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Q:

I have been told conflicting information about documenting a positive COVID-19 test. Is physician documentation that a patient has COVID-19 sufficient for the hospital to receive additional payment?

A:

The short answer is no. However, reminiscent of the late Paul Harvey, here is the rest of the story.

COVID-19: Timeline to a New Code

The CDC announced the release of a new code specifically for reporting COVID-19 during the March 18th ICD-10-CM Coordination and Maintenance Committee Meeting. This code became effective on April 1st, 2020. Following is a timeline of events prompting the speed with which this code was made available for use:

• January 31, 2020: An emergency meeting was convened by the World Health Organization (WHO) Family of International Classifications (WHOFIC) Network Classification and Statistics Advisory Committee (CSAC) and a new ICD-10 emergency code was established.
• U07.1, 2019-nCoV acute respiratory disease

• February 20, 2020: The CDC published supplemental guidance for coding encounters related to COVID-19. At that time hospitals were instructed to used ICD-10-CM code B97.29 (Other coronavirus as the cause of diseases classified elsewhere) when coding a confirmed COVID-19 infection. Note, ICD-10-CM code B97.29 was to be used by hospitals for discharges occurring on or after January 1, 2020, and on or before March 31, 2020.

• March 18, 2020: The Coordination and Maintenance Committee Meeting met virtually. It was announced that the COVID-19 code (U07.1) effective date was changed from October 1, 2020 to April 1, 2020 due to the national health emergency.

• March 31, 2020: The CDC released the document ICD-10-CM Official Coding and Reporting Guidelines for coding COVID-19 April 1, 2020 – September 30, 2020. The guidelines indicated that you are to “Code only a confirmed diagnosis of the 2019 novel coronavirus disease (COVID-19) as documented by the provider, documentation of a positive COVID-19 test result, or a presumptive positive COVID-19 test result. For a confirmed diagnosis, assign code U07.1, COVID-19. This is an exception to the hospital inpatient guideline Section II, H. In this context, “confirmation” does not require documentation of the type of test performed; the provider’s documentation that the individual has COVID-19 is sufficient.”

• April 1, 2020: The CDC published an ICD-10-CM Tabular Lists of Diseases and Injuries Addenda which established a new chapter (Chapter 22: Codes for special purposes [U00-U85https://www.cdc.gov/nchs/icd/icd10cm.htm">CDC ICD-10-CM webpage as well as the CMS ICD-10-CM webpage. The updated guidelines includes a new section in Chapter 1 (Certain Infectious and Parasitic Diseases) related to coding COVID-19.

Hospital Inpatient Setting: Timeline to Additional Payment for Treating COVID-19 Patients

• March 27, 2020: The Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law. Within this law was the following guidance regarding additional payment for treatment of patients diagnosed with COVID-19:
• Sec. 3710 Medicare Hospital Inpatient Prospective Payment System Add-On Payment for COVID-19 Patients During Emergency Period: “For discharges occurring during the emergency period, in the case of a discharge of an individual diagnosed with COVID-19, the Secretary shall increase the weighting factor that would otherwise apply to the diagnosis-related group to which the discharge is assigned by 20 percent. The Secretary shall identify a discharge of such an individual through the use of diagnosis codes, condition codes, or other such means as may be necessary.”
  
  
• April 24, 2020: MLN Matters Article MM11764 details guidance in Change Request 11764 regarding coding COVID-19 and the implementation of the temporary payment adjustment as mandated by section 3710 of the CARES Act.

• August 14, 2020: Transmittal 10300 (Update to the Implementation of the Increased Payments for COVID-19 Discharges Under the Inpatient Prospective Payment System (IPPS) Under Section 3710 of the CARES Act) was released to prospectively update “the implementation of section 3710 of the CARES Act to require that a positive laboratory test be documented in the patient’s medical record for the increased payment for COVID-19 discharges under the Inpatient Prospective Payment System (IPPS).”
• Note, Transmittal 10300 has since been rescinded and replaced with Transmittal 10361 (Change Request 11925).

• August 17, 2020: MLN Matters Article SE20015 initially released on April 15, 2020 was revised on August 17, 2020 to add the following language:
• “To address potential Medicare program integrity risks, effective with admissions occurring on or after September 1, 2020, claims eligible for the 20 percent increase in the MS-DRG weighting factor will also be required to have a positive COVID-19 laboratory test documented in the patient’s medical record. Positive tests must be demonstrated using only the results of viral testing (i.e., molecular or antigen), consistent with CDC guidelines. The test may be performed either during the hospital admission or prior to the hospital admission.

For this purpose, a viral test performed within 14 days of the hospital admission, including a test performed by an entity other than the hospital, can be manually entered into the patient’s medical record to satisfy this documentation requirement. For example, a copy of a positive COVID-19 test result that was obtained a week before the admission from a local government-run testing center can be added to the patient’s medical record. In the rare circumstance where a viral test was performed more than 14 days prior to the hospital admission, CMS will consider whether there are complex medical factors in addition to that test result for purposes of this documentation requirement.”

Coding vs. Billing for COVID-19

As indicated earlier in this article, the ICD-10-CM guidelines indicate that you code only confirmed cases of COVID-19 as documented by the provider, documentation of a positive COVID-19 test result, or a presumptive positive COVID-19 test result.

However, CR 11925, for admissions occurring on or after September 1, 2020 hospitals are “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.”

What do you do when a physician documents that a patient has a confirmed case of COVID-19 but there is no positive test result in the record?

Both, CR 11925 and MLN Matters SE20015 provide the following guidance:

“A hospital that diagnoses a patient with COVID-19 consistent with the ICD-10-CM Official Coding and Reporting Guidelines but does not have evidence of a positive test result can decline, at the time of claim submission, the additional payment resulting from the application at the time of claim payment of the 20 percent increase in the MS-DRG relative weight to avoid the repayment. To do so, the hospital will inform its MAC and the MAC will notate the claim with MAC internal claim processing coding for processing. The Pricer software will not apply the 20 percent increase to the claim when that MAC internal claim processing coding is present on a claim with the ICD-10-CM diagnosis code U07.1 (COVID-19). The updated Pricer software package reflecting this change will be released in October 2020.

To notify your MAC when there is no evidence of a positive laboratory test documented in the patient’s medical record, enter a Billing Note NTE02 “No Pos Test” on the electronic claim 837I or a remark “No Pos Test” on a paper claim.”

Hospital IPPS Payments under Section 3710 the CARES Act

CMS has made available the document COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing. Section F of this document, titled Hospital IPPS Payments under the CARES Act, answers questions about section 3710 of the CARES Act and provides examples illustrating the increase in IPPS operating MS-DRG payments. Note, during the COVID-19 Public Health Emergency (PHE), this document has been updated on a fairly regular basis and as of the October 28, 2020, the update is 152 pages in length. I encourage you to check for updates on a regular basis.  

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 27th – November 2nd.

