Knowledge Base Category -

Medicare MLN Articles & Transmittals

Change to the Laboratory National Coverage Determination (NCD) Edit Software for October 2022

• MLN Release Date: June 24, 2022
• What You Need to Know: CMS advises you to make sure your billing staff know about changes to the Laboratory NCD Edit Module for October 2022 and how to access the NCD spreadsheet that lists relevant changes.
• MLN MM12803: (link)

One-Time Notification: New Edit for PPS Outpatient and Inpatient Bill Types Receiving Outlier Payment When Device Credit is Reported

• Transmittal Release Date: July 7, 2022
• What You Need to Know: A new edit is being implemented to provide MACs with a way to review the charges and device reduction amount submitted on claims for fully or partially credited devices. Effective January 1, 2023, CMS will suspend outpatient and inpatient prospective payment claims getting an outlier payment when a device credit is reported. This will allow the MACs to review the charges and device reduction amounts for fully and partially credited devices.
• Transmittal 11488 (Change Request 12769): (link)

Coverage Updates

July 6, 2022: Cochlear Implantation Proposed Decision Memo (CAG-00107R)

CMS released a Proposed Decision Memo regarding the National Coverage Determination for Cochlear Implantation (50.3) (link). Among other things, CMS is proposing to expand coverage by broadening the patient criteria and removing the requirement that for individuals with hearing test scores of > 40 % and ≤ 60 %. The public comment period ends August 5, 2022.

July 8, 2022: Home Use of Oxygen Final Decision Memo

Per the Final Decision Memo (link), “Effective July 8, 2022, the MAC may determine reasonable and necessary coverage of oxygen therapy and oxygen equipment in the home for patients who are not described in section B or precluded by section C of this NCD. Initial coverage for patients with other conditions may be limited to the shorter of 90 days or the number of days included in the practitioner prescription at MAC discretion. Oxygen coverage may be renewed if deemed medically necessary by the MAC.”

Compliance Updates

Implanted Spinal Neurostimulators: Document Medical Records

In a recent report, the OIG found that Medicare improperly paid claims for implanted spinal neurostimulators when providers did not provide sufficient documentation supporting medical necessity. You will find a link to the OIG report and helpful resources in the Thursday July 21, 2022, edition of their MLN Connects e-newsletter ( https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-07-21-mlnc">link).

COVID-19 Updates

Coding Long COVID

CMS offered the following advice regarding coding Long COVID in the Thursday July 7, 2022, edition of MLN Connects (link):

• For a post COVID-19 condition, unspecified, like Long COVID, use code DX U09.9. Add other codes for conditions related to the COVID-19 infection, like R50.9 for fever.
• For a current COVID-19 infection, use code DX U07.1. Do not use code DX U09.9.
• For a current COVID-19 infection and conditions from a previous COVID-19 infection, use code U09.9 with code DX U07.1. Add other codes for conditions related to the COVID-19 infection, like R06.02 for shortness of breath.
• For more information, see pages 30-31 of ICD-10-CM Official Guidelines for Coding and Reporting: Fiscal Year 2022 (PDF).

July 13, 2022: CDC Releases Resistant Infections Special Report

The CDC released a report (link) detailing the negative effect of the COVID-19 pandemic on recent years of progress in the United States combating antimicrobial resistance (AR). In a related announcement, the CDC noted the report “concludes that the threat of antimicrobial-resistant infections is not only still present but has gotten worse – with resistant hospital-onset infections and deaths both increasing at least 15% during the first year of the pandemic.”

July 15, 2022: COVID-19 Public Health Emergency Renewed

CMS waited until late Friday, July 15th to post an extension of the COVID-19 public health emergency (PHE) (link). This extends the PHE for ninety days.

Other Updates

July 7, 2022: Special Edition MLN Connects – Physician Fee Schedule Proposed Rule release

CCMS announced the release of the CY 2023 Physician Fee Schedule Proposed Rule in a special edition of their MLN Connects e-newsletter (link). You will find links to related fact sheets and the proposed rule in the newsletter. Comments are due to CMS by September 7, 2022.

July 7, 2022: Appropriate Use Criteria (AUC) Penalty Phase Delayed Again

CMS as posted the following notice on the AUC Program webpage (link), “The payment penalty phase will not begin January 1, 2023 even if the PHE for COVID-19 ends in 2022. Until further notice, the educational and operations testing period will continue. CMS is unable to forecast when the payment penalty phase will begin.”

