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This week we highlight key updates spanning from February 9th through February 15th, 2021.

Resource Spotlight: CMS COVID-19 Toolkit for Healthcare Providers & CDC Toolkit for Older Adults & People at Higher Risk

In January “CMS released a set of toolkits for providers, states and insurers to help the health care system prepare to swiftly administer the vaccine.  These resources are designed to increase the number of providers that can administer the vaccine and ensure adequate reimbursement for administering the vaccine in Medicare, while making it clear to private insurers and Medicaid programs their responsibility to cover the vaccine at no charge to beneficiaries. In addition, CMS is taking action to increase reimbursement for any new COVID treatments that are approved by the FDA.” The CMS COVID-10 webpage provides information on several key topics such as Coding for COVID-19 Vaccine shots and Medicare Monoclonal Antibody COVID-19 infusion.

The CDC has developed a Toolkit for Older Adults & People at Higher Risk webpage designed to provide “guidance and tools to help older adults and people at higher risk and those who serve of care for them make decisions, protect their health, and communicate with their communities.” Several resources are available on this CDC webpage, for example, COVID-19 Vaccine Resources, Guidance and Planning Documents, Web Resources, FAQs, Fact Sheets and Posters.

February 9, 2021: FDA Authorization for Monoclonal Antibodies Treatment of COVID-19

The FDA announced that they have “issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds] who test positive for SARS-CoV-2 and who are high risk for progressing to severe COVID-19.” The UEA also authorizes treatment for patients 65 years or older with “certain chronic medical conditions.” As a reminder, the ICD-10-PCS codes for bamlanivimab and etesevimab are included in the list of 21 new procedure codes implemented by CMS with an effective date of January 1, 2021. CMS also has a webpage dedicated to Monoclonal Antibody COVID-19 infusion.

February 10, 2021: CDC Morbidity and Mortality Weekly Report (MMWR): Maximizing Masks

In the MMWR titled Maximizing Fit for Cloth and Medical Procedure Masks to Improve Performance and Reduce SARS-CoV-2 Transmission and Exposure, 2021, the authors conducted experiments assessing two ways to improve the fit of medical masks to reduce transmission and exposure of COVID-19. They found that for the user to receive the most benefit from wearing mask(s), a better fit is more effective at slowing the spread of the disease.

The CDC has a dedicated webpage titled Masks Protect You & Me where you can download an educational poster and find links to information about masks (i.e. how to wear masks and how to store and wash masks). 

February 10, 2021: CDC Updates Clinical Considerations for Patients who have received COVID-19 Vaccine

The CDC updated their clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. One recent change is for vaccinated persons. Specifically, fully vaccinated persons meeting the following criteria are not required to quarantine when exposed to someone with suspected or confirmed COVID-19:

• A person is fully vaccinated (i.e., ≥ 2 weeks following the receipt of the second dose in a 2-dose series, or ≥2 weeks following receipt of one dose of a single-dose vaccine),
• A person is within 3 months following receipt of the last dose in a series, and
• A person has remained asymptomatic since the current COVID-19 exposure.

February 11, 2021: Alabama Medicaid COVID-19 Emergency Expiration Date Extended

The Alabama Medicaid Agency notes in this Alert that “All previously published expiration dates related to the COVID-19 emergency are once again extended by the Alabama Medicaid Agency (Medicaid). The new expiration date is the earlier of March 31, 2021, the conclusion of the COVID-19 national emergency, or any expiration date noticed by the Alabama Medicaid Agency through a subsequent ALERT.”

February 11, 2021: MLN Connects – COVID-19: Revised Clinician Codes Accepted with CS Modifier

CMS included the following information in their Thursday February 11th edition of MLN Connects:

“Effective March 18, 2020, the Families First Coronavirus Response Act requires Medicare Part B to cover beneficiary cost-sharing for provider visits when a COVID-19 diagnostic test is administered or ordered. CMS updated the list of codes (ZIP) that physicians and non-physician practitioners can use with the Cost-Sharing (CS) modifier.

For dates of service on or after January 1, 2021, through the end of the public health emergency, we’ll accept these codes with the CS modifier:

• HCPCS codes G2250, G2251, and G2252
• CPT codes 98970, 98971, and 98972 (These replace HCPCS codes G2061 – G2063, which are accepted for services provided in 2020)  

CPT codes 98966, 98967, and 98968 are accepted for services with the CS modifier provided on or after March 18, 2020.

