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Medicare Quarterly Provider Compliance Newsletter and a Tangled Web
Published on Sep 29, 2021
20210929
 | CERT 
 | OIG 
“Oh, what a tangled web we weave…when first we practice to deceive.”
- Sir Walter Scott

“Oh, what a tangled web we weave…. when first we practice to protect.” Changing just one word in this quote from “deceive” to “protect” makes it become an apt description of the numerous medical review contractors that are part of the CMS Medical Review and Education Program (link).

This premise is supported by CMS’ stated purpose for this interconnected web of medical review contractors as being to “identify errors through claims analysis and/or medical review activities. Contractors use this information to help ensure they provide proper Medicare payments (and recover any improper payments if the claim was already paid.) Contractors also provide education to help ensure future compliance.”

The Medicare Quarterly Provider Compliance Newsletter is one tool used for provider education. This quarterly newsletter’s aim is to provide guidance to address billing errors identified by Medicare Administrative Contractors (MACs) and other contractors such as Recovery Auditors, the Comprehensive Error Rate Testing (CERT) Review Contractor, and the Supplemental Medical Review Contractor (SMRC). Other governmental organizations, such as the Office of Inspector General (OIG), also conduct reviews and identify issues. The CMS recently announced the release of the July 2021 edition of this newsletter (link).

July 2021 Newsletter Topics:

  • the Comprehensive Error Rate Testing (CERT) program review of glucose testing supplies,
  • Recovery Auditor Issue 0181: Bone Marrow or Stem Cell Transplant: Medical Necessity and Documentation Requirements
  • Recovery Auditor Issue 0081: Negative Pressure Wound Therapy: Medical Necessity and Documentation Requirements.

As I read through the newsletter, I noted that the CERT findings include background information, examples of improper payments and resources. Likewise, the Recovery Auditor review of negative pressure wound therapy includes a problem description, background information, recommendations to prevent denials and improper payments and resources. However, the Recovery Auditor review of bone marrow or stem cell transplant is lacking examples of improper payments and/or recommendations to prevent denials and improper payments. This lack of information led me to the CMS RAC webpage in search of additional information related to the RAC issue 0181. Much to my surprise this issue is no longer on the list of approved RAC issues and is no longer on the individual RACs list of approved issues.

Inpatient Bone Marrow and Stem Cell Transplant Procedures Medical Review Timeline
February 2016: OIG Review

The OIG noted in a February 2016 report (link) that Medicare had paid hospitals $185.9 million for inpatient claims related to bone marrow and stem cell transplant procedures. The OIG identified two hospitals that did not always comply with the Medicare billing requirements for inpatient claims for stem cell transplants that resulted in approximately $4 million in overpayments. In general, lengths of stay (LOS) for these claims ranged from 10 to 21 days. However, the LOS for claims reviewed were one to two days. Based on findings from the two hospitals, the OIG conducted a nationwide review of 143 claims and found that 133 (93%) of the claims did not comply with Medicare billing requirements. The two reasons cited by the OIG for noncompliance included:

  • Hospitals incorrectly billing Medicare Part A for stays that should have been billed as outpatient, or outpatient with observation services, and
  • Hospitals billing an incorrect Medicare Severity-Diagnosis Related Group (MS-DRG).
January 2019: New Review Project for SMRC

In response to the OIG report, the CMS tasked the SMRC (Noridian) with reviewing inpatient bone marrow and stem cell transplant procedures to determine compliance with statutory, regulatory, and sub-regulatory guidance. The SMRC reviewed claims billed on dates of service from January 1, 2017, through December 31, 2017. Specific MS-DRGs requested included:

  • MS-DRG 014: Allogenic bone marrow transplant,
  • MS-DRG 016: Autologous bone marrow transplant with a complication or comorbidity (CC), and
  • MS-DRG 017: Autologous bone marrow transplant without a CC or major CC (MCC).

For this project, Noridian included the following list of specific documentation requirements in each Additional Documentation Request (ADR) sent to providers:

  1. Documentation to support the beneficiary was expected to require an inpatient level of care for at least 2-Midnights
  2. Documentation to support an inpatient level of care was expected and provided. Documentation should include, but is not limited to: Medication Administration Records (MAR), History & Physical, Physician Progress Notes, Nursing Notes, Discharge Summary, Procedure Notes
  3. Inpatient admission order from attending physician
  4. Physician or Non-Physician Practitioner (NPP) order for the stem cell transplant for the dates of service
  5. Medical documentation that supports the beneficiary met criteria for one of the following covered services:
    1. Allogenic Hematopoietic Stem Cell Transplantation (HSCT)
    2. Autologous Stem Cell Transplantation (AuSCT)
  6. Documentation to support enrollment in an approved Clinical Research Study, if applicable
  7. Full detailed itemization of services, including diagnosis codes
  8. Legible handwritten physician and/or clinician signatures
    1. Signature logs and Signature Attestation Statement should be submitted when physician and/or clinician signatures are illegible
  9. Valid electronic physician and/or clinician signatures
  10. Advance Beneficiary Notice of Noncoverage (ABN), if applicable

Results of this review were posted to the SMRC website in October 2019. The error rate for the SMRC Project 01-006 (link) was 86%. Common reasons for denial cited by the SMRC included:

  • Documentation received did not support medical necessity of an inpatient stay,
  • No response by a provider to the documentation request,
  • Signature requirements not being met, and
  • Incorrect coding.
March 2020: RAC Approved Issue 0181: Complex Review of Hospital Inpatient Bone Marrow or Stem Cell Transplants

Six months later, further proof of the interconnected web of medical review contractors concept, a review of bone marrow and stem cell transplants became a RAC approved issue. Each of the 4 RAC Regions added Issue 0181 to their list of Issues in March of 2020 (link). Even Though RAC Issue 0181 is no longer listed on the RAC websites, if your hospital performs these procedures, I encourage you to perform a review of these inpatient records for documentation supporting medical necessity of the procedure and the inpatient stay.

Moving Forward

In July of this year, each of the RACs posted the following notice: “The Centers for Medicare & Medicaid Services (CMS) is required to protect the Medicare Trust Fund against inappropriate payments which pose a risk to the Trust Fund. Therefore, we are resuming Medicare Fee-for-Service medical review activities. The COVID-19 Public Health Emergency (PHE) continues to be monitored very closely.”

It is important to be aware of who your review contractors are, what issues they are focused on, and respond to ADRs in a timely manner. If you are unsure of who your review contractors are you can find out by using the CMS Review Contractor Directory – Interactive Map (link).

Beth Cobb

CMS Proposed Rule: Unleashing Innovative Technology
Published on Oct 20, 2020
20201020
 | Billing 
 | Coding 

Pre-orders have started for Apple’s soon to be released iPhone 12. Imagine what it would be like for devoted iPhone fans if the time from placing a pre-order to when you could actually hold one in your hands followed the CMS timeline for approval for new healthcare technologies. This would definitely not be the timeline for creating and maintaining a consumer base of people wanting the latest technology available in an iPhone.

In September, 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.”

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.

Current Medicare Coverage Pathways

The MCIT pathway is being 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 details current Medicare coverage pathways in this proposed rule. Each pathway is highlighted in the following table. 

Current Medicare Coverage Pathways
PathwayPathway DescriptionStatutorily 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 AdjudicationCoverage 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 ReviewThis 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.

Proposed MCIT Coverage Pathway

The MCIT Coverage Pathway would be specifically for Medicare coverage of devices that are designated as part of the FDA Breakthrough Devices Program and are FDA market authorized. The pathway would involve a coordinated effort by CMS, the FDA and manufacturers as medical devices move through the FDA regulatory process for Breakthrough devices. This simultaneous effort will ensure Medicare coverage on the date of FDA market authorization for all devices that fall within a Medicare benefit category.

MCIT Pathway Proposals:

  • The pathway would be voluntary and be initiated when a manufacturer notifies CMS of its intention to utilize the MCIT pathway.
  • To be part of the MCIT Pathway, the device must be used in accordance with its FDA approved or cleared indication for use.
  • Unlike the pathways in the above table, CMS is proposing that that MCIT Pathway would 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.
  • If CMS has issued an NCD for a specific breakthrough device, it would not be eligible for the MCIT pathway.
  • Coverage would continue for up to 4 years, unless CMS determines the device does not have a Medicare benefit category as determined as part of the pathway process.
  • Reasons that the MCIT pathway may end prior to 4 years includes circumstances where a device becomes subject to an NCD, regulation, statute, or if the device can no longer be lawfully marketed.

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.

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. They are also seeking comments on whether or not a National Coverage Analysis should be opened if a MAC has not issued an LCD within 6 months of the expiration date of the MCIT period.

MCIT Device Eligibility

CMS is proposing that devices having received Breakthrough Device designation within 2 years of the date this proposed rule is finalized will be eligible for coverage for claims submitted on or after the effective date of the final rule. This group of devices would not be eligible for all 4 years of MCIT coverage as the 4 year period starts on the date of FDA market authorization. CMS anticipates 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.

Proposal to Codify Definition of “Reasonable and Necessary”

In addition to the proposed MCIT Pathway, CMS is proposing 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.”