July 16, 2022: New Nationwide 988 Crisis Hotline

HHS announced in a July 15th Press Release (link), the transition from the 10-digit National Suicide Prevention Lifeline to 988 “an easy-to-remember three-digit number for 24/7 crisis care…The 988 Suicide & Crisis Lifeline is a network of more than 200 state and local call centers supported by HHS through the Substance Abuse and Mental Health Services Administration (SAMHSA).”

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e., MAC, RAC, OIG) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). In general, this monthly article spotlights current review activities. However, this month in keeping with the Hallmark Channel’s Christmas in July celebration, MMP would like to recognize the OIG’s Health Care Fraud and Abuse Control Program’s 25th year of operation and celebrate Medicare’s 57th birthday!

Health Care Fraud and Abuse Control Program Celebrates its 25th Year of Operation

On July 5, 2022, The Office of Inspector General (OIG) released the Department of Health and Human Services and The Department of Justice’s Health Care Fraud and Abuse Control (HCFAC) Program Report for Fiscal Year 2021 (link). The OIG’s notice of this report’s release indicated the HCFAC “Program is celebrating its 25th year of operation and continued success in identifying and prosecuting the most egregious instances of health care fraud, preventing future fraud and abuse, and protecting program beneficiaries.”

HCFAC Report OIG and CMS Highlights

• In its 25th year of operation, the Secretary and the Attorney General certified $321.6 million in mandatory funding necessary for the Program. In addition, Congress appropriate $807.0 million in discretionary fundings.
• The OIG was allocated just over $300 million, and the Centers for Medicare and Medicaid Services was allocated almost $600 million.
• During FY 2021, the Federal Government won or negotiated more than $5.0 billion in healthcare fraud judgments and settlements.
• The HCFAC Program’s return on investment (ROI) over the last three years (2019-2021) is $4.00 returned for every $1.00 expended. Note, “this ROI relies on actual recoveries and collections, and does not represent the effect of preventing future fraudulent payments.”

OIG Efforts

• The OIG is the leading oversight agency specializing in health care fraud and “employs a multi-disciplinary approach and uses data-driven decision-making to produce outcome-focused results.”
• The OIG’s priority outcome areas fall into two broad categories:
• Minimize risk to beneficiaries, and
• Safeguard programs from improper payments and fraud.
• In FY 2021, the OIG issued 162 audit reports and 46 evaluations, resulting in 506 new recommendations issued to HHS operating divisions, HHS grantees and other entities. Out of 506 recommendations made in FY 2021, 432 were implemented in FY 2021.

CMS Efforts

• “CMS defines program integrity very simply, “pay it right.” Program integrity focuses on paying the right amount, to legitimate providers and suppliers, for covered, reasonable and necessary services provided to eligible beneficiaries, while concurrently taking aggressive actions to eliminate fraud, waste, and abuse. Federal health programs are quickly evolving; therefore, CMS’s program integrity strategy must keep pace to address emerging challenges.”
• Unified Program Integrity Contractors (UPICs) medical reviews “are uniquely focused on fraud detection and investigation. Currently, UPICs are carrying out program integrity activities in all five geographic jurisdictions: Midwest, Northeast, West, Southeast, and Southwest.
• CMS used the Medical Review Accuracy Contractor (MRAC) to conduct medical review of claim determinations made by Medicare Medical Review Contractors including MACs, UPICs, the Supplemental Medicare Review Contractor (SMRC) and in 2021 the RACs while procurement for the RAC Validation Contractor (RVC) was underway.

Happy 57th Birthday Medicare!

On July 30, 1965, President Lyndon B. Johnson signed into law the bill that led to the Medicare and Medicaid. President and First Lady Truman were the first Medicare Beneficiaries.

Did You Know?

In the CMS 2021 Edition of Medicare Beneficiaries at a Glance (link), in 2019:

• 61.5 million people were enrolled in Medicare,
• 3.8 million of these people were new enrollees,
• 49% of enrollees were between the ages of 65 and 74,
• 63% of enrollees were enrolled in the traditional Medicare Fee-for-Service plan, and
• The top five chronic conditions were high blood pressure, high cholesterol, arthritis, diabetes, and heart disease.

In honor of Medicare’s birthday and in keeping with our monthly focus on Medicare Contractors, following is a list of useful resources provided by the CMS for our readers:

• Review Contractor Interactive Map: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map
• Medicare Fee for Service Compliance Programs webpage: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Overview
• CMS’ Medicare Learning Network (MLN) webpage: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNGenInfo
• Medicare Coverage Database: https://www.cms.gov/medicare-coverage-database/search.aspx
• MLN Fact Sheet: Collaborative Patient Care is a Provider Partnership:
• Medicare Internet Only Manuals:

Did You Know?

