.gov/files/document/mm12178.pdf

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

  • Article Release Date: March 10, 2021
  • What You Need to Know: This MLN article provides highlights from Change Request (CR) 12155 which includes April 2021 updates to the 2021 MPFS. CMS notes in the article that “MACs won’t search their files to either retract payment for claims already paid or to retroactively pay claims. However, MACs will adjust claims that you bring to their attention.”
  • MLN MM12155: https://www.cms.gov/files/document/mm12155.pdf

One-Time Transmittal 10599 (Change Request 12089): HIPAA Electronic Data Interchange (EDI) Front End Updates for July 2021

  • Transmittal Release Date: March 11, 2021
  • What You Need to Know: The purpose of this Change Request (CR) is to provide the July 2021 Combined Common Edits/Enhancements Module (CCEM) edits for the Part A and Part B Medicare Administrative Contractors (A/B MACs) and the Common Electronic Data Interchange (CEDI) contractor. Additionally, this CR directs Shared Systems to appropriately update the CCEM.
  • Change Request 12089: https://www.cms.gov/files/document/r10599otn.pdf

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

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

  • Article Release Date: March 12, 2021
  • What You Need to Know: This article details updates to the RARC and CARC lists and instructs Medicare’s Shared System Maintainers (SSMs) to update MREP and PC Print.
  • MLN MM12102: https://www.cms.gov/files/document/mm12102.pdf

Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2021

  • Article Release Date: March 17, 2021
  • What You Need to Know: Included in this article are the Calendar Year 2021 rate updates and policies for the ESRD PPS. Of note, the January 2021 ESRD PRICER did not apply the network reduction to Intermittent Peritoneal Dialysis (IPD) revenue code 0831 and ultrafiltration revenue code 0881 in error. The revised PRICER is correcting this error.
  • MLN MM12188: https://www.cms.gov/files/document/mm12188.pdf

April 2021 Quarterly Update to HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement

  • Article Release Date: March 25, 2021
  • What You Need to Know: Updates to lists of HCPCS codes subject to the consolidated billing provision of the SNF Prospective Payment System (PPS) are provided in this MLN article.
  • MLN MM12212: https://www.cms.gov/files/document/mm12212.pdf

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

  • Article Release Date: March 23, 2021
  • What You Need to Know: This article and related Change Request (CR) 12171 announced changes in the July 2021 quarterly release of the edit module for clinical diagnostic laboratory services.
  • MLN MM12171: https://www.cms.gov/files/document/mm12171.pdf

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

Updated Billing Requirements for Home Infusion Therapy (HIT) Services on or after January 1, 2021

  • Article Release Date: March 15, 2021
  • What You Need to Know: Following is an excerpt from this article regarding new changes to Medicare claims processing for HIT services on or after January 1, 2021:
  • “As described in the 21st Century Cures Act, Medicare will make a separate payment for HIT services under the permanent HIT benefit to qualified home infusion suppliers, effective January 1, 2021. Home infusion drugs are assigned to three payment categories, as determined by the HCPCS J-code:
  • Payment Category 1: Includes certain intravenous antifungals and antivirals, uninterrupted long-term infusions, pain management, inotropic, and chelation drugs
  • Payment Category 2: Includes subcutaneous immunotherapy and other certain subcutaneous infusion drugs
  • Payment Category 3: Includes certain chemotherapy drugs. MLN Matters article MM11880 lists the home infusion therapy service G-codes and corresponding home infusion therapy drug J-codes.
  • MLN MM12108: https://www.cms.gov/files/document/mm12108.pdf

Common Working File (CWF) Edits for Medicare Telehealth Services and Manual Update

  • Article Release Date: March 18, 2021
  • What You Need to Know: This article is for physicians, non-physician practitioners, nursing facilities, and other providers submitting telehealth claims to MACs for nursing facility services.
  • MLN MM12068: https://www.cms.gov/files/document/mm12068.pdf

Update to Rural Health Clinic (RHC) Payment Limits

Update to the Manual for Telephone Services, Physician Assistant (PA) Supervision, and Medical Record Documentation for Part B Services

  • Article Release Date: March 24, 2021
  • What You Need to Know: This article serves as notice regarding updates made to Chapter 15 of the Medicare Benefit Policy Manual for Physician Supervision for Physician Assistant (PA) Services and Medical Record Documentation for Part B services.
  • MLN MM11862: https://www.cms.gov/files/document/mm11862.pdf

New Provider Enrollment Administrative Action Authorities

  • Article Release Date: March 24, 2021
  • What You Need to Know: This Special Edition MLN article provides information about the CMS Final Rule titled Program Integrity Enhancement to the Provider Enrollment Process. This Final Rule was issued on September 10, 2019. Included in this MLN article is the following note, “In light of the pandemic and various other factors, we will not begin updating the Form CMS-855 applications with affiliation disclosure for at least another 12 months.”
  • MLN SE21003: https://www.cms.gov/files/document/se21003.pdf

REVISED MEDICARE MLN ARTICLES & TRANSMITTALS

Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) PPS Changes

  • Article Release Date: September 22, 2020 – Revised March 9, 2021
  • What You Need to Know: In CR 11879, CMS changes the 25th percentile wage index value from 0.8465 to 0.8649. This MLN article reflects this change.
  • MLN MM11879: https://www.cms.gov/files/document/mm11879.pdf

Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits

  • Article Release Date: February 23, 2021 – Revised March 9, 2021
  • What You Need to Know: This MLN article was revised to reflect the revised CR 12131, which changed the date CMS added HCPCS code 87428 to the correct date of November 10, 2020.
  • MLN MM12131: https://www.cms.gov/files/document/mm12131.pdf

MEDICARE COVERAGE UPDATES

OIG Reports and Guidance regarding Polysomnography Services

MACs paid providers approximately $885 million for selected polysomnography services provided to Medicare beneficiaries from January 1, 2017 through December 31, 2018. The OIG identified in prior audits payments being made with inappropriate diagnosis codes, without documentation supportive of the services provided and to providers exhibiting questionable billing patterns. These findings in combination with increased spending as noted above prompted the OIG to conduct additional audits. This month, the OIG has released reports for two polysomnography audits.

  • OIG Report: Peninsula Regional Medical Center: Audit of Medicare Payments for Polysomnography
  • 10 of 100 randomly selected beneficiary claims included 12 lines of service that did not comply with Medicare requirements. Based on the net overpayments of $17,499, the OIG estimated that Peninsula received at least $66,647 in overpayments for polysomnography services during the audit period.
  • OIG Report: North Mississippi Medical Center: Audit of Medicare Payments for Polysomnography
  • 12 of 100 randomly selected beneficiary claims included 13 lines of services that did not comply with Medicare requirements. Based on the next overpayments of $7,624, the OIG estimated that North Mississippi received at least $67,038 in overpayments for polysomnography services during the audit period.

CMS included the following additional resources for Providers related to correct billing for Polysomnography services in the March 18, 2021 edition of their weekly eNewsletter, MLN Connects:

Claims Processing Instructions for National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs)

MEDICARE EDUCATIONAL RESOURCES

MLN Booklet: Behavioral Health Integration Services

MLN Booklet: Evaluation and Management Service Guide

January 2021 Medicare Quarterly Compliance Newsletter

CMS Posted a link to this newsletter in the March 18, 2021 MLN Connects eNewsletter. In this quarter’s newsletter you can learn about:

  • Prefabricated and custom-fabricated knee orthoses: medical necessity and documentation requirements, and
  • Ankle-foot orthoses and knee-ankle foot orthoses within the reasonable useful lifetime: excessive units.

March 15, 2021” Medicare Learning Network® (MLN) Provider Compliance Products

CMS published a list of Provider Compliance Education Products. These products provide education on how to avoid common coverage and coding/billing errors (i.e. Complying with Medical Record Documentation Requirements (MLN909160), Complying with Medicare Signature Requirements (MLN905364), and Provider Compliance Tips for Polysomnography (Sleep Studies) (MLN4013531)).

OTHER MEDICARE UPDATES

Happy National Nutrition Month®

CMS included the following information in the March 4th edition of MLN Connects:

“Did you know that Medicare covers the following preventive services for nutrition-related health conditions like diabetes, chronic kidney disease, and obesity?

