Knowledge Base Category -

In response to the ongoing COVID-10 public health emergency, CDC’s National Center for Health Statistics (NCHS) will be implementing new ICD-10 diagnosis and procedures codes. The three new ICD-10-CM diagnosis codes are for reporting an individual’s vaccination status.

New Diagnosis Codes

• Z28.310: Unvaccinated for COVID-19
• Z28.311: Partially vaccinated for COVID-19
• Z28.39: Other underimmunization status

There are also seven new ICD-10-PCS procedure codes to describe the introduction or infusion or therapeutics, including vaccines for COVID-19 treatment. In the CMS announcement related to the procedure codes, providers are reminded that “for hospitalized patients, Medicare pays for the COVID-19 vaccines and their administration separately from the Diagnosis-Related Group rate. As such, Medicare expects that the appropriate CPT codes will be used when a Medicare beneficiary is administered a vaccine while a hospital patient.”

New Procedure Codes

• XW013V7: Introduction of COVID-19 vaccine dose 3 into subcutaneous tissue, percutaneous approach, new technology group 7
• XW013W7: Introduction of COVID-19 vaccine booster into subcutaneous tissue, percutaneous approach, new technology group 7
• XW023V7: Introduction of COVID-19 Vaccine dose 3 into muscle, percutaneous approach, new technology group 7,
• XW023W7: Introduction of COVID-19 Vaccine booster into muscle, percutaneous approach, new technology group 7,
• XW0DXR7: Introduction of fostamatinib into mouth and pharynx, external approach, new technology group 7,
• XW0G7R7: Introduction of fostamatinib into upper GI, via natural or artificial opening, new technology group 7, and
• XW0H7R7: Introduction of fostamatinib into lower GI, via natural or artificial opening, new technology group 7.

All ten new codes will become effective April 1, 2022.

Resource: CMS’ MS-DRG Classifications and Software webpage (link), see ICD-10 MS-DRGs V39.1 Effective April 1, 2022 Zip file under “Latest News”

Medicare Coverage Updates

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

• Article Release Date: September 15, 2021 – Revised November 12, 2021
• What You Need to Know: This article lets providers know that CMS will nationally cover autologous Platelet-Rich Plasma (PRP) for the treatment of chronic non-healing diabetic wounds under specific conditions. It was updated to reflect a revised implementation date of November 23, 2021 for MACs.
• MLN MM12403: (link)

October 28, 2021: Transvenous (Catheter) Pulmonary Embolectomy Final Decision Memo

CMS published a Final Decision Memo (link) and is removing the National Coverage Determination (NCD) for Transvenous (Catheter) Pulmonary Embolectomy (NCD 240.6) and permitting coverage determinations to be made by Medicare Administrative Contractors (MACs).

November 12, 2021: CMS Repeals MCIT/R&N Rule

CMS announced they have rescinded the Medicare Coverage and Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule that was published January 14, 2021. CMS notes in a related Press Release (link) that they plan “to work with the FDA, Agency for Healthcare Research and Quality (QHRQ), medical device manufacturers, and other stakeholders to develop and expeditious process to cover innovative devices that benefit Medicare patients, and intends to hold at least two stakeholder public meetings in CY 2022 to inform our future policy-making in this space.”

November 17, 2021: Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) Proposed Decision Memo

CMS posted Proposed Decision Memo (CAG-00439R) (link) which would update the eligibility criteria for a LDCT. Two key changes are decreasing the age of eligibility from 55 years to 50 years and the history of smoking in pack-years from 30 to 20 years. CMS is accepting comments through December 17, 2021.

December 12, 2021: Future Effective Palmetto GBA LCD and Article: Cardiac Resynchronization Therapy (CRT)

CMS published a final Decision Memo, February 15, 2018, related to NCD 20.4 (Implantable Cardioverter Defibrillators). Changes made to this policy included removal of the Class IV Heart Failure requirements for CRT. At that time, CMS noted that coverage determinations for CRT devices are currently made by local Medicare Administrative Contractors (MACs) and not currently subject to an NCD.

Currently, First Coast Services Options, the JN MAC is the only MAC with a CRT coverage policy (LCD L33271 / A57634). That will soon change as Palmetto GBA the JJ and JM MAC has published LCD DL39080 with associated coding and billing article A58821 with a future effective date of December 11, 2021. Palmetto notes in the LCD that it “does not address the decision-making between CRT-pacemaker (CRT-P) or CRT-defibrillator (CRT-D) options other than to emphasize that those patients receiving CRT-D must not only meet coverage criteria in this policy but also meet the NCD for Implantable Automatic Defibrillators (20.4) criteria for the defibrillator portion of their therapy in order to be considered for coverage.”

