Knowledge Base Category -

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).

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

Did You Know?

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

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

Pro Tip: MAC Education

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

CGS (Jurisdiction 15)

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

First Coast Service Options, Inc. (Jurisdiction N)

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

Noridian (Jurisdiction E)

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

Noridian (Jurisdiction F)

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

Novitas Solutions Jurisdiction (Jurisdiction H)

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

Palmetto GBA (Jurisdiction J)

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

WPS (Jurisdiction 5)

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

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

What Can You Do?

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

In case you are not a long-time reader of our newsletter, fall is my favorite time of year. Even though the official start of fall is still a week away, with morning lows in the mid 50’s recently, I have already had my first cup of apple spice tea, first cup of pumpkin spice coffee, and made my first batch of chili in the slow cooker. I have also put out my fall pumpkin themed door mat as we enter the months of celebrating fall, Halloween, Thanksgiving, Christmas.

In the world of Medicare, fall is also a time for new beginnings and celebrations. The new CMS Fiscal Year (FY) starts on October 1st and more importantly this week is all about celebrating the 11th annual Clinical Documentation Integrity (CDI) Week. In keeping with my culinary firsts of the fall, this year’s CDI Week theme is CDI Kitchen: Recipes for a Successful Program. According to a related Association for Clinical Documentation Integrity Specialists (ACDIS) Fact Sheet (link), “the growth of the CDI specialist profession has mirrored the healthcare industry’s increased focus on compliance with regulations, managed care profiles, payment for services rendered, quality of care improvement measurements, and liability exposure. All these factors increasingly depend on the integrity of complete and specific clinical documentation in the medical record.”

MMP would like to wish all the hard-working CDI Professionals that we have the privilege to work with a happy CDI week. To help you prepare for the new CMS fiscal year, while celebrating this week, following are links to key ingredients for a successful start to the CMS FY 2022.

2022 ICD-10-CM Official Guidelines

• Available on CDC website at: https://www.cdc.gov/nchs/icd/icd10cm.htm
• Available on CMS website at: https://www.cms.gov/medicare/icd-10/2022-icd-10-cm

You can read about changes for FY 2022 in a related MMP article (link).

2022 ICD-10-PCS Official Guidelines

• Available on CMS website at: https://www.cms.gov/medicare/icd-10/2021-icd-10-pcs

2022 CMS IPPS Final Rule

• CMS FY 2022 IPPS Final Rule Home Page: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2022-ipps-final-rule-home-page
• Tables 6A-6K are also available on this page in excel format and includes among other things:
• New Diagnosis and Procedure codes,
• “Additions to” and “deletions from” the MCC and CC lists, and
• The complete MCC and CC lists.

FY 2022 ICD-10-CM/PCS Codes, MCCs and CCs

There are 165 new diagnosis codes. Of note, including in this list are:

• 11 new Social Determinants of Health (SDOH) ICD-10-CM codes, and
• 4 new COVID-19 related codes including U09.9 (Post COVID-19 condition, unspecified), Z1152 (Encounter for screening for COVID-19), Z20.822 (Contact with and *suspected) exposure to COVID-19), and Z86.16 (Personal history of COVID-19).

There are 212 new ICD-10-PCS procedure codes, including several new codes related to COVID-19 vaccines and monoclonal antibody treatments for COVID-19.

There are nine additions to the MCC list, including J12.82 (Pneumonia due to coronavirus disease 2019) which was implemented January 1, 2021. There are eleven additions to the CC list, which also include two codes implemented January 1, 2021 (M35.81 (multisystem inflammatory syndrome) and M35.89 (Other specific systemic involvement of connective tissue)).

Again, happy CDI week from our team to yours.

CMS Resumes Targeted Probe & Educate Program

In response to the COVID-19 Public Health Emergency (PHE), CMS suspended medical review activities on March 30, 2020. In August 2020, Recovery Auditors, Comprehensive Error Rate Testing Program, and Medicare Administrative Contractor post-payment reviews were resumed. At that time, the Targeted Probe and Educate (TPE) program remained on hold.

On May 8, 2019, CMS put a temporary hold on SSRs and HWDRG reviews as they planned to procure a new contractor to review both types of reviews on a national basis. The expectation was to award the contract by the 3rd quarter of calendar year 2019.

