Knowledge Base Category -

Medicare MLN Articles & Transmittals – Recurring Updates

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

• Article Release Date: April 27, 2021
• What You Need to Know: This article includes quarterly updates effective July 1, 2021 for ASP and Not Otherwise Classified (NOC) drug pricing files for Medicare Part B drugs.
• MLN MM12244: (link)

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – July 2021

• Article Release Date: May 18, 2021
• What You Need to Know: You will find information about updated ICD-10 conversions and coding updates specific to NCDs as a result of newly available code, coding revisions to NCDs released separately and coding feedback received.
• MLN MM12124: (link)

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – July 2021 Update

• Article Release Date: May 21, 2021
• What You Need to Know: July 2021 updates to the 2021 MPFS are detailed in this MLN article.
• MLN MM12289: (link)

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

• Article Release Date: May 21, 2021
• What You Need to Know: MACs perform updates to the RARC and CARC based on the code update schedule and occur around March 1, July 1, and November 1.
• MLN MM12220: (link)

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

• Change Request Release Date: May 21, 2021
• What You Need to Know: This recurring transmittal is a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. Two NCDs specific to this update are NCD 30.3.3 Acupuncture for Chronic Low-Back Pain (cLBP), and NCD 20.33 Transcatheter Mitral Valve Repair/Transcatheter Edge-to-Edge Repair (TMVR/TEER).
• Change Request (CR) 12279: (link)

Other Medicare MLN Articles & Transmittals

New Waived Tests

• Article Release Date: April 27, 2021
• What You Need to Know: This article highlights newly FDA approved Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests.
• MLN MM12204: (link)

Waiver of Coinsurance and Deductible for Hepatitis B Preventive Service Vaccine Code, Section 4104 of the Patient Protection and Affordable Health Care Act (the Affordable Care Act), Removal of Barriers to Preventive Services in Medicare

• Article Release Date: May 11, 2021
• What You Need to Know: The Hepatitis B vaccine (HCPCS 90739) has been added to the preventive services recommended by the U.S. Preventive Services Task Force. Consequently, coinsurance and deductibles won’t apply for this code. Medicare will make a reasonable cost reimbursement for Types of Bill (TOB) 012X, 013X, 022X, and 034X.
• MLN MM12230: (link)

Addition of the Shared System CWF to the Business Requirements for the Healthcare Common Procedure Coding System (HCPCS) Codes U0002QW and 87635QW Mentioned in Change Request 11765

• Article Release Date: May 20, 2021
• What You Need to Know: For labs billing MACs for COVID-19 testing services, this article informs you about a revision to CR 11765 that requires changes to Medicare Common Working File (CWF) for:
• o HCPCS U0002QW [2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC], and
• o 87635 [Infectious agent detection by nucleic acid (DNC or RNA0; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique].
• MLN MM12294: (link)

Other Medicare Updates

New CMS Hospital Star Ratings

On April 28th, CMS updated the Hospital Compare Overall Hospital Quality Ratings (link). Hospital specific scores are based on performance for 5 measure groups (Mortality, Safety of Care, Readmission, Patient Experience and Timely & Effective Care). April 2021 results:

• 455 hospitals received the highest rating of 5 stars,
• 1,018 hospitals received 3 stars, and
• 204 hospitals received a 1 star rating.

Clinical Diagnostic Laboratory Resources about the Private Payor Rate-Based CLFS

CMS posted the following information in the Thursday April 29, 2021 edition of MLN Connects (link): “If you’re a laboratory, including an independent laboratory, a physician office laboratory, or hospital outreach laboratory that meets the definition of an applicable laboratory under the Clinical Laboratory Fee Schedule (CLFS), you must report information, including laboratory test HCPCS codes, associated private payor rates, and volume data.” You can find links to updated resources and the data collection and reporting timeline in the MLN Connects post.

April 29, 2021: CJR Three-Year Extension Final Rule

CMS released the Comprehensive Care for Joint Replacement Model Final Rule which extends the model through December 31, 2021 by adding an additional 3 performance years (PYs). This final rule also revises the episode of care definition, the target price calculation, the reconciliation process, the beneficiary notice requirements and the appeals process. The episode of care definition was revised to include outpatient Total Knee and Total Hip Arthroplasty (TKA/THA) procedures. You can read more about this Model on the CJR CMS webpage (link).

May 7, 2021: Advance Copy of Hospital Interpretive Guidelines for Admission, Discharge and Transfer Notification Requirements

CMS issued a memorandum (link) to State Survey Agency Directors providing an advance copy of the hospital interpretive guidelines for the admission, discharge, and transfer notification requirements outlined in the Interoperability and Patient Access final rule. This guidance is for Hospitals, Psychiatric Hospitals and Critical Access Hospitals and it will also be published in an updated Appendix A of the State Operations Manual.

May 2021: United Healthcare Sepsis Claims Review Change Effective July 1, 2021

While this article focuses on Medicare updates, I believe it is important for Clinical Documentation Integrity Specialists and Utilization Review staff to be aware of this notice. United Healthcare (UHC) has announced (link) that “effective July 1, 2021, Medicare Advantage and commercial claims for sepsis-related treatment may be reviewed on a pre-payment or post payment basis.” UHC will use their Sepsis Clinical Guidelines which includes using Sepsis-3.

May 10, 2021: University of Miami to Pay $22 Million to Settle Claims Involving Medically Unnecessary Laboratory Tests and Fraudulent Billing Practices

This Department of Justice release (link) indicates that the University of Miami (UM):

• Knowingly engaged in improper billing relating to its Hospital Facilities,
• Billed federal health care programs for medically unnecessary laboratory tests for patients who received kidney transplants at the Miami Transplant Institute (MTI) – a transplant program operate by UM and Jackson Memorial Hospital (JMH) and
• Caused JMH to submit inflated claims for reimbursement for pre-transplant laboratory testing conducted at the MTI.