More information about cost-sharing: Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) (PDF) MLN Matters Article”

February 12, 2021: CDC Guidance – What to Expect After Getting a COVID-19 Vaccine

This CDC webpage provides COVID-19 vaccine information including the following:  

• Common side effects,
• Helpful tips,
• When to call the doctor,
• Scheduling your second shot,
• About the second shot,
• Additional reminders, and
• A printable handout for vaccine recipients.

February 13, 2021: CDC Updates Interim Guidance on Duration of Isolation and Precautions for Adults with COVID-19

The CDC indicates, on this webpage, that “Accumulating evidence supports ending isolation and precautions for adults with laboratory-confirmed COVID-19 using a symptom-based strategy.” Currently, the available data indicates the following:

• Adults with mild to moderate COVID-19 remain infectious no longer than 10 days after symptom onset,
• Most adults with more severe to critical illness “likely remain infectious no longer than 20 days after symptoms onset,
• Severely Immunocompromised patients have been found to remain infectious beyond 20 days,
• Once recovered from the virus, adults can shed detectable but non-infectious COVID-19 in upper respiratory specimens up to 3 months after illness onset.

The CDC notes that “These findings strengthen the justification for relying on a symptom-based rather than test-based strategy for ending isolation of most patients, so that adults who are no longer infectious are not kept unnecessarily isolated and excluded from work or other responsibilities.”

CDC COVID Data Tracker – United States COVID-19 Cases

Q:

We had a patient in the ER who was having a miscarriage, and she received an intramuscular injection of Methotrexate.  What CPT code should be used to report the Methotrexate injection in this scenario?

A:

Methotrexate is classified as a chemotherapy drug, specifically an antimetabolite. Therefore, the intramuscular injection of Methotrexate should be reported with CPT code 96401, representing injection of a non-hormonal antineoplastic.  You should not report the injection using CPT code 96372 for a therapeutic drug.

Per CPT guidelines, the CPT codes for chemotherapy administration should be used when an anti-neoplastic drug is given, even if the diagnosis is not related to cancer.

It is unusual for a chemotherapy type drug to be given in the ER, so you may need a new charge code created for those rare circumstances when a drug such as Methotrexate is given by intramuscular route.

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

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.

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Q:

On January 19, 2021, CMS issued a final Decision Memo that included revised criteria for Medicare coverage of Transcatheter Edge-to-Edge Repair (TEER) for mitral regurgitation formerly known as Transcatheter Mitral Valve Repair (TMVR). When should our hospital start following the new criteria such as the requirements for treatment of functional (secondary) mitral regurgitation?

A:

Medicare is a huge bureaucracy and to change rules is not simply a snap of the fingers – there are manuals to update, Medicare contractors and providers to educate, and electronic systems to tweak. This means changes are not instantaneous and take some time to fully implement.

There are differences in the expected compliance with a coverage decision memorandum and a National Coverage Determination (NCD).  CMS addresses this in the Medicare Program Integrity Manual, Chapter 13, section 13.1.1:

A Decision Memo is not immediately binding on Medicare contractors though they are encouraged to consider it. Here is the language from the Medicare Program Integrity Manual, Chapter 13 concerning decision memos:

“Coverage Decision Memorandum- CMS prepares a decision memorandum before preparing the national coverage decision. The decision memorandum is posted on the CMS Web site, that tells interested parties that CMS has concluded its analysis, describes the clinical position, which CMS intends to implement, and provides background on how CMS reached that stance. Coverage Decision Memos are not binding on contractors or ALJs. However, in order to expend MR funds wisely, contractors should consider Coverage Decision Memo posted on the CMS Web site. The decision outlined in the Coverage Decision Memo will be implemented in a CMS-issued program instruction within 180 days of the end of the calendar quarter in which the memo was posted on the Web site.”

