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March 30, 2020: OIG Released Strategic Plan for the Next Five Years (2020-2025)

On March 30th, the OIG published their Strategic Plan for the next five years (2020-2025).  Christi A. Grimm, Principal Deputy Inspector General, notes that this “plan is dynamic to accommodate a rapidly changing health and human services environment, including emergent threats and vulnerabilities. This Strategic Plan is a roadmap to guide our entire multidisciplinary workforce in planning and conducting the most consequential oversight work, optimizing use of our available resources and delivering results for our stakeholders. To support our workforce, OIG will continue to prioritize investment in data analytics, technology, expertise, and training. This strengthens OIG’s modern approach to oversight that allows us to quickly adapt to emerging risks, including the corona virus disease 2019 (COVID-19) pandemic.”

The Strategic Plan includes examples of past accomplishments related to their three stated Goals.

Goal 1: Fight Fraud, Waste and Abuse

Past Accomplishment: Nationwide Brace Scam

• April 2019: With law enforcement partners, OIG dismantled one of the largest fraud schemes involving telemedicine and medically unnecessary back, shoulder, wrist and knee braces.
• Impact: Twenty-four defendants were charged for allegedly participating in the scheme, in which over $1.7 billion in Medicare claims were fraudulently submitted.

Goal 2: Promote Quality, Safety and Value

Past Accomplishment: Identifying and Combating Potential Abuse and Neglect of Beneficiaries

• OIG issued an early alert followed by two June 2019 reports identifying thousands of Medicare claims that indicate abuse and neglect of Medicare beneficiaries.
• Impact: CMS has provided details about actions taken and plans to take ensuring incidents of potential abuse or neglect in SNFs are identified and reported.

Goal 3: Advance Excellence and Innovation

Past Accomplishment: Data at OIG’s Fingertips

• Self-service data and analytics tools empower OIG to use data proactively.
• Impact: OIG has created portals offering access to data analytics tools used to oversee the Medicare programs and also enable grants oversight work.

 

April 3, 2020: OIG Report – Hospital Experiences Responding to the COVID-19 Pandemic: Results of a National Pulse Survey March 23 – 27, 2020

On April 3rd, the OIG provided their findings from a survey they conducted with a goal of being able to provide decision makers “with a national snapshot of hospitals’ challenges and needs in responding to the coronavirus 2019 (COVID-19) pandemic. The information represents brief telephone interview (“pulse surveys”) conducted March 23-27, 2020 with hospital administrators from 323 hospitals across 46 States, the District of Columbia, and Puerto Rico. The rate of contact with this random sample was 85 percent.

If you have been following the barrage of COVID-19 news available via television, radio, internet, it shouldn’t surprise you that the following list represents the most significant challenges reported by hospitals:

• Severe shortages of testing supplies and extended waits for results,
• Widespread shortages of Personal Protective Equipment (PPE),
• Difficulty maintaining adequate staffing and supporting staff,
• Difficulty maintaining and expanding hospital capacity to treat patients,
• Shortages of critical supplies, materials, and logistic support,
• Anticipated shortages of ventilators,
• Increased costs and decreased revenue, and
• Changing and sometimes inconsistent guidance.

It is important to note that there are five different instances in this report where the OIG reminds the reader “the hospital input and suggestions in this report reflect a specific point in time- March 23-27, 2020. We recognize that HHS is also getting input from hospitals and other frontline responders and has already taken and continues to take actions” related to findings in this report. 

On April 6, 2020 Rick Pollack, President and CEO of the American Hospital Association (AHA), released a Statement on HHS OIG Report. In the statement, he opened by noting this report is important and timely and “the HHS Office of the Inspector General accurately captures the crisis that hospitals and health systems, physicians and nurses on the front lines face of not having enough personal protective equipment (PPE), medical supplies and equipment in their fight against COVID-19.” He ends the AHA Statement with the following: “The AHA continues to urge that all possible levers be used by both the government and the private sector to ensure front line heroic providers battling against COVID-19 have what they need for protection and to provide care for their patients and communities -- countless lives are depending on it.”

A Full Summary and the Report are available on the OIG website.

 

April 8, 2020: OIG Releases Notice of Recently Added OIG Work Plan Items

Just five days after the Pulse Survey Report was released, the OIG updated their OIG Work Plan with the following items related to COVID-19:

You can access the entire OIG Work Plan at: https://go.usa.gov/xvjmP.

 

COVID-19 Portal

In addition to the Strategic Plan, Survey and Work Plan, the OIG has also created a COVID-19 Portal on their website. The portal provides links to information about COVID-19 Fraud, Infectious Disease Preparedness and Response and Policy Statements and Guidance. Additionally, you can find links to resources, recent new put out by the OIG and the opportunity to submit questions regarding OIG’s authorities during the COVID-19 public health emergency.

Q:

What is the principal diagnosis if a patient presents to the hospital with Sepsis and COVID-19?

A:

If a patient has COVID-19 that has progressed to sepsis, we are instructed to see Section I.C.1.d. Sepsis, Severe Sepsis, and Septic Shock.  If sepsis meets the definition of principal diagnosis, sepsis should be sequenced first, followed by COVID-19. 

When COVID-19 meets the definition of principal diagnosis, and sepsis develops after admission, code U07.1 (COVID-19) should be sequenced first, followed by the appropriate code for sepsis.

Remember:  Code only confirmed cases of COVID-19

If a physician documents “presumed” COVID-19, and has tested positive for the virus, code U07.1 (COVID-19) as confirmed.  A positive test at a local or state level can be coded as COVID-19.  The Center for Disease Control and Prevention (CDC) confirmation of local and state tests for the COVID-19 virus is no longer required.

If a physician documents “suspected”, “possible”, “probable”, or “inconclusive” COVID-19, do not assign code U07.1.  Assign a codes(s) explaining the reason for the encounter such as fever, or contact with and (suspected) exposure to other viral communicable diseases (Z20.828).

Resources:

ICD-10-CM Official Coding and Reporting Guidelines (April 1, 2020 through September 30, 2020)

https://www.cdc.gov/nchs/data/icd/COVID-19-guidelines-final.pdf

https://www.cdc.gov/nchs/data/icd/ICD-10-CM-April-1-2020-addenda.pdf

American Hospital Association (AHA) Coding Clinic webinar ICD-10-CM Coding for COVID-19

Watch the FREE AHA webinar on COVID-19 and receive one CEU.  https://www.codingclinicadvisor.com/webinar/icd-10-cm-coding-covid-19

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week’s updates span from April 2nd through April 13th.

Johns Hopkin’s Coronavirus Resource Center

In last week’s COVID-19 updates article we highlighted the Institute for Health Metrics and Education (IHME) COVID-10 Projection Models (link to Project: https://covid19.healthdata.org/projections). This week I want to make readers aware of the Johns Hopkin’s Coronavirus Resource Center where you will find world and U.S. specific numbers as well as critical trends.

 

April 2, 2020: CDC Posts Guidance on How to Certify Deaths due to COVID-19

The National Centers for Health Statistics (NCHS) is responding to COVID-19 with new resources to monitor and report deaths. On April 2nd the document Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19) was posted on the CDC’s National Vital Statistics System (NVSS) Coronavirus Disease (COVID-19) Death Data and Reporting Guidance webpage. This document provides guidance to death certifiers on proper cause-of-death certification for cases where confirmed or suspected COVID-19 infection resulted in death. You can also find provisional death counts for COVID-19 (updated daily Monday through Friday) and NVSS COVID-19 Alerts on this webpage.

 

April 3, 2020: Lessons Learned from the Front Lines: COVID-19

On April 3, CMS Administrator Seema Verma, Deborah Birx, MD, White House Coronavirus Task Force, and officials from the FDA, CDC, and FEMA participated in a call on COVID-19 Flexibilities. Several physician guests on the front lines presented best practices from their COVID-19 experiences. You can listen to the conversation here.

 

April 3, 2020: Palmetto GBA updates COVID-19 Accelerated Payment Hotline FAQs

Following is an example of one question available in this FAQs document:  

• Question: How many months will we be able to ask for help?
• Answer: CMS' payment provision at this time is for a three-month or six-month operating period, depending upon your provider type.
  