This settlement resolves allegations made in three lawsuits filed under the qui tam (whistleblower) provisions of the False Claims Act.

May 18, 2021: CMS Delays Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule

MMP first wrote about this Proposed Rule in October 2020 (link). CMS published a notice further delaying this final rule until December 15, 2021 (link). They note this additional time provides “an opportunity to address all of the issues raised by stakeholders, especially Medicare patient protections, evidence criteria and lack of coordination between coverage, coding and payment.”

Medicare Coverage Updates

May 18, 2021: CMS Initiates National Coverage Analysis for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

• Coverage Analysis Issue: The United States Preventive Services Task Force (USPSTF) recently published an updated recommendation for certain persons at high risk for lung cancer based on age and smoking history for screening for lung cancer with LDCT.
• CMS Actions: CMS received a complete, formal request to reconsider the National Coverage Determination 210.14 and are soliciting public comment. The public comment period ends on June 17, 2021.
• Resources
• March 9, 2021 USPSTF Lung Cancer Screening Recommendation Statement: (link)
• Coverage Analysis (CAG-00439R): (link)
• NCD 210.14: (link)

National Coverage Determination (NCD) Removal

• Article Release Date: May 24, 2021
• What You Need to Know: 6 NCDs are being removed from the NCD Manual based on rulemaking in the Calendar Year 2021 Medicare Physician Fee Schedule.
• NCD 20.5 Extracorporeal Immunoadsorption (ECI) Using Protein A Columns,
• NCD 20.5 Extracorporeal Immunoadsorption (ECI) Using Protein A Columns,
• NCD 100.9 Implantation of Gastrointestinal Reflux Devices,
• NCD 110.19 Abarelix for the Treatment of Prostate Cancer,
• NCD 220.2.1 Magnetic Resonance Spectroscopy, and
• NCD 220.6.16 FDG PET for Inflammation and Infection.
• MLN MM12254: (link)

National Coverage Determination (NCD 110.24) Chimeric Antigen Receptor (CAR) T-cell Therapy

• Article Release Date: May 24, 2021
• What You Need to Know: Effective for claims with dates of service on or after August 7, 2019, CMS covers autologous treatment for cancer with T-cells expressing at least 1 CAR when administered at healthcare facilities:
• MLN MM12177: (link)

National Coverage Determination (NCD) 210.3 – Screening for Colorectal Cancer (CRC) – Blood-Based Biomarker Tests

• Article Release Date: May 26, 2021
• What You Need to Know: Effective January 19, 2021, CMS determined that the blood-based biomarker test is an appropriate CRC screening test once every three years for Medicare patients when performed in a CLIA certified lab, ordered by a treating physician, and the patient is:
• Aged 50-85 years, and
• Asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test, or fecal immunochemical test); and, • At average risk of developing CRC (no personal history of adenomatous polyps, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of CRCs or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis CRC).
• MLN MM12280: (link)

Medicare Educational Resources

Revised MLN Booklet: Behavioral Health Integration Services

CMS issued a revised version of this MLN Booklet (link) to add CY 2021 MPFS Final Rule CMS-1734-F Updates and add new HCPCS code G2214 (Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional).

Revised MLN Booklet: Medicare Mental Health

CMS issued a revised version of this MLN Booklet (link) to include a new outpatient psychiatric services medical records checklist, an acute care hospital section, and CPT codes updates and additions.

Revised MLN Fact Sheet: Complying with Medicare Signature Requirements

CMS issued a revised version of this MLN Fact Sheet (link) to include information about signing documentation written by a medical student.

Revised MLN Booklet: Medicare Diabetes Prevention & Diabetes Self-Management Training

CMS issued a revised version of this MLN Booklet (link) to add information about flexibilities extended in the March 1, 2020, COVID-19 Interim Final Rule and the CY 2021 Physician Fee Schedule Final Rule to all patients receiving services as of March 31, 2020. They also spotlight that in January 2020, the American Association of Diabetes Educator (AADE) changed their name to the Association of Diabetes Care & Education Specialists (ADCES).

National Osteoporosis Month

National Osteoporosis Month falls in May each year. Following is information CMS provided in their Thursday May 6th edition of MLN Connects:

“Medicare covers bone mass measurements, and your patients pay nothing if you accept assignment. During National Osteoporosis Month, talk to your Medicare patients about their risk factors and bone health.

More Information:

• Medicare Preventive Services educational tool (link)
• Preventive Services webpage (link)
• CDC Osteoporosis webpage (link)
• National Osteoporosis Foundation website (link)
• Information for your patients on bone mass measurements” (link)

MLN Booklet: Outpatient Rehabilitation Therapy Services: Complying with Documentation Requirements

The Thursday May 13, 2021 edition of the CMS e-newsletter, MLN Connects (link), included the following information related to complying with Medicare billing requirements for outpatient rehabilitation therapy services:

“An Office of Inspector General report (link) found that payments for physical therapy services didn’t comply with Medicare billing requirements. Review the Outpatient Rehabilitation Therapy Services: Complying with Documentation Requirements (PDF) (link) booklet to help you bill correctly, reduce common errors, and avoid overpayments. CMS listed additional resources in the newsletter.

April 2021 MLN Fact Sheet: Medical Record Maintenance & Access Requirements

This MLN Fact Sheet (link) provides information on updated documentation maintenance and access requirements for billing services to Medicare patients. It also includes how long providers are to keep the documentation and who is responsible for providing access.

