Knowledge Base Category -

Background

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act) enforced that a prescribing practitioner, subject to certain exceptions, may prescribe controlled medications to a patient only after conducting an in-person evaluation of the patient.

 

In response to the COVID-19 public health emergency (PHE), on January 31, 2020, the Drug Enforcement Agency (DEA) granted temporary exceptions to the Ryan Haight Act. To prevent lapses in care, the exceptions allowed a practitioner to prescribe controlled medication via telemedicine encounters, even when the practitioner had not conducted an in-person medical evaluation of the patient.

 

The telemedicine flexibilities authorized practitioners to prescribe schedule II-V controlled medications via audio-video telemedicine encounters, including schedule III-V narcotic-controlled medications approved by the FDA for maintenance and withdrawal management treatment of opioid use disorder via audio-only telemedicine encounters.

 

March 1, 2023: First Temporary Rule Proposed

On March 1, 2023, The Drug Enforcement Agency (DEA) worked with the Department of Health and Human Services (HHS) to release two notices of proposed rulemakings (NPRMs):

 

• The General Telemedicine Rule where the practitioner can prescribe controlled substances via telemedicine without the patient having a prior in-person medical evaluation, and
• The Buprenorphine Rule which proposed to expand patient access to prescriptions for controlled medications by telemedicine encounters relative to the pre-COVID-19 PHE landscape.

 

“The purpose of the two proposals was to make permanent some of the telemedicine flexibilities established during the COVID-19 PHE in order to facilitate patient access to controlled medications via telemedicine when consistent with public health and safety, while maintaining effective controls against diversion.”

 

May 10, 2023: First Temporary Rule Issued

This rule extended the full set of telemedicine flexibilities regarding the prescribing of controlled medications, as had been in place under the COVID-19 PHE, through November 11, 2023. The rule also provided a one-year grace period, through November 11, 2024, to any practitioner-patient telemedicine relationships that have been or will be established on or before November 11, 2023.

 

October 6, 2023: Second Temporary Rule Issued

The DEA and HHS issued a Second Temporary Rule extending the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE, through December 31, 2024.

 

“This extension authorizes all DEA-registered practitioners to prescribe schedule II-V controlled medications via telemedicine through December 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before November 11, 2023.”

 

The stated purpose of the Second Temporary Rule “is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards.”

 

Note, the DEA is working to develop new standards or safeguards by the fall of 2024.

 

Resource

Federal Register: Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, October 6, 2023 unpublished document at https://www.federalregister.gov/public-inspection/2023-22406/second-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled

Coverage Updates

 

September 6, 2023: National Coverage Determination (NCD) Dashboard

CMS released an NCD dashboard that was last updated on August 23, 2023. This document details the seven accepted NCD requests that are on the CMS Wait List, the four open NCD topics currently undergoing a National Coverage Analysis (NCA) with opportunities for public comment, and the two NCDs finalized in the past twelve months. Links to all thirteen topics are included in this document. https://www.cms.gov/files/document/ncd-dashboard.pdf

COVID-19 Update

September 11, 2023: FDA Approves and Authorizes Updated COVID-19 Vaccines

The FDA has approved an update COVID-19 vaccine that was developed to target current circulating variants. The updated mRNA vaccines for 2023-2024 were manufactured by ModernaTX Inc. and Pfizer Inc. and have been updated to include a monovalent (single) component that corresponds to the Omicron variant ZBB.1.5. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating

 

September 14, 2023: Special MLN Connects: COVID-19 Updated mRNA Vaccines for Patients 6 Months or Older

CMS issues a special MLN Connects announcing the FDA’s approval of updated vaccines noting that the CDC recommends everyone 6 months and older get an updated COVID-19 vaccine. Also includes in this announcement are six new CPT codes effective September 11, 2023 for the vaccine and administration of the vaccine. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2023-09-14-oce

Other Updates

September 14, 2023: MLN Connects: Social Determinants of Health Resources

In this edition of MLN Connects, CMS let providers know about a new CMS infographic to help you understand and use Z codes. They also included links to additional resources.

