Knowledge Base - Full Library

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from August 17th through the 24th.

Resource Spotlight: OSHA Guidance on Preparing Workplaces for COVID-19

The Occupational Safety and Health Administration has published Guidance on Preparing Workplaces for COVID-19. This guide provides information about how a COVID-19 outbreak could affect workplaces, classifying worker exposure to SARS-CoV-2 and what to do to protect workers at low, medium and high or very high risk of exposure.

You can find additional guides made available by OSHA on their COVID-19 webpage at  https://www.osha.gov/SLTC/covid-19/.

August 17, 2020: Resumption of Routine Inspections, Updated Enforcement Guidance to States, and Toolkit for Nursing Homes

CMS announced in a Press Release that routine inspections of all Medicare and Medicaid certified providers and suppliers is set to resume. Inspections had been suspended in response to the COVID-19 pandemic. CMS directed the resumption of the following as soon as resources are available: 

• Onsite revisit surveys,
• Non-immediate jeopardy complaint surveys, and
• Annual recertification surveys.

Additional actions included in the press release:

• Guidance provided on resolving enforcement cases previously on hold because of survey prioritization changes, and
• Temporary expansion of the desk review policy,
• Guidance on the re-prioritization of routine state survey agency activities on Clinical Laboratory Improvement Amendments (CLIA),
• Updates to the “Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes.”

August 19, 2020: HHS Expands Access to Childhood Vaccines during COVID-19 Pandemic

In an August 19th Press Release, HHS announced that a third amendment to the Declaration under the Public readiness and Emergency Preparedness Act (PREP Act) has been issued to increase access to childhood vaccines by authorizing State-licensed pharmacists (and pharmacy interns acting under their supervision to administer vaccines to individuals ages three through eighteen years. There are several requirements the pharmacist must meet. For example, “the licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.”

HHS Secretary Alex Azar states in the announcement that “today’s action means easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic.”

August 19, 2020: FDA COVID-19 Daily Roundup: UV Lights and Lamps FAQs

In their August 19th COVID-19 Daily Roundup, the FDA announced the posting of FAQs for consumers about UV lights and lamps. The FAQs answer questions about the use of lamps for disinfection during the COVID-19 pandemic.

August 20, 2020: Kaiser Health News Article: Scam Alert: Things a COVID Contract Tracer Wouldn’t Say

This Kaiser Health News (KHN) article by Julie Appleby opens with letting readers know that, “State officials and federal agencies warn there’s a new phone scam circulating: Some callers posing as COVID-19 contact tracers try to pry credit card or bank account information from unsuspecting victims. This article provides examples of what scammers are trying and links to consumer alerts from several sources include the Federal Trade Commission and the Better Business Bureau among others.

August 21, 2020: Update to the ICD-10 Diagnosis Codes for Vaping Related Disorder and Diagnosis and Procedure Codes for the 2019 Novel Coronavirus (COVID-19) - MLN Article Revised

CMS first released MLN Matters article MM11623 on January 24, 2020. CMS revised this article on August 21, 2020. Now in its further iteration, the article has been revised to reflect an updated Change Request (CR) 11623 which updated the title, Background section and includes new procedure codes in Version 37.2 of the ICD-10 Medicare Severity - Diagnosis Related Groups (MS-DRG) Grouper and ICD-10 Medicare Code Editor (MCE). The CR release date, transmittal number and link to the transmittal also changed.

August 23, 2020: FDA Issues Emergency Use Authorization (EUA) for Investigational Convalescent Plasma to Treat COVID-19

The FDA indicated in a news release that “today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.” The EUA requires that fact sheets providing information regarding the use of convalescent plasma in COVID-19 treatment be available to health care providers and patients. 

August 24, 2020: HHS Press Release – Health Plans added to June 2020 Plasma Donation Guidance

HHS announced in a Press Release that the Office of Civil Rights (OCR) has “issued amended guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered health care providers (e.g., hospitals, pharmacies, laboratories) and health plans to contact their patients and beneficiaries who have recovered from COVID-19 to inform them about how they can donate their plasma containing antibodies (known as "convalescent plasma") to help treat others with COVID-19.” This announcement includes a link to the amended guidance.

August 24, 2020: Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment – MLN Article Revised

CMS first released MLN Matters article MM11937 on August 7, 2020. This article was revised on August 24, 2020 to reflect an updated CR 11937 that includes additional COVID-19 codes 86408, 86409, 0225U and 0226U, effective August 10, 2020. CR 11937 also added codes 0015M and 0016M, effective October 1, 2020. The CR release date, transmittal number and link to the transmittal also changed.

MEDICARE TRANSMITTALS – RECURRING UPDATES

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

• Article Release Date: August 4, 2020
• What You Need to Know: This article informs providers about updated ICD-10 conversions and coding updates specific to National Coverage Determinations (NCDs). Change Request 11905 includes coding changes for the following NCDs:
• NCD 20.4 Implantable Cardiac Defibrillators (ICDs)
• NCD 50.3 Cochlear Implants
• NCD 90.2 Next Generation Sequencing (NGS)
• NCD 220.6.17 Positron Emission Tomography (FDG) for Oncologic Conditions
• MLN MM11905: https://www.cms.gov/files/document/mm11905.pdf

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – October 2020 Update

• Article Release Date: August 7, 2020
• What You Need to Know: This article provides information about the issuance of updated payment files in October of the 2020 MPFS.
• MLN MM11939: https://www.cms.gov/files/document/mm11939.pdf

Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

• Article Release Date: August 7, 2020
• What You Need to Know: This article informs laboratories of changes resulting from the quarterly update to the clinical laboratory fee schedule. With the ongoing Public Health Emergency (PHE) this quarterly update includes changes made due to the COVID-19 pandemic.
• MLN MM11937: https://www.cms.gov/files/document/mm11937.pdf

Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2021

• Article Release Date: August 21, 2020
• What You Need to Know: This article identifies changes required as part of the annual IPF PPS update. Changes are applicable to discharges occurring from October 1, 2020, through September 30, 2021 (FY 2021). The related Change Request (CR) applies to the Medicare Claims Processing Manual (CLM), Chapter 3, Section 190.4.3.
• MLN 11949: https://www.cms.gov/files/document/mm11949.pdf

OTHER MEDICARE TRANSMITTALS

New Waived Tests

• Article Release Date: July 28, 2020
• What You Need to Know: This article provides information about five new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests that have been approved by the FDA. These tests are marketed immediately after approval so CMS must notify the MACs of the new tests for accurate claims processing. “Note: MACs will not search their files to either retract payment or retroactively pay claims. However, MACs should adjust claims if you bring those claims to their attention.
• MLN Matters MM11916: https://www.cms.gov/files/document/mm11916.pdf

Update to Osteoporosis Drug Codes Billable on Home Health Claims

• Article Release Date: August 7, 2020
• What You Need to Know: Change Request (CR) adds instructions for billing and payment of additional codes for osteoporosis drugs under the home health benefit.
• MLN MM11846: https://www.cms.gov/files/document/mm11846.pdf

