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This week we highlight key updates spanning from April 27th through May 3rd, 2021.

Spotlight: Noridian JF Ask the Contractor (ACT) Question and Answer: Targeted Probe & Educate during the Pandemic

Noridian JF recently posted Questions and Answers from their January ACT Call (link). Following is an excerpt from one of the Q&A’s regarding the Medicare Administrative Contractors (MACs) Targeted Probe and Educate (TPE) program:

“Q8: Our facility has not received a Targeted Probe and Education (TPE) audit or an Additional Documentation Request (ADR) since the pandemic started. Can Noridian please clarify whether these audits have been restarted?

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A8: MACs have not received direction from CMS to resume TPE audits. Currently MACs are conducting service specific claim reviews. More information can be found on Noridian’s Medical Review webpage under Post-Pay Reviews. Individual providers will be notified if they have an open, pending TPE file when we have direction from CMS to resume TPE activities.”

April 26, 2021: QW Modifier Added to HCPCS 87636

CMS published MLN MM12269 (link) to inform providers of the addition of the QW modifier to HCPCS code 87636 [Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza type virus types A and B, multiplex amplified probe technique].

CMS ends this MLN article by noting that “claims for tests you perform in facilities having a CLIA certificate of waiver must include the QW modifier. MACs won’t search their files to either retract payment for claims already paid or to retroactively pay claims. However, they will adjust claims you bring to their attention.”

April 27, 2021: CDC Clinical Outreach & Communication Activity Call: Johnson & Johnson/Janssen COVID-19 Vaccine and TTS Update for Clinicians

The CDC conducted an initial call related to the Johnson & Johnson vaccine and Cerebral Venous Sinus Thrombosis with Thrombocytopenia (CVST) on April 15, 2021. The April 27th call provided updates for clinicians about the Johnson & Johnson vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS) (link). For those that missed this call, the CDC webpage for this call includes a video of the session and call materials.

April 27, 2021: Memorandum Update to Interim Final Rule – Additional Policy & Regulatory Revisions in Response to the COVID-19 PHD related to Long-Term care Facility Testing Requirements and Revised COVID-19 Focused Survey Tool e

CMS has updated this Memorandum (link) that was initially provided to State Survey Agency Directors in August of 2020. CMS has revised the COVID-19 Focused Survey Tool for surveyors. They “are also adding to the survey process the assessment of compliance with the requirements for facilities to designate one or more individual(s) as the infection preventionist(s) (IPs) who are responsible for the facility's infection prevention and control program (IPCP) at 42 CFR § 483.80(b).” Additionally, they “are making a number of revisions to the survey tool to reflect other COVID-19 guidance updates.”

April 29, 2021: Expanding COVID-19 Training and Support for Health Centers

HHS announced (link) that 122 organizations, including Primary Care Associations (PCAs), National Training and Technical Assistance Partners (NTTAPs), and Health Center Controlled Networks (HCCNs), have been awarded $32 million to “use the funds to provide health centers with critical COVID-19 related training, technical assistance, and health information technology.” This was made possible through the American Rescue Plan.

Medicare MLN Articles & Transmittals – Recurring Updates

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.2, Effective July 1, 2021

• Article Release Date: March 31, 2021
• What You Need to Know: NCCI edits were developed to promote national correct coding methodologies and to control improper coding that leads to inappropriate payment in Part B claims. This article alerts providers about the quarterly updates to the NCCI PTP edits in Change Request (CR) 12226 effective July 1, 2021. CMS includes the following bolded statement in the CR, “the edits previously contained in the Mutually Exclusive edit file are NOT being deleted but are being moved to the Column One/Column Two Correct Coding edit file.”
• MLN MM12226: link

April 2021 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: April 1, 2021
• What You Need to Know: Billing instructions for various payment policies CMS made in the April 2021 ACS payment system update are referenced in this article.
• MLN MM12183: link

Other Medicare MLN Articles&Transmittals

Updated to the Payment for Grandfathered Tribal Federally Qualified Health Centers (FQHCs) for Calendar Year (CY) 2021

• Article Release Date: March 31, 2021
• What You Need to Know: This article is for FQHCs billing MACs for services provided to Medicare patients.
• MLN MM12202: link