 

As a reminder, effective October 1, 2023, CMS finalized their proposal to change the severity level designation for diagnosis codes Z59.00 (Homelessness, unspecified), Z59.01 (Sheltered homelessness), and Z59.02 (Unsheltered homelessness) from NonCC to CC. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2023-09-14-mlnc

 

September 19, 2023: CMS Requires States to Pause Disenrollments and Reinstate Coverage for Impacted Individuals

CMS indicated in a Press Release that they issued a call to action on August 30 about a potential issue where systems were inappropriately disenrolling children and other enrollees, even when the state had information indicating the person was still eligible for Medicaid coverage. As of September 19, 30 states report having system issues and “as a result, to avoid CMS taking further action, all 30 states were required to pause procedural disenrollments for impacted people unless they could ensure all eligible people are not improperly disenrolled due to this issue.” https://www.cms.gov/newsroom/press-releases/coverage-half-million-children-and-families-will-be-reinstated-thanks-hhs-swift-action

Did You Know?

Effective October 1, 2023, there is a new Place of Service (POS) Code 27 – “Outreach Site/Street.” This POS is defined as “a non-permanent location on the street or found environment, not described by any other POS code, where health professionals provide preventive, screening, diagnostic, and/or treatment services to unsheltered homeless individuals.”

 

In the August 10^th Transmittal 12202, CMS indicated that “Medicare has not identified a need for this new code. However, in order to comply with HIPAA and its goals of promoting administrative simplification, contractors are to accept claims containing this new code in accordance with its effective date. Medicare contractors shall therefore implement the systems and/or local-contractor-level changes needed for Medicare to return as unprocessable claims with the new code should it appear on a Medicare claim.”

 

Why it Matters?

On September 20, 2023, CMS rescinded Transmittal 12202 and replaced it with Transmittal 12254 indicating that the transmittal has been revised to “align with broader CMS efforts to address economic, social, and other obstacles impacting Medicare beneficiary healthcare access by revising the IOM as well as the policy section and business requirements 13313.2.”

 

The policy note has changed to indicate that “Contractors are to accept claims containing this new code in accordance with its effective date. Medicare contractors shall therefore implement the systems and/or local-contractor-level changes needed for processing claims with the new code should it appear on a Medicare claim.”

 

What Can I Do?

Make sure key stakeholders at your facility are aware of this change to the new POS Code 27.

 

Resources

 

August 10, 2023 Transmittal 12202: New Place of Service (POS) Code 27 – “Outreach Site/Street” https://www.cms.gov/files/document/r12202cp.pdf

 

September 20, 2023 Transmittal 12254: New Place of Service (POS) Code 27 – “Outreach Site/Street” https://www.cms.gov/files/document/r12254cp.pdf

“The primary objective of the IPPS and the LTCH PPS is to create incentives for hospitals to operate efficiently and minimize unnecessary costs, while at the same time ensuring that payments are sufficient to adequately compensate hospitals for their legitimate costs in delivering necessary care to Medicare beneficiaries.”

• Source: Appendix A: Economic Analysis of FY 2024 IPPS Final Rule

 

There are eighteen days until the October 1^st start to the 2024 CMS Fiscal Year. As you continue to prepare, this article focuses on New Technologies Add-On Payments (NTAPs). Section E. Add-On Payments for New Services and Technologies for FY 2024 begins on page 58,793 of the FY 2024 IPPS Final Rule.

 

New Technologies Eligible for Add-On Payment (NTAPs) Background

Section 1886(d)(5)(K)(i) of the Act requires the Secretary to establish a mechanism to recognize the costs of new medical services and technologies under the payment system under the subsection which establishes the system for paying for the operating costs of inpatient hospital services.

 

The system of payment for capital costs is established in section 1886(g) of the Act. For this reason, capital costs are not included in the add-on payments for a new medical service or technology.  

 

NTAPs are not budget neutral and the “newness” for payment is limited to the 2-to-3-year period after the date a technology becomes available.

 

In response to the COVID-19 public health emergency (PHE) and as new therapies received approval to treat COVID-19, CMS established the New COVID-19 Treatments Add-on Payment (NCTAP). With the PHE ending in May of this year, the add-on payments for NCTAPs will end September 30, 2023.

 

There are three pathways for a new service or technology to be approved for the add-on payment (Traditional pathway, Certain Antimicrobial Products Alternative Pathway, and Certain Transformative New Devices Alternative Pathway).

