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 July 27th through August 3rd.

Resource Spotlight: CDC Toolkit for Young Adults: 15 to 21

As parents across the country are facing the dilemma of whether or not to send their child back to school or attend school “remotely,” the CDC has developed a series of Factsheets for Young Adults covering a variety of topics related to COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/communication/toolkits/young-people-15-to-21.html

July 28, 2020: CMS Updates COVID-19 Data

In a CMS Press Release, they announced the first monthly update of data providing a snapshot of the impact of COVID-19 on the Medicare population.

About the Data

• For the first time the data included information for American Indian/Alaskan Native Medicare beneficiaries,
• The data confirms “that the COVID-19 public health emergency is disproportionately affecting vulnerable populations, particularly racial and ethnic minorities,”
• The data is based on COVID-19 cases and hospitalizations from January 1, 2020 to June 20, 2020,
• The data is based on Medicare claims and encounter data CMS received by July 17, 2020,
• Key data points about the data are that black beneficiaries, beneficiaries eligible for both Medicare and Medicaid and beneficiaries with end-stage renal disease (ESRD) are being hospitalized at a higher rate, and
• “CMS paid $2.8 billion in Medicare fee-for-service claims for COVID-related hospitalizations, on an average of $25,555 per beneficiary.”

July 28, 2020: CDC Clinician Outreach and Communication Activity (COCA) Call: COVID-19 and Diabetes

For those that were unable to attend the July 28th session, the CDC hosted a call focused on current information about the impact and increased risk for COVID-19 complications in people with diabetes and the importance of diabetes prevention, management, and support. The CDC has made available a video recording, slides and transcript of this call.  

July 28, 2020: Dramatic Trends in Medicare Beneficiary Telehealth Utilization and COVID-19

The U.S Department of Health and Human Services (HHS) issued a Press Release announcing the release of a “new report showing the dramatic utilization trends of telehealth services for primary care delivery in Fee-for-Service (FFS) Medicare in the early days of the coronavirus disease 2019 (COVID-19) pandemic…Even after Medicare in-person primary care visits resumed in May, there continues to be steady demand for telehealth visits which are now more broadly available to Medicare beneficiaries and providers during the PHE. This suggests there will be continued interest in telehealth post-pandemic for millions of Medicare beneficiaries.”

July 29, 2020: Palmetto GBA FAQs: COVID-19 Accelerated/Advance Payment (AAP) Repayment FAQ

Palmetto GBA, the JJ and JM MAC has posted an FAQ document “to help providers understand the process and options of repaying accelerated/advance payments (AAPs) issued for COVID-19.”

July 29, 2020: OIG Updates FAQs – Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to COVID-19 Public Health Emergency

The OIG is accepting questions “from the health care community regarding the application of OIG's administrative enforcement authorities, including the Federal anti-kickback statute and civil monetary penalty (CMP) provision prohibiting inducements to beneficiaries (Beneficiary Inducements CMP).”

The most recent addition to this document was on July 29th when the OIG answers the question of whether or not “an oncology practice can offer free or discounted lodging to its financially needy patients who are Federal health care program beneficiaries if, prior to the COVID-19 public health emergency, such patients would have had access to free or discounted housing at a nonprofit lodging facility while receiving chemotherapy or radiation treatment?”

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.

July 29, 2020: FDA Posts FAQs about Antibody (Serology) Testing During COVID-19 PHE

The FDA announced the release of FAQs for patients and consumers about antibody (serology) testing during the COVID-19 pandemic in their July 30th Edition of the COVID-19 Update: Daily Roundup. Topics reviewed in the FAQs includes:

• Antibodies and antibody testing: the basics,
• Understanding antibody test results,
• Practical information on antibody tests: who needs them where to get them; and
• Additional Resources where you are provided to the CDC webpage Using Antibody Tests for COVID-19.

July 30, 2020: CMS MLNConnects Newsletter: COVID-19 Lab Claims Requiring the NPI of the Ordering/Referring Professional – Update

The following information was included in the July 30, 2020 edition of CMS MLNConnects eNewsletter: “During the COVID-19 Public Health Emergency (PHE), CMS relaxed requirements for a limited number of laboratory tests required for a COVID-19 diagnosis. These tests do not require a practitioner order during the PHE. We added a new test to this list (PDF): CPT 87426 (Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [COVID-19]).

Any health care professional authorized under state law may order these tests. Medicare will pay for these tests without a written order from the treating physician or other practitioner:

• If an order is not written, you do not need to provide the National Provider Identifier (NPI) of the ordering or referring professional on the claim
• If an order is written, include the NPI of the ordering or referring professional, consistent with current billing guidelines

For More Information:

• Laboratory tests with modified requirements (PDF)
• Interim final rule”

July 30, 2020: National Public Health Experts to America: Donate Plasma

The HHS Press Office announced the release of a series of public service announcements (PSAs) to Americans seeking to “dramatically increase donations of convalescent plasma by the end of August in the whole-of-America fight against the coronavirus disease 2019 (COVID-19) pandemic.” Messaging in the PSAs to Americans includes the following three points:

• If you have recovered from COVID-19 after a confirmed test for the virus and have had no symptoms for at least two weeks, find a location and donate plasma;
• There are thousands of locations around the country where you can donate, and
• Donation locations can be found by visiting gov.

July 30, 2020: CMS and CDC Announces Provider Reimbursement for Counseling Patients to Self-Isolate at Time of COVID-19 Testing

In a July 30th Special Edition MLNConnects eNewsletter, CMS and the CDC announced “that payment is available to physician and health care providers to counsel patients, at the time of Coronavirus Disease 2019 (COVID-19) testing, about the importance of self-isolation after they are tested and prior to the onset of symptoms.”

Provider counseling will include the discussion of the following:

• Immediate need for isolation, even before test results are available,
• The importance to inform their immediate household that they too should be tested for COVID-19,
• Review the signs and symptoms and services available to them to aid in isolating at home, and
• If a patient tests positive for COVID-19, they will be counseled to wear a face mask at all times, that they will be contacted by public health authorities to provider information for contact tracing, and to tell immediate household and recent contacts in case it is appropriate for them to also be tested for COVID-19 and self-isolate.

MLN SE20011 was revised on July 30th to add information about Counseling and COVID-19 Testing and how to bill for the counseling services.

July 31, 2020: CDC and CMS COVID-19 Counseling Reimbursement Resources

The CDC’s Clinician Outreach and Community Activity (COCA) issued a COCA Now email about COVID-19 Counseling Reimbursement noting that “counseling can help slow the spread of the virus and keep families and communities safe.” In the announcement the CDC provides links for Healthcare Providers and Public Health Professionals to CDC and CMS developed resources. 

Resources for Healthcare Providers

• 3 Key Steps to Take While Waiting for Your COVID-19 Test Result
• Infographic describing what to expect during contact tracing
• Health care provider Q&A about reimbursement for counseling
• Provider-patient counseling talking points
• Provider counseling checklist  

Resources for Public Health Professionals
Patient Resources:

• 3 Key Steps to Take While Waiting for Your COVID-19 Test Result
• Infographic describing what to expect during contact tracing

Provider Resources:

• Health care provider Q&A about reimbursement opportunity
• Provider-patient counseling talking points
• Provider counseling checklist
• CMS Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19)

You can sign up for future COCA Now Messages on the CDC website at undefined.

August 3, 2020: Proposed Expansion of Telehealth Benefits Permanently Beyond the COVID-19 Public Health Emergency (PHE)

CMS announced in a Press Release proposed changes to expand telehealth permanently simultaneous to an Executive Order on Improving Rural Telehealth Access signed by President Trump.  “Before the public health emergency (PHE), only 14,000 beneficiaries received a Medicare telehealth service in a week while over 10.1 million beneficiaries have received a Medicare telehealth service during the public health emergency from mid-March through early-July.”

CMS is proposing to permanently allow some of the 135 services added, during the PHE, to the list of services that can be paid when delivered by telehealth, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments. CMS is seeking public input on other services to permanently add to the telehealth list beyond the PHE in order to give clinicians and patients time as they get ready to provide in-person care again.” CMS is also proposing to extend payment for other telehealth services, such as emergency department visits, through the calendar year in which the PHE ends.

The entire list of services being proposed are included in the calendar year (CY) 2021 Physician Fee Schedule Proposed Rule also issued on August 3rd, 2020. 

