Knowledge Base Category -

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.

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.

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.

Did You Know?

The 2023 ICD-10-PCS files are now available on the CMS website (link). For FY 2023, there are 331 new codes and 64 deleted codes bringing the total number of ICD-10-PCS codes to 78,496.

Included in the files is the FY 2023 ICD-10-PCS Guidelines for Coding and Reporting. Changes to the guidelines for FY 2023 includes:

• New Root Operation guideline B3.19 (Detachment procedures of extremities), and
• In response to public comment and internal review, two revised sections:
• Body Part general guideline B4.1c, and
• Device general guideline B6.1a.

Changes to the ICD-10 PCS codes will be in effect for discharges occurring from October 1, 2022, through September 30, 2023.

Body Part General Guideline B4.1c

The revision made to B4.1c clarifies the meaning of a “continuous section of a tubular body part.”

• B4.1c FY 2022 Guideline: “If a procedure is performed on a continuous section of a tubular body part, code the body part value corresponding to the anatomically most proximal (closest to the heart) portion of the tubular body part.”
• FY 2023 B4.1c Revision: “If a singular vascular procedure is performed on a continuous section of an arterial or venous body part, code the body part value corresponding to the anatomically most proximal (closest to the heart) portion of the arterial or venous body part.”

Device General Guideline B6.1a

Guidance at B61.a informs coders that when a device is intended to remain after the procedure is completed but requires removal before the end of the operative episode in which it is inserted, both the insertion and removal of the device should be coded.

The revision made to B6.1a is the text for the example provided for when you would code both insertion and removal.

• FY 2022: “(for example, the device size is inadequate or a complication occurs)”
• FY 2023: “(for example, the device size is inadequate or an event documented as a complication occurs).”

Why it Matters?

CMS notes, on the opening page of the 2023 ICD-10-PCS Official Guidelines for Coding and Reporting, “These guidelines have been developed to assist both the healthcare provider and the coder in identifying those procedures 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.”

What Can You Do?

Prepare for the October 1, 2022, start of the CMS FY 2023 by informing coding and clinical documentation professionals at your facility that the FY 2023 ICD-10-PCS files have been released allowing adequate time to review the new ICD-10-PCS codes as well as revisions to the coding and reporting guidelines.

Did You Know?

Did you know that coding advice regarding Diabetes and Cataracts has changed?

Why it Matters?

You may not be capturing the most accurate severity of illness of the patient.

What Can You Do?

Read the following Coding Clinics: September-October 1985, page 11 and 4th Quarter 2016, page 142.

Advice from 1985 stated that Diabetic Cataracts are rare but may appear in Type 1 Diabetics. Simply put, we were advised that most cataracts occurring in a diabetic patient were not coded as a diabetic complication.

Advice from 2016 now states that diabetes and cataracts should be coded as related conditions as they are not rare and are a major cause of eye sight issues in diabetics. The Coding Clinic advice from 1985 was revised because more is known about cataracts and that the occurrence in diabetic patients was found to be higher and occurring at younger ages than nondiabetics.

Did You Know?

June is cataract awareness month and according to the National Eye Institute (link), most cataracts are age-related, there are no early symptoms of cataracts and later symptoms includes blurry vision, colors that seem faded, sensitivity to light, trouble seeing at night and double vision.

A cataract is diagnosed by a dilated eye exam and the treatment is surgery. Cataract surgery is one of the most common operations in the United States. In fact, more than half of all Americans aged eighty or older either have cataracts or have had surgery to get rid of cataracts.

Why it Matters?

Being a high-volume surgery, means scrutiny by CMS and Medicare Contractors to assure documentation in the medical record supports medical necessity of the procedure.

Recovery Audit Contractors

RAC Issue 0002 cataract removal (link) has been an approved complex review for procedures performed in the outpatient hospital setting and ambulatory surgery centers (ASCs) since February 1, 2017. RACs will review documentation to determine if cataract surgery meets Medicare coverage criteria, meets applicable coding guidelines, and/or is medically reasonable and necessary. Applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) are included in this RAC issue webpage.

Comprehensive Error Rate Testing (CERT)

In the 2021 CERT Medicare Fee-for-Service supplemental improper payment report, cataract removal and lens insertion is listed in Table D1: Top 20 Service Types with Highest Improper Payments: Part B (link).

