Knowledge Base Category -

I have recently noticed a resurgence of a favorite commercial from my childhood featuring a little boy, Mr. Turtle, Mr. Owl, and a tootsie roll pop (link). Although it’s a given that we will never know how many licks it takes to get to the center of a Tootsie Roll pop, it’s no mystery as to why the OIG believes CMS has paid millions in overpayments for neurostimulator implantation surgeries. Let’s unwrap this OIG report (link) and get to the center of it.

Why This Audit was Conducted

CMS analysis revealed that claims for spinal neurostimulator implantation surgeries increased by nearly 175 percent between 2007 and 2018. “CMS researched possible causes for the increased volume of these procedures that would indicate the services are increasingly necessary, but CMS did not find any plausible reason for the increase in services and concluded that a financial motivation was the most likely cause for the increase.”

Strategic Health Solutions, the first Supplemental Medical Review Contractor (SMRC), was tasked with reviewing post-payment claims of Medicare Part B spinal neurostimulator implantation surgeries. They reviewed claims with dates of service from January through September of 2014 and identified a 72% error rate.

Without a “plausible reason for the increase in services” and the SMRC review’s high error rate, the OIG conducted this review to “determine whether health care providers complied with Medicare requirements when they billed for neurostimulator implantation surgeries.”

What are Neurostimulators?

• What is it? A battery-powered electronic device enclosed in a small metal container that is surgically implanted under a patient’s skin and connected to wires called leads
• Types of Neurostimulators: Spinal cord, deep brain, and vagus nerve stimulator (VNS) devices.
• Conditions that can be treated with neurostimulator: chronic pain, Parkinson’s disease, essential tremor, dystonia, obsessive-compulsive disorder, seizures, and epilepsy.

Medicare Coverage Requirements for Neurostimulators

As noted above, there are several conditions where treatment with a neurostimulator implant may be warranted. Medicare has several National Coverage Determinations (NCDs) related to neurostimulators that detail the indications and limitations of coverage, including:

• NCD 160.2: Treatment of Motor Function Disorders with Electrical Nerve Stimulation,
• NCD 160.7: Electrical Nerve Stimulators,
• NCD 160.18 – Vagus Nerve Stimulation, and
• NCD 160.24 – Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease.

OIG Claims Selection by the Numbers

• 2016-2017: The audit period for this review,
• $1.4 billion: The Medicare payments made to providers during the audit period,
• 58,213: The number of beneficiaries who had at least one neurostimulator implantation during the audit period.
• HCPCS Codes 61885, 61886, or 63685: The codes used to identify beneficiaries who had undergone a neurostimulator implantation surgery.
• 124 claims: The stratified random sample of claims reviewed in this audit.
• $1,000: All claims reviewed were for paid amounts greater than $1,000.
• $3.4 million: The amount paid to 102 providers for the 124 claims in the audit sample.
• Audit sample claim specific indication for neurostimulator:
• 87 claims were for treatment of chronic pain,
• 4 claims were for treatment of seizures, and
• 13 claims were for essential tremors and Parkinson’s disease.
• Note, the remaining two claims involved a neurostimulator implant with an investigational device exemption.

Audit Error Rates

The OIG found that 40% of health care provided did not comply with Medicare requirements. Based in this finding, they estimated that:

• Providers received $636 million in unallowable Medicare payments, and
• Medicare beneficiaries paid $54 million in related unnecessary coinsurance amounts.

An independent contractor reviewed the medical records and determined that 48 (49%) of the 106 claims did not contain documentation supporting compliance with the applicable NCD indications. The OIG report lists types of missing/incomplete documentation by NCD, for example:

• NCD 160.7:
• No documentation of other failed treatment modalities or that other treatment prior to a neurostimulator was felt to be unsuitable or contraindicated, and
• No documentation of the multidisciplinary screening includes a psychological evaluation.

OIG Audit Conclusions & Recommendations

The “tootsie-roll center” of this audit are the OIG’s audit conclusions and recommendations. Both lay the groundwork for steps for providers moving forward. The OIG concluded that:

• Medical records lacked documentation to support the NCD coverage requirements for neurostimulator implants,
• There were limited instances when providers “stated that they did not fully understand these Medicare coverage requirements,”
• These claims did not require prior authorization, nor were they subject to pre-payment reviews, and
• There is no edit in the CMS software to initiate such a review.
• It was not until after the completion of this audit that CMS published the CY 2021 OPPS Final Rule that added prior authorization of spinal neurostimulators to the Prior Authorization for Certain Hospital Outpatient Department Services program effective for services on or after July 1, 2021(link). The OIG notes that this final rule does not include claims for neurostimulator implantation for Parkinson’s disease or seizure disorders.
• Note, in May of 2021, the CMS limited the prior authorization requirement to CPT code 63650 (implantation of spinal neurostimulator electrodes, accessed through the skin).