Revised Medicare MLN Articles&Transmittals

Penalty for Delayed Request for Anticipated (RAP) Submission – Implementation

• Article Release Date: July 31, 2020 – Most recent revision April 1, 2021
• What You Need to Know: This is the third revision to the original July 31, 2020 MLN article. Information in the article is for Home Health Agencies (HHA) who bill MACs for services provided. The April 1, 2021 revision reflects the revised CR 11855. The revised CR changes the principal diagnosis code reporting instructions in Chapter 10, Section 40.1 and the service date reporting instructions in Chapter 10, Section 40.2 of the Medicare Claims Processing Manual. The changes make sure claims successfully match their corresponding RAP. Changes in the text of the document are in red print.
• MLN MM11855: link

Common Working File (CWF) Edits for Medicare Telehealth Services and Manual Update

• Article Release Date: March 18, 2021 – Revised April 6, 2021
• What You Need to Know: This article reflects a revised Change Request CR 12068. The substance of the article did not change.
• MLN MM12068: link

Medicare Coverage Updates

April 13, 2021: Final Decision Memo for AlloMap® Molecular Expression Testing for Detection of Reject of Cardiac Allografts

CMS indicates in the background section of this Decision Memo (link), that the “AlloMap is intended to give physicians information on the risk of acute cellular rejection in their patients following heart transplant.” CMS received a request in January of 2013 to non-cover this assay as the requester felt this particular assay “does not perform adequately,” has “poor sensitivity,” and “no intrinsic predictive capability.” A national coverage analysis was issued October 16, 2020. CMS received three comments. CMS did not issue a National Coverage Determination for this testing and notes in the Final Decision Memo that, “in the absence of an NCD, coverage determinations for AlloMap® Molecular Expression Testing for Detection of Rejection of Cardiac Allografts…will continue to be made by the local Medicare Administrative Contractors (MACs).”

April 13, 2021: Final Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds

CMS indicates in this Decision Memo (link) that they “will cover autologous platelet-rich plasma (PRP) for the treatment of chronic non-healing diabetic wounds under section 1862(a)(1)(A) of the Social Security Act (the Act) for a duration of 20 weeks, when prepared by devices whose FDA cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers. Coverage of autologous PRP for the treatment of chronic non-healing diabetic wounds beyond 20 weeks will be determined by local Medicare Administrative Contractors (MACs). Coverage of autologous PRP for the treatment of all other chronic non-healing wounds will be determined by local Medicare Administrative Contractors (MACs) under section 1862(a)(1)(A) of the Act.”

April 13, 2021: National Coverage Analysis (NCA) Tracking Sheet for Transvenous (Catheter) Pulmonary Embolectomy

Currently, this procedure is non-covered. CMS internally generated this NCA reconsideration (link) based on stakeholder feedback and have had several requests for this NCD to be removed. The public comment period is from April 13, 2021 through May 13, 2021. The proposed decision memo due date is October 13, 2021.

Medicare Educational Resources

New MLN Booklet: How to Use the Medicaid National Correct Coding Initiative (NCCI) Tools

CMS has issued a new Medicare Learning Network booklet titled How to Use the Medicaid National Correct Coding Initiative (NCCI) Tools (link). This publication is aimed at helping providers learn to navigate the CMS Medicaid NCCI webpages, work with Medicaid Procedure-to-Procedure edits, and manually unlikely edits. CMS notes that the Medicare NCCI Program has significant differences from the Medicaid NCCI initiative and provides related links to the Medicaid NCCI Initiative and Medicare NCCI Program.

Revised MLN Booklet: Behavioral Health Integration Services

CMS has issued a revised version of the Behavioral Health Integration Services 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).

CMS’ Diagnosis Coding: Using ICD-10-CM and ICD-10-PCS Web-Based Training Courses Revised

CMS has updated their ICD-10-CM and PCS web-based training courses. These courses can help you learn how to identify structure and format, recognize features and find codes. You can access both revised courses on the CMS MLN Web-Based Training webpage at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/WebBasedTraining.

Revised MLN Booklet: Medicare Billing: Form CMS-1450 and the 837 Institutional

In mid-April, CMS published a revised version of this MLN Booklet (link. In the revised version, CMS updated MSP information in the Medicare Claims Submission section of the booklet and added a new Where to Submit FFS Claims section.

