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Republished from Kaiser Health News

Jordan Rau, Kaiser Health News 

The federal government has penalized 774 hospitals for having the highest rates of patient infections or other potentially avoidable medical complications. Those hospitals, which include some of the nation’s marquee medical centers, will lose 1% of their Medicare payments over 12 months.

The penalties, based on patients who stayed in the hospitals anytime between mid-2017 and 2019, before the pandemic, are not related to covid-19. They were levied under a program created by the Affordable Care Act that uses the threat of losing Medicare money to motivate hospitals to protect patients from harm.

On any given day, one in every 31 hospital patients has an infection that was contracted during their stay, according to the Centers for Disease Control and Prevention. Infections and other complications can prolong hospital stays, complicate treatments and, in the worst instances, kill patients.

“Although significant progress has been made in preventing some healthcare-associated infection types, there is much more work to be done,” the CDC says.

Now in its seventh year, the Hospital-Acquired Condition Reduction Program has been greeted with disapproval and resignation by hospitals, which argue that penalties are meted out arbitrarily. Under the law, Medicare each year must punish the quarter of general care hospitals with the highest rates of patient safety issues. The government assesses the rates of infections, blood clots, sepsis cases, bedsores, hip fractures and other complications that occur in hospitals and might have been prevented. The total penalty amount is based on how much Medicare pays each hospital during the federal fiscal year — from last October through September.

Hospitals can be punished even if they have improved over past years — and some have. At times, the difference in infection and complication rates between the hospitals that get punished and those that escape punishment is negligible, but the requirement to penalize one-quarter of hospitals is unbending under the law. Akin Demehin, director of policy at the American Hospital Association, said the penalties were “a game of chance” based on “badly flawed” measures.

Some hospitals insist they received penalties because they were more thorough than others in finding and reporting infections and other complications to the federal Centers for Medicare & Medicaid Services and the CDC.

“The all-or-none penalty is unlike any other in Medicare’s programs,” said Dr. Karl Bilimoria, vice president for quality at Northwestern Medicine, whose flagship Northwestern Memorial Hospital in Chicago was penalized this year. He said Northwestern takes the penalty seriously because of the amount of money at stake, “but, at the same time, we know that we will have some trouble with some of the measures because we do a really good job identifying” complications.

Other renowned hospitals penalized this year include Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in Los Angeles; UCSF Medical Center in San Francisco; Beth Israel Deaconess Medical Center and Tufts Medical Center in Boston; NewYork-Presbyterian Hospital in New York; UPMC Presbyterian Shadyside in Pittsburgh; and Vanderbilt University Medical Center in Nashville, Tennessee.

There were 2,430 hospitals not penalized because their patient complication rates were not among the top quarter. An additional 2,057 hospitals were automatically excluded from the program, either because they solely served children, veterans or psychiatric patients, or because they have special status as a “critical access hospital” for lack of nearby alternatives for people needing inpatient care.

The penalties were not distributed evenly across states, according to a KHN analysis of Medicare data that included all categories of hospitals. Half of Rhode Island’s hospitals were penalized, as were 30% of Nevada’s.

All of Delaware’s hospitals escaped punishment. Medicare excludes all Maryland hospitals from the program because it pays them through a different arrangement than in other states.

Over the course of the program, 1,978 hospitals have been penalized at least once, KHN’s analysis found. Of those, 1,360 hospitals have been punished multiple times and 77 hospitals have been penalized in all seven years, including UPMC Presbyterian Shadyside.

The Medicare Payment Advisory Commission, which reports to Congress, said in a 2019 report that “it is important to drive quality improvement by tying infection rates to payment.” But the commission criticized the program’s use of a “tournament” model comparing hospitals to one another. Instead, it recommended fixed targets that let hospitals know what is expected of them and that don’t artificially limit how many hospitals can succeed.

Although federal officials have altered other ACA-created penalty programs in response to hospital complaints and independent critiques — such as one focused on patient readmissions — they have not made substantial changes to this program because the key elements are embedded in the statute and would require a change by Congress.

Boston’s Beth Israel Deaconess said in a statement that “we employ a broad range of patient care quality efforts and use reports such as those from the Centers for Medicare & Medicaid Services to identify and address opportunities for improvement.”

UCSF Health said its hospital has made “significant improvements” since the period Medicare measured in assessing the penalty.

“UCSF Health believes that many of the measures listed in the report are meaningful to patients, and are also valid standards for health systems to improve upon,” the hospital-health system said in a statement to KHN. “Some of the categories, however, are not risk-adjusted, which results in misleading and inaccurate comparisons.”

Cedars-Sinai said the penalty program disproportionally punishes academic medical centers due to the “high acuity and complexity” of their patients, details that aren’t captured in the Medicare billing data.

“These claims data were not designed for this purpose and are typically not specific enough to reflect the nuances of complex clinical care,” the hospital said. “Cedars-Sinai continually tracks and monitors rates of complications and infections, and updates processes to improve the care we deliver to our patients.”

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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 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

Spotlight: Cigna Updates Authorization Policy for CTA and FFR-CT Analysis

The Society of Cardiovascular Computed Tomography (SCCT) announced in a January 29, 2021 Press Release that effective February 1, 2021, Cigna no longer requires pre-authorization for Computed Tomography Angiogram (CTA) of the heart, coronary arteries and bypass grafts with contrast material, including 3D imaging post-processing.