MMP and RealTime Medicare Data (RTMD) have collaborated to highlight Health Awareness Month topics throughout the year with an infographic spotlight on Medicare Fee-for-Service (FFS) paid claims data comparatives and a related article. May is Stroke Awareness Month. The American Heart Association notes this month was created to promote public awareness and reduce the incidence of stroke in the United States. This article focuses on the National Institutes of Health Stroke Scale (NIHSS).

Did You Know?

Originally, the National Institutes of Health Stroke Scale (NIHHS) was developed to measure baseline data for patients involved in acute stroke clinical trials. In 1995, after the publication of the Trial, the NIHSS became the de facto standard for rating clinical deficits in stroke trials.*

Prior to the implementation of ICD-10-CM, there was no way for Coding Professionals to capture the NIHSS. In fact, it wasn’t until FY 2017 that coding guidance was added to the ICD-10-CM Official Guidelines for Coding and Reporting related to coding NIHSS codes (link).

Why Does this Matter?

In the FY 2018 IPPS Final Rule, CMS finalized a refinement to the Stroke 30-Day Mortality Measure (MORT-30-STK) for the FY 2023 payment determination by including the NIHSS. CMS noted in Final Rule that they had “received comments that the more rigorous risk adjustment facilitated by the NIH Stroke Scale would help ensure the measure accurately risk adjusts for different hospital populations without unfairly penalizing high-performance providers, and the NIH Stroke Scale is well validated, highly reliable, widely used by providers caring for stroke patients, and a strong predictor of mortality and short- and long-term functional outcomes. However, we were not able to test the ICD-10 CM codes for NIH Stroke Scale score in claims during measure development because those codes were not available for hospitals to use in their claims until October 2016. Therefore, we proposed this measure now to inform hospitals they should begin to include the NIH stroke severity scale codes in the claims they submit for patients with a discharge diagnosis of ischemic stroke.”

This month’s related RTMD infographic spotlights how often one of the NIHSS codes was included on Ischemic Stroke MS-DRGs 061, 062, and 063 Medicare FFS paid claims in FY 2019. Across RTMD’s Footprint, 40.1% of the claims included an NIHSS. Drilling down to the state compare, you will find a wide variance in how often the NIHSS codes are being captured.

The February 1, 2021 Update to the MORT-30-STK Measure notes that “the major revision is to include the NIH Stroke Scale as a measure of stroke severity in the risk-adjustment.”

What You Can Do About It?

Be aware that the absence of an NIHSS on your acute stroke claims can negatively impact the risk adjustment for your Hospital 30-Day Mortality Following Acute Ischemic Stroke Hospitalization Measure.

Then moving forward:

• Make sure this information is consistently being documented in your medical records, and
• Educate your Coding staff about the NIHSS and the need to ensure it is coded on all of your acute stroke cases.

Education Resource

The National Institutes of Health (NIHs) website Know Stroke (link) includes health professional specific resources related to NIHSS.

*”Using the National Institutes of Health Stroke Scale A Cautionary Tale.” Lyden, Patrick. AHA Stroke Journal, 11 Jan 2017, https://www.ahajournals.org/doi/10.1161/strokeaha.116.015434

This week, as we highlight key updates spanning from May 18h through May 24th, 2021, will be our last weekly COVID-19 update. While COVID-19 remains a serious issue, the availability of COVID-19 vaccinations and the significant decrease in new cases being reported are positive reasons to end this weekly addition to our newsletter. MMP is thankful to all front line workers who have worked tirelessly and continue to care for patient’s diagnosed with COVID-19.

Resource Spotlight: CDC Clinical Outreach Call – Underlying Medical Conditions and Severe COVID-19: Evidence-based Information for Healthcare Providers

The CDC is offering this call on Thursday May 27, 2021 from 2:00 PM – 3:00 PM ET. They note that clinicians will be updated “on the underlying medical conditions associated with severe COVID-19, describe methods used to rate the evidence linking conditions to severe COVID-19, review the evidence on risk for conditions included, and provide resources for healthcare providers caring for patients with underlying medical conditions.” If you are interested in this information but unable to attend, call materials will be posted on this CDC webpage after the call. (link)

May 17, 2021: U.S. Attorney’s Office and OIG Advise Providers Not to Charge Individuals Seeking COVID-19 Vaccines

The U.S. Department of Justice issued a notice for immediate release (link) advising the public that they should not be asked to pay to receive the COVID-19 vaccine and warned COVID-19 vaccination providers to not seek payments from people who received a vaccine.

May 19, 2021: HHS Issues Request for Information (RFI) regarding the Medical Reserve Corps (MRC) Program

The American Rescue Plan provides $100 million to the MRC Program. HHS issued an RFI (link) to “solicit specific input regarding current strengths and needs of MRC units and stakeholders, resource gaps highlighted during the COVID-19 response and recommendations for short- and long-term priorities for the MRC.

May 19, 2021: FDA Reminder – Antibody Testing Not for Assessing Immunity after COVID-19 Vaccination

The FDA issued a reminder (link) to the public and health care providers that the currently authorized antibody test should not be used to assess “immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.”

May 20, 2021: Medicare COVID-19 Data Snapshot Updated

This most recent release of Preliminary COVID-19 Data (link) includes Medicare claims and encounter data from January 1, 2020 to March 20, 2021 and were received by April 16, 2021. As of April 16, 2021 there have been 691,077 Medicare Fee-for-Service COVID-19 hospitalizations with a total Medicare payment for these hospitalizations of $16.6 billion and the average payment for a beneficiary hospitalized with COVID-19 being $24,033.

