Knowledge Base Category -

Did You Know?

August is National Immunization Awareness Month (NIAM). According to the CDC (link), NIAM “is an annual observance held in August to highlight the importance of vaccination for people of all ages.”

Why It Matters?

Immunity from childhood vaccines can wear off over time. Maintaining current with your immunizations throughout life helps you combat vaccine preventable diseases. The CDC advises (link) that all adults need:

• COVID-19 vaccine,
• Influenza (flu) vaccine every year, and
• Tetanus and diphtheria (Td) or Tetanus, diphtheria, and pertussis (Tdap) vaccine every ten years.

On a personal note, I received a Tetanus shot on my twenty-first birthday, making it easier to remember to get an updated Tdap shot on my thirty-first, forty-first, and most recently fifty-first birthday.

Forgive me for getting on my soap box for a minute, a vaccination to prevent shingles is also a must for adults. Having watched my mother suffer through the agonizing pain of shingles, I ask the question, why would you suffer through this disease when two doses of Shingrix provides strong protection against shingles and postherpetic neuralgia (PHN)? In fact, the CDC cites that “in adults 50 to 69 years old with healthy immune systems, Shingrix was 97% effective in preventing shingles; in adults 70 years and older, Shingrix was 91% effective (link). This series of two vaccines was my gift to myself when I turned fifty.

One more request is that you consider receiving a pneumonia vaccine. Based on the following CDC stats about Pneumonia in the United States, as a nation, we could do better.

• In 2020, the percent of adults aged eighteen and over who had ever received a pneumococcal vaccination was 25.5%.
• Data from 2018 revealed that 1.5 million emergency department visits had a primary diagnosis of pneumonia.
• Mortality data from 2020 revealed there were 47,601 deaths from pneumonia and deaths per 100,000 population was 14.4.

There are four pneumococcal vaccines licensed for use in the United States by the Food and Drug Administration:

PCV13: Prevnar 13® (pneumococcal conjugate vaccine or PCV13) is a registered trademark by Wyeth LLC and marketed by Pfizer Inc. This vaccine provides protection against infections caused by six more serotypes than PCV7. This vaccine is part of the routine childhood immunization schedule. Additionally, in 2011, it was licensed by the FDA for use in adults 50 years or older. The CDC recommends PCV13 for

• All children younger than 2 years old, and
• People 2 years or older with certain medical conditions.

The CDC advises adults 65 years and older to discuss the need for this vaccine with their health care provider.

PCV 15: Vaxneuvance™ (Pneumococcal 15-valent Conjugate Vaccine)

On July 16, 2021, Merck announced (link) the FDA approval of Vaxneuvance™, a new vaccine for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes.

PCV20: Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine)

On June 8, 2021, Pfizer announced (link) the FDA approval of the Prevnar 20™ vaccine for adults 18 years or older and noted that it is “the first approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S.”

PPSV23: Pneumovax23® (pneumococcal polysaccharide vaccine or PPSV23) is a Merck product. This vaccine was approved by the FDA in 1983 and helps protect against twenty-three types of pneumococcal bacteria. The CDC recommends this vaccine for

• All adults 65 years or older,
• People 2 through 64 years old with certain medical conditions (i.e., diabetes, heart disease or COPD), and
• Adults 19 through 64 years old who smoke cigarettes.

What Can You Do?

As a healthcare provider, work with your patients to identify what vaccinations they have and have not received and utilize available resources on the CDC website for healthcare providers related to vaccinations, for example:

• Immunization Schedules Resources for Health Care Providers: https://www.cdc.gov/vaccines/schedules/hcp/resources.html, and
• Adult Vaccination Information for Healthcare and Public Health Professionals: https://www.cdc.gov/vaccines/hcp/adults/index.html.

As a healthcare consumer:

• Keep your vaccination records up to date (link),
• Use the CDC’s Adult Vaccine Assessment Tool (link) to determine which vaccines are recommended for you, and
• Share all this information with your healthcare provider so you make an informed decision on what immunizations you may need.