The improper payment rate for this surgery was 12.7%. The CERT cites two types of errors, insufficient documentation, and incorrect coding, as being the cause of improper payments. Specifically, the insufficient documentation project improper payment was $190,495,888 and the incorrect coding improper payment was $27,844,602.

Medicare Administrative Contractors (MACs)

Jurisdiction 15 (J15) MAC: CGS

Prior to the COVID-19 public health emergency, the J15 MAC CGS’ Targeted Probe and Educate (TPE) activities included cataract removal reviews. Their last results posted (link) was for reviews completed from January 1, 2020, through March 31, 2020, with a claim error rate in Ohio of 30.8%.

CGS’ review results list documentation that should be included to prevent denials. CGS has also published an cataract extraction with intraocular lens ADR checklist (link) for providers who are submitting medical records for review.

JF MAC: Noridian

In May 2021, Noridian, published a notification of their intent to perform a service specific targeted review of cataract removal (link). Noridian published review findings in November and December of 2021.

The review of claims for Arizona, Utah, Montana, North Dakota, South Dakota, and Wyoming included claims from May 3, 2021, through October 26, 2021. The overall claims error rate was 26.6% and payment error rate was 27%.

Their review of claims for Alaska, Idaho, Oregon, and Washington included claims from May 3, 2021, through November 16, 2021. The overall claim error rate was 71.3% and payment error rate was 70.5%.

In both reviews, claims were denied for the following two reasons:

• Documentation was not received timely in response to the additional documentation request (ADR), and
• Documentation did not support medical necessity per LCD requirements.

Noridian’s review results articles includes provider education detailing under what circumstances the surgery would be considered medical necessary and the required medical record documentation to support medical necessity.

Noridian also cites the 45-calendar day requirement for timely submission of documentation by providers.

Supplemental Medical Review Contractor (SMRC)

On February 16, 2022, the SMRC published a notification of their intent to review cataract surgeries performed in the physician office, outpatient hospital and specialty facility clinical access hospitals (link). In the background section of the notification, they note that “this type of surgery has been a topic of interest for the Office of Inspector General (OIG) for a number of years. The OIG looked into surgery in both the outpatient facility and ambulatory service center settings. CMS data reflects a potential vulnerability.”

What Can You Do?

With so many entities focused on reviewing cataract surgery claims, moving forward providers should:

• Respond to ADRs in a timely manner,
• Become familiar with medical necessity indications and documentation requirements detailed in Medicare coverage documents (NCDs, LCDs, LCAs),
• Be aware of who is performing cataract surgery reviews,
• Read published review results to understand reasons for denials and ways to prevent future denials, and
• Ensure physicians performing these procedures are also aware of Medicare coverage requirements.

Medicare MLN Articles & Transmittals

Section 127 of the Consolidated Appropriations Act: Graduate Medical Education (GME) Payment for Rural Track Programs (RTPs)

• Article Release Date: April 28, 2022
• What You Need to Know: Your billing staff needs to be aware of a new definition for RTPs, changes in Section 127 of the Consolidated Appropriations Act (CAA), 2021, and the documentation requirements for hospitals requesting indirect and direct GME rate increases.
• MLN MM12709: (link)

Update of Internet Only Manual (IOM), Pub. 100-04, Chapter 15 – Ambulance

• Article Release Date: April 28, 2022
• What You Need to Know: This article reports an update to the Medicare Claims Processing Manual. It also provides background guidance on how ambulance providers should bill for Medicare Part B ambulance services when a patient dies before the ambulance arrives and when a patient dies after being loaded on the ambulance.
• MLN MM12707: (link)

Changes to Beneficiary Coinsurance for Additional Procedures Furnished During the Same Clinical Encounter as Certain Colorectal Cancer Screening Tests

• Article Release date: April 29, 2022
• What You Need to Know: Beginning January 1, 2022, CMS began to gradually reduce the coinsurance for any procedure beyond a planned colorectal cancer screening test until the procedure is completely free for dates of service on or after January 1, 2030.
• MLN MM12656: (link)

Calendar Year 2023 Modifications/Improvements to Value-Based Insurance Design (VBID) Model – Implementation

