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Prior to 2017, the Office of Inspector General’s (OIG) Work Plan was published on an annual and sometimes semi-annual basis. The OIG began updating the Work Plan on a monthly basis effective June 15, 2017. The change was made as the OIG acknowledged that the “work planning process is dynamic, and adjustments are made throughout the year to meet priorities and to anticipate and respond to emerging issues with the resources available.” The Work Plan includes items for several agencies (i.e., Centers for Medicare & Medicaid Services (CMS), Administration for Children and Families, Office of Civil Rights (OCR)). There are two recent additions to the Work Plan that I would like to share with you.

Active Work Plan Item: Impact of Expanding the Hospital Transfer Payment Policy for Early Discharges to Post-acute Care

This item (link) was added to the Work Plan in May 2021. The OIG plans to determine the impact for Medicare and hospitals if the Post-Acute Care (PAC) MS-DRG list was expanded to include all MS-DRGs. In the detail of this Work Plan item, the OIG notes that “Analysis of Medicare claims data demonstrates significant occurrences of early discharges from hospitals to PAC facilities for MS-DRGs that are not currently subject to the PAC transfer payment policy. Medicare pays a full prospective payment system (PPS) rate to hospitals for these early discharges.”

The Post-Acute Care Transfer (PACT) Policy was implemented to prevent Medicare from paying for the same care twice. This policy currently reduces reimbursement to a hospital when:

• A hospitalization codes to an MS-DRG designated as a Transfer MS-DRG,
• The patient’s length of stay (LOS) is at least 1 day less than the geometric mean length of stay (GMLOS) for the MS-DRG, and
• The patient is discharged to one of the “qualified discharges” (03-Skilled Nursing Facility (SNF), 05-Children’s Hospital or Designated Cancer Center, 06-Home with Home Health within 3 days of discharge, 50-Discharges/Transferred to Hospice Home, 51-Discharged/Transferred to Hospice, General Inpatient Care or Inpatient Respite, 62-Inpatient Rehabilitation Facilities & Units, 63-Long Term Care Hospitals, and 65-Psychiatric Hospitals & Units)

Annually, CMS publishes a list of MS-DRGs subject to the PACT policy in Table 5 of the applicable Fiscal Year IPPS Final Rule. For FY 2021 there are 765 MS-DRGs and 280 (36.6%) have been designated a PACT MS-DRG.

Discharge Dispositions hospice home (50) and hospice general inpatient care/respite (51) were added to this policy in FY 2019 as required by the Bipartisan Budget Act of 2018. At that time, CMS actuaries estimated that the change would “generate an annual savings of approximately $240 million in Medicare payments in FY 2019, and up to $540 million annually by FY 2028.” With these estimates it is no wonder the OIG has added this item to their Work Plan. The OIG has an expected issue date for a report in FY 2022.

Active Work Plan Item: Audit of the Effectiveness of HHS’s Governance to Ensure Hospitals Implement Measures to Prevent, Detect, and Recover from Cyberattacks

This item (link) was also added to the Work Plan in May 2021. As an active member of MMP’s HIPAA/HITECH Privacy Committee, I felt it was important to make our readers aware of this item. If you listen to the news, this is a very timely item as hospitals are constantly under threat of the theft of electronic protected health information (ePHI) by ransomware, malware, insider threats, and even honest mistakes.

“In October 2020, the Cybersecurity and Infrastructure Security Agency, Federal Bureau of Investigation, and Department of Health and Human Services (HHS) issued a joint cybersecurity advisory (link) regarding ransomware activity targeting the health care and public health sector. The advisory stated that threat actors have continued to develop new functionality and tools, thereby increasing the ease, speed, and profitability of ransomware attacks.”

OIG Audit Plan

• “Audit HHS's governance over its programs to determine whether HHS's Office of Civil Rights (OCR) has performed periodic audits of hospitals to assess compliance with Health Insurance Portability and Accountability Act (HIPAA) Security, Privacy, and Breach Notification rules and determine whether these audits effectively assessed ePHI protections.”
• “Determine whether CMS's certification process for participation in the Medicare program requires hospitals participating in the Medicare program to implement minimum security safeguards to prevent and detect cyberattacks, ensure continuity of patient care, and protect beneficiary data.”
• “Conduct security assessments at 10 U.S. hospitals to determine whether they have adequately implemented HIPAA security requirements or effective cybersecurity measures to prevent, detect, and recover from cyberattacks.”