CMS recently released the Calendar Year (CY) Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule. In last week’s newsletter (link) we reviewed proposed changes to the Inpatient Only (IPO) List. This week’s focus is on the Ambulatory Surgery Center Covered Procedure List (CPL) and the Hospital Outpatient Prior Authorization Program proposals.

Ambulatory Surgery Center (ASC) Covered Procedure List (CPL)

The CMS evaluates the ASC CPL yearly to determine whether to add or remove specific procedures from the list. Covered surgical procedures performed on or after January 1, 2022, are:

• Procedures specified by the Secretary and published in the Federal Register,
• Separately paid under the OPPS,
• Would not be expected to post a significant safety risk to a Medicare beneficiary when performed in an ASC, and
• Standard medical practice dictates the expectation that the beneficiary would not typically require active medical monitoring and care at midnight following the procedure.

For CY 2023, CMS proposed to add one procedure to the ASC CPL:

• CPT 38531 (Biopsy or excision of lymph node(s); open, inguinofemoral node(s)).

RTMD Data Analysis

I turned to our sister company, RealTime Medicare Data (RTMD) to help estimate the potential impact to hospital outpatients if this procedure can also occur in an ASC setting. The claims data represents Medicare Fee-for-Service paid claims in calendar year 2021 for CPT 38531 for all states in the RTMD footprint. Currently, this includes all states except Kentucky and Ohio.

• Overall Claims Volume: 4,606
• CPT Payment: $13,088,298.18
• Top 5 States
• California had 411 claims with a payment of $1,468,801.23,
• Florida had 338 claims with a payment of $939,648.34,
• Texas had 253 claims with a payment of $705,682.74,
• Pennsylvania had 245 claims with a payment of $721,419.95, and
• New York has 229 claims with a payment of $651,816.93.

CMS ends this section of the proposed rule by noting they “believe that any additions to the CPL should be added in a carefully calibrated fashion to ensure that the procedure is safe to be performed in the ASC setting for a typical Medicare beneficiary. We expect to continue to gradually expand the ASC CPL, as medical practice and technology continue to evolve and advance in future years. We encourage stakeholders to submit procedure recommendations to be added to the ASC CPL, particularly if there is evidence that these procedures meet our criteria and can be safely performed on the typical Medicare beneficiary in the ASC setting.”

Hospital Outpatient Prior Authorization Program

The Prior Authorization for Certain Hospital Outpatient Department (OPD) Services initiative became effective on July 1,2020 and made a prior authorization request (PAR) a condition of payment for specific service categories. Service categories effective July 1, 2020, included:

• Blepharoplasty,
• Botulinum toxin injections,
• Panniculectomy,
• Rhinoplasty, and
• Vein ablation.

Effective July 1, 2021, CMS added cervical fusion with disc removal and implanted neurostimulators as new service categories.

You can learn more about this initiative on the CMS Hospital OPD Services initiative webpage (link).

CMS has proposed to add Facet Joint Interventions as a new service category and would include facet joint injections, medial branch blocks and facet joint nerve destruction CPT codes. This list of applicable CPT codes is in Table 79 of the proposed rule. If finalized, this would be effective for dates of services on or after March 1, 2023.

CMS Data Analysis

CMS performed data analysis of CPT codes 64490-64495 (Facet Injections and Medical Branch Blocks) and CPT Codes 64633-64636 (Nerve destruction services). Analysis revealed facet joint intervention claims volume increased by 47 percent between 2012 and 2021. This reflected a 4 percent average annual increase which is higher than the 0.6 percent annual increase for all outpatient department services.

Contractor Scrutiny

As part of the discussion for adding facet joint interventions to this initiative, CMS includes discussion of prior audits performed by the OIG and Department of Justice.

• OIG Report Medicare Improperly Paid Physicians for More Than Five Spinal Facet-Joint Injections Sessions During a Rolling 12-Month Period (A-09-20-03003) published October 2020 (link): The OIG found that MACs in the 11 jurisdictions with a coverage limitations made improper payments of $748,555.
• OIG Report Medicare Improperly Paid Physicians for Spinal Facet-Joint Denervation Sessions (A-09-21-03002) published December 2021 (link): The OIG found that Medicare improperly paid physicians $9.5 million.

In addition to past reports, there are two active OIG Work Plan items related to facet joint procedures.