Note: Hospital sub-units are eligible for payment for a three-month operating period. Only Inpatient acute care hospitals, children's hospitals, certain cancer care hospitals, and critical access hospitals are eligible for payment for a six-month operating period at this time.

 

April 4, 2020: CDC Post: Cloth Face Covers Guidance to Help Slow the Spread of COVID-19

The CDC posted guidance regarding cloth face covers including the following:

• Recommendations regarding the use of cloth face coverings,
• How to wear a face cloth,
• Sew and no sew instructions for a face cloth, and
• Cloth face covers FAQs.

 

April 6, 2020: FDA Coronavirus Daily Update: Diagnostics Update to Date

• The FDA has worked with more than 270 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect COVID-19.
• To date, 28 emergency use authorizations have been issued for diagnostic tests.
• The FDA has been notified that more than 145 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
• The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

 

April 6, 2020: OIG Issues Policy Statement and FAQs Regarding Application of Certain Administrative Enforcement Authorities Due to Declaration of COVID-19 Outbreak

The OIG issued the Policy Statement to “notify interested parties that OIG will exercise its enforcement discretion not to impose administrative sanctions under the Federal anti-kickback statute for certain remuneration related to COVID-19 covered by the Blanket Waivers of Section 1877(g) of the Social Security Act (the Act) issued by the Secretary on March 30, 2020 (the Blanket Waivers), subject to the conditions specified herein.”

The OIG also provided a link to a related FAQ webpage where they encourage providers to submit questions regarding how OIG would view an arrangement that is directly connected to the public health emergency. Currently, OIG offers an answer to the following question:

• Can health care providers and practitioners furnish services, not to exceed their scope of practice, for free or at a reduced rate, to assist skilled nursing facilities (SNFSs) or other long-term-care providers that are facing staffing shortages due to the COVID-19 outbreak?

 

April 7, 2020: Eli Lilly Announces New $35 Co-Pay Available

Eli Lilly introduced the Lilly Insulin Value Program. Mike Mason, president, Lilly Diabetes noted in the announcement that “too many people in the U.S. have lost their jobs because of the COVID-19 crises, and we want to make sure that no one goes without their Lilly insulin…we’ve been providing affordability solutions for a long time, but more is needed to help people during this unprecedented period.” About the Program

• The program became effective on April 7th and covers most Lilly insulins including all Humalog® (insulin lispro injection 100 units/mL) formulations.
• This Program is for people with commercial insurance and those without insurance to be able to fill their monthly prescription of Lilly insulin for $35.
• The savings can be obtained by calling the Lilly Diabetes Solution Center at (833) 808-1234. The Center is open 8 am to 8 pm (EDT) Monday through Friday.

 

April 7, 2020: CMS Waivers and COVID-19 Response Call

During this call the CMS provided updates on recent CMS actions taken to address the COVID-19 public health emergency. You can view the call slide deck at https://www.cms.gov/files/document/cms-waivers-and-covid-19-response.pdf.

 

April 7, 2020: CMS Letter to Clinicians

CMS posted a Letter outlining a summary of actions taken by CMS to ensure clinicians have maximum flexibility to provide patient care during the COVID-19 outbreak. This summary includes information about telehealth and virtual visits, accelerated and advanced payments, and recent waiver information.

 

April 7, 2020: CMS Updates Non-Emergent, Elective Medical Services, and Treatment Recommendations Document

CMS initially announced in a March 18th Press Release that all elective surgeries, non-essential medical, surgical, and dental procedures be delayed during the 2019 Novel Coronavirus (COVID-19) outbreak.

Working with medical societies and association, CMS announced on April 7th that the recommendations to limit medical services that can be deferred. “A tiered framework is recommended to prioritize services and care to those who require emergent or urgent attention to save a life, manage a severe disease, or avoid further harms from an underlying condition.”

 

April 8, 2020: CMS Issues New Wave of Infection Control Guidance

Based on CDC guidelines, CMS announced in April 8th Press Release a new wave of infection control guidance for several health settings. “For hospitals, psychiatric hospitals and CAHs, the revised guidance, for example, provides expanded recommendations on screening and visitation restrictions, discharge to subsequent care locations for patients with COVID-19, recommendations related to staff screening and testing, and return-to-work policies.”

 

April 9, 2020: CMS Temporarily Suspends a Number of Rule to Boost Frontline Medical Staff

Changes affecting doctors, nurses, and other clinicians were announced focusing “on reducing supervision and certification requirements so that practitioners can be hired quickly and perform work to the fullest extent of their licenses. The new waivers sharply expand the workforce flexibilities CMS announced on March 30.” This Press Release provides a link to a complete list of waivers announced today and in recent weeks.

 

April 9, 2020: COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing – Updated

CMS announced in Special Edition MLN Connects that the COVID-19 FAQs have been updated. They advise that you check this resource often as it is updated on a regular basis. They noted that a date is added at the end of an FAQ when it is new or the content has been updated. As of Monday April 13th this 38 page document included FAQs related to the following topics:

• Payment for specimen collection for purposed of COVID-19 testing,
• Diagnostic laboratory services,
• Hospital services,
• Ambulance services,
• Rural Health Clinics and Federally Qualified Health Centers,
• Medicare telehealth. (CMS notes this document does not include flexibilities that might be exercised under the CARES Act),
• Physician Services
• Home Infusion Services,
• Accountable Care Organizations,
• Opioid Treatment Programs,
• Inpatient Rehabilitation Facility services,
• Skilled Nursing Facility services,
• General billing requirement,
• Home Health,
• Drugs and Vaccines under Part B,
• Medicare payment to facilities accepting government resources, and
• Oxygen

 

April 10, 2020: MLN SE20011 Medicare Fee-for-Service Response to the Public Health Emergency on the Coronavirus (COVID-10) Revised

Following is a list of revisions made to this MLN article:

• Link to all the blanket waivers related to COVID-19,
• Provide place of service coding guidance for telehealth claims,
• Link to the Telehealth Video for COVID-19,
• Add information on the waiver of coinsurance and deductibles for certain testing and related services,
• Add information on the expanded use of ambulance origin/destination modifiers,
• Provide new specimen collection codes for clinical diagnostic laboratories billing, and
• Add guidance regarding delivering notices to beneficiaries.

 

April 10, 2020: Special MLNConnects – Sequestration Adjustment Suspended

CMS announced in an April 10th Special Edition MLNConnects that Section 3709 of the CARES Act temporarily suspends the 2% payment adjustment currently applied to all Medicare Fee-for-Service (FFS) claims due to sequestration. The suspension is effective for claims with dates of service from May 1 through December 31, 2020.

 

April 11, 2020: Expanded Coverage for Essential Diagnostic Services amid COVID-19 Public Health Emergency

The CMS and the Departments of Labor and the Treasury announced in a CMS Press Release that guidance has been issued ensuring Americans with private health insurance have coverage of COVID-19 diagnostic testing and certain other related services, including antibody testing, at no cost. The guidance is made available in the format of an FAQ Document. Following are just a few of the questions that are answered in the guidance:

• The types of group health plans and health insurance that are subject to this guidance,
• What plans are insurers are required to comply with and for how long, and
• What items and services plans and insurers must provide.

 

April 13, 2020: United Healthcare Waiving CMS Originating Site Restriction & Audio-Video Requirement

The UnitedHealthcare Telehealth webpage was most recently updated on April 13, 2020. Included on this page is the announcement that they will be waiving the CMS originating site restriction and audio-video requirement for Medicare Advantage, Medicaid, and Individual and Group Market health plan members from March 18, 2020 until June 18, 2020. You can read the entire announcement on the UnitedHealthcare COVID-19 Telehealth webpage at: https://www.uhcprovider.com/en/resource-library/news/Novel-Coronavirus-COVID-19/covid19-telehealth-services/covid19-telehealth-services-telehealth.html.

 

April 13, 2020: Immediate Infusion of $30 Billion into the Health Care System

Late Monday afternoon I started receiving the following notice in my inbox from different MACs around the country:

“Recognizing the importance of delivering funds in a fast and transparent manner, $30 billion is being distributed immediately through a program administered by the Department of Health and Human Services – with payments arriving via direct deposit beginning April 10, 2020 – to eligible providers throughout the American health care system. These payments are unrelated to the Accelerated and Advanced Payments you may have requested from Medicare.