  • Medical nutrition therapy
  • Diabetes screening
  • Diabetes self-management training
  • Intensive behavioral therapy for obesity
  • Intensive behavioral therapy for cardiovascular disease
  • Annual wellness visit

During National Nutrition Month®, encourage your patients to develop healthy eating patterns and make food choices to meet their individual nutrient needs, goals, backgrounds, and tastes. More Information:

Information for your patients on nutritional therapy services, diabetes screenings, diabetes self-management training, obesity behavioral therapy, cardiovascular behavioral therapy, and yearly “wellness” visits

MLN Fact Sheet: Health Professional Shortage Area Physician Bonus Program

This fact sheet explains how the Medicare Health Professional Shortage Area (HPSA) Physician Bonus Program works. It has information about how to get bonus payments when you deliver Medicare-covered services to patients in a geographic HPSA. Key Takeaways noted in this Fact Sheet includes:

  • HPSAs are geographic areas of populations that lack enough health care providers to meet the health care needs of that population.
  • CMS pays a 10 percent bonus payment when health care providers deliver Medicare-covered services to patients in a geographic HPSA.
  • CMS pays HPSA bonuses quarterly based on the amount paid for professional services.

Link to MLN Fact Sheet (ICN MLN903196) February 2021: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/HPSAfctsht.pdf

March 17, 2021: American Hospital Association (AHA) Response to the American Rescue Plan Act of 2021 (ARP)

President Biden signed this $1.9 trillion coronavirus relief plan into law on March 11, 2021. In a related American Hospital Association Legislative Advisory, AHA notes their concern “that the law does not include an extension of relief from Medicare sequester cuts, which will go back into effect at the beginning of next month, and also fails to provide loan forgiveness for Medicare accelerated payments for hospitals.”

You can read more about the ARP Act of 2021 in related HHS and CMS Fact Sheets:

March 12, 2021: CMS Published Lists of Participants for Emergency Triage, Treat and Transport (ET3) Model

Link to Model CMS webpage:
link to Press Release: https://www.cms.gov/newsroom/press-releases/cms-announces-final-participants-emergency-triage-treat-and-transport-et3-model-furthers-commitment

March 18, 2021: MLN Connects Clinical Laboratory Data Reporting Delayed Until 2022 Reminder

CMS included the following information regarding the Protecting Access to Medicare Act of 2014 (PAMA) data collection and reporting periods:

For Clinical Diagnostic Laboratory Tests that are not Advanced Diagnostic Laboratory Tests, the requirement for you to report private payor data between January 1 and March 31, 2020, was delayed 2 years.  You must report data from the original collection period. Reporting will resume on a 3-year cycle beginning in 2025. (Section 3718 of the Coronavirus Aid, Relief, and Economic Security Act). Current timeline:

  • Collect Data for January 1 through June 30, 2019
  • Report data between January 1 and March 31, 2022

For more information, see the PAMA Regulations webpage.

March 17, 2021: Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule Delayed

CMS published an interim final rule in the Federal Register in keeping with the January 20, 2021 “Regulatory Freeze Pending Review” Memorandum. The Final Rule is being delayed until May 15, 2021. CMS is seeking public comments through April 16, 2021. In addition to operational practicalities cited by CMS as making them incapable of implementing the MCIT program on March 15, 2021, CMS notes the following additional reasons:

  • “The higher than anticipated volume of devices receiving FDA breakthrough device designation exponentially complicates the operational concerns that we have identified. Further, public comments highlighted the importance of the agency having the ability to not only cover an FDA-designated breakthrough device expeditiously, but also to be able to have coding and payment levels established at the same time.”

Beth Cobb

February 2021 Medicare Transmittals and Other Updates
Published on Mar 02, 2021
20210302

MEDICARE MLN ARTICLES & TRANSMITTALS – RECURRING UPDATES

 

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

  • Article Release Date: February 23, 2021
  • What You Need to Know: This article informs providers about the Average Sales Price (ASP) methodology, which is based on quarterly data manufacturers submit to CMS.
  • MLN Article MM12133: https://www.cms.gov/files/document/mm12133.pdf

Quarterly Updated for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) – April 2021

  • Article Release Date: February 23, 2021
  • What You Need to Know: The DMEPOS CBP files are updated on a quarterly basis to implement necessary changes to HCPCS codes, ZIP codes, single payment amounts, and supplier files.
  • MLN Article MM12128: https://www.cms.gov/files/document/mm12128.pdf

 

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

 

Review of Hospital Compliance with Medicare’s Transfer Policy with Resumption of Home Health Services & Other Information on Patient Discharge Status Codes

  • Article Release Date: February 22, 2021
  • What You Need to Know: CMS reminds providers that an accurate discharge status code is essential to assure proper payment under the Medicare Severity-Diagnosis Related Group (MS-DRG) payment system. Detailed information regarding the CMS Transfer Policy is included in this article.
  • MLN Article SE21001: https://www.cms.gov/files/document/se21001.pdf

Billing for Services when Medicare is a Secondary Payer

  • Article Release Date: February 23, 2021
  • What You Need to Know: CMS details what to do if you think a claim was inappropriately paid and provides key reminders related to billing for services when Medicare is a secondary payer.
  • MLN Article SE21002: https://www.cms.gov/files/document/se21002.pdf

Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits

  • Article Release Date: February 23, 2021
  • What You Need to Know: New HCPCS codes for 2021 that are subject to and excluded from CLIA edits are discussed in this article.
  • MLN Article MM12131: https://www.cms.gov/files/document/mm12131.pdf

 

MEDICARE EDUCATIONAL RESOURCES

 

MLN Fact Sheet: Intravenous Immune Globulin (IVIG) Demonstration (Demonstration Ends on December 31, 2023)

The IVIG demonstration began in October 2014, has been extended twice, and is now set to end on December 31, 2023. This MLN Fact Sheet, dated February 2021, provides education on the IVIG demonstration and includes information on:

  • Supplier eligibility and participation,
  • Beneficiary eligibility and participation, and
  • Billing and coding requirements.

 

OTHER MEDICARE UPDATES

Medicare Mid-Build Off-Campus Outpatient Department Exception Audit Results

On February 2nd CMS posted a webpage dedicated to their 21st Century Cures Act Mid-Build Audits. In overview, the Cures Act provided the criteria which off-campus departments of a provider must meet to comply with Mid-build exception requirements. CMS completed 334 provider audits that requested the mid-build exception. They found that 202 of the facilities failed to qualify for the exception. They note in the audit findings that “Providers that failed the mid-build exception audit and have been billing for the services provided by their off-campus provider-based departments under the OPPS, likely have received overpayments. Also, providers that have passed the mid-build exception audit and have not been billing for the services provided by their off-campus provider-based departments under the OPPS, likely have been underpaid.

CMS will issue audit determination letters to all affected providers on January 19, 2021. The letter will provide the final determination on meeting the exception, the appropriate point of contact information, and further instructions. The 21st Century Cures Act states that the mid-build exception audit determinations are final and may not be appealed.” The Audit Results and FAQ documents are available on this CMS webpage.

Improving Accuracy of Medicare Payments

CMS shared the following information in the Thursday February 4, 2021 Edition of MLN Connects:  

The U.S. Bureau of Labor Statistics (BLS) conducts numerous surveys of hospitals and health care providers that are used by the government to make economic decisions that affect the entire medical care system. Key users include CMS, the Federal Reserve Bank, and the U.S. Congress.  CMS uses these surveys to adjust Medicare Fee-for-Service payments each year, affecting approximately $300 billion in payments.

If you’re contacted by BLS, please participate in the survey to help ensure the data are as accurate as possible. Recently, many health care providers didn’t complete the survey, which can reduce the representativeness of the data and increase volatility in estimates. Your participation in these surveys helps address these issues and increase the validity of the data. Participation is voluntary, confidential, and the data are only used for statistical purposes.

More Information:

February 22, 2021: OIG Report – $4 Million in improper payments for Spinal Facet-Joint Injections

The OIG found that 49 of 100 sampled claims were inappropriately paid by Noridian Healthcare Solutions, LLC to physicians in Jurisdiction E for spinal facet-joint injections. They note that improper payments occurred due to insufficient education to physicians and their billing staff. Based on their findings, the OIG estimated that $4.2 million was improperly paid to physicians. Recommendations for Noridian included recovering the $12,546 in improper payments found in the sampled claims, notify appropriate physicians so they can identify, report, and return any overpayments in accordance with the 60-day rule and provide annual training to physicians and their billing staff. You can read the entire report at https://oig.hhs.gov/oas/reports/region9/92003010.pdf.