Last month, MMP published an article highlighting the new RAC issue 0210: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea (link). Since then, all the Recovery Auditor regions have added this new complex issue to their list of approved issues.

What Can You Do?

If your hospital is providing this service, now is the time to review a few medical records against your MACs coverage requirements to ensure you are following the provisions of the policy and billing and coding article. The RAC issue includes a listing of each of the MACs LCDs and Billing and Coding Articles.

For those in the Palmetto MAC jurisdictions J and M, Palmetto has published an article (link) about HNS that includes links to a hypoglossal nerve stimulator checklist and their LCD.

You can also visit Inspire Medical System, Inc’s Inspire Sleep Apnea Innovations webpage (link). Information available for patients includes:

• Cost and Eligibility,
• Patient Stories,
• FAQ,
• Free Informational Events, and
• A four-question assessment to see if you qualify for this system.

Information available for Healthcare Professionals (link) includes:

• Indications/Contraindications,
• A Patient Experience Report,
• Reimbursement information (Hospital, Physician and Sleep Services Billing Guides),
• Training and Education Tools, and
• Digital Health Documents.

On June 30th, a proposed rule was released titled, Conditions of Participation for Rural Emergency Hospitals and Critical Access Hospital COP Updates (CMS-3419-P). A related CMS Fact Sheet (link) notes that “Rural Emergency Hospitals (REHs) are a new provider type established by the Consolidated Appropriations Act of 2021 to address the growing concern over closures of rural hospitals. The REH designation provides an opportunity for Critical Access Hospitals (CAHs) and certain rural hospitals to avert potential closure and continue to provide essential services for the communities they serve.”

The proposed CoPs for REH providers were modeled closely after the CoPs for Critical Access Hospitals (CAHs) and in some instances CoPs for hospitals and ambulatory surgery centers (ASCs).

Per CMS, discussion of Medicare payment; quality reporting and enrollment policies are to be included in the calendar year (CY) 2023 Outpatient Prospective Payment System-Ambulatory Surgery Center (OPPS/ASC) proposed rule. The REH CoPs final rule is expected to be included in the CY 2023 OPPS/ASC final rule.

Definition for a Rural Emergency Hospital

REHs are defined as being “A facility that is enrolled in the Medicare program as an REH; does not provide any acute care inpatient services (other than post-REH, that is after discharge from an REH, or post-hospital extended care services furnished in a distinct part unit licensed as a skilled nursing facility (SNF)); has a transfer agreement in effect with a level I or level II trauma center; meets certain licensure requirements; meets requirements of a staffed emergency department; meets staff training and certification requirements established by the Secretary of the Department of Health and Human Services (the Secretary); and meets certain CoPs applicable to hospital emergency departments and CAHs with respect to emergency services.”

Fast Facts about REHs

• To become an REH, a facility must have been a CAH or have been classified as a rural hospital with not more than 50 beds as of the date the Consolidated Appropriations Act (CAA) of 2021 was signed into law on December 27, 2020.
• REHs are required to provide emergency department services and observation care. An REH can elect to add additional outpatient medical and health services.
• An REH must have a staffed Emergency Department 24 hours a day, 7 days a week.
• An REH must have a physician, nurse practitioner, clinical nurse specialist, or physician assistant available to furnish rural emergency hospital services in the facility 24 hours a day.
• An REH can act as an originating site for telehealth services furnished on or after January 1, 2023.

REH Payment

REH providers will begin receiving payment for services furnished on or after January 1, 2023. Like other providers participating in Medicare, REHs must enter into a provider agreement with CMS. REHs will receive Medicare payment that is:

• Equal to the amount of payment that would otherwise apply under the Medicare Hospital OPPS for covered outpatient department services increased by 5 percent.
• In addition, an additional monthly facility payment to an REH. The details of the payment policies for REHs will be developed in separate notice and comment rulemaking.
• The beneficiary co-payments for these services will be calculated the same way as under the OPPS for the service, excluding the 5 percent payment increase.

REHs Relationship with Hospitals

CMS notes that “hospital admissions and transfers account for roughly 20 percent of all patient dispositions from the emergency department across the U.S. As a result, we can expect that REHs will transfer at least 20 percent of their patients so we agree with commenters and are therefore proposing to require that REHs have established relationships with hospitals that have the resources and capacity available to deliver care that is beyond the scope of care delivered at the REH.”

Outpatient Surgical Procedures in an REH

CMS acknowledges there will be a need for outpatient surgical services in communities where CAHs convert to an REH. They have proposed “at § 485.524(d) to set forth standards for an REH performing outpatient surgical services that are consistent with the CAH requirements for surgical services at § 485.639. These include proposed standards for ensuring that the services are conducted in a safe manner by qualified practitioners with specific protocols for administering anesthesia.” They expect “REHs, like ASCs, to provide surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission.”