 

For the alternative pathways, a technology is not required to have a specified FDA designation at the time the application for NTAP is made. Instead, “CMS reviews the application based on the information provided by the applicant only under the alternative pathway specified by the applicant at the time of new technology add-on payment application submission. However, to receive approval for the new technology add-on payment under that alternative pathway, the technology must have the applicable FDA designation and meet all other requirements in the regulations in § 412.87(c) and (d), as applicable.”

 

Coding NTAPs

Section X New Technology was added to ICD-10-PCS effective October 1, 2015. CMS has indicated (https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2016-Section-X-New-Technology-.pdf) that “Section X was created in response to public comments received regarding New Technology proposals presented at ICD-10 Coordination and Maintenance Committee Meetings, and general issues facing classification of new technology procedures.”  To receive payment for an eligible NTAP, the applicable section X New Technology ICD-10-PCS code must be on the claim submitted for adjudication.

 

NTAPs by the Numbers

Before looking ahead to FY 2024, I wanted to see what new technologies have been coded in FY 2023 claims with dates of service from October 1, 2022 through March 31, 2023. The following claims volume was provided by our sister company RealTime Medicare Data (RTMD), represents claims volume for the entire nation, and is specific to the Medicare Fee-for-Service population.   

FY 2023

25: The number of technologies eligible for add-on payment.

 

94,210: The number of claims with dates of service from October 1, 2022 through March 2023 that included an ICD-10-PCS code eligible for add-on payment.

 

7,551: The number of claims with an ICD-10-PCS new technology code when the technologies eligible for the COVID-19 Treatments Add-On Payment (NCTAP) (convalescent plasma, Olumiant, and Veklury® (remdesivir)) were excluded from the claims volume. 

 

FY 2024

33: The number of technologies eligible for add-on payment.

 

58,524.5: The number of Medicare beneficiaries that CMS expects will receive one of the new technologies. Note, the .5 is not an error. CMS’ estimated cases for the NTAP Livtencity™ is 129.5 cases.

 

$495,497,861.97: CMS’ estimated Medicare spending on NTAPs in FY 2024.

 

Moving Forward

Identifying and coding new technologies is an opportunity not to be missed for those hospitals providing these services. That said, some questions come to mind for you to think about:

• Is your hospital providing any of these services or technologies?
• Who needs to be aware of what the new technologies are? (i.e., Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
• What process do you have in place to alert your Coding Staff of the need to code the new technology ICD-10-PCS codes?

 

Resource

FY 2024 IPPS CMS webpage: https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/fy-2024-ipps-final-rule-home-page

Did You Know?

Noridian Healthcare Solutions, LLC (Noridian) is the current Supplemental Medical Review Contractor (SMRC). “With CMS directed topic selections and timeframes, Noridian conducts nationwide medical reviews (Part A, Part B, and DME), in accordance with all applicable statutes, laws, regulations, national and local coverage determination policies, and coding guidance, to determine whether Medicare claims have been billed in compliance with coverage, coding, payment, and billing practices.”

 

Reviews are assigned to the SMRC based on analysis of national claims data issues identified by other Federal agencies (i.e., OIG, Government Accountability Office (GAO), the Comprehensive Error Rate Testing Program (CERT), and Program for Evaluating Payment Patterns Electronic Report (PEPPER)).

 

Why It Matters?

As of August 15, 2023, the SMRC has thirteen current projects. Examples of current projects includes hyperbaric oxygen of lower extremities diabetic wounds, hospice general inpatient (GIP) level of care, cryosurgery of the prostate, and Mohs surgery.

 

Also, as of August 15, 2023, Noridian has completed sixty projects since being awarded the $227 million SMRC contract by CMS in 2018. Error rates for their completed projects range from 1% to 98%.

 

The 1% error rate was for a sample of claims reviewed related to the 20% add-on payment for COVID-19 that was in place during the COVID-19 Public Health Emergency. The 98% error rate was for a review of claims for Medicare Part B emergency ambulance services.

