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.

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.

“Oh, what a tangled web we weave…when first we practice to deceive.”

- Sir Walter Scott

“Oh, what a tangled web we weave…. when first we practice to protect.” Changing just one word in this quote from “deceive” to “protect” makes it become an apt description of the numerous medical review contractors that are part of the CMS Medical Review and Education Program (link).

This premise is supported by CMS’ stated purpose for this interconnected web of medical review contractors as being to “identify errors through claims analysis and/or medical review activities. Contractors use this information to help ensure they provide proper Medicare payments (and recover any improper payments if the claim was already paid.) Contractors also provide education to help ensure future compliance.”

The Medicare Quarterly Provider Compliance Newsletter is one tool used for provider education. This quarterly newsletter’s aim is to provide guidance to address billing errors identified by Medicare Administrative Contractors (MACs) and other contractors such as Recovery Auditors, the Comprehensive Error Rate Testing (CERT) Review Contractor, and the Supplemental Medical Review Contractor (SMRC). Other governmental organizations, such as the Office of Inspector General (OIG), also conduct reviews and identify issues. The CMS recently announced the release of the July 2021 edition of this newsletter (link).

July 2021 Newsletter Topics:

• the Comprehensive Error Rate Testing (CERT) program review of glucose testing supplies,
• Recovery Auditor Issue 0181: Bone Marrow or Stem Cell Transplant: Medical Necessity and Documentation Requirements
• Recovery Auditor Issue 0081: Negative Pressure Wound Therapy: Medical Necessity and Documentation Requirements.

As I read through the newsletter, I noted that the CERT findings include background information, examples of improper payments and resources. Likewise, the Recovery Auditor review of negative pressure wound therapy includes a problem description, background information, recommendations to prevent denials and improper payments and resources. However, the Recovery Auditor review of bone marrow or stem cell transplant is lacking examples of improper payments and/or recommendations to prevent denials and improper payments. This lack of information led me to the CMS RAC webpage in search of additional information related to the RAC issue 0181. Much to my surprise this issue is no longer on the list of approved RAC issues and is no longer on the individual RACs list of approved issues.

Inpatient Bone Marrow and Stem Cell Transplant Procedures Medical Review Timeline

February 2016: OIG Review

The OIG noted in a February 2016 report (link) that Medicare had paid hospitals $185.9 million for inpatient claims related to bone marrow and stem cell transplant procedures. The OIG identified two hospitals that did not always comply with the Medicare billing requirements for inpatient claims for stem cell transplants that resulted in approximately $4 million in overpayments. In general, lengths of stay (LOS) for these claims ranged from 10 to 21 days. However, the LOS for claims reviewed were one to two days. Based on findings from the two hospitals, the OIG conducted a nationwide review of 143 claims and found that 133 (93%) of the claims did not comply with Medicare billing requirements. The two reasons cited by the OIG for noncompliance included:

• Hospitals incorrectly billing Medicare Part A for stays that should have been billed as outpatient, or outpatient with observation services, and
• Hospitals billing an incorrect Medicare Severity-Diagnosis Related Group (MS-DRG).

January 2019: New Review Project for SMRC

In response to the OIG report, the CMS tasked the SMRC (Noridian) with reviewing inpatient bone marrow and stem cell transplant procedures to determine compliance with statutory, regulatory, and sub-regulatory guidance. The SMRC reviewed claims billed on dates of service from January 1, 2017, through December 31, 2017. Specific MS-DRGs requested included:

• MS-DRG 014: Allogenic bone marrow transplant,
• MS-DRG 016: Autologous bone marrow transplant with a complication or comorbidity (CC), and
• MS-DRG 017: Autologous bone marrow transplant without a CC or major CC (MCC).

For this project, Noridian included the following list of specific documentation requirements in each Additional Documentation Request (ADR) sent to providers:

1. Documentation to support the beneficiary was expected to require an inpatient level of care for at least 2-Midnights
2. Documentation to support an inpatient level of care was expected and provided. Documentation should include, but is not limited to: Medication Administration Records (MAR), History & Physical, Physician Progress Notes, Nursing Notes, Discharge Summary, Procedure Notes
3. Inpatient admission order from attending physician
4. Physician or Non-Physician Practitioner (NPP) order for the stem cell transplant for the dates of service
5. Medical documentation that supports the beneficiary met criteria for one of the following covered services:
1. Allogenic Hematopoietic Stem Cell Transplantation (HSCT)
2. Autologous Stem Cell Transplantation (AuSCT)
6. Documentation to support enrollment in an approved Clinical Research Study, if applicable
7. Full detailed itemization of services, including diagnosis codes
8. Legible handwritten physician and/or clinician signatures
1. Signature logs and Signature Attestation Statement should be submitted when physician and/or clinician signatures are illegible
9. Valid electronic physician and/or clinician signatures
10. Advance Beneficiary Notice of Noncoverage (ABN), if applicable

Results of this review were posted to the SMRC website in October 2019. The error rate for the SMRC Project 01-006 (link) was 86%. Common reasons for denial cited by the SMRC included:

• Documentation received did not support medical necessity of an inpatient stay,
• No response by a provider to the documentation request,
• Signature requirements not being met, and
• Incorrect coding.