• In the Department of Justice case reference in the proposed rule, the DOJ reported on a $250 million health care fraud scheme where “to obtain prescriptions, the evidence showed that the patients had to submit to expensive, unnecessary and sometimes painful back injections, known as facet joint injections.”

CMS notes, “both our data analysis and research show that the increases in volume for these procedures are unnecessary, and further program integrity action is warranted.”

RTMD Data Analysis

I once again turned to RTMD to help estimate the potential impact of adding Facet Joint Interventions to the prior authorization initiative. Keep in mind that data volume includes all procedures and there may be claims that could include multiple facet procedures in the same encounter.

Facet Injections and Medical Branch Blocks (CPT 64490-64495)

• Overall Claims Volume: 391,410
• CPT Payment: $141,144,372.81
• Top 5 States
• Texas had 40,472 claims with a payment of $13,102,475.35
• California had 24,109 claims with a payment of $11,433,125.41,
• Massachusetts had 23,738 claims with a payment of $9,892,874.58,
• New York had 18,901 claims with a payment of $6,922,608.02, and
• Pennsylvania had 18,624 claims with a payment of $6,764,696.64.

Facet Joint Nerve Destruction (CPT codes 64633-64636)

• Overall Claims Volume: 185,564
• Sum CPT Paid: $124,386,756.18
• Top 5 States
• Texas had 19,051 claims with a payment of $12,335,211.47,
• California had 11,620 claims with a payment of $10,144,086.72,
• Florida had 8,641 claims with a payment of $4,970,708.01,
• Illinois had 8,023 claims with a payment of $4,782,664.98, and
• Pennsylvania had 7,711 claims with a payment of $5,205,371.13.

CMS is accepting comments on the proposed rule through September 13, 2022.

Resource

CMS CY 2023 Proposed Rule webpage: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Annual-Policy-Files

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).”

True to form, the CMS announced the release of the Calendar Year (CY) 2023 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule late last Friday July 16th. This week we review the proposed changes to the Inpatient Only (IPO) list.

CMS once again reminds providers in this proposed rule that “Designation of a service as inpatient only does not preclude the service from being furnished in a hospital outpatient setting but means that Medicare will not make payment for the service if it is furnished to a Medicare beneficiary in the hospital outpatient setting (65 FR 18443). Conversely, the absence of a procedure from the list should not be interpreted as identifying that procedure as appropriately performed only in the hospital outpatient setting (70 FR 68696).”

Before reviewing proposals, here is a quick look back at the “flip flopping” of CMS over the past two calendar years. In CY 2021, CMS removed 298 musculoskeletal-related services from the IPO List and finalized the elimination of the list over three years. In CY 2022, CMS did an about face and finalized the following changes:

• The IPO list will not be eliminated over three years,
• Most procedures removed from the IPO list in CY 2021 were added back to the list for CY 2022, and
• The five longstanding criteria for determining whether a service or procedure should be removed from the IPO list was codified in regulation text.

Calendar Year 2023 Proposed Procedures for Removal from the IPO List

CMS is proposing to remove ten procedures from the IPO list.

CPT code 16036 (Escharotomy; each additional incision (list separately in addition to code for primary procedure)). This code is an add-on code typically billed with primary procedure CPT 10635 (escharotomy; initial incision) which was removed from the IPO list in CY 2007.

CPT code 22632 (Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; each additional interspace (list separately in addition to code for primary procedure)). This code is an add-on code typically billed with primary procedure CPT 22630 (Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar), which was removed from the IPO list in CY 2021. Note, this code was removed from the IPO list in CY 2021 and replaced back on the list for CY 2022.