 

In July of this year, in addition to reporting an error rate for the reviewed claims, Noridian began reporting an error rate for the number of claims denied due to no response to an Additional Documentation Request (ADR). To date, SMRC medical review findings that include the no response error rate, includes:

 

Project 01-080: Vitamin B12 with Modifier 25 Findings of Medical Review

Error Rate for Reviewed Claims: 43%

No Response to ADR Denials: 39%

Results Published July 18, 2023

https://noridiansmrc.com/completed-projects/01-080/

 

Project 01-081: Outpatient Dental Services CPT 41899 Findings of Medical Review

Error Rate for Reviewed Claims: 95%

No Response to ADR: 20%

Results Published July 18, 2023

https://noridiansmrc.com/completed-projects/01-081/

 

Project 01-093: Overlapping Claims – Hospital Transfers During the PHE Findings of Medical Review

Error Rate for Reviewed Claims: 12%

No Response to ADR: 8%

Results Published July 18, 2023

https://noridiansmrc.com/completed-projects/01-093/

 

Project 01-050: Podiatry Findings of Medical Review

Error Rate for Reviewed Claims: 45%

No Response to ADR Denials: 29%

Published August 8, 2023

https://noridiansmrc.com/completed-projects/01-050/

 

Project 01-072: Neurostimulator Implantation Findings of Medical Review

Error Rate for Reviewed Claims: 39%

No Response to ADR Denials: 23%

Results Published August 15, 2023

https://noridiansmrc.com/completed-projects/01-072/

 

Noridian notes they must notify CMS of identified improper payments and noncompliance with documentation requests. They will initiate claims adjustments and/or overpayment recoupment by the standard overpayment recovery process.

 

What Can I Do?

First and foremost, make sure you have a process to receive and respond to ADR requests from the SMRC and other review contractors (i.e., CERT).

 

If a claim is denied for no receipt of documentation, you can complete the following steps posted to the Noridian Jurisdiction E (JE) MAC website:

 

SMRC Reviews Denied for No Documentation

“When a claim is denied for no receipt of documentation requested by the SMRC, the next step is to submit the documentation to the MAC that issued the demand letter for the overpayment. This must occur within 120 calendar days of the demand letter.

 

This situation is considered a reopening and the MAC will send the submitted documentation to the SMRC for a re-review decision. The SMRC has up to 60 calendar days to make this decision. The SMRC will then mail a letter to the supplier with their findings, either to pay the claim or they will outline the reasons for denial.

 

The SMRC will next notify the MAC of the payment or denial decision. The MAC will adjust the claim and a remittance advice with the adjustment results will be generated. The provider has the right to appeal the SMRC decision, if the claim remains denied.

 

Based on the timeframes and steps listed above, please call the MAC about the status of the SMRC re-review only after at least 140 days have passed from when documentation was sent.”

 

Last, become familiar with information available on the SMRC website (https://noridiansmrc.com/). 

CMS issued a display copy of the FY 2024 IPPS Final Rule on Monday, August 1, 2023. This article contains a high-level look at the final operating payment rate changes, Rural Emergency Hospitals change, social determinants of health codes severity designation changes, when the New COVID-19 Treatment Add-On Payments are set to end, and updates to the Affordable Care Act Quality Programs.

 

Proposed Payment Rate Changes

The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and meaningful electronic health record (EHR) use was 2.8%. This finalized increase is 3.1%.

 

The increase in operating and capital payment rates will generally increase hospital payments in FY 2024 by $2.2 billion.

 

Rural Emergency Hospitals (REHs) and Graduate Medical Education (GME)

REH’s became a new provider type effective January 1, 2023. You can read more about them in a related MLN Fact Sheet. CMS finalized their proposal to allow REH’s serve as training sites for Medicare GME payment purposes to “help support graduate medical training in rural areas.”

 

Severity Level Designation Change for Z Codes Describing Homelessness

The U.S. Department of Health and Human Services (HHS) defines Social Determinants of Health (SDOH) as "the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks." Effective February 18, 2018, the AHA Coding Clinic published advice allowing the reporting of SDOH codes Z55-Z65, based on information documented by all clinicians involved in the care of the patient.

 

For FY 2024, CMS finalized their proposal to change the severity level designation for diagnosis codes Z59.00 (Homelessness, unspecified), Z59.01 (Sheltered homelessness), and Z59.02 (Unsheltered homelessness) from NonCC to CC for FY 2024.

 

COVID-19 Treatment Add-On Payment (NCTAP) to End September 30, 2023

In response to the Public Health Emergency (PHE), CMS established NCTAP for eligible discharges during the PHE. In the FY 2022 final rule, CMS finalized the extension of NCTAP through the end of the FY in which the PHE ends. With the PHE ending on May 11, 2023, discharges involving eligible products would continue to be eligible for the NCTAP through September 30, 2023 (that is, through the end of FY 2023).”