Q:

Does a provider have to explicitly link a respiratory condition to COVID-19, if the COVID-19 test is positive?  For example:  Pneumonia with a positive COVID-19 test.

A:

No. A provider does not need to explicitly link the results of the COVID-19 test to the respiratory condition, as long as the positive test result itself, is part of the medical record.  For the example above, code U07.1 (COVID-19) as the principal diagnosis with code J12.89 (Other Viral Pneumonia) as a secondary diagnosis.

References:

Frequently Asked Questions Regarding ICD-10-CM Coding for COVID-19

Coding Clinic for ICD-10-CM/PCS, Second Quarter 2020: Page 3, effective May 29, 2020.

The ICD-10-CM Officials Guidelines “have been developed to assist both the healthcare provider and the coder in identifying those diagnoses that are reported. The important of consistent, complete documentation in the medical record cannot be overemphasized. Without such documentation accurate coding cannot be achieved. The entire record should be reviewed to determine the specific reason for the encounter and the conditions treated.”

The Guidelines for FY 2021 were released at the beginning of July and can be found on the CDC ICD-10-CM webpage as well as the 2021 ICD-10-CM CMS webpage. This article highlights changes to already current sections in the guidelines as well as new sections for EVALI and COVID-19.

Documentation by Clinicians Other than the Patient’s Provider: Social Determinants of Health (SDOH)

Over the past several years this section of the Guidelines has included more and more instances when “code assignment may be based on medical record documentation from clinicians who are not the patient’s provider.” These instances include: Body Mass Index (BMI), depth of non-pressure chronic ulcers, pressure ulcer stage, coma scale, NIH stroke scale (NIHSS), and social determinants of health codes found in categories Z55-Z65.

The 2021 Guidelines adds the following statement regarding assignment of social determinant codes:

“Patient self-reported documentation may also be used to assign codes for social determinants of health, as long as the patient self-reported information is signed-off by and incorporated into the health record by either a clinician or provider.”

Coding COVID-19

Chapter 1 of the Guidelines, Certain Infectious and Parasitic Diseases, includes a new section for Coronavirus infections. Coders are advised to “code only a confirmed diagnosis of the 2019 novel coronavirus disease (COVID-19) as documented by the provider or documentation of a 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 a positive test result for COVID-19; the provider’s documentation that the individual has COVID-19 is sufficient.”

If the provider documents “suspected,” “possible,” “probable,” or “inconclusive” COVID-19, do not assign code U07.1. Instead, code the signs and symptoms reports. See guideline I.C.I.g.I.g.”

This new COVID-19 section also provides guidance for the following coding issues:

• Sequencing of codes,
• Acute respiratory manifestations of COVID-19,
• Non-respiratory manifestations of COVID-19,
• Exposure to COVID-19,
• Screening for COVID-19,
• Signs and Symptoms without definitive diagnosis of COVID-19,
• Asymptomatic individuals who test positive for COVID-19,
• Personal history of COVID-19,
• Follow-up visits after COVID-19 infection has resolved, and
• Encounter for antibody testing.

New coding guidance related to COVID-19 is also included in chapters 15 and 16 (“Pregnancy, Childbirth, and the Puerperium” and “Infection in Newborn, respectively”).

Diabetes Mellitus and the Use of Insulin, Oral Hypoglycemics, and Injectable Non-Insulin Drugs

Lately, it seems like every time I turn on the television there is a commercial for a new “long-acting” drug to treat diabetes. For this reason, it is very timely that the following guidance has been added to the FY 2021 Guidelines:

“If the patient is treated with both insulin and an injectable non-insulin antidiabetic drug, assign codes Z79.4, Long-term (current) use of insulin, and Z79.899, Other long term (current) drug therapy. If the patient is treated with both oral hypoglycemic drugs and an injectable non-insulin antidiabetic drug, assign codes Z79.84, Long-term (current) use of oral hypoglycemic drugs, and Z79.899, Other long-term (current) drug therapy.”

Note, this same guidance has been added to the section Secondary diabetes mellitus and the use of insulin or oral hypoglycemic drugs.

Mental and Behavioral Disorders Due to Psychoactive Substance Use

In the “psychoactive substance use, unspecified,” the guidelines previously advised that “as with all other unspecified diagnoses, the codes for unspecified psychoactive substance use…should only be assigned based on provider documentation and when they meet the definition of a reportable diagnosis.”

New for FY 2021, the following bolded guidance has been added:

“These codes are to be used only when the psychoactive substance use is association with a physical disorder included in chapter 5 (such as sexual dysfunction and sleep disorder), or a mental or behavioral disorder, and such a relationship is documented by the provider.”

Hypertensive Heart and Chronic Kidney Disease

FY 2020 Guidance: “If a patient has hypertensive chronic kidney disease and acute renal failure, an additional code for the acute renal failure is required.”

FY 2021 Guidance: “If a patient has hypertensive chronic kidney disease and acute renal failure, the acute renal failure should also be coded. Sequence according to the circumstances of the admission/encounter.”

Vaping-Related Disorders

It is hard to believe that this time last year the CDC, FDA, and state health authorities were diligently working to identify the cause of the national outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI). According to the CDC webpage devoted to this disease, as of February 18, 2020 a total of 2,807 hospitalized EVALI cases or deaths had been reported to the CDC from all 50 states, the District of Columbia, and two U.S. territories (Puerto Rico and U.S. Virgin Islands).

Initial vaping coding guidance was released in 2019 and a new ICD-10-CM code was implemented on April 1, 2020. Information about both can be downloaded from the CDC ICD-10-CM webpage at https://www.cdc.gov/nchs/icd/icd10cm.htm.

Specific to the Coding Guidelines, the following has been added for FY 2021:

“For patients presenting with condition(s) related to vaping, assign code U07.0, Vaping-related disorder, as the principal diagnosis. For lung injury due to vaping, assign only code U07.0. Assign additional codes for other manifestations, such as acute respiratory failure (subcategory J96.0-) or pneumonitis (code J68.0).

Associated respiratory signs and symptoms due to vaping, such as cough, shortness of breath, etc., are not coded separately, when a definitive diagnosis has been established. However, it would be appropriate to code separately any gastrointestinal symptoms, such as diarrhea and abdominal pain.”

Puerperal Sepsis

For FY 2021, the guidelines advise that “Code O85 should not be assigned for sepsis following an obstetrical procedure (See Section I.C.1.d.5.b., Sepsis due to a postprocedural infection).”

Chapter 21: Factors Influencing Health Status and Contact with Health Services (Z00-Z99) – Observation

The three observation z code categories “are for use in very limited circumstances when a person is being observed for a suspected condition that is ruled out. The observation codes are not for use if an injury or illness or any signs or symptoms related to the suspected condition are present. In such cases the diagnosis/symptom code is used with the corresponding external code cause.”

FY 2020 Guidance: “The observation codes are to be used as principal diagnosis only. The only exception to this is when the principal diagnosis is required to be a code from category Z38, Liveborn infants according to place of birth and type of delivery.”

FY 2021 Guidance: “The observation codes are primarily to be used as a principal/first-listed diagnosis. An observation code may be assigned as a secondary diagnosis code when the patient is being observed for a condition that is ruled out and is unrelated to the principal/first-listed diagnosis (e.g., patient presents for treatment following injuries sustained in a motor vehicle accident and is also observed for suspected COVID-19 infection that is subsequently ruled out).”

Chapter 22: Codes for Special Purposes (U00-U85) NEW

This new chapter for FY 2021 includes the Vaping-related disorder code, U07.0 and COVID-19 code, U07.1. The reader is referenced back to prior sections in the Guidelines for guidance on coding both of these conditions.

While I have highlighted updates for FY 2021, I believe the Guidelines are an essential annual read for Coding and Clinical Documentation Integrity (CDI) Professionals. As I think of school systems struggling with the decision of whether to and when to reopen schools, you can consider reading the FY 2021 Coding Guidelines your required summer reading for the coming Fiscal Year.

