Knowledge Base Category -

October 30, 2023: MLN MM13390: ICD-10 & Other Coding Revisions to National Coverage Determinations: April 2024 Update (CR 1 of 2)

CMS advises providers to make sure your billing staff knows about newly available codes, recent coding changes, and NCD coding information.  https://www.cms.gov/files/document/mm13390-icd-10-other-coding-revisions-national-coverage-determinations-april-2024-update-cr-1-2.pdf

October 30, 2023: MLN MM13391: ICD-10 & Other Coding Revisions to National Coverage Determinations: April 2024 Update (CR 2 of 2)

CMS advises providers to make sure your billing staff knows about newly available codes, recent coding changes, and NCD coding information. https://www.cms.gov/files/document/mm13391-icd-10-other-coding-revisions-national-coverage-determinations-april-2024-update-cr-2-2.pdf

November 3, 2023: MLN MM13244: Separate Payment for Disposable Negative Pressure Wound Therapy Devices on Home Health Claims

Effective January 1, 2024, Medicare will make separate payment for HCPCS code A9272 on type of bill (TOB) 032x, instead of 034x. Also, Medicare Administrative Contractors (MACs) will apply deductible and coinsurance.

https://www.cms.gov/files/document/mm13244-separate-payment-disposable-negative-pressure-wound-therapy-devices-home-health-claims.pdf

November 6, 2023: MLN MM13055: Allowing Audiologists to Provide Certain Diagnostic Tests Without a Physician Order – Revised

Initially published June 1, 2023, this article was revised on November 6, 2023 to add two new CPT codes effective January 1, 2024, based on Change Request (CR) 13279.

Did You Know?

CMS announced in the CY 2024 Physician Fee Schedule (PFS) Final Rule, effective January 1, 2024 that they are pausing their efforts to implement the Appropriate Use Criteria (AUC) Program for reevaluation and rescinding the AUC regulations at 42 CFR 414.94, reserving this section for future use.

Why It Matters?

On November 3, 2023, CMS posted the following notice on the AUC Program webpage:

“Effective January 1, 2024, providers and suppliers should no longer include AUC consultation information on Medicare FFS claims. Additionally, CMS will no longer qualify PLEs or CDSMs and will remove this information from the AUC website. The claims processing instructions and guidance for the educational and operations testing period will also be removed.”

What Can I Do?

Share this information with the appropriate stakeholders at your facility and consider this an early Thanksgiving blessing that CMS acknowledged the challenges to implementing the regulations at 42 CFR 414.94.

CMS issued the CY 2024 OPPS/ASC Final Rule on November 2, 2023. You can read about changes to the Inpatient Only (IPO) Procedure List and ASC Coverage Procedure List (CPL) in a related article in this week’s newsletter. This article highlights additional topics that historically our clients have reached out to us to learn about.

OPPS Remedy for 340B-Acquired Drug Payment Policy

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” proposed changes to the calculation of the OPPS conversion factor beginning in CY 2025.

The 340B final remedy was also issued on November 2^nd. In this final rule, CMS finalized their proposed methodology of estimating the reduction in drug payments to affected 340B covered entity hospitals in CY 2018 through September 27, 2022, and will make total lump sum payments in the amount of $9.004 billion.

CMS will be issuing instructions to the MACs to issue a one-time lump sum payment to the affected hospitals within 60 calendar days of the MAC’s receipt of the instructions.

Based on updated analyses, the final rule Addendum AAA was updated with new hospital-specific payment amounts and accounts for all payment activity that has happened since the proposed rule was issued. Updated claims data reflects that affected hospitals received approximately $10.6 billion less in 340B drug payments (including money that would have been paid by Medicare and money that would have come from the beneficiaries as copayments) than they would have for drugs provided in CY 2018 through September 27, 2022, had the 340B policy not been implemented.