Medicare Educational Resources

CMS MLN Fact Sheet: Medicare Billing: 837P & Form CMS-1500 Updated

CMS has recently updated this MLN Fact Sheet (link) by adding a new Test Transaction Tool and information about late claims exceptions, new electronic filing exceptions and new waiver requests criteria.

Other Updates

Amount in Controversy Threshold Requirement for ALJ Hearing for CY 2022

Beginning in January 2005, the established amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and reviews in the Federal District court, is to be adjusted annually. The amounts are to remain the same in CY 2022 as they have been in CY 2021:

• ALJ hearing requests - $180
• Federal District Court reviews - $1,760

This information was posted in the Thursday, September 30, 2021 Federal Register (link).

October 27, 2021: OIG Report – 2021’s Top Unimplemented Recommendations

The full title of this report is 2021 OIG’s Top Unimplemented Recommendations: Solutions to Reduce Fraud, Waster, and Abuse in HHS Programs (link). In this year’s iteration of this annual report, the OIG focuses on “the top 25 unimplemented recommendations that, in OIG’s view, would most positively affect HHS programs in terms of cost savings, public health and safety, and program effectiveness and efficiency, if implemented.”

The CMS noted in a related Fact Sheet (link) to the Final Rule that among other things, this “rule finalizes modifications to the ESRD Treatment Choices (ETC) Model policies to encourage certain health care providers to decrease disparities in rates of home dialysis and kidney transplants among ESR patients with lower socioeconomic status. This makes the model one of the agency’s first CMS Innovation Center models to directly address health equity.”

November 3, 2021: CMS Appropriate Use Criteria (AUC) Program Update

The CMS has updated the AUC Program webpage with the following notice: “The EDUCATIONAL AND OPERATIONS TESTING PERIOD for the AUC Program has been extended beyond CY 2021. There are no payment consequences associated with the AUC program during the Educational and Operations Testing Period. We encourage stakeholders to use this period to learn, test and prepare for the AUC program. The payment penalty phase will begin on the later of January 1, 2023 or the January 1 that follows the declared end of the public health emergency (PHE) for COVID-19. For more information please review the CY 2022 Physician Fee Schedule Final Rule: (link) see pp. 661-716.”

November 10, 2021: Automatic Exception Policy for MIPS Individual Physicians

CMS announced they will be applying an automatic extreme and uncontrollable circumstances (EUC) policy to all individual Merit-based Incentive Payment System (MIPS) eligible clinicians for the 2021 MIPS performance year. A QPP COVID-19 Response Fact Sheet is available on the CMS Quality Payment Program webpage (link).

November 12, 2021: CMS Fact Sheet Medicare Parts A & B Premiums and Deductibles for 2022

CMS issued a Fact Sheet (link) announcing the 2022 premiums, deductibles, and coinsurance amounts for the Medicare Part A and Part B programs, and the 2022 Medicare Part D income-related monthly adjustment amounts. CMS notes that the increases in part are due to the uncertainty regarding the potential use of the new Alzheimer’s drug, Aduhelm™ which costs $56,000 per person, per year.

November 12, 2021: Nursing Home Visitation Guidance during the COVID-19 PHE Revised & COVID-19 Survey Activities

CMS published a revised memorandum regarding nursing home visitation and COVID-19 (link). Specifically, the following statement has been added to the memorandum summary, “visitation is now allowed for all residents at all times.” While noting that current nursing home COVID-19 data shows approximately 86% of residents and 74% of staff after fully vaccinated, CMS continues to emphasize the importance of maintaining infection prevention practices.

CMS also published a second memo, Changes to COVID-19 Survey Activities which includes steps to assist State Survey Agencies (SAs) to address the backlog of facility complaint and recertification surveys. You can read about both memos in a related CMS News Alert (link).

November 19, 2021: COVID-19 Booster Shots Expanded to All Adults

The FDA announced (link) an amended the emergency use authorization (EUA) for the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccinations.