MEDICARE TRANSMITTALS – RECURRING UPDATES

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 26.3, Effective October 1, 2020

• Article Release Date: June 23, 2020
• What You Need to Know: Change Request (CR) 11840 providers the quarterly updates to the NCCI PTP edits.
• MLN MM11840: https://www.cms.gov/files/document/mm11840.pdf

Quarterly Update to the End Stage Renal Disease Prospective Payment System (ERSD PPS)

• Article Release Date: June 29, 2020
• What You Need to Know: CR 11835 informs providers about the twenty new diagnosis codes eligible for the ESRD PPS comorbidity payment adjustment effective October 1, 2020.
• MLN MM11835: https://www.cms.gov/files/document/mm11835.pdf

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

• Article Release Date: July 2, 2020
• What You Need to Know: This article updates the Quarterly ASP Medicare Part B Files and informs providers of revisions to prior quarterly filing prices.
• MLN MM11854: https://www.cms.gov/files/document/mm11854.pdf

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

• Article Release Date: July 2, 2020
• What You Need to Know: This article provides FY 2020 Updates to the SNF PPS payment rates, as required by statue.
• MLN MM11859: https://www.cms.gov/files/document/mm11859.pdf

Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes – July 2020 Update

• Article Release Date: July 6, 2020
• What You Need to Know: Change Request (CR) 11769 released on June 23, 2020 updates the HCPCS code set for codes related to drugs and biologicals effective July 1, 2020. The related MLN article MM11769 provides links to the updated quarterly HCPCS complete code set.
• MLN MM11769: https://www.cms.gov/files/document/mm11769.pdf

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2020

• Article Release Date: July 10, 2020
• What You Need to Know: This article announced changes included in the October 2020 quarterly release of the edit module for clinical diagnostic laboratory services.
• MLN MM11889: https://www.cms.gov/files/document/MM11889.pdf

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

• Article Release Date: July 10, 2020
• What You Need to Know: This article informs you of the availability of payment allowances for the seasonal influenza virus vaccines as updated on an annual basis, effective August 1 each year.
• MLN MM11882: https://www.cms.gov/files/document/mm11882.pdf

Other Medicare Transmittals

Revising Chapters 3 and 5 of Publication (Pub.) 100-08, to Reflect the Recent Final Rule CMS-1713-F

• Article Release Date: July 1, 2020
• What You Need to Know: CR 11599, released June 19, 2020, revises the Medicare Program Integrity Manual, Chapters 3 (Verifying Potential Errors and Taking Corrective Actions) and 5 (Items and Services Having Special DMEPOS Review Considerations) to include finalized regulatory updates, including those related to face-to-face encounter and written order requirements.
• MLN Matters MM11599: https://www.cms.gov/files/document/mm11599.pdf

Change to the Payment of Allogeneic Stem Cell Acquisition Services

• Article Release Date: July 13, 2020
• What You Need to Know: Currently payment for this service is included in the MS-DRG payment for allogeneic hematopoietic stem cell transplants when transplants occurred in the inpatient setting. Change Request (CR) Transmittal R10218CP provides instructions to pay inpatient hospital Allogeneic Stem Cell Acquisition services on a reasonable cost basis.
• MLN Matters MM11729: https://www.cms.gov/files/document/mm11729.pdf

Revised Medicare Transmittals

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)—July 2020 Update

• Article Release Date: February 25, 2020 – Revised June 22, 2020
• What You Need to Know: This MLN article was revised to reflect a revised Change Request (CR) 11655 in which CMS removed the CPT code 0048U from the business requirement for NCD 90.2 Next Generation Sequencing (NGS) and corresponding removals of CPT 0048U and its associated diagnosis codes from the NCD 90.2 NGS spreadsheet. Changes were made due to the CPT code not meeting the policy criteria in NCD 90.2 for NGS.
• MLN MM11655: https://www.cms.gov/files/document/mm11655.pdf

July 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS) Revised

• Article Release Date: June 8, 2020 – Revised July 2, 2020
• What You Need to Know: This article was revised to reflect updates in the related CR R10207CP. Updates include the following:
• Added CPT code 99458 with status indicator "B".
• "New Separately Payable Procedure Codes – Surgical Procedures" has been updated with corrected APC assignment for HCPCS code C9760.
• "OPPS PRICER Logic and Data Changes for the July 2020 Update" has been removed. There is also a new, "Inadvertent Deletion of CPT code 0126T" added.
• Therefore, the existing section 16 "Changes to the Wage Index" has become section 15. Table 1 has been updated by adding a new PLA COVID-19 code, 0202U.
• Table 2 has been updated by adding CPT code 99458 with status indicator "B".
• Table 21 has been updated by changing APC number for HCPCS code C9760 from APC 1591 to APC 1589. We also changed the CR release date, transmittal number and link to the transmittal. All other information is unchanged.
• MLN MM11814: https://www.cms.gov/files/document/mm11814.pdf

July 2020 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: June 24, 2020 – Revised July 2, 2020
• What You Need to Know: This article describes changes to and billing instructions for various payment policies implemented in the July 2020 ASC payment system update. This notification also includes HCPCS updates. The July 2nd revision was made to correct the last section in Section 6.e, on page 10. CMS notes it should have stated, “C9058 is replaced by Q5120 effective July 1, 2020.”
• MLN MM11842: https://www.cms.gov/files/document/mm11842.pdf

Overview of the Repetitive, Scheduled Non-emergent Ambulance Prior Authorization Model

• Article Release Date: May 4, 2015 – Revised July 24, 2020
• What You Need to Know: This article was revised to provide information on transportation information for beneficiaries in the Additional Information section of this article.
• MLN SE1514: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1514.pdf

Modify Edits in the Fee for Service (FFS) System when a Beneficiary has a Medicare Advantage (MA) Plan

• Article Release Date: May 1, 2020 – Revised July 21, 2020
• What You Need to Know: This article was revised to reflect revisions in Change Request (CR) 11850 also issued on July 21, 2020. This CR reflects additional sections to the Medicare Claims Procession Manual – Chapter 32 – Billing Requirements for Special Services. Section 66.2 of the chapter identifies CAR-T as having significant costs for Medicare Advantage. Due to the significant cost Providers may bill the A/B MAC for this NCD service provided to a MA beneficiary.
• MLN MM11580: https://www.cms.gov/files/document/mm11580.pdf

Medicare Coverage Updates

MLN Booklet: How to Use the Medicare Coverage Database (MCD)

• Booklet Release Date: June 2020
• What You Need to Know: This MLN education booklet provides information on what the MCD is, why you would use it, a background about Medicare coverage and coverage determinations, how up-to-date is the MCD and how to search the MCD.
• ICN MLN901347 June 2020: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/MedicareCvrgeDatabase_ICN901346.pdf

National Coverage Determination (NCD) 160.18 Vagus Nerve Stimulation (VNS) MLN Article Revised

• MLN Article Revised: June 23, 2020
• What You Need to Know: This article was revised to reflect the revised CR11461 issued on June 23, 2020. The revised CR clarifies instructions for the MACs and changed the implementation date to July 22, 2020.
• MLN MM11461: https://www.cms.gov/files/document/mm11461.pdf

Medicare Compliance Tips

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

• Booklet Release Date: June 2020
• What You Need to Know: This MLN education booklet provides information on what is the Medicare NCCI, why would you use it, how up to date are the NCCI tables and manual, how to locate the NCCI tables and manual and using the NCCI tools.
• ICN 901346 June 2020: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/How-To-Use-NCCI-Tools.pdf

Medicare Quarterly Provider Compliance Newsletter

• Newsletter Release Date: July 2020
• What You Need to Know: This newsletter is released on a quarterly basis to share Medicare Contractor Audit Findings and provide information on how to address and avoid top issues in a particular quarter. The July 2020 edition includes information from the following three RAC Auditor Reviews:
• New Issue #0099 – Skilled Nursing Facility Consolidated Billing: Outpatient Facility – Not Separately Payable Services: Unbundling,
• New Issue #0129 – Hyperbaric Oxygen Therapy for Diabetic Wounds: Medical Necessity and Documentation Requirements, and
• New Issue #0103 – Urological Supplies: Medical Necessity and Documentation Requirements.
• ICN MLN5829840 July 2020: https://www.cms.gov/files/document/medicare-quarterly-provider-compliance-newsletter-volume-10-issue-4.pdf

Other Medicare Updates

CMS Announces the Creation of the Office of Burden Reduction and Health Informatics

In a June 23rd Press Release, CMS announced a new Office of Burden Reduction and Health Information meant “to unify the agency’s efforts to reduce regulatory and administrative burden and to further the goal of putting patients first.” CMS Administrator Seema Verma said in the announcement that “The Office of Burden Reduction and Health Informatics will ensure the agency’s commitment to reduce administrative costs and enact meaningful and lasting change in our nation’s health care system…Specifically, the work of this new office will be targeted to help reduce unnecessary burden, increase efficiencies, continue administrative simplification, increase the use of health informatics, and improve the beneficiary experience.”

