Knowledge Base - Full Library

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.”

Did you know?

Did you know that a new code has been created to identify unspecified Depression, NOS, effective October 1, 2021?

Previously in ICD--10, when a provider documented Depression, NOS, it was assigned to Major Depression, Single Episode, code (F32.9); however, only 10% out of 30% of patients that report symptoms of Depression, have Major Depression. Therefore, a new code has been created to capture Depression NOS.

• Depression, Unspecified (F32.A) • Depression NOS (F32.A) • Depressive Disorder NOS (F32.A)

Major Depression, Single Episode, Unspecified and Major Depression NOS is still assigned to code (F32.9).

Why it matters.

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

What can I do?

Read Coding Clinic for ICD-10-CM/PCS, Fourth Quarter 2021: Page 9

July is UV Safety Awareness Month. A related RealTime Medicare Data (RTMD) infographic in this week’s newsletter focuses on Medicare Fee-for-Service claims data related to the treatment costs of Melanoma.

Did You Know?

Anyone can get skin cancer, but people with certain characteristics are at greater risk—

• A lighter natural skin color.
• Skin that burns, freckles, reddens easily, or becomes painful in the sun.
• Blue or green eyes.
• Blond or red hair.
• Certain types and a large number of moles.
• A family history of skin cancer.
• A personal history of skin cancer.
• Older age.

Why Does this Matter?

According to the CDC (link), skin cancer is the most common form of cancer in the United States. The most common types of skin cancer are basal cell and squamous cell and “survey data suggests that each year, about 4.3 million adults are treated for basal cell and squamous cell carcinomas at a cost of about $4.8 billion.”

What Can You Do About It?

Be proactive in lowering your risk for melanoma and other skin cancers by following key sun safety tips from the FDA (link):

• Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s rays are most intense,
• Wear clothing to cover skin exposed to the sun, such as long-sleeved shirts, pants, sunglasses, and broad-brimmed hats.
• Use broad spectrum sunscreens with SPF values of 15 or higher regularly and as directed.
• Reapply sunscreen at least every two hours, and more often if you are sweating or jumping in and out of the water.

Also, be mindful that certain medications can cause sensitivity to the sun, for example:

• Antibiotics (ciprofloxacin, doxycycline, levofloxacin, ofloxacin, tetracycline, trimethoprim),
• Antihistamines including Diphenhydramine (common brands include Benadryl and Nytol),
• Oral contraceptives and estrogens, and
• Non-steroidal anti-inflammatory drugs (ibuprofen, naproxen, celecoxib, piroxicam, ketoprofen).

You can read more about this on the FDA website (link).

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 Educational Resources

MLN Fact Sheet: Complying with Outpatient Rehabilitation Therapy Documentation Requirements

This MLN Fact Sheet was update in May 2022 (link) to add information about the 2 new therapy assistant service modifiers created by CMS. This Fact Sheet is intended to help providers learn to avoid common billing errors when submitting therapy claims to Medicare.

COVID-19 Updates

June 7, 2022: AAPM&R Long COVID Cardiovascular Complications Guidance Statement

The American Academy of Physical Medicine and Rehabilitation (AAPM&R) announced (link) new guidance for diagnosing and treating cardiovascular complications. They estimate that eight to twenty-five million Americans have or have had symptoms of Long COVID and that cardiovascular complications are common. The Guidance officially titled the Multi-Disciplinary Collaborative Consensus Guidance Statements on the Assessment and Treatment of Cardiovascular Complications in Patients with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) (link), includes recommendations for the assessment and treatment of patients with PASC cardiovascular complications,

June 14, 2022: Surveys for Compliance with Vaccination Requirements Memorandum (QSO-22-17-ALL)

CMS released this memorandum (link) to notify providers of a change in surveys for compliance with Omnibus COVID-19 health care staff vaccination requirements. Per the memorandum summary:

• Survey oversight of the staff vaccination requirement for Medicare and Medicaid certified providers and suppliers will continue to be performed during initial and recertification surveys but will now only be performed in response to complaints alleging non-compliance with this requirement, not all surveys. Under prior guidance, all surveys included oversight of the staff vaccination requirement, and
• CMS will revise QSO 22-11 to ensure deficiency determinations reflect good faith efforts implemented by providers and suppliers and incorporate harm or potential harm to patients and residents resulting from any non-compliance.

June 17, 2022: FDA COVID-19 Vaccine Authorization for Children Down to 6 Months of Age

The FDA announced (link) their authorization for the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age. This announcement includes information about vaccine effectiveness and safety.

Other Updates

CMS Posts First Two Price Transparency Enforcement Actions

CMS has posted (link) civil monetary penalty (CMP) notices for the first two hospitals for not fully implementing the price transparency requirements. In both instances the hospitals did not respond to the request for a Corrective Action Plan (CAP). The CMS letters includes details of specific violations.

June 14, 2022: AHA Letter to Congress Urging Action to Stop July 1, 2022, Sequester Cuts

As part of the CARES Act in 2020, sequestration was suspended through December 31, 2020. The 2% cut was ultimately suspended through March 31st of this year. The December 10, 2021, Protecting Medicare and American Farmers from Sequester Cuts Act enacted phasing back in the cuts with a 1% payment adjustment effective April 1, 2022, and planned return to the full 2% cut effective July 1, 2022.

On June 14th, the American Hospital Association (AHA) submitted a letter to Congress (link) urging action to prevent the 2% cut scheduled to go in effect on July 1st. The letter ends by noting that “without immediate action, the AHA estimates hospitals will lose at least $3 billion by the end of the year. These further Medicare payment cuts threaten access to care for patients and communities.”

June 15, 2022: Supreme Court Rules in Favor of Hospitals over 340B Medicare Reimbursement Cuts

In a unanimous decision (link), the Supreme Court ruled that the decision to reduce reimbursement rates to hospitals participating in the 340B program was unlawful.

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.