Based on their conclusions, the OIG recommended that CMS instruct the Medicare Administrative Contractors:

• Recover overpayments,
• Advise applicable providers to exercise reasonable diligence to identify, report, and return over-payments in accordance with the 60-day rule,
• Conduct provider outreach and education regarding Medicare coverage requirements, and
• Require prior authorization for procedures for Parkinson’s disease and seizures.

CMS agreed with all recommendations but indicated that neurostimulator implantation for Parkinson’s disease and seizure disorders are currently on the Medicare Inpatient Only (IPO) Procedure List and their prior authorization authority does not extend to inpatient services. The OIG noted that “CMS’s inability to implement this control for inpatient claims…leaves this area vulnerable to future overpayments.”

Steps Moving Forward

I encourage you to:

• Become familiar with the Medicare coverage requirements at the National and Local MAC level,
• Identify the documentation deficiencies by NCD detailed in this OIG report,
• Work with your Physician’s offices to ensure all documentation needed to support the medical necessity of the procedure is in the medical record, and
• Learn about current MAC specific provider outreach and education activities in a related article in this week’s newsletter.

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e. MAC, RAC, OIG, etc.) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). Monthly, our newsletter spotlights current review activities in this P.A.R. Pro Tips article. This month’s focus is on neurostimulator implantation surgeries.

Did You Know?

Effective for services on or after July 1, 2021, implanted spinal neurostimulator procedures was one of two new procedures added to the list of procedures included in the Prior Authorization for Certain Hospital Outpatient Department (OPD) Services program ( https://www.cms.gov/research-statistics-data-systems/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives/prior-authorization-certain-hospital-outpatient-department-opd-services">link).

On October 5, 2021, the Office of Inspector General released the report Medicare Overpaid More Than $636 Million for Neurostimulator Implantation Surgeries (link). The OIG made several recommendations to CMS in response to the review findings. One recommendation being that MACs conduct provider outreach and education.

Pro Tip: MAC Neurostimulation Implantation Surgery Provider Outreach and Education Efforts

In response to neurostimulation implantation being added to the Prior Authorization for Certain OPD Services program and to recommendations made by the OIG in their report, the MACs have been conducting provider outreach and education. This article highlights resources available by the different MACs. You can read more about the OIG report in a related article in this week’s newsletter.

CGS (Jurisdiction 15)

The CGS OPD Prior Authorization webpage (link) includes medical record documentation needed to meet coverage criteria for all procedures in this program including implanted spinal neurostimulators.

First Coast Service Options, Inc. (Jurisdiction N)

First Coast published the article Implantation of spinal neurostimulator in their October 13, 2021, First Coast eNews article (link).

You can also find general documentation requirements and links to Local Coverage Determination (LCD) and Local Coverage Article (LCA) for Spinal Cord Stimulation for Chronic Pain on their PA Program general documentation requirements webpage (link).

National Government Services (J6 and JK MAC)

In July, NGS posted a news article (link) to their website highlighting information about prior authorization for implanted spinal neurostimulators including:

• The applicable HCPCS code,
• Documentation Requirements, and
• Links to related content.

You will find a link to the required coversheet to request prior authorization for performing an implanted spinal neurostimulator procedure and National Coverage Determination (NCD) 160.7 Electrical Nerve Stimulators on the NGS Prior Authorization Documentation webpage (link) includes a

Noridian (JE and JF MAC)

Both Noridian JE (link) and Noridian JF (link) have an article posted under Medical Review on their website, that provides general documentation requirements and links to their LCD and LCA for Spinal Cord Stimulators for Chronic Pain.

Novitas Solutions Jurisdiction (JH and JL MAC)

Novitas recently published the article Prior Authorization: Implantation of Spinal Neurostimulator in (link), highlighting the components of the spinal cord neurostimulator system, documentation requirements, best practice documentation feedback/tips and links to related content including their LCD and LCA titled Spinal Cord Stimulation.

In July 2021, Novitas updated their Prior Authorization Program for certain hospital outpatient department services general documentation requirements article to include guidance for implanted spinal neurostimulators (trial or permanent) and cervical fusion with disc removal (link).

Finally, in case you missed it, you can view a September 8, 2021 webinar (link) recording focused on reviewing the two new services requiring PA effective dates of service on and after July 1, 2021.

Palmetto GBA (JJ and JM MAC)

On October 12, 2021, Palmetto GBA updated their article titled Implantation of Spinal Neurostimulator. You can find this article on their Outpatient Department Prior Authorization (PA) webpage (link). Additional resources available on the Palmetto website includes:

• A Documentation Checklist (link) highlighting the documentation requirements for trial or permanent implanted spinal neurostimulators,
• An on-demand webinar video (link) highlighting the two services added to Outpatient PA program effective July 1, 2021 (implanted spinal neurostimulators and cervical fusion with disc removal), and an
• Links LCD (L37632) and LCA (A56876) for Spinal Cord Stimulators for Chronic Pain (link).