Providers need to bear in mind however, that the final NCD backdates the effective date of the changes to the date of the decision memo. The issue lies with the implementation date which is communicated in a CMS Transmittal once the NCD changes are finalized. Medicare Administrative Contractors (MACs) will not start enforcing the new rules until the implementation date, but then they will enforce rules for dates of service on and after the date of the decision memo. This means once the final update to the NCD is made and manualized, the effective date will revert to the date of the decision memo but following the new rules will be based on an implementation date.  Claims submitted on and after the implementation date, will follow the new guidelines for dates of service on and after January 19, 2021 (decision memo date).

Best practice is for providers to educate all key stakeholders on the changes in the decision memo and implement new requirements, such as documentation of persistent symptoms in a patient with functional mitral regurgitation despite maximally tolerated guideline-directed-medical therapy (GDMT), as quickly as possible. Until an implementation date is communicated, providers should not stop complying with the requirements of the current NCD if they are continuing to submit claims for the service.  Another option for providers is to follow the new criteria in the Decision Memo and hold claims until after the implementation date of the revised NCD.

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

Q:

Is there a HCPCS code for the drug Zepzelca?

A:

Effective 01-01-2021, there is a new HCPCS code J9223 for this drug.  The generic name is Lurbectedin, which is why you may not have seen it.  The HCPCS code dose is per 0.1 mg, so you want to be sure to assign the appropriate conversion factors / multipliers since the doses with be greater than 0.1 mg.

For Medicare, It has a status indicator G, so you don’t have to worry about assigning modifier JG if you are purchasing it through a 340B discount program.

For Medicare, if

1. the date of service for the claim was between June 15 2020 and December 31, 2020, and if
2. the drug was used to treat metastatic small cell lung cancer, look at HCPCS code C9399.

This code represents a new drug that has received FDA approval but for which a HCPCS code has not yet been assigned. Click here for the FDA link. For more information about HCPCS code C9399, refer to the Medicare Claims Processing Manual, chapter 17, section 90.3.

United Healthcare COVID-19 Prior Authorization Updates & Discharge Planning Resources

On January 8, 2021, United Healthcare updated their COVID-19 Prior Authorizations Update webpage

webpage noting that “to streamline operations for providers, we’re extending prior authorization timeframes for open and approved authorizations and we’re suspending prior authorization requirements for may services.” Further details and specific dates are available on this webpage for the following:

• Temporary National Skilled Nursing Facility Prior Authorization Suppression,
• Genetic and Molecular CPT Code/Prior Authorization Update Beginning Oct. 1, 2020,
• Extensions of Existing Prior Authorizations,
• Diagnostic Radiology for COVID-19,
• Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS),
• Infertility Treatment and Embry Cryopreservation – Update on Guidance and Coverage, and
• Site of Service Reviews

On a related COVID-19 Ongoing Patient Cares Updates webpage, United Healthcare indicates that they have “a special team focused on COVID-19 discharge matters and that during the national Public Health Emergency (PHE), they “will generally respond to requests within two hours, from 8 a.m. to 8 p.m. Eastern Time.”

January 19, 2021: WPS Article – Documentation Required When Changing Patient Status from Inpatient to Outpatient

WPS posted the following information in their January 19, 2021 eNews:

“The Medical Review department is receiving insufficient documentation when a patient’s status changes from inpatient to outpatient. Documentation must show:

• Orders and notes indicating why the facility is changing the patient status
• Medical reason for care furnished to the beneficiary
• Names of participants involved in decision making change to the patient’s status

Please review the documentation requirements for changing a patient’s status from inpatient to outpatient available in our resource, Documentation Tips.”

January 19, 2021: CGS Article – Redetermination Submission Checklist

CGS has developed a Redetermination Submission Checklist for Part A and Part B Providers to help you provide all of the information the MAC will need when submitting a redetermination.

January 22, 2021: Palmetto GBA JJ Updates Active Service Specific Post-Payment Medical Review List

Palmetto GBA updated their post-payment medical review lists for MAC Jurisdiction J and M.