The automatic payments will come from Optum Bank with "HHSPAYMENT" as the payment description. Find more information about these payments at http://www.hhs.gov/provider-relief/index.html.”

When you access the hhs.gov webpage, the announcement includes the following bolded sentence: These are payments, not loans, to healthcare providers, and will not need to be repaid.

On March 26, 2019, the National Coverage Determination (NCD) 20.4: Implantable Cardiac Defibrillators (ICDs) was updated to reflect changes in the February 15, 2018 Final Decision Memo (CAG-00157R4).  Almost a year later, on March 3, 2020, CMS released MLN Matters article SE2006 updating provider on Medicare coverage rules and policies for NCD 20.4.

Background

This MLN article addresses concerns that CMS has received related to the following three indications in the NCD 20.4:

• Patients with a prior Myocardial Infarction (MI) and a measured left ventricular ejection fraction (LVEF) ≤30,
• Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachycardia (VT) or cardiac arrest due to ventricular fibrillation (VF), and have NYHA Class II or II heart Failure, LVEF ≤ 35 percent, and
• Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of cardiac arrest or sustained VT, NYHA Class II or III heart failure, LVEF ≤ 35 percent, and been on optimal medical therapy for at least 3 months.
  

Response to Concerns

Concern: Heart Failure ICD-10 Codes Requirement

“CMS believes that perhaps some have misinterpreted correct coding principles with respect to the use of” the ICD-10 heart failure diagnosis codes (I150.21, I50.22, I50.23, I50.41, I50.42, and I50.43).

CMS Response: CMS agrees that patients do not have to have “active heart failure” to qualify for an ICD and notes that patients “also do not have to have “active heart failure” in order to append one of these codes as required based on NCD language. CMS notes when a patient has had to undergo treatment at some time in the past for clinical signs and symptoms of heart failure and his or her left ventricular function is still impaired, it would be appropriate to code a heart failure code. 

Concern: CMS has received a suggestion that the unspecific heart failure code (I50.9) should be added to the covered codes for this NCD.

CMS Response: CMS disagrees with the addition of this code as “one cannot determine what type of heart failure may be, or may have been present.”

Concern: Related articles outlining the coding requirements (including heart failure codes) are more restrictive than the NCD.

MMP Reminder: CPT/HCPCS and ICD-10 Codes are not published in NCD 20.4. Rather, they can be found in the following related Medicare Administrative Contractor Articles:

• First Coast JN (A56341)
• NGS J6/JK (A56326)
• Noridian JE (A56340)
• Noridian JF (A56342)
• Novitas JH/JL (A56355)
• Palmetto JJ/JM (A56343)
• WPS J5/J8 (A56391)

CMS Response: CMS disagrees and asserts that the articles are not more restrictive. They do agree that “the NCD does not specifically use the terms encompassed by the heart failure code descriptors.”

CMS concludes this MLN article ends with the following statement:

“It is incumbent upon the provider to select the proper code(s). We believe the listed covered codes encompass the various clinical scenarios that occur for patients who meet the NCD coverage requirements and are provided, not to write additional parameters into the NCD, but to ensure there is an appropriate code for the covered indications.”

You can read more about specific changes made in the Final Decision Memo in a related MMP article at http://www.mmplusinc.com/news-articles/item/ncd-20-4-implantable-cardiac-defibrillators-icds. 

Resources

NCD 20.4: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110

MLN Matters SE20006: https://www.cms.gov/files/document/se20006.pdf

Institute for Health Metrics and Education (IHME) COVID-19 Projections Models

In a related FAQs document the IHME indicates that they “were initially asked to develop models by our colleagues at the University Of Washington School Of Medicine to help in planning their response. As other US hospital systems and state governments reached out for help in determining when COVID-19 would overwhelm their ability to care for patients, we pushed to release a national-level tool. Ultimately, these forecasts were developed to provide hospitals, health care workers, policymakers, and the public with crucial information about what demands COVID-19 may place on hospital capacity and resources, so that they could begin to plan.” The Models assume social distancing is in place and the data is updated frequently (link to Project: https://covid19.healthdata.org/projections).

March 27, 2020: The Coronavirus Aid, Relief, and Economic Security (CARES) Act signed into Law

The CARES Act is jam packed with efforts to provide relief to hospitals, businesses and individuals during the National State of Emergency due to Coronavirus (COVID-19).  Following are resources to help you learn more about this Act.

• The CARES Act: https://files.taxfoundation.org/20200325223111/FINAL-FINAL-CARES-ACT.pdf
• S. Committee or Small Business and Entrepreneurship Small Business Owner’s Guide to the CARES Act: https://www.sbc.senate.gov/public/_cache/files/2/9/29fc1ae7-879a-4de0-97d5-ab0a0cb558c8/1BC9E5AB74965E686FC6EBC019EC358F.the-small-business-owner-s-guide-to-the-cares-act-final-.pdf
• Senate Health, Education, Labor and Pensions (HELP) Committee Summary https://www.help.senate.gov/imo/media/doc/CARES%20Section-by-Section%20FINAL.PDF

SEC. 3710. MEDICARE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM ADD-ON PAYMENT FOR COVID–19 PATIENTS DURING EMERGENCY PERIOD.

Section 3710 of the CARES Act indicates that “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.” Note, this add-on payment will be available through the duration of the COVID-19 emergency.

March 31, 2020: ICD-10-CM Official Coding Guidelines for COVID-19 April 1, 2020 – September 30, 2020

ICD-10-CM Official Guidelines for COVID-19 for April 1, 2020 through September 30, 2020 were released. Included in this document are the following topics:

• Code only confirmed cases
• Sequencing of codes,
• Acute Respiratory Illness due to 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; and
• COVID-19 infection in pregnancy, childbirth and the puerperium

I would like to call attention to the specific guidance regarding coding confirmed cases. The guidelines indicate 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.”

With the add-on payment for hospitals treating COVID-19 patients only occurring when a patient is identified by diagnosis codes, it is essential for Physicians to document when a case is confirmed so that Coding Professionals can code the new ICD-10-CM code U07.1 that became effective April 1, 2020.

The complete guidelines are available on the CDC ICD-10-CM webpage and the CMS 2020-ICD-10-CM webpage.

March 31, 2020: Palmetto GBA Provides Accelerated Payment Posts FAQs

Included in last week’s COVID-19 Updates was information about the CMS announcing an expansion of its accelerated and advance payment program. You can read more about this in the March 28 CMS Press Release. On March 31st Palmetto GBA, the Jurisdictions J and M Medicare Administrative Contractor (MAC) Posted Accelerated Payment Hotline FAQs on their website. 

As a reminder, CMS has established COVID-19 hotlines at each MAC to assist providers with their accelerated payment requests. MAC hotline numbers, details on the eligibility and the request process are available in a Fact Sheet.  The expansion of this program is only for the duration of the public health emergency.

March 31, 2020: Cigna COVID-19 Billing Guidelines and FAQ Document for Providers  

This March 31, 2020 document includes the following new guidance as of March 31st pertaining to reimbursement for treatment of confirmed cases of COVID-19:

“Effective 3/30/2020, customer cost-share (if applicable depending on the customer’s benefit plan) for COVID-19 treatment (inpatient and outpatient) for in-network and out-of-network providers is waived until 5/31/2020.This applies to treatment with dates of service of 2/3/2020 to 5/31/2020. Covered treatment includes all services covered under Medicare and applicable state regulations for the management of a COVID-19 diagnosis. In-network providers will be reimbursed consistent with their fee schedules for services rendered. Out-of-network providers will be reimbursed 100% of Medicare or Medicaid allowable depending on the customer’s benefit plan. When COVID-19 is confirmed, the following codes should be used for treatment once COVID-19 is confirmed.

‍March 31, 2020: Special Edition MLN Connects:

In a March 31st Special Edition of MLN Connects, CMS further expounded upon the sweeping Blanket Waivers and Flexibilities announced on March 30th, provided information about Professionals billing for Telehealth Services during the Public Health Emergency and provided the following information about new specimen collection codes for laboratories billing for COVID-19 Testing:

Clinical diagnostic laboratories: To identify and reimburse specimen collection for COVID-19 testing, CMS established two Level II HCPCS codes, effective with line item date of service on or after March 1, 2020:

• G2023 - Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source
• G2024 - Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), from an individual in a skilled nursing facility or by a laboratory on behalf of a home health agency, any specimen source               

These codes are billable by clinical diagnostic laboratories.