Proposal: “An item or service would be considered ‘‘reasonable and necessary’’ if it is— (1) safe and effective; (2) not experimental or investigational; and (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is:

  • 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;
  • Furnished in a setting appropriate to the patient’s medical needs and condition;
  • Ordered and furnished by qualified personnel;
  • One that meets, but does not exceed, the patient’s medical need; and
  • At least as beneficial as an existing and available medically appropriate alternative.”

Proposal: An item or service would be “appropriate for Medicare patients” under (3) if it is covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals.

Proposal: An item or service deemed appropriate for Medicare coverage based on commercial coverage would be covered on that basis without also having to satisfy the bullets listed above.

CMS Seeking Comments to the Proposed Rule

In the world of CMS proposed rules, this one makes for a quick read at just 13 pages in the Federal Register. CMS is seeking comments on many aspects of this proposed rule and comments must be received by CMS no later than 5 p.m. on November 2, 2020.

Resources

CMS Press Release: CMS Acts to Spur Innovation for America’s Seniors https://www.cms.gov/newsroom/press-releases/cms-acts-spur-innovation-americas-seniors

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

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

Proposed Rule (CMS-3372-P)

https://www.federalregister.gov/documents/2020/09/01/2020-19289/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and

Beth Cobb

Medicare Transmittals Effective October 2020
Published on Sep 09, 2020
20200909

To paraphrase a Barbara Mandrell song, I was a pumpkin spice latte fan before pumpkin spice was cool. In fact, two weeks ago I drank my first pumpkin spice latte for 2020. Did you know that one grande pumpkin spice latte from Starbucks has about 150mg of caffeine? That is enough caffeine to be equivalent to about two shots of expresso. To keep with musical references, Amy Grant once referred to expresso as being a “nap in a can” on one of her live albums. 

So why the focus on caffeine? The October 1st start date of the 2021 CMS Fiscal Year is just 22 days from today and CMS has been publishing updates effective October 1st at a pace worthy of a shot or two of expresso to keep you energized as you prepare for these changes. This article highlights recently released MLN articles providing guidance on updates effective October 1st.

Modify Edits in the Fee for Service (FFS) System when a Beneficiary has a Medicare Advantage (MA) Plan

  • Article Release Date: July 21, 2020 – Revised July 21, 2020
  • What You Need to Know: This article is “for providers, especially hospitals, submitting claims to Medicare Administrative Contractors (MACs) for Part A services provided to Medicare beneficiaries when a beneficiary’s Medicare Advantage (MA) plan becomes effective during the inpatient admission.”
  • MLN MM11580: https://www.cms.gov/files/document/mm11580.pdf
  • Change Request 11580: https://www.cms.gov/files/document/r10229CP.pdf
  • Effective Date: October 1, 2020
  • Implementation Date: October 5, 2020

Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Code 87426

New Waived Tests

  • Article Release Date: July 28, 2020
  • What You Need to Know: This article provides information about five new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests that have been approved by the FDA. These tests are marketed immediately after approval so CMS must notify the MACs of the new tests for accurate claims processing. “Note: MACs will not search their files to either retract payment or retroactively pay claims. However, MACs should adjust claims if you bring those claims to their attention.
  • MLN Matters MM11916: https://www.cms.gov/files/document/mm11916.pdf
  • Change Request 11916: https://www.cms.gov/files/document/r10230CP.pdf
  • Effective Date: October 1, 2020
  • Implementation Date: October 5, 2020

July 31, 2020: CMS Releases Inpatient Psychiatric Facility (IPF), Skilled Nursing Facilities (SNF), and Hospices FY 2021 Final Rules

CMS announced in a News Alert that they are “finalizing three Medicare payment rules that further advance our efforts to strengthen the Medicare program by better aligning payments for inpatient psychiatric facilities (IPF), skilled nursing facilities (SNF) and hospices.”   For fact sheets on each final rule, visit:

Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year 2021

  • Article Release Date: August 21, 2020
  • What You Need to Know: This article provides updates related to the IPF PPS FY 2021 Final Rule including information about:
  • Market Basket Update,
  • FY 2021 Wage Index Update,
  • IPF Quality Reporting Program,
  • PRICER Updates,
  • ICD-10 CM/PCS Updates,
  • Cost of Living Adjustment (COLA) Adjustment, and
  • Rural Adjustment.
  • MLN MM11949: https://www.cms.gov/files/document/mm11949.pdf
  • Change Request 11949: https://www.cms.gov/files/document/r10312CP.pdf
  • Effective Date: October 1, 2020
  • Implementation Date: October 5, 2020

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

  • Article Release Date: August 7, 2020 – Revised August 24, 2020
  • What You Need to Know: This article provides information about the quarterly update to the clinical laboratory fee schedule. On August 24th it was updated to reflect changes to Change Request (CR) 11937 that includes additional COVID-19 codes 86408, 86409, 0225U, 0226U, effective August 10, 2020. This CR also added codes 0015M and 0016M, effective October 1, 2020.
  • MLN MM11937: https://www.cms.gov/files/document/mm11937.pdf
  • Change Request 11937: https://www.cms.gov/files/document/r10318CP.pdf
  • Effective Date: October 1, 2020
  • Implementation Date: October 5, 2020

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – October 2020 Update

October 2020 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files – REVISED

Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2021

  • Article Release Date: July 2, 2020 – Revised August 19, 2020
  • What You Need to Know: This article was revised to reflect a revised CR 11859 which “shows that effective for Fiscal Year (FY) 2021, a 5 percent cap will be adopted and applied to all Skilled Nursing Facility providers on any decrease to a provider’s FY 2021 final wage index from that provider’s final wage index of the prior fiscal year (FY 2020).”
  • MLN MM11859: https://www.cms.gov/files/document/MM11859.pdf
  • Change Request 11859: https://www.cms.gov/files/document/r10314CP.pdf
  • Effective Date: October 1, 2020
  • Implementation Date: October 5, 2020

October 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS)

October 2020 Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.3

October Quarterly Update for the 2020 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

  • Article Release Date: August 28, 2020
  • What You Need to Know: This article provides details about the changes to the DMEPOS fee schedules that Medicare updates quarterly, when necessary, to implement fee schedule amounts for new and existing codes, as applicable, and apply changes in payment policies. Specific to the ongoing Public Health Emergency (PHE) due to the COVID-19 pandemic, “the October 2020 DMEPOS and PEN fee files continue to include the non-rural contiguous non-CBA 75/25 blended fees required by Section 3712(b) of the CARES Act signed into law on March 27, 2020.
  • MLN MM11956: https://www.cms.gov/files/document/mm11956.pdf
  • Change Request 11956: https://www.cms.gov/files/document/r10334CP.pdf
  • Effective Date: October 1, 2020
  • Implementation Date: October 5, 2020

Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice PRICER for FY 2021

Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) PRICER Changes for FY 2020

As if all of this isn’t expresso worthy, the FY 2021 Inpatient Prospective Payment System Final Rule was released last Wednesday September 2nd. So grab yourself a pumpkin spice latte and enjoy while reading about MS-DRGs changes in the IPPS Final Rule discussed in a related article in this week’s edition of Wednesday@One.

Beth Cobb

April Medicare Transmittals and Other Updates
Published on Apr 28, 2020
20200428

MEDICARE TRANSMITTALS – RECURRING UPDATES

 

April 2020 Average Sales Price (AS) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

  • Article Release Date: March 20, 2020
  • What You Need to Know: Article informs MACs about new and revised Average Sales Price (ASP) and ASP Not Otherwise Classified (NOC) drug pricing files for Medicare Part B drugs.
  • MLN MM11701: https://www.cms.gov/files/document/mm11701.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 26.2, Effective July 1, 2020

  • Article Release Date: March 27, 2020
  • What You Need to Know: This MLN article is a companion article to Change Request 11734 which providers the quarterly updated to the NCCI PTP edits. CMS advises making sure your billing staffs know the updates.
  • MLN MM11734: https://edit.cms.gov/files/document/mm11734.pdf

July 2020 Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

  • Article Release Date: March 27, 2020
  • What You Need to Know: Related Change Request (CR) 11745 informs MACs about new and revised Average Sales Price (ASP) and ASP Not Otherwise Classified (NOC) drug pricing files for Medicare Part B drugs. The Centers for Medicare & Medicaid Services (CMS) supplies MACs with the ASP and NOC drug pricing files for Medicare Part B drugs on a quarterly basis. Payment allowance limits under the Outpatient Prospective Payment System (OPPS) are incorporated into the Outpatient Code Editor (OCE) through separate instructions that are available in Chapter 4, Section 50 of the Medicare Claims Processing Manual. Make sure your billing staffs are aware of these changes.
  • MLN MM11745: https://www.cms.gov/files/document/mm11745.pdf

April 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS)

Quarterly Update to the Fiscal Year 2020 Inpatient Psychiatric Facilities Pricer

  • Article Release Date: April 10, 2020
  • What You Need to Know: CR 11759 updates the Inpatient Psychiatric Facilities (IPF) Pricer software used in Medicare claims procession. This update includes updates to the comorbidity tables to include the new ICD-10 diagnosis code for COVID-19 (U01.7) effective for claims with discharges on or after April 1, 2020.
  • MLN MM11758: https://www.cms.gov/files/document/mm11759.pdf