Medicare MLN Articles & Transmittals – Recurring Updates

Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) PPS Changes

• Article Release Date: October 27, 2021
• What You Need to Know: This article provides highlights to changes in the FY 2022 IPPS Final Rule.
• MLN MM12373: (link)

New Waived Tests

• Article Release Date: November 1, 2021
• What You Need to Know: This article provides information about CLIA requirements, new CLIA waived tests approved by the FDA and the use of modifier QW for CLIA-waived tests.
• MLN MM12504: (link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – April 2022 (CR 1 of 2)

• Article Release Date: November 1, 2021
• What You Need to Know: This article highlights updates to NCDs. The implementation date for updates is November 23, 2021, and the effective date is April 1, 2022.
• MLN MM12480: (link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – April 2022 (CR 2 of 2)

• Article Release Date: November 1, 2021
• What You Need to Know: This article highlights updates to NCDs. The implementation date for the updates is December 2, 2021, and the effective date April 1, 2022.
• MLN MM12482: (link)

2022 Annual Update to the Therapy Code List

• Article Release Date: November 12, 2021
• What You Need to Know: 5 CPT codes have been added to this list for CY 2022. This article details some of the requirements for using these codes.
• MLN MM12446: (link)

The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year (FY) 2019 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals (LTCHs)

• Article Release Date: November 16, 2021
• What You Need to Know: You will find information about updated data available that decides the Disproportionate Share (DSN) adjustments for IPPS Hospitals, Low-Income Patient (LIP) for IRFs and payments for LTCH discharges.
• MLN MM12516: (link)

Summary of Policies in the Calendar Year (CY) 2022 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, CT Modifier Reduction List, and Preventive Services List

• Article Release Date: November 17, 2021
• What You Need to Know: This article summarizes policies in the CY 2022 MPFS.
• MLN MM12519: (link)

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update

• Article Release Date: November 18, 2021
• What You Need to Know: Make sure your billing staff know about the latest updates to the code sets, what you must do if you use MREP or PC Print and where to find the official code lists.
• MLN MM12478: (link)

Revised Medicare MLN Articles & Transmittals

Skilled Nursing Facility (SNF) Claims Processing Updates

• Article Release Date: Initial article August 11, 2021 – Revised November 5, 2021
• What You Need to Know: This article was updated to add guidance regarding an emergency room claim falling within a covered SNF Part A or Swing Bed Stay.
• MLN MM12344: (link)

Medicare Part B CLFS: Revised Information for Laboratories on Collecting & Reporting Data for the Private Payor Rate-Based Payment System

• Article Release Date: Initial article February 27, 2019 – most recent revision November 4, 2021
• What You Need to Know: This article was updated to note that for CDLTs that are not ADLTs, the data reporting is delayed by one year and includes information about the Online Data Collection System.
• MLN SE19006: (link)

Did You Know?

• Lung cancer is the third most common cancer and the leading cause of cancer deaths in the United States,
• In 2021, the National Cancer Institute (NCI) estimated that the number of new lung cancer cases is over 235,000, with a median age at diagnosis of 71 years; and
• Cancer of the lung and bronchus accounted for over 130,000 deaths in 2021 (more than the total number of estimated deaths from colon, breast and prostate cancer combined), with a median age at death of 72 years.
Source: CMS Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) Proposed Decision Memorandum (CAG-00439R)

According to the CDC’s Lung Cancer Awareness webpage (link):

• Lung Cancer is the leading cause of cancer death among both men and women in the United States, and
• Different people have different symptoms for lung cancer. Most people do not have symptoms until the cancer is advanced.

Why Should You Care?

You can be your own advocate to lower your lung cancer risks:

• If you smoke, quit!
• Stay away from secondhand smoke,
• Get your house tested for Radon,
• If appropriate, get screened for Lung Cancer with LDCT.

Lung cancer screening with LDCT is a covered Medicare Preventive Service and is covered annually with no copayment, coinsurance, or deductible when you meet the Medicare coverage requirements (link).

On November 17, 2021, the CMS posted proposed National Coverage Determination (NCD) and Decision Memorandum (CAG-00439R) (link) for NCD 210.14 Screening for Lung Cancer with Low Dose Computed Tomography (LDCT).

Beneficiary Eligibility criteria:
Proposed changes to the eligibility criteria include expanding the age eligibility from 55 to 50 years and decreasing the tobacco smoking history in pack-years from thirty pack-years to twenty pack years.

Counseling and Shared Decision-Making Visit
Before a beneficiary’s first LDCT screening, the beneficiary must receive a counseling and shared decision-making visit meeting all criteria outlined in the Proposed Decision Memo.