Medicare Wellness Visits Educational Tool Revised

CMS noted in the April 22, 2021 edition of MLN Connects (link) that their Medicare Wellness Visit Education Tool has been revised. Providers can use this tool to learn about the annual wellness visit (AWV) and Initial preventive physical exam (IPPE).

Other Medicare Updates

April 8, 2021: CMS Issues FY 2022 Proposed Rules

In a Special Edition MLN Connects (link), CMS issued Proposed Rules for:

• SNF Prospective Payment System: FY 2022 Proposed Rule
• Hospice Payment Rate Update for FY 2022,
• IRF Prospective Payment System: FY 2022 Proposed Rule, and
• IPF: Proposed Medicare Payment&Quality Reporting Updates.

Links to each proposed rule and a related Fact Sheet are available in this announcement. CMS is accepting comments on all four proposed rules until June 7, 2021.

Question:

As a follow-up to last week’s question about Lovenox, (link) we have the same question regarding insulin: We have NOT been charging for insulin administration given in any form (ex. IM, Infusion), but should we?

Answer

Palmetto, GBA considers Insulin to be a self-administered drug when given by subcutaneous route. For Medicare, you would NEVER report a subcutaneous injection for insulin (CPT code 96372). Palmetto says if you give insulin by a different route, it is appropriate to report the administration CPT code, such as IM or IV.

Cahaba, GBA the prior Medicare Administrative Contractor (MAC) for Jurisdiction J, had told Provider that insulin is a self-administered drug regardless of the route. The Palmetto policy is not as strict as Cahaba’s.

Again, here is a link to Palmetto’s self-administered drug list, which includes discussion about drugs on the list given by other than subcutaneous route.
Local Coverage Article for Self-Administered Drug Exclusion List

Remember, insulin is sometimes documented using other names, and it is easy to miss these drugs if you are not familiar with some of the brand names. If you need a reminder, review the Wednesday@One article at the link below from September 2018 which lists some of the more common insulin names and types.

Do You Know When to Code Z79.4?
https://www.mmplusinc.com/kb-articles/do-you-know-when-to-code-z79-4

This week we highlight key updates spanning from April 20th through April 26th, 2021.

Resource Spotlight: HHS’ COVID-19 Public Education Campaign & Community Corps

HHS has launched a public education campaign “to increase public confidence in and uptake of the COVID-19 vaccines while reinforcing basic prevention measures such as mask wearing and social distancing.” HHS is expanding the campaign through the creation of the COVID-19 Community Corps. Members of this group will receive resources to build vaccine confidence in your community, including:

• Fact Sheets,
• Social Media Content, and
• Regular email updates with the latest vaccine news and resources to share.

You can sign up to be a member of the COVID-19 Community Corps at https://wecandothis.hhs.gov/covidcommunitycorps.

April 20, 2021: I Received the Johnson & Johnson Vaccine, Now What?

The CDC has created a Johnson & Johnson/Janssen COVID-19 vaccine update page (link). The April 20th update highlights the following “What you need to know” information:

• “The use of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine is paused for now. This is because the safety systems that make sure vaccines are safe received a small number of reports of people who got this vaccine experiencing a rare and severe type of blood clot with low platelets.
• Seek medical care right away if you develop any of the symptoms listed in the question and answer – what if I got the J&J/Janssen COVID-19 vaccine?
• If you have any questions at all, call your doctor, nurse, or clinic.”

April 20, 2021: COVID-19 Update – FDA Revoked EUA for Bamlanivimab When Administered Alone

In last week’s article, I reported that on April 16th, the FDA revoked the Emergency Use Authorization (EUA) for Bamlanivimab when administered alone. CMS released a Special Edition MLN Connects related to this revocation (link). They note that they will cover and pay for Bamlanivimab, when administered alone, for dates of service from November 10, 2020 through April 16, 2021.

April 22, 2021: CDC & Dialysis Organizations Partner to Provide COVID-19 Vaccine

The CDC announced in the Thursday April 22nd MLN Connects newsletter (link) that they are partnering with dialysis organizations nationwide to make the COVID-19 vaccine available to patients and health care personnel in outpatient dialysis clinics. CMS reminds you that there is no copayment, coinsurance or deductible for receiving a COVID-19 vaccine.