The OIG has an expected issue date for a report in FY 2022.

2016-2017 OCR HIPAA Audits Industry Report

As mentioned above, the OIG plans to determine if the OCR has performed periodic audits of hospitals. On December 17, 2020, the Office for Civil Rights (OCR) released its 2016-2017 HIPAA Audits Industry Report. The Health Information Technology for Economic and Clinical Health (HITECH) Act requires HHS to periodically audit covered entities (CEs) and business associates (BAs) for compliance with the HIPAA Rules. This Industry Report was published to share overall findings from audits conducted with 166 CEs and 41 BAs. To provide insight into what was included in the audit, following is the summary of audit findings from the December HHS Press Release (link):

• Most covered entities met the timeliness requirements for providing breach notification to individuals,
• Most covered entities that maintained a website about their customer services or benefits satisfied the requirement to prominently post their Notice of Privacy Practices on their website,
• Most covered entities failed to provide all the required content for a Notice of Privacy Practices,
• Most covered entities failed to provide all the required content for breach notification to individuals,
• Most covered entities failed to properly implement the individual right of access requirements such as timely action within 30 days and charging a reasonable cost-based fee,
• Most covered entities and business associates failed to implement the HIPAA Security Rule requirements for risk analysis and risk management.

The HHS Press Release ended with the following statement from OCR Director Roger Severino, “The audit results confirm the wisdom of OCR’s increased enforcement focus on hacking and OCR’s Right of Access initiative…We will continue our HIPAA enforcement initiatives until health care entities get serious about identifying security risks to health information in their custody and fulfilling their duty to provide patients with timely and reasonable, cost-based access to their medical records.”

As described in the Welcome to the PAR article, MMP Associates monitor websites monthly to identify new Medicare Fee-for-Service review targets and review results. Invariably, we will come across useful “Did You Know” information that we will be sharing in this monthly PAR Pro Tips article.

Pro Tip: MACs Post-Payment Reviews Expanded

In 2020, in response to the COVID-19 Public Health Emergency (PHE), CMS put a halt to the Medicare Administrative Contractor (MAC) Targeted Probe and Education (TPE) Program. In August 2020, CMS advised MACs to resume post-payment reviews with dates of service before March 2020. Most recently, CMS announced in the Thursday June 3, 2021 MLN Connects (link), that MACs can now begin conducting post-payment reviews for claims after March 2020.

Pro Tip: New April 2021 Medicare Quarterly Provider Compliance Newsletter

Also, in the June 3rd MLN Connects newsletter, CMS announced the release of the April 2021 Medicare Quarterly Provider Compliance Newsletter. Per the introduction of this newsletter, it aims to “help health care professionals to understand the latest findings identified by MACs and other contractors such as Recovery Auditors and the Comprehensive Error Rate Testing (CERT) review contractor, in addition to other governmental organizations as the Office of Inspector General (OIG).” Two RAC Issues detailed in the newsletter includes acute care hospitals claims review

Recovery Auditor (RAC Issue 0067): Inpatient Psychiatric Facility Services: Medical Necessity and Documentation Requirements

RAC Issue 0067 (link) was approved by CMS for the RACs to review on September 1, 2018 for provider types Inpatient Hospital and Inpatient Psychiatric Facility (IPF). The April newsletter includes a discussion of the problem, background information and guidance, and resources to assist providers in meeting medical necessity and documentation requirements for providing psychiatric services.

Did You Know?

• Palmetto JJ, Palmetto JM, and WPS J5 are currently conducting post-payment reviews of MS-DRG 885 (Psychoses) claims,
• Six of the twelve MACs have published a Local Coverage Determination (LCD) and Local Coverage Article (LCA) specific to psychiatric services, and
• MS-DRG 885 claims have been a focus by the CERT review contractor since 2011. The annual improper payment rate reported by the CERT for this MS-DRG has been as high as 14.4% with the lowest rate being 2.9% in 2020.

Recovery Auditor (RAC Issue 0074): Drugs and Biologicals: Incorrect Units Billed (Single-Dose Vials)

RAC Issue 0067 RAC Issue 0074 (link) was approved by CMS for the RACs to review on December 21, 2017 for provider types Outpatient Hospital and Professional Services.

The RACs performed “complex reviews for single dose vials to assure compliance with Medicare policy. They reviewed claims to determine the actual amount administered and the correct number of billable/payable units.” You can find case examples in CMS’ newsletter.