According to a CMS TPE Q&A document (link), when performing medical review as a part of this program, Medicare Administrative Contractors (MACs):

• Focus on specific providers/suppliers who, through data analysis, have been identified as varying significantly from their peers,
• Typically review 20-40 claims per provider/supplier, per item or service (round),
• Provide individualized education based on review results after a round, and
• Perform up to three rounds of reviews per item or service.

The CMS announced in the Thursday August 12, 2021, edition of MLN Connects (link) that the TPE Program is restarting “to help educate providers and reduce future denials and appeals.”

Livanta to Begin Short Stay Reviews and Higher Weighted DRG Reviews

Kepro and Livanta are the two Beneficiary and Family Centered Care Quality Improvement Organizations (BFCC-QIOs) that serve all regions across the nation. The BFCC-QIO scope of work, among other things includes performing certain types of medical record reviews. Two specific reviews are Short Stay Reviews (SSRs) and Higher Weight Diagnosis-Related Group (HWDRG) review.

It wasn’t until April of 2021, that Livanta announced they had been awarded this contract. On August 11, 2021, Livanta released a Provider Bulletin (link) to announce the official start of claims reviews. The bulletin includes information on the following topics:

• What Hospitals Can Expect,
• Hospital Inpatient Claim Review Types,
• HWDRG Review Process,
• SSR Process, and
• Questions and Education.

The review process for each type of medical review includes the timing of when they will begin requesting records. For HWDRG reviews, they expected to send the first medical record request the week of August 16th. For SSRs, Livanta anticipated sending the first individual medical record requests on or about the week of September 20, 2021. Note, record requests will be sent to your Medical Record point of contact via fax when possible or U.S. mail if fax is not possible. A hospital sample will consist of 30 claims reviewed within a rolling 3-month period and records must be submitted electronically.

I encourage you to visit Livanta’s webpage (link), read the Provider Bulletin and share this information with appropriate staff at your facility.

“The primary objective of the IPPS and the LTCH PPS is to create incentives for hospitals to operate efficiently and minimize unnecessary costs, while at the same time ensuring that payments are sufficient to adequately compensate hospitals for their legitimate costs in delivering necessary care to Medicare beneficiaries.”

- Source: Appendix A: Economic Analysis of FY 2022 IPPS Final Rule

CMS released the display copy of the Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS) Final Rule (CMS-1752-F) on Monday August 2, 2021. This article focuses on New Technology Add-On Payments (NTAP) for FY 2022.

New Technology Add-On Payment Pathways

There are now several pathways for a new services or technology to be approved for New Technology Add-On Payments (NTAPs) including:

• Traditional Pathway: To meet this pathway, the medical service or technology must be new, must be costly such that the DRG rate otherwise applicable to discharges involving the NTAP is inadequate, and must demonstrate a substantial clinical improvement over existing services or technologies.
• Certain Antimicrobial Products Alternative Pathway: In FY 2021 the alternative pathway for Qualified Infectious Disease Products (QIDPs) was expanded to include products approved under the Limited Population for Antibacterial and Antifungal Drugs (LPAD) pathway. In the Final Rule, CMS finalized policy to refer more broadly to “certain antimicrobial products” rather than specifying FDA programs for antimicrobials (i.e., QIDPs and LPADs). Products approved through this pathway will be considered new and not substantially similar to an existing technology and will not need to demonstrate that it meets the substantial clinical improvement criterion. However, the technology will need to meet the cost criterion.
• Certain Transformative New Devices Alternative Pathway: Beginning in FY 2021, “if a medical device is part of FDA’s Breakthrough Devices Program and received FDA marketing authorization, it will be considered new and not substantially similar to an existing technology for purposes of the new technology add-on payment under the IPPS.” However, the new device must meet the cost criterion and must receive marketing authorization for the indication covered by the Breakthrough Device Program designation.

For the alternative pathways, a technology is not required to have a specified FDA designation at the time the application for NTAP is made. Instead, “CMS will review the application based on the information provided under by the applicant under the alternative pathway specified by the applicant. However, to receive approval for the new technology add-on payment under that alternative pathway, the technology must have the applicable designation and meet all other requirements in the regulations in § 412.87(c) and (d), as applicable.”