“The amounts included in Addendum AAA are the amounts that hospitals will receive, except that payment amounts may be affected by MACs continuing to follow normal accounting processes for collecting repayment amounts stemming from provider-specific overpayment obligations, adjustments resulting from errors identified through the lump-sum technical correction process described below, as well as other unique situations such as provider bankruptcy or payment suspension, any of which may impact the provider’s net payment amount.”

Unfortunately, the lump sum payments do not include interest and CMS is following budget neutrality requirements to make these payments. This means that “beginning in CY 2026, we will reduce all payments for non-drug items and services to all OPPS providers, except new providers (hospitals with a CMS CCN effective date of January 2, 2018, or later), by 0.5 percent each year until the total estimated offset of $7.8 billion is reached. We currently estimate that the payment decrease will be completed after approximately 16 years. To implement this reduction and exception for new providers, we are finalizing the proposed regulation text changes at § 419.32(b)(1)(iv)(B) as proposed, except for changing the implementation date of the 0.5 percent reduction from CY 2025 to CY 2026.”

CMS notes in the 340B remedy final rule that “generally the impact of that annual 0.5 percent reduction to the OPPS conversion factor on individual providers, as well as categories of providers, will depend on the percentage of their OPPS payments that are conversion factor-based, and in most cases will be a decrease of slightly less than 0.5 percent of overall OPPS payments.”

Beneficiary Cost Sharing

CMS noted in the final rule that commenters overwhelmingly supported their proposed approach and rationale for accounting for beneficiary cost sharing. They finalized their “policy to account for beneficiary cost sharing as proposed. We will exercise our authority under section 1833(t)(2)(E) of the Act (42 U.S.C. 1395l(t)(2)(E)) to make adjustments “as necessary to ensure equitable payments,” to pay the full $9.0 billion difference, including $1.8 billion, an amount that is approximately equivalent to what affected 340B covered entity hospitals would have collected from beneficiaries for these 340B-acquired drugs if the 340B Payment Policy had not been in effect from CY 2018 through September 27, 2022, so that affected 340B covered entity hospitals are paid the approximate amount they would have been paid in full without application of the 340B Payment Policy.”

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.

Did you Know?

November is Lung Cancer Awareness Month and annually the American Cancer Society has designated the third Thursday of November as the Great American Smokeout®.

Why it Matters?

In June of this year HHS published a request for information in the Federal Register seeking input on the Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation to guide the Department’s efforts to sustain and strengthen existing programs and drive further progress toward smoking cessation, with an emphasis on serving populations and communities disproportionately impacted by smoking-related morbidity and mortality. Comments had to be submitted by July 30, 2023. https://www.federalregister.gov/documents/2023/06/30/2023-13928/request-for-information-draft-hhs-2023-framework-to-support-and-accelerate-smoking-cessation

In a related Fact Sheet, HHS noted that “smoking causes approximately 30 percent of all cancer deaths in the nation – making it the largest single driver of cancer deaths in America…the Biden-Harris administration has made it a priority to reach the Cancer Moonshot goal of reducing cancer mortality by 50% within 25 years. Driving progress towards smoking cessation is essential to achieving this goal.”

What Can I Do About It?

For health care providers, know what resources are available for your patients.

Counseling to Prevent Tobacco Use

This service falls in the benefit category of additional preventive services. National Coverage Determination (NCD 210.4.1) Counseling to Prevent Tobacco Abuse details the covered indications for this service. Specifically, CMS covers this service for outpatient and hospitalized patients with Medicare Part B who meet the following criteria:

• The patient uses tobacco, regardless of whether they exhibit signs and symptoms of tobacco-related disease,
• The patient is competent and alert when counseling is delivered, and
• The counseling is provided by a qualified physician or other Medicare-recognized practitioner.

Counseling Frequency

Medicare covers two cessation attempts per year and each attempt may include a maximum of four intermediate or intensive sessions, with the patient getting up to eight sessions per year. There is no copayment, coinsurance, or deductible for the patient.

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).