Condition of Participation: Discharge Planning

The proposed Discharge Planning CoPs for REHs are closely aligned with the requirements for hospitals and CAHs.

Distinct Part SNF Unit

Per CMS, “According to a policy brief published by RUPRI Center for Rural Health Policy Analysis, there were 472 nursing home closures between 2008 and 2018 in nonmetropolitan counties in the U.S. The policy brief noted that 10.1 percent of the country’s nonmetropolitan counties had no nursing homes. Given the closures of rural nursing homes and the lack of nursing homes in rural communities, residents living in rural areas may not have adequate access to SNF services. The provision of these services in distinct part units of REHs may help address this access issue.”

A study by the consulting firm CLA’s study (“A Path Forward: CLA’s Simulations on Rural Emergency Hospital Designation”), estimates between 11 and 600 CAHs would benefit from conversion to REH status.

Critical Access Hospitals

This proposed rule also includes proposed updates to the CoPs for CAHs by proposing to:

• Add a definition of primary roads to the location and distance requirements,
• Establish a patient’s rights CoP, and
• Allow for a unified and integrated systems for infection control and prevention and antibiotic stewardship program, medical staff, and quality assessment and performance improvement program (if the CAH is part of a health system containing more than one hospital or CAH).

I encourage you to read the proposed rule and submit comments. One important issue CMS is seeking input on is whether REHs should be permitted to provide low-risk labor and delivery, and whether they should require an REH also provide outpatient surgical services in the event surgical labor and delivery intervention is necessary. CMS is accepting comments through August 29, 2022.

Resource

Proposed Rule - Conditions of Participation for Rural Emergency Hospitals and Critical Access Hospital COP Updates (CMS-3419-P): (link)

In the Thursday June 30 2022, edition of MLN Connects (link), CMS included the following information about Pfizer-BioNTech vaccines for children as young as six months and new CPT vaccine codes:

“On June 17, 2022, the FDA amended the Pfizer-BioNTech COVID-19 vaccine emergency use authorization (PDF) (link) to authorize use for all patients 6 months – 4 years old. Get important vial and dosing information. (link) CMS issued new CPT codes effective June 17, 2022:

Code 91308 for vaccine product:

• Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use
• Short descriptor: SARSCOV2 VAC 3 MCG TRS-SUCR

Code 0081A for vaccine administration, first dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; first dose
• Short descriptor: ADM SARSCV2 3MCG TRS-SUCR 1

Code: 0082A for vaccine administration, second dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; second dose
• Short descriptor: ADM SARSCV2 3MCG TRS-SUCR 2

Code 0083A for vaccine administration, third dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; third dose
• Short descriptor: ADM SARSCV2 3MCG TRS-SUCR 3

Visit the COVID-19 Vaccine Provider Toolkit (link) for more information, and get the most current list of billing codes, payment allowances, and effective dates. (link) Note: you may need to refresh your browser if you recently visited this webpage.”

June 2022 Medicare Transmittals and Proposed Rules

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)—July 2022

• Article Release Date: May 9, 2022 – Revised June 21, 2022
• What You Need to Know: This article details information about newly available codes, separate NCD coding revisions and coding feedback. It was updated on June 21, 2022, to reflect a revised Change Request (CR) 12705. The substance of the article did not change. NCDs updated includes:
• NCD 20.31 Intensive Cardiac Rehabilitation (ICR) Programs,
• NCD 20.31.1 Pritikin Program,
• NCD 20.31.2 Ornish Program for Reversing Heart Disease,
• NCD 20.31.3 ICR Benson-Henry Program,
• NCS 90.2 Next Generation Sequencing (NGS),
• NCD 160.18 Vagus Nerve Stimulation (VNS),
• NCD 180.1 Medical Nutrition Therapy (MNT), and
• NCD 270.3 Blood Derived Products for Chronic Non-healing Wounds
• MLN MM12705: (link)

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

• Article Release Date: May 18, 2021 – 2nd Revision June 22, 2022
• What You Need to Know: This MLN was revised to reflect CR 12124 which changed the business requirements for NCD 90.2, Next Generation Sequencing. This change resulted in a new spreadsheet for this NCD by retaining all ICD-10 Not Otherwise Classified (NOC) diagnosis codes that had been proposed for deletion effective July 1, 2022. CMS advised that “Although we’re not moving forward with deleting the aforementioned ICD-10 NOC diagnosis codes from NCD 90.2, we continue to strongly encourage providers and laboratories to make sure they provide the best possible and most specific code on the claim in accordance with the implementation of ICD-10 in 2015. We’ll be monitoring these laboratory claims and may take future action to reinstate removal of these ICD-10 NOC codes.”
• MLN MM12124: (link)