 

Affordable Care Act Quality Programs

 

Hospital Readmission Reduction Program (HRRP)

CMS did not propose or finalize any changes to this value-based purchasing program that reduces payments to hospitals with excess readmissions.

 

Hospital-Acquired Condition (HAC) Reduction Program

This program creates an incentive for hospitals to reduce the incidence of hospital-acquired conditions by reducing payment by 1% for applicable hospitals ranking in the worst-performing quartile on select measures. For FY 2023, due to the ongoing COVID-19 PHE, no hospital was subject to the 1-percent payment reduction. You can read more about this program in a related FY 2023 CMS Fact Sheet.

 

For FY 2024, CMS finalized the proposal to establish a validation reconsideration process for hospitals who fail data validation beginning with the FY 2025 program year, affecting calendar year 2022 discharges. They also finalized modification of the validation targeting criteria to include hospitals granted extraordinary circumstances exceptions (ECEs) beginning with the FY 2027 program year, affecting calendar year 2024 discharges.

 

Hospital Value-Based Purchasing (VBP) Program

This is a budget-neutral program funded by reducing hospitals’ base operating DRG payments each fiscal year by 2% and redistributing the entire amount back to the hospitals as value-based incentive payments. Like the HAC Reduction Program, CMS finalized hospitals’ keeping the 2% payment due to the ongoing COVID-19 PHE. For FY 2024, CMS finalized several changes to this program for FY 2024, for example, CMS:

 

• Adopted the Severe Sepsis and Septic Shock: Management Bundle measure in the Safety Domain beginning with the FY 2026 program year.
• Adopted a modified version of the Medicare Spending Per Beneficiary (MSPB) Hospital measure beginning with the FY 2028 program year, and
• Adopted a modified version of the Hospital-level Risk-Standardized Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) measure beginning with the FY 2030 program year.

 

Resources

August 1, 2023 CMS Fact Sheet: FY 2024 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule – CMS-1785-F and CMS-1788-F Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fy-2024-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective-0

CMS FY 2024 Final Rule Home Page: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2024-ipps-final-rule-home-page

CMS published the CY 2024 OPPS/ASC Proposed Rule on July 13, 2023. By now, many news outlets have authored articles about this proposed rule. This article highlights topics that historically our clients have reached out to us to learn about.

Medicare Inpatient Only (IPO) Procedure List

Although CMS received several requests recommending services for removal from the IPO list, CMS did not find sufficient evidence that met the criteria and did not propose to remove any service from the IPO list for CY 2024.

 

CMS has proposed to add nine services with newly created codes by the AMA CPT Editorial Panel which will be in effect January 1, 2024 to the list and to reassign CPT code 0646T (Transcatheter tricuspid valve implantation (ttvi)/replacement with prosthetic valve, percutaneous approach, including right heart catheterization, temporary pacemaker insertion, and selective right ventricular or right atrial angiography, when performed) from status indicator “E1” to status indicator “C.” The proposed changes are available in Table 47 of the proposed rule.

 

OPPS Payment Methodology for 340B OPPS Payment Methodology for Purchased Drugs and Biologicals

On July 7, 2023, CMS published a proposed rule, referred to as “remedy proposed rule” to address reduced payment amounts to 340B hospitals for CYs 2018 through 2022 and to comply with the statutory requirement to maintain budget neutrality. The “remedy proposed rule” proposes changes to the calculation of the OPPS conversion factor beginning in CY 2025.

 

In the “remedy proposed rule,” CMS proposes to make one time lump-sum payments to each of the approximately 1,600 340B covered entity hospitals. Addendum AAA to the proposed rule lists the proposed lump-sum payment for each eligible hospital.

 

For CY 2024, CMS proposes to continue to pay the statutory default rate, which is generally ASP plus 6 percent.

 

340B Modifiers “JG” and “TB”

The Inflation Reduction Act of 2022 expanded the provider types that must report one of these modifiers no later than January 1, 2024 to now include critical access hospitals, Maryland All-Payer or Total Cost of Care Model Hospitals, and Non-excepted off-campus provider-based departments (PBD).

 

In the CY 2023 OPPS/ASC final rule, CMS maintained the requirements that 340B hospitals report one of two modifiers, “JG” – Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes, or “TB” – Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes for select entities.