WPS (J5 and J8 MAC)

WPS has published an article (link) highlighting the July 1, 2021 addition of implanted spinal neurostimulators to the hospital outpatient department Prior Authorization Program.

On August 18, 2021, WPS posted a YouTube video (link) detailing the process for submitting a prior authorization request for implanted spinal neurostimulators.

WPS also has a live event scheduled for October 26, 2021, titled Prior Authorization – Understanding Implanted Spinal Neurostimulators in the Hospital Outpatient Department (http://wpsghalearningcenter.com/catalog/Teleconferences/J8%20Teleconferences/all">link). They note in the announcement that this teleconference will answer questions on:

• Inpatient Psychiatric Facility (IPF),
• Inpatient Rehabilitation Services,
• Routine Foot Care, and
• Wound care in a Critical Access Hospital (CAH).

What Can You Do?

Take advantage of resources made available by your MAC related to implanted spinal neurostimulators.

This week is National Case Management Week. Given the ongoing COVID-19 public health emergency (PHE), now more than ever it is important to celebrate the hard work and dedication of Case Managers. The American Case Management Association (ACMA) and the Case Management Society of America (CMSA) both recognize this week as an opportunity to spotlight the great things about case managers and the case management industry.

American Case Management Association (ACMA)

The ACMA’s official definition of Case Management, as approved by their membership in April 2020, as follows:

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

For 2021, the ACMA Case Management Week theme is Case Management: Transitions through Care, Compassion, Community. MMP believes it takes all three qualities to carry out the definition of Case Management and would like to celebrate the hard work and dedication of all the Case Managers that we have the opportunity to work with.

Monthly, MMP includes a “Medicare Updates” article at the end of the month. With the October 1st start of the CMS FY 2022, as well as quarterly outpatient updates, this special edition “Medicare Updates” article highlights guidance effective October 1, 2021.

October 2021 Prospective Payment System Final Rules

FY 2022 Hospital IPPS and Long-Term Care Hospital (LTCH) Rates Final Rule (CMS-1752-F)

• CMS Fact Sheet: (link)
• FY 2022 IPPS Final Rule Home Page: (link)

FY 2022 Inpatient Psychiatric Facility (IPF) PPS Final Rule (CMS-1750-F)

• CMS Fact Sheet: (link)

FY 2022 Inpatient Rehabilitation Facility (IRF) PPS Final Rule (CMS-1748-F)

• CMS Fact Sheet: (link)

FY 2022 Skilled Nursing Facility (SNF) PPS Final Rule (CMS-1746-F)

• CMS Fact Sheet: (link)

FY 2022 Hospice Payment Rate Update Final Rule (CMS-1754-F)

• CMS Fact Sheet: (link)

Medicare Change Requests (CRs) & MLN Articles

Quarterly Update to the End-Stage Renal Disease Prospective Payment System (ESRD PPS)

• Article Release Date: September 24, 2021
• What You Need to Know: Article includes updates to diagnosis codes eligible for the ESRD PPS co-morbidity payment adjustment.
• CR 12307 & MM12307: (link)

October 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.3

• Article Release Date: September 22, 2021
• What You Need to Know: Article details claims processing changes for hospital outpatient departments, community mental health centers, all non-OPPS hospital providers, limited services when provided in a home health agency not under the HH PPS, and a hospice patient for the treatment of a non-terminal illness.
• CR 12432 & MM12432: (link)

October Quarterly Update for 2021 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

• Article Release Date: September 21, 2021
• What You Need to Know: DMEPOS fee schedule changes include changes related to the COVID-19 Aid, Relief, and Economic Security (CARES) Act, 2020.
• CR 12453 & MM12453: (link)

October 2021 Update to the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: September 21, 2021
• What You Need to Know: Article includes three updates related to new COVID-19 codes.
• CR 12436 & MM12436: (link)

October 2021 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: September 17, 2021
• What You Need to Know: Article reviews changes in the October 2021 ASC payment system update.
• CR 12451 & MM12451: (link)

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

• Article Release Date: September 10, 2021
• What You Need to Know: Article provides a link to new proprietary laboratory analysis (PLAs) codes.
• CR 12435 & MM12435: (link)

Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2022

• Article Release Date: August 12, 2021
• What You Need to Know: Article includes information regarding rate updates.
• CR 12364 & MM12364: (link)

Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update for FY 2022

• Article Release Date: August 10, 2021
• What You Need to Know: CR 12366 issued official instruction to the MACs for the FY 2022 SNF payment rate updates.
• CR 12366 & MM12366: (link)