Correction to Editing Update for Vaccine Services

• Article Release Date: August 7, 2020
• What You Need to Know: This article informs you that Medicare is changing the Common Working File (CWF) to bypass line-item dates of service for vaccines reported on inpatient Part B claims with Type of Bill (TOB) 12X and 22X when the dates of service (DOS) equal a posted outpatient TOB 73X or 77X service dates, or if present, occurrence span code visit date, regardless of the date of service.
• MLN MM11867: https://www.cms.gov/files/document/mm11867.pdf

Billing for Home Infusion Therapy Services on or After January 1, 2021

• Article Release Date: August 7, 2020
• What You Need to Know: This article provides guidance, for qualified Home Infusion Therapy (HIT) suppliers who bill Medicare Part B MACs, about claims processing systems changes necessary to implement Section 5012(d) of the 21st Century Cures Act. Changes will be effective on or after January 1, 2021.
• MLN Article: MM11880: https://www.cms.gov/files/document/mm11880.pdf

Telehealth Expansion Benefit Enhancement Under the Pennsylvania Rural Health Model (PARHM) – Implementation

• Article Release Date: August 10, 2020
• What You Need to Know: This article provides information about the PARHM and the “Transformation Plans” for participating hospitals. CR 11870 expands the allowable telehealth services for Model-participant hospitals. Without this CR, some hospitals may fail to meet healthcare transformation goals set by the Model. Make sure your billing staffs are aware of these changes.
• MLN Article MM11870: https://www.cms.gov/files/document/mm11870.pdf

The Intravenous Immune Globulin (IVIG) Demonstration: Demonstration is ending on December 31, 2020

• Article Release Date: August 21, 2020
• What You Need to Know: This article is notification of the IVIG Demonstration ending December 31, 2020.
• MLN MM11877: https://www.cms.gov/files/document/mm11877.pdf

REVISED MEDICARE TRANSMITTALS

Influenza Vaccine Payment Allowances – Annual Update for 2020-2021 Season

• Article Release Date: July 10, 2020 – Revised July 31, 2020
• What You Need to Know: This MLN article was revised to reflect an updated Change Request (CR) 11882 that extended the implementation date to no later than October 1, 2020 and for mass adjustments no later than November 1, 2020.
• MLN MM11882: https://www.cms.gov/files/document/mm11882.pdf

October 2020 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files – REVISED

• Article Release Date: July 2, 2020 – Revised August 14, 2020
• What You Need to Know: Changes made on August 14th were a revised Change Request (CR) release date, transmittal number and web address. All other information remained the same.
• MLN MM11854: undefined

Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2021

• Article Release Date: July 2, 2020 – Revised August 19, 2020
• What You Need to Know: This article was revised to reflect a revised CR 11859 which “shows that effective for Fiscal Year (FY) 2021, a 5 percent cap will be adopted and applied to all Skilled Nursing Facility providers on any decrease to a provider’s FY 2021 final wage index from that provider’s final wage index of the prior fiscal year (FY 2020).”
• MLN MM11859: https://www.cms.gov/files/document/MM11859.pdf

MEDICARE COVERAGE UPDATES

CMS Transmittal 10228 (Change Request 11884): Updates to Chapters 1-8, 10, and 11 to Publication 100-08 (Medicare Program Integrity Manual)

• Transmittal Release Date: July 27, 2020
• What You Need to Know: The purpose of Change Request (CR) 11884 is to update all references of Program Safeguard Contractor (PSC) and Zone Program Integrity Contractor (ZPIC) to Unified Program Integrity Contractor (UPIC) within Chapters 1-8, 10, 11, and Exhibits in the Medicare Program Integrity Manual (Publication 100-08).
• CR11884: https://www.cms.gov/files/document/r10228pi.pdf

CMS Proposes Updates to Coverage Policy for Artificial Hearts and Ventricular Assist Devices (VADs)

CMS announced in an August 12, 2020 Press Release their proposed updates to coverage policies for artificial hearts and VADs, “both of which are used to treat patients with life-threatening advanced heart failure.” The proposed decision memorandum would:

• Eliminate the coverage with evidence development (CED) requirement for artificial hearts,
• MACs would become responsible for providing coverage determinations for artificial hearts, and
• Providers updated coverage criteria for VADs “that better aligns with current medical practice and provides additional flexibility for patients and providers to choose the most appropriate treatments.”

CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-proposes-updates-coverage-policy-artificial-hearts-and-ventricular-assist-devices-vads

OTHER MEDICARE UPDATES

July 31, 2020: CMS Releases Inpatient Psychiatric Facility (IPF), Skilled Nursing Facilities (SNF), and Hospices FY 2021 Final Rules

CMS announced in a News Alert that they are “finalizing three Medicare payment rules that further advance our efforts to strengthen the Medicare program by better aligning payments for inpatient psychiatric facilities (IPF), skilled nursing facilities (SNF) and hospices.”   For fact sheets on each final rule, visit:

• IPF PPS – https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2021-final-medicare-payment-and-policy-changes-inpatient-psychiatric-facilities-cms-1731
• SNF PPS – https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2021-payment-and-policy-changes-medicare-skilled-nursing-facilities-cms-1737-f
• Hospices PPS -- https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2021-hospice-payment-rate-update-final-rule-cms-1733-f

CY 2021 Physician Fee Schedule (PFS) Proposed Rule with Comment Period

CMS announced the release of this proposed rule in an August 3, 2020 CMS Fact Sheet. A few of the proposals highlighted in the Fact Sheet includes:

• A proposed CY 2021 PFS conversion factor of $32.26 which is down $3.83 from the CY 2020 PFS conversion factor of $36.09,
• Proposal to add several services to the Medicare telehealth list on a Category 1 basis,
• Proposal to create a third temporary category of criteria for adding services to the Medicare telehealth services list. Category 3 describes services added during the PHE for the COVID-19 pandemic that will remain on the list through the calendar year in which the PHE ends. The PHE determination as a result of COVID-19 was most recently renewed on July 23, 2020,
• Proposal to make permanent following the COVID-19 PHE, the same policy that was finalized under the May 1st COVID-19 IFC, for the duration of the COVID-19 PHE. This proposal would allow nurse practitioners (NPs), clinical nurse specialists (CNSs), physician assistants (PAs) and certified nurse-midwives (CNMs) to supervise the performance of diagnostic tests in addition to physicians, and
• Proposal to make permanent our Part B policy for maintenance therapy services that we adopted on an interim basis for the PHE in the May 1st COVID-19 IFC that grants a physical therapist (PT) and occupational therapist (OT) the discretion to delegate the performance of maintenance therapy services, as clinically appropriate, to a therapy assistant – a physical therapist assistant (PTA) or an occupational therapy assistant (OTA). 

