Knowledge Base Category -

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.

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.

CMS issued two Transmittals in June detailing updates being made in the Medicare Program Integrity Manual. This article highlights changes to Chapter 3 – Verifying Potential Error and Taking Corrective Actions. A related article in this week’s newsletter highlights changes to Chapter 6 – Medicare Contractor Medical Review Guidelines for Specific Services.

Transmittal 10197 (Change Request (CR) 11730) was issued on June 26, 2020. The purpose of this CR is to clarify CMS’ authority to request and require documentation, upon request, to determine the appropriateness of claims for payment. Changes are being made in the following two sections of Chapter 3:

• Section 3.2.3.2: Time Frames for Submission, and
• Section 3.2.3.8: No Response or Insufficient Response to Additional Documentation Requests (ADRs).

Transmittal Background

Under the General Information section of this Transmittal CMS notes the following:

• There are times when Medicare Contractors (MACs, Comprehensive Error Rate Testing (CERT), Supplemental Medical Review Contractor (SMRC), Recovery Audit Contractor (RACs), Unified Program Integrity Contractors (UPICs), and other contractors may not be able to make a pre- or post- payment determination based on information available on the claim, its attachments, or the billing history when applicable. When this happens a Contractor may require a provider or supplier to submit medical and related supporting documentation to determine payment amounts due. “CMS and its contractors require that sufficient documentation and information be furnished to support that selected claims meet applicable coverage, coding, and billing requirements for payment.”
• When a Medicare Contractor sends a provider an Additional Documentation Request (ADR), they request information be provided within specified time frames. “In cases where no supporting documentation is received to conduct a medical review, the claim shall be denied.”

Section 3.2.3.2: Time - Frames for Submission

Current Manual Guidance: This section applies to MACs, RACs, CERT, and ZPICs as indicated.

Effective July 27, 2020: This section will apply to MACs, RACs, CERT, SMRC, and UPICs, as indicated.

Current Manual Guidance: There is no additional information prior to subsection A.

Effective July 27, 2020: Contractors will be required, “when authoring correspondence related to ADRs, to cite sections 1815(a), 1833(e), and 1862(a)(1)(A) of the Act exclusively when referring to the authority for requiring submission of documentation.

“Contractors are authorized to collect medical documentation by the Social Security Act (the Act).

Section 1815(a) of the Act states that "...no such payments shall be made to any provider unless it has furnished such information as the Secretary may request in order to determine the amounts due such provider under this part for the period with respect to which the amounts are being paid or any prior period."

Section 1833(e) of the Act states that "[n]o payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period." In addition, Contractors are required to ensure that payment is limited to those items and services that are reasonable and necessary.

Section 1862(a)(1)(A) of the Act states that “[n]ot withstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services— which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

Subsection 3.2.3.2.A: Prepayment Review Time Frames

Current Guidance: MACs and ZPICs

• Shall notify providers that documentation requested is to be submitted within 45 calendar days of the request,
• Should not grant an extension to providers who need more time to comply with the request, and
• Shall deny claims for which the requested documentation was not received by day 46.

Effective July 27, 2020: MACs and UPICs

• Shall notify providers “when they expect documentation to be received,”
• Should not grant extension to providers who need more time to comply with the request, and
• Shall deny claims “when” the requested documentation “to support payment is not received by the expected timeframe.”

Subsection 3.2.3.2.B: Post payment Review Time Frames

Current Guidance: MACs, CERT, and RACs, ZPICs

• MAC, CERT, and RACs shall notify providers that documentation requests is to be submitted within 45 calendar days of the request.
• ZPICs requesting documentation shall be within 30 calendar days of the request.
• Since there are no statutory requirements for when post payment reviews are to be completed, “MACs, CERT, and ZPICs have the discretion to grant extensions to providers who need more time to comply with the request. The number of extensions and the number of days for each extension is solely within the discretion of the MACs, CERT and ZPICs. RACs shall follow the time requirements outlined in their SOW.”

 Effective July 27, 2020: MACs, CERT, SMRC, UPICs and RACs

• “Shall notify providers when they expect documentation to be received.”
• “MACs, CERT, SMRC, UPICs and RACs have the discretion to gran extensions to providers who need more time to comply with the request. The MACs, CERT, SMRC, UPICs and RACs shall deny claims when the requested documentation to support payment is not received by the expected timeframe (including any applicable extensions).”

Subsection 3.2.3.8: No Response or Insufficient Response to Additional Documentation Requests

Current Guidance: This section applies to MACs, RACs, CERT, and ZPICs/UPICs, as indicated.

Effective July 27, 2020: This section will apply to MACs, RACs, CERT, SMRC, and UPICS, as indicated.

Subsection 3.2.3.8.A.: Additional Documentation Requests

Current Guidance: Information is to be provided with 45 calendar days for MACs and RACs or 30 calendar days for ZPICs/UPICs after the date of request (or within a reasonable time following an extension). If not received, the contractors “shall deny the claim, in full or in part, as not reasonable and necessary.”

Effective July 27, 2020:

The following sentence has been added to the beginning of this section:

• “The reviewer authority to request that documentation be submitted, to support claims payment, is outlined in Section 3.2.3.2 of this chapter.”

Also, specific calendar day timeframes have been replaced with the following:

• “If information is requested from both the billing provider or supplier and/or a third party and no response is received within the expected timeframes (or within a reasonable time following and extension), the MACs, RACs, SMRC, and UPICs shall deny the claim, in full or in part, as not reasonable and necessary.”

MACs will be the contractor responsible for counting denials as automated or non-medical record review.

Subsection 3.2.3.8.B: No Response

During Prepayment Review

Current Guidance: A claim shall be denied by MACs and ZPICs/UPICs if no response is received within 45 calendar days after the date of the ADR.

Effective July 27, 2020: Claims shall be denied by the MACs and UPICs if no response is received within “the expected timeframes.”