CMS issued the FY 2022 IPPS Proposed Rule (CMS-1762-IFC) on Tuesday April 27, 2021. You can find a high level review of what is being proposed in a related MMP article (link). Another article in this week’s newsletter focuses on a couple of topics in section D, Proposed Changes to Specific MS-DRG Classifications, of the Proposed Rule. Each topic synopsis includes the potential financial impact if the proposal is finalized.

This article highlights proposed O.R. designation changes for ICD-10-PCS procedure codes as well as a change finalized for FY 2021. Calculating the potential financial impact of proposals was accomplished through a collaboration with RealTime Medicare Data (RTMD). RTMD’s database currently includes Medicare Fee-for-Service paid claims data for all U.S. states and territories except Kentucky and Ohio. RTMD claims dates of service in this article includes:

• FY 2019 Medicare Fee-for-Service claims for all 48 states in RTMD’s footprint collectively, and
• Venal Cava Filter: FY 2020 Medicare Fee-for-Service paid claims as the change from an O.R. to Non-O.R. procedure was finalized in FY 2021.

O.R. and Non-O.R. Procedures Status Re-Designation

In the Acute Care Hospital Inpatient setting, discharges are assigned to one Medicare Severity Diagnosis-Related Group (MS-DRGs) for the entire hospitalization. The MS-DRG System groups together similar clinical conditions and the procedures furnished during a hospitalization.

Principal Diagnoses, MCCs (Major Complications/Comorbidities), CCs (Complications/Comorbidities) and Procedures may all impact MS-DRG assignment. Notice, I did not say will impact MS-DRG assignment. This is because there are specific MCCs, CCs and O.R. Procedures designated by CMS that will impact MS-DRG assignment and other secondary diagnoses and Non-O.R. designated procedures that won’t.

When ICD-10-CM/PCS was implemented on October 1, 2015, there were several new O.R. Procedure Codes impacting MS-DRG assignment that had Coding Professionals and CDI Specialists questioning if the resources to perform the procedures truly supported the O.R. Procedure designation. CMS soon realized this too and included proposals in the FY 2017 IPPS Proposed Rule for consideration to re-designate certain ICD-10-PCS procedures codes from O.R. Procedures to Non-O.R. Procedures as well as Non-O.R. Procedures to O.R. Procedures. CMS received requests and recommendations for over 800 procedure codes and were unable to fully evaluate and finalize comments in time for the release of the FY 2017 IPPS Final Rule. The next year, in FY 2018, they began the process of proposing and finalizing changes to ICD-10-PCS procedures codes O.R. status designation.

Since FY 2018, CMS has continued to propose and re-designate ICD-10-PCS procedure codes O.R. status designation and the FY 2022 Proposed Rule is no exception.

FY 2022 O.R. to Non-O.R. Procedures Proposal and Potential Financial Impact

• 31 specific ICD-10-PCS procedures codes have been proposed for re-designated as Non-O.R. procedures.
• In FY 2019 there were 13,714 claims paid where one of these 31 codes was the principal procedure code driving the MS-DRG assignment.
• CMS paid $220,018,645.02 to hospitals for these 13,714 claims.

When CMS first began this process in FY 2018, MMP provided our clients with a detailed accounting of their hospital specific surgical MS-DRGs claims impacted by the proposed rule and what the equivalent medical MS-DRG would be based on the medical principal diagnosis and minus the surgical procedure. What we found was that the decrease in payment from a surgical MS-DRG to a medical MS-DRG ranged from a 35% to 58% with an average decrease of 40%. Multiplying the payment for the 13,714 claims by 40% equates to a potential decrease in payment to hospitals of $88,007,458.

FY 2022 Non-O.R. Procedures to O.R. Procedures Proposal and Potential Financial Impact

• 46 specific ICD-10-PCS procedure codes have been proposed for re-designation from Non-O.R. Procedure to O.R. Procedures.
• In FY 2019 there were 3,604 medical MS-DRG claims paid that included one of the 46 codes proposed for re-designation.
• CMS paid $47,122,242.22 to hospitals for these 3,604 claims.
• Following the same logic as with O.R. to Non-O.R. procedures, adding 40% to the payment would result in an additional potential payment to hospitals of $47,122,242.22.

Vena Cava Filter ICD-10-PCS Procedure Code 06H03DZ

In FY 2018, based on feedback from one commenter, CMS did not finalize the re-designation of ICD-10-PCS code 06H03DZ (Insertion of intraluminal device, into inferior vena cava, percutaneous approach) from O.R. to a Non-O.R. procedure. However, CMS did finalize the re-designation of ICD-10-PCS procedure code 06H03DZ to a Non-O.R. procedure in the FY 2021 Final Rule.

In the FY 2022 Proposed Rule, one requestor “respectfully disagreed” with this decision. CMS notes that their clinical advisors continue to state that this change “better reflects the associated technical complexity and hospital resource use of this procedure.”

Potential Financial Impact

COVID-19 PHE had a tremendous impact on inpatient hospital utilization in 2020 and as mentioned at the start of this article, CMS has proposed to use FY 2019 data to approximate the expected FY 2022 inpatient hospital utilization. However, since this proposed change was finalized in the FY 2021 Final Rule, the potential impact below is based on FY 2020 claims provided by RTMD.

• 12,469 claims in FY 2020 included ICD-10-PCS procedure code 06H03DZ as the principal procedure code.
• Total Charges by hospitals for this group of claims was $1,773,710,236.89.
• CMS paid $343,009,156.37 to hospitals for this group of claims.
• Potential impact of this change for FY 2021 will be a decrease in payment of $343,009,156.37.