Beth Cobb

January 2021 Medicare Transmittals and Other Updates
Published on Jan 27, 2021
20210127

REVISED MEDICARE MLN ARTICLES & TRANSMITTALS

 

January 2021 Update of the Ambulatory Surgical Center (ASC) Payment System

  • Transmittal 10557 Release Date: January 8, 2021
  • What You Need to Know: Transmittal 10546, dated December 31, 2020, has been rescinded and replaced by Transmittal 10557 to correct Attachment B with the addition of missing existing HCPCS J0390, J0745, J2560, 0583T, and Q5118.
  • Link to Transmittal 10557: https://www.cms.gov/files/document/r10557cp.pdf

Fiscal year (FY) 2021 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes

  • Transmittal 10571 Release Date: January 15, 2021
  • What You Need to Know: Transmittal 10360, dated September 18, 2020, has been rescinded and replaced with Transmittal 10571 to correct a value in section G. Updating the PSF for Wage Index, Reclassifications and Redesignations and Wage Index Changes and Issues.
  • Link to Transmittal 10571: https://www.cms.gov/files/document/r10571cp.pdf

April 2021 Update to the Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS)

  • Transmittal 10572 Release Date: January 15, 2020
  • What You Need to Know: Transmittal 10496, dated November 25, 2020, has been rescinded and replaced with Transmittal 10572 to update the background section and to add business requirements 12062.6 and 12062.3. All other information remains the same.
  • Link to Transmittal 10572: https://www.cms.gov/files/document/r10572cp.pdf

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

  • Article Release Date: November 4, 2020 –Revision Date January 20, 2020
  • What You Need to Know: CMS issued a revised Change Request (CR) 12027 on January 14, 2021 to revise the release date, transmittal number, and web address of the CR. This MLN Article was updated to reflect this information. No other substantive changes were made.
  • Link to MLN MM12027: https://www.cms.gov/files/document/mm12027.pdf

Calendar Year (CY) 2021 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

  • Article Release Date: December 18, 2020 – Revised Date January 20, 2021
  • What You Need to Know: This article was revised to reflect a revised CR 12080 where CMS changes the payment determination for code 0177U in the crosswalk from 81310 to 81309.
  • Link to MLN12080: https://www.cms.gov/files/document/mm12080.pdf

 

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

 

Special Edition MLN Article: Assisted Suicide Funding Restriction Act of 1997

  • Article Release Date: January 5, 2021
  • What You Need to Know: “The Assisted Suicide Funding Restriction Act of 1997 (P.L. 105-12) prohibits the use of Federal funds to provide or pay for any health care item or service, or health benefit coverage, for the purpose of causing, or assisting to cause, the death of any individual including mercy killing, euthanasia, or assisted suicide. The prohibition does not pertain to the provision of an item or service for the purpose of alleviating pain or discomfort, even if such use may increase the risk of death, so long as the item or service is not furnished for the specific purpose of causing or accelerating death.”
  • Link to SE20014: https://www.cms.gov/files/document/se20014.pdf

 

MEDICARE COVERAGE UPDATES

 

January 19, 2021: Final Decision for Screening for Colorectal Cancer – Blood based Biomarker Tests (CAG-00454N)

Following is the summary information from this Final Decision Memo: 

“The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to cover a blood-based biomarker test as an appropriate colorectal cancer screening test once every 3 years for Medicare beneficiaries when performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:

The patient is:

  • age 50-85 years, and,
  • asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and,
  • at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).

The blood-based biomarker screening test must have all of the following:

  • FDA market authorization with an indication for colorectal cancer screening; and
  • proven test performance characteristics for a blood-based screening test with both sensitivity greater than or equal to 74% and specificity greater than or equal to 90% in the detection of colorectal cancer compared to the recognized standard (accepted as colonoscopy at this time), based on the pivotal studies included in the FDA labeling.

The currently available Epi proColon® test does not meet the criteria for an appropriate blood-based biomarker CRC screening test.  Based on the evidence at this time, we will non-cover the Epi proColon® test.”

January 19, 2021: Final Decision Memo for Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation (CAG-00438R)

NCD 20.33 became effective August 7, 2014. Abbot Vascular’s MitraClip® is currently the only FDA-approved device for the percutaneous treatment of mitral regurgitation. This Decision Memo renamed the procedure from Transcather Mitral Valve Repair (TMVR) to TEER.

 

MEDICARE EDUCATIONAL RESOURCES

 

January 6, 2021: Letter from the Desk of the Palmetto GBA Medical Directors: Caring for Medicare Patients is a Partnership

In this letter to Physicians, the Palmetto GBA Medical Directors stated that “as a patient’s treating physician or nonphysician practitioner, you may order, refer and/or give health care services for your patient in partnership with other providers (i.e., DME Suppliers or Home Health Agencies). Understanding the applicable Medicare coverage criteria (for example, medical necessity) and documentation guidelines for those services is extremely important for the accurate and timely processing and payment of both your claims and the claims of other entities, including physicians, other health care providers and suppliers who give services for your patient.

Other physicians and health care providers may need your documentation or certification supporting the medical necessity of the services they give secondary to your referral or order. Audits conducted by the Comprehensive Error Rate Testing (CERT) program, Recovery Audit Contractors (RACs), Recovery Auditors (RAs) and Medicare Administrative Contractors (MACs) have frequently shown that available documentation lacks information to establish medical necessity. Audits also have consistently shown that the medical records given by physicians lack sufficient documentation to justify an item or service ordered by them. This lack of physician documentation is causing a lack of payment for services and may result in denied or delayed care for your patient.” For more information regarding this Physician’s role, Palmetto provided a link to the MLN Fact Sheet titled Caring for Medicare Patients is a Partnership.”

 

OTHER MEDICARE UPDATES

 

December 31, 2020: OIG Report: The CMS Could Improve Its Wage Index Adjustment for Hospitals in Areas with the Lowest Wages (A-01-20-00502)

The OIG released this report indicating that “when post-pandemic conditions allow for new initiatives, CMS could consider focusing the bottom quartile wage index adjustment more precisely toward the hospitals that are the least able to raise wages without that adjustment…CMS could also consider studying the question of why some hospitals in a particular area were able to pay higher wages than other hospitals in the same area prior to the implementation of the bottom quartile wage index adjustment.” Are the hospitals in your state in the bottom quartile? You can find out by reading the OIG Report.

January 7, 2021: Special Edition MLN Connects – Physician Fee Schedule Update

CMS released the following information regarding Medicare Physician Fee Schedule (MPFS) Payments for CY 2021:

“On December 27, the Consolidated Appropriations Act, 2021 modified the Calendar Year (CY) 2021 Medicare Physician Fee Schedule (MPFS):

  • Provided a 3.75% increase in MPFS payments for CY 2021
  • Suspended the 2% payment adjustment (sequestration) through March 31, 2021
  • Reinstated the 1.0 floor on the work Geographic Practice Cost Index through CY 2023
  • Delayed implementation of the inherent complexity add-on code for evaluation and management services (G2211) until CY 2024

CMS has recalculated the MPFS payment rates and conversion factor to reflect these changes. The revised MPFS conversion factor for CY 2021 is 34.8931. The revised payment rates are available in the Downloads section of the CY 2021 Physician Fee Schedule final rule (CMS-1734-F) webpage.”

January 7, 2021: Letter to State Health Officials – Opportunities to Better Address Social Determinants of Health (SDOH)

CMS has issued a new roadmap for states to address SDOHs to improve outcomes, lower costs, and support state value-based care strategies. In the Press Release, CMS notes this is part of their commitment to accelerate the health care industry’s shift from tradition fee-for-service payment models to value-based models that hold clinicians accountable for cost and quality. 

January 13, 2021: CMS Report – Putting Patients First: The Centers for Medicare & Medicaid Services’ Record of Accomplishments from 2017-2020

CMS announced in a News Alert their release of this report detailing accomplishments by CMS Strategic Initiatives (i.e. Strengthening Medicare, Innovating Payment Models, and Price Transparency) and provides a Case Study of the COVID-19 response. You can learn more about the Patients Over Paperwork initiative on the CMS website at https://www.cms.gov/About-CMS/Story-Page/patients-over-paperwork.

January 14, 2021: MLN Connects – Payment for Outpatient Clinic Visit Services at Excepted Off-Campus Provider-Based Departments

The following information was published in the January 14th edition of the CMS e-newsletter MLN Connects:

“By July 1, 2021, CMS will begin reprocessing claims for outpatient clinic visit services provided at excepted off-campus Provider-Based Departments (PBDs) so they are paid at the same rate as non-excepted off-campus PBDs for those services under the Physician Fee Schedule (PFS). This affects claims with dates of service between January 1 and December 31, 2019. You do not need to do anything.