Resource Spotlight: November 2, 2020 - CDC Adds to List of Medical Conditions Putting Patients at Risk for Severe Illness due to COVID-19

The CDC webpage People with Certain Medical Conditions has once again been updated to add sickle cell disease and chronic kidney disease to the conditions that might increase the risk of severe illness among children. As we approach the holiday season, this webpage also provides guidance regarding what to consider before being around people and things to consider to help make personal and social activities as safe as possible.

October 28, 2020: FDA Enforcement Policy for Non-Invasive Remote Monitoring Devices during COVID-19 PHE (Revised)

The FDA initially issued guidance in June 2020 “to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency.” They note in this October 28, 2020 Announcement that the guidance has been updated and that it is intended to remain in effect only for the duration of the Public Health Emergency (PHE) related to COVID-19.

October 28, 2020: Fourth COVID-19 Interim Final Rule with Comment Period (IFC-4) – Eliminating Barriers, Flexibilities, Extension CJR Model,

CMS announced, in an October 28 Press Release, the release of a fourth COVID-19 Interim Final Rule. In a related Fact Sheet, CMS indicates that this final rule, “removes administrative barriers to eliminate potential delays to patient access to a lifesaving vaccine. In addition, the rule:

• Creates flexibilities for states maintaining Medicaid enrollment during the COVID 19 PHE;
• Establishes enhanced Medicare payments for new COVID-19 treatments;
• Takes steps to ensure price transparency for COVID-19 tests, and
• Provides an extension of Performance Year 5 for the Comprehensive Care for Joint Replacement (CJR) model; and
• Creates flexibilities in the public notice requirements and post-award public participation requirements for a State Innovation Waiver under Section 1332 of the Patient Protection and Affordable Care Act during the COVID-19 PHE.”

October 28, 2020: Fourth COVID-19 Interim Final Rule with Comment Period (ICF-4): New COVID-19 Treatments Add-On Payment (NCTAP)

As a segue to the new add-on payment, Section D. of ICF-4 reviews section 3710 of the CARES Act and the IPPS New Technology Add-On Payment process before transitioning to the FDA Coronavirus Treatment Acceleration Program created for possible coronavirus therapies. One aspect of this program is the issuance of Emergency Use Authorizations (EUAs) during the COVID-19 Public Health Emergency (PHE). “CMS has determined that it is appropriate for CMS to consider drug and biological products which are authorized for emergency use for COVID-19, with letters of authorization, and are used to treat COVID-19 disease, to fall within the drugs and biologicals” Medicare benefit category.

CMS believes that as “drugs or biological products become available and are authorized or approved by FDA for the treatment of COVID-19 in the inpatient setting, it would be appropriate to increase the current IPPS payment amounts to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE.”

CMS indicates effective with the date of ICF-4 and until the end of the PHE, when a therapy meets specific criteria it will be eligible for NCTAP. They also note that currently there are only two drug and biological products that meet the criterion. The following table highlights the two products and the ICD-10-PCS codes assigned to the products.

“CMS is setting the NCTAP amount for a case that meets the NCTAP eligibility criteria equal to the lesser of: (1) 65 percent of the operating outlier threshold for the claim or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment, including the adjustment to the relative weight under section 3710 of the CARES Act. As with the new technology add-on payment and outlier payments, the costs of the case are determined by multiplying the covered charges by the operating cost-to-charge ratio. In addition, the NCTAP will not be included as part of the calculation of the operating outlier payments.”

To date, no drug or biological product has a EUA for treatment of COVID-19 patients in the outpatient setting. However, this Interim Final Rule includes the criteria for separate payment for New COVID-19 Treatments in the Outpatient Setting for the remainder of the PHE if and when a product is granted EUA.

October 28, 2020: Incentive Payments to Nursing Home Curing COVID-19 Deaths and Infections

Over 10,000 nursing homes will be receiving money from the approximately $333 million in first round performance payments to be made by HHS through the Health Resources and Services Administration (HRSA). HHS Secretary Alex Azar indicated in an HHS Press Release that "These $333 million in performance payments are going to nursing homes that have maintained safer environments for residents between August and September. We've provided nursing homes with resources and training to improve infection control, and we're rapidly providing incentives to those facilities that are making progress in the fight against COVID-19."

October 30, 2020: CDC Morbidity & Mortality Report: COVID-19 Exposure and Infection Among Health Care Personnel

The CDC’s Morbidity and Mortality Weekly Report (MMWR) for October 30th focused on COVID-19 exposure and infection among health care professionals in Minnesota from March 6th through July 11, 2020. The report summary acknowledges that it is already known that health care personnel (HCP) are at increased risk for COVID-19 from workplace exposures. The authors of this report found that “HCP in congregate living and long-term care setting experience considerable risk and post a transmission risk to residents. Improved access to personal protective equipment, flexible medical leave and testing is needed.”

October 30, 2020: CMS Announces Launch of the Nursing Home Resource Center

CMS announced the launch of this new online platform which “consolidates all nursing home information, guidance and resources into a user-friendly, one-stop-shop that is easily navigable so providers and caregivers can spend less time searching for critical answers and more time caring for residents. Moreover, the new platform contains features specific to residents and their families, ensuring they have the information needed to make empowered decisions about their healthcare.”

The Resource Center includes information for Providers & CMS Partners and Patients & Caregivers. Resource Topics specific to Providers and CMS Partners includes the following:

• Regulations & Guidance,
• Training & Resources,
• Technical Information,
• COVID-19 Data & Updates, and
• Payment Policy Information.

October 30, 2020: Supply Kits to Safely Administer COVID-19 Vaccines to Americans

An HHS news release indicates that they have “recently contracted with McKesson Corporation to produce, store and distribute these vaccine ancillary supply kits on behalf of the Strategic National Stockpile. Each kit will contain enough supplies to administer up to 100 doses of vaccine and will include:

• Needles (various sizes for the population served by the ordering vaccination provider)
• Syringes
• Alcohol prep pads
• Surgical masks and face shields for vaccinators
• COVID-19 vaccination record cards for vaccine recipients
• Needle information card”

October 31, 2020: BinaxNOW COVID-19 Tests Distribution

HHS announced that in ongoing efforts to prevent COVID-19 outbreaks in high risk communities, 389,040 Abbott BinaxNOW COVID-19 rapid tests have been distributed at no cost to 83 Historically Black Colleges and Universities (HCBU’s) in 24 states. “The Abbott BinaxNOW test is the only rapid point of care test that does not require instrumentation – is easy to use, produces COVID-19 test results within fifteen minutes and costs just five dollars. In addition to responding quickly to flash outbreaks, these tests are ideally suited for the screening and ongoing surveillance of underserved demographic groups and in congregate settings such as group homes, nursing homes, K-12 schools and institutions of higher learning.”

CDC COVID Data Tracker – United States COVID-19 Cases

CMS announced the release of the Transparency in Coverage Final Rule [CMS-9915-F] on October 28, 2020. According to a related CMS Fact Sheet, “This final rule is a historic step toward putting health care price information in the hands of consumers and other stakeholders, advancing the Administration’s goal to ensure consumers are empowered with the critical information they need to make informed health care decisions.”