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – October 2021 Update

• Article Release Date: August 9, 2021
• What You Need to Know: This article includes coding updates. CMS notes “MACs won’t search their files to retract payment for claims that are already paid or to retroactively pay claims impacted by these changes. However, they will adjust claims you bring to their attention.”
• CR 12422 & MM12422: (link)

Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for FY 2022

• Article Release Date: August 5, 2021
• What You Need to Know: Article includes payment rates, wage index and Pricer updates.
• CR 12354 & MM12354: (link)

October 2021 Quarterly Average Sale Price (ASP) Medicare Part B Drug Pricing Files and Revision to Prior Quarterly Pricing Files

• Article Release Date: July 15, 2021
• What You Need to Know: Article details information about the ASP methodology, which is based on quarterly data manufacturers submit to the CMS.
• CR 12342 & MM12342: (link)

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.3, Effective October 1, 2021

• Article Release Date: July 14, 2021
• What You Need to Know: Recurring updates applies to the Medicare Claims Processing Manual (Publication 100-04), Chapter 23, section 20.9.
• CR 12340 & MM12340: (link)

I

nternational Classifications of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations – October 2021

• Article Release Date: May 27, 2021
• What You Need to Know: Article provides updates due to newly available codes, separate NCD coding revisions and coding feedback received.
• CR 12279 & MM12279: (link)

FY 2022 Coding Guidance

ICD-10-PCS Guidelines

• CMS 2022 ICD-10 PCS webpage: (link)

ICD-10-CM Guidelines

• CMS 2022 ICD-10-CM webpage: (link)
• The CDC ICD-10-CM webpage: (link)

Did You Know?

Chances are you; a family member, close friend or acquaintance has been impacted by breast cancer. October is Breast Cancer Awareness Month. According to a World Health Organization (WHO) Breast Cancer Fact Sheet (link):

• In 2020, globally 2.3 million women were diagnosed with breast cancer and there were 685,000 deaths,
• At the end of 2020, there were 7.8 million women alive who were diagnosed with breast cancer in the last 5 years, making it the world’s most prevalent cancer,
• There are more lost disability-adjusted life years (DALYs) by women to breast cancer globally than any other type of cancer,
• Breast cancer occurs in every country of the world in women at any age after puberty but with increasing rates later in life,
• Approximately 0.5-1% of breast cancers occur in men,
• Improvements in survival began in the 1980’s in countries with early detection programs combined with different modes of treatment to eradicate invasive disease.

Why Should You Care?

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

“A WHO survey conducted in 2020 indicated that treatment for cancer had been disrupted in more than 40% of countries surveyed.” A related RealTime Medicare (RTMD) infographic, in this week’s newsletter, highlights the impact of the COVID-19 pandemic on the volume of Medicare Fee-for-Service beneficiaries undergoing screening mammography in RTMD’s footprint.

NCD 220.4 Mammograms

The CMS National Coverage Determination (NCD) 220.4 Mammograms (link) distinguishes the difference between diagnostic and screening mammography.

Diagnostic Mammography

A radiologic procedure furnished to a man or woman with signs and symptoms of breast disease, or a personal history of breast cancer, or a personal history of biopsy - proven benign breast disease and includes a physician's interpretation of the results of the procedure. CMS covers this service if ordered by a Doctor of Medicine or Osteopathy in addition to the following conditions:

• A patient has distinct signs and symptoms for which a mammogram is indicated,
• A patient has a history of breast cancer, or
• A patient is asymptomatic but, based on the patient’s history and other factors the physician considers significant, the physician’s judgment is that a mammogram is appropriate.

Screening Mammography

A radiologic procedure furnished to a woman without signs or symptoms of breast disease, for the purpose of early detection of breast cancer, and includes a physician’s interpretation of the results of the procedure. A screening mammography has limitations as it must be, at a minimum a two-view exposure (cranio-caudal and a medial lateral oblique view) of each breast. Routine screening includes:

• Asymptomatic women 50 years and older, and
• Asymptomatic women 40 years and older whose mothers or sisters have had the disease, is considered medically appropriate, but would not be covered for Medicare purposes.

Guidance for coding and billing for screening mammography is available in the MLN Educational Tool: Medicare Preventive Services (link).

What Should You Do?

Take the initiative to discuss having a screening mammogram with your health care provider. You can also check out the CDC’s webpage Find a Screening Program Near You (link) that highlights the CDC’s national Breast and Cervical Center Early Detection Program (MBCCEDP). This year marks the 30th Anniversary for this program that has provided women who have low incomes, uninsured, and underinsured women across the United States.