Background:

  • November 21, 2018: The CY 2019 Outpatient Prospective Payment System (OPPS) Rulefinalized payment for certain outpatient clinic visit services provided at excepted off-campus PBDs at the same rate that we pay non-excepted off-campus PBDs for those services under the PFS. Previously, CMS and Medicare patients often paid more for the same type of clinic visit in the hospital outpatient setting than in the physician office setting.
  • In 2019: We reduced payment to 70% of the full OPPS rate in off-campus PBDs. In 2020, this rate changed to 40%.
  • September 17, 2019: The U.S. District Court for the District of Columbia declared invalid the CY 2019 payment rule that provided for the reduction for clinic visits provided at excepted off-campus PBDs.
  • January 1 – July 2020: We reprocessed CY 2019 claims paid at the reduced payment rate of 70% to restore the 100% payment rate in accordance with the district court decision.
  • July 17, 2020: The U.S. Court of Appeals for the D.C. Circuit reversedthe district court ruling, upholding our volume control site-neutrality payment policy for off-campus outpatient hospital clinic visits.”

January 19, 2021: OIG Report – CMS and Its Contractors Did Not Use Comprehensive Error Rate Testing Program Data to Identify and Focus on Error-Prone Providers

The OIG’s objective for this review was to “determine whether CMS and its contractors used CERT program data to identify and focus on error-prone providers.” Note, “error-prone provider” is an OIG-created term and in the context of this report “the term refers to providers that had at least one error in each of the 4 CERT years analyzed, an error rate of higher than 25 percent in each of the 4 CERT years analyzed, and a total error amount of at least $2,500.” The OIG identified 100 error-prone providers who collectively received $3.5 million in improper payments for the years 2014 through 2017. This amount equated into an improper payment rate of more than 60.7 percent. Error-prone provider types included the following:

  • 64 durable medical equipment,
  • 22 labs,
  • 5 home health agencies,
  • 4 inpatient rehabilitation hospitals, and
  • 4 hospitals and 1 outpatient physician.

Link to OIG Report in Brief: https://oig.hhs.gov/oas/reports/region5/51700023RIB.pdf

Link to OIG Report: https://oig.hhs.gov/oas/reports/region5/51700023.pdf

January 20, 2021: CMS Memorandum – Hospital Survey Priorities

CMS released a memorandum (QSO-21-13-Hospitals) to State Survey Agency Directors clarifying expectations of State Survey Agencies and Accrediting organizations charged with surveying hospitals for compliance with quality of care requirements as states and communities continued to be impacted by the COVID-19 PHE.

Beth Cobb

CMS Final Rule: Unleashing Innovative Technology
Published on Jan 20, 2021
20210120

In September 2020, CMS released the proposed rule Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Proposed Rule (CMS-3372-P). Per a related CMS Press Release, “Under current rules, FDA approval of a device is followed by an often lengthy and costly process for Medicare coverage. The lag time between the two has been called the “valley of death” for innovative products, with innovators spending time and resources on FDA approval, only to be forced to spend additional time and money on the Medicare coverage process.” Further, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar, stated that “this new proposal would give Medicare beneficiaries faster access to the latest lifesaving technologies and provider more support for breakthrough innovations by finally delivering Medicare reimbursement at the same time as FDA approval.”

CMS issued Final Rule (CMS-3372-F) on January 12th which was published in the Federal Register on January 14, 2021. This Final Rule will take effective on March 15, 2021. CMS notes in a related Press Release that “after the final rule takes effect, upon manufacturer request, Medicare may cover through MCIT eligible breakthrough devices the FDA has approved, including breakthrough devices that received FDA marketing authorization approval within two calendar years prior to the final rule’s effective date, giving Medicare beneficiaries access to these innovative and potentially life-saving devices.”

 

Current Medicare Coverage Pathways

The MCIT pathway was proposed because the prescribed statutory timeframes for the National Coverage Determination (NCD) process limits CMS’ ability to institute immediate national coverage policies for new, innovative medical devices. NCDs and Local Coverage Determinations (LCDs) take, on average, 9 to 12 months to finalize.

CMS detailed current Medicare coverage pathways in the proposed rule. Each pathway is highlighted in the following table. 

Current Medicare Coverage Pathways
Pathway Pathway Description Statutorily Prescribed Timeframe
National Coverage Determinations (NCDs) In general, NCDs are national policy statements published to identify the circumstances under which a Medicare item or service is covered. Pathway generally takes 9 to 12 months to complete.
Local Coverage Determinations (LCDs) LCDs apply only within a Medicare Administrative Contractor’s (MACs) geographic jurisdiction (i.e. Palmetto GBA Jurisdiction J encompasses AL, GA and TN). Pathway can take 9 to 12 months to complete.
Claim-by-Claim Adjudication Coverage decisions made by a MAC in the absence of an NCD or LCD. Case-by-Case basis
Clinical Trial Policy (CTP) The CTP pathway was developed in 2000, can be used for coverage of routine care times and services in a clinical study supported by certain Federal Agencies. CTP in general has not been used by device manufacturers because coverage of a device is not included in this pathway
Parallel Review This is a way for the FDA and CMS to simultaneously review submitted clinical data to help decrease the time between FDA approval and the subsequent CMS NCD. This process involved 2 stages:
  1. FDA & CMS meet with manufacturer to provide feedback on submitted data.
  2. FDA & CMS concurrently review clinical trial results.

FDA Breakthrough Devices Program

The Breakthrough Devices Program is specifically for medical devices and device-led combination products meeting the following two criteria:

  • The device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
  • The device must satisfy one of the following elements:
  • It represents a breakthrough technology;
  • No approved or cleared alternatives exist; or
  • It offers significant advantages over existing approved or cleared alternatives.

MCIT Coverage Pathway

CMS will coordinate with FDA and manufacturers as medical devices move through the FDA regulatory processes to ensure seamless Medicare coverage. This simultaneous effort will ensure Medicare coverage on the date of FDA market authorization for all devices that fall within a Medicare benefit category.

Unlike the pathways in the above table, the MCIT Pathway will allow for immediate national coverage upon the date of FDA market authorization (that is the date the medical device received Premarket Approval (PMA); 510K clearance; or the granting of a De Novo classification request) for the breakthrough device.

Medical Device Eligibility

The MCIT Coverage Pathway is available only to medical devices that meet all of the following:

  • A device is an FDA-designated breakthrough device,
  • A device that was FDA market authorized two years prior to the effective date of the final rule (March 15, 2021) and thereafter,
  • A device is used according to their FDA approved or cleared indication for use,
  • A device that falls within a Medicare benefit category,
  • A device that is not the subject of a Medicare national coverage determination, and
  • A device that is not otherwise excluded from coverage through law or regulation.

Coverage Period

The pathway is a voluntary, opt-in model and will begin when a manufacturer notifies CMS of its intention to utilize the MCIT pathway. CMS finalized that manufacturers may opt-in using no more than an email from the manufacturer to CMS indicating a desire to opt-in and the requested start date of MCIT coverage.

A manufacturer’s requested start date must be no early than the date a device receives market authorization and no later than 2 years after the date of market authorization.

In the proposed rule, CMS indicated that they anticipate two MCIT pathway participants in the first year based on the number of medical devices that received FY 2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles.

MCIT Pathway End Date

MCIT coverage will expire four years after the date of FDA approval, irrespective of when the manufacturer requested activation of their MCIT coverage, at which point, the manufacturer may request CMS to undertake an NCD for the breakthrough device.

Reasons that the MCIT Pathway may End Prior to 4 years

  • The manufacturer withdraws the breakthrough device from the MCIT pathway,
  • The device becomes subject to an NCD,
  • The device becomes non-covered through law, regulation, or at the discretion of the Secretary subsequent to an FDA medical device safety communication or warning letter, or
  • The FDA removes authorization of a device.

When an MCIT Coverage Pathway Ends, What Next?

At the end of the 4-year MCIT pathway, coverage of a device would be subject to one of the following three possible outcomes:

  • NCD affirmative coverage, which may include facility or patient criteria;
  • NCD non-coverage; or
  • MAC discretion (claim-by-claim adjudication or NCD).

CMS encourages interested manufacturers to submit an NCD request during the third year of MCIT to allow time for NCD development.

Definition of “Reasonable and Necessary” Codified

In addition to the MCIT Pathway, CMS proposed and has finalized their intent to “codify in regulations the Program Integrity Manual definition of ‘‘reasonable and necessary’’ with modifications, including to add a reference to Medicare patients and a reference to commercial health insurer coverage policies.”

Reasonable and Necessary Definition

An item or service would be considered ‘‘reasonable and necessary’’ if it is— (i) safe and effective; (ii) not experimental or investigational; and (iii) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it meets all of the following criteria:

(A) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;

(B) Furnished in a setting appropriate to the patient’s medical needs and condition;

(C) Ordered and furnished by qualified personnel;

(D) Meets, but does not exceed, the patient’s medical needs; and

(E) Is at least as beneficial as an existing and available medically appropriate alternative.