Figuring out the plot to a mystery novel involves asking questions and looking for answers to basic questions asked when gathering information (who, what, when, where, and why). CMS Final Rules can at first glance seem like a mystery and require the same process of asking and answering these questions. This article asks key questions and provides you with answers to help you figure out what is included in the Transparency in Coverage Final Rule.

Who is required to Disclose Cost-Sharing Information? 

Group Health Plans and Health Insurance issuers in the Individual and Group Markets.

• Note, the term group health plan includes both insured and self-insured group health plans.

What Type of Cost-Sharing Information is required to be disclosed?

• An estimate of the individual’s cost-sharing liability for covered items or services furnished by a particular provider.
• In-network provider negotiated rates,
• Historical out-of-network allowed amounts, and
• Drug pricing information

What is the required format for Disclosure of Cost-Sharing Information?

• This information must be available on an internet website in machine-readable files, and
• If requested, in paper form.

How many and what type of machine-readable files are required?

Plans and issuers must disclose pricing information in three machine-readable files

• One file will disclosure of payment rates negotiated between plans or issuers and providers for all covered items and services,
• A second file will disclose unique amounts a plan or issuer allowed, as well as associated billed charges, for covered items or services furnished by out-of-network providers during a specific time period.
• A third file will include pricing information for prescription drugs.

How often will issuers be required to update the machine-readable files?

“The final rules adopt, as proposed, the requirement for a plan or issuer to update the information required to be included in each machine-readable file monthly. The final rules clarify that this requirement to update the machine-readable files monthly applies to all three machine-readable files being finalized through the final rules: the In-network Rate File, the Allowed Amount File, and the Prescription Drug File”

What are the benefits of Disclosing Cost-Sharing Information?

CMS indicates in the Final Rule that “by requiring the dissemination of price and benefit information directly to consumers and to the public, the transparency in coverage requirements will provide the following consumer benefits:

• enables consumers to evaluate health care options and to make cost-conscious decisions;
• strengthens the support consumers receive from stakeholders that help protect and engage consumers;
• reduces potential surprises in relation to individual consumers’ out-of-pocket costs for health care services;
• creates a competitive dynamic that may narrow price dispersion for the same items and services in the same health care markets; and
• Puts downward pressure on prices which, in turn, potentially lowers overall health care costs.”

Where can you find a list of the 500 Items and Services Identified by the Departments?

This information is included in the Final Rule in Table 1: 500 Items and Services List. The table includes the applicable HCPCS/CPT code with the code description and a plain language description. For example, the first item in the list is J0702: BETAMETHASONE ACET&SOD PHOS with the plain language description being “Injection to treat reaction to a drug.”

Where can you find definitions of key terms in the Final Rule?

There is a Transparency in coverage – Definitions section towards the end of the final rule. Here you will find definitions for the following key terms:

• Accumulated amounts,
• Beneficiary,
• Billed charge,
• Billing code,
• Bundled payment arrangement,
• Copayment assistance,
• Cost-sharing liability,
• Cost-sharing information,
• Covered items and services,
• Derived amount,
• Historical net price,
• In-network provider,
• Items or services,
• Machine-readable file,
• National Drug Code,
• Negotiated rate,
• Out-of-network allowed amount,
• Out-of-network provider,
• Out-of-pocket limit,
• Plain language,
• Prerequisite, and
• Underlying fee schedule rate.

What are the CMS Intended Outcomes from implementation of this Final Rule?

• Informed Consumers,
• Consumers may become more cost conscious,
• Timely payment of medical bills, and
• Increase competition among Providers

When will the regulations in this Final Rule go into effect?

“The final rules adopt a three-year, phased-in approach with respect to the scope of the requirement to disclose cost-sharing information. Plans and issuers must make cost-sharing information available for 500 items and services identified by the Departments for plan years (in the individual market, for policy years) beginning on or after January 1, 2023, and must make cost-sharing information available for all items and services for plan years (in the individual market, for policy years) beginning on or after January 1, 2024.”

How will Requirements in the Final Rule be enforced?

“States will generally be the primary enforcers of the requirements imposed upon health insurance issuers by the final rules. 233 The Departments expect to work closely with state regulators to design effective processes and partnerships for enforcing the final rules.”

Of note, this final rule also includes amendments to the Department of Health and Human Services (HHS) medical loss ratio (MLR) program “to allow issuers offering group or individual health insurance coverage to receive credit in their MLR calculations for savings they share with enrollees that result from the enrollees shopping for, and receiving care from, lower-cost, higher-value providers.”

MEDICARE TRANSMITTALS – RECURRING UPDATES

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

• Article Release Date: October 9, 2020
• What You Need to Know: This article informs providers about updates to the Quarterly ASP Medicare Part B Pricing Files and informs you of revisions, if needed to prior quarterly pricing files.
• MLN MM12020: https://www.cms.gov/files/document/MM12020.pdf

OTHER MEDICARE TRANSMITTALS

 New Waived Tests

• Article Release Date: October 5, 2020 – Revised October 15, 2020
• What You Need to Know: This article tells you of new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the FDA. CMS notes that “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.”
• Note, this article was revised to correct a date for one of the codes for 87804QW.
• MLN Matters MM11982: https://www.cms.gov/files/document/mm11982.pdf

Ambulance Inflation Factor (AIF) for Calendar Year (CY) 2021 and Productivity Adjustment

• Article Release Date: October 16, 2020
• What You Need to Know: This article provides the CY 2021 AIF for determining the payment limit for ambulance services.
• MLN MM12031: https://www.cms.gov/files/document/mm12031.pdf

REVISED MEDICARE TRANSMITTALS

October 2020 Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.3

• Article Release Date: August 28, 2020 – Revised October 5, 2020
• What You Need to Know: This article was revised to reflect changes made to CR 11944 including adding several items to the Summary of Quarterly Release Modifications table.
• MLN Matters MM11944: https://www.cms.gov/files/document/mm11944.pdf

Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for FY 2020

• Article Release Date: August 31, 2020 – Revised September 24, 2020
• What You Need to Know: This article was revised to reflect a revised CR 11876 which changed the hourly Continuous Home Care rates in the hospice tables.
• MLN Matters MM11876: https://www.cms.gov/files/document/mm11876.pdf

Change to the Payment of Allogeneic Stem Cell Acquisition Services

• Article Release Date: July 13, 2020 – Revised October 21, 2020
• What You Need to Know: This article was revised to reflect the revised CR 11729 issued on October 20, 2020. This revision did not impact the substance of the article.
• MLN Matters: MM11729: https://www.cms.gov/files/document/mm11729.pdf

MEDICARE COVERAGE UPDATES

October 22, 2020: MCD Overview Page and Advanced Search Function Going Away

CMS has posted the following alert on the Medicare Coverage Database (MCD) Notice Board:

“On December 11, 2020, the Overview page of the Medicare Coverage Database (MCD) application will be removed in an effort to streamline the site. The website address will remain cms.gov/medicare-coverage-database but users will be directed to the Search page by default, instead of the Overview page.