Quarterly Update to the Long Term Care Hospital (LTCH) Prospective Payment System (PPS) Fiscal Year (FY) 2020 Pricer

  • Article Release Date: April 24, 2020
  • What You Need to Know: CT 11742 updates the LTCH Pricer software. The new version include the payment policy for an LTCH that is subject to the Discharge Payment Percentage (DPP) payment adjustment described in CR 11616. CR 11742 also included new payment policy for COVID-19.
  • MLN MM11742: https://www.cms.gov/files/document/MM11742.pdf

July 2020 Quarterly Update to the Inpatient Prospective Payment System (IPPS) Fiscal Year (FY) 2020 Pricer

  • Article Release Date: April 24, 2020
  • What You Need to Know: CR 11764 updates the FY 2020 IPPS Pricer software. This new version includes new payment policy for individuals diagnosed with COVID-19.
  • MLN MM11764: https://www.cms.gov/files/document/MM11764.pdf

 

OTHER MEDICARE TRANSMITTALS

 

NCD (20.32) Transcatheter Aortic Valve Replacement (TAVR)

  • Article Release Date: March 13, 2020
  • What You Need to Know: Effective June 21, 2019, CMS will continued coverage of TAVR under Covered with Evidence Development (CED) when the procedure is provided for the treatment of symptomatic aortic valve stenosis and according to a FDA-approved indication for use with an approved device.
  • MLN MM11660: https://www.cms.gov/files/document/mm11660.pdf

The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year 2018 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitations Facilities (IRFs), and Long Term Care Hospitals (LTCHs)

  • Article Release Date: 3/13/2020
  • What You Need to Know: This MLN article includes links to hospital specific data for determining adjustments to be made for caring for low-income patients (LIP).
  • MLN MM11679: https://www.cms.gov/files/document/MM11679.pdf

Supplier Education on Use of Upgrades for Multi-Function Ventilators

  • Article Release Date: April 3, 2020
  • What You Need to Know: This article informs DME suppliers that effective immediately, you may provide and bill for multi-function ventilators described by code E0467 as an upgrade in situations where beneficiaries only meet the coverage criteria for a ventilator.
  • MLN SE20012: https://www.cms.gov/files/document/se20012.pdf

New Waived Tests

  • Article Release Date: April 17, 2020
  • What You Need to Know: Change Request 11747 informs MACs of new Clinical Laboratory Amendments of 1988 (CLIA) waived tests by the FDA. These tests are marketed immediately after approval and as such, the CMS must notify MACs of the new tests for accurate claims processing. The following statement is included in the article: “Note: MACs will not search their files to either retract payment or retroactively pay claims; however, MACs should adjust claims if you bring those claims to their attention.”
  • MLN MM11747: https://www.cms.gov/files/document/mm11747.pdf

 

REVISED MEDICARE TRANSMITTALS

 

New Medicare Beneficiary Identifier (MBI) Get It, Use It – Revised

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

  • Article Revised: March 24, 2020
  • What You Need to Know: This article was revised to reflect an update CR 11604. CR 11640 informs the MACs about new HCPCS codes for 2020 that are subject to and excluded from CLIA Edits.
  • MLN MM11640: https://www.cms.gov/files/document/mm11640.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 26.1, Effective April 1, 2020

  • Article Revised: March 25, 2020
  • What You Need to Know: This article was revised to reflect a revised Change Request (CR) 11628. This revision had no impact on the substance of the article.
  • MLN MM11628: https://www.cms.gov/files/document/mm11628.pdf

Implementation of Additional Requirements to add HCPC and CPT as Paired Items of Service for Prior Authorization and Medicare Claims Processing for Part A, Part B, DME, and Home Health and Hospice

  • Change Request revised date: March 27, 2020
  • What You Need to Know: Transmittal 2438, dated February 21, 2020 was rescinded and replaced with Transmittal 10021, dated March 27, 2020 to remove business requirement 11516.7 and to change the PA Program Indicator in the attachment Criteria Template. All other information remains the same.
  • Transmittal 10021: https://www.cms.gov/files/document/r10021otn.pdf

April 1, 2020: Update to ICD-10-CM for Vaping Related Disorder and 2019 Novel Coronavirus (COVID-19)

  • Article Revised: April 1, 2020
  • What You Need to Know: This article was revised to reflect the update to Change Request (CR) 11623 where the new ICD-10-CM code for the 2019 Novel Coronavirus (COVDI-19) was added.
  • MLN MM11623: https://www.cms.gov/files/document/MM11623.pdf

April 2020 Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.1

  • Article Revised: April 1, 2020
  • What You Need to Know: CR 11680 provides the I/OCE instruction and specifications for the April 1, 2020 updates. This article was revised to reflect the CR revisions adding information to Table 1, including COVID-19 changes.
  • MLN MM11680: https://www.cms.gov/files/document/MM11680.pdf

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

  • Article Revised: April 6, 2020
  • What You Need to Know: This article was revised to reflect revisions to Change Request 1168 where the section on the delay of the CLFS reporting period was removed and the following codes were added:
  • 87635: added to HCPCS file, effective March 13, 2020
  • Two new COVID-19 test codes (G2023 and G2024), effective March 1, 2020
  • MLN MM11681: https://www.cms.gov/files/document/mm11681.pdf

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – April 2020 Update – Revised

Claim Status Category and Claim Status Codes Update

  • Article Revised: April 10, 2020
  • What You Need to Know: This MLN article was revised to reflect a revised Change Request (CR) 11467. Specifically the Uniform Resource Locators (URLs) references (page 2 in this article) in Background Section in the CR was revised.
  • MLN MM11467: https://www.cms.gov/files/document/mm11467.pdf

April 2020 Updated of the Ambulatory Surgical Center (ASC) Payment System - Revised

  • Article Revised: April 14, 2020
  • What You Need to Know: CR 11694 describes changes to and billing instructions for various payment policies implemented in the April 2020 ASC payment system update. MLN 11694 was revised on April 14th due the revised CR that added information on Q4206 to the policy section of the CR (page 6 in the MLN article).
  • MLN MM11694: https://www.cms.gov/files/document/mm11694.pdf

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

  • Article Revised: April 16, 2020
  • What You Need to Know: This article was updated to reflect a revised WPC website address in the background section of Change Request 11638 on page 2 of the article. All other information remained the same.
  • MLN MM11638: https://www.cms.gov/files/document/mm11638.pdf

Implement Operating Rules – Phase III Electronic Remittance Advice (ERAA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) – Update from Council for Affordability Quality Healthcare (CAQH) CORE

  • MLN Article Revised: April 23, 2020
  • What You Need to Know: This article was revised to reflect the revised Change Request (CR) 11490. Specifically, the CR updated the WPC website address. This change was made in this Article as well as changing the CR Release Date to April 23, 2020.

 

MEDICARE COMPLIANCE TIPS

 

Medicare Advance Written Notices of Non-Coverage MLN Booklet Revised

CMS noted in the April 9, 2020 MLNConnects eNewsletter that a revised Medicare Advance Written Notices of Noncoverage Medicare Learning Network Booklet is now available. This booklet provides guidance on how to complete the form and collect payment.

 

OTHER MEDICARE UPDATES

 

Fiscal Year (FY) 2021 Proposed Rules Released April 10, 2020: Skilled Nursing Facilities, Inpatient Psychiatric Facilities, and Hospice

On April 10th CMS released Fact Sheets announcing the FY 2021 Proposed Rules for Skilled Nursing Facilities, Inpatient Psychiatric Facilities and Hospice have been put on display in the Federal Register. In each of the Fact Sheets, CMS notes the proposed rules are being published consistent with legal requirements to update Medicare payment policies. CMS acknowledges that the entire healthcare system is focused on responding to the COVID-19 public health emergency. 

  • FY 2021 Proposed Medicare Payment and Policy Changes for Skilled Nursing Facilities (CMS-1737-P) CMS Fact Sheet
  • FY 2021 Proposed Medicare Payment and Policy Changes for Inpatient Psychiatric Facilities (CMS-1731-P) CMS Fact Sheet
  • FY 2021 Hospice Payment Rate Update Proposed Rule (CMS-1733-P) CMS Fact Sheet

CMS is accepting comments on all three proposed rules through June 9, 2020.

March 18, 2020: Advanced Beneficiary Notice Form Update

CMS put the following announcement on the CMS Fee-for-Service ABN webpage:

“The ABN, Form CMS-R-131, is currently awaiting OMB approval for renewal. CMS will provide instructions when it does get approved.  In the meantime, continue to use the current form until further instruction is provided.”

March 27, 2020: KEPRO Releases Spring 2020, Special COVID-19 Edition Newsletter

The following topics are included in the Spring 2020 edition of KEPRO’s Case Review Connections newsletter:

  • COVID-19 Guidance for Providers,
  • Beneficiary Notice Delivery Guidance in Light of COVID-19,
  • Frequently Asked Questions,
  • An Immediate Advocacy Success Story; and
  • Staff Education about BFCC-QIO Services.