Medicare Coverage Updates

August 20, 2021: Closing the Gap: Left Atrial Appendage Closure Module

Palmetto GBA, the Medicare Administrative Contractors for Jurisdictions J and M, published this module (link) to provide an overview of required documentation to support billing of these claims. This interactive model covers the following:

• Left Atrial Appendage Closure (LAAC) overview,
• Indications & Coverage Criteria,
• Registries & Studies, and
• How to Prevent Denials.

Palmetto GBA offers the following tip to preventing denials, “facilities may want to consider implementing a process of requiring the patient’s history and physical with utilization review prior to scheduling the procedure or have designated staff analyze the beneficiary records for national coverage determination (including shared decision-making [SDM]) compliance before allowing the procedure to be scheduled.”

September 8, 2021: Change Request 12361: Claims Processing Instructions for NCD 20.33 – Transcatheter Edge-to-Edge [TEER] for Mitral Valve Regurgitation

NCD 20.33, TEER for Mitral Valve Regurgitation was previously named Transcatheter Mitral Valve Repair (TMVR). CR 12361 (link) informs MACs that on January 1, 2021 (Effective Date), CMS expanded coverage of mitral valve TEER procedures for the treatment of functional mitral regurgitation (MR) and maintained coverage of TEER for the treatment of degenerative MR through coverage with evidence development (CED) with mandatory registry participation.

CMS notes in the CR summary of changes that “NCDs are binding on the MACs who review and/or adjudicate claims, make coverage determinations, and/or payment decisions, and also binds quality improvement organizations, qualified independent contractors, the Medicare appeals council, and Administrative Law Judges (ALJs) (see 42 Code of Federal Regulations (CFR) section 405.1060(a)(4) (2005)). An NCD that expands coverage is also binding on a Medicare advantage organization.”

A related MLN Article MM12361 (link) was released on September 14, 2021. This article includes the procedure and diagnosis codes on claim lines that the MACs will accept for TEER services. CMS notes that “your MAC won’t search for TEER claims they processed before implementation of CR 12361. They will adjust such claims you bring to their attention.” The implementation date is October 8, 2021.

You can read more about the changes and new requirements for NCD 20.33 in a related MMP article (link).

National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds

• Article Release Date: September 15, 2021
• What You Need to Know: Effective for claims with dates of service on or after April 13, 2021, CMS will nationally cover autologous Platelet-Rich Plasma (PRP) for the treatment of chronic non-healing diabetic wounds under specific conditions. CMS notes that claims should contain HCPCS code G0460, an ICD-10 diagnosis code for diabetes mellitus and an ICD-10 diagnosis code for chronic ulcer. This article provides a link to a list of acceptable diabetes mellitus and chronic ulcer diagnosis codes.
• MLN MM12403: (link)

Medicare Educational Resources

MLN Educational Tool: Medicare Payment Systems

With the beginning of new Prospective Payment System Final Rules just a couple days away now, I want to make our readers aware of a fairly new MLN Education Tool )https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/html/medicare-payment-systems.html#Intro">link) where CMS has combined information about Medicare Payment Systems for Acute Care Hospitals, Hospice, Skilled Nursing, Ambulatory Surgery Centers, Hospital Outpatient, Inpatient Psychiatric Facilities, Inpatient Rehabilitation Facilities and Long-Term Care Hospitals.

July 2021 Medicare Quarterly Provider Compliance Newsletter

CMS announced the release of the July newsletter (link) in the Thursday September 9, 2021, edition of MLN Connects. This newsletter’s aim is to provide guidance to address billing errors.

MLN Booklet: Independent Diagnostic Testing Facility (IDTF)

This MLN Booklet (link) was updated in September. Updates are bolded in red. Of note, guidance for IDFTs related to the COVID-19 Public Health Emergency has been added to this booklet.

MLN Booklet: Transitional Care Management Services Revised

This MLN Booklet (link) focuses on covered services, location, who may provide services, supervision, billing services, documenting services and service benefits specific to Transitional Care Management. With the most recent updates, the CMS has added codes health care professional can bill concurrently with Transitional Care Management services and added language about auxiliary personnel providing services under supervision.

Medicare & You 2022

Medicare & You is the official U.S. government Medicare handbook. The 2022 is now available (link). New and important information about COVID-19-related items & services, cognitive assessment & care plan services, and blood-based biomarker testing have been added to the latest edition of this handbook.

September 9, 2021: Outpatient Clinic Visit Services at Excepted Off-Campus Provider-Based Departments: Payment Update

CMS included the following updated information in the Thursday September 9, 2021 edition of MLN Connects (link):

“By November 1, 2021, CMS will begin reprocessing claims for outpatient clinic visit services provided at excepted off-campus Provider-Based Departments (PBDs) so they’re paid at the same rate as non-excepted off-campus PBDs for those services under the Physician Fee Schedule (PFS). This affects certain claims with dates of service between January 1 - December 31, 2019. You don’t need to do anything; we’ll reprocess all affected claims. You must refund the coinsurance difference to patients (or payers) who paid the higher coinsurance rates based on new remittance advice information.