Cigna also removed pre-authorization, effective February 1, 2021, for Fractional Flow Reserve-Computed Tomography (FFR-CT).

Dustin Thomas, MD, FSCCT, Chair, Advocacy Committee, SCCT indicated in the Press Release that “the favorable policy update shows that Cigna recognized the use of CTA and FFR-CT as front-line test which can lead to improved patient outcomes.”

 

The Local Scene

 

January 25, 2021: CMS Fact Sheet: MAC COVID-19 Test Pricing

CMS notes that “Local Medicare Administrative Contractors (MACs) are responsible for developing the payment amount for claims they receive for newly created HCPCS codes in their respective jurisdictions until Medicare establishes national payment rates.” Included in this Fact Sheet is a table of newly created COVID-19 Test HCPCS codes and the payment amounts for each of the twelve MAC jurisdictions.

 

January 27, 2021: NGS JK Article: Beneficiaries with Medicare Advantage must Provide Medicare Information to Receive COVID-19 Vaccination

In this NGS News and Alerts article, they discuss the problem Providers are facing in obtaining information needed to bill traditional Medicare when a patient has received the COVID-19 vaccine. They advise that “the provider should inform the beneficiary with MA coverage that the services to be rendered on that DOS must be billed to traditional Medicare. Health care providers who furnish monoclonal antibodies to treat COVID-19 and/or administer a COVID-19 vaccine to a patient enrolled with a MA plan should submit such claims to your traditional Medicare contractor, not the MA plan. Please note that when the provider did not pay for the vaccine then they may only bill Traditional Medicare for the administration.

If the beneficiary with MA refuses to provide their traditional Medicare insurance information for billing purposes, then the provider should inform the patient that their refusal to cooperate so that Medicare can be billed will result in that beneficiary becoming liable for the service(s). If your Medicare patient doesn’t want to give the SSN, tell your patient to log into mymedicare.gov to get the MBI.”

 

February 5, 2021: Novitas JH/JL Notice: New Local Coverage Determinations (LCDs) Effective March 21, 2021

Novitas issued a notice informing providers about the following new LCDs and related billing and coding articles that will become effective March 21, 2021. It is noteworthy that two of the LCDs in the announcement are for procedures that are part of the CMS Hospital Outpatient Prior Authorization Program that began July 1, 2020 (Blepharoplasty and Botulinum Toxins).

• Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (L35004)
• Billing and Coding: Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (A57618)
• Botulinum Toxins (L38809)
• Billing and Coding: Botulinum Toxins (A58423)
• Diagnostic Colonoscopy (L38812)
• Billing and Coding: Diagnostic Colonoscopy (A58428)

The following response to comments articles contain summaries of all comments received and Novitas’ responses:

• Response to Comments: Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (A58586)
• Response to Comments: Botulinum Toxins (A58584)
• Response to Comments: Diagnostic Colonoscopy (A58612)

 

February 4, 2021: First Coast JN - LCD and Article Updates

First Coast has posted new LCDs and related Billing and Coding Articles also effective on March 21, 2021. Similar to Novitas, two of the new LCDs are for procedures that are part of the Hospital Outpatient Prior Authorization Program.

• Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (L34028)
• Billing and Coding: Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (A57025)
• Botulinum Toxins (L33274)
• Billing and Coding: Botulinum Toxins (A57715)
• Diagnostic Colonoscopy (L33671)
• Billing and Coding: Diagnostic Colonoscopy (A55937)

The following Response to Comments Articles contain summaries of all comments received and First Coast’s responses:

• Response to Comments: Blepharoplasty, Blepharoptosis Repair and Surgical Procedures of the Brow (A58587)
• Response to Comments: Botulinum Toxins (A58585)
• Response to Comments: Diagnostic Colonoscopy (A58610)

 

February 4, 2021 Daily Newsletter Palmetto GBA JJ/JM OPD PA Alert!
Palmetto GBA posted the following Alert regarding the hospital Outpatient Department Prior Authorization Program prior authorization requests:

“OPD PAs cannot be sent retroactively, they must be submitted prior to the beneficiary receiving the service. Please review the FAQ on the CMS website.”

 

February 8, 2021: WPS J5/J8 Article – New CERT Contractor Update

WPS shared in an article that “The Comprehensive Error Rate Testing (CERT) contractor has a new website for provider information and resources. Providers can access the new website, the C3HUB at https://c3hub.certrc.cms.gov/.”

 

February 12, 2021: First Coast JN Article: Billing Condition Code (CC) 90 and 91

In this article, First Coast reminds providers that CMS issued MLN Matters® (MM) 12049  to implement two new condition codes (CCs):

• 90 – To allow providers to report when the service is provided as part of an Expanded Access approval
• 91 – To allow providers to report when the service is provided as part of an Emergency Use Authorization (EUA)

They go on to note that while this MLN article was released on November 20, 2020, the implementation date for these codes is February 22, 2021 with an effective date for claims received on or after February 1, 2021.

“First Coast loaded the new CCs on February 10. This means the new codes were not in the Fiscal Intermediary Standard System (FISS) until February 10. Any claims submitted before February 10, with these new condition codes, were rejected prior to entering FISS.

Provider action

If you submitted claims before February 10, with either CC 90 or 91 and received a rejection, you can resubmit the claim.”

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.

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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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

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.

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