On April 30, 2021, the Advanced Search function of the MCD application will be removed. All features related to the Advanced Search were incorporated into the new Search function, which was released on September 3, 2020. The new Search function is both faster and easier to use than the Advanced Search, so please switch to the new Search if you haven't already. Bookmarks to advanced-search.aspx and search-results.aspx will no longer work after April 30, 2021.”

MEDICARE EDUCATIONAL RESOURCES

September 28, 2020: MLN Fact Sheet: ICD-10-CM, ICD-10-PCS, CPT, and HCPCS Code Sets

• What You Need to Know: CMS released this educational tool to give “health care providers, suppliers, medical coders, billing and claims staff an easy reference to information on the code sets used to bill Medicare claims.” CMS advises using this tool when submitting inpatient and outpatient diagnoses, procedures, and supplies on Medicare claims.
• ICN MLN900943 September 2020: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCS-Code-Sets-Educational-Tool-ICN900943.pdf

October 2020: Medicare Quarterly Provider Compliance Newsletter

This CMS quarterly newsletter provides information on how to avoid common billing errors and includes top issues of a particular quarter. The October 2020 edition of the newsletter highlights Recovery Auditor Findings related to the following two issues:

Issue #0070: Critical Care Billed on the Same Day as Emergency Room Services: Unbundling

• Provider Types Affected: Physicians and Non-Physician Practitioners (NPPs)
• Problem: “Hospital emergency department services are not payable for the same calendar date as critical care services when billed for the same beneficiary, on the same date of service and by the same service provider (based on Tax ID and Provider Specialty Code).
• Affected Codes: 99281, 99282, 99283, 99284, 99285
• Type of Review: Automated Review

Issue #0131: Pneumatic Compression Device (PCD): Medical Necessity and Documentation Requirements.

• Provider Types Affected: Durable Medical Equipment (DME) Suppliers, including physicians who supply DME
• Problem: When providing PCDs to patients, be sure the patient meets all Medicare coverage criteria.
• Affected codes: E0650, E0651, E0652, E0656, E0657, E0667, E0668, E0669 and E0670.
• Type of review: Complex Review

Link to newsletter: https://www.cms.gov/outreach-and-educationmedicare-learning-network-mlnmlnproductsmln-publications/mln5230120

OTHER MEDICARE UPDATES

September 28, 2020: CMS Guidance Related to the Emergency Preparedness Testing Exercise Requirements – COVID-19

CMS posted a Memo to State Surveyors on their website which included the following summary statements and a link to the memorandum:

“CMS regulations for Emergency Preparedness require specific testing exercises be conducted to validate the facility’s emergency program. During or after an actual emergency, the regulations allow for an exemption to the testing requirements based on real world actions taken by providers and suppliers.

This worksheet presents guidance for surveyors, as well as providers and suppliers, with relevant scenarios on meeting the testing requirements in light of many of the response activities associated with the COVID-19 Public Health Emergency (PHE).”

September 28, 2020: CY 2021 Annual Amount In Controversy (AIC) Adjustments

CMS published the AIC Adjustments for CY 2021 in the Federal Register:

• Administrative Law Judge (ALJ) hearings AIC threshold: $180, and
• Judicial Review AIC threshold: $1,760.

October 5, 2020: Compliance with Residents’ Rights Requirement related to Nursing Home Residents’ Right to Vote

CMS sent this Memorandum to State Survey Agency Directors on October 5, 2020. Following are the three Memorandum Summary bullets:

• The Centers for Medicare & Medicaid Services (CMS) is affirming the continued right of nursing home residents to exercise their right to vote.
• While the COVID-19 Public Health Emergency has resulted in limitations for visitors to enter the facility to assist residents, nursing homes must still ensure residents are able to exercise their Constitutional right to vote.
• States, localities, and nursing home owners and administrators are encouraged to collaborate to ensure a resident’s right to vote is not impeded.

Additionally, CMS has published a letter to be sent to nursing home residents or family members.

October 8, 2020: CMS Press Release: Medicare Advantage and Medicare Part D Quality Ratings

CMS indicates in this Press Release that “according to the latest data, quality ratings of Medicare Advantage and Medicare Part D drug plans remain strong. Most Medicare beneficiaries – about 77 percent – who enroll in Medicare Advantage plans with drug coverage will be in plans with four or more stars in 2021.”

October 9, 2020: New National Action Plan for Combating Antibiotic-Resistant Bacteria

The CDC announced the release of the next National Action Plan for Combating Antibiotic-Resistant Bacteria for 2020-2025. They note in the announcement that antibiotic-resistant infections kill more than 35,000 people in the United States each year.

October 19, 2020: Palmetto GBA Outpatient Department (OPD) Prior Authorization (PA) Alert!

Palmetto GBA included in the following Alert in their October 21, 2020 Daily eNewlsetter:

“As of October 9, 2020, if you are a physician/NPP (Part B provider), you are required to provide two (2) fax numbers to receive your Outpatient Department (OPD) Prior Authorization (PA) decision. If a second fax number is not provided, your OPD PA will be rejected. 

If the requestor is a representative of the Hospital Outpatient Facility, only one (1) fax number is required.

Did you know?
...that the when requesting an OPD PA you must include both the hospital and the requestor’s fax number if the requestor is the physician/NPP (Part B provider)? If not, your PA will be rejected.

Did you know?
...that if the requestor is a representative of the Hospital Outpatient Facility, only one fax number is required.”

October 21, 2020: CMS Announcement, Radiation Oncology Model Delayed

CMS posted the following update to the CMS Radiation Oncology Model webpage:

“UPDATE: (10/21/2020) - CMS has received feedback from a number of stakeholders about the challenges of preparing to implement the RO Model by January 1, 2021. Based on this feedback, CMS intends to delay the RO Model start date to July 1, 2021. We are pursuing rulemaking to make this change.” Note, slides for two recent events related to this model as well as an FAQ document are also available on the Radiation Oncology Model webpage.

October 2020 C2C Innovative Solutions, Inc. Quarterly Newsletter Released

C2C Innovative Solutions Inc. (C2C), the Qualified Independent Contractor (QIC) for Medicare Part A for 26 eastern states, Washington D.C. and two U.S. territories, has released its quarterly newsletter.

October 21, 2020: Alabama Medicaid Alert: National Changes for Office Visit Procedure Codes

The Alabama Medicaid Agency issued an Alert reminding providers about the upcoming changes for Evaluation and Management (E&M) Procedure Codes effective January 1, 2021. This Alert includes links to National Information and Additional Resources about the changes.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 20th through October 26th.

Resource Spotlight: Tips for Voters

As we are just days away from the election, the CDC has created a Tips for Voters to Reduce Spread of COVID-19 webpage which includes 6 steps to follow before you vote and 6 steps to take the day you vote. For those of you who plan to vote in person, the CDC provides a checklist of recommended items to bring with you to your voting site, including:

• Necessary documentation such as your identification (check with your voting site),
• A mask,
• An extra mask,
• Tissues,
• Hand sanitizer with at least 60% alcohol,
• Water,
• Black ink pen, and
• Bring prepared items with you (e.g., registration forms, sample ballots)

October 20, 2020: New FAQs added to COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing

Three new FAQs were added to this now 150 page document on October 20, 2020. Two pertain to Medicare Telehealth (questions 46 and 47 in the Medicare Telehealth section of this document). The third FAQ is related to Medicare beneficiary SNF benefits as follows:

“Question: If a new benefit period was granted pursuant to the section 1812(f) waiver, and the PHE ends in the middle of that new benefit period, would the beneficiary be entitled to the full 100 days of renewed SNF benefits, or would that entitlement end on the day the PHE ends?