April 22, 2021: New Acute Care Delivery at Home Tip Sheet

Also in the April 22nd MLN Connects, CMS provides a link to a new Acute Care Delivery at Home Tip Sheet (link). In addition to the Tip Sheet a link is provided to the CMS Acute Hospital Care at Home webpage where you will find an overview of this program, reporting measures participating hospitals are required to provide, additional resources, and access to past webinars.

April 22, 2021: HHS’ “We Can Do This: Live” Initiative

Building upon the “We Can Do This” public education campaign, HHS announced the launch of their “We Can Do This: Live” series “to pair medical experts with prominent influencers and organizations with large social followings to meet people where they are with the information they need to feel confident about receiving the vaccine. Events will include conversations to answer direct questions about COVID-19, Instagram Live Q&As, and social media account takeovers where doctors, scientists and health officials can provide the public with factual, scientific information about vaccines.” HHS notes in the Press Release (link) that this initiative follows the launch of the COVID-19 Community Corps initiative.

April 23, 2021: Johnson & Johnson (Janssen) COVID-19 Vaccine Pause Lifted

After a “thorough safety review,” the CDC and FDA announced that use of the Johnson & Johnson (Janssen) COVID-19 vaccine should resume. The Fact Sheets related to this vaccine have all been revised to include information about the risk of thrombosis-thrombocytopenia syndrome (TTS). The FDA goes on to note that as of April 23rd they can confirm 15 cases of TTS. All cases were women between 18 and 59 years old, with a median age of 37 years. Symptom onset was between 6 and 15 days after vaccination. (link)

Question:

Is Lovenox in the outpatient setting a self-administered drug for Medicare? Can we charge for the administration?

Answer

For Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M, Lovenox is NOT a self-administered drug, so you can charge for the subcutaneous / intramuscular injection, CPT code 96372. If you are under the jurisdiction of a different MAC, check their self-administered drug list as the drugs can vary from one MAC to the next.

Here is a link to Palmetto’s self-administered drug list. It lists all of the injectable drugs they consider to be self-administered: Local Coverage Article for Self-Administered Drug Exclusion List (cms.gov)

This week we highlight key updates spanning from April 13th through April 19th, 2021.

April 13, 2021: CDC Health Alert: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Johnson & Johnson COVID-19 Vaccination

The CDC issued an official Health Alert relaying information about six cases of cerebral venous sinus thrombosis (CVST) in the U.S. after receiving the Johnson & Johnson COVID-19 vaccine. All six cases were women aged 18 – 48 years and the lag time from vaccination to onset of symptoms ranged from 6 – 13 days. Five of the six women had an initial presenting symptom of a headache. One woman died.

The CDC indicated they would convene an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14th… “until this process is complete, CDC and FDA are recommending a pause in the J&J COVID-19 vaccine out of an abundance of caution.”

Recommendations for Clinicians, Public Health, and the general public are also included in this Alert.

April 13, 2021: New Legal Guidance & Resources to Ensure Expansion of Access to COVID-19 Vaccines

HHS issued a Press Release announcing new resources that have been published to assist in ensuring people with disabilities and older adults access to COVID-19 vaccines. HHS notes that “these resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies – and examples of how the aging and disability network can help employ them to ensure accessibility.”

April 14, 2021: H.R. 1868 Becomes a Law – Sequestration Suspension Extended

The Coronavirus Aid, Relief, and Economic Security (CARES) act was enacted on March 27, 2020 and suspended the 2% sequestration payment adjustment applied to all Medicare FFS claims from May 1 through December 31, 2020. This payment adjustment was included in the Budget Control Act signed into law in August 2011 and became effective April 1, 2013. This Act required that $1.2 trillion in federal spending cuts be achieved over the course of nine years. With no action from Congress, sequestration would last until 2022. You can read more about the 2013 Sequestration in an American Medical Association FAQ document.

Additional legislation extended the suspension through March 31, 2021. A subsequent House Resolution (H.R.) finally made its way through the House and Senate. On April 14, 2021, an Act to Prevent Across-the-Board Direct Spending Cuts, and for Other Purposes was signed into law extending the Sequestration suspension through December 31, 2021.

CMS noted in the Friday April 16, 2021 edition of MLN Connects that Medicare Administrative Contractors will:

• Release any previously held claims with dates of service on or after April 16, 2021, and
• The emergency blanket waiver of the timeframe requirements for completing and transmitting resident assessment information (Minimum Data Set (MDS).

They ended the announcement by noting that you do not need to take any action.

April 15, 2021: CDC Clinical Outreach & Communication Call – Johnson & Johnson/Janssen COVID-19 Vaccine and Cerebral Venous Sinus Thrombosis with Thrombocytopenia – Update for Clinicians on Early Detection and Treatment

The CDC held this call to present the latest evidence on cerebral venous sinus thrombosis (CVST) with thrombocytopenia associated with the Johnson & Johnson/Janssen COVID-19 vaccine. If you missed this April 15th call, you can download the call materials from this CDC webpage.

April 15, 2021: OIG Message on COVID-19 Vaccination Program and Provider Compliancet

The OIG released a letter reminding vaccine providers and the public that the Federal Government is providing this vaccine and must be provided at no cost to recipients. They go on to note they are aware of patient complaints about charges by providers when getting their COVID-19 vaccines.

April 15, 2021: COVID-19 Public Health Emergency Extended

Secretary of Health and Human Services, Xavier Becerra, renewed the Public Health Emergency (PHE) due to the continued consequences of the COVID-19 pandemic. This most current extension will expire on July 20, 2021. In January of this year, HHS sent a letter to governors indicating the likelihood that the PHE will remain in place for all of 2021. They also indicated that states would be given a 60 days’ notice to the states prior to the termination of the PHE due to COVID-19.

April 16, 2021: COVID-19 Health Equity Task Force Virtual Meeting April 30, 2021

HHS posted a “Notice of Meeting” regarding the next COVID-19 Health Equity Task Force (Task Force) virtual meeting scheduled for April 30, 2021. As background, this Task Force was established by a January 21, 2021 Executive Order and the group is tasked with making recommendations for “mitigating the health inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.” This meeting is open to the public and will be lived streamed at www.hhs.gov/live. The confirmed time and agenda will be posted on the Task Forces’ webpage at www.minorityhealth.hhs.gov/healthequitytaskforce/.

April 16, 2021: COVID-19 Health Equity Task Force Virtual Meeting April 30, 2021

CMS included the following information regarding COVID-19 Vaccine history in their Friday April 16, 2020 edition of MLN Connects:

“Starting April 16, in addition to screening your patients, you can check Medicare eligibility (PDF) for COVID-19 vaccine administration history from Fee-for-Service (FFS) claims paid for calendar years 2020 and 2021. This includes Medicare Advantage patients.

You can get the following eligibility information for each paid vaccine administration claim:

• CPT or HCPCS codes
• Date of service
• National provider identifier for who administered the vaccine

We can only provide this information if the provider billed Medicare for administering the vaccine. If your patients got vaccinated and the provider didn’t submit a Medicare claim (like if they got vaccinated at a free event), ask your patients about their COVID-19 vaccination history.”

April 16, 2021: Medicare Telehealth Services List Updated

CMS indicated in the April 16, 2021 edition of MLN Connects that CMS had published an updated list of Medicare telehealth services on March 30th. They noted that due to the public health emergency, many audiology and speech-language pathology services have been added to the list effective March 1, 2021.

April 16, 2021: FDA Revokes EUA for Monoclonal Antibody Bamlanivimab

The FDA announced that they have revoked the Emergency Use Authorization (EUA) for Bamlanivimab, when administered alone, to treat mild-to-moderate COVID-19 in adults and certain pediatric patients. Patizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research stated in this announcement that “while the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital.” .

As a child of the 70’s in the south, the television line up at my house on Saturday night, when we were not at some type of ball game, was Looney Tunes, Hee Haw, Love Boat and Fantasy Island. That said, let us focus on Hee Haw’s Gossip Girls and their song that hopefully won’t get stuck on a loop in your head:

“Now, we’re not ones to go ‘round spreadin’ rumors, Why, really we’re just not the gossipy kind, No, you’ll never hear of us repeating gossip, So you’d better be sure and listen close the first time!”