Additional Payment for NTAP’s

Payment for an NTAP is based on the cost to hospitals for the new medical service or technology. As set forth in § 412.88(b)(2), unless the discharge qualifies for an outlier payment, the additional Medicare payment will be limited to the following:

• For “Traditional Pathway” and “Certain Transformative New Devices”, Medicare will make an add-on payment equal to the lesser of: (1) 65 percent of the costs of the new medical service or technology; or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment.
• For Certain Antimicrobial NTAPs (QIDPs and LPADs), Medicare will make an add-on payment equal to the lesser of: (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.

Coding NTAPs

Section X is the New Technology section that was added to ICD-10-PCS effective October 1, 2015. CMS has indicated that Section X was created in response to public comments received regarding New Technology proposals presented at ICD-10 Coordination and Maintenance Committee Meetings, and general issues facing classification of new technology procedures. The public had opposed many requests to add new codes to the existing ICD-10-PCS sections for the use of specific drugs, devices, or supplies in an inpatient setting, even when the code related to an application for New Technology add-on payments.

NTAPs for FY 2022 by the Numbers

NTAPs are not budget neutral and generally this add-on payment is limited to the 2-to-3-year period after the date a technology becomes available. Due to the COVID-19 Public Health Emergency (PHE) impacting hospital volumes, CMS finalized using FY 2019 data for rate setting. They also finalized a one-year extension of NTAPs for technologies that would have otherwise been discontinued beginning October 1, 2021.

CMS estimates the payment amounts for new technology add-on payments in the Final Rule based on the applicant’s estimates. This amount and the estimated number of patients is highlighted in Appendix A of the Final Rule. Appendix A begins on page 2,174 of the display version of the Final Rule.

• A total of 42 services or technologies have been approved for NTAPs,
• The estimated total amount to be paid to hospitals is $1,424,341,317.63, and
• The estimated number of patients is 468,206.
• The estimated number one NTAP by volume and payment is Veklury® (remdesivir) with an estimated 174,996 cases and estimated total payment of $354,891,888.00. This drug is used in the treatment of COVID-19 patients.

NTAPs FY Trend: Number of Services or Technologies Approved for NTAP

• FY 2020: 18
• FY 2021: 24
• FY 2022: 40

NTAPs FY Trend: Estimated Number of Patients to Receive a New Technology during an Inpatient Stay

• FY 2020: 71,659
• FY 2021: 259,201
• FY 2022: 468,206

New COVID-19 Treatment Add-on Payments (NCTAPs)

As new therapies were approved in response to the COVID-19 PHE, New COVID-19 Treatments Add-on Payment (NCTAP) were created. CMS finalized the following related to NCTAPs in the FY 2022 IPPS Final Rule:

• The NCTAP for eligible COVID-19 products will extend through the end of the fiscal year in which the PHE ends, and
• A hospital will be eligible to receive the NCTAP and the traditional NTAP for qualifying patient stays, through the end of the fiscal year in which the PHE ends, with the NTAP reducing the amount of the NCTAP.

You can learn more about NCTAP’s on the related CMS COVID-19 NCTAP specific webpage (link).

Moving Forward

Identifying and coding new technologies is an opportunity not to be missed for those hospitals providing these services. That said, some questions come to mind for you to think about:

• Is your hospital providing any of these medical services or technology?
• Who needs to be aware of what the new technologies are? (i.e. Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
• What process do you have in place to alert your Coding Staff of the need to code the new technologies?

Resources:

CMS August 2, 2021, Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2022-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-0

FY 2022 IPPS CMS webpage: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2022-ipps-final-rule-home-page

Question

In last week’s article about the OPPS and ASC Proposed Rule you indicated that CMS has proposed to remove 258 procedures that were added to the ASC covered procedure list in CY 2021. What procedures are remaining on the ASC list?

Answer

In the CY 2021 Final Rule, the finalized additions to the ASC Covered Procedure List were separated into two tables:

• Table 59 listed procedures added under the standard review process, and
• Table 60 listed procedures added under the second alternative proposal considered for CY 2021.