August 2020 OIG Report: Inadequate Edits and Oversight Caused Medicare to Overpay More Than $267 Million for Hospital Inpatient Claims with Post-Acute-Care Transfers to Home Health Services

The OIG’s objective in performing this audit was to determine whether Medicare properly paid acute-care hospital inpatient claims subject to the transfer policy when hospitals:

• Did not code the claims as a discharge to home with home health services when the beneficiary resumed home health services within 3 days of discharge,
• Applied condition code 43 indicating that the home health services were not provided within 3 days of discharge, or
• Applied condition code 42 indicating that the home health services were not related to the inpatient hospital services.

The OIG audit 150 inpatient claims with dates of service in fiscal years 2016 and 2017 and found that 147 claims were improperly paid with $722,288 in overpayments. Based on the sample the OIG estimated that Medicare improperly paid $267 million during the 2-year period when services should have been paid at a graduated per diem rate.

• OIG Report Number A-04-18-04067: https://oig.hhs.gov/oas/reports/region4/41804067.pdf

CMS Announces Initiative to Transform Rural Health

CMS announced new funding opportunities to increase access and improve quality. The Community Health Access and Rural Transformation (CHART) Model “also ties payment to value, increase choice and lowers cost to patients.

Link to August 11, 2020 Press Release: https://www.cms.gov/newsroom/press-releases/trump-administration-announces-initiative-transform-rural-health

Link to CHART Model webpage: https://innovation.cms.gov/innovation-models/chart-model

OIG’s Top Unimplemented Recommendations: Solutions to Reduce Fraud, Waste, and Abuse in the HHS Program

The OIG released their annual publication of this report on August 11th. The top 25 recommendations made are based on audits and evaluations issued through December 31, 2019. Seven of the top twenty-five recommendations are related to Medicare Parts A and B. One of the seven recommendations is that CMS re-evaluate the Inpatient Rehabilitation Facility (IRF) payment system.

The U.S. government’s PaymentAccuracy website “is dedicated to ensuring the American people that its government is addressing…and taking concrete steps on prevention and recovery of improper payments.” According to the Department of Health and Human Services Q4 2019 Payment Scorecard, IRF medical necessity errors resulted in overpayments of $6,740M. Program goals include continuing to educate IRF providers through the Targeted Probe and Educate (TPE) program and approve IRF issues for Recovery Audit Contractor (RAC) review, as appropriate.

Link to PaymentAccuracy website: https://www.paymentaccuracy.gov/about-payment-accuracy/

Welcome to this month’s MAC Talk article. This month before diving into updates from the MACs, there have been updates issued about the new ABN form and the resumption of Medicare Contractor Medical reviews since first discussed in the July 2020 MAC Talk article.

New Fee-For-Service (FFS) Advanced Beneficiary Notice of Noncoverage (ABN) Form CMS-R-131

Last month’s MAC Talk article alerted you to the June 24th modification found on the FFS ABN CMS webpage indicating form CMS-R-131 had been approved and use of the form was set to be mandatory on August 31, 2020.

On August 3rd CMS once again modified this CMS webpage further delaying the mandatory implementation date for the new ABN form:

“The ABN, Form CMS-R-131, and instructions have been approved by the Office of Management and Budget (OMB) for renewal.  Due to COVID-19 concerns, CMS has expanded the deadline for use of the renewed ABN, Form CMS-R-131 (exp. 6/30/2023).  At this time, the renewed ABN will be mandatory for use on 1/1/2021.  The renewed form may be implemented prior to the mandatory deadline.  The ABN form and instructions may be found in the download section.”

Medical Review during the COVID-19 Public Health Emergency

On July 6, 2020, CMS released the document Coronavirus Disease 2019 (COVID-19) Provider Burden Relief Frequently Asked Questions (FAQs). The very first FAQ addresses Medicare Fee-for-Service medical reviews indicating CMS’s intent to allow the resumption of medical reviews beginning on August 3, 2020, “regardless of the status of the public health emergency.”

On August 4th Palmetto GBA provided additional detail about the resumption of medical reviews. Specifically,

• MACs are resuming post-payment reviews of items/services provided prior to March 1, 2020,
• The Targeted Probe and Educate (TPE) program will restart later, and
• MACs will continue to offer detailed review decisions and education as appropriate.

On August 19th Palmetto GBA posted a related article Receiving and Responding to a Palmetto GBA Additional Documentation Request (ADR) for Postpayment Review. In addition to details about receiving and responding to requests, this article provides a link to active service specific post-payment medical review topics for Part A inpatient and outpatient hospital services and Part B Physician Services.

August MAC Talk: The Local Scene

July 21, 2020: Noridian JE Article: Part B Provider Responsibility for Prior Authorization for Certain Hospital Outpatient Department Services

At the time of this month’s MAC Talk article, the Prior Authorization program is almost into its third month. Here at MMP we have had several clients seeking clarification on who is responsible for obtaining the prior authorization. The following comment and CMS response is excerpted from page 61453 of the Final Rule (CMS-1717-FC):

Who is Responsible for Obtaining Prior Authorization?

“Comment: We received comments with general questions regarding the proposed process such as who will be responsible for obtaining the prior authorization, that is, the physician or the hospital, and whether all related claims will be denied if prior authorization is not obtained. Some commenters expressed concern that physicians could be denied payment for services rendered if a hospital fails to submit a prior authorization request or fails to notify the physician of a denial.

Response: As noted above, this prior authorization process is being adopted under section 1833(t)(2)(F) of the Act, which is specific to OPD services, which provides payment only to hospital outpatient departments. In light of the different arrangements that could exist in different hospitals, we determined that enabling either the physician or the hospital to submit the prior authorization request on behalf of the hospital outpatient department was the best approach, though the hospital ultimately remains responsible for ensuring this condition of payment is met.”

In an article posted on July 21, 2020 by Noridian Healthcare Solutions, the JE MAC, they indicated the following regarding the physician’s involvement in the prior authorization process:

“Noridian has been receiving requests for prior authorizations from Part B providers, who bill on the CMS-1500 form.

This program is for outpatient hospital services billed on a UB-04 form, with type of bill 13X. Providers who bill on a CMS-1500 form should not submit prior authorization requests for the OPD services, because it is the facility’s responsibility to send in the request. A valid prior authorization request must contain the Part A Provider Transaction Access Number (PTAN), which is six digits. Requests that come from a physician’s office will be rejected.

It is the physicians’ responsibility to assist the facility by ensuring copies of the patient’s medical records are available for the following services:

• Blepharoplasty
• Botulinum Toxin Injections - use for chronic migraine treatment
• Panniculectomy
• Rhinoplasty
• Vein Ablation.”

Noridian published the following subsequent article on August 18, 2020:

“While this prior authorization process is applicable to hospital OPDs, as specified in CMS-1717-FC, CMS allows the PA request to be sent by the physician/practitioner on behalf of the hospital OPD. If a PA request submitted by the physician/practitioner includes all necessary hospital OPD information, it is considered to be sent on behalf of the hospital OPD.