CMS is proposing “to remove the specificity regarding the type of provider who must furnish the counseling and shared decision-making…we do not believe there is an evidentiary reason to continue to limit the shared decision-making visit to physician and non-physician practitioners. We note that this expansion can allow for this service to be furnished “incident to” a physician’s professional service. Removing the specification for the type of practitioner should expand the individuals that can conduct shared decision-making to other health care practitioners, such as health educators and others beyond physicians or non-physician practitioners. This proposed change may broaden access to LDCT screening.”

Reading Radiologist Eligibility Criteria :
CMS notes that the proposed Decision Memo “reduces the eligibility criteria for the reading radiologist and removes the radiology imaging facility eligibility criteria (including removes the requirement that facilities participate in a registry).”

What Can You Do?

As a healthcare provider, be familiar with the Medicare coverage requirements and as a healthcare consumer, you can visit the CDC’s Lung Cancer Awareness webpage (link) to learn about ways to lower your lung cancer risk, take a lung cancer screening quiz, and identify if you are an appropriate candidate for screening with LDCT.

Did You Know?

In response to the COVID-19 Public Health Emergency, the CMS has published several Interim Final Rules with comment period (IFC). Included in the April 6, 2020 IFC, (https://www.govinfo.gov/content/pkg/FR-2020-04-06/pdf/2020-06990.pdf), with respect to pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, CMS adopted a change, “to specify that direct supervision for these services includes virtual presence through audio/video real-time communications technology when use of such technology is indicated to reduce exposure risks for the beneficiary or health care provider.”

The CY 2021 OPPS Final Rule finalized maintaining this policy change being until the end of the PHE or December 31, 2021, whichever is later. The PHE was renewed on October 15, 2021, meaning this change will remain in place at least through January 13, 2022.

CMS again references this policy change in the CY 2022 OPPS Final Rule (https://public-inspection.federalregister.gov/2021-24011.pdf), noting, “the required direct physician supervision can be provided through virtual presence using audio/video real-time communications technology (excluding audio-only) subject to the clinical judgment of the supervising practitioner.”

Why This Matters?

With the recent release of the CY 2022 OPPS/ASC final rule, MMP has had clients ask if CMS will make this option for audio/video real-time physician supervision for these rehabilitation services permanent. Specific to this question, I have listed a few comments by the CMS in the CY 2022 OPPS/ASC final rule:

• Commentors are in favor of adoption of direct supervision via two-way, audio/video communication technology on a permanent basis, or if the decision is made to end this flexibility, they encourage CMS to maintain this policy for a period following the COIVD-19 PHE, such as the end of 2022.
• Most commentors were in favor of developing a service-level modifier to allow CMS to track and collect data.
• Based on public comments, and feedback since the policy was implemented, CMS is convinced “that we need more information on the issues involved with direct supervision through virtual presence before implementing this policy permanently.”

Whether or not this policy becomes permanent, facilities providing cardiac rehabilitation services need to be aware of and compliant with coverage requirements for a couple of reasons. First, this continues to be an area of focus for Medicare review contractors. Second, given that according to the CDC ( https://www.cdc.gov/heartdisease/facts.htm), heart disease costs the United States about $363 billion each year from 2016 to 2017, cardiac rehabilitation is big business. You can read more about how cardiac rehabilitation can help heal your heart on the CDC website (https://www.cdc.gov/heartdisease/cardiac_rehabilitation.htm).

So, just how big of a business is cardiac rehabilitation? To answer this question, I turned to RealTime Medicare Data (RTMD). Specifically, volume and paid claims data below represent Medicare Fee-for-Service outpatient hospital claims in the entire RTMD footprint for calendar years 2019 and 2020 for cardiac rehabilitation CPT codes 93798 (outpatient cardiac rehab with continuous ECG monitoring) and 93979 (outpatient cardiac rehab without continuous ECG monitoring).

