Knowledge Base Category -

On January 19, 2021, CMS at long last published a Final Decision Memo (CAG-00438R) for Transcatheter Mitral Valve Repair (TMVR). The proposed decision memo was a departure from the current TMVR National Coverage Determination (NCD) 20.33. Similarly, the final decision memo is a significant departure from what was proposed.

Background: From TMVR to TEER

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

NCD 20.33 established coverage for the treatment of significant symptomatic Primary MR. CMS’ national tracking analysis focused on TMVR for the treatment of significant symptomatic Secondary MR.

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

In review, what was proposed?

• A document title change from TMVR to Transcatheter Edge-to-Edge Repair (TEER) for mitral regurgitation.
• A covered indication away from coverage for DMR to treatment for FMR.
• A proposal to remove the Coverage with Evidence Development (CED) requirement in NCD 20.33.
• A patient continuing to be symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) and also requiring a patient to meet several new approved FDA criteria (i.e. LVED 20% to 50%, and New York Heart Association (NYHA) Class II, III, or Iva (ambulatory)).
• 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.”
• A detailed list of members to be included in the Heart Team that a patient is to be under the care of during the perioperative period.
• In NCD 20.33 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 proposed “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.”
• CMS supporting a Shared Decision Making (SDM) discussion between the physician and the patient. At the same time, acknowledging that there is no fully developed tool for SDM for TEER at this time.
• Optimal Patient Selection for TEER: CMS acknowledged in the proposed decision memo 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.
• 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.”
• A more extensive list of nationally non-covered indications for this procedure than the current NCD.

 

January 19, 2021 Final Decision Memo for TEER

What was finalized?

• A document title change from TMVR to Transcatheter Edge-to-Edge Repair (TEER) for mitral regurgitation.
• A covered indication for DMR and FMR.
• Continued coverage of this procedure under Coverage with Evidence Development (CED).
• Coverage for a symptomatic moderate-to-severe or severe functional MR (FMR) patient when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) plus cardiac resynchronization therapy if applicable, or treatment for significant symptomatic degenerative MR (DMR) when furnished according to an FDA-approved indication.
• A heart team to include a cardiac surgeon, interventional cardiologist, interventional echocardiographer (cardiologist or anesthesiologist), heart failure cardiologist, and other providers from physician groups as well as advanced patient populations, nurses, research personnel and administration.
• One set of appropriate volume requirements to begin and maintain a mitral valve TEER program.
• CMS continuing to support a Shared Decision Making (SDM) discussion between the physician and the patient.
• Face-to-Face Exam requirements dependent on whether treatment is for FMR or DMR.
• Two indications for CMS non-covering this procedure
• For patients in whom existing co-morbidities would preclude the expected benefit from a mitral valve TEER procedure, and
• In patients with untreated severe aortic stenosis.

 

Final Decision Memo: CMS’ Response to Comments

CMS received 296 comments from 292 separate commenters during the second comment period. They organized comments and their responses into similar topic sections. I have found that taking the time to read comments from the health care community and CMS responses can provide insight into the why and how coverage determinations change or don’t change. Following are key highlights from several of the section types in the final decision memo:  

Timeline for Decision
In response to a commenters concern with the time elapsed between the FDA’s approval for TEER in functional mitral regurgitation patients and the finalized NCD, CMS acknowledged “the delayed publication of this final NCD.  CMS always aims to expeditiously complete rigorous national coverage analyses (NCAs) within statutory timeframes.  2020 was particularly challenging due to the COVID public health emergency.”

NCD Name Change and Scope

“Comment: One commenter recommended that CMS more clearly define technical features of therapies and their anatomical placement that will or will not fall within the parameters of the NCD.  Another commenter requested that TEER be clearly defined, and if it does not include the CARILLON system, a more inclusive term be used that does. 

Response:  This NCD addresses transcatheter edge-to-edge repair (TEER) of the mitral valve, which includes transcatheter devices that approximate the mitral leaflet edges by grasping the anterior and posterior mitral valve leaflets in a fashion analogous to a surgical Alfieri repair.  It does not include other potential transcatheter approaches, for example those that modify or supplement the mitral valve annulus or the chordal apparatus.  This NCD does not address transcatheter mitral valve replacement.”

Coverage with Evidence Development
Commenters overwhelmingly supported the application of coverage with evidence development (CED) for TEER and provided detailed reasons for their support.

“Response:  CMS appreciates these comments and has revised this NCD to cover TEER under CED for both DMR and FMR.  After careful review of the evidence, and consideration of the numerous public comments supportive of CED, CMS agrees with the consensus of the experts, including all of the professional societies and organizations that commented.  There are important evidence gaps that remain for both DMR and FMR and CED is the best path to address those.  It also permits more robust coverage than what we proposed. CMS also acknowledges that while DMR and FMR are important concepts, an important proportion of patients may have mixed degenerative and functional MR.  Furthermore, we believe that CED for both DMR and FMR better preserves the reliability of data submitted through registries and avoids potential reporting bias.”

 

Covered Indications

“Comment: Nine commenters disagreed with requiring the local heart team to determine that mitral valve surgery will not be offered as a treatment option because mitral valve surgery is not a treatment option for most FMR patients.  One commenter further asserted that this requirement unfairly favors surgical mitral valve replacement / repair (which has a lower level of evidence) over TEER (which has a higher level of evidence).

Response:  CMS appreciates these comments.  The COAPT study where benefit was demonstrated for FMR required that a cardiac surgeon determine that mitral valve surgery would not be offered as a treatment option.  However, CMS will finalize the TEER NCD under CED to the FDA labelling.  The CED paradigm allows coverage where evidence is promising but does not yet fully assess the appropriateness of TEER, which is a key element of meeting the reasonable and necessary standard, by conditioning coverage on further evidence development.  Consequently, CMS will remove the requirement that a cardiac surgeon examine the patient and determine that they are ineligible for mitral valve surgery.”

 

Non-Covered Indications

CMS Response to comments: “CMS appreciates these comments.  The COAPT study that demonstrated benefit for FMR included a broad range of specific inclusion and exclusion criteria.  By contrast, the MITRA-FR study, where inclusion and exclusion criteria were less stringent, did not demonstrate that TEER confers a benefit to patients with moderate to severe or severe FMR.  CMS is finalizing the TEER NCD with CED to the FDA labelling. 

Further evidence is needed to assess why the COAPT and MITRA-FR studies reached markedly different conclusions about the benefits of TEER in FMR.  The CED paradigm allows coverage where evidence is promising but does not yet fully assess the appropriateness of TEER, which is a key element of meeting the reasonable and necessary standard, by conditioning coverage on further evidence development.  In the context of CED, CMS will cover TEER to the FDA labelling. However, the presence of severe aortic stenosis may worsen heart failure symptoms and may substantially increase MR severity.58-60 Therefore, we are clarifying that TEER is non-covered in patients with untreated severe aortic stenosis because intervention to the mitral valve may be unnecessary after the aortic stenosis is addressed.”

 

Patient Evaluation

CMS received several commenters regarding who should evaluate a patient’s suitability for this procedure when the patient has functional mitral regurgitation.