 

In the CY 2024 OPPS/ASC proposed rule, CMS notes they “now believe utilizing a single modifier will allow for greater simplicity, especially because both modifiers are used for the same purpose: to identify separately payable drugs and biologicals acquired under the 340B program.”

 

CMS is proposing that all 340B covered entity hospitals would report the “TB” modifier effective January 1, 2025, even if the hospital previously reported the “JG” modifier. The “JG” modifier will remain effective through December 31, 2024. Beginning January 1, 2025, the “JG” modifier would be deleted.

 

CMS notes hospitals currently using the “JG” modifier could choose to continue to use it in CY 2024 or choose to transition to the “TB” modifier during that year.

 

Payment for Intensive Cardiac Rehabilitation Services (ICR) Provided by an Off-Campus Non-Excepted Provider Based Department (PBD) of a Hospital

CMS identified a disparity in payment for ICR services between services provided in a physician’s office and the same services provided by an off-campus, non-excepted PBD and notes that this “creates a significant barrier to beneficiary access to an already underutilized service.”

 

To eliminate this unintended outcome CMS is proposing the following:

“Pay for ICR services provided by an off-campus, non-excepted provider-based department of a hospital at 100 percent of the OPPS rate for CR services (which is also 100 percent of the PFS rate) rather than at 40 percent of the OPPS rate,” and

“Effective January 1, 2024, we propose to exclude ICR from the 40 percent Relativity Adjuster policy at the code level by modifying the claims processing of HCPCS codes G0422 (Intensive cardiac rehabilitation; with or without continuous ECG monitoring with exercise, per session) and G0423 (Intensive cardiac rehabilitation; with or without continuous ECG monitoring without exercise, per session) so that 100 percent of the OPPS rate for CR is paid irrespective of the presence of the “PN’’ modifier (signifying a service provided in a non-excepted off-campus provider-based department of a hospital) on the claim.”

 

Proposed Additions to the ASC Covered Procedures List (CPL) for CY 2024

CMS is proposing to update the ASC CPL by adding 26 dental surgical procedures. They note that they “expect to continue to gradually expand the ASC CPL, as medical practice and technology continue to evolve and advance in future years,” and encourage stakeholders to submit procedure recommendations to be added to the ASC CPL.

 

Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging

Although this falls under the purview of the CY 2024 Physician Fee Schedule Proposed Rule, I often receive questions from clients regarding when CMS plans to fully implement this program.

 

In the proposed rule, CMS notes that they “exhausted all reasonable options for fully operationalizing the AUC program,” and “propose to pause implementation of the AUC program for reevaluation and rescind the current AUC program regulations from §414.94.” They “expect this to be a hard pause to facilitate thorough program reevaluation and, as such…are not proposing a time frame within which implementation efforts may recommence.”

 

The comment period for the CY 2024 Hospital OPPS/ASC and Physician Fee Schedule Proposed Rules ends on September 11, 2023. I encourage you to take the time to review the proposed rules and submit comments.

 

Resources

Hospital Outpatient Prospective Payment-Notice of Proposed Rulemaking with Comment Period CY

2024: https://www.federalregister.gov/documents/2023/07/31/2023-14768/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment

 

Hospital Outpatient Prospective Payment Remedy for the 340B-Acquired Drug Payment Policy-Notice of Proposed Rulemaking with Comment Period: https://www.cms.gov/medicare/medicare-fee-service-payment/hospitaloutpatientpps/hospital-outpatient-regulations-and/cms-1793-p

 

MLN Fact Sheet: Medicare Part B Inflation Rebate Guidance: Use of the 340B Modifier (MLN4800856 March 2023): https://www.cms.gov/files/document/mln4800856-medicare-part-b-inflation-rebate-guidance-use-340b-modifier.pdf

 

CY 2024 Physician Fee Schedule Proposed Rule: https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched

Medicare Transmittals & MLN Articles

 

June 30, 2023: MLN MM13269: ICD-10 & Other Revisions to Laboratory National Coverage Determinations: October 2023 Update

CMS advises that you make sure your billing staff is aware of newly available codes, recent coding changes, and how to find NCD coding information.  https://www.cms.gov/files/document/mm13269-icd-10-other-coding-revisions-laboratory-ncds-october-2023-update.pdf