(F) “Not later than March 15, 2022, CMS will issue guidance on the methodology of which commercial insurers are relevant based on the measurement of majority of covered lives. For national and local coverage determinations, which have insufficient evidence to meet paragraphs (b)(3)(i) through (v) of this section, CMS will consider coverage to the extent the items or services are covered by a majority of commercial insurers. As part of CMS’ consideration, CMS will include in the national or local coverage determination its reasoning for its decision if coverage is different than the majority of commercial insurers.”

CMS intends to list MCIT pathway covered devices on the CMS website to ensure all stakeholders will be aware of what is covered through this pathway.

 

Resources

CMS Press Release: CMS Unleashes Innovation to Ensure our Nation’s Seniors have Access to the Latest Advancements

 https://www.cms.gov/newsroom/press-releases/cms-unleashes-innovation-ensure-our-nations-seniors-have-access-latest-advancements

CMS Fact Sheet: Medicare Coverage of Innovative Technology (CMS-3372-F)

https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-innovative-technology-cms-3372-f

Final Rule (CMS-3372-F)

https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00707.pdf

Beth Cobb

January 2021 Special Edition of Medicare Transmittals and Other Updates
Published on Jan 13, 2021
20210113

Monthly, MMP provides a summary of Medicare Transmittals, related MLN Articles, Coverage Updates, CMS education resources and any other Medicare updates we believe to be pertinent to our readers. With the holiday season, December’s updates were released in last week’s Wednesday@One article. Since then, CMS has released additional MLN articles with updates effective early in January. For this reason, following is a list of pertinent updates that providers need to know before the end of January when our usual monthly article is published.

 

MEDICARE TRANSMITTALS – RECURRING UPDATES

 

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

  • Article Release Date: January 5, 2021
  • What You Need to Know: The following major changes made in Change Request (CR) 12120 are highlighted in this MLN article:
  • COVID-19 Laboratory Tests and Services Coding Update,
  • CPT Proprietary Laboratory Analyses (PLA) coding changes effective October 6, 2020,
  • Monoclonal antibody therapy product and administration codes for drugs granted emergency use authorizations (EUAs) to treat mild to moderate cases of COVID-19,
  • New COVID-19 CPT vaccines and administration codes,
  • New device pass-through categories, device offset from payment, transitional pass-through payments for designated devices, and alternative pathway for devices that have a Food and Drug Administration (FDA) Breakthrough Device designation,
  • New HCPCS code describing the administration of subretinal therapies requiring vitrectomy,
  • New HCPCS code describing nasal endoscopy with cryoablation of nasal tissue(s) and/or nerve(s),
  • New HCPCS code describing peripheral intravascular lithotripsy (IVL) procedures,
  • Comprehensive APCs (C-APCs) updates,
  • Changes to the Inpatient-Only List (IPO) for CY 2021,
  • Removals of selected National Coverage Determinations (NCDs) Effective January 1, 2021,
  • Changes to some Opioid Treatment Program (OTP) – related codes,
  • Change to the Status Indicator for HCPCS code P9099 (blood component or product not otherwise classified) from SI “ER” to SI “R,”
  • Drugs, Biologicals, and Radiopharmaceuticals updates,
  • Skin Substitutes,
  • Reporting for certain Outpatient Department services (that are similar to Therapy Services)(“Non-therapy outpatient department services”) and are Adjunctive to Comprehensive APC Procedures,
  • Payment Adjustment for Certain Cancer Hospitals Beginning CY 2021,
  • Method to control for unnecessary increased in utilization of outpatient services /G0463 with Modifier PO,
  • Changes to OPPS Pricer Logic,
  • Updates to the Outpatient Provider Specific File (OPSF),
  • Wage Index Policies in the CY 2021 OPPS,
  • Coverage Determinations reminder, and
  • General Supervision of Outpatient Hospital Therapeutic Services currently assigned to the Non-Surgical Extended Duration Therapy Services (NSEDTS) level of supervision.
  • MLN Article MM12120: https://www.cms.gov/files/document/mm12120.pdf

 

January 2021 Update of the Ambulatory Surgical Center (ASC) Payment System

  • Article Release Date: January 5, 2021
  • What You Need to Know: This article details changes and billing instructions for policies implemented in the January 2021 Ambulatory Surgical Center (ASC) update. Following are key points from the related Change Request (CR) 12129 included in this MLN article are:
  • Three new device pass through categories,
  • Device offset from Payment,
  • Device Pass-Through Payments,
  • New HCPCS code describing the administration of subretinal therapies requiring vitrectomy,
  • New HCPCS code describing nasal endoscopy with cryoablation of nasal tissue(s) and/or nerve(s),
  • Four new HCPCS code describing peripheral intravascular lithotripsy (IVL) procedures,
  • Removal of five National Coverage Determinations (NCDs) effective January 1, 2021 as stated in the CY 2021 Physician Fee Schedule (PFS) final rule.
  • The one existing and fifteen new HCPCS codes for certain drugs and biologicals in the ASC setting that will start to receive separate payment beginning January 1, 2021.
  • Retroactive payment for HCPCS J1097 (Phenylep ketorolac opth soln), brand name Omidria. This code became separately payable October 1, 2020. However, there was no available payment rate for MACs. “Consequently, ASCs that may have submitted claims for this drug, may not have been paid correctly…suppliers who think they may have previously received an incorrect payment or incorrect disposition associated with this correction for J1097, for claims beginning October 1, 2020, may request their MAC adjust the previously processed claims.”
  • Drugs and Biologicals with payments based on Average Sales Price (ASP),
  • Drugs and Biologicals based on ASP methodology with restated payment rates, and
  • Skin substitute procedure edits.

CMS ends this MLN article with the following statement about Coverage Determinations:

“Assignment of an HCPCS code and payment rate under the ASC payment system to a drug, device, procedure, or service doesn’t imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the program. MACs determine whether a drug, device, procedure, or other service meets all program requirements for coverage. For example, MACs determine that it is reasonable and necessary to treat the beneficiary’s condition and whether it’s excluded from payment.”

January 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.0

  • Article Release Date: January 5, 2021
  • What You Need to Know: This article details changes to the January 2021 version of the Integrated Outpatient Code Editor (I/OCE) instructions and specifications for the Integrated OCE that Medicare uses:
  • Under the OPPS and Non-OPPS for hospital outpatient departments, community mental health centers and all non-OPPS providers,
  • For limited services when provided in a Home Health Agency (HHA) not under the Home Health Prospective Payment System, and
  • For a hospice patient for the treatment of a non-terminal illness.
  • MLN Article MM12114: https://www.cms.gov/files/document/mm12114.pdf

 

REVISED MEDICARE TRANSMITTALS

 

Billing for Home Infusion Therapy Services on or After January 1, 2021

  • Article Release Date: August 7, 2020 – Revised December 31, 2020
  • What You Need to Know: A revised Change Request (CR) 11880 was issued on December 31, 2020. This MLN Article was revised to reflect the CR where two codes (J1559 JB and J7799 JB) were added in Table 3.2 on page 7 of this article.
  • MLN MM11880: https://www.cms.gov/files/document/MM11880.pdf

 

MEDICARE EDUCATIONAL RESOURCES

 

Hospital Price Transparency Webcast: Audio Recording & Transcript

CMS provided the following information in their Thursday, January 7, 2021 edition of MLN Connects: “An audit recording, transcript, and clarification are available for the December 8 Medicare Learning Network webcast on Hospital Price Transparency. Effective January 1, each hospital operating in the United States is required to provide clear, accessible pricing information online. Learn about resources to help you prepare for compliance.”