• Article Release Date: April 29, 2022
• What You Need to Know: Information in this article is for hospices, hospitals, and suppliers billing MACs for services provided to Medicare hospice patients enrolled in Medicare Advantage (MA) plans participating in the voluntary Value-Based Insurance Design (VBID) Model’s Hospice Benefit component.
• MLN MM12688: (link)

Quarterly Update for Clinical Laboratory Fee Scheduled (CLFS) and Laboratory Services Subject to Reasonable Charge Payment

• Article Release Date: May 5, 2022
• What You Need to Know: Links in this article will help you find updates pertaining to Advanced Diagnostic Laboratory Tests (ADLTs) and new codes effective July 1, 2022.
• MLN MM12737: (link)

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

• Article Release Date: May 9, 2022
• What You Need to Know: There are no policy changes in this ICD-10 quarterly update. Updates do include newly available codes.
• MLN MM12705: (link)

Revisions to Medicare Part B Coverage of Pneumococcal Vaccinations for the Medicare Benefit Policy Manual Chapter 15, Section 50.4.42

• Article Release Date: May 9, 2022
• What You Need to Know: CMS updated the Medicare coverage for pneumococcal vaccinations to align with the Advisory Committee on Immunization Practices (ACIP) recommendations that vary based on patient age and risk factors.
• MLN MM12723: (link)

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – July 2022 Update

• Transmittal 11408 (Change Request 12747) Release Date: May 12, 2022
• What You Need to Know: CR 12747 details information about new HCPCS and CPT codes, new G codes for the 180-day monitoring period for continuous glucose monitoring (CGM), and codes that are no longer valid.
• Transmittal 11408 (CR 12747): (link)

Elimination of Certificates of Medical Necessity & Durable Medical Equipment Information Forms

• MLN Release Date: May 12, 2022
• What You Need to Know: CMS published this Special Edition (SE) article to alert those that bill Durable Medical Equipment (DME) for services and supplies provided to Medicare patients that effective January 1, 2023, CMS will no longer require Certificates of Medical Necessity (CMNs) and DME Information Forms (DIFs)
• MLN SE22002: (link)

Revised Medicare MLN Articles & Transmittals

New Waived Tests

• Article Release Date: January 18, 2022 – Revised April 27, 2022
• What You Need to Know: CR 12581 changed the HCPCS code for the Cardinal Health H. Pylori Rapid Test – Whole Blood/Serum Cassette (Whole Blood) to 86318QW. This MLN article was updated to reflect the code change.
• MLN MM12581: (link)

Update to Chapter 7, “Home Health Services”, of the Medicare Benefit Policy Manual (Pub 100-02)

• Article Release Date: March 28, 2022 – Revised April 28, 2022
• What You Need to Know: CR 12615 changed the background and policy sections of the CR’s business requirements and manual attachment. This MLN article was updated to reflect the changes.
• MLN MM12615: (link)

Mental Health Visits via Telecommunications for Rural Health Clinics & Federally Qualified Health Centers

• Article Release Date: March 30, 2022 – Revised May 5, 2022
• What You Need to Know: This article was revised to show that RHCs must include modifier CG on claims for mental health visits via telecommunications.
• MLN SE22001: (link)

Coverage Updates

National Coverage Determination (NCD) 210.14 Reconsideration – Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

• Article Release Date: May 3, 2022
• What You Need to Know: This article details changes that have been made to NCD 210.14 including:
• Lowering the minimum age for screening,
• Removing the restriction on who can provide counseling and shared decision-making (SDM), and
• Removing the requirement that facilities participate in a registry.
• MLN MM12691: (link)

Proposed Decision Memo for Home Use of Oxygen (CAG-00296R3)

NCD 240.2 Home use of Oxygen was issued by CMS on September 27, 2021. On May 12, 2022 CMS issued a Proposed Decision Memo (link). CMS notes in the Decision Summary they are proposing to amend “the period of initial coverage for these patients from 120 days to 90 days, in order to align with the 90-day statutory time period.”

Medicare Educational Resources

MLN Booklet: Medicare Mental Health

This booklet (link)">link) explains Medicare-covered mental health and substance use services, eligible professionals, Medicare Advantage coverage, Medicare drug plan (Part D) coverage, medical record documentation and coding. March 2022 updates to this booklet includes updated information about telehealth services and new payment information specific to Clinical Nurse Specialists (CNS), Nurse Practitioners (NPs), Physician Assistants (PAs), and Certified Nurse-Midwifes (CNMs).