April 1, 2020: Update to ICD-10-CM for Vaping Related Disorder and 2019 Novel Coronavirus (COVID-19)

MLN Article MM11623 was revised on April 1st to reflect updated Change Request (CR) 11623 which added the new ICD-10-CM code for the 2019 Novel Coronavirus (COVID-19).

April 1, 2020: CDC Posts Healthcare Infection Prevention and Control FAQs for COVID-19

The FAQs align with the revised Interim Infection Preventio and Control Recommendations for patients with a confirmed COVID-10 diagnosis or are under investigation in healthcare settings. They are being made available to assist healthcare facilities in preventing transmission of COVID-19 in healthcare settings.

April 2, 2020: Key Recommendations Issued to Nursing Homes, State and Local Governments

In an April 2nd CMS Press Release the CMS and CDC, at the direction of the President, “issued critical recommendations to state and local governments, as well as nursing homes, to mitigate the spread of the 2019 Novel Coronavirus (COVID-19) in nursing homes.” Recommendations announced on April 2nd include:

• Nursing homes should immediately ensure that they are complying with all CMS and CDC guidance related to infection control.
• As nursing homes are a critical part of the healthcare system, and because of the ease of spread in long term care facilities and the severity of illness that occurs in residents with COVID-19, CMS/CDC urges State and local leaders to consider the needs of long term care facilities with respect to supplies of PPE and COVID-19 tests.
• Nursing homes should immediately implement symptom screening for all staff, residents, and visitors – including temperature checks.
• Nursing homes should ensure all staff are using appropriate PPE when they are interacting with patients and residents, to the extent PPE is available and per CDC guidance on conservation of PPE.
• To avoid transmission within nursing homes, facilities should use separate staffing teams for residents to the best of their ability, and, as President Trump announced at the White House today, the administration urges nursing homes to work with State and local leaders to designate separate facilities or units within a facility to separate COVID-19 negative residents from COVID-19 positive residents and individuals with unknown COVID-19 status.

In the Press Release CMS Administrator Seema Verma is quoted as saying that “The Trump Administration is calling on the nursing home industry and state and local leaders to join us by taking action now to ensure the safety of their residents, who are among our most vulnerable citizens. The Administration urges them to carefully review our recommendations, and implement them immediately.”

April 3, 2020: Special Edition MLN Connects: COVID-19 Telehealth Billing Correction, Nursing Home Recommendations, Billing for Multi-Function Ventilators, New ICD-10 Diagnosis Code

CMS issued a Special MLN Connects newsletter on April 3rd highlighting revised telehealth billing information, nursing home recommendations released earlier the day, billing for multi-function ventilators and the new ICD-10 COVID-19 Diagnosis code U07.1.

https://www.cms.gov/files/document/2020-04-03-special-edition.pdf

Telehealth: Billing Distant Site Services during Public Health Emergency (PHE) Revised

CMS notes this information corrects a prior message that appeared in our March 31, 2020 Special Edition. Specifically, CMS will now allow for more than 80 additional services to be furnished via telehealth.  Professional claims for all telehealth services with dates of service on or after March 1, 2020, and for the duration of the Public Health Emergency (PHE) are to be billed with the following:

• Place of Service (POS) equal to what it would have been had the service been furnished in-person, and
• Modifier 95, indicating that the service rendered was actually performed via telehealth.

CMS is not requiring the CR modifier. However, CMS does describe two scenarios that do require modifiers on Medicare telehealth professional claims.

• Furnished as part of a federal telemedicine demonstration project in Alaska and Hawaii using asynchronous (store and forward) technology, use GQ modifier, and
• Furnished for diagnosis and treatment of an acute stroke, use G0 modifier.

Billing for Multi-Function Ventilators (HCPCS Code E0467)

Effective immediately, CMS is suspending claims editing for multi-function ventilators when there are claims for separate devices in history that have not met their reasonable useful lifetime.

• For more information on multi-function ventilators, see MLN Matters Special Edition Article SE20012.

April 6, 2020: CMS News Alert: New Video on Telehealth, 45th Medicaid Waiver Approved, and Guidance for Processing Attestations from Ambulatory Surgical Centers (ASCs) Temporarily Enrolling as Hospitals during COVID-19 PHE

In an April 6th Press Release, CMS provided a summary of recent actions taken in response to COVID-19, as part of the ongoing White House Task Force. They note the information in the release is current as of April 6th at 10:00 AM.

• New Video about Telehealth: CMS has released a video providing answers to common questions about telehealth. This benefit has been expanded on a temporary and emergency basis under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act. This Video was posted on YouTube on April 3, 2020.
• Medicaid and Appendix K Waivers: The District of Columbia has received approval for the 45th Medicaid waiver, which provides “urgent regulatory relief to ensure the District can quickly and efficiently care for their most vulnerable citizens.” States can access the CMS developed toolkit to facilitate expedited application and approval of State waivers requests in record time. You can go to the Medicaid.gov website to view all Section 1135 Waivers due to the COVID-19 PHE. The Press Release also references Appendix K Waivers available at 1915(c) Appendix K Waivers.
• ASCs Temporarily Enrolling as Hospitals: The last update in the Press Release notes that as part of the COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers CMS is allowing Medicare-enrolled ASCs to temporarily enroll as hospitals and to provide hospital services to help address the urgent need to increase hospital capacity to take care of patients and provides a link to the Guidance made available on the CMS website.

Background

Last June CMS released a Final Decision Memo (CAG-00430R) for Transcatheter Aortic Valve Replacement (TAVR) Procedures. This procedure is for the treatment of symptomatic aortic valve stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

Final Decision Memo: What Did Not Change

Coverage under Evidence Development

The requirement that a procedure be performed under Coverage with Evidence Development (CED) did not change in the Final Decision Memo. CED means that the service is only covered in the context of a clinical trial (such as a national registry or a clinical study). This allows limited coverage for Medicare beneficiaries in a controlled environment while determining the efficacy, risks, and outcomes of the procedure. Once a new technology or procedure is proven to be safe and effective, CMS may remove the CED requirement and cover the procedure outright within set criteria.

• TAVR is covered according to CMS criteria when the procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system’s FDA approved indication and the heart team and hospital are participating in a prospective, national, audited registry.
• TAVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills criteria set forth in the decision memo.

Link to CMS TAVR CED webpage: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR

The Heart Team

• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals:
• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR; and
• TAVR must be furnished in a hospital with the appropriate infrastructure.

Final Decision Memo: What Did Change

Pre-Procedure Patient Evaluation Requirements

Historically, the TAVR National Coverage Determination (NCD) 20.32 required a face-to-face evaluation of a patient’s suitability for TAVR surgery by two cardiac surgeons. The most recent Final Decision Memo changed the requirement from two cardiac surgeons to a cardiac surgeon and an interventional cardiologist. This change is in line with the requirement of the heart team’s interventional cardiologist(s) and cardiac surgeon(s) jointly participating in the intra-operative technical aspects of TAVR. Following is specific guidance from the Final Decision Memo:

• “The heart team includes the following:
• Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:
• Independently examined the patient face-to-face, evaluated the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
• Documented and made available to the other team members the rationale for their clinical judgement.
• Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.”

Note, in general, I have seen most denials from Medicare Contractors for this procedure being due to a lack of documentation of a face-to-face encounter by two surgeons. What I have found in performing claim reviews for MMP clients is that often there was documentation from a surgeon and an interventional cardiologist which now meets the face-to-face requirement.

Hospital Specific Procedure Volumes

The prior version of the NCD and Final Decision memo both required certain volumes of procedures for the hospital and the heart team based on whether they had previous TAVR experience or not.

For example, hospitals with no previous TAVR experience, the volume of Aortic Valve Replacements has decreased while a specific volume of open heart surgeries and having at least one physician with interventional cardiology privileges has been added to the NCD. Whether or not you currently perform TAVR procedures or are in the planning phase of performing these procedures, I encourage you to review the new requirements in NCD 20.32.