Resources

• CMS FY 2022 IPPS Proposed Rule CMS Fact Sheet:(link)
• CMS FY 2022 Proposed Rule web page: (link)

CMS issued the FY 2022 IPPS Proposed Rule (CMS-1762-IFC) on Tuesday April 27, 2021. You can find a high level review of what is being proposed in a related MMP article (link). This article focuses on two topics in section D, Proposed Changes to Specific MS-DRG Classifications, of the Proposed Rule. Each topic synopsis also includes the potential financial impact if the proposal is finalized.

In the proposed rule, CMS acknowledges the impact that the COVID-19 Public Health Emergency (PHE) had during FY 2020. Subsequently, they have proposed to use FY 2019 data to approximate the expected FY 2022 inpatient hospital utilization.

Calculating the potential financial impact of proposals was accomplished through a collaboration with RealTime Medicare Data (RTMD). RTMD’s database currently includes Medicare Fee-for-Service paid claims data for all U.S. states and territories except Kentucky and Ohio. The potential financial impacts noted in this article represent FY 2019 Medicare Fee-for-Service claims data for all 48 states in RTMD’s footprint collectively.

Type II Myocardial Infarction

“Type 2 myocardial infarction (myocardial infarction due to demand ischemia or secondary to ischemic imbalance) is assigned to code I21.A1, Myocardial infarction type 2 with the underlying cause coded first.”

Source: ICD-10-CM Official Guidelines for Coding and Reporting FY 2021 (link)

A requestor noted that when a type 2 Myocardial infarction (MI) is coded and the principal diagnosis is in MDC 5 (Diseases and Disorders of the Circulatory System), the Grouper logic assigns the MI to the following MS-DRGs:

• MS-DRGs 280, 281 & 282: Acute Myocardial Infarction, Discharged Alive with MCC, with CC, and without CC/MCC, respectively, and
• MS-DRGs 283, 284 & 285: Acute Myocardial Infection, Expired with MCC, with CC, and without CC/MCC, respectively.

The requestor asked if this Grouper logic is appropriate. Through analysis and consultation with their clinical advisors, CMS determined that the current Grouper logic is correct and no proposal for change was made.

During their analysis, CMS did note an issue with a Type 2 MI and the Grouper logic for MS-DRGs 222 and 223 (Cardiac Defibrillator Implant with Cardiac Catheterization with AMI, HF, or Shock with and without MCC, respectively). Currently, Type 2 MI is one of the listed principal diagnosis codes in the logic for this DRG pair. However, Type 2 MI as a secondary diagnosis is not recognized.

Simply put, this means that currently an encounter for a patient undergoing a cardiac defibrillator implant with cardiac catheterization and a Type 2 MI sequences to MS-DRGs 224 and 225 (Cardiac Defibrillator Implant with Cardiac Catheterization without AMI, HF, or Shock with and without MCC).

Clinical advisors recommended, and CMS is proposing to add special logic in MS-DRGs 222 and 223 “to allow cases reporting diagnosis I21.A1…as a secondary diagnosis to group to MS-DRGs 222 and 223 when reported with a listed procedure code for clinical consistency with the other MS-DRGs describing acute myocardial infarction.”

Potential Impact of Type II MI Proposal

Across the RTMD footprint, in FY 2019:

• 208 claims with a secondary diagnosis of type 2 MI grouped to MS-DRG 224 (Cardiac Defibrillator Implant with Cardiac Catheterization without AMI, HF, or Shock with MCC),
• CMS paid $10,938,624.59 to hospitals for MS-DRG 224 claims.
• In FY 2019, the national average payment for the Cardiac Defibrillator MS-DRG with AMI (MS-DRG 222), was $3,967.69 more than MS-DRG 224.
• The national average difference in payment multiplied by the volume of MS-DRG 224 claims equates to an underpayment amount to hospitals of $825,279.52.

Viral Cardiomyopathy

There are five ICD-10-CM diagnosis codes in the Viral Carditis subcategory B33.2. Currently, four of the codes are assigned to the Circulatory MDC 05:

• B33.20: Viral carditis, unspecified,

• B33.21: Viral endocarditis,
• B33.22: Viral myocarditis, and
• B33.23: Viral pericarditis.

However, the remaining code, B33.24 (Viral cardiomyopathy) is assigned to MDC 18 (Infectious and Parasitic Diseases, Systemic of Unspecified Sites). A requestor noted this “discontinuity” and stated that it would be “clinically appropriate” for all five diagnosis be assigned to MDC 05.

CMS agreed with the requestor and has proposed to reassign ICD-10-CM diagnosis code B33.24 from MDC 18 MS-DRGs 865 and 866 (Viral Illness with and without MCC, respectively) to MDC 05 in MS-DRGs 314, 315, and 316 (Other Circulatory System Diagnoses with MCC, with CC, and without CC/MCC, respectively).

Potential Impact of Viral Cardiomyopathy Proposal

In FY 2019, CMS paid sixteen claims with viral cardiomyopathy (B33.24) coded as the principal diagnosis. Specifically, CMS paid:

• $109,042.08 for 13 MS-DRG 865 (Viral Illness with MCC) claims, and
• $12,218.67 for 3 MS-DRG 866 (Viral Illness without MCC) claims.

As noted above, CMS’ proposal would move Viral cardiomyopathy from a DRG pair (MS-DRGs 865 and 866) with a two way severity split (with and without MCC) to a MS-DRG Group (MS-DRGs 314, 315, and 316) with a three way severity split (with MCC, with CC, and without CC/MCC). To estimate the financial impact, I took the conservative approach to calculate the difference in payment for the three MS-DRGs without MCC as if they also did not have a CC. Based on the national average payment, the shift in DRG assignment would equate to a net increase in payment for these sixteen claims of $34,535.43.