Beth Cobb

December Medicare Transmittals and Other Updates
Published on Jan 06, 2021
20210106

MEDICARE TRANSMITTALS – RECURRING UPDATES

 

Update to the Federally Qualified Health Center (FQHC) Prospective Payment System (PPS) for Calendar Year (CY) 2021 – Recurring File Update

  • Article Release Date: December 4, 2020
  • What You Need to Know: Since 2017 CMS has updated the FQHC PPS rate annually. Based on historical data through the second quarter of 2020, the FQHC market basket for CY 2021 is 1.7 percent increasing the FQHC PPS base payment of $173.50 in 2020 to $176.45 for 2021.
  • MLN MM12046: https://www.cms.gov/files/document/mm12046.pdf

Update to Rural Health Clinic (RHC) All Inclusive Rate (AIR) Payment Limit for Calendar Year (CY) 2021

  • Article Release Date: December 4, 2020
  • What You Need to Know: This article provides the CY 2021 payment limit for RHCs. The CY 2021 amount has increased from $86.31 in 2020 to $87.52 effective January 1, 2021. The related Change Request (CR) 12035 was released on October 29, 2020.
  • MLN MM12035: https://www.cms.gov/files/document/mm12035.pdf

Summary of Policies in the Calendar Year (CY) 2021 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, CT Modifier Reduction list, and Preventive Services List

  • Article Release Date: December 4, 2020
  • What You Need to Know: CR 12071 provides a summary of policies in the CY 2021 MPFS Final Rule and makes other policy changes that apply to Medicare Part B. This MLN article is a supplement to the CR.
  • MLN MM12071: https://www.cms.gov/files/document/mm12071.pdf

2021 Annual Update of Per-Beneficiary Threshold Amounts

  • Article Release Date: December 7, 2020
  • What You Need to Know: The related Change Request (CR) 12014 updates the annual per-beneficiary incurred expenses amounts now called the KX modifier thresholds and related policy for CY 2021.
  • MLN MM12014: https://www.cms.gov/files/document/mm12014.pdf

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

  • Article Release Date: December 7, 2020
  • What You Need to Know: Information on the data files, update factors, and other information related to the CY 2021 update to the fee schedule can be found in this article.
  • MLN MM12063: https://www.cms.gov/files/document/mm12063.pdf

Calendar Year (CY) 2021 Annual Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment

  • Article Release Date: December 18, 2020
  • What You Need to Know: Information provided in this article is related to CR 12080 and intended for clinical diagnostic laboratories. CR 12080 provided instructions for CY 2021 CLFS, mapping for new codes for clinical laboratory tests, and an update for laboratory costs subject to reasonable charge payment.
  • MLN MM12080: https://www.cms.gov/files/document/MM12080.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.1, Effective April 1, 2021

  • Article Release Date: December 23, 2020
  • What You Need to Know: This article provides a background on NCCI Edits and refers to CR 12110, which provides quarterly updates to the NCCI PTP edits.
  • MLN MM12110: https://www.cms.gov/files/document/mm12110.pdf

Updating Calendar Year (CY) 2021 Medicare Diabetes Prevention Program (MDPP) Payment Rates

  • Article Release Date: December 23, 2020
  • What You Need to Know: For organizations enrolled as MDDP suppliers, this article includes a link to the accompanying CR 12030, which contained instructions for MACs and the Railroad Specialty MAC to update the MDPP Expanded Model payment rates for CY 2021.
  • MLN MM12030: https://www.cms.gov/files/document/mm12030.pdf

Quarterly Update to Home Health (HH) Grouper

  • Article Release Date: December 30, 2020
  • What You Need to Know: This article provides information regarding the January 2021 update to the HH Grouper software to reflect new COVID-19-related diagnosis code changes.
  • MLN MM12047: https://www.cms.gov/files/document/MM12047.pdf

2021 Annual Update to the Therapy Code List

 

OTHER MEDICARE TRANSMITTALS

 

Review of Hospital Compliance with Medicare’s Transfer Policy with the Resumption of Home Health Services and the Use of Condition Codes (A-04-18-04067)

  • Article Release Date: December 1, 2020
  • What You Need to Know: An OIG audit report released August 2020 (report No. A-04-18-04067) identified Medicare overpayments to hospitals that did not comply with Medicare’s post-acute-care transfer policy. This MLN Special Edition article was published to remind hospitals of proper coding of the patient discharge status code and the use of condition codes 42 and 43.
  • MLN SE20025: https://www.cms.gov/files/document/SE20025.pdf

FAQs on the 3-Day Payment Window for Services Provided to Outpatients Who Later Are Admitted as Inpatients

 

REVISED MEDICARE TRANSMITTALS

 

Changed to the Laboratory National Coverage Determination (NCD) Edit Software for October 2020

  • Article Release Date: July 31, 2020 – Revised November 30, 2020
  • What You Need to Know: This article was revised to reflect changes made to CR 11889 issued on August 14th. CR 11889 was revised to update the codes for NCD 190.15.
  • MLN MM11889: https://www.cms.gov/files/document/MM11889.pdf

Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2021

  • Article Release Date: November 9, 2020 – Revised December 2, 2020
  • What You Need to Know: This is the second time that CMS has updated this MLN article. The December 2nd revisions added information for reporting the use of cinacalcet by ESRD facilities. “Beginning January 1, 2021, cinacalcet is an oral drug eligible for consideration as an ESRD outlier service. ESRD facilities should report revenue code 250 with the drug’s NDC.
  • MLN MM12011: https://www.cms.gov/files/document/mm12011.pdf

New & Expanded Flexibilities for RHCs & FQHCs during the COVID-19 PHE

  • Article Releases Date: April 17, 2020 – Revised December 3, 2020
  • What You Need to Know: Revisions to this article includes additional guidance on telehealth services that have cost-sharing and cost-sharing waived and language changes for clarity that did not alter the substance of the article.
  • MLN MMSE20016: https://www.cms.gov/files/document/se20016.pdf

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

  • Article Release Date: November 4, 2020 – Revised December 10, 2020
  • What You Need to Know: This article was revised due to a revised CR 12027. Revisions made did not impact the substance of this article.
  • MLN MM12027: https://www.cms.gov/files/document/MM12027.pdf

Medicare Claims Processing Transmittal 10521: New Medicare Uniform Billing Committee (NUBC) Type of Bill (TOB), Condition Code and implementing Billing Codes for Opioid Treatment Programs

  • Transmittal 10266 Release Date: August 6, 2020
  • Transmittal 10521 Release Date: December 16, 2020
  • What You Need to Know: Transmittal 10266 was rescinded and replaced by Transmittal 10266 to add the Provider Type "34", note that CAH's are paid via the OTP fee schedule, and clarification on the 2020 OTP fee schedule file (attachment 1) versus the 2021 OTP fee schedule file (new attachment 3). This correction revises business requirement 1856-4.1 and only impacts publication 100-04. All other information remains the same.
  • Transmittal 10521: https://www.cms.gov/files/document/r10521cp.pdf
  • Effective Date: January 1, 2021 for claims received on or after 1/1/2021

Note, a related Medicare Financial Management Transmittal 10521 revises business requirement 1856-4.1 and only impacts publication 100-04. (https://www.cms.gov/files/document/r10521fm.pdf)

Transmittal 10525: Implementation of the New Ambulatory Surgical Center (ASC) Payment Indicator “K5”

  • Transmittal 10245 Release Date: July 30, 2020
  • Transmittal 10525 Release Date: December 17, 2020
  • What You Need to Know: Transmittal 10245 was rescinded and replaced by Transmittal 10525 to remove the word “DRAFT” from Attachment A. CMS created “a new ASC payment indicator, specifically, “K5” to identify codes that describe items, procedures, and services for which pricing information and claims data are not available, and consequently, no ASC payment will be made. This new payment indicator, effective January 1, 2021, provides the assignment, definition, and detail needed for this subset of HCPCS codes.”
  • Transmittal 10525: https://www.cms.gov/files/document/r10525otn.pdf

Telehealth Expansion Benefit Enhancement Under the Pennsylvania Rural Health Model (PARHM) – Implementation

 

MEDICARE COVERAGE UPDATES

 

December 1, 2020: CMS Updates Coverage Policies for Artificial Hearts and Ventricular Access Devices (VADs)

CMS released Decision Memo CAG-00453N on December 1st updating coverage requirements for artificial hearts and VADs. Specifically,

  • Artificial Hearts: “CMS is removing the NCD at § 20.9, ending coverage with evidence development for artificial hearts and permitting Medicare coverage determinations for artificial hearts to be made by the Medicare Administrative Contractors (MACs) under § 1862(a)(1)(A) of the Social Security Act.”
  • VADs: CMS notes in a related Press Release that “The final national coverage determination, which is effective today, also provides updated coverage criteria for VADs that better aligns with current medical practice and that we believe will expand coverage to a greater number of candidates who are likely to benefit from this technology. Specifically, the updated patient criteria in the NCD aligns with the inclusion criteria derived from recent large randomized controlled trials, which demonstrated improved patient outcomes.”

December 21, 2020: Proposed Updates to Coverage Policy for Autologous Blood-Derived Products from Chronic Non-Healing Wounds

CMS proposed to “update coverage of Platelet Rich Plasma (PRP) for the treatment of chronic non-healing diabetic, venous, and pressure wounds. PRP is a blood-derived product prepared from the patient’s own blood to be used as a wound covering in the management of chronic wounds. PRP is currently covered under the Coverage with Evidence Development (CED) pathway for the treatment of chronic, non-healing diabetic, venous, and pressure wounds when beneficiaries are enrolled in a clinical study. This proposed National Coverage Determination would eliminate the CED requirement and nationally cover PRP for the treatment of chronic non-healing diabetic wounds. The proposal also would provide for coverage determinations for PRP for all other chronic non-healing wounds to be made by local Medicare Administrative Contractors.”