August 16, 2019 FDA Announcement:  FDA Expands Indication for Several Transcatheter Heart Valves to Patients at Low Risk for Death or Major Complications Associated with Open-Heart Surgery

Last August, “the U.S. Food and Drug Administration today approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves. These transcatheter valves – Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery.

In low risk patients, open-heart surgery has been the standard-of-care for aortic valve replacement. However, the procedure to insert a transcatheter heart valve is less invasive, and involves a smaller incision and shorter recovery time than open-heart surgery. The FDA is the first medical products regulatory body in the world to expand the indication for these devices to patients at low risk for death or major complications associated with open-heart surgery.”

Final Decision Memo Changes are Now Effective

• Effective Date: June 21, 2019
• Implementation Date: June 12, 2020.

As always, with Decision Memos, the requirements are not effective until the NCD is updated and implemented. However, NCD revisions generally revert to the effective date of the Decision Memo, which is in this case June 21, 2019.

On Friday March 13th CMS published Change Request (CR) 11660  informing Medicare Administrative Contractors (MACs) that effective June 21, 2019, CMS will continue to cover TAVR under CED when the procedure is furnished for the treatment of symptomatic aortic stenosis and according to an FDA approved indication for use with an approved device, in addition to the coverage criteria outlined in the NCD manual. The Implementation date is June 12, 2020.

On Tuesday 3/24/2020 CMS published related MLN Matters Article MM11660.

TAVR Hospital “To Do” List

• Read the updated NCD carefully, making sure you are following all of Medicare’s requirements.
• Ensure your medical record contains documentation of the face-to-face patient examinations by a cardiac surgeon and an interventional cardiologist (experienced in the care and treatment of aortic stenosis) evaluated the patient’s suitability for SAVR, TAVR or medical or palliative therapy;
• Ensure your hospital has the appropriate infrastructure for the procedure;
• Assess your hospital and heart team volumes to be sure you meet the requirements for performing the procedure under the new Decision Memo; and
• Ensure the patient is under the care of a heart team and the heart team’s interventional cardiologist(s) and cardiac surgeon(s) jointly participate in the intra-operative technical aspects of TAVR.

Q:

Sometimes modifier 59 is still confusing to us when we are trying to work through CCI edits for Medicare. Is there any new information about modifier 59 that can help us better understand?

A:

Correct Coding Initiative edits are still referred to by a lot of people as “CCI edits”, so we know exactly what you are talking about. Instead of CCI edits, CMS now refers to these as “Procedure to Procedure” edits (PTP). It’s a different name, but the concept is still the same, and hospitals still have to “work through” – as you say – all these edits to determine when to add a modifier.

In March 2020, CMS released a MLN Matters Article SE1418 regarding the proper use of modifier 59 and modifiers –X{EPSU}. In my opinion, the article includes helpful examples of separate practitioner, structure, and encounter.

You asked about Modifier 59, but as you read through the MLN article, you will also see examples for using the X{EPSU} modifiers instead of modifier 59. Remember, the X{EPSU} modifiers are considered more specific than modifier 59 and should be used in lieu of modifier 59 whenever possible. Be sure to incorporate all of this information into your efforts when deciding if a modifier is needed.

I doubt anyone will ever have all the answers about modifier 59, and I say this based on the number of related inquiries we receive every week. With over 1 million code pairs involved, it’s no wonder there’s ongoing confusion. 

MMP remains committed to continuously monitoring COVID-19 updates specific to our reader base. As such, following is a time-line of key announcements occurring within the last week including sweeping regulatory changes announced by CMS after 5pm on Monday March 30th.   

March 23, 2020: CMS Updates FAQs on Coding & Billing COVID-19

This updated FAQ document addresses questions related to the following:

• Diagnostic Lab Services,
• Physicians’ Services,
• Home Health,
• Hospital Services,
• Drugs and Vaccines Under Part B,
• Ambulance Services, and
• Medicare Payments to Facilities Accepting Government Resources.

March 23, 2020: CMS Posts ICD-10 MS-DRG Version 37.1 R1 Effective April 1, 2020

The CDC and National Center for Health Statistics is implementing the new diagnosis code, U07.1, COVID-19, into the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) effective April 1, 2020. The ICD-10 MCE Version 37.1 R1 uses edits for the ICD-10 codes reported to validate correct coding on claims for discharges on or after April 1, 2020. The ICD-10 MS-DRG Grouper software package to accommodate this new code, Version 37.1R1, is effective for discharges on or after April 1, 2020. Assignment of new ICD-10-CM diagnosis code U07.1, COVID-19, is as follows:

 This announcement also indicates that if diagnosis code U07.1, COVID-19, is reported as a principal diagnosis, it will only exclude itself from acting as a MCC under the CC Exclusion List.

March 23, 2020: Cigna Waives Prior Authorization for Transfer of non-COVID-19 customers to In-Network LTACHs

On March 23rd Cigna announced that “Effective today, Cigna will waive prior authorizations for the transfer of its non-COVID-19 customers from acute inpatient hospitals to in-network LTACHs. In place of prior authorizations, Cigna will require notification from the LTACH on the next business day following the transfer. This policy will remain in place through May 31, 2020 and applies to Cigna commercial and Medicare Advantage plans. Cigna has also waived prior authorizations for the transfer of its patients to other in-network subacute facilities, including skilled nursing facilities and acute rehab centers.” This is the latest effort made by Cigna to protect customers against COVID-19. You can read about additional efforts over the past two weeks in the Announcement.

 

March 24, 2020: United Healthcare Reduces Prior Authorization Requirements

On March 24th, UnitedHealthcare posted an Announcement about efforts in response to COVID-19. The following provision related to post-acute care settings is in this announcement:

• Suspension of prior authorization requirements to a post-acute care setting effective March 24, 2020 through May 31, 2020. Details:
• Waiving prior authorization for admissions to: long-term care acute facilities (LTAC), acute inpatient rehabilitation (AIR), and skilled nursing facilities (SNF).
• Consistent with existing policy, the admitting provider must notify us within 48 hours of transfer and penalties still apply.
• Length of stay reviews still apply, including denials for days that exceed approved length.
• Discharges to home health will not require prior authorization.
• Prior authorization is not required for COVID-19 testing and COVID-19 testing related visits.

This announcement also provides detail regarding suspension of prior authorization requirements when a member transfers to a new provider and a link to a surgical code list of procedures in which site of service reviews are being suspended until April 30th, 2020.  

 

March 24, 2020: OIG FAQs - Waiving Telehealth Cost-Sharing During COVID-10 Outbreak

On March 17, 2020, OIG issued “OIG Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak.”

Since the issuance of the Policy Statement, OIG has received questions regarding the scope of the Policy Statement. The OIG has compiled responses to frequently asked questions related to the Policy Statement in an FAQ document and reports they will update the FAQ document as they receive additional questions.

March 24, 2020: Activation of Systematic Validation Edits for OPPS Providers with Multiple Service Locations – Delayed Until Further Notice

On September 5, 2019 CMS announced a delay of full implementations until April 2020. You can read more about this requirement in a related MMP article at http://www.mmplusinc.com/news-articles/item/claim-edits-for-reporting-of-service-locations.

On March 24th, 2020, CMS announced a delay until further notice for the activation of Systematic Validation Edits for OPPS Providers with Multiple Service Locations. While this is not specifically COVID-19 related, I imagine the delay until further notice is in response to the COVID-19 pandemic.

• MLN SE189007: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE19007.pdf

March 24, 2020: Notice of Emergency Use Authorization Declaration

In a March 24, 2020 Federal Register, post the Secretary of Health and Human Services made the “determination of a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the novel (new) coronavirus, SARS-CoV-2.”

Based on this determination the Secretary “declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.”

March 24, 2020: Cost Report Filing Extensions

Palmetto GBA updated providers about Cost Report filing extensions through the following Q&A:  

Question: Will CMS delay the filing deadline of Fiscal Year End (FYE) December 31, 2019 cost reports due at the end of May due to the Covid-19 outbreak?
Answer: Yes, 42 CFR § 413.24 (f) (2) (ii) allows this flexibility. CMS is currently authorizing delay for the following FYE dates.
 