June 25, 2020: CMS Issues Home Health PPS Proposed Rule [CMS-1730-P] CY 2021

In addition to updating payment rates and wage index for calendar year 2021, “this proposed rule proposes to permanently finalize the changes to §409.43(a) as finalized in the first COVID-19 PHE IFC (85 FR 19230), to state that the plan of care must include any provision of remote patient monitoring and other services furnished via a telecommunications system and describe how the use of such technology is tied to the patient-specific needs as identified in the comprehensive assessment and will help to achieve the goals outlined on the plan of care.”

• Related CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cms-proposes-calendar-year-2021-payment-and-policy-changes-home-health-agencies-and-calendar-year

June 26, 2020: HHS Submits Status Report on Medicare Appeals Backlog at the ALJ Level

In this June 26th report, HHS indicated that they have reduced that “By the end of the second quarter of 2020, a total of 242,995 appeals remain pending at OMHA, which is a 43% reduction from the starting number of appeals identified in the Court’s order (426,594 appeals).”

https://www.aha.org/system/files/media/file/2020/06/alj-delay-status-report-6-26-2020.pdf

AHA Announcement: https://www.aha.org/news/headline/2020-06-26-result-aha-lawsuit-hhs-continues-reduce-appeals-backlog

July 6, 2020: CMS Issues End Stage Renal Disease (ESRD) Prospective Payment System (PPS) Calendar Year (CY) 2021 Proposed Rule (CMS-1732-P)

In addition to proposed updates to payment policies and rates, this rule is also proposing updates to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI and proposes changes to the ESRD Quality Incentive Program (QIP).

• CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-proposes-medicare-payment-changes-support-innovation-and-increased-access-dialysis-home-setting
• CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/end-stage-renal-disease-esrd-prospective-payment-system-pps-calendar-year-cy-2021-proposed-rule-cms

July 15, 2020: OIG Report: Hospitals Overbilled Medicare $1 Billion by Incorrectly Assigning Severe Malnutrition Diagnosis Codes to Inpatient Hospital Claims

This is not the first time the OIG has focused on malnutrition diagnosis codes and based on their findings I do not anticipate this will be the last time. The parameters of the OIG audit included:

• Focusing on Diagnosis Codes E41 (Nutritional marasmus) and E43 (Unspecified severe protein calorie malnutrition), and
• Auditing a random sample of 200 claims with a discharge date in Fiscal Year 2016 or 2017.

OIG Findings:

• 173 of the 200 records reviewed were not correctly billed by the hospitals
• 9 of the 173 incorrectly coded claims the removal of the malnutrition code did not impact DRG assignment or payment.
• The 164 claims that were incorrectly coded results in net overpayments of $914, 128
• The OIG extrapolated their sample and estimated that hospitals received overpayments of$1 billion for FYs 2016 and 2017.

Based on OIG recommendations, “CMS stated that it will instruct its contractors to review a sample of claims in the sampling frame to determine whether they were billed correctly. Based on the findings of the sample review, CMS will determine the appropriate course of action. CMS will recover, as appropriate, any identified overpayments associated with the reviews consistent with agency policy and procedures.” You can read the entire report at https://www.oig.hhs.gov/oas/reports/region3/31700010.pdf.

July 15, 2020: Contract Award for A/B MAC Jurisdiction 6

CMS posted the following information on the CMS MAC What’s New webpage:

“On July 15, 2020, the Centers for Medicare & Medicaid Services (CMS) awarded National Government Services, Inc. (NGS) a new contract for the administration of Medicare Part A and Part B Fee-for-Service (FFS) claims for Illinois, Minnesota, and Wisconsin (Jurisdiction 6). This contract will also administer Medicare Home Health and Hospice (HH+H) FFS claims for Alaska, American Samoa, Arizona, California, Guam, Hawaii, Idaho, Michigan, Minnesota, Nevada, New Jersey, New York, Northern Mariana Islands, Oregon, Puerto Rico, US Virgin Islands, Wisconsin and Washington. As NGS is the incumbent contractor for this A/B MAC jurisdiction, CMS anticipates that implementation of the new contract will go smoothly, with few, if any, service issues for Medicare beneficiaries and providers. Learn more about this at A/B MAC Jurisdiction 6 Award Fact Sheet (PDF).”

July 17, 2020: The Joint Commission’s (TJC’s) Continued Approval of its Hospital Accreditation Program Limited to 2 Years

CMS published their decision to approve TJC for continued recognition as a national accrediting organization for hospitals participating in the Medicare and Medicaid Programs in the Federal Register on July 17, 2020. CMS can approve an accrediting agency for up to 6 years. However, the Final Notice indicated the TJCs continued approval is effective for only two years from July 15, 2020 through July 15, 2022. The following excerpt from the Federal Register outlines CMS reasons for this shorter term of approval:

“This shorter term of approval is based on our concerns related to the comparability of TJC’s survey processes to those of CMS, as well as what CMS has observed of TJC’s performance on the survey observation. Some of these concerns stem from the level of detail TJC provides in the daily briefings it provides to facilities, as well as TJC’s processes surrounding its staff interview practices. Additionally, we are concerned about TJC’s review of medical records and surveying off-site locations, in particular for the Physical Environment condition of participation. Based on these observations and review of TJC’s processes as discussed at section V.A. (Differences Between TJC’s Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements), we remain concerned about the thoroughness of review conducted within the facilities. While TJC has taken action based on the findings annotated in section V.A., as authorized under §488.8, we will continue ongoing review of TJC’s survey processes across all their approved accrediting programs to ensure that all our recommended changes have been implemented. In keeping with CMS’s initiative to increase AO oversight, and ensure that our requested revisions by TJC are complied with, CMS expects more frequent review of TJC’s activities to avoid any continued inconsistencies.”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 21st through July 27th.    

Resource Spotlight: CDC Natural Disasters, Severe Weather, and COVID-19

Earlier this month the CDC launched the new webpage Natural Disasters, Severe Weather, and COVID-19.  They note that “planning and preparing for hurricanes and other natural disasters can be stressful, even more so during the COVID-19 pandemic. Know how the COVID-19 pandemic can affect disaster preparedness and recovery, and what you can do to keep yourself and others safe.”

You can find guidance on the following topics is available on this webpage:

• Preparing for Hurricanes & COVID-19; Follow tips to help you and your family stay safe during hurricane season this year,
• Public Disaster Shelters & COVID-19: Follow tips to help you prepare and lower your risk of getting sick with COVID-19 while staying in a shelter, and
• Professionals & Emergency Workers: Know how to keep your community safe during and after a natural disaster amid the COVID-19 pandemic.

July 15, 2020: Resuming Elective Orthopedic Surgery During the COVID-19 Pandemic

This article can be found in the July 15, 2020 Issue of The Journal of Bone and Joint Surgery. The guidelines for resuming elective surgery was developed by the International Consensus Group (ICM). Specifically, seventy-seven expert physicians in orthopaedic surgery, infectious disease, microbiology and virology, and anesthesia were involved in this effort. The stated purpose for providing this list of recommendations is to reduce the COVID-19 “pathogen transfer during the reintroduction of elective orthopaedic surgical procedures.” At the outset of this article the authors acknowledge the guidelines are based on current available scientific evidence and may require being altered as new evidence emerges.

July 20, 2020: HHS Protect - Frequently Asked Questions

For a while now, to facilitate the public health response to COVID-19, hospitals have been reporting daily data reports on testing, capacity and utilization, and patient flows. Initially hospitals were advised to send this information to the CDC National Healthcare Safety Network (NHSN). 

Effective July 15, 2020 reporting to the NHSN was no longer an option. Instead, hospitals were to begin submitting data directly to the Federal Government through one of the methods outlined in the COVID-19 Guidance for Hospital Reporting document that was updated on July 10, 2020.

In a July 20, 2020 Press Release, HHS provides Frequently Asked Questions about HHS Protect, “a secure data ecosystem powered by eight commercial technologies for sharing, parsing, housing, and accessing COVID-19 data and driven by four principles: transparency, sharing, privacy, and security.”

July 22, 2020: New Resources to Protect Nursing Home Residents Against COVID-19

Several new initiatives designed to protect nursing home residents was announced in a July 22nd CMS Press Release. CMS Administrator Seema Verma indicates “as caseloads continue to increase in areas around the country, it has never been more important that nursing homes have what they need to maintain a sturdy defense against the virus. These measures will help them do exactly that.”

