Knowledge Base Category -

“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

August is National Immunization Awareness Month (NIAM). A related RealTime Medicare Data (RTMD) infographic in this week’s newsletter focuses on Medicare Fee-for-Service claims data related to the treatment costs of Pneumonia.

Did You Know?

According to CDC data for the United States in 2017

• 3 million people were diagnosed with pneumonia in an emergency department, and
• Approximately 50,000 people died from pneumonia.

Why Does this Matter?

In general, people affected by pneumonia in the United States are adults. Per the CDC, vaccines, and appropriate treatment (like antibiotics and antivirals) could prevent many of these deaths.

What You Can Do About It? Wash Your HandsWhy Does this Matter?

In general, people affected by pneumonia in the United States are adults. Per the CDC, vaccines, and appropriate treatment (like antibiotics and antivirals) could prevent many of these deaths.

What You Can Do About It? Wash Your Hands

Handwashing is one of the most important things you can do. In fact, it’s so important that annually there is a Global Handwashing Day on October 15th and the first week of December in the U.S. is National Handwashing Week. You can download a CDC poster educating people on knowing when and how to wash your hands (link).

When to Wash Your Hands?

• After using the bathroom,
• Before, during, and after preparing food,
• Before eating food,
• Before and after caring for someone at home who is sick with vomiting or diarrhea,
• After changing diapers or cleaning up a child what has used the toilet,
• After blowing your nose, cough, or sneezing,
• After touching an animal, animal feed, or animal waste,
• After handling pet food or pet treats, and
• After touching garbage.

How to Wash Your Hands? Wet, Lather, Scrub, Rinse and Dry

• Wet your hands with clean running water (warm or cold), turn off the tap and apply soap,
• Lather your hands by rubbing them together with the soap. Be sure to lather the backs of your hands, between your fingers, and under your nails,
• Scrub your hands for at least 20 seconds. Need a timer? Hum the “Happy Birthday” song from beginning to end twice,
• Rinse hands well under running water, and
• Dry hands using a clean towel or air-dry time.

What You Can You Do About It? Get Your Pneumonia Vaccine(s)

Did you know that there are two different pneumonia vaccines? Further, did you know they cannot be given at the same time?

According to the CDC (link), if you are recommended to or want to receive both vaccines get Prevnar13® first and talk to your doctor about when to come back to get the Pneumovax23. If you’ve already received the Pneumovax23 vaccine, wait at least a year after that shot to get the Prevnar13® vaccine.

Prevnar13® Pneumococcal conjugate vaccine (PCV13)
This vaccine was approved in 2010. It is approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains.

Pnuemovax23 (Pneumococcal Vaccine Polyvalent)
This vaccine was approved by the FDA in 1983 and has been available for over 35 years. It helps protect against 23 types of pneumococcal bacteria, some of which are common and often cause serious illness.

The CDC recommends this vaccine for:

• All adults 65+, even if you already had a different pneumococcal vaccine, and
• Those 19-64 years old who have certain chronic conditions such as diabetes, heart disease or COPD.

Pneumococcal Shot Administration Coverage
As of September 19, 2014, Medicare Part B covers:

• All adults 65+, even if you already had a different pneumococcal vaccine, and
• Those 19-64 years old who have certain chronic conditions such as diabetes, heart disease or COPD.

There is no copayment, coinsurance, or deductible for Medicare beneficiaries.

HCPCS & CPT Codes

• CPT 90670 – Pneumococcal conjugate vaccine, 13 valent (PCV13), for intramuscular use
• CPT 90732 – Pneumococcal polysaccharide vaccine, 23-valent (PPSV23), adult or immunosuppressed patient dosage, when administered to individuals 2 years or older, for subcutaneous or intramuscular use
• HCPCS G0009 – Administration of pneumococcal vaccine.

Medicare covers all patients receiving pneumonia vaccines and there is no copayment, coinsurance, or deductible.

What Vaccines are Recommended for You?

In addition to pneumonia vaccines, there are additional immunizations that all adults need. Do you know what vaccines you have had or should have? If not, the CDC offers an Adult Vaccine Assessment Tool for all adults 19 years or older (link).

Resources:

• CDC website: https://www.cdc.gov/handwashing/index.html
• 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
• MerckVaccines.com®: https://www.pneumovax23.com/
• Prevnar13® website: https://adult.prevnar13.com/about-prevnar13

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.