The filing deadline for the following cost reports are now June 30, 2020:

• FYE October 31, 2019 due by March 31, 2020
• FYE November 30, 2019 due by April 30, 2020

The filing deadline for FYE December 31, 2019 is now July 31, 2020. This is a blanket extension; you do not need to send a request.

March 24, 2020: AHA and AHIMA FAQs Regarding ICD-10-CM Coding for COVID-19 Revised

This FAQ Document was jointly developed and approved by the American Hospital Association Central Office on ICD-10-CM/PCS and the American Health Information Management Association. MMP encourages you to share this information with your Coders and Clinical Documentation Integrity (CDI) Specialists.

 

March 25, 2020: CDC Posts ICD-10-CM April 1, 2020 Addenda

The April 1, 2020 Addenda posted by the CDC on March 25th includes guidance for the new Vaping Related Disorder as well as COVID-19.

 

March 25, 2020: OIG Coronavirus Portal

The OIG announced the creation of a Portal for all information and announcements related to COVID-19. The portal can be accessed from OIG’s main website or directly at oig.hhs.gov/coronavirus. The OIG is asking for feedback from individuals or entities who need clarification on its oversight authorities during the coronavirus (COVID-19) pandemic.

 

March 26, 2020: CMS News Alert

CMS summarized recent actions they have taken in response to COVID-19 in a March 26, 2020 Press Release . “To keep up with the important work the Task Force is doing in response to COVID-19, click here www.coronavirus.gov. For information specific to CMS, please visit the CMS News Room and Current Emergencies Website.”

 

March 26, 2020: Special Thursday Edition MLNConnects: Beneficiary Notices Delivery Guidance

In a special MLNConnects notice CMS has finally provided hospitals with guidance on how to handle providing beneficiary notices to patients with suspected or confirmed COVID-19. Specifically, “CMS encourages the provider community to be diligent and safe while issuing the following beneficiary notices to beneficiaries receiving institutional care:

• Important Message from Medicare   (IM)_CMS-10065
• Detailed Notices of Discharge   (DND)_CMS-10066
• Notice of Medicare Non-Coverage   (NOMNC)_CMS-10123
• Detailed Explanation of Non-Coverage   (DENC)_CMS-10124
• Medicare Outpatient Observation Notice   (MOON)_CMS-10611
• Advance Beneficiary Notice of Non-Coverage   (ABN)_CMS-R-131
• Skilled Nursing Advance Beneficiary Notice of Non-Coverage   (SNFABN)_CMS-10055
• Hospital Issued Notices of Non-Coverage   (HINN)

In light of concerns related to COVID-19, current notice delivery instructions provide flexibilities for delivering notices to beneficiaries in isolation. These procedures include: 

• Hard copies of notices may be dropped off with a beneficiary by any hospital worker able to enter a room safely. A contact phone number should be provided for a beneficiary to ask questions about the notice, if the individual delivering the notice is unable to do so. If a hard copy of the notice cannot be dropped off, notices to beneficiaries may also delivered via email, if a beneficiary has access in the isolation room. The notices should be annotated with the circumstances of the delivery, including the person delivering the notice, and when and to where the email was sent.
• Notice delivery may be made via telephone or secure email to beneficiary representatives who are offsite. The notices should be annotated with the circumstances of the delivery, including the person delivering the notice via telephone, and the time of the call, or when and to where the email was sent.

CMS encourages providers to review all of the specifics of notice delivery, as set forth in Chapter 30 of the Medicare Claims Processing Manual. https://www.cms.gov/media/137111”

CMS also included the following two FAQ Documents in this special MLNConnects edition:

• 2019-Novel Coronavirus (COVID-19) Medicare Provider Enrollment Relief FAQ, and
• Enforcing Open Payment Deadlines FAQ.

March 27, 2020: CMS Provides Additional Instructions RE: Relief in Quality Reporting Programs

CMS initially announced relief for clinicians, providers, hospitals and facilities participating in quality reporting programs in response to the 2019 Novel Coronavirus (COVID-19). On March 27th CMS provided a Memorandum and Fact Sheet as supplements providing additional guidance to health care providers.

 

March 23, 2020: CMS Approves Medicaid Section 1135 Waivers for 11 Additional States in Response to COVID-19

The Centers for Medicare & Medicaid Services (CMS) approved an additional 11 state Medicaid waiver requests under Section 1135 of the Social Security Act (Act), bringing the total number of approved Section 1135 waivers for states to 13. States approved waivers include the following states:

• Alabama,
• Arizona
• California
• Illinois
• Louisiana
• Mississippi
• New Hampshire
• New Jersey
• New Mexico
• North Carolina
• Virginia

Examples of waivers available under section 1135 of the Act include:

• Temporarily suspend prior authorization requirements;
• Extend existing authorizations for services through the end of the public health emergency;
• Modify certain timeline requirements for state fair hearings and appeals;
• Relax provider enrollment requirements to allow states to more quickly enroll out-of-state or other new providers to expand access to care, and
• Relax public notice and submission deadlines for certain COVID-19 focused Medicaid state plan amendments, enabling states to make changes faster and ensure they can be retroactive to the beginning of the emergency.

These section 1135 waivers are effective March 1, 2020 and will end upon termination of the public health emergency, including any extensions. Last week, CMS approved COVID-19 related state Medicaid section 1135 waiver requests for Florida and Washington. Link to Press Release: https://www.cms.gov/newsroom/press-releases/cms-approves-medicaid-section-1135-waivers-11-additional-states-response-covid-19

March 27, 2020: CMS Approves Additional 1135 Waivers Bringing Total Number of Waivers to 29

New York, Colorado, Hawaii, Idaho, Massachusetts and Maryland have also been granted 1135 waivers. In this announcement CMS also issued important Clinical Laboratory Improvement Amendments (CLIA) Guidance. You can find additional details here: https://www.cms.gov/newsroom/press-releases/cms-news-alert-march-27-2020

March 27, 2020: 34th State Request for Medicaid Emergency Waivers

Included in this Press Release is “guidance to states on how to apply for Section 1135 waivers through the Medicaid Disaster Response Tool Kit, which can be found here. To further the agency’s efforts, CMS has developed checklists and tools to expedite  COVID-19 virus requests and approvals for waivers and other commonly requested flexibilities during the current public health emergency.  Home and community based program resources can be found here.”

March 28, 2020: CMS Expands Accelerated and Advanced Payment Program

In a March 28 Press Release, CMS announced an expansion of its accelerated and advance payment program for Medicare participating health care providers and suppliers. This expansion includes changes from the recently enacted Coronavirus Aid, Relief, and Economic Security (CARES) Act.

Accelerated and advance Medicare payments provide emergency funding and addresses cash flow issues based on historical payments when there is disruption in claims submission and/or claims processing. These expedited payments are typically offered in natural disasters to accelerate cash flow to the impacted health care providers and suppliers. In this situation, CMS is expanding the program for all Medicare providers throughout the country during the public health emergency related to COVID-19.  The payments can be requested by hospitals, doctors, durable medical equipment suppliers and other Medicare Part A and Part B providers and suppliers.

To qualify for accelerated or advance payments, the provider or supplier must:

• Have billed Medicare for claims within 180 days immediately prior to the date of signature on the provider’s/ supplier’s request form,
• Not be in bankruptcy,
• Not be under active medical review or program integrity investigation, and
• Not have any outstanding delinquent Medicare overpayments.

Medicare will start accepting and processing the Accelerated/Advance Payment Requests immediately. CMS anticipates that the payments will be issued within seven days of the provider’s request. 

CMS has established COVID-19 hotlines at each MAC to assist providers with their accelerated payment requests. MAC hotline numbers as well Details on the eligibility and the request process and MAC hotline numbers can be found in a related Fact Sheet.  The expansion of this program is only for the duration of the public health emergency.

March 29, 2020: Trump Administration Engages America’s Hospitals in Unprecedented Data Sharing

On Sunday March 29th CMS announced that letters had been sent to the nation’s hospitals on behalf of Vice President Pence requesting data in connection with their efforts to fight COVID-19 be reported to CMS. Following is what data CMS is requesting:

• Hospitals report COVID-19 testing to the U.S. Department of Health and Human Services (HHS),
• Daily reporting regarding bed capacity and supplies to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) COVID-19 Patient Impact and Hospital Capacity Module.