During Post-payment Review

Current Guidance:

• For MACs claims will be denied as not reasonable and necessary and count as non-medical record reviews if no response is received within 45 calendar days after the date or the ADR (or extension).
• ZPICs/UPICs shall deny the claim if not response is received within 30 calendar days.
• RACs shall count these as complex or non-complex reviews.

Effective July 27, 2020

• MACs, RACs, UPICs and SMRC shall deny claims as not reasonable and necessary if no response is received within the expected timeframes (or extension).
• “These contractors shall cite sections 1815(a), 1833(e), and 1862(a)(1)(A) of the Act exclusively when referring to the authority for requiring submission of documentation, when denying claims for no response within the expected timeframes.”
• The MACs shall count these denials as non-medical record reviews.

Subsection 3.2.3.8.C.: Insufficient Response

The only change made to this section is that the SMRC has been added to the list of applicable contractors.

Moving forward, closely monitor ADR requests to ensure you provide documentation with “expected timeframes.”

In June, CMS issued Transmittal 10184 (Change Request (CR) 11812), providing information about updates being made to the Medicare Program Integrity Manual. Specifically, the Unified Program Integrity Contractors (UPICs) were inserted in several placed in this document. Transmittal specifics will be reviewed later in this article. However, as the UPICs are a recent addition to the acronym soup of Medicare Contractors (i.e., MAC, RAC, CERT, SMRC), I first want to provide you with background information about the UPIC Contractors.

What are the UPICs?

UPICs perform fraud, waste, and abuse detection, deterrence and prevention activities for Medicare and Medicaid claims processed in the United States. Specifically, the UPIC’s perform integrity related activities associated with the following:

• Medicare Part A,
• Medicare Part B,
• Durable Medical Equipment (DME),
• Home Health and Hospice (HH+H), Medicaid, and
• The Medicare-Medicaid data match program (Medi-Medi).

The UPIC contracts operate in five (5) separate geographical jurisdictions in the United States and combine and integrate functions previously performed by the Zone Program Integrity Contractor (ZPIC), Program Safeguard Contractor (PSC) and Medicaid Integrity Contractor (MIC) contracts.

Who Are The UPIC Contractors?

Western Jurisdiction
UPIC Contractor: Qlarant

• Western States: Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington and Wyoming
• Link to website: https://www.qlarant.com

Southwestern Jurisdiction
UPIC Contractor: Qlarant

• Southwestern States: Colorado, New Mexico, Oklahoma, Texas, Arkansas, Louisiana, and Mississippi
• Link to website: https://www.qlarant.com

Mid-Western Jurisdiction
UPIC Contractor: CoventBridge Group

• Midwestern States: Iowa, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Ohio and Wisconsin
• Link to website: https://coventbridge.com/midwest-upic/

Northeastern Jurisdiction
UPIC Contractor: SafeGuard Services LLC (SGS)

• Northeastern States: Maine, Vermont, New Hampshire, Massachusetts, Rhode Island, Connecticut, New Your, Pennsylvania, New Jersey, Delaware, Maryland, and District of Columbia
• Link to website: http://www.safeguard-servicesllc.com

South-Eastern Jurisdiction
UPIC Contractor: SafeGuard Services LLC (SGS)

• South-Eastern States: West Virginia, Virginia, North Carolina, South Carolina, Tennessee, Alabama, Georgia, and Florida
• Link to website: http://www.safeguard-servicesllc.com

UPICs in Action

A June 25, 2019 CMS Blog titled Medicaid Program Integrity: A Shared and Urgent Responsibility highlighted the growth of the Medicaid program from $456 billion in 2013 to an estimated $576 billion in 2016 and with this “growth comes a commensurate and urgent responsibility by CMS on behalf of the American taxpayers to ensure sound stewardship and oversight of our program resources.”

The UPICs were cited in this blog for engaging in the following activity related to Education, Technical Assistance and Collaboration:

• CMS conducts State Program Integrity Reviews to assess the effectiveness of the state's program integrity efforts, including its compliance with federal statutory and regulatory requirements. The reviews also assist in identifying effective state program integrity activities and sharing best practices with other states. As a result of the opioid desk reviews, several states have acknowledged the need to increase their opioid-related audit activity and have engaged with the Unified Program Integrity Contractors (UPICs) to develop projects to address this weakness.

Another example of UPICs in Action is the CMS Victimized Provider Project. This program attempts to validate and remediate a provider’s claims as an identity theft victim. CMS advised providers to do the following if they think their identity has been stolen:

• Contact your UPIC who is the CMS fraud contractor that handles investigations on behalf of Medicare.
• Respond to any inquiry from your UPIC as part of a UPICs investigation is to interview the provider.
• Report any suspected ID theft to the police.

UPIC Actions Shared in the Unified Case Management System

CMS Transmittal 871 was released on March 29, 2019. The purpose of this Change Request (CR 11159) was to add Section 4.12 to Chapter 4 in the Medicare Program Integrity Manual. This new section provides instructions related to the UPIC workload entry and update requirements in the Unified Case Management System (UCM).

The purpose for me sharing this older transmittal with you is to make you aware of how many other Medicare Contractors can and probably are following the efforts of the UPICs. This is important because here at MMP we have found that review target efforts are often duplicated by more than one type of Medicare Contractor (i.e. MACs may select a review target based on SMRC findings).