Pro Tip: Q2 2021 Medicare Fee-for-Service Payments Integrity Scorecard

PaymentAccuracy.gov (link) is an official website of the U.S. government. This website is “a gateway to ensuring federal funds reach the right recipients, preventing improper payments, and reducing fraud, waste, and abuse.” You will find “Program Scorecards”, “The Numbers” and “Resources” on this website.

The most recent Medicare Fee-for-Service Scorecard available is Q2 2021 (link). The Scorecard shares three HHS accomplishments in Reducing Monetary Loss:

• HHS continued the process of adding two additional services (cervical fusion with disc removal and implanted spinal neurostimulator) to the Prior Authorization for Certain Hospital Outpatient Department Services Program effective July 1, 2021. You can read more about this in a related MMP article (link),
• HHS continued RAC and MAC post-payment reviews based on data analysis and the CERT findings, and
• HHS continued to use the Supplemental Medical Review Contractor (SMRC) to complete projects in relation to the Public Health Emergency, recent OIG reports, and CERT findings.

SMRC Project 01-043: DRG COVID 20% Add-On Payment

Specific to the PHE, the SMRC is conducting post-payment reviews of Medicare Part A COVID-19 inpatient claims with dates of service from April 1, 2020, through August 30, 2020. In general, in the inpatient setting, a diagnosis code documented at the time of discharge as being “possible”, “probable”, “suspected”, “likely”, “questionable”, or “still to be ruled out”, is coded as if the condition existed.

One exception to this guidance is coding for COVID-19. The ICD-10-CM Official Coding Guidelines (link) for COVID-19 advises coders to code only confirmed cases “as documented by the provider, documentation of a positive COVID-19 test, result, or a presumptive positive COVID-19 test result.”

While beyond the dates of service of the SMRC Project, it is worth noting that in August 2020, CMS revised MLN article SE20015 (link) by adding guidance “to address potential Medicare program integrity risks, effective with admissions occurring on or after September 1, 2020, claims eligible for the 20 percent increase in the MS-DRG weighting factor will also be required to have a positive COVID-19 laboratory test documented in the patient’s medical record. Positive tests must be demonstrated using only the results of viral testing (i.e., molecular or antigen), consistent with CDC guidelines. The test may be performed either during the hospital admission or prior to the hospital admission.”

One last reminder, the add-on payment for COVID-19 claims will end when the COVID-19 PHE ends. While the Biden Administration has indicated the PHE will likely be in place until December 31, 2021, the current PHE declaration will expire in July.

Steps to a Successful PAR

In a game of golf, a par 3 course usually consists of only par 3 holes. In theory, golfers are able to reach the green on their first stroke and then take two putts to get the ball in the hole. No matter the course, most professional golfers will always use a tee to prevent grass from getting between the ball and the club.

In January of 2017, the OIG, in collaboration with a group of compliance professionals, released a Resource Guide (link) to measure the effectiveness of compliance programs. Items 5.27-5.36 emphasize that a Risk Assessment is key to developing an effective Compliance audit/work plan. Identifying current Medicare review targets to consider when developing your Risk Assessment can be time consuming and overwhelming.

MMP’s PAR Tee’s the Ball

Being sensitive to our client’s already over-tasked day, MMP collaborated with RealTime Medicare Data (RTMD), to develop a proprietary Protection Assessment Report (PAR). MMP’s PAR tees the ball by compiling Medicare Fee-for-Service review targets being conducted by:

• Office of Inspector General (OIG),
• Medicare Administrative Contractors (MACs) – all 12 Jurisdictions,
• Recovery Auditors – all 4 Regions,
• Supplemental Medical Review Contractor (SMRC), and
• Comprehensive Error Rate Testing (CERT) Program.

Additional features of the PAR:

• Inpatient reviews targets that are included in the Program for Evaluating Payment Patterns Electronic Report (PEPPER) are highlighted in the PAR,
• The PAR details all Medicare Contractors that may be focused on one specific review target (i.e., total knee arthroplasty).
• Monthly, MMP Associates monitor websites for the entities listed above. Specifically, monitoring is for new review targets, review results, and new or changes to current coverage policies.
• For review targets with an applicable National Coverage Determination (NCD), Local Coverage Determination (LCD), or Local Coverage Article (LCA), the PAR also includes this information.