March 2020: RAC Approved Issue 0181: Complex Review of Hospital Inpatient Bone Marrow or Stem Cell Transplants

Six months later, further proof of the interconnected web of medical review contractors concept, a review of bone marrow and stem cell transplants became a RAC approved issue. Each of the 4 RAC Regions added Issue 0181 to their list of Issues in March of 2020 (link). Even Though RAC Issue 0181 is no longer listed on the RAC websites, if your hospital performs these procedures, I encourage you to perform a review of these inpatient records for documentation supporting medical necessity of the procedure and the inpatient stay.

Moving Forward

In July of this year, each of the RACs posted the following notice: “The Centers for Medicare & Medicaid Services (CMS) is required to protect the Medicare Trust Fund against inappropriate payments which pose a risk to the Trust Fund. Therefore, we are resuming Medicare Fee-for-Service medical review activities. The COVID-19 Public Health Emergency (PHE) continues to be monitored very closely.”

It is important to be aware of who your review contractors are, what issues they are focused on, and respond to ADRs in a timely manner. If you are unsure of who your review contractors are you can find out by using the CMS Review Contractor Directory – Interactive Map (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)

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 Booster Shots

On August 18, 2021, HHS released a statement, (link), indicating that “the available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease. Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.” HHS goes on to indicate they have a plan to begin offering booster shots this fall of a third dose of the Pfizer and Moderna mRNA vaccines, “beginning the week of September 20 and starting 8 months after an individual’s second dose.”

HHS also anticipates the need for a booster shot for individuals that received the Johnson & Johnson (J&J) vaccine. They note that “administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

COVID-19 Third Dose of Moderna and Pfizer-BioNTech CPT Codes

Concurrent to the recommendation that individuals receive a third Moderna or Pfizer-BioNTech COVID-19 vaccine, the AMA published the following CPT codes.

• Moderna Third Dose
• Effective for Emergency Use Authorization (EUA) as of August 12, 2021.
• Administration code 0013A
• Pfizer-BioNTech Third Dose
• Effective for EUA as of August 12, 2021
• Administration code 0003A

You can find a summary of the SARS-CoV-2 related CPT codes on the AMA website (link).

COVID-19 Myths and Facts

The CDC has a webpage (link) dedicated to dispelling myths about COVID-19 vaccines. For example:

• Yes, the Pfizer-BioNTech and Moderna mRNA vaccines trigger an immune response inside your body and are considered vaccines. The CDC notes that “this type of vaccine is new, but research and development on it has been under way for decades.”
• No, COVID-19 vaccines do not contain microchips.
• No, receiving a COVID-19 vaccine will not make you magnetic.

The World Health Organization (WHO) also has a webpage (link) dedicated to dispelling myths about COVID-19 in general by providing the facts, for example:

• COVID-19 is caused by a virus, not by bacteria. The virus that causes COVID-19 is in a family of viruses called Coronaviridae.
• The COVID-19 virus can spread in hot and humid climates, and
• 5G mobile networks DO NOT spread COVID-19. COVID-19 is a virus and is spread through respiratory droplets when an infected person coughs, sneezes or speaks. People can also be infected by touching a contaminated surface and then their eyes, mouth, or nose.

September is Prostate Cancer Awareness Month. A related RealTime Medicare Data (RTMD) infographic in this week’s newsletter focuses on Medicare Fee-for-Service claims data related to screening for Prostate Cancer.

Did You Know?

According to the CDC:

• 13 out of every 100 American men will get prostate cancer during their lifetime, and
• 2 to 3 men will die from prostate cancer,
• If you are African American or have a family history of prostate cancer you are at increased risk for getting or dying from prostate cancer.

The NIH National Cancer Institute indicates that based on 2011-2017 data, there is a 97.5% 5-year relative survival rate for men diagnosed with prostate cancer.