April 16, 2020: CMS Fact Sheet: Fiscal Year (FY) 2021 Inpatient Rehabilitation Facilities (IRF) Prospective Payment System (PPS) Proposed Rule (CMS-1729-P)

Similar to the proposed rules released on April 10th, CMS indicates this proposed rule is being published consistent with legal requirements. They go on to indicate that “In recognition of the significant impact of the COVID-19 public health emergency, and limited capacity of health care providers to review and provide comment on extensive proposals, CMS has limited annual IRF rulemaking required by statute to essential policies including Medicare payment to IRFs, as well as proposals that reduce provider burden and may help providers in the COVID-19 response.” CMS is accepting comments on this proposed rule until June 15, 2020.

April 21, 2020: CMS Interoperability and Patient Access Final Rule

This Final Rule was initially released on March 9th, 2020. However, it took until April 21st for the

unpublished version to be filed in the Federal Register. The Final Rule is scheduled to be published in the Federal Register on May 1, 2020. Following is an excerpt from a related CMS Press Release detailing how this Rule will impact hospitals:

“To further advance the mission of fostering innovation, the CMS final rule establishes a new Condition of Participation (CoP) for all Medicare and Medicaid participating hospitals, requiring them to send electronic notifications to another healthcare facility or community provider or practitioner when a patient is admitted, discharged, or transferred. These notifications can facilitate better care coordination and improve patient outcomes by allowing a receiving provider, facility, or practitioner to reach out to the patient and deliver appropriate follow-up care in a timely manner.”

Effective Date for New CoP

In the March 9th release of the Final Rule CMS stated the CoPs would be effective 6 months after the Rule was published in the Federal Register. However, the Final Rule currently on display indicates this date has been changed to indicate the new CoPs at 42 CFR Parts 482 and 485 will now be effective 12 months after the Final Rule is published in the Federal Register. This delay is due to CMS recognizing that hospitals, including psychiatric hospitals, and critical access hospitals, are on the front line of the COVID-19 public health emergency. You can learn more about this Final Rule on the CMS Interoperability and Patient Access final rule webpage.

April 24, 2020: 340B Hospital Survey

The 340B hospital survey is now available for hospitals paid under the OPPS, that were enrolled in the 340B program during calendar year Q4 2018 and/or Q1 2019. Both a detailed and "Quick Survey" method are available to submit 340B-acquired drug acquisition cost information to the Centers for Medicare & Medicaid Services through https://www.340bsurvey.com/survey. The survey closes on May 15, 2020.

New Modifiers for Therapy Assistant Services
Published on Dec 17, 2019
20191217

Does it seem that people are less willing to make concessions these days than in the past? I am not sure if this is generally true, but if you look at our governments, it certainly seems so. In Britain, the government cannot agree or compromise to accomplish Brexit, and in our own country, the political parties cannot seem to agree on anything. They also seem completely unwilling to compromise or offer any concessions to the opposing viewpoint. Due to my cynicism from such an environment, I was a bit surprised to read in the 2020 Physician Fee Schedule (PFS) Final Rule  that CMS made 3 significant concessions concerning the requirements for the new modifiers for therapy services provided in whole or in part by a therapy assistant.

These new modifiers are mandated by the Balanced Budget Act (BBA) of 2018 which required that these modifiers:

  • Be established by January 1, 2019;
  • Be applied to claims lines for outpatient therapy services being furnished in whole or in part by a therapy assistant for dates of services beginning on January 1, 2020; and
  • Effectuate a payment reduction for services furnished on and after January 1, 2022.

This is all in keeping with the major intent of the BBA provision that “for services furnished on or after January 1, 2022, payment for outpatient physical and occupational therapy services for which payment is made under sections 1848 or 1834(k) of the Act which are furnished in whole or in part by a therapy assistant must be paid at 85 percent of the amount that is otherwise applicable.”

This means beginning in 2022, therapy services furnished by physical or occupational therapy assistants will be paid less than services provided by therapists – 15% less to be specific. These services will be paid 85% of the usual applicable payment rate. For example, if a unit of therapeutic exercise (CPT 97110) is normally paid $35, when billed with one of the assistant modifiers, the payment would be $29.75. Remember the PFS therapy rates are dependent on your carrier jurisdiction and the multiple procedure payment reductions (MPPR) continue to apply also.

The modifiers that are required to be reported on therapy line items when the services are furnished in whole or in part by a therapy assistant beginning in 2020 are:

  • CQ Modifier: Outpatient physical therapy services furnished in whole or in part by a physical therapist assistant.
  • CO Modifier: Outpatient occupational therapy services furnished in whole or in part by an occupational therapy assistant.

These new modifiers will be reported alongside the GP and GO modifiers used to identify services furnished under a PT or OT plan of care, respectively. Other modifiers used for therapy services, such as the KX and 59 modifiers, should also continue to be reported. Thank goodness the functional limitation reporting modifiers are no longer required.

In the 2019 PFS Final Rule, CMS finalized a de minimis standard under which a service is considered to be furnished in whole or in part by a PTA or OTA when more than 10% of the service is furnished by the PTA or OTA. For example, for therapy services of 60 minutes, 10% would be 6 minutes and for the assistant to furnish more than 10% would be 7 minutes or more. This means once the PTA/OTA furnishes at least 7 minutes of the service, the CQ/CO modifier would be required to be added to the claim for that service. Untimed codes include services such as evaluative services, group therapy, and supervised modalities. Although assistants cannot perform an evaluation or re-evaluation, they can assist the therapists by performing clinical labor tasks such as obtaining vital signs, providing self-assessment tools to the patient and verifying their completion.

So, what are the concessions CMS made concerning the new therapy modifiers?

  • CMS agreed with commenters that the time when a therapist and a therapist assistant furnish services to the same patient at the same time should not be counted as part of the assistant time. This means the time spent by a PTA/OTA furnishing a therapeutic service “concurrently,” or at the same time, with the therapist will not count for purposes of assessing whether the 10 percent standard has been met. The final policy is that only the minutes that the PTA/OTA spends independent of the therapist will count towards the 10 percent de minimis standard.
  • CMS proposed, for billing purposes, that each outpatient therapy service that is subject to the 10 percent de minimis standard would be identified on the claim by a single procedure code, for both untimed codes and codes described in 15-minute-unit increments. Commenters pointed out the 15-minute code issue, so CMS finalized a revised definition of a service to which the de minimis standard is applied to include untimed codes and each 15-minute unit of codes described in 15-minute increments as a service. This revised definition will allow the separate reporting, on two different claim lines, of the number of 15-minute units of a code to which the therapy assistant modifiers do not apply, and the number of 15-minute units of a code to which the therapy assistant modifiers do apply.

For a 15-minute increment that equals 1 unit of a timed code, the assistant would have to furnish 3 or more minutes of the treatment to meet the 10% de minimis standard. If a PTA independently furnishes 8 consecutive minutes of therapeutic exercises to a patient who receives a total of 45 minutes of ther ex (therapist provides the other 37 minutes of ther ex), then the hospital would bill 2 units of CPT 97110 without the CQ modifier and 1 unit of CPT 97110 with the CQ modifier.

  • CMS proposed to add a requirement that the treatment notes explain, via a short phrase or statement, the application or non-application of the CQ/CO modifier for each service furnished that day. CMS agreed that the addition of narrative phrases for each service could be duplicative of existing documentation requirements so they did not finalize this requirement. Neither does the documentation have to specify therapist and therapy assistant minutes.

However, CMS does expect the documentation in the medical record to be sufficient to know whether a specific service was furnished independently by a therapist or a therapist assistant, or was furnished “in part” by a therapist assistant, in sufficient detail to permit the determination of whether the 10% standard was exceeded.

Particularly related to number 1 and 2 above, CMS intends to provide further detail regarding examples of clinical scenarios to illustrate their final policies regarding the applicability of the therapy assistant modifiers through information that will be posted on the cms.gov website. Check the CMS therapy website at https://www.cms.gov/Medicare/billing/therapyServices/index for updates.

The modifier reporting and future payment reductions do not apply to critical access hospitals (CAHs) or to other providers that are not paid based on PFS rates. It also does not apply to outpatient therapy services that are furnished by, or incident to the services of, physicians or nonphysician practitioners (NPPs). This is because only therapists and not therapy assistants can furnish outpatient therapy services incident to the services of a physician or NPP.

Bottom line for hospitals – be sure to have the new therapy assistant modifiers set up and processes in place to get them appended to line item therapy services. Apply the modifiers:

  • To all therapy services’ billing codes that are furnished in whole by therapy assistants,
  • To untimed therapy services’ billing codes when an assistant independently furnishes more than 10% of the service (time of service divided by 10, rounded to the nearest whole integer, plus one minute)
  • To timed 15-minute increments of a timed-code service when the assistant independently furnishes 3 minutes or more of a 15-minute service (for services > 8 minutes, but < 23, determine 10% as described above for untimed codes, i.e. 8-14 minutes – 2 minutes Assistant time; 15-23 minutes – 3 minutes Assistant time).

This last explanation of assistant time for timed codes is my understanding from the discussion in the final rule. I will be looking for more examples from CMS as promised to verify my understanding is correct. I definitely concede that Medicare rules can be difficult to understand and follow.