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

On October 11, 2023, CMS published a Final Decision Memo. CMS summarizes the final changes affecting NCD 20.7 sections B4 and D, which revises 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.

Shared Decision Making

CMS finalized that prior to carotid artery stenting, practitioners must engage in a formal Shared Decision Making (SDM) interaction with the beneficiary. The shared decision-making must include:  

• Discussion of all treatment options included carotid endarterectomy (CEA), CAS (which includes transcarotid artery revascularization (TCAR)), and optimal medical therapy (OMT)).
• Explanation of risks and benefits for each option specific to the beneficiary’s clinical situation.
• Integration of clinical guidelines (e.g., patient comorbidities and concomitant treatments).
• Discussion and incorporation of beneficiary’s personal preferences and priorities in choosing a treatment plan.

CMS goes on to note that "While not requiring use of a validated SDM tool in the NCD, we would like to note that we believe CMS is not the appropriate entity to develop a tool or specify how to develop a tool to assist in decision-making for carotid artery disease treatments. We believe this role is best left to clinical societies and other expert bodies."

Medicare Transmittals & MLN Articles

September 19, 2023: MLN MM13166: ICD-10 & Other Coding Revisions to National Coverage Determinations: October 2023 Update

Relevant NCD coding changes in related Change Request 13166 include:

• NCD 20.20: External Counterpulsation Therapy (ECP) for Severe Angina, effective August 7, 2023,
• NCD 90.2: Next Generation Sequencing (NGS), effective August 7, 2023, and
• NCD 210.1: Prostate Screening Tests, effective October 1, 2023.

https://www.cms.gov/files/document/mm13166-icd-10-other-coding-revisions-national-coverage-determinations-october-2023-update.pdf

October 11, 2023: MLN MM13381: Update for Blood Clotting Factor Add-on Payments

In this MLN article, CMS advises IPPS hospitals to make sure your billing staff knows about additional diagnosis codes eligible for blood clotting factors, and adjustment of certain claims with the added codes. https://www.cms.gov/files/document/mm13381-update-blood-clotting-factor-add-payments.pdf

October 12, 2023: Transmittal 12299: An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring, and (2) Expanding Coverage of Colorectal Screening

Transmittal 11865 issued February 16, 2023 has been rescinded and replaced by Transmittal 12299 to provide clarification on CMS policy and related claims processing instructions for their approach to colonoscopies within the context of a complete colorectal cancer screening. Specifically, this CR is amended to remove the requirement that contractors shall return to provider / return as un-processable certain screening colonoscopy claims that do not include the KX modifier. https://www.cms.gov/files/document/r12299bp.pdf

October 19, 2023: MLN MM13365: Medicare Deductible, Coinsurance, & Premium Rates: CY 2024 Update

CMS advises providers to make sure your billing staff knows about the CY 2024 Medicare Part A and Medicare Part B deductible and coinsurance rates, and Part and Part B premium amounts. https://www.cms.gov/files/document/mm13365-cy-2024-update-medicare-deductible-coinsurance-premium-rates.pdf

Coverage Updates

October 13: NCD 220.6.20 Beta Amyloid PET in Dementia and Neurodegenerative Disease Final Decision Memo

CMS announced a final decision removing this NCD and now permitting Medicare coverage determinations to be made by the MACs. Removing the NCD also removes the current limitation of one PET beta-amyloid scan per lifetime from the coverage requirements.

It has been thirteen years since CMS published the first Medicare Quarterly Compliance Newsletter in 2010.  At that time, this Medicare Learning Network® (MLN) educational product was meant “to help providers understand the major findings identified by Medicare Claims Processing Contractors, Recovery Auditors, Program Safeguard Contractors, Zone Program Integrity Contractors, and other governmental organizations such as the Office of Inspector General.”

In the second edition of this newsletter CMS indicated that it was “designed to help FFS providers, suppliers, and their billing staffs understand their claims submission problems and how to avoid certain billing errors and other improper activities, such as failure to submit timely medical record documentation, when dealing with the Medicare FFS program.”