July 2022 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: June 9, 2022 – Revised June 24, 2022
• What You Need to Know: This article was revised to remove two HCPCS codes from table 3 of the Change Request 12773 reducing the number of new codes from 16 to 14.
• MLN MM12773: ((link)

Medicare Proposed Rules

On Tuesday, June 21, 2022, CMS published a Special Edition MLN Connects ((link) spotlighting the release of two Calendar Year (CY) 2023 proposed rules:

• CY 2023 Home Health Prospective Payment System Rule Update and Home Infusion Therapy Services Requirements Proposed Rule (CMS-176-P), and
• ESRD Facilities: CY 2023 Proposed Rule.

The MLN connects includes links to Fact Sheets highlighting key provisions in each proposed rule. CMS is accepting comments through August 16, 2022, for the Home Health Proposed Rule and August 22, 2022, for the ESRD Facilities proposed rule.

Did You Know?

The 2023 ICD-10-CM Official Guidelines for Coding and Reporting were posted to the CMS website on June 10, 2022 (link). You can also find the guidelines on the CDC ICD-10-CM webpage (link).

Why It Matters?

It is important to annually review the ICD-10-CM Official Guidelines for Coding and Reporting as “these guidelines have been developed to assist both the healthcare provider and the coder in identifying those diagnoses that are to be reported. The importance of consistent, complete documentation in the medical record cannot be overemphasized. Without such documentation accurate coding cannot be achieved. The entire record should be reviewed to determine the specific reason for the encounter and the conditions treated.” As of June 29th, there are only 92 days to become familiar with the October 1, 2022, changes.

Narrative Guideline changes appear in bold text in this document. Following are a few examples of new guidance in FY 2023:

Section 1. A.19 Conventions for the ICD-10-CM – Code assignment and Clinical Criteria

Previous guidance states “The assignment of a diagnosis code is based on the provider’s diagnostic statement that the condition exists. The provider’s statement that the patient has a particular condition is sufficient. Code assignment is not based on clinical criteria used by the provider to establish the diagnosis.”

New for FY 2023, coders are advised that “If there is conflicting medical record documentation, query the provider.”

Section 1.B.14 General Coding Guideline - Documentation by Clinicians Other than the Patient’s Provider

The list of diagnosis considered to be one of the “few exceptions when code assignment may be based on medical record documentation from clinicians who are not the patient’s provider,” continues to expand. Examples of past additions to this list includes:

• Body Mass Index (BMI) was one of the first exceptions. • NIH stroke scale (NIHSS) was added to the list for FY 2017. • Social Determinants of Health (SDOH) were initially added in FY 2019. In FY 2021, additional guidance was added regarding this group of Z codes (Z55-Z65) indicating that “patient self-reported documentation may also be used to assign codes for social determinants of health, as long as the patient self-reported information is signed-off and incorporated into the health record by either a clinician or provider.” • Blood Alcohol Level was added to the list for FY 2022.

New for FY 2023, “Underimmunization status” has been added to the list and should only be reported as a secondary diagnosis.

Section 1.B. 16. General Coding Guideline - Documentation of Complications of Care

Previous guidance stated “there must be a cause-and-effect relationship between the care provided and the condition. New for FY 2023, this sentence now goes on to add that “the documentation must support that the condition is clinically significant. It is not necessary for the provider to explicitly document the term “complication.” For example, if the condition alters the course of the surgery as documented in the operative report, then it would be appropriate to report a complication code.”

You are further advised to query the provider “if documentation is not clear as to the relationship between the condition and the care or procedure.”

Section C.1.d.9 Chapter-Specific Coding Guidelines – Certain Infectious and Parasitic Diseases – Sepsis, Severe Sepsis, and Septic Shock Infections resistant to antibiotics

New to the Guidelines is the following guidance regarding hemolytic-uremic syndrome associated with sepsis: “If the reason for admission is hemolytic-uremic syndrome that is associated with sepsis, assign code D59.31, Infection-associated hemolytic-uremic syndrome, as the principal diagnosis. Codes for the underlying systemic infection and any other conditions (such as severe sepsis) should be assigned as secondary diagnoses.”

What Can You Do?