Note, there are several other changes being proposed, for example:

• A proposal related to surgical ablations for Atrial fibrillation (AF) to revise the surgical hierarchy in MDC 05 to sequence MS-DRGs 231-236 (Coronary Bypass) above MS-DRGs 228 and 229 to enable a more appropriate MS-DRG assignment for these cases, and
  • A proposal to add three procedure code combinations describing removal and replacement of the right knee joint that were inadvertently omitted to the MS-DRGs that the same procedure combinations currently sequence to for the left knee (MS-DRGs 461, 462, 466, 467, and 468 in MDC 08 and MS-DRGs 628, 629, and 630 in MDC 10).

    I encourage key stakeholders take the time to review the proposed rule and remember that CMS is accepting comments on the proposed rule through 5 p.m. EDT on June 28, 2021.

    Resources

    • CMS FY 2022 IPPS Proposed Rule CMS Fact Sheet:(link)
    • CMS FY 2022 Proposed Rule web page: (link)

This week we highlight key updates spanning from May 11h through May 17th, 2021.

Resource Spotlight: Happy Belated National Women’s Health Week

National Women’s Health Week was last week (May 9th – 15th). This effort is led by the U.S. Department of Health and Human Services’ Office on Women’s Health (OWH). According to a related Fact Sheet (link), this year’s week served “as a reminder for women and girls, especially during the outbreak of COVID-19, to make their health a priority and take care of themselves. It is extremely important for all women and girls, especially those with underlying health conditions, such as hypertension, diabetes, obesity, cardiovascular and respiratory conditions and older adults, to take care of your health now.” You can read more about this event on the OWH website by clicking here.

Palmetto Statement in daily newsletter:

“CMS would like to make you aware that the federally supported website (link) that makes it easier for individuals to access COVID-19 vaccines is now live. Vaccines.gov (link) — powered by the trusted VaccineFinder brand — is available in English and Spanish, with high accessibility standard, and will help connect Americans with locations offering vaccines near them. In addition to the website, people in the U.S. are also now able to utilize a text message service, available in both English and Spanish. People can text their ZIP Code to 438829 (GETVAX) and 822862 (VACUNA) to find three locations nearby that have vaccines available.

Vaccines.gov is meant to complement the number of state and pharmacy websites that have been successfully connecting many Americans with vaccinations, by providing a unified federal resource for Americans to use no matter where they are.

In addition to the website and text messaging service, the National COVID-19 Vaccination Assistance Hotline is now available to help those who prefer to get information by phone on where to get a vaccine. Call 1-800-232-0233 to find a location near you.”
Link to announcement

May 11, 2021: CMS Issues Interim Final Rule for Long Term Care Facilities

CMS announced in a Special Edition MLN Connects (link) that they have released an interim final rule “that will ensure long-term care facilities , and residential facilities serving clients with intellectual disabilities, educate and offer the COVID-19 vaccine to residents, clients, and staff.” While the requirements of this rule is for Long-Term Care (LTC) facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID), CMS ends this announcement by indicating they are “seeking comment on opportunities to expand these policies to help encourage vaccine uptake and access in other congregate care settings.”

At the onset of the pandemic, FDA inspections began to be reserved for what they describe as “mission-critical issues” based on the following four factors:

May 13, 2021: CDC Updates Guidance for Fully Vaccinated People

The CDC provided the following two updates on their Guidance for Fully Vaccinated People webpage (link):

• You no longer need to wear a mask or physically distance in any setting, except where required by federal , state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance, and
• You can refrain from testing following a known exposure unless they are residents or employees of a correctional or detention facility or a homeless shelter.

I encourage you to visit this webpage for additional recommendations for indoor and outdoor settings and travel (Domestic and International).

May 14, 2021: CDC Morbidity and Mortality Weekly Report: COVID-19 Vaccine Effectiveness

The CDC posted a report (link) regarding vaccine effectiveness of Pfizer-BioNTech and Moderna COVID-19 vaccines among health care personnel (HCP) at 33 U.S. sites from January to March 2021. In the report summary they indicate what is added by this report is information about COVID-19 effectiveness:

• A single dose of Pfizer-BioNTech or Moderna COVID-19 vaccines is 82% effective against symptomatic COVID-19, and
• Two doses is 94% effective.

May 14, 2021: CDC Call – "What Clinicians Need to Know about Pfizer-BioNTech COVID-19 Vaccination of Adolescents" – In case you missed it, the CDC held a Clinician Outreach and Communication Activity (COCA) call this past Friday, May 14th. This call:

• Provided clinicians with an overview of the Pfizer-BioNTech COVID-19 Vaccination in adolescents who are 12-to-15 years old, and
• Provided information about safety and efficacy of the vaccine, vaccine recommendations, and clinical guidance.

You can access the call materials including slides on this CDC webpage (link).

Over the years, hyperbaric oxygen (HBO) therapy has been and continues to be a review focus by Medicare Review Contractors. Most recently, Palmetto GBA published their findings from a Post-Payment review of claims in their Medicare Administrative Contractor (MAC) Jurisdiction M. But first, let’s take a look back at who else has been reviewing HBO therapy services.