“Response:  CMS appreciates these comments.  CMS has removed the requirement that a cardiac surgeon examine FMR patients to determine that they are ineligible for mitral valve surgery.  CMS agrees that for FMR, cardiac surgery is not generally the standard of care and requiring this consultation would present an undue burden; instead, optimization of GDMT with cardiac resynchronization therapy, if appropriate, is essential.  Therefore, for FMR, CMS is requiring that a cardiologist experienced in treating patients with advanced heart failure must independently examine the patient face-to-face. CMS recognizes that cardiologists may have extensive experience with advanced heart failure without being board eligible/board certified and that a board eligible/board certified Advanced Heart Failure/Transplant cardiologist is not available in some communities. Nonetheless, whenever possible, the heart failure cardiologist should be board certified in Advanced Heart Failure/Transplant.  For DMR, CMS continues to require that a cardiac surgeon independently examine the patient face-to-face because surgery is generally the standard of care.  CMS supports the concept of shared decision-making for all TEER patients.  Regarding the use of telehealth, CMS notes that this final NCD does not change telehealth rules and any services eligible to be furnished via telehealth under existing telehealth rules are allowable under this policy.”

 

Heart Team

CMS provided the following responses to comments about the composition of the heart team:

“Response: CMS believes the heart team must be comprised of multiple practitioners with the expertise to optimally treat patients with DMR and FMR.  CMS has determined that the heart team must be comprised of an interventional cardiologist, a cardiac surgeon, an interventional echocardiographer, a heart failure cardiologist with experience treating patients with advanced heart failure (for FMR patients only) and other providers from other specialty areas as appropriate, along with advanced patient practitioners, nurses, research personnel, and administrators.”

“Response:  This final NCD addresses both DMR and FMR and does not include a requirement for the cardiac surgeon to examine the patient face-to-face for FMR. However, the final NCD does require the cardiac surgeon to examine DMR patients face-to-face. CMS agrees that it is important to have the cardiac surgeon perspective on the heart team.”

“Response:  CMS has finalized the requirement for a cardiologist experienced in treating patients with advanced heart failure (the heart failure cardiologist) be included on the heart team specifically for patients with FMR.  For FMR, discrepancies in the outcomes achieved in the COAPT and MITRA-FR studies that included patients with ostensibly similar patient characteristics demonstrates clearly the critical role of patient selection and of reaching maximally tolerated GDMT prior to pursuing TEER.  CMS agrees with specialty societies and the FDA that optimization of GDMT is essential for achieving good patient outcomes, and therefore, CMS is requiring that the heart team heart failure cardiologist experienced in treating patients with advanced heart failure evaluate TEER candidates with FMR.  There is no requirement that patients with DMR be evaluated by the heart team heart failure cardiologist.  Because this NCD represents an expansion of coverage to FMR, CMS disagrees that a requirement for the heart team heart failure cardiologist to appropriately evaluate FMR patients for maximal GDMT will shut down TEER programs.”

“Response:  CMS agrees that the interventional echocardiographer is an important member of the heart team and is critical during TEER procedures.  We have more completely specified the role of the interventional echocardiographer in TEER procedures in the final NCD.”

 

General Volume Requirements

One “commenter asserted that there should be a common standard to begin or maintain a TEER program and that it should not change from the existing TMVR NCD.”

“Response: We agree.  Based on the comments and finalizing this decision as CED, we have finalized a common standard for all TEER programs under this NCD.  Further, we have reduced the cardiac surgical volume for hospitals to ≥ 20 per year which is half of what we proposed.  These final volume requirements reflect elements of the Expert Consensus document, our review of currently available clinical evidence, and our efforts to align with the TAVR NCD volume requirements for consistency across valve programs that perform both TEER and TAVR.

We note that evidence supports an association between procedural volumes and improved outcomes for both cardiac surgery and TEER, and we agree with the Expert Consensus document that volume requirements are appropriate to ensure good outcomes.  We are finalizing this decision to include CED which requires submission of data to a qualified registry. We believe that these data will assist hospitals in assessing and improving program quality which will be valuable in closely monitoring their TEER programs and ensuring good health outcomes for Medicare patients.”

“Response:  CMS supports the provision of high quality care for our beneficiaries.  Evidence supports an association between procedural volumes and improved outcomes for both cardiac surgery and TEER, and CMS agrees with the Expert Consensus document that volume requirements are appropriate.  Because TEER coverage under CED will require submission of data to a qualified registry, CMS believes that these data will assist hospitals in assessing and improving program quality.  Therefore, CMS is finalizing lower hospital cardiac surgery volume requirements than proposed and applying this requirement for both new and existing programs.  CMS agrees that ensuring patients have appropriate access to TEER is important but also recognizes that having access includes ensuring that patients have good quality care. We believe the reduced hospital surgical volume requirements and other requirements set forth in this final NCD are important to ensure Medicare beneficiaries have access to TEER in programs that deliver high quality care and achieve optimal health outcomes. The final NCD requirements reflect our intent to strike a balance between ensuring hospitals have the experience and capabilities to handle complex structural heart disease cases with an evolving evidence base while also ensuring Medicare beneficiaries have access to needed treatment.”

 

Sunset of TEER CED NCD

“Based on public comments, CMS is aware that stakeholders desire clarity on how long CED will be required for TEER. CMS will consider published, peer-reviewed evidence periodically, following the effective date of this NCD and reconsider the policy when appropriate. The NCD will expire 10 years from the effective date if it is not reconsidered during that time. Upon expiration, coverage will be at the discretion of the MACs.”

 

Moving Forward

Do you know the potential financial impact for non-compliance with the NCD changes? To help find an answer I turned to our sister company, RealTime Medicare Data (RTMD). The following tables highlights  the procedure volumes, charges and payment for the Medicare Fee-for-Service (FFS) population in the RTMD foot print, which currently includes 48 states and DC. Specifically, the tables compare Medicare FFS paid claims for this procedure from January through September of 2018, 2019 and 2020.

 

You will note that the actual paid claims from 2019 to 2020 increased while volumes decreased. I believe the volume decrease is in part due to the COVID-19 pandemic. The increase in payment is likely due to the fact that CMS finalized regrouping this procedure from DRGs 228 and 229 (Other Cardiothoracic Procedures with MCC or without MCC respectively) to DRG 266 and 267 (Endovascular Cardiac Valve Replacement with MCC or without MCC respectively) in the FY 2020 IPPS Final Rule effective October 1, 2019.  The DRG pair 266 and 267 has a higher relative weight and national average reimbursement than the DRG pair 228 and 229.

Also of note, DRGs 228 and 229 are not part of the Transfer DRG List, but DRGs 266 and 267 are both special transfer DRGs.

Not all hospitals provide this and other structural heart procedures. However, if your hospital does MMP strongly encourages you to take the time to read the entire decision memo document and provide education around the changes to all key stakeholders in your facility.

‍

This week we highlight key updates spanning from February 2nd through February 8th, 2021.

Resource Spotlight: CMS Notice – What Partners Need to Know About Medicare Fraud

On February 5th, CMS shared the following information about Medicare Fraud and COVID-19: “As COVID-19 vaccines begin rolling out across the country CMS is taking action to protect the health and safety of our nation’s patients and providers and keeping you updated on the latest COVID-19 resources from HHS, CDC and CMS.

With information coming from many different sources, CMS has compiled resources and materials to help you share important and relevant information on the COVID-19 vaccine with the people that you serve. You can find these and more resources on the COVID-19 Partner Resources Page and the HHS COVID Education Campaign page.

