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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. 

Did You Know?

Breast Cancer Awareness Month was first celebrated in October 1985 as partnership between the American Cancer Society and Imperial Chemical Industries (now AstraZeneca).

Chances are you; a family member, close friend or acquaintance has been impacted by breast cancer. October is Breast Cancer Awareness Month. According to the CDC, each year:

• About 240,000 women in the United States get breast cancer and 42,000 women die from the disease,
• Men can also get breast cancer, but it is not common. About one out of every one hundred breast cancers diagnoses in the United States is found in a man, and
• While most breast cancers are found in women who are 50 years old or older, breast cancer also affects younger women.

Why Should You Care?

Even though family history increases the risk of breast cancer, most women diagnosed with breast cancer have no known family history of the disease. Early detection allows for a higher chance of cure. Mammography is used to detect breast cancer and is one of many Preventative Services covered by Medicare.

What Can I Do?

Know Ways to Lower Your Risk for Breast Cancer

The CDC details thing you can do to help lower your risk of breast cancer including:

• Keep a health weight and exercise regularly,
• Choose not to drink alcohol, or drink alcohol in moderation,
• If you are taking hormone replacement therapy or birth control pills, ask your doctor about the risks, and
• Breastfeed your children, if possible.

   

  Know the Warning Signs of Breast Cancer

  While there are different symptoms of breast cancer, and some people have no symptoms at all, symptoms can include:

• Any change in the size or shape of the breast,
• Pain in any area of the breast,
• Nipple discharge other than breast mild (including blood),
• A new lump in the breast or underarm, thickening or swelling or part of the breast,
• Irritation or dimpling of the breast,
• Redness or flaky skin in the nipple area of the breast.

Be Your Own Patient Advocate

If you have any signs or symptoms that worry you, follow-up with a health care provider as soon as possible.

Talk to your health care provider about when and how often to get a screening mammogram. If you are worried about the cost, the CDC’s National Breast Cancer Early Detection Program (NBCCEDP) (https://www.cdc.gov/cancer/nbccedp/screenings.htm) provides breast and cervical cancer screenings and diagnostic services to women who have low incomes and are uninsured or underinsured.

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

Happy Case Management week. This year, the American Case Management Association (ACMA), the Case Management Society of America (CMSA), and Commission for Case Manager Certification (CCMC) have joined to celebrate National Case Management Week with the theme and goal of “Keeping the person at the heart of collaborative care.”

In keeping with this year’s theme, the ACMA’s defines case management in the health care delivery systems as being “a collaborative practice including patients, caregivers, nurses, social workers, physicians, payers, support staff, other practitioners, and the community. The Case Management process facilitates communication and care coordination along a continuum through effective transitional care management. Recognizing the patient’s right to self-determination, the significance of the social determinants of health and the complexities of care, the goals of Case Management include the achievement of optimal health, access to services, and appropriate utilization of resources."

Medicare & You 2024

The 2024 Medicare and You handbook is now available and can be downloaded in different formats and languages. This is a great resource to help you understand the different parts of Medicare (A, B, C, D) and what services original Medicare Fee-for-Service covers.

There are seven “What’s new & important?” call outs on page two of the handbook, for example:

• Changes to telehealth coverage: You can still get telehealth services at any location in the U.S., including your home, until the end of 2024. After that, you must be in an office or medical facility located in a rural area to get most telehealth services. There are some exceptions, like mental health services.
• More times to sign up for Medicare: If you recently lost (or will soon lose) Medicaid, you may be able to sign up for Medicare or change your current Medicare coverage. There are special situations that allow you to sign up for Medicare.
• COVID-19 care: Medicare continues to cover the COVID-19 vaccine, and several tests and treatments to keep you and others safe.

MMP wishes all the hard working and dedicated Case Managers that we work with a happy case management week.