The procedures proposed for removal from the ASC list for CY 2022 are from Table 60. The procedures listed in Table 59 were not proposed for removal from the ASC list and includes the following CPT/HCPCS codes:

• 0266T: Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed),
• 0268T: Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed),
• 0404T: Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency,
• 21365: Open treatment of complicated (e.g., comminuted or involving cranial nerve foramina) fracture(s) of malar area, including zygomatic arch and malar tripod; with internal fixation and multiple surgical approaches,
• 27130: Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft,
• 27412: Autologous chondrocyte implantation, knee,
• 57282: Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus),
• 57283: Colpopexy, vaginal; intra-peritoneal approach (uteroscacral, levator myorrhaphy),
• 57425: Laparoscopy, surgical, colpopexy (suspension of vaginal apex),
• C9764: Revascularization, endovascular, open or percutaneous, and vessel(s); with intravascular lithotripsy, includes angioplasty within the same vessel(s), when performed, and
• C9766: Revascularization, endovascular, open or percutaneous, any vessel(s); with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel(s), when performed.

Resources:

• CY 2021 OPPS Final Rule and ASC Payment System Final Rule [CMS-1736-FC]: https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppshospital-outpatient-regulations-and-notices/cms-1736-fc
• CY 2022 OPPS and ASC Payment System Proposed Rule {CMS-1753-O]
  Note, see table 45 for procedures proposed for removal from the ASC Covered Procedures List. (link)
• Related MMP Article: CY 2022 OPps and ASC Proposed Rule – Inpatient Only List and ASC Covered Procedure List (link)

For students,’ summer is quickly winding down and at least for my youngest nephew, he starts back to school on August 9th. More years ago, than I care to share, this time of year was crunch time to finish all my required summer reading before facing a quiz in the first week of English class. Inevitably, there were books that I just knew I would not enjoy, that ended up being my favorite read of the summer.

Now, instead of reading literary classics, my summer reading consists of the coming CY OPPS and Physician Fee Schedule Proposed Rules, the coming FY IPPS Final Rule, and the updated ICD-10-CM Official Guidelines for the new October 1st FY. Today, I offer a “Cliffs Notes®” version of changes in the ICD-10-CM Official Guidelines for FY 2022.

The ICD-10-CM Official Guidelines for FY 2022 were released on Monday, July 12 and can be found on the CDC ICD-10-CM webpage (link) as well as the 2022 ICD-10-CM CMS webpage (link).

Section B2. General Coding Guideline – Level of Detail in Coding

2021 Guidance: Diagnosis codes are to be used and reported at their highest number of characters available.

2022 Guidance: Adds to this sentence “and to the highest level of specificity documented in the medical record.

Section B12. General Coding Guideline – Laterality

The following paragraph has been added to this section. For CDI Professionals, note the guidance includes the possible need for a physician query.

“When laterality is not documented by the patient’s provider, code assignment for the affected side may be based on medical record documentation from other clinicians. If there is conflicting medical record documentation regarding the affected side, the patient’s attending provider should be queried for clarification. Codes for “unspecified” side should rarely be used, such as when the documentation in the record is insufficient to determine the affected side and it is not possible to obtain clarification.”

Section B14. General Coding Guideline – Documentation by Clinicians Other than the Patient’s Provider

As a reminder, in 2021 this section was updated to include the following statement regarding the assignment of social determinant codes: “Patient self-reported documentation may also be used to assign codes for social determinants of health, as long as the patient self-reported information is signed-off by and incorporated into the health record by either a clinician or provider.”

New for FY 2022, the guidelines:

• Defines “clinicians,” • Adds “blood alcohol level” to the ever-growing list of code assignment exceptions,” and • Along with BMI, coma scale, and NIHSS, adds blood alcohol level codes and codes for social determinants of health to the list of exception codes that should on be reported as a secondary diagnosis.

Section B18. General Coding Guideline – Use of Signs/Symptom/Unspecified Codes

A new paragraph has been added to this section reminding you that:

• Achieving complete and accurate documentation, code assignment, and reporting of diagnoses and procedures is a joint effort between the healthcare provider and the coder, • Without consistent and complete documentation in the medical record, accurate coding can’t occur, and • The entire record should be reviewed to determine the reason for the encounter and what conditions were being treated.