Recently, I have read that Livanta, one of the current Beneficiary and Family Centered Care – Quality Improvement Organizations (BFCC-QIS), was going to be the new Medicare contractor responsible for Short Stay Reviews (SSRs) and higher-weighed-DRG (HWDRG) reviews nationwide. As background information, in May 2019, BFCC-QIO short stay reviews were put on hold as CMS planned to procure a new BFCC-QIO contractor who would perform SSRs and HWDRG reviews on a national basis. CMS anticipated awarding this contract by the 3rd quarter of calendar year 2019. As of last week, I had been unable to find an award notice from CMS and unlike the Gossip Girls, I have been waiting to find confirmation from CMS or Livanta before sharing information in our newsletter.

This past Friday April 9th, I found that Livanta has provided confirmation on their website, with the following bolded notice:

Attention Providers: Livanta was awarded the contract for performing claim reviews for Short Stay and Higher-Weight Diagnosis Related Group (HWDRG) claims in all U.S. states and territories.

Under the announcement there is a link to a new Livanta National Medicare Claim Review Contractor Webpage. Important information available to Providers on this webpage includes:

• Frequently asked questions such as information about HWDRG and Short Stay Reviews (SSRs).
• Information about a Memorandum of Agreement (MOA) that acute care inpatient hospitals, inpatient psychiatric hospitals, and long-term acute care (LTAC) hospitals are required to submit to Livanta. Note, the MOA template is available as a download on this page.
• Information about medical record reimbursement and the process for submitting medical records to Livanta.

As to the timing of when these reviews will begin, Livanta offers the following information:

“In the coming weeks, Livanta will begin conducting this work in all states, territories, and Washington, D.C. As part of the review activities, Livanta’s reviewers will evaluate whether the services performed were medically necessary and paid appropriately.”

Add Hospital Provider Compliance Audits to the List of OIG Activities You Need to Know

My oldest nephew is in the midst of his second semester of college life. Academically speaking, he excelled during the first semester. Unfortunately, that is not the case with his Freshman English class this spring. Evidently, the class involves writing several papers and his Professor has been less than impressed with my nephew’s writing efforts. My nephew has met with his Professor to try and understand what he can do to improve his writing skills. Unfortunately, even though his Professor has taken the time to talk with him, my nephew doesn’t seem to be able to pinpoint exactly what he needs to do from this discussion.

The OIG has been conducting Medicare Hospital Provider Compliance Audits as far back as March of 2011. To date, they have completed 190 audits. You can find a table of all these audits on the OIG’s Hospital Compliance Reviews webpage. Unlike my nephew’s English Professor, the OIG is very clear about what their audits focus on. Specifically, they focus on what they describe as “risk areas that we identified as a result of prior OIG audits at other hospitals.”

Two years into their Hospital Provider Compliance Audits, the OIG began to extrapolate audit findings with adverse financial consequences for Providers. In May of 2013, Nashville Tennessee based Saint Thomas Hospital, was the first hospital subject to extrapolation. In the Saint Thomas audit, the OIG identified overpayments of $293,359 and extrapolated this amount over the claims during the audit period. Through extrapolation, the OIG recommended that the Hospital refund to the contractor $1,092,248. In general, every hospital that has been subject to extrapolation during an OIG Hospital Provider Compliance Audit has disagreed with the OIG’s method for extrapolation.

OIG Hospital Provider Compliance Audit: Sunrise Hospital & Medical Center The OIG’s most recent audit was released on April 1, 2021 and details their audit of Sunrise Hospital & Medical Center located in Las Vegas, Nevada. Medicare paid the Hospital approximately $245 million for 15 million inpatient and 25,308 outpatient claims from January 1, 2017, through December 31, 2018 (the audit period).

The OIG’s audit covered about $41 million in Medicare payments to the hospital for 2,117 claims potentially at risk for billing errors. Ultimately, the audit included a stratified random sample of 100 claims (85 inpatient and 15 outpatient) with payments totaling $2.4 million. The at risk areas specific to this audit included:

• Inpatient rehabilitation facility claims,
• Inpatient comprehensive error rate testing (CERT) DRG codes,
• Inpatient high-severity level DRG codes,
• Inpatient mechanical ventilation,
• Inpatient claims paid in excess of $25,000,
• Inpatient same day discharge and readmit,
• Outpatient bypass modifiers,
• Outpatient claims paid in excess of $25,000,
• Outpatient claims paid in excess of charges, and
• Outpatient skilled nursing facility (SNF) consolidated billing.