As mentioned earlier, reading the guidelines annually is important and is one tool to ensure accurate coding. Remember, this article does not detail all that is new for FY 2023. When reading the guidelines, look for what is new and each time the guidelines tell you to query the provider if documentation is unclear. Finally, be sure to share this information with your Coding and Clinical Documentation Integrity staff as part of their preparedness plan for the October 1st start of the 2023 CMS Fiscal Year.

Medicare MLN Articles & Transmittals

July 2022 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• MLN Release Date: May 31, 2022
• What You Need to Know: This article includes information about new COVID-19 CPT vaccine and administration codes. You will also find details about new CPT proprietary laboratory analyses (PLA) coding changes and new CPT Category III codes effective July 1, 2022.
• MLN MM127961: (link)

Update to 'J' Drug Code List for Billing Home Infusion Therapy (HIT) Services

• MLN Release Date: May 31, 2022
• What You Need to Know: This article provides information about a new HCPCS drug code for payment beginning July 1, 2022, and updates to the list of home infusion drugs.
• MLN MM12667: (link)

July 2022 Update of the Ambulatory Surgical Center (ASC) Payment System

• MLN Release Date: June 9, 2022
• What You Need to Know: Effective July 1, 2022, there is a new CPT Category III Code, newly established HCPCS codes for drugs, biologicals and radiopharmaceuticals and new skin substitute products and low-cost/high-cost group assignment.
• MLN MM12773: (link)

Revised Medicare MLN Articles & Transmittals

July 2022 Updates to the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: May 31, 2022 – Revised June 16, 2022
• What You Need to Know: This article was revised due to CMS rescinding Transmittal 11435 and replacing it with Transmittal 11457 to correct Table 1 in the attachment A, because it was missing some codes.
• MLN MM12761: (link)

Coverage Updates

Surgical Dressings: Medicare Requirements

Excerpt from May 26, 2022 edition of MLN Connects ((link)

“Medicare covers primary or secondary surgical dressings:

• When used to protect or treat a wound
• If needed after you debride a wound
You must:
• Include clinical information in patients’ medical records that demonstrates a reasonable and necessary need for the type and quantity of surgical dressings
• Evaluate the wound monthly and update the record, unless you document why you can't do a monthly evaluation and how you're monitoring the patient's ongoing use of dressings
For more information, see the Surgical Dressings – Policy Article.”

Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease Tracking Sheet

On June 16, CMS posted a Tracking Sheet (link) regarding National Coverage Determination (NCD) 220.6.20 Beta Amyloid Positron Tomography in Dementia and Neurodegenerative Disease. CMS generated this NCD analysis based on stakeholder feedback during the finalization of the NCD for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. The purpose of the NCD reconsideration is to determine if the current policy of one PET scan per patient per lifetime should be revised.

Did You Know?

About Obstructive Sleep Apnea (OSA)

According to the National Library of Medicine (link), “Obstructive sleep apnea (OSA) is characterized by episodes of complete or partial collapse of the airway with an associated decrease in oxygen saturation or arousal from sleep. This disturbance results in fragmented, nonrestorative sleep. Other symptoms include loud, disruptive snoring, witnessed apneas during sleep, and excessive daytime sleepiness. OSA has significant implications for cardiovascular health, mental illness, quality of life, and driving safety.”

“The short-term prognosis of OSA with treatment is good but the long-term prognosis is guarded. The biggest problem is the lack of compliance with CPAP. Almost 50% of patients stop using CPAP within the first month. Many patients are at risk for adverse cardiac events and stroke. Those patients who do use CPAP regularly do have improved survival compared to those who do not. Further, OSA is also associated with pulmonary hypertension, hypercapnia, hypoxemia, and daytime sedation. In addition, there is a high risk of motor vehicle accidents in these individuals. The overall life expectancy of patients with OSA is lower than the general population.”

For patients not tolerating CPAP, Hypoglossal Nerve Stimulation (HNS) is one available alternative treatment strategy.

About the Inspire® Upper Airway Stimulation (UAS)

The position statement from the American Academy of Otolaryngology (AAO) (2016) states that:

“The AAO considers upper airway stimulation (UAS) via the hypoglossal nerve for the treatment of adult obstructive sleep apnea syndrome to be an effective second-line treatment of moderate to severe obstructive sleep apnea in patients who are intolerant or unable to achieve benefit with positive pressure therapy (PAP). Not all adult patients are candidates for UAS therapy and appropriate polysomnographic, age, BMI and objective upper airway evaluation measures are required for proper patient selection.”

Currently, the only FDA approved HNS is the Inspire® Upper Airway Stimulation (UAS) (Inspire® Medical Systems, Inc.). This system is comprised of:

• a stimulation lead that delivers mild stimulation to maintain multilevel airway patency during sleep,
• a breathing sensor lead that senses breathing patterns, and
• a generator that monitors breathing patterns.
• The system battery life for the implantable components is 7 to 10 years.