 

July 5, 2023: MLN Matters MM13216: Ambulatory Surgical Center Payment System: July 2023 Update - Revised

Now in it’s fourth iteration, CMS has revised this MLN article to change the number of separately payable drugs in Section 5.a to 18 to agree with the change for HCPCS J9322 in Table 3 of Change Request (CR) 13216. Substantive changes are in dark red on page 3. https://www.cms.gov/files/document/mm13216-ambulatory-surgical-center-payment-system-july-2023-update.pdf

 

July 11, 2023: MLN SE19007: Activation of Validation Edits for Providers with Multiple Service Locations – Revised

Now in its fifth iteration, CMS has revised this special edition MLN article to add information on Round 5 testing and national implementation of edits. Substantive changes are in dark red on pages 1 and 4. Note that these are not new requirements, but CMS did announce a delay of activation of these edits on March 24, 2022 until further notice. On August 1, 2023, CMS will start deploying editing into full procedure and have told the MACs to develop implementation plans to permanently turn on the Reason Codes and set them up to RTP claims that don’t match exactly. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/se19007.pdf

 

Coverage Updates

 

July 17, 2023: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease Proposed Decision Memo

CMS is proposing to remove National Coverage Determination (NCD) 220.6.20, ending coverage with evidence development (CED) from positron emission tomography (PET) beta amyloid imaging and permitting Medicare coverage determinations for PET beta amyloid imaging be made by the Medicare Administrative Contractors (MACs). https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=308

 

July 20, 2023: HCPCS Modifier JZ Reminder

Palmetto GBA JJ Part B published a reminder that “the JZ HCPCS modifier is reports on a claim to attest that no amount of drug was discarded and eligible for payment. The modifier should only be used for claims that bill for single-dose container drugs. Effective July 1, 2023 providers are required to use the JZ modifier on applicable claims. https://www.palmettogba.com/palmetto/jjb.nsf/DID/1HF9LYKONE#ls

 

Compliance Education Updates

 

June 2023: Medicare’s Home Health Benefit Brochure Revised

CMS has revised their Medicare home health brochure. This brochure includes information about a beneficiary knowing their rights, where to get more information, what is covered, who can get covered home health care, what to pay, and how to protect yourself and Medicare from fraud. https://tinyurl.com/yc2ej3sv

 

June 2023: MLN Fact Sheet Telehealth Services Revised

CMS has recently updated this Fact Sheet and notes that they have made significant updates to explain recent policy changes. https://www.cms.gov/files/document/mln901705-telehealth-services.pdf

June 29, 2023 HHS Press Release: CDC Recommends Older and Immunocompromised Adults to Receive the RSV Vaccine

HHS Secretary Xavier Becerra issued the following statement in response to the CDC recommendation of the Respiratory Syncytial Virus (RSV) vaccine for seniors over 60: “For the first time in U.S. history, people 60 years and older can now receive a vaccine for protection against RSV virus…As we prepare for the fall vaccine campaign, we will follow the data and science to protect our nation’s most vulnerable adults, those living in nursing or long-term care facilities, and the immunocompromised.” https://tinyurl.com/yw9buepd

June 29, 2023: MLN Connects: New TCET Pathway

CMS published the following information in the June 29, 2023 edition of MLN Connects:

CMS is committed to fostering innovation while ensuring that people with Medicare have faster and more consistent access to emerging technologies that will improve health outcomes. As part of this commitment, CMS announced a proposed Transitional Coverage for Emerging Technologies pathway. This announcement includes a proposed procedural notice and several proposed guidance documents that propose a substantial transformation to our approach to coverage reviews and evidence development. Comment on the Federal Register notice by August 28. More Information:

Related CMS Blog: https://www.cms.gov/blog/transforming-medicare-coverage-new-medicare-coverage-pathway-emerging-technologies-and-revamped, and

CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/notice-comment-transitional-coverage-emerging-technologies-cms-3421-nc

June 29, 2023: MLN Connects: New Details of Plan to Cover New Alzheimer’s Drugs

CMS released new details about how people can get drugs that may slow the progression of Alzheimer’s disease covered by Medicare.  Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. Clinicians will be able to submit this information through a nationwide, CMS-facilitated portal. Related CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cms-announces-new-details-plan-cover-new-alzheimers-drugs

July 7, 2023: OPPS: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 Proposed Rule (CMS 1793-P)

In response to the Supreme Court’s decision in American Hospital Association v. Becerra (142 S. Ct. 1896 (2022), and the district court’s remand, CMS published a proposed rule to remedy the payment rates the Court held were invalid and noted that aspects of this proposed rule policy will affect nearly all hospitals paid under the OPPS. The proposed rule contains the calculations of the amounts owed to each of the approximately 1,600 affected 340B covered entity hospitals. The 60-day comment period will end on September 5, 2023.