Background:

• November 21, 2018: The Calendar Year (CY) 2019 Outpatient Prospective Payment System (OPPS) Rule (link) finalized payment for certain outpatient clinic visit services provided at excepted off-campus PBDs at the same rate that we pay non-excepted off-campus PBDs for those services under the PFS. Previously, CMS and Medicare patients often paid more for the same type of clinic visit in the hospital outpatient setting than in the physician office setting.
• In 2019: We reduced payment to 70% of the full OPPS rate in off-campus PBDs. In 2020, this rate changed to 40%.
• September 17, 2019: The U.S. District Court for the District of Columbia declared invalid the CY 2019 payment rule that provided for the reduction for clinic visits provided at excepted off-campus PBDs.
• January 1 – July 2020: We reprocessed CY 2019 claims paid at the reduced payment rate of 70% to restore the 100% payment rate in accordance with the district court decision.
• July 17, 2020: The U.S. Court of Appeals for the D.C. Circuit reversed the district court ruling, upholding our volume control site-neutrality payment policy for off-campus outpatient hospital clinic visits.”

September 13, 2021: Proposal to Fully Repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule

On September 1, 2020, the CMS released the Proposed Rule Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Proposed Rule (CMS-3372-P). At that time, then Medicare HHS Secretary Alex Azar stated in a related press release that “this new proposal would give Medicare beneficiaries faster access to the latest lifesaving technologies and provider more support for breakthrough innovations by finally delivering Medicare reimbursement at the same time as FDA approval.” A Final Rule was published in the Federal Register on January 14, 2021, with a stated effective date of March 14, 2021. The effective date has since been delayed until December 15, 2021.

On Wednesday September 15, 2021, the CMS issued a Notice of Proposed Rule Making to fully repeal this final rule. (link). The repeal includes a public comment period through October 15, 2021. CMS’s intent is “to conduct future rulemaking to explore an expedited coverage pathway for innovative technologies (balanced with evidence development to ensure beneficial health outcomes for beneficiaries) and a regulatory definition of the Reasonable and Necessary standard for Medicare coverage.”

September 15, 2021: Department of Justice News: Orlando Cardiologist Pays $6.75 Million to Resolve Allegations

In a recent announcement (link), the DOJ indicated that an Orlando Cardiologist paid $6.75 million to resolve allegations that he performed medically unnecessary ablations and vein stent procedures. Specific allegations included:

• Ablations and stent procedures were performed on veins that did not qualify for treatment under accepted standards of medical practice,
• Dr. Pal made misrepresentations in patient records to justify the procedures, including overstating the degree of reflux and diameter of veins, and falsely documenting patient symptoms, and
• In many instances, the ablations were performed either exclusively or primarily by one or more ultrasound technicians outside their scope of practice.”

September 17, 2021: DOJ News – National Healthcare Fraud Enforcement Action

The DOJ announced (link) criminal charges against 138 defendants, including 42 doctors, nurses, and other licensed medical professionals in 31 federal districts across the U.S. for alleged participation in health care fraud schemes resulting in approximately $1.4 billion in alleged losses. Specifically, charges targeted approximately $1.1 billion in fraud committed using telemedicine, $29 million in COVID-19 health care fraud, $133 million connected to substance abuse treatment facilities, and $160 million connected to other health care fraud and illegal opioid distribution schemes.

COVID-19 Updates

August 20, 2021: CMS COVID-19 Flexibilities Reminders: Prior Authorization Process, Utilization Management and Medical Necessity

The CMS issued a letter (link) to Medicare Advantage Organizations (MAOs) noting that with the recent COVID-19 delta variant surge resulting in increased hospitalizations, they encourage MA Plans “to waive or relax plan prior authorization requirements and utilization management processes to facilitate the movement of patients from general acute-care hospitals to post-acute care” settings (i.e., skilled nursing facilities, inpatient rehabilitation facilities, inpatient rehabilitation facilities and home health agencies).

Of note, CMS goes on to remind MAOs that “while they and their contract providers are not required to follow Original Medicare’s documentation requirements or policies for establishing medical necessity, the methods implemented…to determine medical necessity cannot result in coverage standards that are more stringent than standards that apply in Fee-For-Service Medicare.”

August 27, 2021: FAQs Regarding ICD-10-CM/PCS Coding for COVID-19 Updated

The FAQ document jointly developed and approved by the American Hospital Association’ Central Office on ICD-10-CM/PCS and the American health Information Management Association provides answers to questions related to Coding COVID-19. This document (link) was most recently revised August 27, 2021.