Please visit our Prior Authorization for OPD Services Webpage to learn about submitting requests. Last Updated Aug 18, 2020”  

July 29, 2020: Palmetto GBA JJ Part B Claims Payment Issue (CPI) Regarding Stelara®

Palmetto GBA has identified an issue with Stelara®. Specifically, Stelara® billed with HCPCS codes J3357 denying as a self-administrated drug (SAD) when it should be excluded as indicated in the SAD Exclusion List Article #A53066. The issue affected claims with dates of service on or after April 20, 2020. As of July 29th Providers are asked to hold new claims for this HCPCS code until this CPI is updated, indicating editing has been updated. As of August 24, 2020, the status of this issue was the needed updates and adjustments were still pending.

August 3, 2020: Noridian Telehealth and Virtual Visits – During COVID-19 Webinar – September 17, 2020

Noridian Healthcare Solutions, the Medicare Administrative Contractor for jurisdictions E and F, Provider Outreach and Education (POE) staff will be hosting a webinar on September 17, 2020 at 1 p.m. PT. Topics for this session includes:

• Telehealth information
• Service Listings
• Waiver Changes
• Eligible Providers
• Billing Part A and Part B
• Other Telecommunication Services, and
• Questions and Answers

August 5, 2020: Who are the Medical Directors for Palmetto GBA?

Palmetto GBA posted an article highlighting their Medical Directors. Information about each of the Medical Directors includes their specific responsibility at Palmetto GBA (i.e. accountable for coverage policy activities, Director of the MolDX program) and details about their professional background.

August 7, 2020: COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing: Condition Code 44 FAQ

At the time this article was written this CMS FAQ Document was last updated on August 7th when a question regarding the use of Condition Code 44 was answered by CMS.

“Question: CMS is waiving the entire utilization review (UR) condition of participation at 42 CFR 482.30, which requires that a hospital must have a UR committee with a UR plan that provides for review for Medicare and Medicaid patients with respect to the medical necessity of the admissions to the institution, duration of stays, and professional services furnished, including drugs and biologicals. Does that mean that the use of Condition Code 44 is waived as well?

Answer: No, Condition Code 44 still applies. Although CMS has waived the UR condition of participation at 42 CFR 482.30, this does not mean that if a beneficiary’s status is changed from inpatient to outpatient and there is a determination that the inpatient admission does not meet the hospital’s inpatient criteria, that the hospital may bill an inpatient claim. Hospitals should report Condition Code 44 as appropriate.

New: 8/7/20”

August 14, 2020: First Coast Post-Payment Service-Specific Reviews

First Coast posted the following information about post-payment service-specific reviews:

“First Coast is tasked with preventing inappropriate Medicare payments. One of the ways this is conducted is through medical review of claims. Medical review of claims helps to ensure that Medicare pays for services that are covered, correctly coded, and medically reasonable and necessary.

First Coast performs data analysis on a regular basis on all services billed to Medicare to identify services that are frequently not billed and coded correctly per Medicare guidelines. Post-pay service-specific reviews are performed based on results of a widespread data analysis that focuses on specific topics. If you bill Medicare for these services, you may receive an additional development request (ADR) letter asking for documentation. This allows First Coast to validate that you have billed the services correctly according to Medicare guidelines. Once the ADR is received, you will have 45 days to respond to the request with the supporting medical record documentation. The review will be completed within 60 days of receipt of the documentation. When the review is completed, you will be notified of the results.”

August 17, 2020: WPS Billing and Coding Article: Nerve Blocks for Peripheral Neuropathy (A57598) Updated

WPS has updated their Local Coverage Article (A57589), “Billing and Coding: Nerve Blocks for Peripheral Neuropathy” to include ICD-10-CM codes that do not support medical necessity effective September 13, 2020. Use the Local Coverage Determination (LCD) and Billing and Coding/Policy Article Lookup to access our Billing and Coding/Policy Articles.

August 18, 2020: Palmetto GBA Posts Part A Ask the Contractor (ACT): Comprehensive Error Rate Testing FAQs from August 13, 2020 Call

Sandra Booker, Senior Provider Education Consultant for Palmetto GBA noted that “the ACT is intended to open the communication channels between the provider community and Palmetto GBA.” The August 13th call focused on providing education to and answering questions from providers regarding the Comprehensive Error Rate Testing (CERT) program.

One question asked during the call was related to whether or not the CERT is currently performing reviews or are reviews on hold due to COVID-19. Palmetto GBA’s response to the question was that “CMS has allowed them to start the process. Palmetto GBA is not doing the TPE process as of yet. We have not been directed by CMS to continue TPE. But all this information should be published on the Palmetto GBA web site. CERT is now sending letters, so you should be receiving those soon.”

August 21, 2020: Palmetto GBA’s Outpatient Department Prior Authorization Teleconference on September 16, 2020

Palmetto GBA posted an article announcing their next teleconference to provide up-to-date information as well as a chance for providers to ask questions about the Outpatient Department Prior Authorization Program. The teleconference is scheduled from 11 a.m. to 12 p.m. ET. You will find the dial in number and conference ID in the article.

August 21, 2020: Noridian Article – Incorrect Patient Status One of Most Common Errors on Part A Claims

Noridian indicates in this article that incorrect patient status is one of the most common errors on Part A claims. This article includes links to a Quick Reference Guide Patient Status webpage and Quick Reference Billing Guide Condition Codes webpage. Also, as a reminder, an incorrect patient status could have a negative impact for patient admissions assigned a DRG that is included in the post-acute care transfer (PACT) policy. You can read more about the PACT Policy in a related MMP article.

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1736-P) was released on August 4, 2020 and published in the Federal Register on August 12th. In last week’s article we reviewed proposals related to the Inpatient Only Procedure List and proposed new service categories subject to the Hospital Outpatient Department Prior Authorization Program.

This week we move on to proposed changes for supervision of outpatient therapeutic services and the changes to the Ambulatory Surgical Center Covered Procedures List.

Proposed Changes in the Level of Supervision of Outpatient Therapeutic Services in Hospitals and Critical Access Hospitals (CAHs)

In the 2020 OPPS Final Rule, CMS finalized their proposed policy to change the “generally applicable minimum required level of supervision for hospital outpatient therapeutic services from direct supervision to general supervision for services furnished by all hospitals and CAHs.” General supervision means that the procedure is furnished under the physician’s overall direction and control, but that the physician’s presence is not required during the performance of the procedure.

This policy became effective January 1, 2020 and will remain in place for future years unless modified by later notice and comment rulemaking.

In the 2021 OPPS Proposed Rule CMS notes that on March 31, 2020 CMS issued interim final rule with comment period (IFC) to give providers “needed flexibilities to respond effectively to the serious public health threats posed by the spread of the COVID-19.”