To ensure patient privacy, data reported will be not include personal identifying information.

CMS Administrator Seema Verma notes in the announcement, “the nation’s nearly 4,700 hospitals have access to testing data that’s updated daily. This data will help us better support hospitals to address their supply and capacity needs, as well as strengthen our surveillance efforts across the country…America’s hospitals are demonstrating incredible resilience in this unprecedented situation and we look forward to partnering with them going forward.”

March 30, 2020: CMS Makes Sweeping Waivers

At 5:32 PM on March 30th, CMS updated their Coronavirus Waivers and Flexibilities webpage by posting provider-specific fact sheets on new waivers and flexibilities for the following providers:

• Physicians and Other Practitioners (PDF)
• Ambulances (PDF)
• Hospitals (PDF)
• Teaching Hospitals, Teaching Physicians and Medical Residents (PDF)
• Long Term Care Facilities (Skilled Nursing Facilities and/or Nursing Facilities) (PDF)
• Home Health Agencies (PDF)
• Hospices (PDF)
• Inpatient Rehabilitation Facilities (PDF)
• Long Term Care Hospitals & Extended Neoplastic Disease Care Hospitals (PDF)
• Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (PDF)
• Laboratories (PDF)
• End Stage Renal Disease (ESRD) Facilities (PDF)
• Durable Medical Equipment (PDF)
• Participants in the Medicare Diabetes Prevention Program (PDF)
• Medicare Advantage and Part D Plans (PDF)

The document specific to hospitals indicates that “the Trump Administration is issuing an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. Made possible by President Trump’s recent emergency declaration and emergency rule making, these temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration.” Following are a few examples of waivers and flexibilities specific to Hospitals:

Limit Discharge Planning for Hospital and CAHs: To allow hospitals and CAHs more time to focus on increasing care demands, discharge planning will focus on ensuring that patients are discharged to an appropriate setting with the necessary medical information and goals of care. CMS is waiving detailed regulatory requirements to provide information regarding discharge planning, as outlined in 42 CFR §482.43(a)(8), §482.61(e), and 485.642(a)(8). The hospital, psychiatric hospital, and CAH must assist patients, their families, or the patient’s representative in selecting a post-acute care provider by using and sharing data that includes, but is not limited to, home health agency (HHA), skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), and long term care hospital (LTCH) data on quality measures and data on resource use measures. The hospital must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences. During this public health emergency, a hospital may not be able to assist patients in using quality measures and data to select a nursing home or home health agency, but must still work with families to ensure that the patient discharge is to a post-acute care provide that is able to meet the patient’s care needs.

Utilization review: CMS is waiving these requirements at 42 CFR §482.1(a)(3) and 42 C.F.R §482.30, that requires that hospitals participating in Medicare and Medicaid to have a utilization review plan that meets specified requirements. CMS is waiving the entire Utilization Review CoP at §482.30, which requires that a hospital must have a utilization review (UR) plan with a UR committee that provides for review of services furnished to Medicare and Medicaid beneficiaries to evaluate the medical necessity of the admission, duration of stay, and services provided. These flexibilities should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan. Removing these administrative requirements will allow hospitals to focus more resources on providing direct patient care.

 

Nursing services: CMS is waiving the provision at 42 CFR 482.23(b)(4), 42 CFR 482.23(b)(7), and 485.635(d)(4), which requires the nursing staff to develop and keep current a nursing care plan for each patient, and the provision that requires the hospital to have policies and procedures in place establishing which outpatient departments are not required under to have a registered nurse present. These waivers allow nurses increased time to meeting the clinical care needs of each patient and allows for the provision of nursing care to an increased number of patients. In addition, we expect that hospitals will need relief for the provision of inpatient services and as a result, the requirement to establish nursing-related policies and procedures for outpatient departments is likely unnecessary. These flexibilities apply to both hospitals and CAHs, and should be implemented so long as they are not inconsistent with a State or pandemic/emergency plan.

I strongly encourage hospitals take the time to read this entire ten page document.

For over thirty years, Medical Management Plus has made it our mission to help healthcare make sense for our clients. This weekly newsletter is one platform we use to provide what we believe to be current and relevant news to our client base. As the potential of Coronavirus (COVID-19) has turned into a reality we are being forced as a nation to come to grips with a new “normal” which includes among other things social distancing, actually washing our hands for a full 20 seconds with soap and water, and for hospitals preparing for the potential onslaught of patients presenting with COVID-19.

There is a wealth of information about COVID-19 and it is being updated and added to on a daily basis. Finding the time to sort through what is available while carrying out your daily responsibilities can be a challenge. To that end, this article is meant to provide our readers with key information and links to additional resources. The entire staff at MMP appreciates all of the dedicated healthcare workers on the front lines of this pandemic and will continue to monitor the situation and share key updates with you our readers.

February 27, 2020: American Heart Association News: What Heart Patients Should Know About Coronavirus

In this article, the American Heart Association highlights reasons why the Coronavirus is more concerning for individuals with a Cardiac history. With a mother, spouse, and friends who are heart patients, it was concerning to me to learn that in people with known fatty buildup of plaque in their arteries, “evidence indicates similar viral illnesses can destabilize these plaques, potentially resulting in the blockage of an artery feeding blood to the heart, putting patients at risk of heart attack.”

March 4th, 2020: MLN Connects Special Edition: CMS Announces Actions to Address Spread of Coronavirus

On March 4, the Centers for Medicare & Medicaid Services (CMS) announced several actions aimed at limiting the spread of the Novel Coronavirus 2019 (COVID-19). Specifically, CMS issued a call to action to health care providers across the country to ensure they are implementing their infection control procedures, which they are required to maintain at all times. Additionally, CMS announced that, effective immediately and, until further notice, State Survey Agencies and Accrediting Organizations will focus their facility inspections exclusively on issues related to infection control and other serious health and safety threats, like allegations of abuse – beginning with nursing homes and hospitals. The shift in approach allows inspectors to focus their energies on addressing the spread of COVID-19.” This announcement went on to describe memorandums as well as links to each one as follows: To view each memo, please visit:

• Suspension of Survey Activities
• Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge
• Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in nursing homes

March 6th, 2020: Defending Against COVID-19 Cyber Scams

The Cybersecurity and Infrastructure Security Agency (CISA) published a notice warning people to remain vigilant for scams related to COVID-19 which included specific precautions that should be taken. For example, avoid clicking on links in unsolicited emails and be wary of email attachments.

March 9th, 2020: Hospital ED Screening for COVID-19 and Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications

CMS published a Press Release urging hospitals to screen all patients for Coronavirus and published a related Memorandum to provide information in response to questions from hospitals and critical access hospitals (CAHs) regarding implications of COVID-19 and their compliance with EMTALA. Note, this guidance applies to both Medicare and Medicaid providers. This memorandum specifically addresses EMTALA screening obligation and EMTALA stabilization, transfer and recipient hospital obligations.

March 10th, 2020: Memorandum to MA Organizations related to COVID-19

This Memorandum was issued to Medicare Advantage Organizations and Part D Sponsors to inform them of the obligations and permissible flexibilities related to disasters and emergencies resulting from COVID-19. The flexibilities include:

• Waiving cost-sharing for COVID-19 tests,
• Waiving cost-sharing for COVID-19 treatments in doctor’s offices or emergency rooms and services delivered via telehealth,
• Removing prior authorizations requirements,
• Waiving prescription refill limits, Relaxing restrictions on home or mail delivery of prescription drugs, and
• Expanding access to certain telehealth services.

CMS also provided a related Press Release.

March 13, 2020: COVID-19 Emergency Declaration Health Care Providers Fact Sheet

CMS provided a Fact Sheet in response to their announcement about the steps taken through 1135 waivers. One key blanket waiver is for Skilled Nursing Facilities (SNFs). Specifically, “CMS is waiving the requirement at Section 1812(f) of the Social Security Act for a 3-day prior hospitalization for coverage of a skilled nursing facility (SNF) stay provides temporary emergency coverage of (SNF services without a qualifying hospital stay, for those people who need to be transferred as a result of the effect of a disaster or emergency. In addition, for certain beneficiaries who recently exhausted their SNF benefits, it authorizes renewed SNF coverage without first having to start a new benefit period.” A word of caution, a patient must still have a skilled need.