Answer: If a beneficiary has qualified for the special one-time renewal of SNF benefits under the benefit period aspect of the section 1812(f) waiver while the section 1812(f) waiver is in effect, that reserve of 100 additional SNF benefit days would remain available for the beneficiary to draw upon even after the waiver itself has expired.

New: 10/20/20”

As a reminder, Secretary Azar issued the most recent continuation of the Public Health Emergency (PHE) due to the COVID-19 pandemic on October 2, 2020 with an effective date of October 23, 2020.

October 21, 2020: CDC Guidance: Test for Current Infection Updated

The CDC webpage Test for Current Infection has been updated and lists the following considerations for who should get tested:

• People who have symptoms of COVID-19,
• People who had had close contact (within 6 feet of an infected person for a total of 15 minutes or more) with someone with confirmed COVID-19,
• People who have been asked or referred to get testing by their healthcare provider, local or state health department.

October 21, 2020: Expanding Access to COVID-19 Tests and Vaccines

HHS issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer, childhood vaccines, COVID-19 Vaccines when available, and COVID-19 tests. All those authorized to administer tests and vaccines are subject to several requirements. HHS provides a link to the guidance document in their Press Release.

October 22, 2020: Nursing Home COVID-19 Preparedness for Fall & Winter Web-Based Training

The Thursday October 22nd edition of the CMS MLNConnects newsletter informs providers about web-based training available to Nursing Homes to help them prepare for COVID-19, provide resident-centered care, and prevent and control infection. You can visit the Quality, Safety & Education Portal to access free scenario-based trainings for managers and frontline staff. See the flyer for more information.

October 22, 2020: FDA Approved First Treatment for COVID-19

The FDA announced their approval of the “antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.” 

Reminder, effective August 1, 2020, CMS implemented 12 new ICD-10-PCS codes related to COVID-19 became effective, including the administration of Remdesivir.

October 22, 2020: Relief Fund Eligibility Expansion and Updated Reporting Requirements

Relief Fund Eligibility Expansion: HHS announced the expansion of Providers eligible to receive Phase 3 Provider Relief Funding. The announcement includes a list of eligible providers “regardless of whether they accept Medicaid or Medicare.” Note, applicants have until 11:59PM EST on November 6, 2020 to submit an application for payment consideration.

Reporting Requirement Update: An update to the reporting requirements was also included in the announcement. “In response to concerns raised, HHS is amending the reporting instructions to increase flexibility around how providers can apply PRF money toward lost revenues attributable to coronavirus. After reimbursing healthcare related expenses attributable to coronavirus that were unreimbursed by other sources, providers may use remaining PRF funds to cover any lost revenue, measured as a negative change in year-over-year actual revenue from patient care related sources.” Note, this announcement includes links to a policy memorandum and the amended reporting requirements.

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 13th through October 19th.

Resource Spotlight: Hypertension Control Call to Action by Surgeon General

On October 8, 2020, Surgeon General, VADM Jerome M. Adams, M.D., M.P.H., “issued a Call to Action urging Americans to recognize and address hypertension control as a national, public health priority. The Surgeon General's Call to Action to Control Hypertension - PDF* provides strategies for those on the frontlines of health care and public health to address this costly, dangerous and far too common chronic health condition.”

This HHS Press Release includes a video by the Surgeon General and goes on to note that “currently, there are limited data and information about the impact of underlying medical conditions – including hypertension – on the risk for severe illness from COVID-19. While our understanding of COVID-19 is still improving and evolving, we know that people with hypertension may be at an increased risk for severe illness from COVID-19.”

October 8, 2020: CMS Halt to Advance Payment Applications

CMS updated the Fact Sheet: Repayment Terms for Accelerated and Advance Payments Issued to Providers and Suppliers During COVID-19 Emergency. New to this Fact Sheet is the following statement: “Please note that, as of October 8, 2020, CMS will no longer accept applications for accelerated or advance payments as they relate to the COVID-19 PHE, although CMS will continue to monitor the ongoing impacts of COVID-19 on the Medicare provider and supplier community.”

You can also read more about the Accelerated/Advance Payment (AAP) Repayment process in an FAQ document posted to Palmetto GBA’s website on October 14, 2020.

October 9, 2020: Trick or Treating and Other Halloween Activities

With just a little over one week until October 31st, the CDC has created the webpage Trick or Treating and Other Halloween Activities.  On this page you find guidance on the following topics for this spookiest of nights:

• Make trick-or-treating safer,
• Wear a mask,
• Stay at least 6 feet away from others who do not live with you,
• Wash your hands,
• Steps to take for Other Halloween Activities,
• Decorate and carve pumpkins,
• Visit an orchard, forest, or corn maze. Attend a scavenger hunt, and
• Links to posters in pdf format with all of the information on this webpage.

October 14, 2020: AHIP Blog: Health Insurance Providers Respond to Coronavirus (COVID-19)

The America’s Health Insurance Plans (AHIP) national association has compiled an A to Z listing of some health insurance providers who are taking action to ensure Americans have access to the prevention, testing, and treatment needed for COVID-19.

https://www.ahip.org/health-insurance-providers-respond-to-coronavirus-covid-19/

October 14, 2020: List of Covered Telehealth Services Covered During the COVID-19 PHE Expanded

CMS announced in a Press Release the expansion of telehealth services to be covered during the COVID-19 Public Health Emergency (PHE) for Medicare Fee-for-Service beneficiaries. Effective immediately, CMS will begin paying for the new telehealth services for the duration of the PHE.

CMS also announced, in the same Press Release, the release of a supplement to its State Medicaid & CHIP Telehealth Toolkit: Policy Considerations for States Expanding Use of Telehealth, COVID-19 Version that provides numerous new examples and insights into lessons learned from states that have implemented telehealth changes.

October 15, 2020: CMS Changes Medicare Payment for COVID-19 Diagnostic Testing

CMS announced changes to Medicare payment to laboratories for high throughput diagnostic tests effective January 1, 2021. The following highlights the timeline of changes:

• April 2020: CMS increased Medicare payment from approximately $50 to $100 per test.
• Effective January 1, 2021:
• Medicare will pay $100 only to laboratories who can complete COVID-19 diagnostic tests within two days of the specimen collection.
• Medicare will pay $75 for laboratories taking longer than two days.

You will also find a link to CMS’ document, COVID-19 FAQs on Medicare Fee-for-Service Billing, at the end of the Press Release. Note, CMS has added a new section, D. High Throughput COVID-19 Testing, (see pages 12 through 16 of the document). 