Section 4.12 indicates that “the Unified Case Management (UCM) System is a national database that the UPICs use to enter and update Medicare and Medicaid fraud, waste, and abuse data analysis projects, leads, and investigations initiated by the UPIC. Additionally, the UCM allows the UPICs to enter and track various administrative actions (i.e., pre or post-payment reviews, payment suspensions, revocations, etc.), requests for assistance (RFAs), and requests for information (RFIs) that are fulfilled by UPICs at the request of law enforcement, CMS, or other stakeholders….The following agencies/organizations currently have access to the UCM:

• UPICs
• National Benefit Integrity Medicare Drug Integrity Contractor (NBI MEDIC)
• Railroad Retirement Board (RRB)
• CMS contractors (FPS, PIMAS, Acumen, IBM)
• MAC Medical Review Units associated with MPIP
• CMS
• FBI
• DOJ
• HHS/OIG
• Other federal and state partners seeking to address program integrity concerns in judicial or state health care programs

All workload received and/or initiated by the UPIC shall be saved in the UCM and shall contain identifying information on the potential subject(s) of a project, lead, investigation, etc., as well as general information on activities performed by the UPIC to substantiate the allegation of potential fraud, waste, or abuse. Investigative workload initiated by the UPIC shall contain a summary of the pertinent information related to any activities and/or resolution, and all fields in the UCM shall be updated with the applicable information as it is received by the UPIC.”

CMS Transmittal 10184: Medicare Program Integrity Manual (PIM) Chapter 6 Updates

Now, back to the CMS Transmittal 10184 issued on June 19, 2020. The purpose of this Change Request (CR 11812) is to update various sections within Chapter 4, 6, and 8 in the Medicare Program Integrity Manual. Today I want to call your attention to the updates in Chapter 6 – Medicare Contractor Medical Review Guidelines for Specific Services.

Prior to this CR, the following sections in chapter 6:

• 2 - Medical Review of Home Health Services,
• 5.2 - Conducting Patient Status Reviews of Claims for Medicare Part A Payment for Inpatient Hospital Admissions,
• 7 - Medical Review of Inpatient Rehabilitation Facility (IRF) Services, and
• 7.1 - Reviewing for Intensive Level of Rehabilitation Therapy Services Requirements)

Applied to the following CMS Contractors:

• Medicare Administrative Contractors (MACs),
• Supplemental Medical Review Contractor (SMRC),
• Recovery Audit Contractors (RACs), and the
• Comprehensive Error Rate Testing (CERT) Contractor.

Effective July 21, 2020, UPICs have been added to the applicable Contractors in each of these sections.

Additionally, the Zone Program Integrity Contractor (ZPIC) has been removed from sections 6.5.6 (Length of Stay Reviews), 6.5.9 (Circumvention of PPS), and 6.6 (Referrals to the Quality Improvement Organization (QIO)) and replaced by the UPIC as to the Contractor a referral would be made to.

UPICs and RACs

The following note can be found on the CMS Approved RAC Topics webpage:

“CMS often receives referrals of potential improper payments from the MACs, UPICs, and Federal investigative agencies (e.g., OIG, DOJ). At CMS discretion, CMS may require the RAC to review claims, based on these referrals. These CMS-Required RAC reviews are conducted outside of the established ADR limits.”

UPICs and the OIG

The OIG added the Item Results of UPICs’ Benefit Integrity Activities to their Work Plan in June 2020 indicating that “the Unified Program Integrity Contractors (UPICs) are the only benefit integrity contractors that safeguard both the Medicare and Medicaid programs from fraud, waste, and abuse. The Medicare and Medicaid programs provide health coverage to more than 100 million Americans. UPICs must effectively detect and deter fraud, waste, and abuse. This study will continue OIG's work examining the results from benefit integrity contractors' identification and investigation of fraud, waste, and abuse. It also will identify any barriers and challenges UPICs have experienced while conducting unified benefit integrity activities across Medicare and Medicaid.”

It remains to be seen how involved in medical review of inpatient hospital claims for Part A payment the UPICs may become. For now, it’s important to simply be aware of the UPICs in case they do send your hospital a medical record request.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from June 30th through July 6th.   

Resource Spotlight This Week: CMS Guidance Regarding Nursing Home and Hospital Visitation

CMS recently posted visitation guidance for hospitals and nursing homes on the CMS Current Emergencies webpage.

Nursing Home Visitation

First, on June 24th CMS posted the FAQ document discussing steps and recommendations for visitation in nursing homes. “Because nursing home residents are especially vulnerable, CMS does not recommend reopening facilities to visitors (except for compassionate care situations) until phase three when:

• There have been no new, nursing home onset COVID-19 cases in the nursing home for 28 days (through phases one and two)
• The nursing home is not experiencing staff shortages
• The nursing home has adequate supplies of personal protective equipment and essential cleaning and disinfection supplies to care for residents
• The nursing home has adequate access to testing for COVID-19
• Referral hospital(s) have bed capacity on wards and intensive care units” 

Hospital Visitation

Two days later on June 26, 2020 CMS released a document regarding hospital visitation during Phase II. CMS notes in the opening paragraph that “Because hospital patients are vulnerable to potential COVID-19 infection, CMS does not recommend completely reopening facilities to visitors until Phase III. However, CMS also recognizes the significant toll of separation of patients from family and other loved ones.

In collaboration with State and local public health authorities, hospitals should develop plans for visitors that both consider patient and public health safety, as well as the emotional and care needs of patients and their families who are facing illness or life-events in separation. As facilities enter Phase II, facilities may consider additional flexibilities so that patients and their families can visit.”

The remainder of this document is in the form of questions and answers related to moving forward with hospital visitation prior to Phase III.

June 25, 2020: AMA Announced New CPT code for COVID-19 Antigen Tests

According to AMA President Susan R. Bailey, M.D. in this AMA announcement, “The new CPT code for antigen testing to detect the coronavirus is the latest in a series of CPT codes developed in rapid response to the pandemic...Moving quickly during this crisis to meet the medical coding needs of the health care industry has enhanced the reporting of innovative tools now available to advance medicine's overarching goals of reducing the COVID-19 disease burden, improving health outcomes and reducing long-term care costs.”

New Category I CPT code:

• 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 (eg, SARS-CoV, SARS-CoV-2 [COVID-19])

You can read the entire Press Release on the AMA website.