Changes to Jurisdiction J Part A Line of Business (LOB)

Removed from List:

• Denosumab (J0897)

Added to List:

• Nivolumab (Opdivo®) – HCPCS J9299,
• Ocrelizumab (Ocrevus®), 1mg – HCPCS J2350, and
• IVIV Privigin 500mg – HCPCS J1459

Changes to Jurisdiction M Part A LOB

Removed from List:

• Denosumab (J0897)

Added to List:

• Nivolumab (Opdivo®) – HCPCS J9299,
• Ocrelizumab (Ocrevus®), 1mg – HCPCS J2350,
• IVIV Privigin 500mg – HCPCS J1459,
• Infliximab (Remicade®) – HCPCS J1745,
• Neuromuscular Reeducation – CPT 97112,
• Intensity Modulated Radiotherapy (IMRT) Planning – CPT 77301, and
• MLC Device(s) for IMRT – CPT 77338

January 25, 2021: WPS Article: Drug Screening Laboratory Tests – CERT Denials

In their eNews, WPS reported that the CERT “contractor has noted significant error findings for qualitative drug tests and quantitation of drugs screened (therapeutic drug assays and certain chemistry tests). In most cases, the independent laboratories that performed and billed the services did not submit sufficient documentation to support the medical necessity of the tests in accordance with Medicare regulations. The reminders below will help providers responding to CERT claim reviews:

• Medicare requires a signed treating physician order or authenticated progress note identifying all tests the laboratory will perform.  
• An unsigned requisition does not support physician intent. The CERT contractor will not consider it in a Medicare claim review.
• The patient's medical record must include progress notes to support the medical necessity for ordering each test. The billing provider must submit these notes upon request for a Medicare claim review.

If you find documentation issues exist with your referring providers, we recommend educating your providers about these CERT review findings and applicable Medicare regulations. For more information, refer to the CMS Internet-Only Manual, Publication 100-02, Chapter 15, Section 80.6.1, “Requirements for Ordering and Following Orders for Diagnostic Tests,” and Local Coverage Determination (LCD) L34645, “Drug Testing.””

REVISED MEDICARE MLN ARTICLES & TRANSMITTALS

January 2021 Update of the Ambulatory Surgical Center (ASC) Payment System

• Transmittal 10557 Release Date: January 8, 2021
• What You Need to Know: Transmittal 10546, dated December 31, 2020, has been rescinded and replaced by Transmittal 10557 to correct Attachment B with the addition of missing existing HCPCS J0390, J0745, J2560, 0583T, and Q5118.
• Link to Transmittal 10557: https://www.cms.gov/files/document/r10557cp.pdf

Fiscal year (FY) 2021 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes

• Transmittal 10571 Release Date: January 15, 2021
• What You Need to Know: Transmittal 10360, dated September 18, 2020, has been rescinded and replaced with Transmittal 10571 to correct a value in section G. Updating the PSF for Wage Index, Reclassifications and Redesignations and Wage Index Changes and Issues.
• Link to Transmittal 10571: https://www.cms.gov/files/document/r10571cp.pdf

April 2021 Update to the Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS)

• Transmittal 10572 Release Date: January 15, 2020
• What You Need to Know: Transmittal 10496, dated November 25, 2020, has been rescinded and replaced with Transmittal 10572 to update the background section and to add business requirements 12062.6 and 12062.3. All other information remains the same.
• Link to Transmittal 10572: https://www.cms.gov/files/document/r10572cp.pdf

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – April 2021

• Article Release Date: November 4, 2020 –Revision Date January 20, 2020
• What You Need to Know: CMS issued a revised Change Request (CR) 12027 on January 14, 2021 to revise the release date, transmittal number, and web address of the CR. This MLN Article was updated to reflect this information. No other substantive changes were made.
• Link to MLN MM12027: https://www.cms.gov/files/document/mm12027.pdf

Calendar Year (CY) 2021 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

• Article Release Date: December 18, 2020 – Revised Date January 20, 2021
• What You Need to Know: This article was revised to reflect a revised CR 12080 where CMS changes the payment determination for code 0177U in the crosswalk from 81310 to 81309.
• Link to MLN12080: https://www.cms.gov/files/document/mm12080.pdf

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

Special Edition MLN Article: Assisted Suicide Funding Restriction Act of 1997

• Article Release Date: January 5, 2021
• What You Need to Know: “The Assisted Suicide Funding Restriction Act of 1997 (P.L. 105-12) prohibits the use of Federal funds to provide or pay for any health care item or service, or health benefit coverage, for the purpose of causing, or assisting to cause, the death of any individual including mercy killing, euthanasia, or assisted suicide. The prohibition does not pertain to the provision of an item or service for the purpose of alleviating pain or discomfort, even if such use may increase the risk of death, so long as the item or service is not furnished for the specific purpose of causing or accelerating death.”
• Link to SE20014: https://www.cms.gov/files/document/se20014.pdf

MEDICARE COVERAGE UPDATES

January 19, 2021: Final Decision for Screening for Colorectal Cancer – Blood based Biomarker Tests (CAG-00454N)

Following is the summary information from this Final Decision Memo: 

“The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to cover a blood-based biomarker test as an appropriate colorectal cancer screening test once every 3 years for Medicare beneficiaries when performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:

The patient is:

• age 50-85 years, and,
• asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and,
• at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).