Specific to the level of supervision the following policies were adopted in the IFC to be effective for the duration of the Public Health Emergency (PHE) due to COVID-19:

• A policy to reduce the minimum default level of supervision for non-surgical extended duration therapeutic services (NSEDTS) to general supervision for the entire service, including the initiation portion of the service, for which CMS previously required direct supervision on initiation of the service.
• A policy indicating that the requirement for direct supervision of pulmonary, cardiac and intensive cardiac rehabilitation services includes virtual presence of the physician through audio/video real-time communications technology when use of such technology is indicated to reduce exposure risks for the beneficiary or health care provider.

CMS has decided that these policies are appropriate outside of the PHE and are proposing to adopt them for CY 2021 and beyond.

CMS reminds providers that “it is important to remember that the requirement for general supervision for an entire NSEDTS does not preclude these hospitals from providing direct supervision for any part of a NSEDTS when the practitioners administering the medical procedures decide that it is appropriate to do so. Many outpatient therapeutic services including NSEDTS may involve a level of complexity and risk such that direct supervision would be warranted even though only general supervision is required.”

Proposed Additions to the Ambulatory Surgical Center (ASC) Covered Procedures

In general procedures on the ASC covered procedure list (ASC-CPL) are those procedures that are not “expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure.”

CMS has proposed to continue to apply the revised definition of “surgery” adopted in the CY 2019 OPPS/ASC Final Rule that includes procedures that are “surgery-like” procedures that are assigned outside the CPT surgical range, for CY 2021 and subsequent years.

CMS Outlook for the Future of the ASC-CPL

CMS has posed many thoughts/beliefs about the future of ASCs in the proposed rule. Following are some of the statements found in the proposed rule:

• CMS believes “that significant advancements in medical practice, surgical techniques, medical technology, and other factors have allowed certain ASCs to safely perform procedures that were once too complex, including those involving major blood vessels and other general exclusion criteria.
• CMS acknowledges “that ASCs and hospitals have different health and safety requirements. Despite this fact, ASCs often undergo accreditation as a condition of state licensure and share some similar licensure and compliance requirements with hospitals as well as meet Medicare conditions for coverage (see 42 CFR 416.40 through 416.54).”
• CMS reminds the reader that “in recent years, we have added procedures to the ASC-CPL that were largely considered hospital inpatient procedures in the past, such as TKA and certain coronary intervention procedures.”
• “Many procedures that are currently only payable as hospital outpatient services under Medicare fee-for-service are safely performed in the ASC setting for other payors.”
• CMS recognizes “that non-Medicare patients tend to be younger and have fewer comorbidities than the Medicare population.” However, “careful patient selection can identify Medicare beneficiaries who are suitable candidates for these services in the ASC setting.”
• “Medicare Advantage plans are not obligated to adopt the ASC-CPL as it exists in Medicare fee-for-service and…many MA enrollees have had services performed in the ASC setting that are not currently payable under Medicare fee-for-service.”
• “The COVID-19 pandemic has highlighted the need for more healthcare access points throughout the country…Looking ahead to after the pandemic, it will be more important than ever to ensure that the health care system has as many access points and patient choices for all Medicare beneficiaries as possible. Because the pandemic has forced many ASCs to close, thereby decreasing Medicare beneficiary access to care in that setting, we believe allowing greater flexibility for physicians and patients to choose ASCs as the site of care, particularly during the pandemic, would help to alleviate both access to care concerns for elective procedures as well as access to emergency care concerns for hospital outpatient departments.”
• “In this CY 2021 OPPS/ASC proposed rule, we are seeking to continue to promote site neutrality, where possible, between the hospital outpatient department and ASC settings, and expanding the ASCCPL to include as many procedures that can be performed in the HOPD as reasonably possible will advance that goal.”

Table 40. - Proposed Additions to the List of ASC Covered Procedures for CY 2021

Inpatient, outpatient or ASC, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed. CMS is accepting comments on the proposed rule up until 5 p.m. EST on October 5, 2020.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from August 11th through August 17th.

Resource Spotlight: KFF’s Kaiser Health News (KHN) and Guardian U.S. New Interactive Database

In an August 11, 2020 KFF News Release, KHN announced a new interactive database from KHN and Guardian US. This “interactive tool — the nation’s most comprehensive independent database of health care workers who have lost their lives — can be searched by factors such as race and ethnicity, age, occupation, location and whether the workers had adequate access to protective gear. The database is freely available to help local news organizations profile workers in their communities who have lost their lives fighting the pandemic. The profiles include medical professionals like doctors, nurses and paramedics, and others working at hospitals, nursing homes and other medical facilities, including aides, administrative employees, and cleaning and maintenance staff.”

August 10, 2020: CDC Data - Total Cases, Total Deaths and Wearing Masks

On the CDC’s webpage Cases in the U.S. you will find the total number of cases and deaths in the U.S. due to COVID-19. This information is updated daily based on data confirmed at 4:00pm ET the day before. The August 10th updated data indicates that the U.S. has had 5,023,649 total cases (48,690 new cases compared to August 9th) and 161,842 total deaths (558 new deaths compared to August 9th.)

The CDC also has a COVID-19 webpage dedicated to information About Masks. I share this with you because the Physician’s Office in the building where I work has posted signs telling patients that masks with valves or vents are not allowed in the building. The CDC has posted the following information on their About Masks webpage providing an answer to why they are not allowed: 

“The purpose of masks is to keep respiratory droplets from reaching others to aid with source control. Masks with one-way valves or vents allow exhaled air to be expelled out through holes in the material.  This can allow exhaled respiratory droplets to reach others and potentially spread the COVID-19 virus. Therefore, CDC does not recommend using masks if they have an exhalation valve or vent.”

August 10, 2020: COVID-19 Laboratory Reporting Requirements

The CDC posted the following Clinician Outreach and Community Activity (COCA) Now Alert about COVID-19 laboratory reporting requirements:

“The public health response to COVID-19 depends on comprehensive laboratory testing data. The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the HHS Laboratory Data Reporting Guidance released on June 4, 2020 require every COVID-19 testing site to report specific data elements for every diagnostic and screening test performed to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody). The data are to be reported to the appropriate state or local public health department, based on the individual’s residence.

Healthcare providers also have a critical role in collecting several of the data elements when ordering a COVID-19 laboratory test, particularly demographic information such as the patient’s age, sex, race, and ethnicity. Beginning August 1, 2020, testing sites should make every reasonable effort to report these demographic data to state and local health departments using existing public health reporting channels (in accordance with state law or policies).

Complete demographic data will:  

• Ensure that all groups have equitable access to testing, 
• Allow an accurate determination of the burden of infection on vulnerable groups, and  
• Help improve decision-making to better prevent or mitigate further COVID-19 illness among Americans.