The OIG found that the hospital complied with Medicare billing requirements for 46 of the 100 inpatient and outpatient claims reviewed. For the remaining 54 claims, the OIG found that the hospital did not fully comply with Medicare billing requirements. Specific claims and monetary impact included:

• 50 Inpatient claims had billing errors resulting in net overpayments of $1,002,049,
• 36 of these claims were Inpatient Rehabilitation Facility admissions where the OIG believed the Hospital had incorrectly billed for stays not meeting Medicare criteria for acute inpatient rehabilitation.
• 4 Outpatient claims had billing errors resulting in net underpayments of $2,099.
• The OIG estimated that the Hospital received overpayments of at least $23,615,809 for the audit period.

Ultimately, the OIG extrapolated the audit findings and recommended that the Hospital refund to the Medicare contractor $23.6 million in net estimated overpayments. The Hospital disagreed with most of the OIG’s findings. However, at the end of the day, the OIG indicated that “after review and consideration of the Hospital’s comments, we maintain that our findings and recommendations are correct.”

Moving Forward

In spite of the COVID-19 pandemic, the OIG managed to publish the results from nine Hospital Provider Compliance Audits in 2020. Given that the OIG has been conducting this type of audit since 2011 and their propensity to extrapolate audit findings, understanding provider compliance “at risk” issues has become as important as knowing what items are on the OIG’s Work Plan.

This week we highlight key updates spanning from April 6th through April 12th, 2021.

Resource Spotlight: WPS YouTube Video: New COVID-19 Condition Codes for Billing Vaccines/Monoclonal Antibody Infusions

WPS, the Medicare Administrative Contractor (MAC) for Jurisdictions 5 and 8, has published a New COVID-19 Condition Codes YouTube video, which includes information on the new condition codes required when billing for COVID-19 vaccines and monoclonal antibody infusions.

April 6, 2021: FDA Issues Emergency Use Authorization (EUA) for COVID-19 Self-Collected Antibody Test System

The FDA announced that they issued a EUA to Symbiotica, Inc., for the COVID-19 Self-Collected Antibody Test System. This test requires a prescription from a health care provider, is intended as an aid in identifying individuals who have had an “adaptive immune response to SARS-CoV-2, indicating the person may have had a recent or previous COVID-19 infection. Samples collected at home are sent to a Symbiotica, Inc. laboratory for analysis.”

April 8, 2021: Revised MLN Booklet: Hospital Value Based Purchasing

In the Thursday April 8, 2021 MLN Connects newsletter, CMS noted that they have updated the MLN Booklet titled Hospital Value Based Purchasing. CMS made the following content updates to this booklet:

• Added information on relief for clinicians, providers, hospitals, and facilities participating in quality reporting and value-based purchasing programs due to the COVID-19 public health emergency,
• Added Hospital VBP domains and relative weights for FYS 2018-2023,
• Revised Hospital VPB measures for FYS 2021-2023, and
• Revised baseline and performance periods for FYs 2021-2023.

April 8, 2021: CMS Memorandum: Updates to Long-Term Care (LTC) Emergency Regulatory Waivers Issued in Response to COVID-19

CMS released this memorandum to State Survey Agency Directors. In the memorandum summary, CMS indicated they are ending the following waivers for nursing homes:

• The emergency blanket waivers related to notification of Resident Room or Roommate changes, and Transfer and Discharge notification requirements:
• The emergency blanket waiver for certain care planning requirements for residents transferred or discharged for cohorting purposes, and
• The emergency blanket waiver of the timeframe requirements for completing and transmitting resident assessment information (Minimum Data Set (MDS).

April 9, 2021: CDC’s Understanding Viral Vector COVID-19 Vaccines Webpage Updated

There has been confusion and distrust reported in the news and anecdotally on social media regarding the COVID-19 vaccines. Specifically, there has been concerns about the COVID-19 virus being in the vaccine. The CDC’s Understanding Viral Vector COVID-19 Vaccines webpage currently starts with providing the following “What You Need to Know” information:

• “Viral vector vaccines use a modified version of a different virus (the vector) to deliver important instructions to our cells.
• The benefit of viral vector vaccines, like all vaccines, is those vaccinated gain protection without ever having to risk the serious consequences of getting sick with COVID-19.”

Also available on this webpage is a printable infographic titled “How Viral Vector COVID-19 Vaccines Work.”