Debbie Rubio

The 2020 OPPS Final Rule - Clinic Visits and Drug Payment Policies
Published on Dec 11, 2019
20191211

My youngest son got married earlier this month, and I have already conveyed to him and his bride my desire for more grandchildren. Grandkids are such fun because you can love on them and spoil them, then turn them back over to their parents for the serious stuff. A friend of mine has a one-year old granddaughter and I love to spend time with her. She is currently learning the word “no,” and I get to sit back and smile as it is obvious that she knows what it means but pretends she doesn’t. That slight hesitation and determined expression are “cute” from my perspective, but frustrating for her parents as she proceeds with her actions, undeterred by their instruction of “No!”

Do you think the judicial system and affected parties are frustrated by CMS’s decisions to go forward with certain actions when the judicial system has given the instruction of “no?” Maybe CMS is more like teenagers than babies, because they are old enough to argue, and are putting forth appeals, the potential to appeal, and alternative options as they proceed with their original actions. The 2020 Outpatient Prospective Payment System (OPPS) Final Rule was released Friday, November 1, 2019 and CMS is continuing for 2020 a couple of policies the courts have already found to be inappropriate.

First is the reduction in payment for clinic visits performed in excepted off-campus provider-based departments (PBDs). A little history here – in November 2015, Congress passed a law to pay “new” off-campus hospital provider-based departments that began furnishing and billing for services on or after November 2, 2015 at a different, lower payment rate than that of OPPS. This was done to address concerns about higher payments for services provided in hospital outpatient departments than the lower payments for the same services provided in a physician office setting. Hospitals were instructed to report the services in these non-excepted off-campus PBDs with a PN modifier and CMS determined to pay these under the physician fee schedule at 40% of the OPPS rate (a payment reduction of 60%). Services provided in excepted off-campus PBDs and reported with the PO modifier continued to be paid at OPPS rates at that time. That is until 2019, when CMS decided to expand site-neutrality payments further to include clinic visits (HCPCS code G0463) provided in excepted off-campus PBDs. They phased in the 60% payment reduction over two years, with a 30% reduction for 2019 and the full 60% reduction in 2020 – this makes the payment for clinic visits at all off-campus PBDs the same as the physician fee schedule payment for non-excepted PBD services of 40% of OPPS payment rates.

CMS claims they are “removing the payment differential that drives the site-of-service decision and, as a result, unnecessarily increases service volume.” They further claim they are doing this under authority of a certain section of the Social Security Act that gives them power “to adopt a method to control unnecessary increases in the volume of covered outpatient department services.” They are also implementing this payment reduction in a “non-budget neutral manner” which means the costs savings to the Medicare program will not be redistributed back to hospitals. So far, the courts have not agreed with CMS on their authority to implement this payment reduction policy.

On September 17, 2019, the United States District Court for the District of Columbia entered an order vacating the portion of the CY 2019 OPPS/ASC final rule that adopted the payment reduction for clinic visit services furnished by excepted off-campus PBDs. In October, the district court denied CMS’s request for stay and entered final judgment. CMS acknowledges the court’s decision and states they are “working to ensure affected 2019 claims for clinic visits are paid consistent with the court’s order.” Despite these statements, CMS chose to proceed with the second year of the two-year phase-in of the clinic visit policy for 2020. This means for CY 2020, clinic visits (G0463) provided in excepted off-campus PBDs and billed with the PO modifier will be paid at 40% of the OPPS payment rate. CMS states they have appeal rights and are still considering whether to appeal the final judgement or not.

The second policy for which the courts have issued a negative opinion is the payment of drugs purchased through the 340B program at Average Sales Price (ASP) minus 22.5%. The district courts have found that for both the 2018 and 2019 payment reductions, CMS exceeded their statutory authority by making such a large adjustment in payment rate. The case is currently under appeal from CMS and although they are requesting comments on options to remedy the underpayments of those years, they are also proceeding for 2020 with the same reduced payment amount of ASP-22.5% for drugs purchased through the 340B program including such drugs in a non-excepted off-campus PBD.

Since this policy was implemented in a budget-neutral manner (money saved was redistributed to all OPPS hospitals) and a remedy is “no easy task, given Medicare’s complexity,” the courts have remanded the issue to HHS to devise an appropriate remedy while also retaining jurisdiction. There is abundant discussion, comments and responses in the Final Rule about possible options to address the underpayments. As part of one such remedy, CMS is conducting a 340B hospital survey to collect drug acquisition cost data for CY 2018 and 2019. Since the district court has acknowledged that CMS may base the Medicare payment amount on average acquisition cost when survey data are available, it is obvious in the FR that CMS expects the survey data to show that ASP minus 22.5% was a conservative adjustment that overcompensates hospitals. If so, this remedy would get CMS out of their bind and possibly allow the current reduced payment rate to stand. The Final Rule does offer other options for consideration.

For other drugs and biologicals, CMS finalized the following policies:

  • A packaging threshold of $130 – this means Medicare will package items with a per day cost less than or equal to $130, and identify items with a per day cost greater than $130 as separately payable unless they are policy-packaged (such as anesthesia, intraoperative items, and drugs that function as supplies, etc.)
  • A payment rate of ASP plus 6% for pass-through and separately payable non-pass-through drugs other than those purchased through the 340B program
  • Payment rate of Wholesale Acquisition Costs (WAC) plus 3% for drugs paid under WAC (such as when ASP data is not available)

Like stubborn children, the policies of the OPPS Final Rule show that just because CMS has been told “no” does not mean they plan to change their ways. We will be addressing other policies and decisions from the OPPS Final Rule in future articles in this newsletter.

Debbie Rubio

2020 OPPS Final Rule - Supervision of Therapeutic Services and Prior Authorizations
Published on Nov 19, 2019
20191119

Over the past few weeks, articles in our Wednesday@One newsletter have addressed some of the new and revised policies from the 2020 Medicare Outpatient Prospective Payment System (OPPS) Final Rule. One such article last week discussed the continuation of two policies that the courts have already found to be outside of CMS’s authority – 1) the second year and further decrease in payment rates for outpatient clinic visits in excepted off-campus provider-based departments to the same rate (40% of OPPS rates) as paid for services in nonexcepted off-campus PBDs and 2) payment of separately payable drugs purchased through the 340B program at average sales price (ASP) minus 22.5%. This article will examine the changes in the level of supervision required for hospital outpatient therapeutic services and the new requirement for prior authorization for select cosmetic procedures. The change in supervision requirements is a relief for hospitals, especially critical access and small rural hospitals. Unfortunately, the prior authorizations are an added burden on hospitals, regardless of how CMS tries to couch it.

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

Around 2010 and in subsequent years, CMS “clarified” in the OPPS final rules, that they expected direct supervision of therapeutic services in a hospital outpatient setting.  Direct supervision in a hospital was defined to mean that a physician was immediately available to direct or take over performance of the procedure. Due to the difficulties in meeting this requirement, CMS or Congress have continually had a nonenforcement rule for CAHs and small rural hospitals for this policy, the latest of which is expiring December 31, 2019. You can read more about the direct supervision requirements and where we currently stand in a prior Wednesday@One article.

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. CMS took this action to reduce the burden for outpatient hospital providers, to allow more flexibility to provide medical care, and to eliminate what has in effect been a two-tiered system of supervision levels between CAHs/small rural hospitals and all other hospitals. CMS feels comfortable changing the required level of supervision for hospital outpatient therapeutic services because:

  • CMS is not aware of any supervision-related complaints from patients or of any data or information from providers indicating the quality of care for services furnished under general supervision was affected,
  • There are Medicare Conditions of Participation (CoPs) and State and federal laws that require physician direction and supervision of hospital services to ensure the safety, health, and quality standards of outpatient therapeutic services,
  • Hospitals and physicians can decide to furnish direct supervision for services when they believe a higher level of supervision is necessary to ensure the quality and safety of the procedure and to protect the patient from complications that might occur,
  • CMS retains the ability to change the supervision level of an individual hospital outpatient therapeutic service or the default minimum level to a more intensive level of supervision, and
  • CMS plans to monitor care furnished to Medicare beneficiaries to determine if there is any decline in the quality of therapeutic outpatient services provided as a result of this policy.

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

Prior Authorization for Select Hospital Outpatient Services

As part of their responsibility to protect the Medicare Trust Funds, CMS routinely monitors the utilization of services. They have identified several surgical procedures with higher than expected volume increases that could be potentially noncovered by Medicare due to their cosmetic nature. In order to manage the growth of Medicare spending and control unnecessary increases in the volume of hospital outpatient department (OPD) services, CMS is implementing a policy for the prior authorization of certain procedures to “reduce the instances in which Medicare pays for these services when they are merely cosmetic and not medically necessary.”