Below are some additional resources for more information about this COVID-19 laboratory reporting requirement:

• CDC’s How to Report COVID-19 Laboratory Data website
• HHS’s CARES Act Section 18115 Laboratory Data Reporting Guidance
• HHS Press Release: HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing
• HHS’s Frequently Asked Questions: Laboratory Data Reporting for COVID-19 Testing”

August 10, 2020: New CPT Codes to Streamline COVID-19 Testing Currently Available in the United States

An August 10, 2020 AMA announcement includes a summary of SARS-Co-V-2 related CPT codes that have been approved and published for the 2021 CPT code set. The most recent new codes are effective August 10, 2020 and includes:

• 86408 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (COVID-19) screen,
• 86409 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (COVID-19) neutralizing antibody titer.
• New Proprietary Laboratory Analysis (PLA) code 0225U: Infectious disease (bacterial or viral respiratory tract infection) pathogen-specific DNA and RNA, 21 targets, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), amplified probe technique, including multiplex reverse transcription for RNA targets, each analytic reported as detected or not detected
• New PLA code 0226U Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), ELISA, plasma, serum

The AMA included the following statement in the announcement of these codes:

“Please note that, per the standard early release delivery process for CPT codes, you will need to manually upload these code descriptors into your EHR system. These CPT codes will arrive as part of the complete CPT code set in the data file for 2021 later this year.” You can find links to downloads for all of the new codes related to COVID-19 in this announcement.

August 12, 2020: FDA says Help Stop the Spread of Coronavirus and Protect Your Family

The FDA posted an infographic and details about the simple steps that can and should be taken to slow the spread of COVID-19 and protect everyone. I believe the key takeaway from this guidance is the very first sentence:

“The COVID-19 pandemic requires that we remain vigilant in our everyday lives.”

As you have probably heard many times by now but continue to see examples of noncompliance on a daily basis, the simple steps to stop the spread includes washing your hands, covered you mouth and nose with a cloth face covering or non-surgical mask when around others, and avoid crowds and practice social distancing (stay at least 6 feet apart from others).

August 14, 2020: CDC Morbidity and Mortality Weekly Report: COVID-19-Associated Multisystem inflammatory Syndrome in Children MIS-C) – United States, March – July 2020

This August 14, 2020 Weekly Morbidity and Mortality Report was written by Godfred-Cato S, Bryant B, Leung J, et al, and indicates that as of July 29, 2020:

• A total of 570 MIS-C patients with onset dates from March 2 to July 18, 2020, had been reported from 40 state health departments, the District of Columbia, and New York City.
• The median patient age was 8 years (range = 2 weeks–20 years); 55.4% were male,
• 5% were Hispanic or Latino (Hispanic), 33.1% were non-Hispanic black (black), and 13.2% non-Hispanic white (white).
• Obesity was the most commonly reported underlying medical condition, occurring in 30.5% of Hispanic, 27.5% of black, and 6.6% of white MIS-C patients.

August 17, 2020: MLN Article Update - New COVID-19 Policies for IPPS Hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) due to Provisions of the CARES Act

MLN article SE20015, initially released on April 15, 2020, has been updated on August 17th to add an update regarding the implementation of Section 3710 of the CARES Act for IPPS hospitals to address potential Medicare program integrity risks. Specifically, “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… The Pricer will continue to apply an adjustment factor to increase the MS-DRG relative weight that would otherwise be applied by 20 percent when determining IPPS operating payments for discharges that report the ICD‑10‑CM diagnosis code U07.1 (COVID-19). CMS may conduct post-payment medical review to confirm the presence of a positive COVID-19 laboratory test and, if no such test is contained in the medical record, the additional payment resulting from the 20 percent increase in the MS-DRG relative weight will be recouped.”

Q:

Have Medicare Contractors started performing Medical Reviews again?

A:

In last week’s newsletter we answered this question by reviewing recent CMS Guidance regarding Medicare Administrative Contractors (MACs), Supplemental Medical Review Contractor (SMRC) and Recovery Audit Contractor (RAC) resuming medical reviews.

Since then, the Comprehensive Error Rate Testing (CERT) has posted the following notice on the CMS CERT webpage: 

“Effective August 11, 2020, the Centers for Medicare & Medicaid Services (CMS) is resuming Comprehensive Error Rate Testing (CERT) program activities that were temporarily suspended in response to the public health emergency (PHE) for the 2019-Novel Coronavirus (COVID-19) pandemic. Specifically, the CERT program will resume sending documentation request letters to and conducting phone calls with providers or suppliers to request medical documentation for claims in Reporting Year (RY) 2021 (claims submitted 7/1/2019 through 6/30/2020) and RY 2022 (claims submitted 7/1/2020 through 6/30/2021).  

Due to the cyclical nature of the CERT program improper payment measurement and the statutory timeline required for improper payment reporting under the Payment Integrity Information Act of 2019 (PIIA) (i.e., reporting annually), improper payment measurements cannot pause for an extended period without missing the statutorily required due dates.  

The CERT program will not resume sending documentation request letters to, or conducting phone calls with, providers or suppliers to request medical documentation for claims in RY 2020 (claims submitted 7/1/2018 through 6/30/2019). The CERT program will report the 2020 Medicare Fee-for-Service (FFS) program improper payment rate in the November 2020 Department of Health and Human Service (HHS) Agency Financial Report (AFR) based on the data that CMS currently has or that providers or suppliers voluntarily submit.

CMS has altered CERT program activities in the short term (i.e., ceasing provider contact for RY 2020 claims) and adjusted data collection in the longer term (i.e., sample size reduction for RY 2021 and RY 2022 claims) to account for the challenges incurred by providers and suppliers during the PHE, while continuing to maintain appropriate accountability measures and meet statutory obligations.”

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1736-P) was released on August 4, 2020.

CMS estimates “that total OPPS payments for CY 2021, including beneficiary cost-sharing, to the approximately 3,628 facilities paid under the OPPS (including general acute care hospitals, children’s hospitals, cancer hospitals, and CMHCs) would increase by approximately 1.6 billion compared to CY 2020 payments, excluding our estimated changes in enrollment, utilization, and case-mix.”

Inpatient Only Procedure List

In years past, this is where I would remind you that CMS has specific criteria for determining whether or not a procedure should be removed from the Inpatient Only (IPO) List and assigned to an Ambulatory Payment Category (APC) group. However, not this year because this year CMS is proposing to:  

• Eliminate the IPO list over a three-year transitional period with the list completely phased out by CY 2024, and
• Begin with the removal of nearly 300 musculoskeletal-related services,

CMS is requesting comments on “whether three years is an appropriate time frame for transitioning to eliminate the IPO list; other services that are candidates for removal from the IPO list for CY 2021; and the sequence in which to remove additional clinical families and/or specific services from the IPO list in future rulemaking.”

Short Inpatient Hospital Stays

The Two-Midnight Rule, as finalized in the FY 2014 IPPS Final Rule, clarified when an inpatient admission is considered reasonable and necessary for purposes of Medicare Part A payment. This policy established a benchmark for when a patient is considered appropriate for inpatient hospital admission and payment.