The remaining eight procedures proposed for removal from the IPO list are all maxillofacial procedures removed from the IPO list in CY 2021 and replaced back on the list for CY 2022:

• CPT code 21141 (Reconstruction midface, lefort I; single piece, segment movement in any direction (e.g., for long face syndrome), without bone graft).
• CPT code 21142 (Reconstruction midface, lefort I; 2 pieces, segment movement in any direction, without bone graft).
• CPT code 21143 (Reconstruction midface, lefort I; 3 or more pieces, segment movement in any direction, without bone graft).
• CPT code 21194 (Reconstruction of mandibular rami, horizontal, vertical, C, or L osteotomy; with bone graft (includes obtaining graft)).
• CPT code 21196 (Reconstruction of mandibular rami and/or body, sagittal split; with internal rigid fixation).
• CPT code 21347 (Open treatment of nasomaxillary complex fracture (lefort II type); requiring multiple open approaches).
• CPT code 21366 (Open treatment of complicated (e.g., comminuted or involving cranial nerve foramina) fracture(s) of malar area, including zygomatic arch and malar tripod; with bone grafting (includes obtaining graft)); and
• CPT code 21422 (Open treatment of palatal or maxillary fracture (lefort I type);).

Calendar Year 2023 Proposed Additions to the IPO List

CMS has proposed the addition of eight newly created codes by the AMA CPT Editorial Panel to the IPO list for CY 2023:

• 157X1 (Implantation of absorbable mesh or other prosthesis for delayed closure of defect(s) (i.e., external genitalia, perineum, abdominal wall) due to soft tissue infection or trauma,
• 228XX (Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); second interspace, lumbar (List separately in addition to code for primary procedure),
• 49X06 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), initial, including placement of mesh or other prosthesis when performed, total length of defect(s); greater than 10 cm, incarcerated or strangulated),
• 49X10 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), recurrent, including placement of mesh or other prosthesis when performed, total length of defect(s); 3 cm to 10 cm, incarcerated or strangulated),
• 49X11 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), recurrent, including placement of mesh or other prosthesis when performed, total length of defect(s); greater than 10 cm, reducible,
• 49X12 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), recurrent, including placement of mesh or other prosthesis when performed, total length of defect(s); greater than 10 cm, Incarcerated or strangulated,
• 49X13, (Repair of parastomal hernia, any approach (i.e., open, laparoscopic, robotic), initial or recurrent, including placement of mesh or other prosthesis, when performed; reducible), and
• 49X14 (Repair of parastomal hernia, any approach (i.e., open, laparoscopic, robotic), initial or recurrent, including placement of mesh or other prosthesis, when performed; incarcerated or strangulated).

All proposed changes to the IPO list, including the CPT code, longer descriptor, proposed action (deletion or addition), proposed status indicator and for proposed deletions the proposed APC assignment are listed in Table 46 of the proposed rule.

CMS is accepting comments on the proposed rule through September 13, 2022.

Resources

CY 2023 OPPS Proposed Rule

• CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-proposes-rule-advance-health-equity-improve-access-care-and-promote-competition-and-transparency
• CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center
• Proposed Rule: https://www.federalregister.gov/public-inspection/2022-15372/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment

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.

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.

Did You Know?

CMS published the July 2022 update of the Outpatient Prospective Payment System (OPPS) (link). The purpose of the change request (CR) is to describe change to and billing instructions for various payment policies effective July 1, 2022.

Why it Matters?

In related MLN matters article MM12761 (link), CMS advises you to let your billing staff know about these changes, including:

• New COVID-19 CPT vaccines and administration codes,
• CPT proprietary laboratory analyses (PLA) coding changes,
• Advanced Diagnostic Laboratory Tests (ADLTs) under the Clinical Laboratory Fee Schedule (CLFS) changes,
• New CPT Category III codes effective July 1, 2022,
• Procedures Assigned to New Technology Ambulatory Payment Categories (APCs),
• The addition of over the counter (OTC) COVID-19 tests being added to the Comprehensive APC (C-APC) Exclusion List,
• Drugs, Biologicals, and Radiopharmaceuticals updates,
• Skin Substitutes changes, and
• The CMS reminder that “The fact that a drug, device, procedure, or service is assigned a HCPCS code and a payment rate under the OPPS doesn’t imply coverage by the Medicare Program, but indicates only how the product, procedure, or service may be paid if covered by Medicare. MACs determine whether a drug, device, procedure, or other service meets all program requirements for coverage. For example, MACs determine that it’s reasonable and necessary to treat the patient’s condition and whether it’s excluded from payment.”

What Can You Do?

Share this information with the appropriate staff at your facility.