Strategic Health Solutions, LLC: April 2012 to March 31, 2013 Claims Review

In 2014, Strategic Health Solutions, LLC, the first Supplemental Medical Review Contractor (SMRC), completed a review of 2,000 HBO claims with dates of service April 1, 2012 to March 31, 2013. Of the 2,000 claims, 594 were denied for no response and 570 were denied after review resulting in an error rate of 58%. Documentation cited as not being in the record included:

• Specific timelines and goals for therapy. For example, the documentation simply stated “continue HBO” or “until healed”
• Radiology and pathology reports confirming diagnoses such as osteomyelitis or gas gangrene
• Monitoring for improvement or lack of improvement

In addition, when documentation was provided, descriptions of diabetic wounds did not meet Wagner Criteria for Grade three (III) or four (IV) wounds and therapy was provided beyond the 30 days allowed under Medicare coverage guidelines.

OIG: February 2018 Report: Wisconsin Physicians Service Paid Providers for HBO Services that Did Not Comply with Medicare Requirements

For this audit (link), the OIG focused on WPS who is the current Medicare Administrative Contractor for Jurisdictions 5 and 8. Based on their results, the OIG estimated that WPS overpaid providers in Jurisdiction 5 $42.6 million dollars during the audit period of claims paid in 2013 and 2014.

OIG: December 2018 Report: First Coast Options, Inc., Paid Providers for HBO Services that Did Not Comply with Medicare Requirements

Similar to the WPS Audit, the OIG focused on 2013 and 2014 claims and estimated that First Coast overpaid providers in Jurisdiction N $39.7 million (link).

Noridian SMRC: October 2020 Outpatient HBO Notification of Medical Review

In October 2020, the current SMRC announced a post-payment review of HBO therapy with dates of service from January 1, 2018 through December 31, 2018 (link). Noridian indicates in the notification that, “over the years, HBO therapy services formed the basis of several Office of Inspector (OIG) reports. Findings from these OIG reports note that Medicare beneficiaries received treatments for non-covered conditions, medical documentation did not adequately support treatments, and that Medicare beneficiaries received more treatments than were considered medically necessary.”

Palmetto GBA: January to March 2021 Claims Review

As mentioned at the beginning of this article, Palmetto GBA has completed a post-payment service specific probe review of HBO therapy for North Carolina, South Carolina, Virginia and West Virginia (link)). Cumulatively, 285 claims were reviewed and 144 were completely or partially denied resulting in an overall claim denial rate of 50.53 percent. Examples of top denial reasons includes:

• No documentation of medical necessity,
• The recommended protocol was not ordered and/or followed,
• Billing Error,
• Units billed more than ordered, and
• Services not documented,

Based on the “medium to high impact severity errors,” Palmetto plans to continue this targeted medical review.

Moving Forward:

If your facility provides HBO therapy, make sure you are aware of Medicare’s requirements for HBO therapy, which can be found in the National Coverage Determination (NCD) 20.29 for Hyperbaric Oxygen Therapy (link)). Note, this NCD includes a list of covered indications and a longer list of non-covered indications.

Also, I recommend reading Palmetto’s review article as it includes ways to avoid denials. Palmetto GBA has two education resources related to HBO for Providers:

• An HBO Checklist that you can use as an audit tool to assure you are submitting all required documentation (link)), and
• An HBO Module (link)), which provides an overview of HBO therapy and information about physician responsibilities, the treatment plan, and administration of HBO therapy.

This week we highlight key updates spanning from May 4th through May 10th, 2021.

May 3, 2021: New COVID-19 Coverage Assistance Fund: Paying for COVID-19 Vaccine Administration

HHS posted a Press Release (link) announcing the new COVID-19 Coverage Assistance Fund (CAF). This program will cover the cost of administering a COVID-19 vaccine for individuals enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing.

May 4, 2021: Funding to Increase COVID-19 Vaccinations in Underserved & Rural Communities

HHS announced (link) the availability of $250 million, through the American Rescue Plan, “to develop and support a community-based workforce who will serve as trusted voices sharing information about vaccines, increase COVID-19 vaccine confidence, and address any barriers to vaccination for individuals living in vulnerable and medically underserved communities.”

In addition to underserved communities, HHS announced (link) the availability of nearly $1 billion to increase vaccination efforts in rural communities.

May 5, 2021: FDA Issues Roadmap for FDA Inspectional Oversight

The FDA has issued a new report titled “Resiliency Roadmap for FDA Inspectional Oversight” (link). This report outlines their “inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.”

At the onset of the pandemic, FDA inspections began to be reserved for what they describe as “mission-critical issues” based on the following four factors:

• Product received breakthrough therapy or regenerative medicine advanced therapy designation,
• Product is used to treat a serious disease or medical condition and there is no substitute,
• Product required follow-up due to recall, or there is evidence of serious adverse events or outbreaks of a foodborne illness, and
• Product is related to FDA’s COVID-19 response (e.g., drug shortages).

May 6, 2021: Increased Payment for COVID-19 Monoclonal Antibody Infusions & Two New HCPCS Codes

CMS announced (link) an increase in the national average payment rate, for administering monoclonal antibodies to treat COVID-19, from $310 to $450 for most health care settings. Further, “in support of providers’ efforts to prevent the spread of COVID-19, CMS will also establish a higher national payment rate of $750 when monoclonal antibodies are administered in the beneficiary’s home, including the beneficiary’s permanent residence or temporary lodging (e.g., hotel/motel, cruise ship, hostel, or homeless shelter.)” CMS has updated the COVID-19 Vaccines and Monoclonal Antibodies webpage (link) to reflect the payment updates.

Along with CMS establishing a higher national payment rate for monoclonal antibodies in the beneficiary’s home, CMS has added two new HCPCS codes for the administration of the monoclonal antibodies infusion in the home (M0244 and M0246). Note, these will be paid in the same manner as HCPCS codes, M0243 and M0245.