October 15, 2020: Supplemental Medical Review Contractor (SMRC) Medical Review Notification: DRG COVID-19 20% Add On Payment

Noridian Healthcare Solutions, the current SMRC added Project 01-043 to their list of active projects on October 15, 2020. They will be conducting post-payment Medicare Part-A acute inpatient reviews of claims billed with dates of service from April 1, 2020 through August 30, 2020. Following is the background information included in this Notification:

“Medicare Severity Diagnosis Related Group (MS-DRG) is a system used to classify various diagnoses and procedures for acute care inpatient hospital stays so Medicare can accurately reimburse the hospital under the Inpatient Prospective Payment System (IPPS). In response to the declaration of the COVID-19 outbreak as a Public Health Emergency (PHE), the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Public Law 116-136), was enacted on March 27, 2020. Section 3710 of the CARES Act directs the Secretary to increase the weighting factor of the assigned Diagnosis-Related Group (DRG) by 20 percent for an individual diagnosed with COVID-19 discharged during the COVID-19 PHE period. Discharges of an individual diagnosed with COVID-19 will be identified by the presence of appropriate International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes. Notably, in August of 2020, the Office of Inspector General (OIG) placed an “Audit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed With COVID-19” on its active work plan.”

October 16, 2020: Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) MLN Article Revised

MLN SE20011 was originally released March 16, 2020. This latest revision to the article clarifies HCPCS codes that Critical Access Hospitals (CAHs) should use in the, Families First Coronavirus Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services section. The Skilled Nursing Facility (SNF) Benefit Waiver Period section, now clarifies that the SNF waiver applies to swing-bed services in rural hospitals and CAHs.

October 16, 2020: Special Edition MLNConnects: Enforcement Discretion Relating to Certain Pharmacy Billing

CMS announced that in order to provide onsite COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is exercising discretion during this global emergency to “allow Medicare-enrolled immunizers, including but not limited to pharmacies working with the United States, to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare SNF residents.”

In a related Press Release, the U.S. Department of Health and Human Services (HHS) also announced on October 16th “agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) nationwide with no out-of-pocket costs.”

October MAC Talk: The Local Scene

September 28, 2020: Noridian Provider Outreach & Education Webinar: Compliance Program – What Every Provider Needs to Know

Noridian’s Provider Outreach and Education (POE) will be hosting the Compliance Program webinar next Wednesday October 28, 2020 at 3 p.m. CT. Topics to be covered include:

• What is the Compliance Program,
• Compliance Fundamental Elements,
• Compliance Laws and Statues,
• Documentation and Functions of Medical Records, and
• Noteworthy Information and Resources.

Link to Webinar Announcement: https://med.noridianmedicare.com/web/jfa/article-detail/-/view/10529/compliance-program-what-every-provider-needs-to-know-webinar-october-28-2020

September 29, 2020: Novitas Solutions Reminds Providers about Requirements to be Eligible for 20 Percent Increase in MS-DRG Weighting Factor

This Novitas article opens by reminding the reader that the CARES Act established a 20 percent increase in the relative weight of the diagnosis related group (DRG) billed for a Medicare fee-for-service inpatient hospitalization during the COVID-19 public health emergency. They go on to reinforce that effective for admissions on after September 1, 2020 that without documentation of a positive COVID-19 test in the record, the hospital is not eligible to receive the 20 percent increase. I encourage you to read this article as it goes on to provide coding and billing guidance.

September 29, 2020: Palmetto GBA Article: Cardiovascular Disease and Intensive Behavioral Therapy

Palmetto highlights the fact that hypertension (HTN), coronary artery disease (i.e., myocardial infarction and angina pectoris), heart failure and stroke are all Cardiovascular Disease (CVD) diagnoses. This article reminds health care providers that CMS believes “Intensive Behavioral Therapy (IBT) for CVD is reasonable and necessary for the prevention or early detection of illness or disability, and is appropriate for” Medicare beneficiaries. This article highlights risk factors for CVD, the HCPCS code for IBT for CVD (G0446), discusses the components of IBT and provides resources including a link to the National Coverage Determination (NCD) 210.11 Intensive Behavioral Therapy for Cardiovascular Disease.

October 1, 2020: Novitas Solutions: Prior Authorizations for hospital Outpatient Department Tips and Reminders

Similar to WPS, Novitas released an article including tips and reminders to assist you in avoiding a delay or dismissal of a prior authorization request (PAR).

October 2, 2020: Palmetto GBA Article: TPE Notifications Coming to eServices!

Palmetto GBA announced the addition of TPE notification letters to their eServices portal beginning October 10, 2020. At that time, letters will be issued as before through standard mail for non-eServices Users or the new option of electronically for eService Users. At the end of this announcement, Palmetto reminds providers that TPE reviews are on hold due to the COVID-19 pandemic and you will be notified when it TPE reviews do resume.

October 2, 2020: Palmetto GBA Article: Procedure Codes that Require Additional Documentation

This article  opens by reminding providers that “the submission of additional documentation is required only when certain CPT/HCPCS codes are billed or when additional documentation is needed for Palmetto GBA to process and/or price a service.” Palmetto GBA has included a list of codes requiring additional documentation in the article.

October 6, 2020: Novitas Article: Change to Amount in Controversy (AIC) for Appeals in 2021

This Novitas article provides updated information to the AIC for Appeals filed on or after January 1, 2021, includes the AIC amount, explains how the AIC is calculated and provides examples.

October 6, 2020: Palmetto GBA Article: General Appeals Information

Palmetto GBA reminds providers that you have the right to request an appeal if you disagree with an initial claim determination. This article walks through the five levels of Medicare Fee-for-Service appeals including time limits to appeal, minimum amounts in controversy (AIC) and notes providing additional guidance at the first three levels of appeal.

October 13, 2020: Palmetto GBA Article: Consider Reopening a Claim Instead of a Written Redetermination

Palmetto GBA advises, in the opening of this article, that “there is no need to appeal a claim if you have made a minor error or omission in filing the claim, which in turn caused the claim to be denied. In the case where a minor error or omission is involved, you may request that Palmetto GBA reopen the claim so the error or omission can be corrected rather than going through the written appeals process.” The article goes on to provide examples of what is considered a minor error or omission that can be reopened, modifiers considered simple claims corrections, and provide answers to questions about the process.

October 15, 2020: First Coast Services Options Prior Authorization for Certain Outpatient (OPD) Services FAQs and Retroactive Authorization for Services in the ED

First Coast has recently posted two documents providing information about the Prior Authorization for Certain OPD Services program that began in July of this year.

• FAQ Document based on questions posed during webinars: https://medicare.fcso.com/Prior_authorization/0466250.asp, and
• Retroactive Services in the Emergency Department: https://medicare.fcso.com/Prior_authorization/0474891.asp

Pre-orders have started for Apple’s soon to be released iPhone 12. Imagine what it would be like for devoted iPhone fans if the time from placing a pre-order to when you could actually hold one in your hands followed the CMS timeline for approval for new healthcare technologies. This would definitely not be the timeline for creating and maintaining a consumer base of people wanting the latest technology available in an iPhone.