Thirteen years later, the newsletter is published twice a year instead of quarterly, and there have been additions to who is reviewing records (i.e., Noridian as the current Supplemental Medical Review Contractor (SMRC) and Livanta as the National Medicare Claim Review Contractor for short stay reviews (SSRs) and higher-weighted DRG (HWDRG) reviews nationally).

CMS announced the release of the September 2023 newsletter in the October 5, 2023 edition of MLN Connects. This edition of the newsletter includes guidance from the Comprehensive Error Rate Testing (CERT) and the Recovery Auditor program.

CERT: Hospital Outpatient Services

The CERT guidance affects physicians, non-physician practitioners (NPPs), and providers who bill 12x-19x. For 2022, the CERT reported an improper payment rate of 5.4% for hospital outpatient services. While the error rate is relatively low, it equates to a projected improper payment of $4.4 billion.

Ninety-one percent of the improper payments were attributed to insufficient documentation. CMS notes that “hospital outpatient claims with insufficient documentation errors most commonly were due to a missing order, missing provider’s intent to order, or inadequacies (that is, required elements are missing) with an order.”  An example of a missing order or provider’s intent to order is in the newsletter as well as links to resources to help avoid errors when billing hospital outpatient services.

Recovery Auditor Review 0210: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: Medical Necessity and Documentation Requirements

The Recovery Auditor guidance affects outpatient hospitals, ambulatory surgical centers (ASCs), and professional services. The problem cited related to this RAC topic is that providers should know the documentation and medical necessity requirements when billing for this service.

The CPT code for this procedure 64582 (Open implantation of hypoglossal nerve neurostimulator array, pulse generator, and distal respiratory sensor electrode or electrode array) became effective January 1, 2022 and CMS approved this RAC topic for review on June 7, 2022.

There are very specific indications that must be met for this procedure to be covered (i.e., beneficiary must be 22 years of age or older with a body mass index less than 35, and Shared Decision-Making (SDM) must occur between the beneficiary, sleep physician, and qualified otolaryngologist (if they are not the same).

CMS recommends that providers review coverage indications, limitations, and medical necessity requirements in Local Coverage Determinations (LCDs) and related Local Coverage Articles (LCAs) for billing and coding guidance.

The September Medicare Provider Compliance Newsletter includes links to a National Government Services, Inc. (NGS) LCA and a Palmetto GBA LCD. If neither one of these Medicare Administrative Contractors (MACs) is your MAC, you can find a listing of all MACs that have published an LCD and related LCA on the RAC approved topic description for recovery auditor review 0210 on the CMS webpage.   

CPT Code 64582 by the Numbers

With this being a relatively new CPT code and RAC approved topic, I turned to our sister company, RealTime Medicare Data (RTMD), to quantify actual claims volume and payment for this service. The following data represents Medicare Fee-for-Service paid claims data available in RTMD’s database for all U.S. States and D.C. for calendar year 2022.

Hospital Outpatient Setting

• Claims volume: 5,632
• Sum of CPT Paid: $113,462,444.15
• Average Payment: $20,146.03
• Top five states performing this procedure in the hospital outpatient setting: Florida, Texas, Arizona, South Carolina, and Indiana

   

  ASC Setting

• Claims Volume: 1,052
• Sum of CPT Paid: $5,207,088.00
• Average Payment: $4,949.70
• Top five states performing this procedure in an ASC: Texas, Illinois, New Jersey, New Mexico, and Washington

In addition to ensuring that documentation in the medical record supports indications, documentation requirements, and coding and billing guidance, CMS recommends that you respond to RAC review requests promptly and completely. While this seems obvious, no/insufficient documentation continues to be cited as a cause for claim denials. For this reason, make sure you have processes in place to ensure record requests from contractors make it to the right person and/or department in your hospital, you send all documentation needed to support the service provided, and the review contractor receives the record in a timely manner. 

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

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

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