Medicare MLN Articles & Transmittals – Recurring Updates

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

• Article Release Date: July 2, 2021
• What You Need to Know: This article provides information about changes to the DMEPOS fee schedule that is updated on a quarterly basis. Key points in Change Request 12345 are related to The Coronavirus Aid, Relief, and Economic Security (CAREs) Act, 2020 as it relates to DMEPOS.
• MLN MM12345: (link)

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

• Article Release Date: July 15, 2021
• What You Need to Know: This article talks about the ASP methodology, which CMS bases on quarterly data submitted to them by manufacturers.
• MLN MM12342: (link)

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2021

• Article Release Date: July 15, 2021
• What You Need to Know: This article is related to Change Request 12384 which announced the changes that will be included in the October 2021 quarterly release of the edit module for clinical diagnostic laboratory services.
• MLN MM12384: (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: Change Request (CR) 12340 provides quarterly updated to the NCCI PTP edits.
• MLN MM12340: (link)

Other Medicare MLN Articles & Transmittals

Section 50 in Chapter 30 of Publication (Pub.) 100-04 Manual Updates: ABNs

• Article Release Date: July 14, 2021
• What You Need to Know: This article alerts providers about key changes being made to Chapter 30, Section 50 of the Medicare Claims Processing Manual related to Advance Beneficiary Notices of Non-coverage (ABNs). One key revision listed is the period of effectiveness of the ABN for repetitive or continuous non-covered care.
• MLN MM12242: (link)

Revised Medicare MLN Articles & Transmittals

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

• Article Release Date: Initial article May 24, 2021 – 2nd Revision July 21, 2021
• What You Need to Know: The revised change request added CPT code C9076 (Breyanz). The implementation date was also revised to September 20, 2021. Breyanz joins a list of other CAR T-cell therapies including Kymriah®, Yescarta®, Tecartus™, and ABECMA®.
• MLN MM12177: (link)

Medicare Coverage Updates

July 12, 2021: National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

July 12, 2021: National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease On June 7, 2021, The FDA approved, using accelerated approval, aducanumab (brand name Aduhelm™) with an indication for the treatment of Alzheimer’s disease. Aducanumab is a monoclonal antibody directed against amyloid beta to reduce amyloid accumulations. CMS has initiated a national coverage determination (NCD) analysis (link) and is requesting public comments to several questions.

Medicare Educational Resources

Critical Access Hospital MLN Booklet Revised

JCMS recently revised the MLN Booklet (link) to include changes related to the COVID-19 Public Health Emergency (PHE). Specifically:

• CAH temporary emergency coverage without a qualifying hospital stay due to COVID-19 PHE, and
• Waiving the limitation on number of swing beds (25) and Length of Stay of 96 hours during the COVID-19 PHE.

COVID-19 Updates

Medicare COVID-19 Snapshot Updates

CMS updated their Medicare COVID-19 Data Snapshot slides (link) on June 30, 2021, to provide insight on the Medicare population from January 1, 2020 – April 24, 2021. With this update, data shows that there have been over 4.3 million COVID-19 cases and over 1.2 million COVID-19 hospitalizations.

OIG Fraud Alert: COVID-19 Scams

On July 21, 2021, the OIG updated their Fraud Alert: COVID-19 Scam’s webpage (link). You can find a short YouTube video highlighting 5 things about COVID-19 fraud and tips to protect yourself. For example, “offers to purchase COVID-19 vaccination cards are scams. Valid proof of COVID-19 vaccination can only be provided to individuals by legitimate providers administering vaccines.”

July 19, 2021: COVID-19 PHE Extended

In case you missed it in a recent Wednesday@One article, On July 19, 2021, Xavier Becerra, Secretary of Health and Human Services, renewed the PHE effective July 20, 2021 (link).

Other Updates

CY 2022 Medicare Physician Fee Schedule Proposed Rule

CMS issued this proposed rule on July 13, 2020 (link). Examples of what is being proposed includes:

• Proposals related to telehealth services added during the COVID-19 PHE and a proposal to require use of a new modifier for telehealth services furnished using audio-only communications,
• Proposal to make direct payments to Physician Assistants (PAs) for professional services furnished under Part B beginning January 1, 2022, and
• Proposal to begin the payment penalty phase of the Appropriate Use Criteria (AUC) Program on the later of January 1, 2023, or the January 1 that follows the declared end of the PHE for COVID-19.

You can read additional highlights from the proposed rule in a related CMS Fact Sheet (link).

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).

Welcome to the second monthly 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?

The Prior Authorization for Certain Hospital OPD Services was implemented effective July 1, 2020. On July 1, 2021, two additional services were added to the list of services requiring prior authorization (Spinal Neurostimlators and Cervical Fusion with Disc Removal). The full list of HCPCS codes requiring prior authorization is available on the CMS webpage dedicated to this process (link).

Pro Tip: MAC Education

MACs nationwide have been providing education to providers regarding this program and more specifically the two new services that have been added to the list of services requiring prior authorization. Following is a sampling of information available for hospital outpatient departments:

CGS (Jurisdiction 15)

CGS’ OPD Prior Authorization webpage (link) walks providers through the process of submitting a prior authorization request, outlines medical record documentation requirements to meet coverage criteria, provides a detailed exemption process timeline, and information about claims submission and appeals. There are also several “NOTES” included throughout this webpage, for example:

“Although other providers, such as a physician/staff may submit a PAR on the hospital OPD’s behalf, departmental collaboration is crucial.”