CY 2019	Procedure Volume	% Of Procedure Volume	Sum of Paid Claims
CPT 93798	3,718,721	94.00%	$307,007,481.00
CPT 93797	239,673	6.00%	$19,584,844.68
Combined	3,958,394	100.00%	$326,592,325.68

CY 2019 Top 5 States by Procedure Volume

• Florida (292,461)
• Texas (287,575)
• California (229,235)
• Illinois (186,899), and
• Pennsylvania (164,897)

CY 2020	Procedure Volume	% Of Procedure Volume	Sum of Paid Claims
CPT 93798	2,290,837	94.00%	$178,236,580.99
CPT 93797	150,097	6.00%	$11,486,994.57
Combined	2,440,934	100.00%	$189,723,575.56

CY 2020 Top 5 States by Procedure Volume

• Florida (182,865),
• Texas (180,179),
• California (131,190),
• Illinois (120,897), and
• Pennsylvania (105,882)

Even though the COVID-19 PHE had an impact on procedure volume and sum of paid claims, collectively across the country, Medicare payment for cardiac rehabilitation is big business.

What Can You Do?

• Be aware of documentation needed to support medical necessity of the services provided,
• Submit medical record requests to the Medicare Contractor in a timely manner, and
• Read a related article in this week’s newsletter to learn who is currently targeting Cardiac Rehabilitation and what coverage documents and education resources are available by CMS and Medicare Contractors.

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. This month’s focus is on cardiac rehabilitation.

Did You Know?

Cardiac Rehabilitation (CR) and Intensive Cardiac rehabilitation (ICR) Defined

• CR means a physician-supervised program that furnishes physician prescribed exercise; cardiac risk factor modification, including education, counseling, and behavioral intervention; psychosocial assessment; and outcomes assessment.
• ICR program means a physician-supervised program that furnishes CR and has shown, in peer-reviewed published research, that it improves patients’ cardiovascular disease through specific outcome measurements described in 42 CFR 410.49(c).

Timeline to Medicare Coverage of CR and ICR

• 2008: The Medicare Improvements for Patients and Providers Act of 2008 amended the Act to establish coverage for CR, ICR and pulmonary rehabilitation.
• 2010: The CMS implemented provisions for the three rehabilitation services in the CY 2010 Physician Fee Schedule (PFS) final rule.
• 2014: National Coverage Determination (NCD) 20.10.1 expanded CR coverage to beneficiaries with stable, chronic heart failure
• 2018: Bipartisan Budget Act (BBA of 2018) expanded covered indications for ICR to include beneficiaries with stable, chronic heart failure.
• 2020: CY 2020 PFS final rule updated 42 CFR 410.49 to codify the expansion of coverage.
• March 2021: CMS updated sub-regulatory guidance regarding coverage requirements for outpatient CR to reflect the regulatory text more closely and published an MLN Fact Sheet.

Medicare Review Contractor Activities

Recovery Auditors: On January 8, 2019, CMS approved Issue 0135 (Cardiac Rehabilitation: Medical Necessity and Documentation Requirements). By March of 2019, all four RAC regions had added this issue to their list of complex medical record reviews for outpatient hospital claims.

Medicare Administrative Contractors (MACs): In 2021, three MACs have been performing post-payment reviews of CR and includes

• CGS (J15) has published review results for claims from Ohio with dates of service from January through March 2021. The claims error rate was 64.7%.
• NGS (J6) has published review results of claims with dates of service from January 1, 2019, through February 29, 2020. The claims error rate was 51.18%.
• NGS (JK) posted notice of a service specific post payment review of cardiac rehab on May 26, 2021. The primary focus is to determine whether the medical necessity of the services billed is at the correct code per Medicare guidelines.

Office of Inspector General (OIG): In May 2021, the OIG Published a report titled CMS Needs to Strengthen Regulatory Requirements for Medicare Part B Outpatient Cardiac and Pulmonary Rehabilitation Services to Ensure Providers Fully Meet Coverage Requirements (link).

The OIG reviewed the third highest-paid provider in the country in combined Medicare reimbursement for outpatient cardiac and pulmonary rehabilitation services. The audit period was from April 2016 through March 2018 and covered just over $2.7M in Medicare payments representing 26,408 beneficiary days of rehabilitation services.

As the audit progressed, the focus shifted from the provider to CMS. This occurred due to the OIG noting that “we found that although the provider generally complied with Medicare coverage requirements, it did not meet the intent of the requirements. Therefore, we determined that the larger issue was whether CMS’s regulatory requirements were sufficient to ensure providers complied with the intent of the Medicare coverage requirements.”

Based on their findings, the OIG believes that Medicare payments made by CMS to all providers for outpatient cardiac and pulmonary rehabilitation services during the audit period may not have met requirements. They recommended that CMS revise its regulations to provide sufficient guidance to ensure that providers meet coverage requirements for these services.