September 2, 2021: Resumption in Use and Distribution of Bamlanivimab/Etesevimab in all U.S. States, Territories, and Jurisdictions

In late August, use of this COVID-19 monoclonal antibody treatment was revised to authorize use only in areas where the combined frequency of variants resistant to both treatments administered together was less than or equal to 5%. On September 2nd, the FDA announced (link) that based on most recently available data, Bamlanivimab and Etesevimab, administered together, can be used in all U.S. states, territories, and jurisdictions under the condition of authorization for EUA 94.

September 9, 2021: CDC Clinician Outreach and Communications Activity Call: 2021-2022 Influenza Vaccination Recommendations and Guidance on Coadministration with COVID-19 Vaccines

The CDC held this call on Thursday, September 9, 2021. Presenters provided updates on the Advisory Committee on Immunization Practices (ACIP) recommendations for the 2021-2022 influenza vaccination season and guidance for co-administration of influenza and COVID-19 vaccines. One key take away is that COVID-19 vaccines may be administered without regard to timing of other vaccines. For those that missed this call, you can visit the CDC webpage specific to this call (link) to download a copy of the slides.

September 10, 2021: FDA Statement – COVID-19 Vaccines for Young Children

Acting FDA Commissioner Janet Woodcock M.D., and Peter Marks, M.D, Ph.D., director the FDA’s Center for Biologics Research and Education, released a statement (link) providing an update detailing steps being taken to ensure the safety and efficacy of COVID-19 vaccines for young children. The statement ends with the following advice, “Until we authorize or approve a vaccine for this younger population, it’s especially important that parents and others who interact closely with children under 12 years of age get vaccinated, wear masks, and follow other recommended precautions so that we can protect those who cannot yet protect themselves through vaccination.”

September 10, 2021: HHS Announced $25.5 Billion in COVID-19 Provider Funding

The HHS announced (link) that funding from the American Rescue Plan (ARP) and Provider Relief Fund (PFR) totaling $25.5 billion is being made available for health care providers affected by the COVID-19 pandemic. HHS Secretary Xavier Bacerra noted that “this funding critically helps health care providers who have endured demanding workloads and significant financial strains amidst the pandemic…the funding will be distributed with an eye towards equity, to ensure providers who serve our most vulnerable communities will receive the support they need.”

September 30, 2021: CDC COCA Call: Evaluating and Supporting Patients Presenting with Fatigue Following COVID-19

The CDC will be holding a Clinician Outreach and Communication Activity (COCA) call Thursday September 30, 2021, in which presenters will discuss post-COVID conditions (PCC), “an umbrella term for the wide range of health consequences present four or more weeks after infection with SARS-CoV-2, which includes Long-COVID.” If you are unable to attend, call materials will be available on the CDC specific webpage for this call (link).

Medicare MLN Articles & Transmittals – Recurring Updates

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

• Article Release Date: August 25, 2021
• What You Need to Know: This article providers ICD-10 updates specific to NCDs resulting from newly available codes, separate NCD coding revisions and coding feedback received. Note, one of the updated NCDs is 20.4 Implantable Automatic Defibrillator. As CMS has added codes to this NCD, Novitas and First Coast have both retired their AICD Coding and Billing Articles.
• MLN MM12399: (link)

Implement Operating Rules – Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule – Update from Council for Affordable Quality Health Care (CAQH) Core

• Article Release Date: September 8, 2021
• What You Need to Know: This article alerts billing staff that the next version of the Code Combination List will be published on or about October 1, 2021. Updates are based on a market-based review conducted once every two years to fit in code combinations that Medicare and other health plans are now using.
• MLN MM12428: (link)

Annual Clotting Factor Furnishing Fee Update 2022

• Article release date: September 8, 2021
• What You Need to Know: Make sure your billing staff knows the clotting factor furnishing fee for 2022 is $0.239 per unit.
• MLN MM12420: (link)

Influenza Vaccine Payment Allowances – Annual Update for 2021-2022 Season

• Article release date: September 9, 2021
• What You Need to Know: This article includes a link to the CMS Seasonal Influenza Vaccines Pricing webpage and reminds all physicians, non-physician practitioners, and suppliers who give the flu shot that they must take assignment on the claim for the shot.
• MLN MM12421: (link)

2022 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments

• Article Release Date: September 9, 2021
• What You Need to Know: This article informs providers that the MACs will be receiving files for the automated payments of HPSA bonuses for dates of service from January 1, 2022, through December 31, 2022.
• MLN MM12367: (link)

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – October 2021 Update

• Change Request (CR) 12422 released: September 8, 2021
• What You Need to Know: This CR amends the payment files issued to contractors based upon the 2021 Medicare Physician Fee Schedule (MPFS) Final Rule.
• Related MLN MM12422: (link)