We look forward to partnering with you to promote vaccine safety and encourage our beneficiaries to get vaccinated when they have the opportunity.

COVID-19 Scams

As the country begins to distribute COVID-19 vaccines, scammers are taking advantage of the coronavirus pandemic. The HHS Office of Inspector General alerted the public about COVID-19 fraud schemes, with scammers using telemarketing calls, text messages, social media platforms, and door-to-door visits to perpetrate COVID-19-related scams.

Con artists may also try to get Medicare Numbers or personal information so they can steal identities and commit Medicare fraud. Medicare fraud results in higher health care costs and taxes for everyone. 

What can you do to help prevent Medicare beneficiaries from being a victim of fraud?

Share this important information with Medicare beneficiaries to help them protect themselves from Medicare fraud:  

Medicare covers the COVID-19 vaccine, so there will be no cost to you.  

• You will need to share your Medicare card with your health care provider or pharmacy when receiving your vaccine, even if you’re enrolled in a Medicare Advantage plan.
• If anyone else asks you to share your Medicare Number or pay for access to the vaccine, you can bet it's a scam.
• You can't pay to put your name on a list to get the vaccine.
• You can't pay to get early access to a vaccine.
• Don't share your personal or financial information if someone calls, texts, or emails you promising access to the vaccine for a fee.

Guard your Medicare card like it’s a credit card.

• Medicare will never contact you for your Medicare Number or other personal information unless you’ve given them permission in advance.
• Medicare will never call you to sell you anything.
• You may get calls from people promising you things if you give them a Medicare Number. Don’t do it. 
• Medicare will never visit you at your home.
• Medicare can’t enroll you over the phone unless you called first.  

Learn more tips to help prevent Medicare fraud.

• Learn How to Spot Medicare fraud. Review your Medicare claims and Medicare Summary Notices for any services billed to your Medicare Number you don’t recognize.
• Report anything suspicious to Medicare. If you suspect fraud, call 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048.
• If you need to replace your card because it’s damaged or lost, log into (or create) your secure Medicare account to print an official copy of your Medicare card. You can also use your Medicare account to access your Medicare information anytime, add prescription drugs to help you find and compare health and drug plans in your area, and more. 

 What role can partners play in fighting healthcare fraud, waste and abuse?

• Become a HFPP partner. The Healthcare Fraud Prevention Partnership (HFPP) is a voluntary public-private partnership that helps detect and prevent healthcare fraud through data and information sharing. Partners include federal government, state agencies, law enforcement, private health insurance plans, employer organizations, and healthcare anti-fraud associations.
• By working together, we can be more effective at preventing health care fraud, waste, and abuse. The Healthcare Fraud Prevention Partnership (HFPP) continues to expand nationally by encouraging participation by all eligible public and private health care entities. The insights and input of each member contribute to the overall value of the Partnership.

Questions? Please e-mail us: Partnership@cms.hhs.gov”

 

February 2, 2021: Joint Commission Sentinel Event Alert – Special Pandemic Edition

This Joint Commission newsletter includes information related to:

• What they are hearing from healthcare workers, patients, families, government agencies and more,
• Five ways to support health care workers; and
• Several links to additional resources related to the COVID-19 pandemic developed by the Joint Commission.

 

February 3, 2021: CMS Updates Provider Specific Fact Sheets on Waivers and Flexibilities

CMS updated all of the Provider Specific Fact Sheets on New Waivers and Responsibilities. The Hospitals:   CMS Flexibilities to Fight COVID-19 Fact Sheet, was updated to include information related to coverage of monoclonal antibody therapies and Price Transparency for COVID-19 testing was added.

 

February 4, 2021: FDA Limits Use of Convalescent Plasma

The FDA revised the Letter of Authorization for COVID-19 convalescent plasma. The authorization limits “use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 early in the disease course and to those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response.”

 

February 4, 2021: New COVID-19 Vaccine Coming Soon?

The FDA announced they have scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for February 26, 2021 to discuss Janssen Biotech Inc.’s request for emergency use authorization (EUA) for a COVID-19 vaccine. A meeting agenda and committee roster will be made available to the public no later than two business days prior to the meeting.

 

February 5, 2021: CDC Morbidity and Mortality Weekly Report (MMWR): Decline in COVID-19 Hospitalization Growth Rate Associated with Statewide Mask Mandates

In this CDC MMWR Report, the authors found that from March 22 through October 17, 2020, “10 sites participating in the COVID-19-Associated Hospitalization Surveillance Network in states with statewide mask mandates reports a decline in weekly COVID-19-associated hospitalization growth rates by up to 5.5 percentage points for adults aged 18-64 years after mandate implementation, compared with growth rates during the 4 weeks preceding implementation of the mandate.” The implication for public health practice concluded by the author’s is that “mask-wearing is a component of a multipronged strategy to decrease exposure to and transmission of” COVID-19.

 

February 7, 2021: CDC Tracking COVID-19 Variants

The CDC has created a webpage to report cases of COVID-19 in the U.S. caused by variants. As of February 7, 2021 the CDC is tracking three variants (B.1.17, B.1.351 and P.1). To date B.1.1.7 is the most prevalent variant with 690 reported cases in 33 states. B.1.1.7 is the variant identified in the United Kingdom (UK). This variant was first detected in the US at the end of December 2020 and is noted to spread more easily and quickly than other variants. You can read more about all three variants on the CDC’s New COVID-19 variant webpage.

 

CDC COVID Data Tracker – United States COVID-19 Cases

Resource Spotlight: Reminder – New Requirements for All Air Passengers Arriving in the United States

On January 12, 2021, the CDC announced an order requiring all air passengers arriving to the US from a foreign country to get tested for COVID-19. This order became effective as of 12:01 am EST on January 26, 2021. Specifically, “If you plan to travel internationally, you will need to get tested no more than 3 days before you travel by air into the United States (US) and show your negative result to the airline before you board your flight, or be prepared to show documentation of recovery (proof of a recent positive viral test and a letter from your healthcare provider or a public health official stating that you were cleared to travel).” The CDC has created a webpage specific to this new Order where you will find General FAQs, Passenger specific FAQs, and Aircraft Operators/Airlines/Crew FAQs.

 

January 26, 2021: Import Alert on All Alcohol-Based Hand Sanitizers from Mexico

The FDA announced, in a News Release, that “the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety. Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination.”

 

January 26, 2021: FDA Updates COVID-19 FAQs – Answering Questions About Help Getting a COVID-19 Vaccine

The FDA updated their COVID-19 FAQs webpage with a new FAQ answering the question of whether or not the FDA can help someone get a COVID-19 vaccine. The FDA’s answer is “No. The FDA’s authority includes authorizing or approving COVID-19 vaccines for use in the United States, but the FDA is not responsible for vaccine distribution. Go to the CDC website to find your state and local health departments who are responsible for COVID-19 vaccine distribution. All questions and concerns should be sent to your state government or local health department. The U.S. government’s goal is to have enough COVID-19 vaccine doses for all people in the United States who choose to be vaccinated.

If you are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam. The Federal Trade Commission has easy tips on how to avoid COVID-19 vaccine scams. The FDA encourages you to report a potential COVID-19 drug or medical product scam on our website.”