The blood-based biomarker screening test must have all of the following:

• FDA market authorization with an indication for colorectal cancer screening; and
• proven test performance characteristics for a blood-based screening test with both sensitivity greater than or equal to 74% and specificity greater than or equal to 90% in the detection of colorectal cancer compared to the recognized standard (accepted as colonoscopy at this time), based on the pivotal studies included in the FDA labeling.

The currently available Epi proColon® test does not meet the criteria for an appropriate blood-based biomarker CRC screening test.  Based on the evidence at this time, we will non-cover the Epi proColon® test.”

January 19, 2021: Final Decision Memo for Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation (CAG-00438R)

NCD 20.33 became effective August 7, 2014. Abbot Vascular’s MitraClip® is currently the only FDA-approved device for the percutaneous treatment of mitral regurgitation. This Decision Memo renamed the procedure from Transcather Mitral Valve Repair (TMVR) to TEER.

MEDICARE EDUCATIONAL RESOURCES

January 6, 2021: Letter from the Desk of the Palmetto GBA Medical Directors: Caring for Medicare Patients is a Partnership

In this letter to Physicians, the Palmetto GBA Medical Directors stated that “as a patient’s treating physician or nonphysician practitioner, you may order, refer and/or give health care services for your patient in partnership with other providers (i.e., DME Suppliers or Home Health Agencies). Understanding the applicable Medicare coverage criteria (for example, medical necessity) and documentation guidelines for those services is extremely important for the accurate and timely processing and payment of both your claims and the claims of other entities, including physicians, other health care providers and suppliers who give services for your patient.

Other physicians and health care providers may need your documentation or certification supporting the medical necessity of the services they give secondary to your referral or order. Audits conducted by the Comprehensive Error Rate Testing (CERT) program, Recovery Audit Contractors (RACs), Recovery Auditors (RAs) and Medicare Administrative Contractors (MACs) have frequently shown that available documentation lacks information to establish medical necessity. Audits also have consistently shown that the medical records given by physicians lack sufficient documentation to justify an item or service ordered by them. This lack of physician documentation is causing a lack of payment for services and may result in denied or delayed care for your patient.” For more information regarding this Physician’s role, Palmetto provided a link to the MLN Fact Sheet titled Caring for Medicare Patients is a Partnership.”

OTHER MEDICARE UPDATES

December 31, 2020: OIG Report: The CMS Could Improve Its Wage Index Adjustment for Hospitals in Areas with the Lowest Wages (A-01-20-00502)

The OIG released this report indicating that “when post-pandemic conditions allow for new initiatives, CMS could consider focusing the bottom quartile wage index adjustment more precisely toward the hospitals that are the least able to raise wages without that adjustment…CMS could also consider studying the question of why some hospitals in a particular area were able to pay higher wages than other hospitals in the same area prior to the implementation of the bottom quartile wage index adjustment.” Are the hospitals in your state in the bottom quartile? You can find out by reading the OIG Report.

January 7, 2021: Special Edition MLN Connects – Physician Fee Schedule Update

CMS released the following information regarding Medicare Physician Fee Schedule (MPFS) Payments for CY 2021:

“On December 27, the Consolidated Appropriations Act, 2021 modified the Calendar Year (CY) 2021 Medicare Physician Fee Schedule (MPFS):

• Provided a 3.75% increase in MPFS payments for CY 2021
• Suspended the 2% payment adjustment (sequestration) through March 31, 2021
• Reinstated the 1.0 floor on the work Geographic Practice Cost Index through CY 2023
• Delayed implementation of the inherent complexity add-on code for evaluation and management services (G2211) until CY 2024

CMS has recalculated the MPFS payment rates and conversion factor to reflect these changes. The revised MPFS conversion factor for CY 2021 is 34.8931. The revised payment rates are available in the Downloads section of the CY 2021 Physician Fee Schedule final rule (CMS-1734-F) webpage.”