In their response, CMS noted that in March 2021 they updated sub-regulatory guidance within the Medicare Benefit Policy Manual and Medicare Claims Processing Manual regarding coverage requirements to reflect the regulatory text more closely. CMS also noted they will take the OIG recommendation into consideration when determining next steps regarding the regulations for these rehabilitation services.

P.A.R. Pro Tips: Cardiac Rehabilitation Provider Outreach and Education Efforts )

Both CMS and the MACs have made available several resource documents related to outpatient cardiac rehabilitation services.

CMS

• March 2021 MLN Fact Sheet: Overview of the Conditions of Coverage for Medicare Part B Outpatient Cardiac Rehabilitation Services (link).
• March 24, 2021, Transmittals updating Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Program Manual Sections
• R10573CP (link)
• R10573BP (link)

CGS (J15 MAC)

• CGS Article: Cardiac Rehabilitation: Coverage and Documentation requirements (link)
• Cardiac Rehab with Continuous ECG Monitoring ADR checklist (link)

NGS (J6 and JK MAC))

• NGS Article: Reminder for Billing Cardiac Rehabilitation Session and Session Limitations (link)

Noridian (JE and JF MAC)

• Noridian has published outpatient CR local coverage article (LCA) for JE (A54068) and JF (A54070).
• Noridian has a dedicated webpage on their website titled Cardiac and Pulmonary Rehabilitation Programs (link).

Novitas Solutions (JH and JL MAC)

• Novitas has published LCA A55758.
• Noridian recently published a September 15, 2021 Ask the Contractor (ACT) Q&A document (link). Question four is about cardiac the KX modifier and Cardiac Rehab.

Palmetto GBA (JJ and JM MAC) )

• Palmetto GBA has published LCA A53775.
• On October 28, 2021, Palmetto GBA published a CR: Coverage Criteria & Documentation Requirements Module (link).

What Can You Do?

• Become familiar with indications for CR/ICR & Medicare documentation requirements,
• Submit medical record requests to the Medicare Contractor in a timely manner, and
• Read a related article in this week’s newsletter to learn the temporary direct supervision policy change due to the COVID-19 PHE and paid claims amounts paid to providers by CMS in CY’s 2019 and 2020 for CR/ICR services.

It has been a while since we have published an article solely focused on COVID-19 issues. However, November has been a busy month related to COVID-19 vaccines, Medicare Contractor COVID-19 specific audits, telehealth, and a shift in treatment payment from Medicare Fee-for-Service to Medicare Advantage Plans for their enrollees. As we have reiterated so often since the beginning of the COVID-19 Public Health Emergency (PHE), MMP is thankful to all front-line workers who have and continue to provide care to patients diagnosed with COVID-19 and emotional support to their families.

October 29, 2021: FDA Authorizes COVID-19 Vaccine for Emergency Use for Children

The FDA announced (link) emergency use authorization for Pfizer-BioNTech COVID-19 Vaccines for children 5 to 11 years of age. The announcement includes key points for parents and caregivers. For example, “Safety: The vaccine’s safety was studied in approximately 3,100 children ages 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.”

CMS including the following information related to vaccinations for children in the Thursday, November 4th edition of MLN Connects (link):

CMS now covers the Pfizer-BioNTech COVID-19 Vaccine for children ages 5 – 11. Health care providers and other entities administering COVID-19 vaccines:

• Must provide vaccines regardless of the patient’s health coverage
• Cannot charge patients for the vaccine or administering it, including deductibles and coinsurance

More Information:

• CDC COVID-19 Vaccination Program Provider Requirements and Support (link)
• CMS COVID-19 Provider Toolkit (link)
• CMS Press Release (link)

October 29, 2021: Supplemental Medical Review Contractor (Noridian) Posts New Project: Audio Only Telehealth Services During the PHE

The CMS released this Final Rule and notes in a related Fact Sheet (link) this final rule “would accelerate the shift from paying for Medicare home health services based on volume to a system that pays for value.” CMS finalized making permanent current blanket waivers related to home health aide supervision and the use of telecommunications in conducting assessment visits that are currently in place due to the COVID-19 public health emergency. The CMS does note that “while we are finalizing the limited use of telecommunications technology when performing the 14-day supervisory visit requirement when a patient is receiving skilled services, we expect that in most instances, the HHAs would plan to conduct the 14-day supervisory assessment during an on-site, in person visit, and that the HHA would use interactive telecommunications systems option only for unplanned occurrences that would otherwise interrupt scheduled in-person visits.”