Successful Shot Selection

One step to improving your golf game is picking a target to use as a reference for setting up your shot. MMP’s PAR aids in your successful review target selection. This is accomplished by “dropping in” your hospital specific Medicare Fee-for-Service paid claims data (volume, charges and payments), provided by RTMD, for target areas included in the report. Sorting by volume and or payments helps you take aim on what is important for your hospital.

Third Wednesday of the Month PAR Focus

Moving forward, the third Wednesday@One of each month will include insights from our ongoing monitoring of external auditor’s websites. If you are interested in learning more about the PAR, you can contact us by completing the form below this article.

Question:

What is the significance of coding the National Institutes of Health Stroke Scale Scores (NIHSS) that were implemented in 2017?

Answer

The NIHSS is a neurological exam that is scored on all acute stroke patients. The provider or clinician will calculate and document the score. The coder is to assign R29.7—based on the score or scores.

Score	Description
0	No Stroke
1-4	Minor Stroke
5-15	Moderate Stroke
16-20	Moderate/Severe Stroke
21-24	Severe Stroke

CMS has been gathering claims data on strokes from July 1, 2018 - June 30, 2021 which will be publically reported in FY 2022. For FY 2023 the data will start affecting hospital reimbursement as part of the 30-Day Stroke Mortality Measure. Hospitals should report the first NIHSS, which is typically documented after arrival to the hospital along with the appropriate stroke code. You may report additional NIHSS codes and use the POA indicator No for those additional codes.

In a recent Wednesday@One article (link) and related Infographic, RTMD’s claims data revealed only 40.1% of the claims included an NIHSS code. The reason the reporting of the NIHSS codes is so low may be due to the wording of the coding guideline. The guideline states, codes R29.7—may be used in conjunction with the stroke codes, so many hospitals are opting not to code them.

The main point of this article is to make sure you always report a NIHSS code with an acute stroke code and that they appear on the claim. Omitting the R29.7- code will adversely impact your hospital’s future reimbursement.

References:
Coding Clinic, Fourth Quarter 2016, page 61
NIHSS Stroke Scale, ICD-10-CM Coding Guidelines

Question:

During cataract extraction, the physician sometimes injects an antibiotic into a part of the eye anatomy. Can we code the injection procedure(s) in addition to the cataract extraction CPT code?

Answer

No, do not code the eye injection in addition to the CPT code for the cataract extraction. This applies to the injection of an antibiotic as well as steroids and non-steroidal anti-inflammatory drugs Specific examples of injections not separately reportable with the cataract extraction code include: anterior chamber, intravitreal, retrobulbar, Tenon’s capsule, and subconjunctival.

Reference: National Correct Coding Initiative (NCCI) Policy Manual, chapter VIII, page 18.

Did you know?

Did you know that coding advice regarding Diabetes and Cataracts has changed?

Why it matters.

You may not be capturing the most accurate severity of illness of the patient.

What can I do?

Read the following Coding Clinics: September-October 1985, page 11 and 4th Quarter 2016, page 142.

Advice from 1985 stated that Diabetic Cataracts are rare, but may appear in Type 1 Diabetics. Simply put, we were advised that most cataracts occurring in a diabetic patient were not coded as a diabetic complication.

Advice from 2016 now states that diabetes and cataracts should be coded as related conditions as they are not rare and are a major cause of eye sight issues in diabetics. The Coding Clinic advice from 1985 was revised because more is known about cataracts and that the occurrence in diabetic patients was found to be higher and occurring at younger ages than nondiabetics.

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.

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.”

For most students, the school year has come to an end. However, for those of you that are involved in the Prior Authorization for Certain Hospital Outpatient Department (ODP) process at your hospital, there is some essential summer reading requirements that you need to complete in the next couple of weeks. p>

Background

This program was finalized in the Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) Final Rule and is specific to the Hospital Outpatient Department setting. Effective July 1, 2020, a Prior Authorization was required for the following five procedures:

• Blepharoplasty
• Botulinum toxin injections
• Panniculectomy
• Rhinoplasty
• Vein ablation

CMS believes this program will be an effective tool in controlling unnecessary increases in volume by ensuring payments are only being made for medically necessary services. You will find additional resource information and updates on the CMS webpage created for this program (link) .

2021 Program Updates

Two New Procedures to Require Prior Authorization

CMS has added Implanted Spinal Neurostimulators and Cervical Fusion with Disc Removal to this process, effective July 1, 2021. These two services are not replacing, but are being added to the list of procedures currently requiring prior authorization.