New Initiatives

• New Funding: HHS will devote $5 billion of the Provider Relief Fund authorized in the CARES Act to Medicare-certified long term care facilities and state veterans’ home (“nursing homes”), to build nursing home skills and enhance nursing response to COVID-19, including infection control.
• Enhanced Testing: Rapid point-of-care diagnostic testing devices will be distributed to nursing homes. Along with the deployment of more than 15,000 testing devices over the next few months, “CMS will being requiring, rather than recommending, that all nursing homes in states with a 5% positivity rate or greater test all nursing home staff each week.”
• Additional Technical Assistance and Support:
• Task Force Strike Teams were deployed in 18 nursing homes in Illinois, Florida, Louisiana, Ohio, Pennsylvania and Texas between July 18 and July 20 with a focus on the following four key areas of support:
• Keeping COVID-19 out of facilities,
• Detecting COVID-19 cases quickly,
• Preventing transmission, and
• Managing staff.
• Nursing Home COVID-19 Training: An online, self-paced, on-demand Nursing Home COVID-19 Training consisting of 23 modules will be made available to all 15,400 nursing homes nationwide. In order for nursing homes to be able to receive additional funding from the Provider Relief Fund Program, participation in this Training is required.
• Weekly Data on High Risk Nursing Home: “The White House and CMS will release a list of nursing homes with an increase in cases that will be sent to states each week as part of the weekly Governor’s report.”

July 23, 2020: COVID-19 Public Health Emergency Declaration to Renew on July 25th

Alex M. Azar II, Secretary of Health and Human Services declared an initial Public Health Emergency due to the COVID-19 pandemic on January 31, 2020. A PHE lasts for the duration of the emergency or 90 days and may be extended by the Secretary. On July 25, 2020, the PHE due to COVID-19 has been extended for the second time. You can learn more about Public Health Emergency Declarations in a CMS

Q&A document.

July 24, 2020: Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Code 87426

MLN Article MM11927 provides information about the addition of the QW modifier to HCPCS code 87426] (Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiqualitative, multiple-step method; severe acute respiratory syndrome coronavirus 9eg, SARS-CoV, SARS-CoV-2 [COVID-19]]/

At the end of this MLN article CMS includes the following note:

“Providers should be aware that MACs will not search their files to either retract payment for claims already paid or to retroactively pay claims. However, MACs will adjust claims that you bring to their attention.”

July 24, 2020: Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19)

MLN Article SE20011 has now been revised for the eleventh time. In this latest revision, CMS has added clarifying language to the Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services section to show it applies to lab tests regardless of the HCPCS codes used to report those tests.

July 27, 2020: FDA Reiterates Warning about Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

In a Press Announcement, FDA Commissioner Stephen M. Hahn, M.D. notes that “Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products….We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers.”

The agencies do-not-use list of dangerous hand sanitizer products is being updated regularly. It is important to note that the FDA has indicated that “In most cases, methanol does not appear on the product label.”

Welcome to this month’s MAC Talk article. Before diving into updates from the MACs, there are two issues I want to alert readers about. First, a reminder about the updated ABN form. Second, CMS’ indication that Medicare Contractor can resume medical reviews as of August 3, 2020.

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

On June 24th the FFS ABN CMS webpage was modified to add the following statement:

“The ABN, Form CMS-R-131, and form instructions have been approved by the Office of Management and Budget (OMB) for renewal.  The use of the renewed form with the expiration date of 06/30/2023 will be mandatory on 8/31/2020.  The ABN form and instructions may be found in the download section.”

Link to webpage: https://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN

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.

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.

Link to document: https://www.cms.gov/files/document/provider-burden-relief-faqs.pdf

July MAC Talk: The Local Scene

June 16, 2020: Palmetto GBA Article: Botulinum Toxin Injections

In this article, Palmetto provides detail from their Local Coverage Determination (L33458) including dosage and frequency of botulinum toxin injections, documentation expectations for coverage of the services provided, and a checklist to ensure documentation requirements are in the medical record.

This was timely information in advance of the July 1, 2020 implementation date for the Prior Authorization Program for Certain Hospital Outpatient Department (OPD) Services.

June 29, 2020: CGS J15

CGS posted the following information to their website on June 29th:

On April 6, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment (CMS-1744-IFC) instructing the DME MACs to suspend or not enforce various requirements found in local coverage determinations and related policy articles. On May 8, 2020, CMS published CMS-5531-IFC extending non-enforcement of the clinical indications for coverage to therapeutic continuous glucose monitors (CGMs). These changes are effective for claims with dates of service on or after March 1, 2020 and for the duration of the COVID-19 Public Health Emergency (PHE). Please see the full details regarding DME MAC implementation of CMS-1744-IFC and CMS-5531-IFC in the article here.”

July 2, 2020: Noridian JF Article: The Difference Between and Appeal and a Rebuttal

“When a provider does not agree with an overpayment determination, they may appeal the decision. An appeal disputes the overpayment and provides documentation to show medical necessity for the procedures in question. The limitation on recoupment provision mandates that no recoupment begins when a valid and timely request for a first level or second level appeal is received.

A rebuttal does not dispute the amount of the overpayment, nor does it dispute the overpayment determination. A rebuttal permits the provider a vehicle to indicate why the proposed recoupment should not be taken at the designated time. This allows providers to submit a statement advising if the recoupment occurs, it will cause financial hardship for their facility. The contractor, based on the rebuttal statement, determines whether to delay or begin recoupment. The rebuttal process is not an appeal and does not change anything regarding the debt owed.”

Internet Only Manual, (IOM), Publication 100-06, Chapter 3, Section 200.1.4: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/fin106c03.pdf 

Link to Noridian JF webpage: https://med.noridianmedicare.com/web/jfa/article-detail/-/view/10529/the-difference-between-an-appeal-and-a-rebuttal

July 6, 2020: WPS GHA eNews - Prior Authorization (PA) for Hospital Outpatient Department Services Facts

Effective June 17, 2020, providers billing on a 13x Type of Bill (TOB) should submit a PA request to their MAC before providing the following services:

• Blepharoplasty

• Botulinum toxin injections
• Panniculectomy
• Rhinoplasty
• Vein Ablation 

Providers should note the following:

• Prior authorization requests for botulinum toxin injections are only for injection CPT codes 64612 and 64615

• Prior authorization requests for botulinum toxin injections must include both the administration site and drug CPT codes
• Units of service for botulinum toxin injections should include the expected units of waste
• Each date of service requires its own prior authorization request
• CPT code 21235 no longer requires a prior authorization request
• Prior authorization is for dates of service July 1, 2020, and after
• Expedited requests must include justification that the standard review time for making a decision would seriously risk the health of the beneficiary
• Requests are not valid if they do not have the facility PTAN and NPI for the Hospital Outpatient Department 

For additional information, see Prior Authorization for Hospital Outpatient Department Services (HOPD) Overview. Please note, you need to select J5A or J8A to see the entire article.

July 6, 2020: Noridian JF to Host ABN Webinar – August 6, 2020

Noridian announced they will be hosting an ABN webinar on August 6th at 11 a.m. CT. This event includes:

• The new ABN form
• ABN Basics
• ABN Completion
• ABN Tips
• ABN Resources
• Noteworthy information

The Noridian announcement provides a link to sign up for this webinar.

July 9, 2020: New and Improved ST PEPPER Format for Short-Term (ST) Acute Care Hospital PEPPER

The PEPPER Team sent a notice about a “new and improved” format for the PEPPER Report. Hospitals will notice changes with the release of the Q1FY20 report scheduled to be available on July 15th.

The PEPPER Team noted in the announcement that “while all of the data and information that you are used to seeing in your PEPPER will still be available, the new format will include the following improvements:

• Greater accessibility
• Cleaner presentation
• Improved readability.

To help introduce Providers to the new format of PEPPER, the PEPPER Team prepared a recorded webinar demonstration of the new PEPPER, which is available on the PEPPER website.

