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Medicare MLN Articles & Transmittals – Recurring Updates

January 2022 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Fields and Revisions to Prior Quarterly Pricing Files

• Article Release Date: October 1, 2021
• What You Need to Know: Billing staff need to be aware of these quarterly updates to Medicare ASP and Not Otherwise Classified (NOC) Part B drug pricing files.
• MLN MM12469: (link)

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 28.0, Effective January 1, 2022

• Article Release Date: October 1, 2021
• What You Need to Know: Billing staff need to be aware of these quarterly updates to Medicare ASP and Not Otherwise Classified (NOC) Part B drug pricing files.
• MLN MM12469: (link)

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2022

• Article Release Date: October 1, 2021
• What You Need to Know: Billing staff need to be aware of these quarterly updates to Medicare ASP and Not Otherwise Classified (NOC) Part B drug pricing files.
• MLN MM12469: (link)

New/Modifications to the Place of Service (POS) Codes for Telehealth

• Article Release Date: October 14, 2021
• What You Need to Know: The POS Workgroup has revised the description of existing POS code 2 and added a new POS code 10.
• MLN MM12427: (link)

Claim Status Category and Claim Status Codes Update

• Article Release Date: October 14, 2021
• What You Need to Know: This article updates, as needed, the Claims Status and Claim Status Category Codes approved by the National Code Maintenance Committee.
• MLN MM12299: (link)

April 2022 Update to the Java Medicare Code Editor (MCE) for New Edit 20 – Unspecified Code Edit

• Article Release Date: October 22, 2021
• What You Need to Know: This article tells about system changes needed to update the MCE to accept a new MCE edit 20 (Unspecified Code Edit).
• MLN MM12471: (link)

Revised Medicare MLN Articles & Transmittals

Medicare Clarifies Recognition of Interstate License Compact Pathways

• Article Release Date: Initial article May 5, 2020 – Revision September 16, 2021
• What You Need to Know: The CMS revised this MLN article to clarify recognition of licenses through interstate license compact pathways as valid and full licenses for purposes of meeting federal license requirements.
• MLN SE20008: (link)

Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2022

• Article Release Date: August 12, 2021 – Revised October 6, 2021
• What You Need to Know: This MLN article was revised to reflect revised CR 12417 which corrected the fixed dollar loss threshold amount to $16,040.
• MLN MM12417: (link)

National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy – This CR Rescinds and Fully Replaced CR 11783

• Article Release Date: May 24, 2021 – Revised October 6, 2021
• What You Need to Know: In this fourth iteration of this MLN article, information has been added on the use of the KX modifier on professional claims. Substantive changes are in dark red font.
• MLN MM12177: (link)

Medicare Coverage Updates

September 27, 2021: Final Decision Memo – Home Use of Oxygen and Home Oxygen to Treat Cluster Headaches

The CMS posted a final national coverage determination (NCD) and decision memo ((link) for two separate, but medically related NCDs.

• NCD 240.2.2: Home Oxygen Use to Treat Cluster Headaches (CH)
• CMS is removing this NCD from the Medicare NCD manual,
• Ending Coverage with Evidence Development (CED), and
• Allowing MACs to make coverage determinations regarding the use of home oxygen and oxygen equipment for CH.
• NCD 240.2: Home Use of Oxygen
• CMS is expanding patient access to oxygen and oxygen equipment in the home, and
• Permitting MACs to cover the use of home oxygen and oxygen equipment in order to treat CH and other acute conditions.

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.

Question:

How do we bill mammography services when a beneficiary undergoes a screening and diagnostic mammogram on the same day?

Answer:

According to the MLN educational tool: Medicare Preventive Services (https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html#MAMMO), “if you perform and bill a screening mammogram and a diagnostic mammogram on the same day, use modifier -GG to show a screening mammography turned into a diagnostic mammography.”

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.

“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 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.