Section C. Chapter-Specific Coding Guideline – Chapter 1: Certain Infectious and Parasitic Diseases -Coronavirus infections – Section 1g – Coronavirus Infections

This section includes several updates related to coding COVID-19, for example:

• Updated information related to follow-up visits after COVID-19 infection has resolved, and • New information related to Post COVID-19 Condition

Section C. Chapter-Specific Coding Guidelines – Chapter 5: Mental, Behavioral and Neurodevelopment disorders – Section b. 5 – Blood Alcohol Level

Blood Alcohol Level is a new section in Chapter 5 that provides the following guidance related to coding blood alcohol levels: “A code from category Y90, Evidence of alcohol involvement determined by blood alcohol level, may be assigned when this information is documented and the patient’s provider has documented a condition classifiable to category F10, Alcohol related disorders. The blood alcohol level does not need to be documented by the patient’s provider in order for it to be coded.”

Although there are other updates to be found in the FY 2022 Guidelines, as I promised a “Cliffs Notes®” review, I will stop here and encourage you to add this document to your own summer reading list.

In general, my day-to-day focus as it relates to Medicare Fee-for-Service guidance, is the acute hospital inpatient and outpatient setting. Last week, CMS issued Christmas in July gifts, in the form of 4 final FY 2022 payment rules. While not my day-to-day focus, highlights, and links to information about the final rules are important enough to share with you, our readers, who may be impacted.

FY 2022 Skilled Nursing Facility (SNF) Prospective Payment System (CMS-1746-F)

Major provisions in this final rule are highlighted in a related CMS Fact Sheet (link) and includes:

• FY 2022 Updates to the SNF Payment Rates,
• Methodology for Recalibrating the Patient Driven Patient Model (PDPM) Parity Adjustment,
• Rebase and Revise the SNF Market Basket by using the 2018-based SNF market basket to update the PPS payment rates, instead of the 2014-based SNF market basket,
• Section 134 of the Consolidated Appropriations Act, 2021 – New Blood Clotting Factor Exclusion from SNF Consolidated Billing,
• Changes in the PDPM ICD-10 Code Mappings,
• SNF Quality Reporting Program (SNF QRP) update, and
• SNF Value-Based Purchasing (SNF VBP) Program.

FY 2022 Hospice Payment Rate Update Final Rule (CMS-1745-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

• FY 2022 Routine Annual Rate Setting Changes,
• Other Medicare Hospice Payment Policies,
• Changes to the Hospice Conditions of Participation (CoPs) in response to the COVID-19 Public Health Emergency (PHE),
• Hospice Quality Reporting Program, and
• Home Health Quality Reporting Program.

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

Major provisions in this final rule in a related CMS Fact Sheet (link) includes:

• Updates to IRF Payment Rates,
• IRF Quality Reporting Program (IRF QRP) Updates, and
• Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues.

FY 2022 Inpatient Psychiatric Facility (IPF) Prospective Payment System Final Rule (CMS-1750-F)

Major provisions highlighted in a related CMS Fact Sheet (link) includes:

• FY 2022 Updates to the IPF Payment Rates,
• Updates to the IPF Teaching Policy, and
• IPF Quality Reporting Program (IPF QRP) Updates.

The Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (link) was released on July 19, 2021.

CMS estimates “that total payments to OPPS providers (including beneficiary cost-sharing and estimated changes in enrollment, utilization, and case-mix) for calendar year (CY) 2022 would be approximately $82.704 billion, an increase of approximately $10.757 billion compared to estimated CY 2021 OPPS payments.”

CMS, in general, plans to use 2019 claims data for rate setting due to the COVID-19 PHE. Examples of specific decreases or increases in claims in CY 2020 cited by CMS includes:

• An approximate 20 percent decrease in the overall volume of outpatient hospital claims,
• An approximate 30 percent decrease in volume in the APCs for hospital emergency department and clinic visits,
• For HCPCS code Q3013 (Telehealth originating site facility fee) in the hospital outpatient claims, the approximate 35,000 services billed in CY 2019 increased to 1.8 million services in the CY 2020.

Inpatient Only Procedure List

Historically, CMS used the following five criteria to assess for removal of a procedure from the Inpatient Only (IPO) list.