July 13, 2020: First Coast JN Prior Authorization for Certain Hospital Outpatient Department Services Tips and Reminders

First Coast has posted the following information on their website regarding this program:

The PA team has been receiving and processing prior authorization requests (PAR) for certain hospital OPD services. View the following reminders prior to submitting your request:

• Providers are reminded that the PAR must include a PAR coversheet along with appropriate documentation. 
• Providers are asked to make sure the PAR hospital outpatient procedures Medicare fax/mail coversheet is being used and that all fields on the PAR coversheet are completed.
• Remember that PA is only required for procedures on the CMS list

• The PA is only required for the hospital outpatient department (OPD) who will be billing on the type of bill (TOB) 13X
• PA for hospital OPD does not apply to Ambulatory Surgical Centers (ASCs)

• PAR resubmissions must include the following:
• A copy of the initial PAR cover sheet and all documentation from the initial submission
• Any additional information/documentation

Click here to view additional information related to the prior authorization program.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 14th – July 20th.   

Resource Spotlight: CDC COVID-19 One-Stop Shop Toolkits

The CDC has compiled a COVID-19 One-Stop Shop Toolkits webpage where you will find videos, social media, public service announcements, print resources, checklists, FAQs, and web resources for the following audiences:

• Young Adults: 15 – 21,
• Childcare Programs & Summer Camps,
• Youth Sports,
• K-12 Schools,
• Businesses & Workplaces,
• Community & Faith-Based Organizations,
• General Public,
• Domestic Travelers,
• Shared & Congregate Housing, and
• Parks & Recreational Facilities.

July 14, 2020: FDA COVID-19 Daily Roundup – FDA Posts Hand Sanitizer Quiz

Hand sanitizer has been and continues to be a hot commodity during the COVID-19 Pandemic. Do you know where to store and not store hand sanitizer? Is hand sanitizer a drug? When should you consider a hand sanitizer to be expired? These are questions you will find answers to in a Hand Sanitizer Quiz posted by the FDA in their July 14th COVID-19 Daily Roundup. The FDA indicates the quiz provides answers to frequently asked questions and “can help consumers learn how to correctly use hand sanitizer.”

July 14, 2020: Department of Health and Human Services (HHS) Initiative for More and Faster COVID-19 Testing in Nursing Homes

HHS announced “a one-time procurement of devices and tests targeted to facilitate on-site testing among nursing home residents and staff. Through this crucial action, nursing homes will be able to augment their current capacity for coronavirus testing, bolstering their response and helping to prevent the spread of SARS-CoV-2, the virus that causes COVID-19.”

Nursing Home Numbers as of July 9, 2020 according to CMS:

• 200,000: The number of confirmed of suspected cases of COVID-19,
• 35,000: The number of COVID-19 deaths.

“The Centers for Disease Control and Prevention recommends that nursing homes perform baseline testing of all residents and staff, followed by regular screening and surveillance through routine testing to detect potential outbreak situations early and reduce morbidity and mortality.”

July 15, 2020: HHS Makes Changes to COVID-19 Daily Data Reporting for Hospitals

Vice President Pence sent a letter to hospital administrators on March 29, 2020 requesting daily data reports on testing, capacity and utilization, and patient flows be sent to the CDC National Healthcare Safety Network (NHSN) to facilitate the public health response to COVID-19.

Effective July 15, 2020 reporting to the NHSN is no longer an option. Instead, hospitals are to submit this data directly to the Federal Government through one of the methods outlined in the COVID-19 Guidance for Hospital Reporting document that was updated on July 10, 2020.

CDC Director Robert Redfield indicated in a prepared remarks that the CDC’s NHSN “is an important surveillance system in our nation’s hospitals, which focuses on fighting antibiotic resistance.

In April, HHS leaders, with input from CDC, created a new system, called HHS Protect, that allows us to combine data through systems like NHSN, as well as other public and private sources. The data reported from hospitals that went into HHS Protect either came through the NHSN, directly to HHS Protect from the states, or through a system called TeleTracking.

What we have now asked is that, going forward, states provide data from hospitals directly through the TeleTracking system or directly to the HHS Protect system.”

July 16, 2020: CDC Webinar: Clinical Management of Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with COVID-19

Previously, the CDC provided a Clinician Outreach and Communication Activity (COCA) MIS-C with COVID-19 call on May 19, 2020. That call focused on providing clinicians information about clinical characteristics of MIS-C, how cases have been diagnosed and treated, and how clinicians have responded to recently reported cases associated with COVID-19. This past Thursday July 17, 2020, a second webinar was held focusing on the clinical management of this patient population. The CDC has provided a recording and slide deck for both webinars.   

July 16, 2020: July 2020 Updated of the Hospital Outpatient Prospective Payment System (OPPS) MLN Article MM11814 Revised

Now in its third iteration, CMS updated MLN Article MM11814 on July 16th. Revisions made reflect the revised Change Request (CR) 11814. Specific revisions include:

• Update to the section on “COVID-19 Laboratory Tests and Services and Other Laboratory Tests Coding Update,”
• Table 1 updated to add 3 new COVID-19 codes: 87426, 0223U, and 0224U,
• HCPCS code Q5112 status indicator was changed from SI=E2 to SI=K, effective April 15, 2020 through September 30, 2020 and section 9 “Drugs, Biologicals, and Radiopharmaceuticals” has been updated by adding new subsections j and k to reflect the change.

July 16, 2020: FDA Closes its COVID-19 Industry Hotline

In the FDA’s Daily Roundup for July 16th they announced that as of 8:00 PM on Friday July 17th they would be closing their COVID-19 Industry Hotline. Moving forward to meet current needs, the FDA will be “providing support for industry and laboratory questions about COVID-19 and medical devices through this directory Contacts for Medical Devices During the COVID-19 Pandemic.”

July 17, 2020: HHS Distributing $10 Billion in Additional Funding to Hospitals in High Impact COVID-19 Areas

The Department of Health and Human Services (HHS) indicated in a July 17th announcement that they are set to begin distributing $10 billion in a second round of high impact COVID-19 area funding to hospitals this week.  In this second round of funding, amounts to be distributed “was based on a formula for hospitals with over 161 COVID-19 admissions between January 1 and June 10, 2020, or one admission per day, or that experienced a disproportionate intensity of COVID admissions (exceeding the average ratio of COVID admissions/bed). Hospitals will be paid $50,000 per eligible admission.” The HHS announcement provides links to a list of hospital recipients of funds as well as a state-by-state breakdown on the funding.

In a related statement by AHA President and CEO Rick Pollack, he thanked HHS for this additional relief but went on to note that “since this distribution of funding for “hot spots” does not take into account the latest spike in cases and hospitalizations in some parts of the country, we look forward to working with the Administration to ensure that additional relief will be distributed to ‘hot spots’ and all hospitals."

July 17, 2020: Medicare Fee-for-Service (FFE) Response to the Public Health Emergency on COVID-19 MLN Article Revised

It seems on an almost weekly basis now MLN SE20011 is being revised. The latest revision updates information on CDC nursing home patients/residents testing and adds clarifying language to the Skilled Nursing Facility (SNF) Benefit Period Waiver – Provider information section.

July 17, 2020: Alabama Medicaid Extends COVID-19 Emergency Expiration Date

Alabama announced in this Alert that “All previously published expiration dates related to the Coronavirus (COVID-19) emergency are once again extended by the Alabama Medicaid Agency (Medicaid). The new expiration date is the earlier of August 31, 2020, the conclusion of the COVID-19 National emergency, or any expiration date noticed by the Alabama Medicaid Agency through a subsequent ALERT.”

July 20, 2020: Office of Civil Rights (OCR) Issues Guidance on Civil Rights Protections Prohibiting Race, Color, and National Origin Discrimination During COVID-19

The OCR announced in a Press Release that they are “issuing guidance to ensure that recipients of federal financial assistance understand that they must comply with applicable federal civil rights laws and regulations that prohibit discrimination on the basis of race, color, and national origin in HHS-funded programs during COVID-19. This Bulletin focuses on recipients' compliance with Title VI of the Civil Rights Act of 1964 (Title VI).”

July 28, 2020 – Save the Date: CDC Webinar: COVID-19 and Diabetes: The Importance of Prevention, Management, and Support

My husband, mother and brother all have adult onset diabetes. This puts each one of them at higher risk for severe illness if they were to contract COVID-19. On Tuesday, July 28, 2020 the CDC is hosting a COCA call where presenters will focus on current information available about this increased risk and the importance of diabetes prevention, management and support. Information for participating in this webinar is available on the CDC website at https://emergency.cdc.gov/coca/calls/2020/callinfo_072820.asp?deliveryName=USCDC_1052-DM32990.