 

January 28, 2021: Marketplace Special Enrollment Period for COVID-19 Public Health Emergency February 15, 2021 through May 15, 2021

In response to an Executive Order, HHS “announced a Special Enrollment Period (SEP) for individuals and families for Marketplace coverage in response to the COVID-19 Public Health Emergency, which has left millions of Americans facing uncertainty and exceptional circumstances while millions of Americans have experienced new health problems during the pandemic. This SEP will allow individuals and families in states with Marketplaces served by the HealthCare.gov platform to enroll in 2021 health insurance coverage. Beginning February 15, 2021 and through May 15, 2021, these Marketplaces will operationalize functionality to make this SEP available to all Marketplace-eligible consumers who are submitting a new application or updating an existing application. State-based Marketplaces (SBMs) operating their own platform have the opportunity to take similar action within their states.”

 

January 28, 2012: Declaration to Increase Workforce Authorized to Administer COVID-19 Vaccines

HHS has issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to add to the “categories of qualified persons authorized to prescribe, dispense, and administer COVID-19 vaccines authorized by the U.S. Food and Drug Administration.” One new category includes authorizing “any physician, registered nurse, or practical nurse whose license or certification expired within the past five years to prescribe, dispense and/or administer COVID-19 vaccines in any state or U.S. territory so long as the license or certification was active and in good standing prior to the date it went inactive.” The unpublished version of this document is scheduled for publication in the Federal Register on February 2, 2021.

 

January 29, 2021: Alabama Department of Public Health Expands COIVD-19 Vaccination Eligibility

The Alabama Department of Public Health (ADHP) announced that “beginning February 8, people 65 or older and additional groups of critical workers will be eligible to get the vaccine.” Alabama Governor Kay Ivey indicated in the announcement that “We have all been frustrated that the supply of vaccine coming from the federal government hasn’t kept up with the demand…To be blunt, we simply haven’t gotten the vaccine that we’ve been promised, and this has created a major backlog of aggravation. Today’s announcement will ensure that as more vaccine is released, we will have a plan in place to get the vaccine in people’s arms more quickly.” Additional information about the vaccine is available on the ADHP COVID-19 Vaccine webpage. For those in Alabama who are interested in knowing when the vaccine becomes available at your local health department you can sign up for email notification at https://www.alabamapublichealth.gov/notify.

 

February 1, 2021: OIG Adds Audits of Medicare Part B Telehealth Services during the COVID-19 Public Health Emergency to their Work Plan

The OIG has added telehealth to their Work Plan. Following is a detailed description of this planned audit:

“Telehealth is playing an important role during the public health emergency (PHE), and CMS is exploring how telehealth services can be expanded beyond the PHE to provide care for Medicare beneficiaries. Because of telehealth's changing role, we will conduct a series of audits of Medicare Part B telehealth services in two phases. Phase one audits will focus on making an early assessment of whether services such as evaluation and management, opioid use order, end-stage renal disease, and psychotherapy (Work Plan number W-00-21-35801) meet Medicare requirements. Phase two audits will include additional audits of Medicare Part B telehealth services related to distant and originating site locations, virtual check-in services, electronic visits, remote patient monitoring, use of telehealth technology, and annual wellness visits to determine whether Medicare requirements are met.”

 

CDC COVID Data Tracker – United States COVID-19 Cases

This week we highlight key updates spanning from January 19th through January 25th, 2021.

 

Resource Spotlight: Reminder - CDC Clinician Outreach and Communication Activity (COCA) January 28, 2021 Call: Treating Long COVID: Clinician Experience with Post-Acute COVID-19 Care

This call will be Thursday, January 28, 2021 from 2:00PM – 3:00 PM ET. “During this COCA Call, presenters will share their firsthand experiences with treating long COVID, focusing on the pulmonary, neurologic, and psychological aspects. They will also describe their experiences with establishing clinics that provide care for patients with these long-term effects.”

 

January 19, 2021: OCR Announces Enforcement Discretion for Online or Web-Based Scheduling for COVID-19 Vaccinations

In a Press Release, the Office of Civil Rights (OCR) “announced that it will exercise its enforcement discretion and will not impose penalties for violations of the HIPAA Rules on covered health care providers or their business associates in connection with the good faith use of online or web-based scheduling applications (collectively, “WBSAs”) for the scheduling of individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency.  This exercise of enforcement discretion is effective immediately, but has retroactive effect to December 11, 2020.”

 

January 19, 2021: AMA Announces COVID-19 Vaccine CPT Codes Update

The AMA announced the CPT code set is being updated to include new vaccine and administration codes unique to the COVID-19 vaccine in development by Janssen Pharmaceutica, a division of Johnson & Johnson. This code will be effective on the condition that they receive vaccine approval or emergency use authorization from the FDA. Unlike the two vaccines currently being distributed nationwide, the Janssen vaccine is a single-dose COVID-19 vaccine.

 

January 21, 2021: Dr. Anthony S. Fauci Remarks at the World Health Organization Executive Board Meeting

Dr. Fauci, Chief Medical Advisor to the President, spoke during a WHO Executive Board Meeting. During his remarks, Dr. Fauci detailed the U.S. response to COVID-19. He ended with the following statement, “And finally, given that a considerable amount of effort will be required by all of us moving forward, the United States stands ready to work in partnership and solidarity to support the international COVID-19 response, mitigate its impact on the world, strengthen our institutions, advance epidemic preparedness for the future, and improve the health and wellbeing of all people throughout the world.”

 

January 22, 2021: Acute Hospital Care at Home Program Updates

This program expands the CMS Hospital Without Walls initiative launched in March 2020 by “creating additional flexibility that allows for certain health care services to be provided outside of a traditional hospital setting and within a patient’s home.” The list of approved hospitals was updated on January 22nd and now includes 38 systems totaling 92 hospitals in 24 states.

 

January 25, 2021: CDC Updates FAQs about COVID-19 Vaccination

The CDC has posted several different webpages specific to the COVID-19 Vaccine. The FAQs web page contains answers to questions about the vaccine, about getting vaccinated, vaccine distribution, and vaccine safety.

 

CDC COVID Data Tracker – United States COVID-19 Cases

Annually, the Comprehensive Error Rate Testing (CERT) program measures improper payments in the Medicare Fee-For-Service (FFS) program. As shared in a related MMP article, “improper payment rates are not necessarily indicative of or are measures of fraud. Instead, improper payments are payments that did not meet statutory, regulatory, administrative, or other legally applicable requirements and may be overpayments or underpayments.” This article focuses on the trend in common causes of improper payments.  

 

Fiscal Year 2020 Supplemental Improper Payment Data - Common Causes of Improper Payments

The CERT groups improper payments into five categories. The following table compares common causes of improper payments broken out by the type of error for past four years. While Medical Necessity and Incorrect Coding errors are on the decline, there is an increasing trend in the percentage of errors due to insufficient documentation.

Insufficient Documentation

The increase in “insufficient documentation” errors is further evidenced in the 2020 Report, Table D4: Top 20 Service Types with Highest Improper Payments: Part A Hospital IPPS. It should come as no surprise that the DRGs in this table with a high percentage of “insufficient documentation” errors are surgical procedures. Following are DRGs in Table D4 with an Insufficient Documentation error greater than 90%.