Why Does this Matter? Know the Symptoms

The CDC advises that if you are having any of the following symptoms, you need to see your doctor right away:

• Difficulty starting urination.
• Weak or interrupted flow of urine.
• Frequent urination, especially at night.
• Difficulty emptying the bladder completely.
• Pain or burning during urination.
• Blood in the urine or semen.
• Pain in the back, hips, or pelvis that doesn’t go away.
• Painful ejaculation.

The NIH National Cancer Institute indicates that based on 2011-2017 data, there is a 97.5% 5-year relative survival rate for men diagnosed with prostate cancer.

What You Can Do About It? Screening for Prostate Cancer

There are two tests commonly used to screen for prostate cancer:

• A blood test called a prostate specific antigen (PSA) test and
• A digital rectal examination (DRE).

The U.S. Preventive Services Task Force recommendation is that men aged 55 to 69 years should participate in a shared decision making process with their physician by discussing the potential benefits and harms of screening with a PSA test and incorporating their values and preferences in the decision.

This recommendation applies to men who:

• Are at average risk for prostate cancer,
• Are at increased risk for prostate cancer,
• Do not have symptoms of prostate cancer, and
• Have never been diagnosed with prostate cancer.

Medicare Preventive Service: Prostate Cancer Screening – Coverage & Coding

HCPCS & CPT Codes

• G0102 (Prostate cancer screening; digital rectal exam): A patient’s copayment or coinsurance, and deductible will apply.
• G0103 (Prostate cancer screening; prostate specific antigen test): there is no copayment, coinsurance, or deductible for the patient.

Resources:

• CDC website: https://www.cdc.gov/cancer/prostate/
• NIH National Cancer Institute Cancer Stat Facts: Prostate Cancer: https://seer.cancer.gov/statfacts/html/prost.html
• U.S. Preventive Services Task Force Final Recommendation Statement for Prostate Screening: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prostate-cancer-screening
• CMS MLN Educational Tool (MLN006559 May 2021): Medicare Preventive Services at https://www.cms.gov/medicare/prevention/prevntiongeninfo/medicare-preventive-services/mps-quickreferencechart-1.html#PNEUMO

COVID-19 Updates

August 12, 2021: FDA Authorized Additional Vaccine Dose for Certain Immunocompromised Individuals

The FDA has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID- 19 Vaccine and the Moderna COVID-19 Vaccine to allow for additional doses “in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.” (link). CMS updated their COVID-19 webpage on August 13, 2021 (link), to reflect that they will pay the same amount to administer this additional dose as they did for the other doses (approximately $40 each). .

August 16, 2021: Actemra® (Tocilizumab) Supply Shortage

Genentech released a statement (link) indicating that due to “the unprecedented surge in worldwide demand and supply constraints driven by Delta variant spikes in much of the rest of the world that preceded the current situation in the U.S., has led to a global shortage of Actemra® (tocilizumab) supply for at least the next several weeks…This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV-- well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase.”

August 18, 2021: COVID-19 Booster Shots

The U.S. Department of Health and Human Services (HHS) published a Press Release (link) regarding the need for COVID-19 booster shots. Specifically, data has shown that protection from vaccination begins to decrease over time and they have a plan to begin offering booster shots “subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices.”

Other Updates

July 19, 2021: CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1753-P) – Hospital Price Transparency

The September 17, 2021 deadline to comment on the CY 2022 OPPS and ASC Payment System Proposed Rule is fast approaching. In a related CMS Fact Sheet (link), CMS noted several proposed “modifications designed to increase compliance and reduce hospital burden beginning January 1, 2022.” One key proposal for hospitals to be aware of is the proposed increase in Civil Monetary Penalties (CMP) for non-compliance with the Hospital Price Transparency rule. Specifically, CMS has proposed the following:

• Set a minimum CMP of $300/day that would apply to smaller hospitals with a bed count ≤30, and
• Apply a penalty of $10/bed/day for hospitals with a bed count >30, not to exceed a maximum daily dollar amount of $5,500.

Under the proposed increases, the new penalty for a full year of noncompliance would be a minimum of $109,500 per hospital and a maximum total penalty of $2,007,500 per hospital.

August 11, 2021: Hospital Price Transparency Stakeholder Webinar

This CMS webinar focused on how to meet the requirements of the Hospital Price Transparency Final Rule (link) for posting standard charge information in a comprehensible machine-readable file (link). CMS experts reviewed 8 steps to a Machine-Readable File of All & Services and provided hospital compliance examples. For those that missed this event, a pdf copy of this presentation is available on the Hospital Price Transparency Resources web page (link). (link)