CMS is seeking comments on the proposed national coverage determination.

 

 

MEDICARE EDUCATIONAL RESOURCES

 

 

December 10, 2020: MLN Call – Physician Fee Schedule Final Rule: Understanding 4 Key Concepts

CMS hosted a Medicare Learning Event to provide information about the following four key concepts in the 2021 PFS Final Rule:

  • Extending Telehealth & Licensing Flexibilities,
  • Evaluation and Management (E/M) Visits and Analogous Services,
  • Quality Payment Program Updates, and
  • Opioid Use Disorder/Substance Use Disorder Provisions.

You can access the Presentation on the 2020-12-10 Physician Fee Schedule webpage

KEPRO Case Review Connections: Acute Care Edition Winter 2020

KEPRO has released their Winter 2020 Edition of their Case Review Connections e-newsletter for Acute Care. Examples of what’s in this newsletter are the Medical Director’s Corner, a notice about them now accepting Medical Records electronically and an immediate advocacy success story.

MLN Educational Tool Medicare Preventive Services Updated in December

CMS has revised this Medicare Learning Network educational too. The tool provides information about coding, coverage and the beneficiary’s copayment/coinsurance and deductible.

 

OTHER MEDICARE UPDATES

 

December 1, 2020: CMS Releases 2021 Medicare Physician Fee Schedule (PFS) Final Rule

The following list highlights several of the changes found in the PFS Final Rule for 2021:

  • Within the Final Rule, CMS issued two interim final rules with comment period.
  • The first interim final rule is “to establish coding and payment for virtual check-in services to support the continued need for coding and payment to reflect the provisions of lengthier audio-only services outside of the PHE for COVID,19, if not as substitutes for in-person services.”
  • The second interim final rule is “to establish coding and payments for PPE as a bundled service and certain supply pricing increases in recognition of the increased market-based costs for certain types of PPE.”
  • Payments have been Increased to physicians and other practitioners for additional time spent with patients providing chronic disease management,
  • Sixty additional services have been added to the telehealth list that will continue to be covered beyond the COVID-19 public health emergency (PHE),
  • CMS established on an interim final basis a new HCPCS G-code describing 11-20 minutes of medical discussion to determine the necessity of an inpatient visit.”
  • CMS commissioned a study of its telehealth flexibilities during the COVID-19 PHE,
  • The increase in payment rates for office/outpatient face-to-face evaluation and management (E/M) visits finalized in 2020 goes into effect in 2021. According to a related CMS Press Release, the payment increases “support clinicians who provide crucial care for patients with dementia or manage transitions between the hospital, nursing facilities, and home,”
  • Simplified coding and documentation changes for Medicare billing for E/M office visits goes into effect January 1, 2021 modernizing guidelines developed in the 1990’s,
  • CMS Finalized the following workforce flexibilities that have been provided during the COVID-19 PHE:
  • “Certain non-physician practitioners such as nurse practitioners and physician assistants can supervise the performance of diagnostic tests within their scope of practice and state law, as they maintain required statutory relationships with supervising or collaborating physicians.
  • Physical and occupational therapists will be able to delegate “maintenance therapy” – the ongoing care after a therapy program is established – to a therapy assistant.
  • Physical and occupational therapists, speech-language pathologists, and other clinicians who directly bill Medicare can review and verify, rather than re-document, information already entered by other members of the clinical team into a patient’s medical record. As a result, practitioners have the flexibility to delegate certain types of care, reduce duplicative documentation, and supervise certain services they could not before, increasing access to care for Medicare beneficiaries.”
  • CMS notes in a related Fact Sheet that “direct supervision may be provided using real-time, interactive audio and video technology through the later of the end of the calendar year in which the PHE ends or December 31, 2021.”
  • CMS finalized the elimination of six older National Coverage Determinations (NCDs) and noted in the final rule “that if the previous NCD barred coverage for an item or service under title XVIII (that is, national noncoverage NCD), a MAC would now be able to cover the item or service if the MAC determined that such action was appropriate under the statue…proactively removing obsolete broad non-coverage NCDs removes barriers to innovation and reduces burden for stakeholders and CMS.” The effective date for removal of the following six NCDs is on the date of the final rule:
  • NCD 20.5 – Extracorporeal Immunoadsorption (ECI) Using Protein A Columns,
  • NCD 30.4 – Electrosleep Therapy,
  • NCD 100.9 – Implantation of Gastrointestinal Devices,
  • NCD 110.19 – Abarelix for the Treatment of Prostate Cancer
  • NCD 220.2.1 – Magnetic Resonance Spectroscopy, and
  • NCD 220.6.16 - FDG PET for Inflammation and Infection.

December 2, 2020: OIG Fall 2020 Semiannual Report to Congress

The OIG Semiannual Report reflects work performed from April 1, 2020 through September 30, 2020. Following are some of the high-level findings from the report by the numbers:

  • 97 – the number of audit reports completed
  • 27 – the number of evaluation reports completed
  • $337 million – the amount identified in expected recoveries,
  • $446 million – costs questions by the OIG because of an alleged violations, costs not supported by adequate documentation, or the expenditure of funds where the intended purpose is unnecessary or unreasonable,
  • $2 billion – potential savings identified for HHS; and
  • 416 – The number of new audit and evaluation recommendations made by the OIG.

December 7, 2020: 2021 IPPS Final Rule Correction Notice Published in Federal Register

This document corrects technical and typographical errors in the September 18, 2020 issue of the FY 2021 IPPS Final Rule.

December 10, 2020: CMS Proposed Modifications to the HIPAA Privacy Rule

HHS notes in their announcement the proposed changes will “support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry.” The Summary statement in the Proposed Rule indicates that “these modifications address standards that may impede the transition to value-based health care by limiting or discouraging care coordination and case management communications among individuals and covered entities (including hospitals, physicians, and other health care providers, payors, and insurers) or posing other unnecessary burdens. The proposals in this NPRM address these burdens while continuing to protect the privacy and security of individuals’ protected health information.”

December 10, 2020: CMS Proposes New Rules to Address Prior Authorization and Reduce Burden on Patients and Providers

CMS released the following information in a December 12, 2020 Special Edition of MLNConnects:

On December 10, under President Trump’s leadership, CMS issued a proposed rule that would improve the electronic exchange of health care data among payers, providers, and patients and streamline processes related to prior authorization to reduce burden on providers and patients. By both increasing data flow and reducing burden, this proposed rule would give providers more time to focus on their patients and provide better quality care. For More Information:

December 16, 2020: CMS Report – National Healthcare Spending in 2019

“The National Health Expenditure Accounts (NHEA) are the official estimates of total health care spending in the United States. Dating back to 1960, the NHEA measures annual U.S. expenditures for health care goods and services, public health activities, government administration, the net cost of health insurance, and investment related to health care. The data are presented by type of service, sources of funding, and type of sponsor.

U.S. health care spending grew 4.6 percent in 2019, reaching $3.8 trillion or $11,582 per person.  As a share of the nation's Gross Domestic Product, health spending accounted for 17.7 percent.”

You can download the entire report on the CMS National Health Expenditure Data Historical webpage.

December 18, 2020: Special Edition MLNConnects: Monitoring for Hospital Price Transparency

CMS indicated in this Special Edition MLNConnects that they plan “to audit a sample of hospitals for compliance starting in January, in addition to investigating complaints that are submitted to CMS and reviewing analyses of non-compliance, and hospitals may face civil monetary penalties for noncompliance.” CMS also reminds providers of their Hospital Price Transparency website where they have provided several resources for hospitals as they work towards compliance with Hospital Price Transparency. 

December 31, 2020: Palmetto GBA offers Introduction to 2021 E&M Changes

Palmetto GBA included the following information in their December 31st Daily Newsletter:

“Effective January 1, 2021, the Centers for Medicare and Medicaid Services (CMS) implemented a new coding, prefatory language, and interpretive guidance framework that the American Medical Association Current Procedural Terminology Editorial Panel issued for office and outpatient E/M visits. Please review the information in this job aid and share it with your staff.” You can access this introduction education material at: https://www.palmettogba.com/palmetto/providers.nsf/ls/JJ%20Part%20B~BWSU772836?opendocument.

January 1, 2021: CMS Releases MLN Guide Titled Evaluation and Management (E/M) Services

CMS has released publication ICN: 006764 that serves as a guide to learning the principles of documentation, common sets of codes used to bill for services, and other considerations.