Note: MACs will begin accepting Prior Authorization Requests (PARs) for these two new services on June 17, 2021, for services rendered on or after July 1, 2021.

February 26, 2021: Exemption(s)

CMS noted that “MACs are in the process of identifying those hospital OPDs that will be exempt from the prior authorization process. Starting February 1, 2021 MACs began calculating the affirmation rate of initial prior authorization requests submitted. Hospital OPD providers who met the affirmation rate threshold of 90% or greater will receive a written Notice of Exemption no later than March 1, 2021. Those hospital OPDs will be exempt from submitting prior authorization requests for dates of service beginning May 1, 2021.”

CMS’ Prior Authorization Program Operational Guide was updated on May 13, 2020. Updates are highlighted in red. There are a couple of specific updates to hospitals exempted from having to submit a Prior Authorization Request (PAR):

• The exemption will include PARs for the two new services being added to the program effective July 1, 2021.
• A word of caution, if you have been exempted from this process, you must continue to ensure documentation supports medical necessity of the procedure being performed. CMS has advised that they will be sending post-payment Additional Documentation Requests (ADRs) for a 10-claim sample from the time period you were exempted to determine compliance. Note, the sample may include claims for the two new services (cervical fusion with disc removal and implanted spinal neurostimulators).

May 13, 2021: Change to Implanted Spinal Neurostimulators

“CMS is temporarily removing CPT codes 63685 and 63688 from the list of OPD services that require prior authorization. The only service that will require prior authorization for implanted spinal neurostimulators is CPT code 63650. Providers who plan to perform both the trial and permanent implantation procedures using CPT code 63650 in the OPD will only require prior authorization for the trial procedure. When the trial is rendered in a setting other than the OPD, providers will need to request prior authorization for CPT code 63650 as part of the permanent implantation procedure in the hospital OPD.”

CMS has added the following paragraph to the program Operational Guide related to when a PAR is required:

“Providers who plan to perform both the trial and permanent implantation procedures using CPT 63650 in the hospital OPD will only be required to submit a PAR for the trial procedure. To avoid a claim denial, providers must place the Unique Tracking Number (UTN) received for the trial procedure on the claim submitted for the permanent implantation procedure. When the trial is rendered in a setting other than hospital OPD, providers will need to request PA for CPT 63650 as part of the permanent implantation procedure in the hospital OPD.”

May 14, 2021: MAC Educating Providers

CMS released Change Request (CR) 12214 (link) to instruct Medicare Administrative Contractors (MACs) to provide education regarding the prior authorization (PA) process for cervical fusion with disc removal and implanted spinal neurostimulators in the hospital OPD setting. One part of this education will be MACs sending introductory letters detailing the July 1, 2021 updates and general “What You Need to Know” information to physicians and providers. Templates of these letters are included in this CR.

Cervical Fusion with Disc Removal and Implanted Spinal Neurostimulators by the Numbers

In an effort to quantify the volume and payment related to the two new procedures, I worked with RealTime Medicare Data (RTMD). For those who may be new readers of our newsletter, RTMD’s current data base consists of Medicare Fee-for-Service paid claims data for hospital inpatient discharges, outpatient hospital services, and CMS 1500 professional services for 48 states and territories. The following data is specific to U.S. states for calendar years (CY) 2019 and 2020. Since COVID-19 had an impact on planned surgical procedures, I believe it is important to view both years of data

Cervical Fusion with Disc Removal

CY2019

• Procedure Volume: 20,203
• Paid Claims Amount: $163,592,946.40

CY2020

• Procedure Volume: 17,569
• Paid Claims Amount: $164,226,275.35

Implanted Spinal Neurostimulators

CY2019

• Procedure Volume: 27,056
• Paid Claims Amount: $43,991,713.02

CY2020

• Procedure Volume: 19,853
• Paid Claims Amount: $34,603,818.02

Moving Forward

This is where the urgent summer reading comes in. For those actively involved in this process, I encourage you:

• To read CMS’ OPD Operational Guide and Frequently Asked Questions, both of which were last updated on May 13, 2021,
• Review your MACs website for education offering related to updates to this program. You will find contact information for all of the MACs in the OPD Operational Guide.
• Make sure your Physicians performing these procedures are aware of the documentation requirements supporting medical necessity of the procedure. In addition to MAC contact information, the OPD Operational Guide includes “Required Documentation” for each of the procedure.
• Finally, if you are currently exempt from the PAR process, be on the lookout for ADR requests from your MAC in the not too distant future.

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.