January 7, 2021: Letter to State Health Officials – Opportunities to Better Address Social Determinants of Health (SDOH)

CMS has issued a new roadmap for states to address SDOHs to improve outcomes, lower costs, and support state value-based care strategies. In the Press Release, CMS notes this is part of their commitment to accelerate the health care industry’s shift from tradition fee-for-service payment models to value-based models that hold clinicians accountable for cost and quality. 

January 13, 2021: CMS Report – Putting Patients First: The Centers for Medicare & Medicaid Services’ Record of Accomplishments from 2017-2020

CMS announced in a News Alert their release of this report detailing accomplishments by CMS Strategic Initiatives (i.e. Strengthening Medicare, Innovating Payment Models, and Price Transparency) and provides a Case Study of the COVID-19 response. You can learn more about the Patients Over Paperwork initiative on the CMS website at https://www.cms.gov/About-CMS/Story-Page/patients-over-paperwork.

January 14, 2021: MLN Connects – Payment for Outpatient Clinic Visit Services at Excepted Off-Campus Provider-Based Departments

The following information was published in the January 14th edition of the CMS e-newsletter MLN Connects:

“By July 1, 2021, CMS will begin reprocessing claims for outpatient clinic visit services provided at excepted off-campus Provider-Based Departments (PBDs) so they are paid at the same rate as non-excepted off-campus PBDs for those services under the Physician Fee Schedule (PFS). This affects claims with dates of service between January 1 and December 31, 2019. You do not need to do anything.

Background:

• November 21, 2018: The CY 2019 Outpatient Prospective Payment System (OPPS) Rulefinalized payment for certain outpatient clinic visit services provided at excepted off-campus PBDs at the same rate that we pay non-excepted off-campus PBDs for those services under the PFS. Previously, CMS and Medicare patients often paid more for the same type of clinic visit in the hospital outpatient setting than in the physician office setting.
• In 2019: We reduced payment to 70% of the full OPPS rate in off-campus PBDs. In 2020, this rate changed to 40%.
• September 17, 2019: The U.S. District Court for the District of Columbia declared invalid the CY 2019 payment rule that provided for the reduction for clinic visits provided at excepted off-campus PBDs.
• January 1 – July 2020: We reprocessed CY 2019 claims paid at the reduced payment rate of 70% to restore the 100% payment rate in accordance with the district court decision.
• July 17, 2020: The U.S. Court of Appeals for the D.C. Circuit reversedthe district court ruling, upholding our volume control site-neutrality payment policy for off-campus outpatient hospital clinic visits.”

January 19, 2021: OIG Report – CMS and Its Contractors Did Not Use Comprehensive Error Rate Testing Program Data to Identify and Focus on Error-Prone Providers

The OIG’s objective for this review was to “determine whether CMS and its contractors used CERT program data to identify and focus on error-prone providers.” Note, “error-prone provider” is an OIG-created term and in the context of this report “the term refers to providers that had at least one error in each of the 4 CERT years analyzed, an error rate of higher than 25 percent in each of the 4 CERT years analyzed, and a total error amount of at least $2,500.” The OIG identified 100 error-prone providers who collectively received $3.5 million in improper payments for the years 2014 through 2017. This amount equated into an improper payment rate of more than 60.7 percent. Error-prone provider types included the following:

• 64 durable medical equipment,
• 22 labs,
• 5 home health agencies,
• 4 inpatient rehabilitation hospitals, and
• 4 hospitals and 1 outpatient physician.

Link to OIG Report in Brief: https://oig.hhs.gov/oas/reports/region5/51700023RIB.pdf

Link to OIG Report: https://oig.hhs.gov/oas/reports/region5/51700023.pdf

January 20, 2021: CMS Memorandum – Hospital Survey Priorities

CMS released a memorandum (QSO-21-13-Hospitals) to State Survey Agency Directors clarifying expectations of State Survey Agencies and Accrediting organizations charged with surveying hospitals for compliance with quality of care requirements as states and communities continued to be impacted by the COVID-19 PHE.

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