In September, CMS released the proposed rule Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Proposed Rule (CMS-3372-P). Per a related CMS Press Release, “Under current rules, FDA approval of a device is followed by an often lengthy and costly process for Medicare coverage. The lag time between the two has been called the “valley of death” for innovative products, with innovators spending time and resources on FDA approval, only to be forced to spend additional time and money on the Medicare coverage process.” Further, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar, stated that “this new proposal would give Medicare beneficiaries faster access to the latest lifesaving technologies and provider more support for breakthrough innovations by finally delivering Medicare reimbursement at the same time as FDA approval.”

FDA Breakthrough Devices Program

The Breakthrough Devices Program is specifically for medical devices and device-led combination products meeting the following two criteria:

• The device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
• The device must satisfy one of the following elements:
• It represents a breakthrough technology;
• No approved or cleared alternatives exist; or
• It offers significant advantages over existing approved or cleared alternatives.

Current Medicare Coverage Pathways

The MCIT pathway is being proposed because the prescribed statutory timeframes for the National Coverage Determination (NCD) process limits CMS’ ability to institute immediate national coverage policies for new, innovative medical devices. NCDs and Local Coverage Determinations (LCDs) take, on average, 9 to 12 months to finalize.

CMS details current Medicare coverage pathways in this proposed rule. Each pathway is highlighted in the following table. 

‍Proposed MCIT Coverage Pathway

The MCIT Coverage Pathway would be specifically for Medicare coverage of devices that are designated as part of the FDA Breakthrough Devices Program and are FDA market authorized. The pathway would involve a coordinated effort by CMS, the FDA and manufacturers as medical devices move through the FDA regulatory process for Breakthrough devices. This simultaneous effort will ensure Medicare coverage on the date of FDA market authorization for all devices that fall within a Medicare benefit category.

MCIT Pathway Proposals:

• The pathway would be voluntary and be initiated when a manufacturer notifies CMS of its intention to utilize the MCIT pathway.
• To be part of the MCIT Pathway, the device must be used in accordance with its FDA approved or cleared indication for use.
• Unlike the pathways in the above table, CMS is proposing that that MCIT Pathway would allow for immediate national coverage upon the date of FDA market authorization (that is the date the medical device received Premarket Approval (PMA); 510K clearance; or the granting of a De Novo classification request) for the breakthrough device.
• If CMS has issued an NCD for a specific breakthrough device, it would not be eligible for the MCIT pathway.
• Coverage would continue for up to 4 years, unless CMS determines the device does not have a Medicare benefit category as determined as part of the pathway process.
• Reasons that the MCIT pathway may end prior to 4 years includes circumstances where a device becomes subject to an NCD, regulation, statute, or if the device can no longer be lawfully marketed.

CMS intends to list MCIT pathway covered devices on the CMS website to ensure all stakeholders will be aware of what is covered through this pathway.

When an MCIT Coverage Pathway Ends, What Next?

At the end of the 4-year MCIT pathway, coverage of a device would be subject to one of the following three possible outcomes:

• NCD affirmative coverage, which may include facility or patient criteria;
• NCD non-coverage; or
• MAC discretion (claim-by-claim adjudication or NCD).

CMS encourages interested manufacturers to submit an NCD request during the third year of MCIT to allow time for NCD development. They are also seeking comments on whether or not a National Coverage Analysis should be opened if a MAC has not issued an LCD within 6 months of the expiration date of the MCIT period.

MCIT Device Eligibility

CMS is proposing that devices having received Breakthrough Device designation within 2 years of the date this proposed rule is finalized will be eligible for coverage for claims submitted on or after the effective date of the final rule. This group of devices would not be eligible for all 4 years of MCIT coverage as the 4 year period starts on the date of FDA market authorization. CMS anticipates two MCIT pathway participants in the first year based on the number of medical devices that received FY 2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles.

Proposal to Codify Definition of “Reasonable and Necessary”

In addition to the proposed MCIT Pathway, CMS is proposing to “codify in regulations the Program Integrity Manual definition of ‘‘reasonable and necessary’’ with modifications, including to add a reference to Medicare patients and a reference to commercial health insurer coverage policies.”

Proposal: “An item or service would be considered ‘‘reasonable and necessary’’ if it is— (1) safe and effective; (2) not experimental or investigational; and (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is:

• Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
• Furnished in a setting appropriate to the patient’s medical needs and condition;
• Ordered and furnished by qualified personnel;
• One that meets, but does not exceed, the patient’s medical need; and
• At least as beneficial as an existing and available medically appropriate alternative.”

Proposal: An item or service would be “appropriate for Medicare patients” under (3) if it is covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals.

Proposal: An item or service deemed appropriate for Medicare coverage based on commercial coverage would be covered on that basis without also having to satisfy the bullets listed above.

CMS Seeking Comments to the Proposed Rule

In the world of CMS proposed rules, this one makes for a quick read at just 13 pages in the Federal Register. CMS is seeking comments on many aspects of this proposed rule and comments must be received by CMS no later than 5 p.m. on November 2, 2020.

Resources

CMS Press Release: CMS Acts to Spur Innovation for America’s Seniors https://www.cms.gov/newsroom/press-releases/cms-acts-spur-innovation-americas-seniors

CMS Fact Sheet: Proposed Medicare Coverage of Innovative Technology (CMS-3372-P)

https://www.cms.gov/newsroom/fact-sheets/proposed-medicare-coverage-innovative-technology-cms-3372-p

Proposed Rule (CMS-3372-P)

https://www.federalregister.gov/documents/2020/09/01/2020-19289/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 6th through October 12th.

Resource Spotlight: CDC Updates Guidance on How Coronavirus Spreads

On October 5th, the CDC updated their guidance on how Coronavirus spreads. The CDC’s How COVID-19 Spreads webpage opens by noting the spread of COVID-19 is mainly through close contact (within about 6 feet) and that people who are infected but asymptomatic can also spread the virus. The next sentence in the opening paragraph reminds the reader how much is still unknown about this disease as the CDC states “we are still learning about how the virus spreads and the severity of illness it causes.”

New to this page is the fact that the CDC is now on record as stating they believe “COVID-19 can sometimes be spread by airborne transmission” The following example provided by the CDC brings to mind the choir practice in March that resulted in multiple people testing positive for COVID-19, including three patients being hospitalized and two dying.

“There is evidence that under certain conditions, people with COVID-19 seem to have infected others who were more than 6 feet away. These transmissions occurred within enclosed spaces that had inadequate ventilation. Sometimes the infected person was breathing heavily, for example while singing or exercising.

• Under these circumstances, scientists believe that the amount of infectious smaller droplet and particles produced by the people with COVID-19 became concentrated enough to spread the virus to other people. The people who were infected were in the same space during the same time or shortly after the person with COVID-19 had left.”

September 29, 2020: CMS Updates COVID-19 Testing Methodology for Nursing Homes

Although this update occurred in late September. After talking with my mother, who is now a permanent resident of an Assisted Living Community where a Skilled Nursing Unit (SNF) is housed on the opposite side of the building, I felt it was important to share. Especially after my mom mentioning during a phone conversation that she is getting testing weekly for COVID-19 and the employees are getting tested twice a week.