June 30, 2020: CDC Updates Training for Healthcare Professionals Webpage

Examples of topics available to Healthcare Professionals on this CDC webpage related to COVID-19 includes:

• Clinical Outreach and Communication Activity (COCA) Calls where you can learn the latest clinical information and guidance about COVID-19. Recent calls address infection control in nursing homes and dental settings, multisystem inflammatory syndrome in children (MIS-C0), and clinical perspective from across the nation’s healthcare systems.
• COVID-19 Prevention in Long-term Care Facilities
• COVID-10 Prevention in Hemodialysis Facilities
• Donning and Doffing PPE
• Optimization Strategies for Healthcare PPE
• COVID-19 in Animals

July 1, 2020: MLN SE20011 Medicare Response to Public Health Emergency on the COVID-19 Revised Again!

MLN article SE2011 is now in its’ ninth iteration. In this latest revision CMS revised the billing instructions for SNF. Changes include instructions to readmit the beneficiary on day 101 to start the Skilled Nursing Facility (SNF) benefit period waiver. All other information remains the same, for now.

July 1, 2020: New Point of Origin Code for Transfer from a Designated Disaster Alternate Care Site

MLN article MM11836 initially released on June 12, 2020 and was updated on July 1, 2020 to reflect an updated Change Request (CR) that changes the implementation date to August 3, 2020. The CR announced a new Point of Origin (PoO) Code “G” to indicate a “Transfer from a Designated Disaster Alternative Care Site (ACS),” due to changes relative to the COVID-19 Public Health Emergency (PHE).

July 2, 2020: New OIG Work Plan Item – Use of Medicare Telehealth Services during COVID-19 Pandemic

Following is the detail regarding the new Use of Telehealth Services during COVID-19 Pandemic Work Plan Item:

• “In response to the coronavirus disease 2019 (COVID-19) pandemic, CMS made a number of changes that allowed Medicare beneficiaries to access a wider range of telehealth services without having to travel to a health care facility. Although these changes are currently temporary, CMS is exploring whether telehealth flexibilities should be extended. These two concurrent reviews will be based on Medicare Parts B and C data and will examine the use of telehealth services in Medicare during the COVID-19 pandemic. The first review will examine the extent to which telehealth services are being used by Medicare beneficiaries, how the use of these services compares to the use of the same services delivered face-to-face, and the different types of providers and beneficiaries using telehealth services. The second review will identify program integrity risks with Medicare telehealth services to ensure their appropriate use and reimbursement during the COVID-19 pandemic.”

There were also several Items related to COVID-19 added to the OIG Work Plan in June:

• A Review of Medicare Data to Understand Hospital Utilization During COVID-19,
• Trend Analysis of Medicare Laboratory Billing for Potential Fraud and Abuse with COVID-19 Add-on Testing,
• Medicaid Telehealth Expansion During COVID-19 Emergency,
• Audit of Foster Care Services During Coronavirus Disease 2019 (COVID-19),
• Meeting the Challenges Presented by COVID-19: Nursing Homes,
• Opioid Treatment Program Challenges During the COVID-19 Pandemic,
• Audit of Nursing Home’ Reporting of COVID-19 Information Under CMS’s New Requirements

July 2, 2020: FDA Warns Consumers about Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

The FDA notes in this Press Announcement that they have seen an increase in hand sanitizer products labeled to contain ethanol (also known as ethyl alcohol) that have tested positive for methanol contamination. “State officials have also reported recent adverse events from adults and children ingesting hand sanitizer products contaminated with methanol, including blindness, hospitalizations and death. The agency continues to warn the public not to use specific products listed here and is communicating with manufacturers and distributors of these dangerous products about recalling them.”

July 5, 2020: CDC Health Advisory: Serious Adverse Health Events Associated with Methanol-based Hand Sanitizers

In the wake of the FDA’s warning to the public, the CDC posted an Official Health Advisory on Sunday July 5th highlighting the FDA’s June 19th warning to not use any hand sanitizer manufactured by “Eskbiochem SA de CV” in Mexico, due to the potential presence of methanol, a “toxic alcohol….which can cause blinding and/or death when absorbed through the skin or when swallowed.” This alert goes on to provide recommendations for Clinical and Public Health Officials as well as the general public.

July 6, 2020: Open Letter to the American Public Urging Simple Steps to Stop the Spread of COVID-19

The American Hospital Association (AHA), American Medical Association (AMA), and the American Nurses Association (ANA) posted an Open Letter to the American Public. This letter opens by noting that “Since the beginning of the COVID-19 pandemic, we have urged the American people to protect themselves, their neighbors and their loved ones amidst the worst global health crisis in generations.”

They drive home the fact that as the country has begun to “reopen” there has been “a dramatic uptick in COVID-19 cases” that is negating hard-won gains during the months of staying at home. According to the CDC as of July 6, 2020 the U.S. has had 2,886,267 total cases and 129,811 deaths. More significantly, from July 5th to July 6th there were 44,361 new cases and 235 deaths reported.

A key message in the letter is the urging for everyone to help stop the spread of the virus following three simple steps known to help:

• Wearing a face mask,
• Maintaining physical distancing, and
• Washing your hands.
  

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from June 18th – 29th.  

Resource Spotlight This Week: CDC Social Media Toolkit

The CDC Social Media Toolkit was created to help localize efforts in responding to the virus that causes COVID-19. The following messages and graphics are available to help in this effort:

• Ensure current, correct messaging from a trusted source,
• Create collateral materials, and
• Share resources.

“All graphics and suggested messages are available for use on social media profiles and web pages.

Within this guide you will find information and suggested messages from our COVID-19 response. For more images and CDC content you can visit our Communication Resources page. All social media content is public domain and free to use by anyone for any purpose without restriction under copyright law. Please remember to use the #COVID19 hashtag when tweeting out any COVID-19 related content.”

June 18, 2020: JAMA Network Article: Disparities in Coronavirus 2019 Reported Incidence, Knowledge, and Behavior Among US Adults

The authors of this JAMA Network article undertook this endeavor “to determine the association of sociodemographic characteristics with reported incidence, knowledge, and behavior regarding COVID-19 among US adults.”

US National Survey Parameters:

• Survey was conducted electronically from March 29 to April 13, 2020,
• Survey “oversampled COVID-19 hotspot areas,” and
• Participant criterion included age ≥ 18 years old and residence in the US.

Researchers found that African American participants, men, and people younger than 55 years showed less COVID-19-related knowledge than other groups. Survey results detailed in this article also provides insight into the probability of having COVID-19 or knowing someone who does, knowledge about the spread of and symptoms of COVID-19, and factors associated with hand washing and leaving the house.

June 19, 2020: MLN MM11742 Long Term Hospital (LTCH) Prospective Payment System (PPS) Fiscal Year (FY) 2020 Pricer Revised

MLN article MM11742 was revised to reflect a revised Change Request (CR) 11742 also issued on June 19th. CMS made the following revisions to CR 11742:

• Revise the COVID-19 blanket waiver for the LTCH ALOS policy,
• To include revising the effective date and policy section, and
• Revise the CR release date, transmittal number, and web address of the CR.

June 19, 2020: American Hospital Association (AHA) urges HHS to extend Public Health Emergency (PHE)

In a letter to the Secretary of Health and Human Services (HHS), AHA President and Chief Executive Officer, Richard J. Pollack urged “to extend the public health emergency beyond its current July 25, 2020 expiration date so health care providers can continue to offer the most efficient and effective care possible during the continuing COVID-19 pandemic.” Mr. Pollack urged for the continuance of the PHE until four criteria outlined in the letter are met.

June 22, 2020: CMS Press Release: Call to Action Based on New Data Detailing COVID-19 Impacts on Medicare Beneficiaries

In a June 22nd Press Release, CMS is calling for a renewed commitment to value-based care based on Medicare claims data providing an early look at the impact of COVID-19 on the Medicare population. The initial data reflects claims with a COVID-19 diagnosis (B97.29 from 1/1/2020 – 3/31/2020) and U07.1 (starting 4/1/2020) billed in any of the 25 diagnosis code fields on the claim or encounter record with a date of service from January 1st through May 16, 2020. Data is broken down by Medicare beneficiaries’ state, race/ethnicity, age, gender, dual eligibility for Medicare and Medicaid, and urban/rural locations. Moving forward, CMS indicates that this data will be updated monthly.

“The data shows that older Americans and those with chronic health conditions are at the highest risk for COVID-19 and confirms long-understood disparities in health outcomes for racial and ethnic minority groups and among low-income populations.” This Press Release includes a link to more information on the Medicare COVID-19 data, an FAQ document related to the data release, and a blog by CMS Administrator Seema Verma.

June 25, 2020: Changes to Staffing Information and Quality Measures Posted on the Nursing Home Compare Website and Five Star Quality Rating System Due to the COVID-19 PHE

CMS announced the following changes in a Memorandum Summary:

• “Staffing Measures and Ratings Domain: On July 29, 2020, Staffing measures and star ratings will be held constant, and based on data submitted for Calendar Quarter 4 2019.
• Also, CMS is ending the waiver of the requirement for nursing homes to submit staffing data through the Payroll-Based Journal System. Nursing homes must submit data for Calendar Quarter 2 by August 14, 2020.
• Quality Measures: On July 29, 2020, quality measures based on a data collection period ending December 31, 2019 will be held constant.”

June 25, 2020: CDC Revises Who is at Risk for Severe Illness from COVID-19

On June 25th, the CDC made revisions to the list of people at increased risk of severe illness from COVID-19. They noted that revisions were made to reflect data available as of May 29, 2020, and as new information becomes available, they will again update the information.

With this update comes several changes to the list of conditions. Prior to this update the CDC had indicated that “older adults and people of any age who have serious underlying medical conditions might be at higher risk for severe illness from COVID-19:

• People aged 65 years and older,
• People living in a nursing home or long-term care facility,
• Other high-risk conditions include:
• People with chronic lung disease or moderate to severe asthma,
• People who have serious heart conditions,
• People who are immunocompromised including cancer treatment,
• People of any age with severe obesity (Body Mass Index [BMI] >40) or certain underlying medical conditions, particularly if not well controlled, such as those with diabetes, renal failure, or liver disease might also be at risk,
• People who are pregnant should be monitored since they are known to be at risk with severe viral illness, however, to date data on COVID-19 has not shown increased risk,
• Many conditions can cause a person to be immunocompromised, including cancer treatment, bone marrow or organ transplantation, immune deficiencies, poorly controlled HIV or AIDs, and prolonged use of corticosteroids and other immune weakening medications.

The June 25th revisions indicate that people of any age with the following conditions are at increased risk of severe illness from COVID-19:

• Chronic Kidney Disease,
• Chronic Obstructive Pulmonary Disease,
• Immunocompromised state (weakened immune system) from solid organ transplant,
• Obesity (body mass index {BMI} of 30 or higher),
• Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies,
• Sickle cell disease,
• Type 2 Diabetes, and
• Children who are medically complex, who have neurologic, genetic, metabolic conditions, or who have congenital heart disease are at higher risk for severe illness from COVID-19 than other children.

June 26, 2020: Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on COVID-19 MLN Article Revised Again

MLN Article SE20011 initially released on March 16, 2020 has been updated twice in the past week and is now in its eight iteration. First, on June 19th, a revision added the section, “Medicare Coverage of COVID-19 Testing for Nursing Home Residents and Patients.” Following is an excerpt from the information added to this MLN article:

“Starting on July 6, 2020, and for the duration of the public health emergency, consistent with sections listed below of CDC guidelines titled, “Interim SARS-CoV-2 Testing Guidelines for Nursing Home Residents and Healthcare Personnel,” Original Medicare and Medicare Advantage plans will cover diagnostic COVID-19 lab tests and non-cover tests not considered diagnostic.

• Viral Testing of Residents for SARS-CoV-2
• Initial Viral Testing in Response to an Outbreak
• Recommended testing to determine resolution of infection with SARS-CoV-2
• Public health surveillance for SARS-CoV-2

Tests that are considered non-diagnostic are not covered.”

This article was again updated on June 26th to add a section titled Skilled Nursing Facility (SNF) Benefit Period Waiver – Provider Information and Billing Instruction. In this update CMS provides examples of when to document on the claims that a patient meets the requirement SNF requirement waiver.

June 28, 2020: CDC Updates Considerations for Wearing Cloth Face Coverings

On June 28th the CDC updated this webpage and is recommending people wear cloth face coverings in public settings and when around people outside of their household, especially when other social distancing measures are difficult to maintain. You will find information about the following on this webpage:

• Evidence for effectiveness of cloth face coverings,
• Who should wear a cloth face covering,
• Who should not wear a cloth face covering,
• Feasibility and Adaptations,
• Face shields,
• Surgical Masks, and
• Links to recent studies.

June 29, 2020: New Supplies of Remdesivir for the United States

The Department of Health and Human Services (HHS) announced an agreement to secure more than 500, 000 treatment courses of Remdesivir for the US from Gilead Sciences through September. Per the announcement “hospitals will receive the product shipped by AmerisourceBergen and will pay no more than Gilead’s Wholesale Acquisition Price (WAC), which amounts to approximately $3,200 per treatment course.”

Daniel O’Day, Chairman and CEO of Gilead Sciences indicated in a related Open Letter that normal pricing of a medicine is according to the value provided and cites an approximately $12,000 hospital savings per patient. He went on to indicate that “We have decided to price remdesivir well below this value. To ensure broad and equitable access at a time of urgent global need, we have set a price for governments of developed countries of $390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient.”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from June 8th – June 15th

Weekly COVID-19 Resource Spotlight: CDC Communication Toolkit for Migrants, Refugees, and Other Limited-English-Proficient Populations

According to the CDC, the Toolkit Communication Toolkit was created to help public health professionals, health departments, community organizations, and healthcare systems and providers reach populations who may need COVID-19 prevention messaging in their native languages. Currently there are materials available in 28 languages ranging from Amharic to Vietnamese. The toolkit provides:

• Current messaging from a trusted source.
• Information in plain language available for downloading and sharing.
• Translated materials to help communities disseminate messages to a wider audience.

June 8, 2020: Addressing the Disparate Impact of COVID-19 on African Americans and Other Racial and Ethnic Minorities.

This HHS Office of Civil Rights Fact Sheet details initiatives underway to address the disparate impact of COVID-19 on African Americans and other racial and ethnic minorities. A link to this document as well as other COVID-19 Announcements can be found on the HHS Civil Rights and COVID-19 webpage.

June 8, 2020: New FDA Webpages: Innovation to Respond to COVID-19 and Education Resources

In their June 8th COVID-19 Update: Daily Roundup, the FDA announced that they had published two new web pages to help the public access information:

• Innovation to Respond to COVID-19 provides an overview of FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible, and
• Educational Resources provides links to FDA-produced COVID-19-related resources that help explain FDA’s work.

June 9, 2020: CMS Recommendations for Re-Opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare and a Guide for Patients as they consider In-Person Care Options

As the country moves towards “re-opening our towns” CMS has provided two documents for consideration during this transition. First is a guide for patients and beneficiaries as they consider “in-person” care options. Recommendations for the following topics can be found in this guide:

• Do Not Postpone Necessary Care.
• Is It Safe to Go to your Doctor or Hospital?
• Consider Telehealth or Virtual Visits.
• What to Expect when you Seek Healthcare.
• Should I get tested for COVID-19 before seeking healthcare?
• Vulnerable Populations: When Possible, Stay Home.

This new guide is available in English and Spanish.

Second, is CMS’ document providing recommendations for re-opening facilities to provide non-emergent, Non-COVID-19 healthcare. The recommendations are intended for states or regions who have determined with their public health officials that they have passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, proceeded to Phase I, and are now ready for Phase II of re-opening. In this document, CMS recommends:

• Optimization of telehealth services, when available and appropriate, to minimize the need for in-person services.
• All individuals at higher risk for severe COVID-19 illness should continue to shelter in place unless an in-person healthcare visit is warranted.
• The phased recommendations in this document “may guide healthcare systems, providers, and facilities as they consider delivering in-person care to non-COVID-19 patients in regions with lower or declining-without-rebound, levels of COVID-19.”

You can read more in a June 9th Press Release that includes links to both of these documents.

June 10, 2020: COVID-19 FAQs for Non Long-Term Care Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IIDs)

CMS released this FAQ Document on June 10th and indicates that “The purpose of this FAQs document is to clarify existing guidance and flexibilities and provide stakeholders with additional information based on questions received regarding the following entities:

• Ambulatory Surgical Centers (ASCs)
• Hospitals & Critical Access Hospitals (CAHs)
• Hospice
• Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID)
• Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs).”

June 10, 2020: Using Telehealth to Expand Access to Essential Health Services during the COVID-19 Pandemic

The CDC has created a webpage dedicated to the use of telehealth. Their purpose in providing this guidance is “to describe the landscape of telehealth services and provide considerations for healthcare systems, practices, and providers using telehealth services to provide virtual care during and beyond the COVID-19 pandemic. As of June 10th, you will find the following on this webpage:

• Telehealth background,
• Telehealth modalities,
• Benefits and Potential Uses for Telehealth,
• Strategies to Increase Telehealth Update,
• Telehealth Reimbursement,
• Safeguards for Telehealth Services,
• Potential Limitations of Telehealth, and

June 12, 2020: CMS One-Time Notification: New Point of Origin Code for Transfer from a Designated Disaster Alternate Care Site

This Change Request (CR) 11836 implements a new Point of Origin (PoO) Code “G” to indicate a “Transfer from a Designated Disease Alternative Care Site (ACS),” due to changes relative to the COVID-19 Public Health Emergency.

“Background: The National Uniform Billing Committee (NUBC) practice is to align Discharge Status Codes and Point of Origin (PoO) Codes whenever possible. It came to the Committee's attention that there is a Discharge Status Code for Alternate Care Sites (ACS) but no specific matching PoO Code. Relative to the COVID-19 Public Health Emergency, NUBC created a new Point of Origin (PoO) Code "G" to be effective 07/01/2020, and defined as "Transfer From a Designated Disaster Alternate Care Site."

June 12, 2020: OCR Issues Guidance on HIPAA and Contacting Former COVID-19 Patients about Blood and Plasma Donation

The OCR has released a document answering the question of whether or not covered healthcare providers are permitted to use protected health information (PHI) to identify and contact patients who have recovered from COVID-19 to provide them with information about donating blood and plasma that could help other COVID-19 patients. The short answer is yes. As the late Andy Rooney would say, you can find the entire two page document for “the rest of the story” on the HHS.gov HIPAA and COVID-19 webpage.

June 13, 2020: HHS Awards $15 Million to Support Telehealth Providers During the COVID-19 Pandemic

The Department of Health and Human Services (HHS) announced that they have awarded $15 million to 159 organizations across five health workforce programs to increase telehealth capabilities in response to the COVID-19 pandemic. These awards are funded through the Coronavirus Aid, Relief and Economic Security (CARES) Act.

HHS indicated in the announcement that “these investments will train students, physicians, nurses, physician assistants, allied health and other high-demand professionals in telehealth. This will enable these professionals to maximize telehealth for COVID-19 referrals for screening and testing, case management, outpatient care, and other essential care during the crisis.”

This announcement provides a link to the complete list of award recipients.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from June 1st through June 8th.

Resource Spotlight This Week:

As our nation works to “re-open” and move forward towards a “new normal,” it is important to understand Policy Actions in your state and states you may be traveling to. This week’s spotlight resource can help provide that information. On June 3rd the Kaiser Family Foundation (KFF) published the State Data and Policy Actions to Address Coronavirus. Following is a list of key information that is available on this webpage:

• COVID-19: Confirmed cases & Deaths by State,
• State Social Distancing Actions,
• State COVID-19 Health Policy Actions,
• State Actions on Telehealth,
• State Reports of Long-Term Care Facility Cases and Deaths Related to COVID-19 (as of May 28, 2020),
• Guidance for Long-Term Care Facilities Related to COVID-19 (as of May 7, 2020),
• Adults at Higher Risk of Serious Illness if Infected with Coronavirus,
• Medicaid Expansion Status and Health Insurance Coverage,
• Private Insurance Deductibles and Self-Insured Plans,
• Health Care Provider Capacity, and
• Influenza and Pneumonia Deaths and Vaccinations

This publication was authored by Jennifer Tolbert, Cornelia Hall, Kendral Orgera, Natalie Singer, Salem Mengisut, and Marina Tian.

June 1, 2020: Nursing Home COVID-19 Data and Inspection Results leads to Enhanced Enforcement Actions

In a June 1st Press Release, the CMS announced enhanced enforcement directed towards nursing homes with violations of longstanding infection control practices.

A couple of key points in a related State Survey Memo summary are as follows:

• “Following the March 6, 2020 survey prioritization, CMS has relied on State Survey Agencies to perform Focused Infection Control surveys of nursing homes across the country. We are now initiating a performance-based funding requirement tied to the Coronavirus Aid, Relief and Economic Security (CARES) Act supplemental grants for State Survey Agencies. Further, we are providing guidance for the limited resumption of routine survey activities.
• CMS is also enhancing the penalties for noncompliance with infection control to provide greater accountability and consequence for failures to meet these basic requirements... The enhanced enforcement actions are more significant for nursing homes with a history of past infection control deficiencies, or that cause actual harm to residents or Immediate Jeopardy.”

CMS also provided link to the following information in the Press Release:

• Letter to the Governors (PDF)
• State breakdown of the Nursing Home COVID-19 data (PDF).

June 3, 2020: CMS Innovation Center Models COVID-19 Related Flexibilities

CMS posted an announcement on the CMS Innovation Center COVID-19 Flexibilities webpage regarding flexibilities being made to several CMS Innovation Center Value-Based Payment Models in response to COVID-19. For example, the Comprehensive Care for Joint Replacement (CJR) Model performance year 5 has been extended through March 2021.

In a news blog CMS indicated the Innovation Center will work “directly with model participants on the specific model changes and the processes for implanting them. CMS will also continue to review the data from our models during this COVID-19 pandemic, to identify short-term and long-term lessons learned.”

June 4, 2020: PEPPER Q1 FY 2020 Release Delayed

The PEPPER Team sent out a notice alerting providers that in keeping with the CMS effort to take measures to free up the attention of providers during the COVID-19 pandemic, the release of the Q1FY20 PEPPER for short-term (ST) acute care hospitals has been delayed. When information becomes available, the PEPPER Team will notify providers about the rescheduled release date.

June 4, 2020: FDA Video – Explaining Different Categories of Tests in Fight against COVID-19

The FDA has released a new video to provide information about the diagnostic tests and antibody tests used in the fight against COVID-19.

June 4, 2020: OCR Alert: HHS Awards More than a Half Billion Dollars to Help Vulnerable and Underserved Communities Gain Access to COVID-19 Testing

The OCR indicates in this alert that they are “sharing this update to promote awareness about COVID-19 testing and testing-related availability to people who are geographically isolated, economically disadvantaged, or medically vulnerable, including people with HIV, pregnant women, people experiencing homelessness, agricultural workers, residents of public housing, older persons and our nation’s veterans.

‎In case you missed it: On ‎May ‎7, ‎2020, the U.S. Department of Health and Human Services, through the Health Resources and Services Administration (HRSA), awarded nearly $583 million to 1,385 HRSA-funded health centers in all 50 states, the District of Columbia, and eight U.S. territories to expand COVID-19 testing. Nearly 88 percent of HRSA-funded health centers report testing patients, with more than 65 percent offering walk-up or drive-up testing. Health centers are currently providing more than 100,000 weekly COVID-19 tests in their local communities.

This Alert provided the following links:

• The Full Press Release may be found on HHS’s website here.
• For a list of award recipients, visit https://bphc.hrsa.gov/emergency-response/expanding-capacity-coronavirus-testing-FY2020-awards. 
• To learn more about health center capacity and the impact of COVID-19 on health center operations, patients and staff, visit https://bphc.hrsa.gov/emergency-response/coronavirus-health-center-data.
• For more information about COVID-19, visit http://coronavirus.gov
• For more information about COVID-19 and civil rights, visit https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/index.html

June 4, 2020: CMS News Alert – Nursing Home COVID-19 Data and Inspection Results Available on Nursing Home Compare

CMS announced in a June 4, 2020 Press Release that they are posting the first set of underlying COVID-19 nursing home data as well as posting results from targeted inspections announced on March 4, 2020 that allowed inspectors to focus on the most serious health and safety threats like infectious disease and abuse during the pandemic.

COVID-19 Nursing Home Data

As of May 31, 2020

• About 13,600 (approximately 88%) of Medicare and Medicaid Nursing Homes had reported the required data to the CDC.
• These facilities reported 95,000 confirmed COVID-19 cases and almost 32,000 deaths.

The CMS announced the next set of data will be released in two weeks and then plans to update the data weekly.

June 4, 2020: New Laboratory Data Reporting Guidance for COVID-19 Testing

The U.S. Department of Health and Human Services (HHS) announced new guidance specifying what additional data must be reported to HHS by laboratories along with COVID-19 test results. “The requirement to include demographic data like race, ethnicity, age, and sex will enable us to ensure that all groups have equitable access to testing, and allow us to accurately determine the burden of infection on vulnerable groups,” said ADM Brett P. Giroir, MD, Assistant Secretary for Health. “With these data we will be able to improve decision-making and better prevent or mitigate further illnesses among Americans.”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from May 26th – June 1st 2020.   

Resource Spotlight This Week:

This week’s spotlight is the CDC’s CDC COVID Data Tracker. The Data Tracker includes maps, charts, and data on the following:

• S. Cases of COVID-19,
• S. COVID Testing,
• S. Forecasting,
• S. Trends,
• S. Cases and Deaths by County,
• Social Impact,
• School Closures, Mobility, and
• A “Learn More” tab covering topics ranging from COVID-19 FAQs and hospitalization rates to information on the use of cloth face coverings to daily life and coping.

May 26, 2020: Fact Sheet for State and Local Governments – CMS Programs & Payment for Care in Hospital Alternate Care Sites (ACS)

In order to expand capacity to care for patients during the COVID-19 Public Health Emergency (PHE) alternate care sites are being developed. CMS indicates that the purpose of this Fact Sheet is to provide “state and local governments developing alternate care sites with information on how to seek payments through CMS programs – Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) – for acute inpatient and outpatient care furnished at the site.”

May 27, 2020: The Joint Commission to Resume some Survey and Review Activities in June

The Joint Commission announced in their Wednesday May 27 Edition of Joint Commission Online that they are “committed to working closely with organizations, with safety being the first and foremost priority. As we start to resume some of these survey and review activities, account executives will begin to contact organizations due for a survey to assess the impact that the coronavirus pandemic had on their operations and their current state.”

They go on to note “our survey will focus on a thorough assessment but will not retroactively review compliance…rather, we will work to understand how you have adapted to the pandemic and review your current practices to assure you are providing safe care and working in a safe environment.”

May 27, 2020: COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing

CMS has once again updated this now seventy-one page FAQ document. In addition to now containing a table of contents, new FAQS have been posted for the following topics:

• Hospital IPPS Payments under the CARES Act,
• Expansion of Virtual Communication Services for FQHCs/RHCs,
• Medicare telehealth,
• General Billing Requirements, specifically related to COVID-19 testing administered prior to and in association with a procedure.

Also, the following three new sections have been added to this document:

• Diagnosis Coding under ICD-10-CM,
• Chronic Care Management Services, and
• Outpatient Therapy Services

May 29, 2020: Alabama Medicaid Alert: Additional Laboratory Testing for COVID-19

Alabama Medicaid announced in a May 29th Alert that Providers may begin submitting claims on June 1, 2020, for dates of service on or after April 1, 2020 for the following testing procedure codes:

• 86328 Immunoassay for infectious agent antibody (ies), qualitative or semi quantitative, single step method (e.g., reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]).
• 86769 Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]).

June 1, 2020: CDC Updates COVID-19 Transmission Webpage to Clarify Information about Types of Spread

The CDC announced in an email update that “after media reports appeared that suggested a change in CDC’s view on transmissibility, it became clear that these edits were confusion. Therefore, CDC has once again edited the page to provide clarity. 

The primary and most important mode of transmission for COVID-19 is through close contact from person-to-person. Based on data from lab studies on COVID-19 and what we know about similar respiratory diseases, it may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this isn’t thought to be the main way the virus spreads.” This page also includes a link to a video titled “How does COVID-19 Spread?”

June 1, 2020: Medicare Fee-for-Service Response to the Public Emergency on COVID-19 MLN Article Revised

CMS revised MLN SE20011 on June 1st to add a section on Clarifications for using the “CR” Modifier and “DR” Condition Code. All other information remained the same.

• MLN SE20011: https://www.cms.gov/files/document/se20011.pdf