 

DRGs 266 & 267: Endovascular Cardiac Valve Replacement

In the 2020 Report, 97% of the overall error rate for this DRG pair was attributed to Insufficient Documentation. Structural heart procedures Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR) both sequence to DRGs 266 & 267. Both procedures have a related National Coverage Determination (NCD) outlining the requirements for the procedures to be considered medically necessary. (TAVR NCD 20.32 and TMVR NCD 20.33).

June 30, 2020, CMS released a Proposed Decision Memo for TMVR procedures and includes significant changes in coverage indications. The comment period ended July 30, 2020. The Final Decision memo should have been published in September 2020. Well past the September 2020 deadline, CMS finally published the Final Decision Memo (CAG-00438R) on January 19, 2021. At first glance, there are significant changes in the Final Decision Memo when compared to what was proposed.

 

DRGs 273 & 274: Percutaneous Intracardiac Procedures

In the 2020 Report, 100% of the overall error rate for this DRG pair is attributed to insufficient documentation. The structural heart procedure Left Atrial Appendage Closure (LAAC) sequences to DRGs 273 and 274. Similar to the TAVR and TMVR procedures, the LAAC procedure has an NCD.

 

DRGs 226 & 227: Cardiac Defibrillator without Cardiac Cath

In the 2020 Report, 90.8% of the overall error rate for this DRG pair is attributed to insufficient documentation. The related coverage determination is NCD 20.4. Additionally, almost all Medicare Administrative Contractors have published a Local Coverage and Billing Article.

 

Cardiac Defibrillator Shared Decision Making

NCD 20.4 was revised in 2018 and now requires documentation of Shared Decision Making with the patient prior to the procedure being performed. This continues to be challenge for hospitals.

In the Public Comment section of the February 18, 2018 Cardiac Defibrillator Final Decision Memo (CAG-00157R4), CMS responded to a comment with the following statement:

“CMS believes in the importance of an evidenced based tool but they are not specifying the type of tool that is required. They do provide an example of an evidence based decision aid for patients with heart failure who are at risk for sudden cardiac death and are considering an ICD. This tool was funded by the National Institutes on Aging and the Patient-Centered Outcomes Research Institute and can be found at https://patientdecisionaid.org/wp-content/uploads/2017/01/ICD-Infographic-5.23.16.pdf. CMS notes that this tool is based on published clinical research and interviews with patients and includes discussion of the option for future ICD deactivation.”

On December 21, 2020, WPS, the Medicare Administrative Contractor for Jurisdictions 5 and 8, posted the following information in their e-newsletter:

“The Comprehensive Error Rate Testing (CERT) contractor recently issued errors related to formal shared decision making encounter using an evidence-based tool prior to ICD implantation. In these cases, submitted emergency room, history and physical, consultation, and other progress notes did not include adequate documentation to support this encounter took place prior to surgery.

For more information regarding coverage criteria for ICDs, see the CMS Internet-Only Manual (IOM) Publication 100-03, Chapter 1 , section 20.4.”

As recent as last week, Palmetto GBA, the Medicare Administrative Contractor for Jurisdiction J and M, announced a new education module available to providers related to DRG 227. They indicate that the “purpose of this module is to educate providers on this DRG so claims can be submitted correctly.”

 

Moving Forward

Preventing “insufficient documentation” errors is not an insurmountable challenge. It is important to identify when a procedure has a related National or Local Coverage Determination. If the answer is yes, read the NCD carefully and make sure you are following all of Medicare’s requirements to support the medical necessity for the procedure and make sure the information is documented in the record.

This week we highlight key updates spanning from January 12th through January 18th, 2021.

 

Resource Spotlight: AMA Resource – Find your COVID-19 Vaccine CPT® Codes

The AMA has created this resource “to help you determine the appropriate CPT code combination for the type and dose of vaccine that you are using.” You will be asked to answer questions on the left side of the screen regarding the vaccine manufacturer and dose being administered. Once you have done this the appropriate CPT code combinations will appear on the right side of the webpage.

 

January 4, 2021: FDA Communication - Risk of False COVID-19 Results with Curative SARS-CoV-2 Test

The FDA sent an Alert to patients and health care providers regarding the risk of false results, particularly false negative COVID-19 results with the Curative SARS-CoV-2 test. This communication goes on to provide important recommendations for health care providers, patients, and caregivers.

 

January 7, 2020: COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing Document Updated

This now 166 page document added the following FAQ on January 7th:

“Question: How did CMS implement the increased payment under the IPPS for COVID-19 patients under the provisions of section 3710 of the CARES Act?

Answer: To implement this temporary statutory adjustment, the IPPS Pricer will apply an adjustment factor to increase the Medicare Severity-Diagnosis Related Group (MS-DRG) relative weight that would otherwise apply by 20 percent when determining IPPS operating payments (including the calculation of payments such as for disproportionate share hospitals (DSHs), indirect medical education (IME), outliers, new technologies, and low volume hospitals and the hospital specific rates for sole community hospitals (SCHs) and Medicare-dependent hospitals (MDHs)) for discharges of patients with a principal or secondary diagnosis of COVID-19. For additional information regarding which claims are eligible for the 20 percent increase in the MS-DRG weighting factor, please see the Medicare Learning Network (MLN) Matters article “New COVID-19 Policies for Inpatient Prospective Payment System (IPPS) Hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) due to Provisions of the CARES Act” available on the CMS website at https://www.cms.gov/files/document/se20015.pdf.

Updated: 1/7/21”

 

January 11, 2021: New Web Platform for 1135 Waivers and Inquiries

In a January 11, 2021 memorandum to State Survey Agency Directors, CMS announced a new platform for submission of 1135 waiver requests and inquiries. They indicate in the memorandum summary that “with very limited exception, the new web system should be sued for all 1135 waiver requests and/or PHE-related inquiries submitted on or after January 11, 2021.” CMS is providing training on this new system on YouTube at CMS YouTube 1135 Waiver and Inquiry Web Training.

 

January 12, 2021: Negative COVID-19 Test Required for All Air Passengers Entering United States

The CDC Director signed an order on January 12, 2021 expanding the requirement for a negative COVID-19 test to all air passengers entering the United States. The CDC notes that “testing before and after travel is a critical layer to slow the introduction and spread of COVID-19. This strategy is consistent with the current phase of the pandemic and more efficiently protects the health of Americans.” The order will become effective on January 26, 2021.

 

January 14, 2021: Federal COVID-19 Testing Report: Data Insights from Six Federal Health Care Programs

The OIG released this Full Report and an Accompanying Release “that provides insights and data on the COVID-19 testing efforts of six federal health care programs from February 1, 2020, to August 31, 2020—the first seven months following the declaration of a public health emergency in the United States. Although this report does not represent a comprehensive view of the Federal Government’s testing efforts, it provides insights on the populations covered by a variety of federal health care programs. The insights summarized below are intended to help stakeholders—such as Congress; federal and state agencies; and health care entities—understand and plan for current and future response efforts.”

 

January 14, 2021: CDC Clinician Outreach and Communication Activity (COCA) Call Announced: Treating Long COVID: Clinician Experience with Post-Acute COVID-19 Care

This call will be Thursday, January 28, 2021 from 2:00PM – 3:00 PM ET. “During this COCA Call, presenters will share their firsthand experiences with treating long COVID, focusing on the pulmonary, neurologic, and psychological aspects. They will also describe their experiences with establishing clinics that provide care for patients with these long-term effects.”