• Most outpatient departments are equipped to provide the services to the Medicare population.
• The simplest procedure described by the code may be furnished in most outpatient departments.
• The procedure is related to codes that we have already removed from the IPO list.
• A determination is made that the procedure is being furnished in numerous hospitals on an outpatient basis.
• A determination is made that the procedure can be appropriately and safely furnished in an ASC and is on the list of approved ASC services or has been proposed by us for addition to the ASC list

In a complete one-eighty, CMS has proposed to halt the elimination of the IPO list and, “after clinical review of the services removed from the IPO list in CY 2021,” add the 298 services removed in CY 2021 back to the IPO list beginning in CY 2022. CMS has also proposed to codify the five longstanding criteria for potential removal from the IPO list.

CMS noted that “many commenters, including hospital associations and hospital systems, professional associations, and medical specialty societies, vociferously opposed eliminating the IPO list. These commenters primarily cited patient safety concerns, stating that the IPO list serves as an important programmatic safeguard and maintains a common standard of medical judgment in the Medicare program.”

CMS requests public comments on several questions related to the IPO list. For example, “what information or support would be helpful for providers and physicians in their considerations of site-of-service selections?

Proposed Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2022 and Subsequent Years

Once a surgical procedure has been removed from the IPO List, documentation in the record must support the need for the inpatient admission. CMS reminds providers that “removal of a service from the IPO list has never meant that a beneficiary cannot receive the service as a hospital inpatient – as always, the physician should use his or her complex medical judgment to determine the appropriate setting on a case-by-case basis.”

For CY 2020, CMS finalized a two-year exemption from site-of-service claim denials, Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO) referrals to RACs, and RAC reviews for “patient status” (that is, site-of-service) for procedures that are removed from the IPO list under the OPPS beginning on January 1, 2020.

For CY 2021, CMS finalized “that procedures removed from the IPO list after January 1, 2021, were indefinitely exempted from site-of-service claims denials under Medicare Part A, eligibility for BFCC-QIO referrals to RACs for noncompliance with the 2-Midngiht rule, and RAC reviews for “patient status” (that is, site-of-service).” This exemption was to remain in place until Medicare claims data indicated a procedure was being performed more than 50 percent of the time in the outpatient setting.

On Monday, July 19th, WPS posted the following notice about spinal neurostimulators prior authorization requests:

For CY 2022, CMS has proposed to “rescind the indefinite exemption and instead apply a 2-year exemption from two midnight medical review activities for services removed from the IPO list on or after January 1, 2021.”

As a provider, keep in mind this exemption is specific to site-of-service claim denials and does not include exemption from medical necessity reviews of services provided based on a National or Local Coverage Determinations (NCDs and LCDs) when applicable.

Proposed Changes to the Ambulatory Surgical Center (ASC) Covered Procedure List (CPL)

CMS is also doing an about face for the ASC CPL. Of the 267 procedures added to the list in CY 2021, CMS has proposed to remove 258 procedures as they do not believe they meet the proposed revisions to the CY 2022 ASC CPL criteria.

CMS notes, “Based on our internal review of preliminary claims submitted to Medicare, we do not believe that ASCs have been furnishing the majority of the 267 procedures finalized in 2021. Because of this, we believe it is unlikely that ASCs have made practice changes in reliance on the policy we adopted in CY 2021. Therefore, we do not anticipate that ASCs would be significantly affected by the removal of these 258 procedures from the ASC CPL.”

A complete list of the 258 procedures can be found in table 45 of the proposed rule.

Proposed Revisions to the CY 2022 ASC CPL Criteria

In CY 2021, CMS revised their policy for adding surgical procedures to the ASC CPL. For CY 2022, they have proposed to revise the requirements for covered surgical procedures to reinstate the specifications established prior to CY 2021. One key proposal would once again define covered surgical procedures as surgical procedures specified by the Secretary and published in the Federal Register and/or via the Internet on the CMS website that are separately paid under the OPPS, that would not be expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure.

Inpatient, outpatient or ASC, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed.

While this article highlights a couple of topics in the proposed rule, I encourage you to review the entire document for other key proposals such as the proposed increase in civil monetary penalties (CMP) for hospital noncompliance with the Price Transparency requirements. You can also read more about what is being proposed in a related CMS Fact Sheet (link).