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

• Article Release Date: September 10, 2021
• What You Need to Know: This article provides information about quarterly updates to the CLFS, effective October 1, 2021.
• MLN MM12435: (link)

October 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: September 16, 2021
• What You Need to Know: Changes to and billing instructions for various payment policies are included in this Change Request. Information related to COVID-19 in this update includes:
• New COVID-19 CPT Administration Codes,
• New COVID-19 HCPCS Vaccine Administration Code for Administering in the Beneficiary’s Home, and
• Changes for COVID-19 Monoclonal Antibody Therapy Product and Administration Codes.
• Change Request (CR) 12436: (link)

October 2021 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: September 17, 2021
• What You Need to Know: This article highlights HCPCS updates included in the October 2021 ASC payment system update.
• MLN MM12451: (link)

Revised Medicare MLN Articles & Transmittals

Medicare FFS Response to the PHE on COVID-19

• Article Release Date: Initial article March 16, 2020 – 19th iteration September 8, 2021
• What You Need to Know: The latest revision to this MLN Special Edition article includes more information about Skilled Nursing Facility (SNF) waivers. Substantive changes are in dark red font on page 13 of this document. Specifically, CMS reminds providers that while the 3-day qualifying hospital stay is being waived prior to transfer to a SNF, “these emergency measures don’t waive or change any other existing requirements for SNF coverage under Part A such as the SNF level of care criteria, which remain in effect under the emergency.”
• MLN SE20011: (link)

Welcome to this month’s edition of MMP’s P.A.R. Pro Tips. For those new to the Wednesday@One, MMP has collaborated with RealTime Medicare Data (RTMD), to develop a proprietary Protection Assessment Report (P.A.R.). This report is a combination of current Medicare Fee-for-Service review targets with hospital specific Medicare Fee-For-Service paid claims data. As a bonus to our Wednesday@One readers, we have begun to provide useful “Did You Know” information that we come across in our ongoing review of key websites (i.e., Medicare Administrative Contractors (MACs), OIG, Recovery Auditors, etc.)

Did You Know?

Late last month, we reported that CMS had given the green light for Medicare Administrative Contractors (MACs) to resume the Targeted Probe and Educate (TPE) Program. This program had been on hold since March of 2020 due to the COVID-19 Public Health Emergency (PHE).

MACs are now reporting that effective September 1, 2021, they will discontinue sending post-payment additional documentation requests (ADR) and will resume reviews conducted under the TPE Medical Review Strategy.

Pro Tip: MAC Education

MACs nationwide have been releasing information about the resumption of the TPE Program.

CGS (Jurisdiction 15)

CGS has posted a letter to providers (link) walking through the TPE process and providing links to resources. At the time this article was written, CGS Part A Medical Review Activity Log (link) indicated that the TPE review types were still paused.

First Coast Service Options, Inc. (Jurisdiction N)

First Coast’s TPE webpage (link) you will find a link to a Targeted Probe and Educate Manual with guidance ranging from what is TPE to filing appeals.

Noridian (Jurisdiction E)

Noridian held a Targeted Probe and Educate (TPE) A/B webinar this past Friday, September 10, 2021. Topics included in the webinar included the TPE process, initiating reviews, providing notification, and completing and closing files. If you missed it, you can sign up for an October 14, 2021 webinar that will cover the same information (link).

Noridian (Jurisdiction F)

Following is an excerpt from an announcement (link) that Noridian posted on their website on September 8, 2021, “CMS has authorized the Medicare Administrative Contractors (MACs) to conduce a 20-40 claim preview for A/B providers utilizing the normal TPE process. If the Round One results in an acceptable error rate, no further action is required, and the TPE review will be closed.”

Novitas Solutions Jurisdiction (Jurisdiction H)

Novitas most recently updated their TPE webpage (link) on September 7, 2021, where you will find links to TPE Q&As, current TPE activities, historical TPE reviews, and documentation checklists. As of 9/7/2021, the only listed TPE Topic list is Therapy Services.

Palmetto GBA (Jurisdiction J)

Palmetto GBA was one of the first to update their Active Medical Review list (link), they note that TPE cases that remained open during the PHE have been closed.

WPS (Jurisdiction 5)

CMS issued the following notice on August 30, 2021, “CMS has authorized WPS to resume the TPE program effective September 1, 2020. Providers selected for review based on data analysis aberrancies will receive notification prior to the start of their TPE review.” Topics under review listed on their website (link) includes:

• Inpatient Psychiatric Facility (IPF),
• Inpatient Rehabilitation Services,
• Routine Foot Care, and
• Wound care in a Critical Access Hospital (CAH).

What Can You Do?

Make sure that employees involved with the TPE program at your facility are aware of the resumption of the program and make sure someone is checking your MAC’s websites on an ongoing basis for any updates, new review targets and TPE review results.