MLN Fact Sheet Medical Record Maintenance & Access Requirements (MLN4840534)

This Fact Sheet (link) provides information on updated documentation maintenance and access requirements for billing services to Medicare patients. It also tells you how long to keep the documentation and who is responsible for providing access. CMS updated this Fact Sheet in April to add information on medical records to support home health referrals.

Biosimilars Curriculum: Resources for Teaching Your Students

CMS provided information about the FDA’s Biosimilar Curriculum Toolkit in the May 12, 2022 MLN Connects newsletter (link). This toolkit can be used to instruct students in medicine, nursing, physician assistant and pharmacy programs.

New Comprehensive Error Rate Testing (CERT) Outreach and Education Task Force PowerPoint

On May 4, 2022, the CERT Medicare Administrative Contractor (MAC) Outreach and Education Task Force (link) posted a PowerPoint detailing the role of the MACs and the CERT Contractor in reducing the error rate.

COVID-19 Updates

April 29, 2022: Counterfeit At-Home OTC COVID-19 Diagnostic Tests

The FDA released a notice (link) indicating they are aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States and advises they should not be used or distributed. This notice provides information to help you determine if you have a counterfeit test. To date, the two products that they have identified as counterfeit are:

• Counterfeit Flowflex COVID-19 Test Kits, and
• Counterfeit iHealth COVID-19 Antigen Rapid Test Kits.

May 10, 2022: AHA and Others Urge Continuation of the COVID-19 Public Health Emergency (PHE)

In a letter to HHS Secretary Becerra (link), the American Hospital Association along with several other organizations (i.e., AARP, American Diabetes Association, American Medical and Nurses Associations) urge the PHE be maintained “until we experience an extended period of greater stability and, guided by science and data, can safely unwind the resulting flexibilities.” A little over a week later, there were less than 60 days before the end of the current PHE. As the government has indicated they will provided at least 60 days’ notice prior to ending the PHE, it appears it will continue at least to October 2022.

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). Monthly, our newsletter spotlights current review activities. This month’s focus is on the April 2022 release of CMS’ Medicare Provider Compliance newsletter.

Background

In the Tax Relief and Health Care Act of 2006, the U.S. Congress authorized the expansion of the Recovery Audit Program nationwide by January 2010 to further assist the CMS in identifying improper payments.

The first Medicare Quarterly Compliance Newsletter was issued in October 2010 as a Medicare Learning Network® (MLN) educational product, “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 is “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.”

Twelve years later, much has changed since the release of the first quarterly newsletter.

• Instead of a network of contractors (i.e., Carriers and Fiscal Intermediaries) processing more than 1 billion claims each year, there are twelve Medicare Administrative Contractor (MAC) regions where the MACs process the claims,
• In addition to the Recovery Auditors and the OIG, there are new contractors auditing claims, for example the Supplemental Medicare Review Contractor (SMRC) and the Unified Program Integrity Contractors (UPICs) who assumed the responsibilities of the former ZPIC contractor,
• The OIG no longer publishes an annual workplan, instead the Work Plan is updated monthly to be able “to anticipate and respond to emerging issues with resources available,” and
• As of the April 2022 edition, this newsletter is now released twice a year instead of quarterly.

What has not changed is the ongoing challenge for providers to meet Medicare rules and regulations required to accurately order, schedule, perform, code and bill medically necessary services.

April 2022 Medicare Provider Compliance Newsletter

In the April 2022 edition of the newsletter (link), you will find information about:

• The Comprehensive Error Rate Testing (CERT) review of hospice certification and recertification of terminal illness,
• The CERT review of refills of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items provided on a recurring basis, and
• The Recovery Auditor review of Issue 0184: total hip arthroplasty (THA) medical necessity and documentation requirements.

This article focuses on the RAC’s review of total hip arthroplasty (link).

RAC Issue 0184: Total Hip Arthroplasty: Medical Necessity and Documentation Requirements

Total hip arthroplasty procedures were removed from the Medicare Inpatient Only (IPO) procedure list effective January 1, 2020. RAC issue 0184 was approved in August 2020. This RAC Issue entails a review of medical records (complex review) for provider types of inpatient hospital, outpatient hospital and professional services.