There are two external components, including:

• A patient sleep remote providing a noninvasive means for a patient to activate the generator, and
• A physician programmer allowing the physician to noninvasively interrogate and confiture the generator settings.

In June 2017, Inspire® Medical Systems, Inc. announced the FDA approval for the next-generation device, Inspire 3028 implantable pulse generator, which includes magnetic resonance (MR) conditional labeling to allow patients to undergo MRI safely. The Inspire 3028 device is 40% smaller and 18% thinner than the current Inspire neurostimulator which received FDA approval in April 2014. Patients can undergo MRI on the head and extremities if certain conditions and precautions are met (Inspire® Medical Systems, 2017). Additionally, the AHI range was extended from 20-65 event/hour to 15-65 events per hour.

Why it Matters?

In 2020, every Medicare Administrative Contractor (MAC) published a Local Coverage Determination (LCD) and related Billing and Coding Article (LCA) for HNS. In general, coverage guidance in each of the LCD’s includes the following statements:

“Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.”

In several of the MAC’s Response to Comments articles, commenters requested that CPAP refusal or non-acceptance should be included with CPAP failure or intolerance as criteria. The refusal/non-acceptance should be clearly documented along with conversations of the benefits of CPAP and the limitations of HNS.

In each instance, the MAC responded to this request by noting that failure of conservative therapy should be tried and failed and or not tolerated prior to a surgical approach and no change was made to the LCD.

Coding and Billing

Effective January 1, 2022, there are three new CPT codes related to implantation, revision, or removal of the HNS system:

• CPT 64582 (Open implantation of hypoglossal nerve stimulator array, pulse generator, and distal respiratory sensor electrode or electrode array).
• CPT 64583 (Revision or replacement of hypoglossal nerve stimulator array and distal respiratory sensor electrode or electrode array, including connections to existing pulse generator), and
• CPT 64584 (removal of hypoglossal nerve rose stimulator array pulse generator, and distal respiratory sensor electrode or electrode array).

First New RAC Issue in 2022

On June 7, 2022, the first approved RAC issue in 2022 was posted to the CMS Medicare Fee-for-Service Recovery Audit Program webpage (link):

• RAC Issue 0201: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: Medical Necessity and Documentation Requirements.
• Review Type: Complex
• Provider Type: Outpatient Hospital, Ambulatory Surgical Center, and Professional Services
• Issue description: Hypoglossal nerve stimulation (HNS) is reasonable and necessary for the treatment of moderate to severe obstructive sleep apnea (OSA) when coverage criteria are met. Documentation will be reviewed to determine if HNS meets Medicare coverage criteria, applicable coding guidelines, and/or are medically reasonable and necessary.

What Can You Do?

As of June 13th, this newly approved RAC Issue has not been added to the list of issues being reviewed by any of the four Recovery Auditor Regions. If your hospital is providing this service, now is the time to review a few medical records against your MACs coverage requirements to ensure you are following the provisions of the policy and billing and coding article. The RAC issue includes a listing of each of the MACs LCDs and Billing and Coding Articles.

For those in the Palmetto MAC jurisdictions J and M, Palmetto has published an article (link) about HNS that includes links to a hypoglossal nerve stimulator checklist and their LCD.

You can also visit Inspire Medical System, Inc’s Inspire Sleep Apnea Innovations webpage (link). Information available for patients includes:

• Cost and Eligibility,
• Patient Stories,
• FAQ,
• Fee Events, and
• A four-question assessment to see if you qualify for this system.

Information available for Healthcare Professionals (link) includes:

• Indications/Contraindications,
• A Patient Experience Report,
• Reimbursement information (Hospital, Physician and Sleep Services Billing Guides),
• Training and Education Tools, and
• Digital Health Documents.

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e., MAC, RAC, OIG) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). In general, this article spotlights current review activities. This month’s focus is on medical review activity accomplishments touted in recently released Government Accountability Office (GAO) and Office of Inspector General (OIG) reports, a new OIG Work Plan Item and a new Supplemental Medical Review Contractor (SMRC) project.

GAO Report: Priority Open Recommendations: Department of Health and Human Services

(link)

(GAO-22-105646) published May 26, 2022, and publicly released June 2, 2022.