“A PAR is valid for one claim/date of service.” Unlike MMP’s Protection Assessment Report (P.A.R.), the PAR related to this CMS program is an acronym for Prior Authorization Request.

First Coast Service Options, Inc. (Jurisdiction N)

In late June, First Coast modified their article Vein ablation and related services (link). This article includes:

• Clinical definitions of veins, varicose veins, endovenous ablation, and chronic venous insufficiency,
• Applicable HCPCS codes,
• Documentation requirements,
• Best practice/documentation feedback/tips and help,
• Billing and coding alerts, and
• References, including links to applicable Local Coverage Determination (LCD) and related Local Coverage Article (LCA).

First Coast also released an updated Prior Authorization (PA) program Q&A document (link) on July 15th.

National Government Services (NGS Jurisdiction K)

On July 7, 2021, NGS posted an Outpatient Department Prior Authorization for Implanted Neurostimulators Alert (link). The alert begins by reminding providers that HCPCS 63650 is the only code that needs to be prior authorized for trial and permanent placement. The alert goes on to provide documentation requirements and links to related content.

Noridian (Jurisdiction E)

Noridian has created a Prior Authorization Lookup Tool to help providers determine which HCPSC codes require a prior authorization (link). They are also providing Prior Authorization for Certain Hospital Outpatient Department (OPD) Services webinars (link). One is scheduled for today July 21, 2021, and another one is scheduled for August 12, 2021.

Novitas Solutions Jurisdiction (Jurisdiction H)

On the Novitas webpage that is dedicated to this program (link), you will find the following:

• Program background information,
• Quick links to key documents,
• General information,
• Upcoming Education events,
• Links to all applicable LCDs and LCAs,
• Information about expedited requests, and
• Contact Information.

Palmetto GBA (Jurisdiction J)

Palmetto has made available a Cervical Disc Spinal Fusion and Spinal Cord Stimulator On-Demand Webcast (link). On July 15th, Palmetto also posted an article detailing the Prior Authorization Exemption Process (link).

WPS (Jurisdiction 5)

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

“Providers who perform and bill CPT code 63650 (percutaneous implantation of neurostimulator electrode array, epidural) must remember to request prior authorization (PA) for both the trial and permanent placement.

Providers should submit a PA for the trial placement only if the plan is to perform the procedure in a hospital outpatient department (HOPD). Providers should submit one prior authorization request (PAR) when both the trial and the permanent placement will be in the same HOPD. WPS will only assign one Unique Tracking Number (UTN) that the provider should use to bill for both claims.

If the trial and permanent placement are to occur at two separate HOPDs, then the provider will need two separate UTNs as each HOPD has their own Provider Transaction Access Number (PTAN) and National Provider Identifier (NPI).”

What Can You Do?

For those involved in the Prior Authorization process at your hospital, be sure and check out available resources on your MAC specific webpage. CMS’s Review Contractor Directory – Interactive Map (link) among other Medicare Contractors, provides links to your state specific MAC.

Did you know?

Previously, there were only three ICD-10-CM codes to identify personal history of carcinoma in-situ. These sites only included the breast, cervix uteri, and other site. Effective October 1, 2019, six new codes were created for personal history of in-situ neoplasms (Z86.002 – Z86.007). Two of these sites are listed below:

• Melanoma (Z86.006) (Personal history of melanoma in-situ)
• Skin (Z86.007) (Personal history on in-situ neoplasm of skin)

Why Should I Care?

ICD-10-CM codes are used for numerous occasions, i.e., accurate payments, quality management, data statistics, public health reporting, etc. The more accurate and specific codes are reported, the more accurate and specific data outcomes will be.

What Should I Do?

Report the new codes, if the documentation describes more specific sites, to allow for more specific coding and reporting of personal history of carcinoma in-situ sites.

References Coding Clinic for ICD-10-CM/PCS, Fourth Quarter 2019: Page 19

Did you know?

Romidepsin was first approved by the FDA November 5, 2009, for the treatment of cutaneous T-cell lymphoma (CTCL) and then approved in June 2011 for other peripheral T-cell lymphomas (PTCLs). HCPCS code C9065 was established as a temporary code to report the drug Romidepsin in the outpatient prospective payment system (OPPS) until a permanent J code was established.

Why it matters.

This code was to be terminated on June 30, 2021. However, on June 21, 2021, MLN article MM12289 (Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – July 2021 Update (link) was revised to reflect that HCPCS J9314 (Injection, romidepsin, non-lyophilized (e.g., liquid), 0.1mg) was removed from the table of new HCPCS codes for July 1, 2021 and after.

Shortly after the release of the revised MLN article, Medicare Administrative Contractors (MACs) posted announcements on how to report administration of this drug. For example, the JN MAC, First Coast’s June 29, 2021 announcement (link), indicated “HCPCS code C9065 was set to be terminated on June 30; however, a permanent J code has not yet been established. For services on or after July 1, please continue using HCPCS code C9065 on your OPPS claims to report the drug Romidepsin.”

What can You do?

Make sure you billing staff is aware of this update.