  • The affected procedures are blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty and vein ablation. A listing of the affected CPT codes can be found in the final rule. (See page 316 of the 2020 OPPS Final Rule pdf.)
  • The requirement would begin for dates of service on or after July 1, 2020.
  • Prior authorization is a process through which a request for provisional affirmation of coverage is submitted to Medicare or its contractors for review before the service is provided to the patient and before the claim is submitted.
  • The PA request should include all documentation necessary to show that the service meets applicable Medicare coverage, coding and payment rules.
  • Claims submitted for services that require a PA that have not received a provisional affirmation of coverage from Medicare would be denied unless the provider is exempt.
  • Claims associated with the denied service, such as anesthesiology services, physician services, and/or facility services will also be denied.
  • Upon submission of a PA request, CMS or its contractors would issue a decision (affirmative or non-affirmative) within 10 business days.
  • Providers can request an expedited review if a delay could seriously jeopardize the patient’s life, health or ability to regain maximum function and a decision will be rendered within 2 business days. Documentation supporting the risk of serious jeopardy must be submitted with the request for an expedited PA.
  • Exemption Process - CMS may elect to exempt providers from the PA process who achieve a PA affirmation threshold of at least 90% during a semiannual assessment. This exemption could be removed if the provider subsequently has a rate of non-payable claims greater than 10%.
  • A non-affirmation PA decision is not appealable, but the provider will receive a detailed explanation as to why the request was non-affirmed and can resubmit an unlimited number of requests. Appeal rights exist once a claim is denied.
  • There will be more sub-regulatory guidance before the requirement becomes effective, but the final rule indicates either the hospital or the physician may submit the PA request, though the hospital is ultimately responsible for ensuring this condition of payment is met.
  • A unique tracking number (UTN) corresponding to the PA decision must be included on the OPD claim.

CMS argues this is not an additional burden on hospitals since no new documentation is required beyond what should already be present in the record and the hospital is just having to submit the records before the procedure instead of afterwards as they would have to do in the case of a Medicare medical review. Everyone knows it will be an additional burden, but the good news is that hospitals are used to PA requirements from most other payers, it causes the hospital to get the required documentation together before providing the service, and it likely will prevent some inappropriate payments for cosmetic procedures that do not meet Medicare’s medical necessity requirements.

So, a little relief for some, a little burden for others – is that a wash?

Debbie Rubio

CMS Considers Changes to Lab Date of Service Policy
Published on Sep 03, 2019
20190903

Back in 2017, I wrote the section below about changes to the laboratory date-of-service policy changes from the 2018 OPPS Final Rule. The importance of laboratory date of service (DOS) requirements is that they are used to determine whether a hospital bills Medicare directly for a clinical diagnostic laboratory test (CDLT) or whether the laboratory performing the test bills Medicare. Remember, most CDLTs are conditionally packaged under OPPS, and are only paid separately to the hospital when they are: (1) the only service provided to a beneficiary on a claim; (2) considered a preventive service; (3) a molecular pathology test; or (4) an advanced diagnostic laboratory test (ADLT) that meets certain criteria. Preventive services, molecular pathology tests, and ADLTs are assigned an OPPS status indicator (SI) of “A” and paid under the Clinical Lab Fee Schedule (CLFS). CDLTs with an SI of “Q4” are paid separately under the CLFS when they are the only types of services on the claim, but payment is bundled when they appear with other outpatient services.

Excerpt from Prior Wednesday@One Article on Laboratory Date of Service Rule

“Laboratory date of service (DOS) rules start simple:

  1. The DOS for clinical diagnostic laboratory services generally is the date the specimen is collected.
  2. For archived lab specimens that are stored for more than 30 days before testing, the DOS is the date the specimen was obtained from storage.

Now this is where it starts getting complicated with what is known as the 14-day rule.

  1. The DOS is the date the test was performed (instead of the date of collection) if the following conditions are met:
  2. The test is ordered by the patient’s physician at least 14 days following the date of the patient’s discharge from the hospital;
  3. The specimen was collected while the patient was undergoing a hospital surgical procedure;
  4. It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted;
  5. The results of the test do not guide treatment provided during the hospital stay; and
  6. The test was reasonable and medically necessary for the treatment of an illness.
  7. Another 14-day rule applies to chemotherapy sensitive tests performed on live tissue under the same conditions as described above with only slight variation to the first condition:
  8. The decision regarding the specific chemotherapeutic agents to test is made at least 14 days after discharge;

Both of these 14-day rules apply to hospital inpatients and outpatients and the key point is that the test is ordered at least 14 days after discharge.  These DOS requirements determine whether the hospital bills Medicare for a clinical diagnostic laboratory test (CDLT) or whether the laboratory performing the test bills Medicare directly. When the 14-day rule applies, laboratory tests are not bundled into the hospital stay, but are instead paid separately under Medicare Part B to the testing laboratory.

Stakeholders expressed concerns about the current (2017) DOS policy because it requires hospitals to bill for tests they did not perform and that may have no relationship to or bearing on treatment received by the patient while in the hospital and it creates billing difficulties for the hospital. CMS agreed with these concerns and modified the date of service rule for hospital outpatients for molecular pathology tests and advanced diagnostic laboratory tests (ADLTs) that are not packaged under OPPS.  These types of lab test have a Status Indicator of “A” on Addendum B.

The new rule (from the 2018 OPPS Final Rule) states that in the case of a molecular pathology test or an ADLT, the DOS of the test must be the date the test was performed only if—

  • The test was performed following a hospital outpatient’s discharge from the hospital outpatient department;
  • The specimen was collected from a hospital outpatient during an encounter (as both are defined in 42 CFR 410.2);
  • It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter;
  • The results of the test do not guide treatment provided during the hospital outpatient encounter; and
  • The test was reasonable and medically necessary for the treatment of an illness.

This new exception to the laboratory DOS policy does not apply to ADLT or molecular pathology tests when performed on a specimen collected from a hospital inpatient.

This new laboratory DOS policy will enable laboratories performing ADLTs and molecular pathology tests excluded from the OPPS packaging policy to bill Medicare directly for those tests, instead of requiring them to seek payment from the hospital outpatient department.  In fact, for molecular pathology tests and ADLTs meeting the above requirements, the DOS must be the date the test was performed and the test must be billed by the performing laboratory. Hospital laboratories cannot bill for these tests unless they perform them.”

Although the “new” lab DOS rule from the 2018 OPPS Final Rule described above was originally set to be implemented July 2, 2018, many hospitals and laboratories reported to CMS they were having administrative difficulties implementing the DOS exception. For that reason, CMS has repeatedly exercised enforcement discretion regarding the new rule, with the latest enforcement discretion in effect until January 2, 2020.

Because of continued concerns about the readiness of labs and hospitals to implement the new rule and additional concerns that some entities performing molecular pathology testing subject to the laboratory DOS exception, such as blood banks and blood centers, may not be enrolled in the Medicare program and may not have established a mechanism to bill Medicare directly, CMS is rethinking this DOS rule. In the 2020 OPPS Proposed Rule, they are seeking comments on three options for potential changes to the laboratory DOS exception.

  1. Changing the Test Results Requirements – Under this option, the test would be considered a hospital service unless the ordering physician determines that the test does not guide treatment during a hospital outpatient encounter.
  1. Limiting the Laboratory DOS Exception to ADLTs
  1. Excluding Blood Banks and Blood Centers from the Laboratory DOS Exception

These options would only affect the new lab DOS exception put forth in the 2018 OPPS Final Rule that applies to molecular pathology tests and ADLTs. The basic lab DOS rules and the 14-day rule DOS exception and the chemotherapy sensitivity test DOS exception would not be affected.

I encourage hospitals and laboratories affected by these date of service rules to read the discussion in the Proposed Rule and to submit comments to CMS. (Lab DOS Policy section begins on page 201 of 247 pages of the pdf printed version.)

Debbie Rubio

Appropriate Use Criteria is Coming Soon
Published on Aug 20, 2019
20190820

A recent story by National Public Radio (NPR) discussed the delay in the implementation of the law requiring physicians to consult clinical guidelines before ordering certain imaging tests. The story notes that critics believe the delay has resulted in unnecessary costs and radiation exposure. I am not agreeing or disagreeing with any of the concerns raised by the story, but I want to point out a few things I know based on my understanding of the new requirements and my experience in healthcare. First, not all physicians order unnecessary tests. The article quotes studies that have found widespread overuse, including one study that reported 26% of the CTs and MRIs they reviewed were inappropriate. However, this was at a large academic medical center, so hopefully most physicians use their training to appropriately order advanced imaging exams.

A fallacy in the story in my opinion is how easy the new process will be – “4 clicks on the computer – or less than a minute.” I am skeptical that the ordering physician’s process will be that easy and there are numerous requirements on the back end, i.e. the performing entity and the interpreting professional claim requirements. Beginning July 1, 2018 through December 31, 2019, providers could voluntarily participate in the program. January 1, 2020 through December 31, 2020 is the Educational and Operations Testing Period in which providers are encouraged to participate, but claims will not be denied. These voluntary and testing periods are beneficial to providers to work out the kinks in what is an anything-but-simple process.

On July 26, 2019, CMS released a transmittal that details the requirements for the Testing Period in 2020. The basic premise of the program - Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging is:

Step One – When an advanced imaging service is ordered for a Medicare beneficiary, the ordering professional must consult a qualified Clinical Decision Support Mechanism (CDSM), an interactive, electronic tool that assists practitioners in making the most appropriate treatment decision for a patient’s specific clinical condition. The CDSM will provide the ordering professional with a determination of whether the order adheres to AUC, does not adhere to AUC, or if there is no AUC applicable (for example, no AUC is available to address the patient’s clinical condition).

Step Two – The ordering physician must communicate the status and outcome of use of the CDSM to the furnishing entity and physician.

Step Three – The furnishing providers and practitioners must report on their Medicare claim, modifiers describing the CDSM status and decision, if applicable, and when appropriate, a HCPCS indicating which CDSM was used.