 

CDC COVID Data Tracker – United States COVID-19 Cases

Resource Spotlight: COVID-19 Public Health Emergency (PHE) Extended

On January 7, 2021, Alex M. Azar II, Secretary of Health and Human Services renewed the Public Health Emergency (PHE) due to COVID-19 effective January 21, 2021. PHE declarations last for the duration of the PHE or 90 days and may then be extended.

 

January 4, 2021: FDA Communication - Risk of False COVID-19 Results with Curative SARS-CoV-2 Test

The FDA sent an Alert to patients and health care providers regarding the risk of false results, particularly false negative COVID-19 results with the Curative SARS-CoV-2 test. This communication goes on to provide important recommendations for health care providers, patients, and caregivers.

 

January 5, 2021: COVID-19 Updates in the January 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

MLN Matters Article MM12120 was published January 5, 2021 and provides highlights from the January 2021 updates of the Hospitals OPPS outlined in Change Request (CR) 12120. Several highlights in this article are related to COVID-19 and includes the following:

• COVID-19 Laboratory Tests and Services Coding Update,
• CPT Proprietary Laboratory Analyses (PLA) Coding Changes Effective October 6, 2020 and January 1, 2021,
• Monoclonal Antibody Therapy Product and Administration Codes for drugs granted emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 positive cases at high risk for progressing to severe COVID-19 and/or hospitalization,
• New COVID-19 CPT Vaccines and Administration Codes, and
• Comprehensive APC (C-APC) Exclusion for COVID-19 Treatments. Specifically, this article reminds providers that “in the interim final with request for comments (IFC) entitled, ‘‘Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency”, published on November 6, 2020, we stated that effective for services furnished on or after the effective date of the IFC and until the end of the PHE for COVID-19, there’s an exception to the OPPS C-APC policy to ensure separate payment for new COVID–19 treatments that meet certain criteria (85 FR 71158 through 71160). Under this exception, any new COVID-19 treatment that meets the two following criteria will, for the remainder of the PHE for COVID-19, will always be separately paid and won’t be packaged into a C-APC when it’s provided on the same claim as the primary CAPC service. MLN Matters: MM12120 Related CR 12120 Page 9 of 17

1. The treatment must be a drug or biological product (which could include a blood product) authorized to treat COVID-19, as indicated in Section I, “Criteria for Issuance of Authorization,” of the letter of authorization for the drug or biological product, or the drug or biological product must be approved by the FDA for treating COVID-19.

2. Second, the EUA for the drug or biological product (which could include a blood product) must authorize the use of the product in the outpatient setting or not limit its use to the inpatient setting, or the product must be approved by the FDA to treat COVID-19 disease and not limit its use to the inpatient setting.

For further information regarding the exception to the C-APC policy for COVID–19 treatments, please refer to the IFC (85 FR 71158 through 71160) at https://www.federalregister.gov/documents/2020/11/06/2020-24332/additional-policy-andregulatory-revisions-in-response-to-the-covid-19-public-health-emergency.”

 

January 7, 2021: COVID-19 Vaccine and Long-Term Care Facilities

CMS information related to the COVID-19 vaccine in their weekly MLN Connects e-newsletter. Specifically, they indicated that the CDC has recommended early vaccination for health care personnel and residents in long-term care facilities and has developed a Long-Term Care Facility toolkit to assist in preparing for and building confidence in the vaccine.

 

January 7, 2021: Preventing Chronic Disease (PCD) Essay: Chronic Disease and COVID-19

The CDC announced the release of a new PCD essay on COVID-19 and Chronic Disease. Specifically, senior leadership of the CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), NCCDPHP Director Karen A. Hacker, MD, MPH, and Peter A. Briss, MD, MPH, Medical Director of NCCDPHP’s Office of Medicine and Science, discuss the importance of prevention and care during the COVID-19 pandemic.

 

January 7, 2020: AHA, COVID-19 and Hospital Price Transparency Rule

The American Hospital Association (AHA) submitted a January 7, 2021 letter to Secretary Azar urging that CMS “exercise enforcement discretion with respect to the hospital price transparency rule.” The letter goes on to indicate that “Hospitals ability to comply with the rule at this time is particularly challenged by an increase in the volume of COVID-19 patients and the need to distribute multiple vaccines.”

 

January 8, 2021: FDA Alert Regarding SARS-CoV-2 Viral Mutation

The FDA notes in this Alert that they are “monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test.”

 

January 8, 2021: FDA’s COVID-19 Update - Moderna COVID-19 Vaccine FAQs

In their January 8, 2021 COVID-19 Update, the FDA announced the post of a new webpage, Moderna COVID-19 Vaccine FAQs. Questions range from how well does the Moderna COVID-19 vaccine prevent COVID-19? To, is it possible to obtain an 11th dose from the multi-dose vial of the Moderna COVID-19 vaccine?

 

January 11, 2021: What to Expect After Getting a COVID-19 Vaccine

The CDC has a What to Expect after Getting a COVID-19 Vaccine webpage which includes information on the following:

• Common side effects,
• Helpful tips,
• When to call the doctor,
• Scheduling your second shot,
• About your second shot,
• Things to remember, and
• A printable handout for a vaccine recipient.

 

CDC COVID Data Tracker – United States COVID-19 Cases

In mid-November 2020, CMS published a CMS.gov Fact Sheet detailing the estimated improper payment rates for CMS Programs for Fiscal Year (FY) 2020.

Audit findings are used to calculate a Medicare Fee-for-Service (FFS) program improper payment rate. “The CERT program considers any claim that was paid when it should have been denied or paid at another amount (including both overpayments and underpayments) to be an improper payment.”

CMS reminds the reader in the Fact Sheet that improper payment rates are not necessarily indicative of or are measures of fraud. Instead, improper payments are payments that did not meet statutory, regulatory, administrative, or other legally applicable requirements and may be overpayments or underpayments.”

The following tables compares the improper payment rate for FY 2018, FY 2019, and FY 2020.

Fiscal Year 2020 Supplemental Improper Payment Data

On December 21, 2020, CMS released the Supplemental Improper Payment Data Report that delves into the details behind the final Improper Payment Rate and Improper Payments. This report includes a review of claims submitted from July 1, 2018 through June 30, 2019.

 

“0 or 1 Day” LOS Claims Continued Outlier

Since the Two-Midnight Rule was implemented, the annual data has included a table comparing improper payment rates for Part A hospital claims by Length of stay. At 19.9% for 2020, the Improper Payment Rate for “0 or 1 day” LOS claims is at an all-time high since the CERT began reporting improper payments by LOS.    

Compliance with Short Stays

Short stay reviews have been under scrutiny for several years. With the consistent increase in the improper payment rate for this patient population it is not surprising that the OIG is once again targeting short stays for review. You can read more about this in a related MMP article.

In this New Year, I hope all of our readers found some joy during the holiday season while socially distancing, wearing your masks and washing your hands. Having taken a couple of weeks off from our full newsletter, we are getting back to business. MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from December 15th, 2020 through January 4, 2021.

 

Resource Spotlight: Avoid COVID-19 Vaccine Scams

With the roll-out of COVID-19 vaccines, reminders abound to protect yourself against vaccine scams. Do you know the signs of potential scams? On December 21, 2020, Federal Agencies warned of emerging fraud schemes related to COVID-19 vaccines. This two page document includes:

• Potential indicators of fraudulent activity,
• Tips to avoid COVID-19 vaccine-related fraud, and
• General online/cyber fraud prevention techniques.