November 4, 2021: MA Plans to Begin Payment for COVID-19 Vaccine and Monoclonal Antibody Products

CMS announced (link) that effective for dates of service on or after January 1, 2022, Original Medicare will no longer being paying claims for COVID-19 vaccination and monoclonal antibody products for beneficiaries enrolled in a Medicare Advantage (MA) Plan. Providers will need to submit claims to the MA Plan. More information is available on the following CMS webpages:

• Medicare Billing for COVID-19 Vaccine Shot Administration (link)
• Monoclonal Antibody COVID-19 Infusion (link)

November 4, 2021: Supplemental Medical Review Contractor (Noridian) Project 01-043 DRG COVID 20% Add-On Payment Review Results Posted

The SMRC posted review results of claims related to the add-on payment for COVID-19 (link). Claims reviewed were for dates of service from April 1, 2020, through August 30, 2020, and the denial rate was 1%. Noteworthy is the fact that as of September 1, 2020, CMS requires that claims eligible for the 20 percent increase in the MS-DRG weighting factor have a positive COVID-19 lab test documented in the record. While the SMRC review results were low, I believe that this may remain a review focus by the SMRC or another Medicare review contractor for claims on or after September 1, 2020.

November 5, 2021: Medicare and Medicaid Programs; Omnibus COVID-19 health Care Staff Vaccination Interim Final Rule with Comment Period

November 5, 2021, The effective date for this Interim Final Rule with Comment Period (IFC) (link) is November 5, 2021. Along with the IFC, CMS has published the following related resources:

• CMS Press Release: (link)
• CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule: (link)
• Slides and Video from National Stakeholder Call are available on the CMS Current Emergencies COVID-19 webpage: (link)

The CMS released the Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule on November 2, 2021. In a related Fact Sheet (link), they note that this Final Rule “includes policies that align with several key goals of the Administration, including addressing the health equity gap, fighting the COVID-19 Public Health Emergency (PHE), encouraging transparency in the health system, and promoting safe, effective, and patient-centered care.”

CMS estimates “that the OPPS expenditures, including beneficiary cost-sharing, for CY 2022 would be approximately $82.1 billion, which is approximately $5.9 billion higher than estimated OPPS expenditures in CY 2021.”

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

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

CMS noted in the Proposed Rule, “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.”

After reviewing recommendations made by commentors, CMS finalized the removal of 255 of the 258 codes proposed from the ASC CPL. Table 62 in the Final Rule includes the complete list of 255 procedures.

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 finalized their proposal to revise the requirements for covered surgical procedures to reinstate the general standards and exclusion criteria established prior to CY 2021.

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 services are performed.

Hospital Price Transparency Increase in Civil Monetary Penalties

CMS noted in the Proposed Rule from initial months of experience with enforcing the hospital price transparency requirements that they expressed “concern by what appears to be a trend towards a high rate of hospital noncompliance identified by CMS through sampling and reviews to date.” One approach to address this trend was their proposal to impose potentially higher penalties and “to scale the CMP to ensure the penalty amount would be more relevant to the characteristics of the noncompliant hospital.”

CMS agrees with commenters in the Final Rule “that application of a scaling approach using bed count would be an effective way to ensure compliance, consistency and fairness in application of penalties across noncompliant hospitals” and finalized their proposal as follows:

• Hospitals with a bed count ≤ 30 will have a minimum Civil Monetary Penalty (CMP) of $300 per day or $109,500 for a full CY of noncompliance,
• Hospitals with at least thirty-one beds up to and including 550 beds will have a penalty of $10 per bed per day or a range from $113,150 to $2,007,500 penalty for a full CY of noncompliance depending on bed size, and
• Hospitals with greater than 550 beds will have a daily dollar penalty of $5,500 or $2,007,500 for a full CY of noncompliance.

Learn about changes to the Inpatient Only (IPO) by clicking here.

Resource

CY 2022 OPPS Final Rule CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-oppsasc-final-rule-increases-price-transparency-patient-safety-and-access-quality-care

The CMS released the Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule on November 2, 2021. This article focuses on changes to the Inpatient Only (IPO) List and medical review of claims. Click here for an article reviewing changes to the ASC covered procedure list and hospital price transparency civil monetary penalties.