CMS also clarified that “when a beneficiary enters a hospital for a surgical procedure not designated as an inpatient-only (IPO) procedure as described in 42 CFR 419.22(n), a diagnostic test, or any other treatment, and the physician expects to keep the beneficiary in the hospital for only a limited period of time that does not cross 2 midnights, the services would be generally inappropriate under Medicare Part A.”

In the CY 2016 OPPS/ASC Final Rule CMS “finalized a proposal to allow for case-by case exceptions to the 2-midnight benchmark, whereby Medicare Part A payment may be made for inpatient admissions where the admitting physician does not expect the patient to require hospital care spanning 2 midnights, if the documentation in the medical record supports the physician’s determination that the patient nonetheless requires inpatient hospital care.” The following criteria are relevant to making this determination:

• Complex medical factors such as history and comorbidities;
• The severity of signs and symptoms;
• Current medical needs; and
• The risk of an adverse event.

Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2021 and Subsequent Years (2-Midnight Rule)

Once a surgical procedure has been removed from the IPO List, documentation in the record must support the need for the inpatient admission. CMS once again reminds providers in this proposed rule that “removal of a service from the IPO list has never meant that a beneficiary cannot receive the service as a hospital inpatient – as always, the physician should use his or her complex medical judgment to determine the generally appropriate setting.”

In the CY 2020 OPPS Final Rule, CMS finalized a two-year exemption from site-of-service claim denials, Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO) referrals to RACs, and RAC reviews for “patient status” (that is, site-of-service) for procedures that are removed from the IPO list under the OPPS beginning on January 1, 2020.

For CY 2021, CMS is proposing to continue the two-year exemption for procedures removed from the IPO list beginning on January 1, 2021. They are also requesting comments on whether this continues to be the appropriate time frame, or if a longer or shorter period may be warranted.

As a provider, it is important to be mindful that this exemption is specific to site-of-service claim denials. This exemption does not include medical necessity based on a National or Local Coverage Determinations (NCDs and LCDs) meaning irrespective of site-of-service, a short stay claim can still be denied for lack of documentation supporting medical necessity of the procedure.

Hospital Outpatient Department Prior Authorization Program: Proposed New Service Categories

With the CY 2020 OPPS/ASC Final Rule (CMS-17-17-FC), CMS established the nationwide prior authorization process and requirements for certain hospital outpatient department (OPD) services.  Effective July 1, 2020 the following services now require prior authorization:

• Blepharoplasty,
• Botulinum toxin injections,
• Panniculectomy,
• Rhinoplasty, and
• Vein Ablation.

As part of their responsibility to protect the Medicare Trust Funds, CMS routinely monitors the utilization of services. Through claims analysis, CMS notes in the proposed rule that they have identified an increase in volume of cervical fusion with disc removal procedures and implanted spinal neurostimulator procedures that was significantly higher than overall trends for all OPD services.

CMS notes they “researched possible causes for the increase in volume that would indicate the services are increasingly necessary.” However, CMS notes that “after reviewing all available data, we found no evidence suggesting other plausible reasons for the increases, which we believe means financial motivation is the most likely cause. We believe utilizing codes because of financial motivations, as opposed to medical necessity reasons, has resulted in an unnecessary increase in volume.”

CMS continues to believe prior authorization “is an effective mechanism to ensure Medicare beneficiaries receive medically necessary care while protecting the Medicare Trust Funds from unnecessary increased in volume by virtue of improper payments, without adding onerous new documentation requirements.”

Therefore, CMS is proposing to add cervical fusion with disc removal and implanted spinal neurostimulators to this program effective for services provided on or after July 1, 2021. Following are the specific procedure codes being proposed for inclusion in this program:

Cervical Fusion with Disc Removal

• 22551: Fusion of spine bones with removal of disc at upper spinal column, anterior approach, complex, initial, and
• 22552: Fusion of spine bones with removal of disc in upper spinal column below second vertebra of neck, anterior approach, each additional interspace

Implanted Spinal Neurostimulators

• 63650: Implantation of spinal neurostimulator electrodes, accessed through the skin,
• 63685: Insertion or replacement of spinal neurostimulator pulse generator or receiver, and
• 63688: Revision or removal of implanted spinal neurostimulator pulse generator or receiver

Be on the lookout for additional highlights from the proposed rule in next week’s newsletter. In the meantime, I encourage key stakeholders at your facility to take the time to review the proposed rule. For those wishing to submit comments, CMS is accepting them up until 5 p.m. EST on October 5, 2020.

Q:

Given the ongoing COVID-19 Public Health Emergency, has CMS extended the Testing Period for the Appropriate Use Criteria Program set to begin in Calendar Year 2020?

A:

Yes, CMS updated their Appropriate Use Criteria Program webpage on August 10, 2020 with the following Notice:

“The EDUCATIONAL AND OPERATIONS TESTING PERIOD for the AUC Program has been extended through CY 2021. There are no payment consequences associated with the AUC program during CY 2020 and CY 2021. We encourage stakeholders to use this period to learn, test and prepare for the AUC program.”

Q:

Have Medicare Contractors started performing Medical Reviews again?

A:

On July 6, 2020, CMS released the document Coronavirus Disease 2019 (COVID-19) Provider Burden Relief Frequently Asked Questions (FAQs). The very first FAQ addresses Medicare Fee-for-Service medical reviews.

Q. Is CMS suspending most Medicare Fee-For-Service (FFS) medical review during the Public Health Emergency (PHE) for the COVID-19 pandemic?

A. On March 30 CMS suspended most Medicare Fee-For-Service (FFS) medical review because of the COVID-19 pandemic. This included pre-payment medical reviews conducted by Medicare Administrative Contractors (MACs) under the Targeted Probe and Educate program, and post-payment reviews conducted by the MACs, Supplemental Medical Review Contractor (SMRC) reviews and Recovery Audit Contractor (RAC). As states reopen, and given the importance of medical review activities to CMS’ program integrity efforts, CMS expects to discontinue exercising enforcement discretion beginning on August 3, 2020, regardless of the status of the public health emergency. If selected for review, providers should discuss with their contractor any COVID-19-related hardships they are experiencing that could affect audit response timeliness. CMS notes that all reviews will be conducted in accordance with statutory and regulatory provisions, as well as related billing and coding requirements. Waivers and flexibilities in place at the time of the dates of service of any claims potentially selected for review will also be applied.

American Hospital Association Letter to CMS

The American Hospital Association (AHA) expressed concern about CMS’s decision to resume medical review audits on August 3, 2020 in a July 29, 2020 letter to CMS Administrator Seema Verma. The letter ends with the AHA stating that “to be clear, we urge the agency to refrain from differentiation between medical review audits and the other flexibilities you have created, and instead ensure all of the relevant waivers remain active during the pandemic.”