In May 2022, the GAO added five new priority recommendations for HHS bringing the total to fifty-six open priority recommendations. According to the GAO, priority open recommendations warrant priority attention from heads of key departments or agencies because implementation could save substantial amounts of money; improve congressional or executive branch decision-making on major issues; eliminate mismanagement, fraud, and abuse; or ensure that programs comply with laws and that funds are legally spent. The fifty-six recommendations fall into one of eight areas:

• COVID-19 response and other public health emergency preparedness,
• Public health and human services program oversight,
• FDA oversight,
• Improper payments in Medicare and Medicaid,
• Medicaid program,
• Medicare programs,
• Health information technology and cybersecurity, and
• Health insurance premium tax credit payment integrity.

Specific to improper payments, the GAO notes estimates of improper payments in the Medicare and Medicaid programs continue to be unacceptably high totaling about $148 billion in fiscal year 2021. They identified the following six priority recommendations that they believe if implemented could reduce improper payments by assessing documentation requirements, minimizing program risks, and conducting prepayment claim reviews, among other things:

1. Recommendation: The Administrator of CMS should institute a process to routinely assess, and take steps to ensure, as appropriate, that Medicare and Medicaid documentation requirements are necessary and effective at demonstrating compliance with coverage policies while appropriately addressing program risks.
2. Recommendation: The Administrator of CMS should complete a comprehensive, national risk assessment and take steps, as needed, to assure that resources to oversee expenditures reported by states are adequate and allocated based on areas of highest risk.
3. Recommendation: The Administrator of CMS should eliminate impediments to collaborative audits in managed care conducted by audit contractors and states, by ensuring that managed care audits are conducted regardless of which entity—the state or the managed care organization (MCO)—recoups any identified overpayments.
4. Recommendation: The Administrator of CMS should consider and take steps to mitigate the program risks that are not measured in the Payment Error Rate Measurement (PERM), such as overpayments and unallowable costs; such an effort could include actions such as revising the PERM methodology or focusing additional audit resources on managed care.
5. Recommendation: To better ensure proper Medicare payments and protect Medicare funds, CMS should seek legislative authority to allow the recovery auditors (RA) to conduct prepayment claim reviews.
6. Recommendation: As CMS continues to implement and refine the contract-level risk adjustment data validation (RADV) audit process to improve the efficiency and effectiveness of reducing and recovering improper payments, the Administrator should enhance the timeliness of CMS’s contract-level RADV process.

I encourage you to read the report to see HHS’ response to these recommendations.

OIG Spring 2022 Semiannual Report to Congress (SAR):

This OIG’s Semiannual Report to Congress (link) details work performed to identify significant risks, problems, abuses, deficient, remedies, and investigative outcomes related to the administration of HHS programs during the reporting period October 1, 2021 through March 31, 2022. Following are examples of three completed audits:

• An estimate that during 2016 and 2017, providers received $636 million in unallowable Medicare payments associated with neurostimulator implantation surgeries, and beneficiaries paid $54 million in related unnecessary copays and deductibles.
• The OIG found that Medicare could have saved approximately $993 million in 2017 and 2018 if the transfer payment policy to early discharges to home health care was expanded to inpatient rehabilitation facilities (IRFs).
• The OIG published four reports where they identified Medicare Advantage plans submitting diagnosis codes for use in CMS’s risk adjustment program that did not comply with Federal requirements. Collectively, the OIG estimated that the four Medicare Advantage plans audited received just over $15.8 million net overpayments for high-risk diagnosis codes.

May 2022 OIG Work Plan Item: Follow-up Review of Inpatient Claims Under the Post-Acute Care Transfer Policy (PACT)

For certain MS-DRGs under the PACT policy, Medicare pays hospitals a per diem rate when an inpatient is transferred to specific post-acute care settings. You can read more about this policy in a related MMP article (link). The OIG notes that in a prior review they identified overpayments to hospitals that did not comply with the policy. This follow-up audit is to determine whether CMS’s Common Working File (CWF) edits are working properly in detecting inpatient claims under the PACT policy and are automatically recovering overpayments, and whether MACs are receiving the automatic notifications and acting to recover overpayments.

New SMRC Reviews: SNF 3 Day Stay Waiver PHE Notification of Medical Review

On June 7, 2022, the SMRC added Project 01-056 (link) to their list of Current Projects (link). In response to the COVID-19 Public Health Emergency (PHE), CMS enacted 1135 blanket waivers, one of which waived the long-standing requirement for a beneficiary to have a medically necessary 3-day hospital stay prior to admission to Skilled Nursing Facility (SNF).

Data analysis done by the SMRC, and CMS has identified this to be an area of potential vulnerability. The SMRC has been tasked with performing medical review on SNF claims with zero hospital days prior to admission for SNF claims from March 1, 2020, through December 31, 2021. As a reminder, in general, COVID-19 blanket waivers are in effect until the end of the PHE.