March 13, 2020: Guidance for Infection Control and Prevention of COVID-19 in Nursing Homes Revised

In a Revised Memorandum to State Survey Agency Directors, CMS advised facilities to “restrict visitation of all visitors and non-essential health care personnel, except for certain compassionate care situations, such as end-of-life situation.”

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

As follow-up to the March 13th Emergency Declaration Health Care Providers Fact Sheet, CMS indicated in this Special MLN article (SE20011) that they have issued blanket waivers consistent with those issues for past public health emergencies (PHE) declarations. “These waivers prevent gaps in access to care for beneficiaries impacted by the emergency. You do not need to apply for an individual waiver if a blanket waiver is issued.”

March 16, 2020: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp

The FDA announced they have issued Emergency Use Authorization (EUAs) to Hologic for its Panther Fusion SARS-COV-2 Assay, and LabCorp for its COVID-19 RT-PCR test.

March 16, 2020: COVID-19 & HIPAA

On March 16th HHS released this Bulletin providing information about a Limited Waiver of HIPAA Sanctions and Penalties during a Nationwide Public Health Emergency.

March 17, 2020: CMS Coronavirus Partner Virtual Toolkit

CMS released a Virtual Toolkit to help you stay up-to-date on CMS materials available on COVID-19. CMS encourages you to bookmark the webpage and check back often. 

March 17, 2020: CMS Expands Medicare Telehealth Coverage & the OIG Releases Waiving Telehealth Cost-Sharing Policy Statement

Expanded Medicare telehealth coverage was announced that will “enable beneficiaries to receive a wider range of healthcare services from their doctors without having to travel to a healthcare facility.

• Medicare Telemedicine Health Care Provider Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet
• Telehealth FAQs: https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf

At the same time, the OIG released a Policy Statement regarding Physicians and Other Practitioners that reduce or waive amounts owed by the beneficiary during the COVID-19 outbreak.

• OIG Policy Statement: https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/policy-telehealth-2020.pdf
• OIG Fact Sheet: https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/factsheet-telehealth-2020.pdf

The Office of Civil Rights published a related Notification of Enforcement Discretion for Telehealth in which they indicated the following:

• They “will exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency.  This notification is effective immediately.”
• They are “exercising its enforcement discretion to not impose penalties for noncompliance with the HIPAA Rules in connection with the good faith provision of telehealth using such non-public facing audio or video communication products during the COVID-19 nationwide public health emergency.  This exercise of discretion applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19.
• Under this Notice, covered health care providers may use popular applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA Rules related to the good faith provision of telehealth during the COVID-19 nationwide public health emergency. 
• Providers are encouraged to notify patients that these third-party applications potentially introduce privacy risks, and providers should enable all available encryption and privacy modes when using such applications. 
• Under this Notice, however, Facebook Live, Twitch, TikTok, and similar video communication applications are public facing, and should not be used in the provision of telehealth by covered health care providers.

March 17, 2020: Medicaid Telehealth

As a companion piece to the Medicare Telehealth Guidance, CMS released a Medicaid Telehealth Guidance to states document. Additionally, Medicaid.gov has a webpage dedicated to Telemedicine.

March 18, 2020: CMS Releases Recommendations on Surgeries & Procedures during COVID-19 Response

CMS announced in a Press Release that all elective surgeries, non-essential medical, surgical, and dental procedures be delayed during the 2019 Novel Coronavirus (COVID-19) outbreak. This CMS Press Release includes a link to specific tiered recommendations. For example, Tier 1a has an action to Postpone procedure or surgery and provides specific examples of carpal tunnel release, EGD, colonoscopy and cataracts.

March 18, 2020: Updated COVID-19 FAQs for State Medicaid and CHIP Agencies

In an effort to protect the health and safety of providers and patients, including those covered by Medicaid and the Children’s Health Insurance Program (CHIP), CMS provided an updated FAQ Document.

March 18, 2020: Kaiser Family Foundation (KFF) New COVID-19 Tool:

KFF has developed a New Tool providing the Latest State-Level Data on COVID-19 Cases and Deaths, Provider Capacity and the various policy actions that states have taken to combat the crisis. Information will be updated regularly.

March 18, 2020: Medicare Fee-for-Service (FFS) Response to Public Health Emergency on the Coronavirus (COVID-19) MLN Article Revised

• What You Need to Know: This article was revised to include information about the Telehealth waiver.
• MLN Matters SE20011: https://www.cms.gov/files/document/se20011.pdf

March 22, 2020: CMS Press Release Relief for Quality Reporting Programs

CMS announced “unprecedented relief for clinicians, providers, and facilities participating in Medicare quality reporting programs…Specifically, CMS announces it is granting exceptions from reporting requirements and extensions for clinicians and providers….with respect to upcoming measure reporting and data submission for those programs.” This action is in response to 2019 Novel Coronavirus (COVDI-19). This Press Release includes a table detailing the specific extensions being granted.

March 23, 2020 OIG Releases Fraud Alert

The OIG has released “a COVID-19 Fraud Alert to warn about several health care fraud scams that harm patients and the federal programs designed to serve them.  This alert has general information about these schemes and how to protect yourself and your community against bad actors.”

Alabama Public Health: COVID-19 Webpage

The Alabama Public Health Department has created a COVID-19 webpage which includes guidance for healthcare providers, what to do if you suspect you have COVID-19, a current “Situation Summary,” and lists several resources available from the Alabama Department of Public Health, the CDC, CMS and additional resources such as the World Health Organization and American Veterinary Medical Association (AVMA).

CDC Handouts & Posters

The CDC has made available Handouts and Posters in English, Spanish and simplified Chinese. Topics available includes:

• Share Facts About COVID-19,
• What You Need to Know,
• What to do if you are sick,
• Stop the spread of germs poster, and
• Symptoms of Coronavirus Disease 2019 poster.

A Wash Your Hands poster is also available in English, Spanish, French, Arabic, Bengali, Chinese, Portuguese, and Urdu.

World Health Organization (WHO): COVID-19 Advice for the Public: Myth Busters

The WHO has posted several Facts about the Coronavirus that can be downloaded and shared as a graphic. A few of the facts available are:

• Taking a hot bath does not prevent the new coronavirus,
• Vaccines against pneumonia do not provide protection against the new coronavirus, and
• There is no evidence that regularly rinsing the nose with saline has protected people from infection with the new coronavirus.

Additional Websites Providing COVID-19 Resources:

• Palmetto GBA Coronavirus (COVID-19) Resources at: https://www.palmettogba.com/COVID-19
• gov Coronavirus Disease 2019 (COVID-19) at: https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/covid19/index.html
• AMA COVID-19 at: https://www.ama-assn.org/search?search=COVID+19
• Environmental Protection Agency (EPA) Coronavirus Disease 2019 (COVID-19) at: https://www.epa.gov/coronavirus
• Note: Included on this page is a link to a List of disinfectants for use against Coronavirus (COVID-19).

This week should have marked the 31st Annual Health Information Professionals (HIP) Week; however, with many of our valued HIM professionals focused on work involving COVID-19, AHIMA has decided to postpone HIP week. The MMP team would still like to acknowledge and celebrate health information professionals at your facility, no matter when your celebration takes place.

This year’s theme, “Connecting People, Systems, and Ideas,” highlights the unique skills, abilities, experiences, and actions at the heart of the health information profession. Health Information Management (HIM), an allied health profession, leads efforts to ensure the availability, accuracy, integrity, and security of all data related to patient healthcare encounters, thus achieving better clinical and business decisions that enhance healthcare quality. HIM professionals work in multiple settings, including hospitals, clinics, physician offices, government and health insurance agencies, and other organizations. They play a key role in the effective management of health data to deliver quality healthcare to the public.

“As our healthcare ecosystem continues to evolve, health information professionals remain committed to the principles of delivering the best in patient care through the use of high-quality data that transforms health and healthcare,” said AHIMA CEO Wylecia Wiggs Harris, PhD, CAE. “HIP Week is an opportunity to celebrate the HIM profession and the dedicated HIM professionals who carry out AHIMA’s mission -- empowering people to impact health.”

Resource: AHIMA.org