Medicare Administrative Contractors (MACs) Guidance

On August 4, 2020, Palmetto GBA posted an article to their website providing additional detail about the resumption of medical reviews. Specifically,

• Beginning August 17th, the MACs are resuming post-payment reviews of items/services provided prior to March 1, 2020,
• The Targeted Probe and Educate (TPE) program will restart later, and
• MACs will continue to offer detailed review decisions and education as appropriate.

CMS included this same guidance in their August 6, 2020 MLNConnects e-newsletter.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from August 4th through August 10th.

Resource Spotlight: COVID-19 “Long Hauler” Symptoms Survey Report

It seems that surviving COVID-19 is not the end of the story and that symptoms can linger long after recovery from the acute illness. Dr. Natalie Lambert & Survivor Corps have released a report titled COVID-19 "Long Hauler" Symptoms Survey Report. In this report Survivor Corps is described as “a grassroots movement connecting, educating and mobilizing COVID-19 survivors with the medical, scientific and academic research community to help stem the tide of this pandemic and assist in the national recovery.” You will find in this report which of the 50 most common symptoms reported by Long Hauler in the survey with the 12 symptoms recognized by the CDC. 

August 3, 2020: OIG Releases Two Toolkits for Health Care Providers and Community Responders

The OIG released two emergency response toolkits designed to help health care providers and community responders in their response to the COVID-19 pandemic and other emergencies as they arise.

Toolkit: Insights for Communities from OIG’s Historical Work on Emergency Response

This toolkit includes past OIG reports published from 2004 to 2020 about community emergency preparedness and response that are separated out into the following topics:

• Funding,
• Training,
• Laboratory Testing,
• Vaccination Programs, and
• Emergency Planning.

Link to toolkit: https://go.usa.gov/xfV3p

Toolkit: Insights for Health Care Facilities from OIG's Historical Work on Emergency Response

This toolkit includes past OIG reports published from 2002 to 2020 about health care facility emergency preparedness and response that are separated out into the following topics:

• Facility Operations,
• Facility Staffing,
• Facility Coordination with Community, and
• Facility Emergency Planning.

Link to toolkit: https://go.usa.gov/xfV3G

August 4, 2020: OIG Updates FAQs – Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to COVID-19 Public Health Emergency

MMP’s August 5, 2020 COVID-19 in the News article included information about the most recent FAQ answered by the OIG. On August 4th, the OIG has provided an answer to the question of whether or not clinical laboratories can offer free COVID-19 antibody testing to Federal health care program beneficiaries who are contemporaneously receiving other medically necessary blood tests during the COVID-19 public health emergency.

You can read the answer to this and all other questions posted on the OIG website at https://oig.hhs.gov/coronavirus/authorities-faq.asp.

August 6, 2020: Telemedicine, Clinical Experiences, Resources for Hospitals and Urgent Care Centers

CMS include the following information in their Thursday August 6th edition of MLNConnects:

“The Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released an Express message that includes: 

• Use of Telemedicine in Alternate Care Sites Webinar Recording: Hear from speakers in operations and management
• COVID-19 and Clinical Experiences from the Field: Reports and findings from journal and news articles, clinical rounds presentations, and webinars
• COVID-19 Hospital Resource Compilation: Guidance on hospital surge, crisis standards of care, workforce protection, and resumption of services
• COVID-19 and Urgent Care Centers: Lessons Learned for the Future: Urgent Care Association shares their experiences and plans to work with local medical communities

For More Information:

• ASPR TRACIE Fact Sheet 
• ASPR TRACIE website 
• ASPR TRACIE Novel Coronavirus Resources webpage”

August 7, 2020: HHS Announced Allocation of CARES Act Provider Relief Fund for Nursing Homes

The Department of Health and Human Services (HHS) announced in a press release that the Provider Relief Fund (PRF) “distribution will total approximately $5 billion, and will be used to protect residents of nursing homes and long-term care facilities from the impact of COVID-19.” They go on to note that approximately $2.5 billion will be used for upfront funding to support increased testing, staffing, and PPE needs.

August 7, 2020: HHS Fact Sheet: Explaining Operation Warp Speed

On August 7th, HHS released the Fact Sheet: Explaining Operation Warp Speed (OWS). In answer to the question of the goal of this operation, HHS indicates that OWS “aims to deliver 300 million doses of a safe, effective vaccine for COVID-129 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as counter measures).” This Fact Sheet also provided answers to the following questions about OWS:

• How will the goal be accomplished?
• What’s the plan and what’s happened so far?
• Who’s leading Operation Warp Speed?
• What is being done to make these products affordable for Americans?
• How is Operation Warp Speed being funded?

August 10, 2020: CDC Data - Total Cases, Total Deaths and Wearing Masks

On the CDC’s webpage Cases in the U.S. you will find the total number of cases and deaths in the U.S. due to COVID-19. This information is updated daily based on data confirmed at 4:00pm ET the day before. The August 10th updated data indicates that the U.S. has had 5,023,649 total cases (48,690 new cases compared to August 9th) and 161,842 total deaths (558 new deaths compared to August 9th.)

The CDC also has a COVID-19 webpage dedicated to information About Masks. I share this with you because the Physician’s Office in the building where I work has posted signs telling patients that masks with valves or vents are not allowed in the building. The CDC has posted the following information on their About Masks webpage providing an answer to why they are not allowed: 

“The purpose of masks is to keep respiratory droplets from reaching others to aid with source control. Masks with one-way valves or vents allow exhaled air to be expelled out through holes in the material.  This can allow exhaled respiratory droplets to reach others and potentially spread the COVID-19 virus. Therefore, CDC does not recommend using masks if they have an exhalation valve or vent.”

August 10, 2020: COVID-19 Laboratory Reporting Requirements

The CDC posted the following Clinician Outreach and Community Activity (COCA) Now Alert about COVID-19 laboratory reporting requirements:

“The public health response to COVID-19 depends on comprehensive laboratory testing data. The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the HHS Laboratory Data Reporting Guidance released on June 4, 2020 require every COVID-19 testing site to report specific data elements for every diagnostic and screening test performed to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody). The data are to be reported to the appropriate state or local public health department, based on the individual’s residence.

Healthcare providers also have a critical role in collecting several of the data elements when ordering a COVID-19 laboratory test, particularly demographic information such as the patient’s age, sex, race, and ethnicity. Beginning August 1, 2020, testing sites should make every reasonable effort to report these demographic data to state and local health departments using existing public health reporting channels (in accordance with state law or policies).

Complete demographic data will:  

• Ensure that all groups have equitable access to testing, 
• Allow an accurate determination of the burden of infection on vulnerable groups, and  
• Help improve decision-making to better prevent or mitigate further COVID-19 illness among Americans.

Below are some additional resources for more information about this COVID-19 laboratory reporting requirement:

• CDC’s How to Report COVID-19 Laboratory Data website
• HHS’s CARES Act Section 18115 Laboratory Data Reporting Guidance
• HHS Press Release: HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing
• HHS’s Frequently Asked Questions: Laboratory Data Reporting for COVID-19 Testing”