Proposed Rule: https://www.cms.gov/medicare/medicare-fee-service-payment/hospitaloutpatientpps/hospital-outpatient-regulations-and/cms-1793-p

Related CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/hospital-outpatient-prospective-payment-system-remedy-340b-acquired-drug-payment-policy-calendar

July 12, 2023: Medicare Dental Services

CMS has created a Medical Dental Coverage webpage for health care providers. You will find links to information about what Medicare does and does not cover, what are inextricably linked dental services, if Medicare pays for multiple dental visits, who can provide and bill for dental services, how to submit a claim and additional resources. https://www.cms.gov/Medicare/Coverage/MedicareDentalCoverage

Beneficiary Notice of Noncoverage, Form CMS-R-131 Renewed

Reminder, the ABN, Form CMS-R-131, and form instructions have been approved by the Office of Management and Budget (OMB) for renewal. The renewed form has an expiration date of January 31, 2026, and became mandatory on June 30, 2023. Any ABN signed on or after June 30, 2023, with a prior expiration date will not be considered valid. https://www.cms.gov/medicare/medicare-general-information/bni/abn

July 20, 2023: The Joint Commission Eliminates Additional 200 Standards Across All Accreditation Programs

The Joint Commission announced in a press release that they are eliminating and consolidating more than 200 standards, effective August 27, 2023. “The second phase of this project includes a focus on The Joint Commission’s other accreditation programs in addition to the Hospital Accreditation Program (i.e., Ambulatory Health Care, Behavioral Health Care, and Laboratory). https://www.jointcommission.org/resources/news-and-multimedia/news/2023/07/the-joint-commission-eliminates-additional-200-standards-across-all-accreditation-programs/

There are five covered indications in section B of National Coverage Determination (NCD) 20.7 Percutaneous Transluminal Angioplasty (PTA) for when PTA is covered.  

In June 2022, the Multispecialty Carotid Alliance (MSCA) submitted a letter to CMS for reconsideration of covered indication B4 (concurrent with carotid stent placement in patients at high risk for carotid endarterectomy (CEA).

Last week, on July 11, 2023, CMS published Proposed Decision Memo CAG-00085R8: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting. CMS notes, the scope of this reconsideration is limited to PTA concurrent with CAS including transcarotid artery revascularization (TCAR) procedures.

CMS summarizes that their proposals, which affect NCD 20.7 sections B4 and D, will revise Medicare coverage for PTA of the carotid arteries concurrent with stenting by:

1. Expanding coverage to individuals previously only eligible for coverage in clinical trials.
2. Expanding coverage to standard surgical risk individuals by removing the limitation of coverage to only high surgical risk individuals.
3. Removing facility standards and approval requirements.
4. Adding formal shared decision-making with the individual prior to furnishing CAS; and
5. Allowing MAC discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.

CAS By the Numbers

CY 2022 PTA of Carotid Artery Concurrent with Stenting Top 5 States by Volume & Overall Nationwide
Provider State	Claims Volume	Total Claims Payment
FL	1,250	$19,318,373.57
TX	1,158	$20,279,078.22
CA	1,007	$24,699,603.30
PA	541	$10,394,841.24
NY	523	$13,379,059.31
Nationwide	13,471	$246,555,039.68
Data Source: RealTime Medicare Data (RTMD) Medicare Fee-for-Service paid claims data for DOS CY 2022

Moving Forward

CMS is seeking comments on whether the shared decision-making interaction should require the use of a validated shared decision-making tool and/or if there are other options to achieve the goal of truly informed decision-making. The comment period is from July 11, 2023 through August 10, 2023.  

Resources

NCD 20.7: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=201

Proposed Decision Memo CAG-0085R8: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&ncaid=311&fromTracking=Y&