New England Journal of Medicine (NEJM): COVID-19 Rx: Treatment Solutions

Although this free resource was released on May 19th, in keeping with the education offerings from the FDA Hand Sanitizer Quiz and CDC webinars, I wanted to make you aware of this education resource from the NEJM Group. According to the May NEJM Group anouncement, this series of five COVID-19 interactive cases was “designed to teach clinicians on the frontlines of the pandemic, the detailed cases feature clinical information on each of the five fictional patients. In one, the patient is a young woman who arrives to the emergency room with fever and cough. In another, an elderly man with probable Covid-19 and respiratory distress and a history of hypertension and COPD was transferred to the ICU from an outside hospital.”

In a June 30th Press Release, CMS proposed to update National Coverage Determination (NCD) 20.33 noting that currently the NCD covers the transcatheter procedure for patients with symptomatic degenerative mitral regurgitation (MR). Before we take an in depth look at the changes in the Proposed Decision Memo (CAG-00438R), I want to provide relevant background information about the Transcatheter Mitral Valve Repair (TMVR) procedure.

Background

August 2014

The current NCD has been effective since August 7, 2014. Per the related 2014 Decision Memo, the FDA approved the first TMVR device.

Abbott Vascular’s MitraClip® was approved “for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.”

Abbott Vascular’s MitraClip® is currently the only FDA-approved TMVR device. The procedure involves clipping together a portion of the mitral valve leaflets as a treatment for reducing MR to improve recovery of the heart from overwork, improve function and potentially halt the progression of heart failure.

August 2019

At the request of the Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography & Interventions (SCAI), CMS opened a National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). The expected release of a Proposed Decision Memo was to have been February 14, 2020.

National Coverage Analysis Issue

 TMVR is used in the treatment of mitral regurgitation (MR). There are two types of MR.

• Primary (degenerative) MR results from structural failure of mitral valve, and
• Secondary (functional) MR results from left ventricular (LV) dysfunction with a largely preserved mitral valve.

Currently, the NCD establishes coverage for the treatment of significant symptomatic Primary MR. The national tracking analysis focused on TMVR for the treatment of significant symptomatic Secondary MR.

June 30, 2020 Proposed Decision Memo for TMVR (CAG-00438R)

TMVR to TEER

CMS opens the Decision Summary by indicating they are replacing the acronym TMVR with TEER (Transcatheter Edge-to-Edge Repair) “to more precisely define the treatment addressed in this proposed NCD, which is applicable to TEER for the treatment of functional mitral regurgitation (MR) and degenerative MR.”

From Coverage for Primary (Degenerative) MR to Coverage for Secondary (Functional) MR

CMS notes that “Cardiac surgery for secondary MR has been shown to improve symptoms but not survival…However, recent evidence reviewed here demonstrates that TEER may improve symptoms, quality of life, and survival of appropriately selected patients with secondary MR.”

CMS has removed Primary (degenerative) MR as an indication for the TEER procedure noting that coverage determinations for on-labeled uses of FDA approved devices for this group of patients will be made by Medicare Administrative Contractors (MACs).

The NCD will now provide coverage indications for the TEER procedure for patients with Secondary (functional) MR.

Coverage with Evidence Development (CED) Requirement Removed from NCD

Currently TMVR is non-covered for the treatment of MR when not furnished under CED. This is no longer a requirement in the Proposed Decision Memo.

Shared-Decision Making

“CMS recognizes the importance of shared decision-making (SDM) in many clinical scenarios and has required SDM in other NCDs (for example, implantable cardiac defibrillators: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110). 

CMS supports patient SDM in TEER but there is no fully developed tool available at this time.  CMS strongly encourages standardized decision aids or tools [the National Quality Forum (NQF) has published standards for decision aids (www.qualityforum.org/Projects/c-d/Decision_Aids/Final_Report.aspx)] to facilitate the decision making process between a patient and physician and will be monitoring this space closely. 

Tools are in development for other conditions and procedures.  For example, the Patient-Centered Outcomes Research Institute (PCORI) funded research (CER-1306-04350/ NCT02266251), to create and assess a personalized decision assistance tool designed to evaluate important health outcomes between SAVR to TAVR for operable patients with aortic valve disease considering aortic valve replacement.  The work also aims to develop and assess a personalized risk assessment tool designed to evaluate expected health outcomes with TAVR for inoperable patients considering aortic valve replacement.”

Proposed Coverage Requirements for TEER Procedure

1. TEER for mitral valve would be covered as follows:
2. When performed to treat symptomatic moderate-to-severe or severe Functional MR when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT).

Guideline Directed Medical Treatment (GDMT)

“The specialty societies publish detailed guidelines for the diagnosis and management of heart failure.  The most recent full guideline was published in 2013, with a focused update in 2016. In addition to lifestyle changes, cornerstones of pharmacologic treatment of systolic heart failure include angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), angiotensin receptor-neprilysin inhibitors (ARNI), beta-blockers, mineralocorticoid antagonists (MRA), and diuretics.  For eligible patients, implantable cardiac defibrillators (ICD) can improve survival, while cardiac resynchronization therapy (CRT) can improve symptoms, reduce MR, reduce hospitalizations, and increase survival.”

• Eligible patients must also meet the following criteria:
• Ischemic or non-ischemic cardiomyopathy; and
• Left ventricular ejection fraction of 20 to 50%; and
• New Your Heart Association Functional Class II, III, or Iva (ambulatory); and
• Left ventricular end-systolic dimension ≤ 70mm; and
• Local heart team has determined that mitral valve surgery will not be offered as a treatment option.

FDA Expansion of Approved Indications for MitraClipNote™

 The FDA expanded the approved indications for MitraClip™ on March 14, 2019. The proposed coverage requirements above align with the FDA’s expanded indications.

• Procedure must be furnished according to FDA-approved indication and meet the following conditions:
• All requirements set for in 2a through 2c; and
• The patient is under the care of a heart failure specialist experienced in the care and treatment of mitral valve disease; and
• The heart team also included a heart failure physician specialist experienced in the care and treatment of mitral valve disease; and
• The heart team cardiac surgeon and interventional cardiologist have:
• Independently examined the patient face-to-face, evaluated the patient’s suitability for surgical mitral valve repair, TEER, maximally tolerated GDMT, or palliative therapy; and
• Documented and made available to the other heart team members the rationale for their clinical judgment.

Face-to-Face Examination during COVID-19 Public Health Emergency (PHE)

Per the Proposed Decision Memo, “In the interim final rule with comment period [CMS-1744-IFC], CMS finalized that to the extent an NCD or LCD would otherwise require a face-to-face or in-person encounter for evaluations, assessments, certifications or other implied face-to-face services those requirements would not apply during the public health emergency (PHE) for the COVID-19 pandemic.  This would include the proposed face-to-face examination by the heart team cardiac surgeon and interventional cardiologist.”

2. Requirements in this section apply to TEER for Functional MR as specific in section 1.
3. The patient (pre-op and post-op) is under the care of a heart team that must include:
4. Cardiac surgeon; and
5. Interventional cardiologist; and
6. Interventional echocardiographer; and
7. Providers from other physician groups as well as advanced patient practitioners, nurses, research personal and administrators.
8. The interventional cardiologist or cardiac surgeon must perform the mitral valve TEER. They may jointly participate in the intra-operative technical aspects of TEER as appropriate.
9. Mitral valve TEERs must be performed in hospitals with appropriate infrastructure including but not limited to:
10. On-site heart valve surgery and interventional cardiology programs,
11. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
12. Appropriate volume requirements.

Appropriate Volume Requirements

There are two sets of qualifications for appropriate volume requirements (qualifications to begin a mitral valve TEER program and qualifications for mitral valve TEER experience). CMS is proposing “to modify this requirement consistent with the same requirement for the interventional cardiologist as set forth in the June 2019 TAVR NCD Decision Memo. While clinically appropriate, this modification also establishes consistency across valve program areas.”

Proposed Reasons for TEER to Not Be Covered for the treatment of functional MR

1. Coexisting aortic or tricuspid valve disease requiring surgery or transcatheter intervention; or
2. COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use; or
3. ACC/AHA Stage D heart failure; or
4. Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg as assessed by echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization laboratory is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with a v wave less than twice the mean of the pulmonary capillary wedge pressure (PCWP); or
5. Hemodynamic instability requiring inotropic support or mechanical heart assistance; or
6. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction; or
7. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.

TEER of the mitral valve for the treatment of functional MR is not covered for patients in whom existing co-morbidities would preclude the expected benefit from correction of the mitral valve.