The September 29th updated guidance came about in response to CMS receiving concerns from some governors of rural states that the frequency guidelines were not working well for some rural areas and updates the August 26th guidance.

October 6, 2020: CMS Interim Final Rule (IFC) –Requirements & Enforcement Process for Reporting COVID-19 Data Elements

CMS summarized the IFC as follows:

“CMS is committed to continuing to take critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-10) Public Health Emergency (PHE). On September 2, 2020, the Federal Register published an interim final rule with comment period (IFC) (85 FR 54820). CMS has released new regulatory requirements for all hospitals and critical access hospitals (CAHs) at 42 C.F.R. §§482.42(e) and 485.640(d), respectively, to report information in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for COVID-19. Failure to report the specified data needed to support broader surveillance of COVID-19 may lead to the imposition of the remedy to terminate a provider’s participation from the Medicare and Medicaid programs.”

You will find a link to the memorandum sent to CMS Locations State Agencies, Hospitals/CAHs, and other stakeholders as well as Hospital Mandatory COVID-19 Reporting Enforcement Workflow pdf document on this CMS webpage.

October 6, 2020: FDA Launches New Webpage: COVID-19 Vaccines

In their October 6, 2020 COVID-19 Daily Roundup, the FDA announced the launch of a new webpage, COVID-19 Vaccines, to highlight new information as it becomes available. On this webpage, Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research indicate that “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”

October 7, 2020: Regeneron Seeks Emergency Use Authorization Request

Regeneron announced their submission to the FDA for an Emergency Use Authorization (EUA) for their REGN-COV2 investigational antibody combination for COVID-19. The announcement goes on to indicate that “if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.”

October 7, 2020: FDA Recommendations on Instructions for Patients Self-Collecting Nasal Samples for COVID-19 Testing

In an FDA Letter to Health Care Providers, the FDA is recommending that “providers provide visual (written or video) step-by-step instructions, in addition to verbal instructions, to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing…the instructions provided to patients should incorporate the following information:

• The entire tip of the swab (usually ½ to ¾ of an inch) should be placed inside the nose, and the side of the swab tip should be rubbed with moderate pressure against as much of the wall of the anterior nares region as possible, moving the tip through a large circular path inside the nose.
• At least four of these sweeping circles should be performed in each nostril using the same swab. This should take approximately 10-15 seconds per nostril.
• Simply twirling the swab against one part of the inside of the nose or leaving the swab in the nose for 10-15 seconds, is not proper technique and may result in an insufficient sample.”

The letter also includes links to additional resources and how to report problems with SARS-COV-2 testing to the FDA.

October 7, 2020: AMA Press Release – New CPT codes for Multi-Virus Tests Detect COVID-19 and Flu – Approved for Immediate Use

The AMA announced an update to the Current Procedural Terminology (CPT®) code set including “new code additions and editorial revisions for reporting medical services sparked by the public health response to the COVID-19 pandemic.”

The following two new codes allow for detection of COVID-19 and common viral infections, including influenza A/B and respiratory syncytial virus.

• 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 virus types A and B, multiplex amplified probe technique
• 87637- Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique

It is important to note that revisions to the code set have been approved for immediate use.

October 8, 2020: New Repayment Terms for Medicare Loans made to Providers during COVID-19

The recently enacted “Continuing Appropriations Act, 2021 and Other Extensions Act” amended the repayment terms for the Expanded Accelerated and Advance Payments (AAP) Program. CMS released a Special Edition MLNConnects providing details regarding the new recoupment terms giving providers and suppliers one additional year to start their loan repayments. “CMS issued $106 billion in payments to providers and suppliers in order to alleviate the financial burden health care providers faced while experiencing cash flow issues in the early stages of combating the Coronavirus Disease 2019 (COVID-19) public health emergency.” This article includes links to a Fact Sheet (PDF) and FAQs (PDF) document providing more information about the repayment terms.

Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M also released an

Article on October 8th letting providers know that they will be issuing “letters to any provider or facility that received an APP with full details regarding repayment of their accelerated or advanced payment. The letter will include a list of the provider’s accelerated or advance payment(s), including the amount(s), the date(s) that repayment will begin, and the related Accounts Receivable (AR) number(s). If a provider received accelerated or advance payment(s) in multiple disbursements, each disbursement amount will be listed, along with the corresponding date that repayment for each disbursement will begin.”

October 8, 2020: MLNConnects Notification – COVID-19: Optimizing PPE and Child Health and Wellness

CMS provided the following information in their Thursday October 8th edition of MLNConnects:

The Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released:

• Optimizing Healthcare PPE and Supplies Webinar Q&A: Read responses to questions from the September 24 webinar
• PPE Preservation Planning Toolkit: Reuse, repurpose, or reduce the use of Personal Protective Equipment (PPE)
• Crisis Standards of Care  in Post-Acute and Long-Term Care Facilities: Respond to crisis standards of care
• Child Health and Wellness Webinar Recording: Listen to the first webinar in the Hidden Consequences: How the COVID-19 Pandemic is Impacting Children series

For More Information:

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

October 8, 2020: SNF and LTCH Quality Reporting Programs: COVID-19 Public Reporting – Revised

Also included in the Thursday October 8th edition of MLNConnects, are updated COVID-19 public reporting tip sheets for Skilled Nursing Facilities (SNFs) and Long-Term Care Hospitals (LTCHs).

October 9, 2020: CMS Takes Action to Protect Integrity of COVID-19 Testing

CMS notes in an October 9th Press Release that “since August 12, 2020, CMS issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without an appropriate CLIA certificate. Of those 171 letters, 34 percent went to facilities conducting laboratory testing without a CLIA certificate and 66 percent were issued to laboratories performing COVID-19 testing outside the scope of the existing CLIA certification. The letters ordered these laboratories to stop immediately to safeguard the integrity of COVID-19 testing, and protect patients from potential endangerment if provided inaccurate or unreliable test results. Following receipt of the letter, laboratories are required to provide CMS an attestation certifying they have ceased testing.”

CDC COVID Data Tracker – United States COVID-19 Cases

Q:

Given the ongoing COVID-19 Pandemic, has CMS delayed the start date for the Hospital Price Transparency requirement?

A:

There has been no delay in this requirement. CMS actually reaffirmed the January 1, 2020 effective date by including the following information in their Thursday October 1, 2020 MLNConnects newsletter:

Hospital Price Transparency: Requirements Effective January 1

Starting January 1, 2021, each hospital operating in the United States is required to provide clear, accessible pricing information online about the items and services they provide in two ways:

• Comprehensive machine-readable file with all items and services
• Display of shoppable services in a consumer-friendly format

Is your organization prepared to be compliant? Visit the new Hospital Price Transparency website for resources to help you prepare:

• Final Rule
• FAQs (PDF)
• 8 Steps to a Machine-Readable File (PDF)
• 10 Steps to a Consumer-Friendly Display (PDF)
• Quick Reference Checklists (PDF)