CMS reminds providers that “The removal of a service from the IPO list does not require the service to be performed only on an outpatient basis…we reiterate that services that are removed from the IPO list can be and are performed on individuals who are admitted as inpatients (as well as individuals who are registered hospital outpatients) when the patient’s condition warrants inpatient admission (65 FR 18456). It is a misinterpretation of CMS payment policy for providers to create policies or guidelines that establish the hospital outpatient setting as the baseline or default site of service for a procedure based on its removal from the IPO list. As stated in previous rulemaking, services that are no longer included on the IPO list are payable in either the inpatient or hospital outpatient setting subject to the general coverage rules requiring that any procedure be reasonable and necessary, and payment should be made pursuant to the otherwise applicable payment policies (84 FR 61354; 82 FR 59384; 81 FR 79697).”

Criteria used prior to CY 2021 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 CY 2021, CMS removed 298 musculoskeletal-related services from the IPO List and finalized the elimination of the list over three years. For CY 2022, CMS has done a one-eighty and finalized the following changes:

• The IPO list is not being eliminated,
• A reference of phasing out the IPO list through a 3-year transition has been removed,
• The five longstanding criteria for determining whether a service or procedure should be removed from the IPO list is being codified in regulation text, and
• Most of the procedures removed from the IPO list in CY 2021 are being added back to the list.

Commenters believed a few codes should not be added back to the IPO list and CMS agreed. CPT codes not being added back to the IPO list includes:

• CPT 22630: Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar,
• CPT 23472: Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (for example, total shoulder),
• CPT 27702: Arthroplasty, ankle; with implant (total ankle) and corresponding anesthesia codes:
• CPT 01638: Anesthesia for open or surgical arthroscopic procedures on humeral head and neck, sternoclavicular joint, acromioclavicular joint, and shoulder joint; total shoulder replacement, and
• CPT 01486: Anesthesia for open procedures on bones of lower leg, ankle, and foot; total ankle replacement

AccuCinch Device: New Inpatient Only Procedure

For the July 2021 update, the AMA’s CPT Editorial Panel established CPT code 0643T (Transcatheter left ventricular restoration device implantation including right and left heart catheterization and left ventriculography when performed, arterial approach) to describe the AccuCinch device implantation procedure.

CMS proposed to assign this code to status indicator (SI) “E1” (Items, codes, and services not covered by any Medicare outpatient benefit category; statutorily excluded; not reasonable and necessary) to indicate the service is not covered by Medicare.

A commenter requested the code be reassigned the inpatient-only SI “C,” believing “this is the more appropriate assignment for the ventricular restoration therapy based on the complex patient population enrolled in the US clinical trial. The commenter explained that the investigational device, the AccuCinch® Ventricular Restoration System, is currently under evaluation in the CORCINCH-HF pivotal trial (NCT04331769).”

CMS noting that “Based on the interventional structural heart (SH) technique involved in the procedure, use of an experimental device, and close monitoring of the patient that is required during the intra- and post-op period consistent with the resources available in the hospital inpatient setting, we believe the AccuCinch procedure should be designated as an inpatient-only procedure. We note that the CORCINCH-HF pivotal trial (NCT04331769) was approved by Medicare and meet’s CMS’ standards for coverage as an Investigation Device Exemption (IDE) study effective November 11, 2020.”

CMS finalized change the SI “E1” to “C” for CPT code 0643T.

Information about this procedure is available on the Ancora Heart, Inc. website at https://www.ancoraheart.com/ and information about the clinical trial at https://clinicaltrials.gov/ct2/show/NCT04331769.

Table 48 of the Final Rule lists changes made to the IPO list for CY 2022. Addendum E to this Final Rule includes all inpatient only procedure codes for CY 2022.

Medical Review of Certain Inpatient Hospital Admissions

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-Midnight rule, and RAC reviews for “patient status” (that is, site-of-service).” This exemption was to remain in place until Medicare claims data showed a procedure was performed more than 50 percent of the time in the outpatient setting.

For CY 2022, CMS finalized the proposal 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 based on a National or Local Coverage Determinations (NCDs and LCDs) when applicable. Once a surgical procedure has been removed from the IPO List, documentation in the record must support the need for the inpatient admission.

Resources

CY 2022 OPPS Final Rule

• CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-oppsasc-final-rule-increases-price-transparency-patient-safety-and-access-quality-care
• CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cy-2022-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0