Beth Cobb

CY 2021 OPPS and ASC Final Rule – Supervision of Therapeutic Services and ASC Covered Procedure List
Published on Dec 22, 2020
20201222

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule (CMS-1736-FC) was released on December 2, 2020 and is scheduled to be published in the Federal Register on December 29th. A Wednesday@One article released earlier this month highlighted changes to the Inpatient Only Procedure List and the Hospital Outpatient Department Prior Authorization Program.

This week’s article details finalized changes for supervision of outpatient therapeutic services and the Ambulatory Surgical Center (ASC) Covered Procedures List.

Changes in the Level of Supervision of Outpatient Therapeutic Services in Hospitals and Critical Access Hospitals (CAHs)

In the 2020 OPPS Final Rule, CMS finalized their proposed policy to change the “generally applicable minimum required level of supervision for hospital outpatient therapeutic services from direct supervision to general supervision for services furnished by all hospitals and CAHs.” General supervision means that the procedure is furnished under the physician’s overall direction and control, but that the physician’s presence is not required during the performance of the procedure.

This policy became effective January 1, 2020 and will remain in place for future years unless modified by later notice and comment rulemaking.

In the 2021 OPPS Proposed Rule, CMS noted that a March 31, 2020 interim final rule with comment period (IFC) was issued with the intent to give providers “needed flexibilities to respond effectively to the serious public health threats posed by the spread of the COVID-19.”

Specific to the level of supervision the following policies were adopted in the IFC to be effective for the duration of the Public Health Emergency (PHE) due to COVID-19:

  • A policy to reduce the minimum default level of supervision for non-surgical extended duration therapeutic services (NSEDTS) to general supervision for the entire service, including the initiation portion of the service, for which CMS previously required direct supervision on initiation of the service.
  • A policy indicating that the requirement for direct supervision of pulmonary, cardiac and intensive cardiac rehabilitation services includes virtual presence of the physician through audio/video real-time communications technology when use of such technology is indicated to reduce exposure risks for the beneficiary or health care provider.

CMS decided that these policies are appropriate outside of the PHE and proposed to adopt them for CY 2021 and beyond.

NSEDTS Level of Supervision

In the final rule, CMS finalized their proposal without modification to reduce the minimum default level of supervision for NSEDTS to general supervision. They do “note that the requirement for general supervision for an entire NSEDTS does not preclude these hospitals from providing direct supervision for any part of a NSEDTS when the practitioners administering the medical procedures decide that it is appropriate to do so. Many outpatient therapeutic services, including NSEDTS, may involve a level of complexity and risk such that direct supervision would be warranted even though only general supervision is required.”

In response to a comment from Med PAC, CMS intends to “monitor NSEDTS for safety or service quality issues that may arise from the change to general supervision as the minimum default level of supervision for the initiation period of these services.”

Direct Supervision of Pulmonary, Cardiac, and Intensive Cardiac Rehabilitation Services Using Interactive Telecommunication Technology

Several commenters expressed concerns regarding the proposed change to direct supervision for these three rehabilitation services.

Ultimately, CMS finalized their “proposed policy to permit direct supervision of these services using virtual presence only until the later of the end of the calendar year in which the PHE ends or December 31, 2021. Specifically, the required direct physician supervision can be provided through virtual presence using audio/video real-time communications technology (excluding audio-only) subject to the clinical judgement of the supervising practitioner, as discussed in IFC-1 (85 FR 19246).

When the policy to permit direct supervision through virtual presence ends, we will resume our current policy to require direct physician supervision of pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, and that the supervising practitioner must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. This does not mean that the supervising practitioner must be present in the room when the procedure is performed.”

CMS also clarified “that, to the extent our policy allows direct supervision through virtual presence using audio/video real-time communications technology during the PHE, the requirement could be met by the supervising practitioner being immediately available to engage via audio/video technology (excluding audio-only), and would not require real-time presence or observation of the service via interactive audio and video technology throughout the performance of the procedure.”

Proposed Additions to the Ambulatory Surgical Center (ASC) Covered Procedures

In general procedures on the ASC covered procedure list (ASC-CPL) are those procedures that are not “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.”

CMS proposed to continue to apply the revised definition of “surgery” adopted in the CY 2019 OPPS/ASC Final Rule that includes procedures that are “surgery-like” procedures that are assigned outside the CPT surgical range, for CY 2021 and subsequent years.

CMS Outlook for the Future of the ASC-CPL

CMS reiterated many thoughts/beliefs about the future of ASCs included in the proposed rule. Following are some of the statements found in the final rule:

  • CMS believes “that significant advancements in medical practice, surgical techniques, medical technology, and other factors have allowed certain ASCs to safely perform procedures that were once too complex, including those involving major blood vessels and other general exclusion criteria.”
  • CMS acknowledges “that ASCs and hospitals have different health and safety requirements. Despite this fact, ASCs often undergo accreditation as a condition of state licensure and share some similar licensure and compliance requirements with hospitals as well as meet Medicare conditions for coverage (see 42 CFR 416.40 through 416.54).”
  • CMS reminds the reader that “in recent years, we have added procedures to the ASC-CPL that were largely considered hospital inpatient procedures in the past, such as total knee arthroplasty (TKA) and certain coronary intervention procedures.”
  • “Many procedures that are currently only payable as hospital outpatient services under Medicare fee-for-service are safely performed in the ASC setting for other payors.”
  • CMS recognizes “that non-Medicare patients tend to be younger and have fewer comorbidities than the Medicare population.” However, “careful patient selection can identify Medicare beneficiaries who are suitable candidates for these services in the ASC setting.”
  • “Medicare Advantage plans are not obligated to adopt the ASC-CPL as it exists in Medicare fee-for-service and…many MA enrollees have had services performed in the ASC setting that are not currently payable under Medicare fee-for-service.”
  • “The COVID-19 pandemic has highlighted the need for more healthcare access points throughout the country…Looking ahead to after the pandemic, it will be more important than ever to ensure that the health care system has as many access points and patient choices for all Medicare beneficiaries as possible. Because the pandemic has forced many ASCs to close, thereby decreasing Medicare beneficiary access to care in that setting, we believe allowing greater flexibility for physicians and patients to choose ASCs as the site of care, particularly during the pandemic, would help to alleviate both access to care concerns for elective procedures as well as access to emergency care concerns for hospital outpatient departments.”
  • “In the CY 2021 OPPS/ASC proposed rule, we sought to continue to promote site neutrality, where possible, between the hospital outpatient department and ASC settings, and expand the ASC CPL to include as many procedures that can be performed in the HOPD as reasonably possible to advance that goal.”

CMS finalized without modification the addition of the eleven proposed procedures to the ASC-CPL. These procedures are listed in Table 59 of the final rule.

Table 59: Final Additions to the List of ASC Covered Surgical Procedures for CY 2021

CY 2021 CPT /HCPCS Code CY 2021 Long Descriptor Final CY 2021 ASC Payment Indicator
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) G2
0268T Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed) J8
0404T Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency G2
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 G2
27130 Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft J8
27412 Autologous chondrocyte implantation, knee G2
57282 Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus) G2
57283 Colpopexy, vaginal; intra-peritoneal approach (uterosacral, levator myorrhaphy) G2
57425 Laparoscopy, surgical, colpopexy (suspension of vaginal apex) G2
C9764 Revascularization, endovascular, open or percutaneous, any vessel(s); with intravascular lithotripsy, includes angioplasty within the same vessel (s), when performed G2
C9766 Revascularization, endovascular, open or percutaneous, any vessel (s); with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel (s), when performed J8

Specific to the addition of total hip arthroplasty (THA) to the ASC-CPL, CMS notes in the final rule that they “are aware that beneficiaries may incur greater cost-sharing for THA procedures in an ASC setting under our proposal, but note that this is not an occurrence that is unique to THA.” Section 4011 of the 21st Century Cures Act added the requirement that the Secretary make a searchable website available to the public, “with respect to an appropriate number of items and services, the estimated payment amount for the item or service under the OPPS and the ASC payment system and the estimated beneficiary liability applicable to the item or service.” CMS implemented this provision by providing an Outpatient Procedure Price Lookup tool available at https://www.medicare.gov/procedure-price-lookup. “This web page allows beneficiaries to compare their potential cost-sharing liability for procedures performed in the hospital outpatient setting versus the ASC setting.” CMS that this tool will include cost-sharing liability for THA in the outpatient hospital and ASC settings in the future.

At the end of the day, whether a procedure is performed in the Inpatient, Outpatient or ASC setting, 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.

Beth Cobb

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