May 7, 2021: CDC Updates SARS-CoV-2 Mode of Transmission

The CDC had updated their Scientific Brief: SARS-CoV-2 Transmission (link). Recent updates to this brief includes:

• Updates have been made to reflect current knowledge about SARS-CoV-2 transmission,
• “Modes of SARS-CoV-2 transmission are now categorized as inhalation of virus, deposition of virus on exposed mucous membranes, and touching mucous membranes with soiled hands contaminated with virus.
• Although how we understand transmission occurs has shifted, the ways to prevent infection with this virus have not. All prevention measures that CDC recommends remain effective for these forms of transmission.”

May 10, 2021: EUA Expanded for Pfizer-BioNTech COVID-19 Vaccine

The FDA announced (link) the expansion of the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. “The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.”

CMS issued the FY 2022 IPPS Proposed Rule (CMS-1762-IFC) on Tuesday April 27, 2021. Following are highlights from the Proposed Rule.

Proposed Payment Rate Changes

The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) use is approximately 2.8 percent.

Overall, CMS estimates hospitals payments will increase by $2.5 billion.

COVID-19 Impact on Inpatient Hospitalization Utilization Data

CMS notes, in a related Fact Sheet, that their goal when setting inpatient hospital payment rates is to use the best available data. Given the impact that the COVID-19 Public Health Emergency (PHE) had during FY 2020, CMS is proposing to use the FY 2019 data to approximate the expected FY 2022 inpatient hospital utilization.

New Technology Add-On Payment (NTAP) Policy

There is good news for hospitals regarding the proposal being made related to the New Technology Add-On Payment (NTAP) policy. As background, the NTAP policy provides additional payment beyond the MS-DRG for cases where a CMS designated new technology was used and coded on the claim. Note, this “is not budget neutral and is generally limited to the 2-to 3-year period following the date of the FDA approval or clearance for marketing.”

“CMS is proposing a one-year extension of new technology add-on payments for 14 technologies for which the new technology add-on payment would otherwise be discontinued beginning FY 2022.”

New COVID-19 Treatments Add-on Payment (NCTAP)

CMS established the NCTAP policy for eligible discharges during the PHE. This policy was “designed to mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments. CMS is proposing to extend this policy for eligible products through the end of the fiscal year in which the COVID-19 PHE ends.

The PHE was once again extended in April 2021 and is currently set to expire on July 20, 2021. (link to release) However, in January of this year, HHS sent a letter (link to letter) to governors indicating the likelihood that the PHE will remain in place for all of 2021. If this proposal is finalized, and the PHE ends on December 31, 2021, that would mean the NCTAP policy will be in place until September 30, 2022.

To learn more about the NCTAP policy visit the CMS NCTAP webpage by clicking here.

Quality Program Proposals

CMS is proposing a measure suppression policy that would allow CMS to suppress use of measure data if they determine that the COVID-19 PHE has affected quality measures and resulting quality scores significantly. This measure suppression policy is being proposed for:

• The Hospital Readmission Reduction Program (HRRP),
• The Hospital-Acquired Condition (HAC) Reduction Program, and
• The Hospital Value-Based Purchasing (VBP) Program.

Also, with the Hospital Compare website now being the Care Compare website, CMS is proposing to update regulatory text for the HRRP and HAC Reduction Program to reflect the name change. The new Care Compare webpage ( link to site ) allows you to compare care by providers across the continuum of care (i.e. hospitals, nursing homes, home health, and hospice).

Specific to the HRRP, CMS is “seeking public comment on closing the gap in health equity through possible future stratification of results by race and ethnicity for condition/procedure-specific readmission measures and by expansion of standardized data collection to additional social factors, such as language preference and disability status.”

The Hospital VBP Program is funded by reducing participating hospitals base operating MS-DRG payments by 2%. The total estimated amount is then redistributed to hospitals based on their Total Performance Score (TPS). It is possible for your hospital to earn back a value-based incentive payment percentage that is less than, equal to, or more than the applicable reduction for that FY. The estimated amount available for incentive payments to hospitals in the current FY 2021 is $1.9 billion.

Due to the proposed measure suppression for the Hospital VBP Program, CMS is “proposing to not calculate a TPS for any hospitals based on one domain and to instead award to all hospitals value based payment amount for each discharge that is equal to the amount withheld.”

Graduate Medical Education (GME)

The Consolidated Appropriations Act (CAA), 2021, Section 126, “requires the distribution of an additional 1,000 new Medicare-funded medical residency positions to train physicians. CMS is proposing to distribute the slots to qualifying hospitals, as specified by the law, including those located in rural areas and those serving areas with a shortage of health care professionals.”

The 1,000 new slots would be phased in at no more than 200 per years beginning in FY 2023 (October 1, 2022). The estimated additional funding will total approximately $1.8 billion from FY 2023 through FY 2031.

Repeal of Hospital Negotiated Charges with Medicare Advantage Payers

Tom Nickels, Executive Vice President of the American Hospital Association, indicated in an April 27, 2021 AHA Statement on the release of the Proposed Rule that “based on our initial review, we are very pleased CMS is proposing to repeal the requirement that hospitals and health systems disclose privately negotiated contract terms with payers on the Medicare cost report. We have long said that privately negotiated rates take into account any number of unique circumstances between a private payer and a hospital and their disclosure will not further CMS's goal of paying market rates that reflect the cost of delivering care. We once again urge the agency to focus on transparency efforts that help patients access their specific financial information based on their coverage and care.” (Link to statement)

CMS is accepting comments on the proposed rule through 5 p.m. EDT on June 28, 2021.

Resources

• CMS FY 2022 IPPS Proposed Rule CMS Fact Sheet: Link
• CMS FY 2022 Proposed Rule web page: link