Social factors can have a positive and negative impact on our health and our general outlook on life. Hospitals have been tasked with assessing and identifying social factors that impact a patient’s health and well-being. Once identified, hospitals are taking action to mitigate the negative impact of social factors that are contributing to wide health disparities and inequities.

This article will review Social Determinants of Health (SDOH), Health Related Social Needs (HRSN), and Social Drivers of Health (SDOH).

Social Determinants of Health (SDOH)

HHS Health People 2030 National Health Initiative

The U.S. Department of Health and Human Services through their Healthy People 2030 national health initiative defines SDOH as being “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.” They group SDOH into the five domains of economic stability, education access and quality, health care access and quality, neighborhood and built environment, and social and community context.  

SDOH can negatively impact our health especially as we age. Collectively, the U.S. population is getting older, in fact “people aged 65 years and older made-up 17 percent of the population in 2020. By 2040, that number is expected to grow to 22 percent. An aging population means higher use of health care services and a greater need for family and professional caregivers.”

To learn more about how the Healthy People 2030 initiative is addressing SDOH and available resources, visit the initiative website at https://health.gov/healthypeople/priority-areas/social-determinants-health.

SDOH and ICD-10-CM Z Codes

ICD-10-CM Z codes are found in Chapter 21: Factors Influencing Health Status and Contact with Health Services (Z00-Z99). The SDOH codes are a subset of this chapter and range from Z55 – Z65 and are used to document SDOH data (i.e., housing, food insecurity, lack of transportation).

CMS recently published information about a new CMS infographic to help you understand and use Z codes to improve the quality and collection of health equity data in the September 14, 2023 edition of MLN Connects (https://www.cms.gov/training-education/medicare-learning-network/newsletter/2023-09-14-mlnc#_Toc145581413).

ICD-10-CM Official Guidelines for Coding and Reporting Documentation Tips Regarding SDOH Z Codes

• Code assignment may be based on medical record documentation from clinicians involved in the care of the patient who are not the patient’s provider (i.e., Social Workers, Case Managers, or Nurses).
• Patient self-reported documentation may be used when the information is signed-off by and incorporated into the medical record by either a clinician or provider.
• SDOH codes should be assigned only when the documentation specifies that the patient has an associated problem or risk factor. For example, you would not use ICD-10-CM code Z60.2 (Problems related to living alone) without documentation of a risk or unmet needs for assistance at home.

   

  Z Codes IPPS FY 2024 Change in Severity Designation

  In the 2024 IPPS Final Rule, CMS recognized that homelessness is an indicator of increased resource utilization in the acute inpatient hospital setting. Therefore, they finalized the proposal to change the severity designation for three codes to a CC (comorbidity) for the purposes of MS-DRG assignment:

• Z59.00: Homelessness, unspecified,
• Z59.01: Sheltered homelessness (due to economic difficulties, currently living in a shelter, motel, temporary or transitional living situation, scattered site housing, or not having a consistent place to sleep at night), and
• Z59.02: Unsheltered homelessness (residing in a place not meant for human habitation, such as cars, parks, sidewalks, or abandoned buildings (on the street)).

CMS noted in a FY 2024 IPPS Final Rule fact sheet that as SDOH codes are increasingly added to billed claims, they plan “to continue to analyze the effects of SDOH on severity of illness, complexity of services, and consumption of resources.”

Did You Know?

There is a new code to assign for Encounter for Screening for COVID-19.

Why It Matters?

Prior to October 1, 2023, coders assigned code (Z20.822) for contact with and (suspected) exposure to COVID-19, for COVID-19 screening, per the federal Public Health Emergency (PHE).  However, as of May 11, 2023, the federal PHE expired.  Therefore, the new code is to be assigned beginning with all encounters on or after October 1, 2023.

What Can I Do?

Stay abreast of all new ICD-10-CM codes and guidelines and new Coding Clinic references.

References

Coding Clinic for ICD-10-CM/PCS, Second Quarter 2012, Page 3

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