The AUC program applies to:

  • Advance imaging services such as computed tomography (CT), Positron emission tomography (PET), Nuclear medicine (NM), and Magnetic resonance imaging (MRI). The specific CPT/HCPCS codes affected are listed in the transmittal.
  • The following settings:
  • Physician offices
  • Hospital outpatient departments (including emergency departments)
  • Ambulatory Surgical Centers (ASCs)
  • Independent diagnostic testing facilities
  • Services paid under the Medicare Physician Fee Schedule (MPFS), the Hospital Outpatient Prospective Payment System (OPPS), or the Ambulatory Surgical Center (ASC) fee schedule

CMS does allow exceptions to participation in the program for ordering professionals with a significant hardship (such as limited access to the internet, etc.), patients with an emergency medical condition, and inpatients paid under Medicare Part A. It is confusing to me why applicable settings include hospital emergency departments when patients with an emergency medical condition are exempt. I have submitted a question to CMS for clarification regarding this and will share through the Wednesday@One newsletter any information I receive.

The modifiers to be reported (MA-MH and QQ) describe whether a CDSM was consulted or not and if not, the reason, or if so, the outcome/decision. The modifier is to be appended to the advanced imaging line item code on the claim. If a modifier is reported that indicates a CDSM was consulted (ME, MF or MG), then the claim should additionally contain a G-code (on a separate claim line) to report which qualified CDSM was consulted. These are informational-only G-codes that will not result in any payment, similar to the codes previously required for Functional Limitation Reporting for therapy services. Providers will have to deal with the same issues of submitting a $0 or minimal charge for these codes. The transmittal includes descriptions of all the modifiers and G-codes.

The plan at this time is to fully implement the requirements of AUC effective January 1, 2021. Upon full implementation, claims for the affected imaging services will be denied if they do not contain information regarding the ordering professional’s consultation with CDSM, or exception to such consultation. The ultimate goal of the program is to identify professionals with outlier-ordering patterns and require those practitioners to obtain prior authorizations for these tests. That requirement will likely be several more years down the road.

Just thinking of the processes hospitals and radiologists will have to put into place to make this happen makes my head spin. And that is all after the process the ordering practitioner goes through – (no need to worry about that though as it is only 4 clicks on the computer). Now is the time, during this Testing phase, for hospitals to develop and implement the necessary processes for this program – how will you receive, document, and internally communicate the information from the ordering practitioner; how will the correct modifier get on the claim line item; and how will the appropriate G-code get added to the claim. And still to be worked out is how institutional providers will report line level ordering physician information on the institutional claim since that capability is not currently available.

Sometimes there are good reasons for delaying a well-intentioned idea.

Debbie Rubio

OPPS Status Indicators and the July OPPS Updates
Published on Jun 04, 2019
20190604

School is out for the summer and my youngest grandchild graduated from pre-school, where she learned her ABC’s. There is no summer break from learning in real life and if you work with Medicare outpatient claims, you have to learn your A, C, E1, E2, G, J1, etc. status indicators.

Each quarter, CMS issues an update for the Outpatient Prospective Payment System (OPPS). These updates sometimes include policy changes, but generally consist mainly of coding updates, such as new HCPCS codes and revised OPPS status indicator assignments. The status indicators (SI’s) describe how particular HCPCS codes and APCs are paid (or not paid) under OPPS, so it is important for providers to understand what the various status indicators mean. CMS provides a table of the definitions of the status indicators in Addendum D1 of the OPPS Final Rule each year – the 2019 addenda can be found here.

Below are descriptions of the status indicators that appear in the July 2019 OPPS Update.

SI “A” means the service is paid under a fee schedule or payment system other than OPPS. For example, you see this code in the tables below for laboratory services that are paid under the Clinical Laboratory Fee Schedule (CLFS). Another common type of service with this SI is therapy services (PT, OT and SLP services).

SI “C” is an inpatient only procedure. These codes will not be paid when billed on an outpatient claim with limited exceptions. For inpatient only procedures, the patient should be admitted as an inpatient.

SI “E1” are services that are not covered for outpatients and will not be paid when submitted on an outpatient claim. They are services that are not an outpatient benefit, are statutorily excluded, or are not medically necessary for outpatients.

SI “E2” are not paid under OPPS because pricing information and claims data are not yet available.

SI “G” indicates drugs and biologicals that receive pass-through payment.

SI “J1” indicates the primary procedure of a comprehensive APC. The payment for all adjunctive services on the claim with the J1 service is packaged into the payment for the primary J1 service, with only a few exceptions.

SI “K” are drugs and biologicals eligible for separate payment under OPPS because they exceed the per day cost threshold for separately payable drugs.

SI “L” are for flu and pneumonia vaccines. They are paid at reasonable cost and are not subject to deductibles and co-insurance

SI “M” are services that are not billable to the MAC and are not paid under OPPS. Notice in the tables below that these services say “provided by physician” or “interpretation and report” meaning they are professional (physician or other qualified health care professional) services and not to be billed by the hospital.

SI “N” indicates services for which the payment for the service is packaged into the payment of other services. This means there is no separate payment made for this HCPCS code. Even though these services are not paid separately, it is important to report the codes so CMS can know all of the components of a primary service.

SI “Q1” is a conditionally packaged service which means the payment for this service is packaged in certain circumstances. Q1 services are packaged if they appear on the same claim with services with an SI of S, T, or V (visit). If the Q1 service does not meet packaging criteria (no S, T, or V code on the claim), it is separately paid. It defaults to the status indicator of its APC when paid separately.

SI “Q4” is for laboratory services with packaged payment. These lab services are only paid separately if they are the only type of services provided on the claim. Most clinical lab services have been conditionally packaged since 2014 and have this status indicator.

SI “S” are procedures and service paid under OPPS similar to SI “T” but to which a payment reduction for multiple procedures/services does not apply. All S services on a claim are paid at 100% of the OPPS payment rate.

SI “T” are procedures and services paid under OPPS but to which a reduction applies for multiple procedures. The first T procedure on a claim is paid at 100%, but subsequent T procedures on the same claim are paid at 50% of the OPPS payment rate.

Below are tables of the code additions and changes from the July 2019 OPPS Updates. All changes are effective July 1, 2019.

Table A includes some miscellaneous additions and changes such as a temporary new C-code, some status indicator changes, and the reassignment of a skin substitute. Notice the change of 0541T and 0542T from E1 (non-payable) due to FDA approval in March of the device associated with these codes – the codes are now S and M respectively, to reflect the technical payment to the hospital and the professional payment for the physician report.

Although payment for skin substitutes are packaged with an SI of N, a lower and higher payment for the application of the product is made due to the assignment of the skin substitute to the Low Cost Group or High Cost Group based on product cost. The reporting of different application HCPCS codes for the low and high cost groups drives the appropriate payment.

Table AMiscellaneous New/Changed Codes 
HCPCS CodeLong DescriptorOPPS Status IndicatorDescription of Change
C9756Intraoperative near-infrared fluorescence lymphatic mapping of lymph node(s) (sentinel or tumor draining) with administration of indocyanine green (ICG) (List separately in addition to code for primary procedure)NNew temporary HCPCS C-Code
A4563Rectal control system for vaginal insertion, for long term use, includes pump and all supplies and accessories, any type eachASI change from N; separately payable under the DME fee schedule
Q4176Neopatch, per square centimeterNSkin substitute reassigned from Low to High Cost Group
0541TMyocardial imaging by magnetocardiography(mcg) for detection of cardiac ischemia, by signal acquisition using minimum 36 channel grid, generation of magnetic-field time-series images, quantitative analysis of magnetic dipoles, machine learning-derived clinical scoring, and automated report generation, single study;SSI change from E1 due to FDA approval of associated device
0542TMyocardial imaging by magnetocardiography(mcg) for detection of cardiac ischemia, by signal acquisition using minimum 36 channel grid, generation of magnetic-field time-series images, quantitative analysis of magnetic dipoles, machine learning-derived clinical scoring, and automated report generation, single study; interpretation and reportMSI change from E1 due to FDA approval of associated device

There were numerous new codes, including several for biosimilars, and some code replacements for drugs and biologicals as shown in Table B.