Optimal Patient Selection for TEER

CMS acknowledges that there are limitations in the trial/study evidence available to assist the heart team in optimal patient selection for TEER. They note in the proposed Decision Memo that they will carefully monitor treated patients for adherence to the criteria and will assess patient outcomes over the next four years through evidence published in the peer reviewed literature. At that time, contingent upon real-world demonstration of outcomes consistent with those achieved in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial), they will consider modifying criteria.

CMS is seeking comments on the proposed national coverage determination. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period. I strongly encourage those involved in providing this service to read the proposed decision.

Q:

What are the determining factors for when a procedure is performed for diagnostic versus therapeutic purposes?

A:

First, determine the objective of the procedure.  Is the procedure performed to:  

• Make a diagnosis, or
• Eliminate a condition?

For example, a physician may remove all necrotic tissue that is present in a slow healing wound.  A sample of that tissue was sent to pathology to see what organisms may be growing. This would be a therapeutic removal of tissue as the objective was to remove all of the necrosis to promote wound healing.

Another example is found in Coding Clinic, Third Quarter 2017, page 12, which addresses the coding of abdominal paracentesis. The advice found here tells us to use the qualifier ‘Z’ if there is a therapeutic component to the procedure (0W9G3ZZ, Drainage of Peritoneal Cavity, Percutaneous Approach).  The physician may send a fluid sample to pathology to look for malignant cells or leukocytes. However, the objective of the paracentesis is to relieve the pain and discomfort from ascites, which is a therapeutic procedure.

It is important to note that if both a diagnostic and therapeutic paracentesis are performed separately, then both should be coded.

Biopsies are good examples of diagnostic procedures, such as, a pancreas biopsy in a patient with a pancreatic mass or bone marrow biopsy for unexplained anemia.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 6th through July 13th.   

Resource Spotlight This Week: National Institute on Aging Provides Government COVID-19 Resources for Older Adults

The National Institutes of Health (NIH) National Institute on Aging has developed a webpage to provide Government COVID-19 Resources for Older Adults. Guidance and Information available on this page includes:

• Federal Resources on Caregiving during COVID-19,
• COVID-19 Financial & Housing Resources for Families,
• Health Information on Coronavirus,
• COVID-19 and Healthcare,
• COVID-19 Safety and Emergency Response,
• COVID-19 Resources for Veterans, and
• Employment Resources for COVID-19

July 6, 2020: EPA Approves First Surface Disinfectant Products Tested on the SARS-CoV-2 Virus

The Environmental Protection Agency (EPA) announced in a News Release that they have approved two products that safely and effectively kill the novel coronavirus, SARS-CoV-2, on surfaces.

• Lysol Disinfectant Spray (EPA Reg. No. 777-99), and
• Lysol Disinfectant Max Cover Mist (EPA Reg. No. 777-127)

July 6, 2020: New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) During the COVID-19 Public Health Emergency MLN Article Revised

MLN SE20016 was initially issued on April 17, 2020. Now in the third iteration, this article was revised on July 6th to include:

• Additional guidance on telehealth services that have cost-sharing waived and additional claims examples, and
• An additional section on the RHC Productivity Standard.

July 7, 2020: HHS Launches ‘Surge’ COVID-19 Testing in Hospital Jurisdictions in Florida, Louisiana and Texas

HHS Announced free COVID-19 testing in Jacksonville, Florida; Baton Rouge, Louisiana; and Edinburg, Texas to “temporarily increase federal support to communities where there has been a recent and intense level of new cases and hospitalizations related to the ongoing outbreak.” HHS, in partnership with eTrueNorth plans to offer 5,000 tests per-city per-day at no charge to people being tested. “The temporary surge testing sites will be live anywhere from five to 12 days.”

July 8, 2020: MLN SE20011 Medicare Fee-for-Services Response to Public Health Emergency on COVID-19 Revised Again

MLN SE20011 article has once again been updated. This most recent revision was to add a row at the end of the Waiver/Flexibility table (page 7) to address services provided by the hospital in the patient’s home as a provider-based outpatient department when the patient is registered as a hospital outpatient.

CMS also added the new section Teaching Physicians and Residents: Expansion of CPT Codes that May Be Billed with the GE Modifier.

July 8, 2020: Department of the Treasury and the Small Business Administration Releases the Paycheck Protection Program (PPP) Loan Data

The PPP was established by the CARES Act and was meant to provide small businesses with funds to pay up to 8 weeks of payroll costs including benefits. On Monday July 8th the Department of Treasury and Small Business Administration released a summary of cumulative PPP data. As of July 8th almost 5 million loans have been approved with the average loan size being $106,542. Downloaded data is available for loans above and below $150,000 by state.

You can also access this date and read more about this program on the U.S. Department of Treasury website at https://home.treasury.gov/policy-issues/cares/assistance-for-small-businesses.

Note, larger companies across the nation applied for and received funding from this program. However, since then, the Department of Treasury has indicated in an FAQ document that “it is unlikely that a public company with substantial market value and access to capital markets will be able to make the required certification in good faith, and such a company should be prepared to demonstrate to SBA, upon request, the basis for its certification.” These companies were given the option to repay the money without penalty and have done just that. COVID Stimulus Watch, a public service of Good Jobs First has made available a list of awards, a list of funds that were later refunded.

July 8, 2020: MLN Article MM11815 Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment – REVISED

MLN Article MM11815 was initially released June 12, 2020. This article was updated on July 9, 2020 to reflect a revision to related Change Request (CR) 11815. The revision added information on COVID-19 codes 87426, 0223U and 0224U. The effective date for all three of these new codes was June 25, 2020.

July 9, 2020: Medicare Part A & B Provider Outreach and Education Multi-MAC Collaboration Group Published Modifiers Used During COVID-19 Table

The Provider Outreach and Education A/B MAC Workgroup has developed a table titled Modifiers Used during the COVID-19 Public Health Emergency (PHE). Information included in the table includes the following:

• The Type of Bill (TOB) the modifier would be used on Part A (UB04) or Part B (1500),
• Details about each modifier,
• Links to reference materials for each modifier, and
• When applicable, any exception/special usage for the modifier.

July 9, 2020: HHS Awards More Than $21 Million to Support Health Centers’ COVID-19 Response

HHS indicates in this News Release the awarding of more than $21 million to support health centers’ COVID-19 response efforts noting “the majority of this investment - $17 million – supports 78 Health Center Program look-alikes (LALs) with funding to expand capacity for COVID-19 testing.” Included in this announcement are links to the award recipients as well as links to where you can find more information about the following:

• Health center capacity and the impact of COVID-19 on health center operations, patients, and staff,
• Health Center Program look-alikes, and
• Health Center Controlled Networks.

July 10, 2020: HHS Announces Over $4 Billion in Additional Relief Payments to Healthcare Providers Impacted by the Coronavirus Pandemic

HHS through the Health Resources and Services Administration (HRSA) announced:

• Approximately $3 billion in funding to hospitals serving an large percentage of vulnerable populations on thin margins, and
• Approximately $1 billion to specialty rural hospitals, urban hospitals with certain rural Medicare designations, and hospitals in small metropolitan areas.

HHS is also opening the provider portal to allow dentists to apply for relief. You can read the full announcement on the HHS website at https://www.hhs.gov/about/news/2020/07/10/hhs-announces-over-4-billion-in-additional-relief-payments-to-providers-impacted-by-coronavirus-pandemic.html.

July 10, 2020: HHS Releases May and June COVID-19 State Testing Plans

HHS announced that they have made available May and June COVID-19 Testing plans from all states, territories, and localities. Plans include details on response to surge cases and how to reach vulnerable populations including minorities, immunocompromised individuals and older adults.

Assistant Secretary for Health AMD Brett P. GIroir, M.D. noted in the announcement that “Overall, the plans submitted by the states were very good to excellent; and all will be improved by the ongoing collaboration of states with federal experts. Testing is not just about numbers – it is about targeting testing to the right people at the right time, and incorporation of testing into a comprehensive state plan for COVID-19…We are pleased at what nearly every state has achieved to date, and look forward to continuing to expand SARS-CoV-2 testing capacity in the U.S."

July 10, 2020: Additional Resources Directed to Nursing Homes in COVID-19 Hotspot Areas

In a June 10th Press Release, CMS announced their plan to deploy Quality Improvement Organizations (QIOs) nationwide to provide immediate assistance to nursing homes in hotspot areas as identified by the White House Coronavirus Task Force with an end goal of protecting vulnerable Americans.