They Federal Agencies have also released a pdf document titled Protect Yourself Avoid COVID-19 Vaccine Scams.

 

December 13, 2020: 8 Things to Know about the U.S. COVID-19 Vaccination Program

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/8-things.html?ACSTrackingID=USCDC_2067-DM44618&ACSTrackingLabel=Vaccines%20%7C%20COVID-19&deliveryName=USCDC_2067-DM44618

 

December 15, 2020: FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

The FDA announced a EUA for the Ellume COVID-19 Home Test. This is the first over-the-counter (OTC) fully at home diagnostic test granted EUA. FDA Commissioner Stephen M. Hahn, M.D. noted in this announcement that “today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can but it, swab their nose, run the test and find out their results in as little as 20 minutes.”

 

December 14 & December 18 2020: Special Edition MLNConnects - COVID-19 Vaccine Codes for Pfizer-BioNTech and Moderna

Late in the afternoon, CMS issued the following information regarding the Pfizer-BioNTech Vaccine:

“On December 11, 2020, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older. Review Pfizer’s Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) regarding the limitations of authorized use.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for the administration of the vaccine (when furnished consistent with the EUA). Review our updated payment and HCPCS Level I CPT code structure for specific COVID-19 vaccine information. Only bill for the vaccine administration codes when you submit claims to Medicare; don’t include the vaccine product codes when vaccines are free.

Related links:

• CMS COVID-19 Provider Toolkit
• CMS COVID-19 FAQs
• CDC COVID-19 Vaccination Communication Toolkit for medical centers, clinics, and clinicians
• FDA COVID-19 Vaccines webpage”

On December 22, 2020, CMS issued another Special Edition MLNconnects announcing that the FDA had issued a EUA for Moderna’s COVID-19 vaccine on December 18, 2020. Similar to the Pfizer-BioNTech announcement, this announcement includes links to the EUA and a Fact Sheet for Healthcare Providers Administering the Vaccine regarding the limitations of authorized use.  

 

December 16, 2020: FDA Issues EUA for BinaxNOW COVID-19 Ag Card Home Test

The FDA issued a new EUA for this at home test authorized for use by patients at home with a prescription. This test is authorized for individuals 15 years or older “who are suspected of COVID-19 by their healthcare provider within the first seven days of symptoms onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.”

 

December 17, 2020: CMS Memo – COVID-19 Infection Control for Psychiatric and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID)

In this Memorandum (Ref: QSO-21-07-Psych Hospital, PRTF & ICF/IID) to State Survey Agency Directors, CMS indicated the following in the Memorandum Summary:

• CMS is committed to taking critical steps to protect all Americans including those with intellectual and developmental disabilities to ensure America’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE).
• CMS is providing guidance to psychiatric hospitals, Psychiatric Residential Treatment Facilities (PRTFs) and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) to improve their infection control and prevention practices, in part, to prevent or lessen the need for use of seclusion and restraint as an infection control intervention.
• All Psychiatric hospitals, PRTFs and ICF/IIDs should monitor the CDC website for information and resources, and contact the local health department, when necessary.

 

December 17, 2020: AMA Announces Additional CPT codes for COVID-19 Vaccines

The AMA announced new CPT codes for the AstraZeneca vaccine noting that the codes will be effective for use “on the condition that the AstraZeneca vaccine receives approval or emergency use authorization from the Food and Drug Administration (FDA).”

 

December 17, 2020: New FDA webpage: Pfizer-BioNTech COVID-19 Vaccine FAQs

The FDA announced they have posted a new FAQs webpage covering specifics related to the Pfizer-BioNTech COVID-19 Vaccine. Questions range from very specific to this vaccine to more general questions, “such as how does a vaccine go from emergency use authorization to licensure.”

 

December 18, 2020: CDC Clinical Outreach and Communication Activity (COCA) Call: What Clinicians Need to Know About the Pfizer-BioNTech and Moderna COVID-19 Vaccines

The CDC hosted this call on December 18, 2020. In an overview statement, this call provided clinicians with an overview of the Pfizer-BioNTech and Moderna COVID-19 vaccines. Specific information included vaccine characteristics and administration, vaccinating special populations, and contraindications. In case you missed this COCA webinar hosted by the CDC on December 18th, you can access a recording of the presentation, a copy of the slides and a copy of the transcript on the CDC website.

 

December 18, 2020: Special Edition 2 MLNConnects: COVID-19 Add-On Payments for New Treatments

On December 18, 2020, in a second Special Edition MLNConnects, CMS provided the following information:

“CMS issued an Interim Final Rule with Comment Period, which established the New COVID-19 Treatments Add-on Payment (NCTAP) under the Medicare Inpatient Prospective Payment System (IPPS), effective from November 2, 2020, until the end of the Public Health Emergency (PHE) for COVID-19. To mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments during the COVID-19 PHE, the Medicare program will provide an enhanced payment for eligible inpatient cases that involve use of certain new products with current Food and Drug Administration approval or emergency use authorization to treat COVID-19. Visit the NCTAP webpage for more information.”

 

December 18, 2020: Calendar Year (CY) 2021 Annual Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Payment Charge

MLN Article MM12080 provides instructions for clinical diagnostic laboratories for the CY 2021 CLFS, mapping new codes for clinical laboratory tests (including several new codes related to COVID-19 testing), and updates laboratory costs subject to the reasonable charge payment.

 

December 18, 2020: OCR Issues Guidance on HIPAA, Health Information Exchanges (HIE), and Disclosures of Protected Health Information (PHI) for Public Health Purposes

The OCR issued guidance providing “examples relevant to the COVID-19 public health emergency on how HIPAA permits covered entities and their business associated to disclose PHI to an HIE for reporting to a Public Health Authority (PHA) that is engaged in public health activities.”

 

December 21, 2020: U.S. Surgeon General Calls for COVID-19 Survivors to Donate Plasma

Surgeon General VADM Jerome Adams urges individuals who have recovered from COVID-19 to consider donating COVID-19 Convalescent Plasma (CCP). He notes that “just like wearing a mask, donating CCP is a way for individuals to help in our nation’s fight against COVID-19.  Donating CCP is safe, and may spare others from lengthy hospitalizations, and from suffering the most severe effects of COVID-19.” This HHS announcement includes a link to a YouTube recorded by the Surgeon General.

 

December 23, 2020: MLN Article – Instructions to Medicare Administrative Contractors (MACs) on COVID-19 Emergency Declaration Blanket Waivers for Medicare-Dependent, Small Rural Hospitals and Sole Community Hospitals

MLN Article MM12070 is for Medicare-Dependent, Small Rural Hospitals and Sole Community Hospitals (SCHs). The article provides information about the actions CMS is taking to help health care providers contain the spread of COVID-19 with the COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers and includes a link to all of the current blanket waivers.

 

December 23, 2020: MLN Article – Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Codes 87811 and 87428

MLN Matters article MM12093 informs providers of the addition of the QW modifier to the following CMS HCPCS Codes:

• 87811 [Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])] and code
• 87428 [Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B].