The review only focuses on total (involving the entire joint) hip arthroplasties to determine if documentation supports that a THA was medically necessary according to the guidelines outlined in the Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) of the following MACS:

• Jurisdiction N MAC: First Coast Service Options, Inc.,
• Jurisdictions H and L MAC: Novitas Solutions, Inc.,
• Jurisdictions 6 and K MAC: National Government Services, Inc.,
• Jurisdictions J and M MAC: Palmetto GBA LLC, and
• Jurisdictions E and F MAC: Noridian Healthcare Solutions, LLC.

Unlike the CERT reviews included in this newsletter, the RAC review does not include an improper payment amount. What you will find are the CPT codes for review, the reminder to respond to review requests promptly and ensure records include documentation supporting the medical necessity of the THA, and links to the MAC’s LCDs and LCAs.

Total Hip Arthroplasty Removal from the Medicare Inpatient Only (IPO) Procedure List

As mentioned above THA procedures were removed from the Medicare IPO List effective January 1, 2020. CMS reminded providers in the CY 2020 Outpatient Prospective Payment System (OPPS) Final Rule that “the removal of any procedure from the IPO list, including THA, does not require the procedure to be performed only on an outpatient basis. That is, when a procedure is removed from the IPO, it simply means that Medicare will pay for it in either the hospital inpatient or outpatient setting; it does not mean that the procedure must be performed on an outpatient basis.”

CMS also finalized a two-year exemption from site-of-service claims denials, Beneficiary and Family Centered Care (BFCC) Quality Improvement Organization referrals to Recovery Auditors, and Recovery Auditor reviews for “patient status” (that is, site-of-service) for procedures removed from the IPO list under the OPPS beginning January 1, 2020.

It is important for providers to be mindful that this exemption does not include medical necessity based on a National or Local Coverage Determination meaning irrespective of site-of-service, a short stay claim can still be denied for lack of documentation supporting medical necessity of the procedure.

THA Site of Service in CY 2020 and 2021

In keeping with the late Paul Harvey’s, The Rest of the Story segments, I turned to RTMD to see where THA’s are being performed since being removed from the IPO list. The following claims data represents Medicare Fee-for-Service paid claims data available in RTMD’s footprint which includes all U.S. states and territories except Kentucky and Ohio. The reader should be reminded that THA was added to the Ambulatory Surgery Center (ASC) Covered Procedure List (CPL) January 1, 2021.

Calendar Year 2020 THA Claims Data in RTMD Database

Inpatient Claims

• Claims Volume: 116,804
• Percent of All 2020 THA Claims: 56.8%
• Sum of Paid Claims: $1,620,651,115.06

Outpatient Claims

Claims Volume: 88,828

Percent of All 2020 THA Claims: 43.2%

Sum of Paid Claims: $893,162,528.27

Calendar Year 2021 Claims Data in RTMD Database

Inpatient Claims

• Claims Volume: 48,330
• Percent of All 2021 THA Claims: 24.37%
• Sum of Paid Claims: $659,846,754.97

Outpatient Claims

• Claims Volume: 128,385
• Percent of All 2021 THA Claims: 62.41%
• Sum of Paid Claims: $1,311,707,091.83

Ambulatory Surgery Center (ASC)

• Claims Volume: 26,218
• Percent of All 2021 THA Claims: 13.22%
• Sum of Paid Claims: $64,580,122.48

There has been a significant shift in site-of-service for THA procedures away from the inpatient hospital setting. While the patient setting should be based on each individual patient, it is also important to be aware of the difference in payment for THA based on the setting.

• In the inpatient setting THA procedures group to MS-DRG 469 with an MCC or MS-DRG 470 without an MCC. In general, most inpatient THA procedures group to MS-DRG 470. The 2021 national average payment for MS-DRG 470 was $11,192.94.
• 2021 ambulatory payment category (APC) national payment rate for THA: $12,314.76.
• 2021 ASC CPL national payment rate for THA: $8,818.37.

Whether hospital inpatient, outpatient or ASC is the most appropriate setting for your patient, you must ensure documentation in the medical record supports indications outlined in your MAC’s LCDs.