Table BDrugs and Biologicals New Codes and Code Changes  
HCPCS Code Long Descriptor OPPS Status IndicatorDescription of Change
C9047Injection, caplacizumab-yhdp, 1 mgGNew code
C9048Dexamethasone, lacrimal ophthalmic insert, 0.1 mgGNew code
C9049Injection, tagraxofusp-erzs, 10 mcgGNew code
C9050Injection, emapalumab-lzsg, 1 mgGNew code
C9051Injection, omadacycline, 1 mgGNew code
C9052Injection, ravulizumab-cwvz, 10 mgGNew code
J9036Injection, bendamustine hydrochloride, (Belrapzo/bendamustine), 1 mgGReplaces C9042 (deleted June 30, 2019)
J7208Injection, factor viii, (antihemophilic factor, recombinant), pegylated-aucl, (jivi), 1 i.u.GReplaces C9141 (deleted June 30, 2019)
J1444Injection, ferric pyrophosphate citrate powder, 0.1 mg of ironNNew code
J9356Injection, trastuzumab, 10 mg and Hyaluronidase-oyskKNew code
Q5112Injection, trastuzumab-dttb, biosimilar, (Ontruzant), 10 mgE2New code
Q5113Injection, trastuzumab-pkrb, biosimilar, (Herzuma), 10 mgE2New code
Q5114Injection, Trastuzumab-dkst, biosimilar, (Ogivri), 10 mgE2New code
Q5115Injection, rituximab-abbs, biosimilar, (Truxima), 10 mgE2New code
J9030BCG live intravesical instillation, 1 mgKReplaces J9031 (deleted June 30, 2019)
J9355Injection, trastuzumab, excludes biosimilar, 10 mgKDescription change to add "excludes biosimilar"
90619Meningococcal conjugate vaccine, serogroups A, C, W, Y, quadrivalent, tetanus toxoid carrier (MenACWY-TT), for intramuscular useE1New CPT Category I vaccine code
90689Influenza virus vaccine, quadrivalent (iiv4), inactivated, adjuvanted, preservative free, 0.25 ml dosage, for intramuscular useLVaccine code SI change from E1

The American Medical Association (AMA) releases new Category III codes twice a year – in January and July to be effective the following July and January respectively. For the July 2019 update, CMS is implementing 20 CPT Category III codes that the AMA released in January 2019 for implementation on July 1, 2019.

Table CNew CPT Category III Codes 
HCPCS Code Long Descriptor OPPS Status Indicator
0543TTransapical mitral valve repair, including transthoracic echocardiography, when performed, with placement of artificial chordae tendineaeC
0544TTranscathetermitral valve annulus reconstruction, with implantation of adjustable annulus reconstruction device, percutaneous approach including transseptal punctureC
0545TTranscatheter tricuspid valve annulus reconstruction with implantation of adjustable annulus reconstruction device, percutaneous approachC
0546TRadiofrequency spectroscopy, real time, intraoperative margin assessment, at the time of partial mastectomy, with reportN
0547TBone-material quality testing by microindentation(s) of the tibia(s),with results reported as a scoreE1
0548TTransperineal periurethral balloon continence device; bilateral placement, including cystoscopy and fluoroscopy (Replaces HCPCS code C9746 - Transperineal implantation of permanent adjustable balloon continence device, with cystourethroscopy, when performed and/or fluoroscopy, when performed, which was effective July 1, 2017, and was deleted June 30, 2019.)J1
0549TTransperineal periurethral balloon continence device; unilateral placement, including cystoscopy and fluoroscopyJ1
0550TTransperineal periurethral balloon continence device; removal, each balloonJ1
0551TTransperineal periurethral balloon continence device; adjustment of balloon(s) fluid volumeT
0552TLow-level laser therapy, dynamic photonic and dynamic thermokinetic energies, provided by a physician or other qualified health care professionalM
0553TPercutaneous transcatheterplacement of iliac arteriovenous anastomosis implant, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the interventionE1
0554TBone strength and fracture risk using finite element analysis of functional data, and bone-mineral density, utilizing data from a computed tomography scan; retrieval and transmission of the scan data, assessment of bone strength and fracture risk and bone mineral density, interpretation and reportM
0555TBone strength and fracture risk using finite element analysis of functional data, and bone-mineral density, utilizing data from a computed tomography scan; retrieval and transmission of the scan dataS
0556TBone strength and fracture risk using finite element analysis of functional data, and bone-mineral density, utilizing data from a computed tomography scan; assessment of bone strength and fracture risk and bone mineral densityS
0557TBone strength and fracture risk using finite element analysis of functional data, and bone-mineral density, utilizing data from a computed tomography scan; interpretation and reportM
0558TComputed tomography scan taken for the purpose of biomechanical computed tomography analysisS
0559TAnatomic model 3D-printed from image data set(s); first individually prepared and processed component of an anatomic structureQ1
0560TAnatomic model 3D-printed from image data set(s); each additional individually prepared and processed component of an anatomic structure (List separately in addition to code for primary procedure)N
0561TAnatomic guide 3D-printed and designed from image data set(s); first anatomic guideQ1
0562TAnatomic guide 3D-printed and designed from image data set(s); each additional anatomic guide (List separately in addition to code for primary procedure)N

Proprietary Laboratory Analyses (PLA) codes are CPT codes for labs or manufacturers to more specifically identify their test. Tests with PLA codes must be performed on human specimens and must be requested by the clinical laboratory or the manufacturer that offers the test. For July 1, 2019, one PLA code was deleted and 21 new codes were added.

Table DNew PLA Codes 
HCPCS Code Long Descriptor OPPS Status Indicator
0057UOncology (solid organ neoplasia), mrna, gene expression profiling by massively parallel sequencing for analysis of 51 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a normalized percentile rank
0084URed blood cell antigen typing, DNA, genotyping of 10 blood groups with phenotype prediction of 37 red blood cell antigensA
0085UCytolethal distending toxin B (CdtB) and vinculin IgG antibodies by immunoassay (ie, ELISA)Q4
0086UInfectious disease (bacterial and fungal), organism identification, blood culture, using rRNA FISH, 6 or more organism targets, reported as positive or negative with phenotypic minimum inhibitory concentration (MIC)-based antimicrobial susceptibilityA
0087UCardiology (heart transplant), mRNA gene expression profiling by microarray of 1283 genes, transplant biopsy tissue, allograft rejection and injury algorithm reported as a probability scoreA
0088UTransplantation medicine (kidney allograft rejection), microarray gene expression profiling of 1494 genes, utilizing transplant biopsy tissue, algorithm reported as a probability score for rejectionA
0089UOncology (melanoma), gene expression profiling by RTqPCR, PRAME and LINC00518, superficialcollection using adhesive patch(es)Q4
0090UOncology (cutaneous melanoma), mRNA gene expression profiling by RT-PCR of 23 genes (14 content and 9 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a categorical result (ie, benign, indeterminate, malignant)
0091UOncology (colorectal) screening, cell enumeration of circulating tumor cells, utilizing whole blood, algorithm, for the presence of adenoma or cancer, reported as a positive or negative resultE1
0092UOncology (lung), three protein biomarkers, immunoassay using magnetic nanosensor technology, plasma, algorithm reported as risk score for likelihood of malignancyQ4
0093UPrescription drug monitoring, evaluation of 65 common drugs by LC-MS/MS, urine, each drug reported detected or not detectedQ4
0094UGenome (eg, unexplained constitutional or heritable disorder or syndrome), rapid sequence analysisA
0095UInflammation (eosinophilic esophagitis), ELISA analysis of eotaxin-3 (CCL26 [C-C motif chemokine ligand 26]) and major basic protein (PRG2 [proteoglycan 2, pro eosinophil major basic protein]), specimen obtained by swallowed nylon string, algorithm reported as predictive probability index for active eosinophilic esophagitisQ4
0096UHuman papillomavirus (HPV), high-risk types (ie, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), male urineQ4
0097UGastrointestinal pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 22 targets (Campylobacter [C. jejuni/C. coli/C. upsaliensis], Clostridium difficile [C. difficile] toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio [V. parahaemolyticus/V. vulnificus/V. cholerae], including specific identification of Vibrio cholerae, Yersinia enterocolitica, Enteroaggregative Escherichia coli [EAEC], Enteropathogenic Escherichia coli [EPEC], Enterotoxigenic Escherichia coli [ETEC] lt/st, Shiga-like toxin-producing Escherichia coli [STEC] stx1/stx2 [including specific identification of the E. coli O157 serogroup within STEC], Shigella/Enteroinvasive Escherichia coli [EIEC], Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia [also known as G. intestinalis and G. duodenalis], adenovirus F 40/41, astrovirus, norovirus GI/GII, rotavirus A, sapovirus [Genogroups I, II, IV, and V])Q4
0098URespiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 14 targets (adenovirus, coronavirus, human metapneumovirus, influenza A, influenza A subtype H1, influenza A subtype H3, influenza A subtype H1-2009, influenza B, parainfluenza virus, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae)Q4
0099URespiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 20 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus, coronavirus OC43, human metapneumovirus, influenza A, influenza A subtype, influenza A subtype H3, influenza A subtype H1-2009, influenza, parainfluenza virus, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumonia, Mycoplasma pneumoniae)Q4
0100URespiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 21 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus, human rhinovirus/enterovirus, influenza A, including subtypes H1, H1-2009, and H3, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus, Bordetella parapertussis [IS1001], Bordetella pertussis [ptxP], Chlamydia pneumoniae, Mycoplasma pneumoniae)Q4
0101UHereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (15 genes [sequencing and deletion/duplication], EPCAM and GREM1 [deletion/duplication only])A
0102UHereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (17 genes [sequencing and deletion/duplication])A
0103UHereditary ovarian cancer (eg, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (24 genes [sequencing and deletion/duplication], EPCAM [deletion/duplication only])A
0104UHereditary pan cancer (eg, hereditary breast and ovarian cancer, hereditary endometrial cancer, hereditary colorectal cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (32 genes [sequencing and deletion/duplication], EPCAM and GREM1 [deletion/duplication only])A

School is never out in the real world, so study the Medicare OPPS status indicator alphabet to know if and how your hospital will be paid for outpatient services.

Debbie Rubio

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