 

December 23, 2020: HHS Announcement – HHS & the Department of Defense (DOD) Purchases 100 Million Additional Doses of COVID-19 Vaccine from Pfizer

HHS indicated in this announcement that Pfizer will deliver at least 70 million doses by June 30, 2021, with the remaining 30 million to be delivered no later than July 31, 2021. Per HHS Secretary Alex Azar,

“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio…This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021.”

 

December 28, 2020: New CDC webpage – New Variant of Virus that Causes COVID-19 Detected

The CDC indicated that the United Kingdom (UK) has seen a rapid increase in COVID-19 cases in London and southeast England since November 2020. A new variant of the virus causing COVID-19 has been linked to the rapid increase in cases. This CDC web page provides current information on:

• What we know,
• What we do not know.
• What it means, and
• What the CDC is doing.

 

December 28, 2020: Special Edition MLN Connects – 2% Sequestration Suspended Through March

CMS released the following information in a Special MLN Connects edition:

“The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended the payment adjustment percentage of 2% applied to all Medicare Fee-For-Service (FFS) claims from May 1 through December 31.  The Consolidated Appropriations Act, 2021, signed into law on December 27, extends the suspension period to March 31, 2021.”

 

December 30, 2020: CDC Clinical Outreach and Communication Activity (COCA) Call: COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions

This call provided clinicians an overview of recommendations for use of COVID-19 vaccines in certain populations. Information provided included recent reports of anaphylaxis following vaccination, and CDC’s update clinical considerations around contraindications and precautions to vaccination. You can access a recording of the presentation, a copy of the slides and a copy of the transcript on the CDC website.

 

December 30, 2020: FDA Hand Sanitizer Safety and Use Communication Toolkit

The FDA released this new toolkit for consumers, patients, and health care professionals to help increase hand sanitizer safety. Information available in the toolkit includes:

• Infographic,
• Social media images and messages,
• Drop-in newsletter article for clinicians,
• Responses for health care professionals to commonly asked questions,
• Fact Sheet,
• Online quiz,
• Consumer articles (in 6 languages), and
• A hand sanitizer safety video.

 

December 30, 2020: Flexibility for Exceeding the 24-hour Time Frame for Patients in ASC Setting During COVID-19 PHE

CMS has released a December 30, 2020 memorandum indicating that “as COVID-19 cases continue to surge, CMS will temporarily exercise survey enforcement discretion regarding the 24-hour time frame to allow patients to remain in the ASC longer, if needed, during the COVID-19 PHE. This applies to ASCs that have not converted to a hospital during the PHE.”

 

December 30, 2020: Revised COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care

CMS notes in this memorandum that they are “making revisions to the non-long term care (NLTC) focused infection control survey tool for acute and continuing care providers to reflect COVID-19 guidance updates, provide clarifications to existing information, and update the appropriate CMS regulatory tag considerations if a citation is warranted.”

 

December 31, 2020: List of Approved Hospitals for Acute Hospital Care at Home Program

CMS posted an updated pdf document listing the 24 systems and 51 hospitals that are currently included in this program. As a reminder, “the Acute Hospital Care at Home program is an expansion of the CMS Hospital Without Walls initiative launched in March 2020 as a part of a comprehensive effort to increase hospital capacity, maximize resources, and combat COVID-19 to keep Americans safe. This program creates additional flexibility that allows for certain health care services to be provided outside of a traditional hospital setting and within a patient’s home.” You can find a link to this document on the CMS Coronavirus Disease 2019 Current emergencies web page.

 

January 1, 2021: Mandatory Deadline for Renewed Advanced Beneficiary Notice (ABN) Form

Reminder, the ABN form was renewed by the Office of Management and Budget (OMG) in 2020. Due to COVID-19 concerns, CMS expanded the deadline for using the renewed from CMS-R_131 (exp. 6/30/2023). The renewed ABN was mandatory for use on 1/1/2021.

CDC COVID Data Tracker – United States COVID-19 Cases

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule (CMS-1736-FC) was released on December 2, 2020 and is scheduled to be published in the Federal Register on December 29th. A Wednesday@One article released earlier this month highlighted changes to the Inpatient Only Procedure List and the Hospital Outpatient Department Prior Authorization Program.

This week’s article details finalized changes for supervision of outpatient therapeutic services and the Ambulatory Surgical Center (ASC) Covered Procedures List.

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

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

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

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

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

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

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

NSEDTS Level of Supervision

In the final rule, CMS finalized their proposal without modification to reduce the minimum default level of supervision for NSEDTS to general supervision. They do “note that the requirement for general supervision for an entire NSEDTS does not preclude these hospitals from providing direct supervision for any part of a NSEDTS when the practitioners administering the medical procedures decide that it is appropriate to do so. Many outpatient therapeutic services, including NSEDTS, may involve a level of complexity and risk such that direct supervision would be warranted even though only general supervision is required.”

In response to a comment from Med PAC, CMS intends to “monitor NSEDTS for safety or service quality issues that may arise from the change to general supervision as the minimum default level of supervision for the initiation period of these services.”

Direct Supervision of Pulmonary, Cardiac, and Intensive Cardiac Rehabilitation Services Using Interactive Telecommunication Technology

Several commenters expressed concerns regarding the proposed change to direct supervision for these three rehabilitation services.

Ultimately, CMS finalized their “proposed policy to permit direct supervision of these services using virtual presence only until the later of the end of the calendar year in which the PHE ends or December 31, 2021. Specifically, the required direct physician supervision can be provided through virtual presence using audio/video real-time communications technology (excluding audio-only) subject to the clinical judgement of the supervising practitioner, as discussed in IFC-1 (85 FR 19246).

When the policy to permit direct supervision through virtual presence ends, we will resume our current policy to require direct physician supervision of pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, and that the supervising practitioner must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. This does not mean that the supervising practitioner must be present in the room when the procedure is performed.”

CMS also clarified “that, to the extent our policy allows direct supervision through virtual presence using audio/video real-time communications technology during the PHE, the requirement could be met by the supervising practitioner being immediately available to engage via audio/video technology (excluding audio-only), and would not require real-time presence or observation of the service via interactive audio and video technology throughout the performance of the procedure.”

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

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

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

CMS Outlook for the Future of the ASC-CPL

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

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

CMS finalized without modification the addition of the eleven proposed procedures to the ASC-CPL. These procedures are listed in Table 59 of the final rule.

Table 59: Final Additions to the List of ASC Covered Surgical Procedures for CY 2021

Specific to the addition of total hip arthroplasty (THA) to the ASC-CPL, CMS notes in the final rule that they “are aware that beneficiaries may incur greater cost-sharing for THA procedures in an ASC setting under our proposal, but note that this is not an occurrence that is unique to THA.” Section 4011 of the 21st Century Cures Act added the requirement that the Secretary make a searchable website available to the public, “with respect to an appropriate number of items and services, the estimated payment amount for the item or service under the OPPS and the ASC payment system and the estimated beneficiary liability applicable to the item or service.” CMS implemented this provision by providing an Outpatient Procedure Price Lookup tool available at https://www.medicare.gov/procedure-price-lookup. “This web page allows beneficiaries to compare their potential cost-sharing liability for procedures performed in the hospital outpatient setting versus the ASC setting.” CMS that this tool will include cost-sharing liability for THA in the outpatient hospital and ASC settings in the future.

At the end of the day, whether a procedure is performed in the Inpatient, Outpatient or ASC setting, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed.