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Administering Lovenox in the Hospital Outpatient Setting, Is It a Self-Administered Drug?
Published on 

4/21/2021

20210421
 | FAQ 
Question:

Is Lovenox in the outpatient setting a self-administered drug for Medicare? Can we charge for the administration?

Answer

For Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M, Lovenox is NOT a self-administered drug, so you can charge for the subcutaneous / intramuscular injection, CPT code 96372. If you are under the jurisdiction of a different MAC, check their self-administered drug list as the drugs can vary from one MAC to the next.

Here is a link to Palmetto’s self-administered drug list. It lists all of the injectable drugs they consider to be self-administered: Local Coverage Article for Self-Administered Drug Exclusion List (cms.gov)

Jeffery Gordon

COVID-19 in the News April 13th through April 19th, 2021
Published on 

4/21/2021

20210421
 | Coding 
 | Quality 

This week we highlight key updates spanning from April 13th through April 19th, 2021.

April 13, 2021: CDC Health Alert: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Johnson & Johnson COVID-19 Vaccination

The CDC issued an official Health Alert relaying information about six cases of cerebral venous sinus thrombosis (CVST) in the U.S. after receiving the Johnson & Johnson COVID-19 vaccine. All six cases were women aged 18 – 48 years and the lag time from vaccination to onset of symptoms ranged from 6 – 13 days. Five of the six women had an initial presenting symptom of a headache. One woman died.

The CDC indicated they would convene an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14th… “until this process is complete, CDC and FDA are recommending a pause in the J&J COVID-19 vaccine out of an abundance of caution.”

Recommendations for Clinicians, Public Health, and the general public are also included in this Alert.

April 13, 2021: New Legal Guidance & Resources to Ensure Expansion of Access to COVID-19 Vaccines

HHS issued a Press Release announcing new resources that have been published to assist in ensuring people with disabilities and older adults access to COVID-19 vaccines. HHS notes that “these resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies – and examples of how the aging and disability network can help employ them to ensure accessibility.”

April 14, 2021: H.R. 1868 Becomes a Law – Sequestration Suspension Extended

The Coronavirus Aid, Relief, and Economic Security (CARES) act was enacted on March 27, 2020 and suspended the 2% sequestration payment adjustment applied to all Medicare FFS claims from May 1 through December 31, 2020. This payment adjustment was included in the Budget Control Act signed into law in August 2011 and became effective April 1, 2013. This Act required that $1.2 trillion in federal spending cuts be achieved over the course of nine years. With no action from Congress, sequestration would last until 2022. You can read more about the 2013 Sequestration in an American Medical Association FAQ document.

Additional legislation extended the suspension through March 31, 2021. A subsequent House Resolution (H.R.) finally made its way through the House and Senate. On April 14, 2021, an Act to Prevent Across-the-Board Direct Spending Cuts, and for Other Purposes was signed into law extending the Sequestration suspension through December 31, 2021.

CMS noted in the Friday April 16, 2021 edition of MLN Connects that Medicare Administrative Contractors will:

  • Release any previously held claims with dates of service on or after April 16, 2021, and
  • The emergency blanket waiver of the timeframe requirements for completing and transmitting resident assessment information (Minimum Data Set (MDS).

They ended the announcement by noting that you do not need to take any action.

April 15, 2021: CDC Clinical Outreach & Communication Call – Johnson & Johnson/Janssen COVID-19 Vaccine and Cerebral Venous Sinus Thrombosis with Thrombocytopenia – Update for Clinicians on Early Detection and Treatment

The CDC held this call to present the latest evidence on cerebral venous sinus thrombosis (CVST) with thrombocytopenia associated with the Johnson & Johnson/Janssen COVID-19 vaccine. If you missed this April 15th call, you can download the call materials from this CDC webpage.

April 15, 2021: OIG Message on COVID-19 Vaccination Program and Provider Compliancet

The OIG released a letter reminding vaccine providers and the public that the Federal Government is providing this vaccine and must be provided at no cost to recipients. They go on to note they are aware of patient complaints about charges by providers when getting their COVID-19 vaccines.

April 15, 2021: COVID-19 Public Health Emergency Extended

Secretary of Health and Human Services, Xavier Becerra, renewed the Public Health Emergency (PHE) due to the continued consequences of the COVID-19 pandemic. This most current extension will expire on July 20, 2021. In January of this year, HHS sent a letter to governors indicating the likelihood that the PHE will remain in place for all of 2021. They also indicated that states would be given a 60 days’ notice to the states prior to the termination of the PHE due to COVID-19.

April 16, 2021: COVID-19 Health Equity Task Force Virtual Meeting April 30, 2021

HHS posted a “Notice of Meeting” regarding the next COVID-19 Health Equity Task Force (Task Force) virtual meeting scheduled for April 30, 2021. As background, this Task Force was established by a January 21, 2021 Executive Order and the group is tasked with making recommendations for “mitigating the health inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.” This meeting is open to the public and will be lived streamed at www.hhs.gov/live. The confirmed time and agenda will be posted on the Task Forces’ webpage at www.minorityhealth.hhs.gov/healthequitytaskforce/.

April 16, 2021: COVID-19 Health Equity Task Force Virtual Meeting April 30, 2021

CMS included the following information regarding COVID-19 Vaccine history in their Friday April 16, 2020 edition of MLN Connects:

“Starting April 16, in addition to screening your patients, you can check Medicare eligibility (PDF) for COVID-19 vaccine administration history from Fee-for-Service (FFS) claims paid for calendar years 2020 and 2021. This includes Medicare Advantage patients.

You can get the following eligibility information for each paid vaccine administration claim:

  • CPT or HCPCS codes
  • Date of service
  • National provider identifier for who administered the vaccine

We can only provide this information if the provider billed Medicare for administering the vaccine. If your patients got vaccinated and the provider didn’t submit a Medicare claim (like if they got vaccinated at a free event), ask your patients about their COVID-19 vaccination history.”

April 16, 2021: Medicare Telehealth Services List Updated

CMS indicated in the April 16, 2021 edition of MLN Connects that CMS had published an updated list of Medicare telehealth services on March 30th. They noted that due to the public health emergency, many audiology and speech-language pathology services have been added to the list effective March 1, 2021.

April 16, 2021: FDA Revokes EUA for Monoclonal Antibody Bamlanivimab

The FDA announced that they have revoked the Emergency Use Authorization (EUA) for Bamlanivimab, when administered alone, to treat mild-to-moderate COVID-19 in adults and certain pediatric patients. Patizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research stated in this announcement that “while the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital.” .

LIVANTA is the New National Medicare Claim Review Contractor for Short Stay and Higher-Weighted DRG Reviews
Published on 

4/14/2021

20210414

As a child of the 70’s in the south, the television line up at my house on Saturday night, when we were not at some type of ball game, was Looney Tunes, Hee Haw, Love Boat and Fantasy Island. That said, let us focus on Hee Haw’s Gossip Girls and their song that hopefully won’t get stuck on a loop in your head:

“Now, we’re not ones to go ‘round spreadin’ rumors, Why, really we’re just not the gossipy kind, No, you’ll never hear of us repeating gossip, So you’d better be sure and listen close the first time!”

Recently, I have read that Livanta, one of the current Beneficiary and Family Centered Care – Quality Improvement Organizations (BFCC-QIS), was going to be the new Medicare contractor responsible for Short Stay Reviews (SSRs) and higher-weighed-DRG (HWDRG) reviews nationwide. As background information, in May 2019, BFCC-QIO short stay reviews were put on hold as CMS planned to procure a new BFCC-QIO contractor who would perform SSRs and HWDRG reviews on a national basis. CMS anticipated awarding this contract by the 3rd quarter of calendar year 2019. As of last week, I had been unable to find an award notice from CMS and unlike the Gossip Girls, I have been waiting to find confirmation from CMS or Livanta before sharing information in our newsletter.

This past Friday April 9th, I found that Livanta has provided confirmation on their website, with the following bolded notice:

Attention Providers: Livanta was awarded the contract for performing claim reviews for Short Stay and Higher-Weight Diagnosis Related Group (HWDRG) claims in all U.S. states and territories.

Under the announcement there is a link to a new Livanta National Medicare Claim Review Contractor Webpage. Important information available to Providers on this webpage includes:

  • Frequently asked questions such as information about HWDRG and Short Stay Reviews (SSRs).
  • Information about a Memorandum of Agreement (MOA) that acute care inpatient hospitals, inpatient psychiatric hospitals, and long-term acute care (LTAC) hospitals are required to submit to Livanta. Note, the MOA template is available as a download on this page.
  • Information about medical record reimbursement and the process for submitting medical records to Livanta.
  • As to the timing of when these reviews will begin, Livanta offers the following information:

    “In the coming weeks, Livanta will begin conducting this work in all states, territories, and Washington, D.C. As part of the review activities, Livanta’s reviewers will evaluate whether the services performed were medically necessary and paid appropriately.”

Beth Cobb

OIG Hospital Provider Compliance Audits
Published on 

4/14/2021

20210414
Add Hospital Provider Compliance Audits to the List of OIG Activities You Need to Know

My oldest nephew is in the midst of his second semester of college life. Academically speaking, he excelled during the first semester. Unfortunately, that is not the case with his Freshman English class this spring. Evidently, the class involves writing several papers and his Professor has been less than impressed with my nephew’s writing efforts. My nephew has met with his Professor to try and understand what he can do to improve his writing skills. Unfortunately, even though his Professor has taken the time to talk with him, my nephew doesn’t seem to be able to pinpoint exactly what he needs to do from this discussion.

The OIG has been conducting Medicare Hospital Provider Compliance Audits as far back as March of 2011. To date, they have completed 190 audits. You can find a table of all these audits on the OIG’s Hospital Compliance Reviews webpage. Unlike my nephew’s English Professor, the OIG is very clear about what their audits focus on. Specifically, they focus on what they describe as “risk areas that we identified as a result of prior OIG audits at other hospitals.”

Two years into their Hospital Provider Compliance Audits, the OIG began to extrapolate audit findings with adverse financial consequences for Providers. In May of 2013, Nashville Tennessee based Saint Thomas Hospital, was the first hospital subject to extrapolation. In the Saint Thomas audit, the OIG identified overpayments of $293,359 and extrapolated this amount over the claims during the audit period. Through extrapolation, the OIG recommended that the Hospital refund to the contractor $1,092,248. In general, every hospital that has been subject to extrapolation during an OIG Hospital Provider Compliance Audit has disagreed with the OIG’s method for extrapolation.

OIG Hospital Provider Compliance Audit: Sunrise Hospital & Medical Center The OIG’s most recent audit was released on April 1, 2021 and details their audit of Sunrise Hospital & Medical Center located in Las Vegas, Nevada. Medicare paid the Hospital approximately $245 million for 15 million inpatient and 25,308 outpatient claims from January 1, 2017, through December 31, 2018 (the audit period).

The OIG’s audit covered about $41 million in Medicare payments to the hospital for 2,117 claims potentially at risk for billing errors. Ultimately, the audit included a stratified random sample of 100 claims (85 inpatient and 15 outpatient) with payments totaling $2.4 million. The at risk areas specific to this audit included:

  • Inpatient rehabilitation facility claims,
  • Inpatient comprehensive error rate testing (CERT) DRG codes,
  • Inpatient high-severity level DRG codes,
  • Inpatient mechanical ventilation,
  • Inpatient claims paid in excess of $25,000,
  • Inpatient same day discharge and readmit,
  • Outpatient bypass modifiers,
  • Outpatient claims paid in excess of $25,000,
  • Outpatient claims paid in excess of charges, and
  • Outpatient skilled nursing facility (SNF) consolidated billing.

The OIG found that the hospital complied with Medicare billing requirements for 46 of the 100 inpatient and outpatient claims reviewed. For the remaining 54 claims, the OIG found that the hospital did not fully comply with Medicare billing requirements. Specific claims and monetary impact included:

  • 50 Inpatient claims had billing errors resulting in net overpayments of $1,002,049,
    • 36 of these claims were Inpatient Rehabilitation Facility admissions where the OIG believed the Hospital had incorrectly billed for stays not meeting Medicare criteria for acute inpatient rehabilitation.
  • 4 Outpatient claims had billing errors resulting in net underpayments of $2,099.
  • The OIG estimated that the Hospital received overpayments of at least $23,615,809 for the audit period.

Ultimately, the OIG extrapolated the audit findings and recommended that the Hospital refund to the Medicare contractor $23.6 million in net estimated overpayments. The Hospital disagreed with most of the OIG’s findings. However, at the end of the day, the OIG indicated that “after review and consideration of the Hospital’s comments, we maintain that our findings and recommendations are correct.”

Moving Forward

In spite of the COVID-19 pandemic, the OIG managed to publish the results from nine Hospital Provider Compliance Audits in 2020. Given that the OIG has been conducting this type of audit since 2011 and their propensity to extrapolate audit findings, understanding provider compliance “at risk” issues has become as important as knowing what items are on the OIG’s Work Plan.

Beth Cobb

COVID-19 in the News April 6th through April 12th, 2021
Published on 

4/14/2021

20210414
 | Coding 
 | Quality 

This week we highlight key updates spanning from April 6th through April 12th, 2021.

Resource Spotlight: WPS YouTube Video: New COVID-19 Condition Codes for Billing Vaccines/Monoclonal Antibody Infusions

WPS, the Medicare Administrative Contractor (MAC) for Jurisdictions 5 and 8, has published a New COVID-19 Condition Codes YouTube video, which includes information on the new condition codes required when billing for COVID-19 vaccines and monoclonal antibody infusions.

April 6, 2021: FDA Issues Emergency Use Authorization (EUA) for COVID-19 Self-Collected Antibody Test System

The FDA announced that they issued a EUA to Symbiotica, Inc., for the COVID-19 Self-Collected Antibody Test System. This test requires a prescription from a health care provider, is intended as an aid in identifying individuals who have had an “adaptive immune response to SARS-CoV-2, indicating the person may have had a recent or previous COVID-19 infection. Samples collected at home are sent to a Symbiotica, Inc. laboratory for analysis.”

April 8, 2021: Revised MLN Booklet: Hospital Value Based Purchasing

In the Thursday April 8, 2021 MLN Connects newsletter, CMS noted that they have updated the MLN Booklet titled Hospital Value Based Purchasing. CMS made the following content updates to this booklet:

  • Added information on relief for clinicians, providers, hospitals, and facilities participating in quality reporting and value-based purchasing programs due to the COVID-19 public health emergency,
  • Added Hospital VBP domains and relative weights for FYS 2018-2023,
  • Revised Hospital VPB measures for FYS 2021-2023, and
  • Revised baseline and performance periods for FYs 2021-2023.
April 8, 2021: CMS Memorandum: Updates to Long-Term Care (LTC) Emergency Regulatory Waivers Issued in Response to COVID-19

CMS released this memorandum to State Survey Agency Directors. In the memorandum summary, CMS indicated they are ending the following waivers for nursing homes:

  • The emergency blanket waivers related to notification of Resident Room or Roommate changes, and Transfer and Discharge notification requirements:
    • The emergency blanket waiver for certain care planning requirements for residents transferred or discharged for cohorting purposes, and
    • The emergency blanket waiver of the timeframe requirements for completing and transmitting resident assessment information (Minimum Data Set (MDS).
April 9, 2021: CDC’s Understanding Viral Vector COVID-19 Vaccines Webpage Updated

There has been confusion and distrust reported in the news and anecdotally on social media regarding the COVID-19 vaccines. Specifically, there has been concerns about the COVID-19 virus being in the vaccine. The CDC’s Understanding Viral Vector COVID-19 Vaccines webpage currently starts with providing the following “What You Need to Know” information:

  • “Viral vector vaccines use a modified version of a different virus (the vector) to deliver important instructions to our cells.
  • The benefit of viral vector vaccines, like all vaccines, is those vaccinated gain protection without ever having to risk the serious consequences of getting sick with COVID-19.”

Also available on this webpage is a printable infographic titled “How Viral Vector COVID-19 Vaccines Work.”

Beth Cobb

Coding Multiple Rib Fractures due to CPR
Published on 

4/7/2021

20210407
 | FAQ 

Question:

What is the code for multiple rib fractures due to Cardiopulmonary Resuscitation (CPR)?

 

Answer:

Assign Other Intraoperative and Postprocedural Complications and Disorders of the Musculoskeletal System (M96.89). Also, use Other Medical Procedures as the Cause of Abnormal Reaction of the Patient, or of Later Complication without Mention of Misadventure at the Time of the Procedure to identify the external cause the injury.

 

Fractures of the ribs are sometimes seen following CPR. Elderly patients with Osteoporosis are at increased for this type of injury.

 

References:        

·        Coding Clinic response to a submitted question.

·        First Quarter 2021, page 5-6

Anita Meyers

COVID-19 in the News March 31st through April 5th, 2021
Published on 

4/7/2021

20210407
 | Coding 

This week we highlight key updates spanning from March 31st through April 5th of 2021.

 

Resource Spotlight: Medicare COVID-19 Data Snapshot Updated March 24,2021

The Medicare COVID-19 Data Snapshot provides summary data and visuals from Medicare Fee-for-Service (FFS) claims data, Medicare Advantage (MA) plans encounter data, and Medicare enrollment information.

 

COVID-19 cases and hospitalization are identified by ICD-10-CM codes:

·        B97.29 from January 1st through March31st 2020, and

·        U071 effective April 1, 2021 forward.

 

The most recent update to the Data Snapshot represents claims data from January 1, 2020 through December 26,2020. As of late 2020 around 63.1 million Americans are enrolled in Medicare with 60% in Medicare FFS, and 40% in MA plans. CMS cautions that data is preliminary as there is always a “claims lag” between services provided and when the claim is in the database.  With that in mind the specific dates of service includes claims received by January22, 2021.

 

Since the last Data Snapshot release:

·        For the first time since CMS began publishing the Data Snapshot, rural cases of COVID-19 (4,271 per 100,000) is higher than in urban areas (4,151 per 100,00),

·        Medicare FFS spending associated with COVID-19hospitals grew to $10.3 billion, and

·        Hypertension remains the most prevalent chronic condition among Medicare FFS COVID-19 hospitalized beneficiaries at 78%.

 

You can read more about the recent Data Snapshot update in a related CMS Press Release.

 

April 1, 2021:  Advancements in Over-the-Counter (OTC) Tests for COVID-19

The FDA announced they had taken “swift action this week to get more tests for screening asymptomatic individuals on the market” by authorizing three tests with serial screening claims. They go on to note these tests had already been authorized for use by the agency to test individuals with COVID-19 symptoms, but this week’s authorization is for testing asymptomatic individuals when used for serial testing.

 

April 1, 2021: Repayment of COVID-19 Accelerated and Advance Payments began March 30, 2021

CMS published MLN article SE21004 on April 1stto inform all Medicare providers and suppliers who requested and receivedCOVID-19 Accelerated and Advance Payments (CAAPs) that they began recovering those payments as early as March 30, 2021. Also included in the article is information on how to identify recovered payments.

 

Additional information including a Press Release, Fact Sheet and Frequently Asked Questions is available on the CMS COVID-19 Accelerated and Advance Payments webpage.

 

April 1, 2021: No Out-of-Pocket Costs to Patients for COVID-19 Vaccine Administration

Currently, the United States Government has purchased all COVID-19 vaccine in the U.S. for administration exclusively by enrolled providers through the CDC COVID-19 Vaccination Program.The Thursday April 1, 2021 edition of the CMS MLN Connects newsletter includes the following reminders for participants in this program:

 

“If you participate in the CDC COVID-19 Vaccination Program, you must:

·        Administer the vaccine with no out-of-pocket cost to your patients for the vaccine or administration of the vaccine

·        Vaccinate everyone, including the uninsured,regardless of coverage or network status

You also can’t:

·        Balance bill for COVID-19 vaccinations

·        Charge your patients for an office visit or other fee if COVID-19 vaccination is the only medical service given

·        Require additional medical or other services during the visit as a condition for getting a COVID-19 vaccination

Report any potential violations of these requirements to the HHS Office of the Inspector General:

·        Call 1-800-HHS-TIPS

·        Submit an online complaint

Submit claims for administering COVID-19 vaccines to:

·        Medicare, if your patient has Medicare Part B coverage or, for 2020 and 2021, Medicare Advantage (Part C)

·        Private insurance company (PDF), including if your patient only has Medicare Part A coverage with supplemental coverage from a private insurer  

·        Your state’s Medicaid program for patients with Medicaid and Children’s Health Insurance Program (CHIP) coverage

·        Health Resources & Services Administration (HRSA) COVID-19 Uninsured Program ,including if your Medicare patient only has Part A coverage with no supplemental coverage”

 

April 2, 2021: International Travel During COVID-19 – CDC Guidance Updated

The CDC has updated their guidance regarding international travel during COVID-19 to note that “fully vaccinated travelers are less likely to get and spread COVID-19. However, international travel poses additional risks and even fully vaccinated travelers are at increased risk for getting and possibly spreading new COVID-19 variants. CDC recommends delaying international travel until you are fully vaccinated.” The update also includes tips for getting tested after travel and self-quarantining.

 

April 5, 2021: Acute Hospital Care at Home Program List of Approved Hospitals Updated

This program is an expansion of the CMS Hospitals Without Walls Initiative launched over a year ago now in March 2020. CMS once again updated the list of approved hospitals. The updated list also includes a note that this list will be moving to the CMS Hospital at Home webpage beginning April 9, 2021.

Beth Cobb

Claims Processing Instructions for Implantable Cardiac Defibrillators
Published on 

4/7/2021

20210407

Reading CMS’s recently released Change Request (CR) 12104  titled Claims Processing Instructions for National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs) made me feel like I had entered the land of Fantasia from The Never Ending Story or as if I was waking up to Sonny and Cher singing I Got You Babe for the umpteenth time in the Bill Murray classic Ground Hog’s Day. Either way, it has been a long road from the release of a Proposed Decision Memo to the transmittal providing claims processing instructions.

 

The Never Ending Story, Gets It’s Ending

·        May 30, 2017: CMS announced the opening of a National Coverage Analysis (NCA)for Implantable Cardioverter Defibrillators.

·        November 20, 2017: CMS issued a Proposed Decision Memo.

·        February 15, 2018: CMS issued a Final Decision Memo.

·        November 21, 2018: Transmittal 209 (CR 10865) was issued reflecting the reconsideration of an updated version of NCD 20.4. CMS noted that a subsequent CR would be released at a later date containing a Claims Processing Manual update with accompanying instructions. Until that time, CMS instructed that Medicare Administrative Contractors (MACs) shall be responsible for implementing NCD 20.4.

·        February 15, 2019: Transmittal 211 was rescinded and replaced with Transmittal 213 to change the implementation date from February 26, 2019 to March 26, 2019.

·        March 26, 2019: CMS’ final implementation date for NCD20.4.

·        March 26, 2019: Eleven of the twelve MACs published a Local Coverage Article titled Billing and Coding: Implantable Automatic Defibrillators including:

        o   First Coast Service Options, Inc. (Jurisdiction N) – Article A56341,

       o   National Government Services, Inc. (Jurisdictions 6 and K) – Article A56326,

        o   Noridian Healthcare Solutions, LLC (Jurisdiction E) – Article A56340,

        o   Noridian Healthcare Solutions, LLC (Jurisdiction F) - Article A56342,

        o   Novitas Solutions, Inc. (Jurisdictions H and L) – Article A56355,

        o   Palmetto GBA (Jurisdictions J and M) – Article A56343, and

        o   Wisconsin Physician Service Insurance Corporation (Jurisdictions 5 and 8) – ArticleA56391.

·        March 2, 2020: CMS published MLN SE20006 updating providers on Medicare coverage rules and policies for NCD 20.4. Specifically, this article addresses concerns related to requiring the use of heart failure diagnosis codes. They end this article by stating that “it is incumbent upon the provider to select the proper code(s). We believe the listed covered codes encompass the various clinical scenarios that occur for patients who meet the NCD coverage requirements and are provided, not to write additional parameters into the NCD, but to ensure there is an appropriate code for the covered indications.”

·        March 23, 2021: CMS released CR 12104 and a related MLN MM12104 on March 24, 2021 detailing the claims processing instructions for NCD 20.4.

 

In Ground Hog’s Day, Bill Murry keeps reliving the same day over and over until he finally turns it around into the perfect day. Almost four years from the opening of the coverage analysis, CMS has provided the final piece to implantable cardiac defibrillators.  

 

Moving Forward to Your Happy Ending

·        First, now is a good time to review NCD 20.4 to understand the indications for when an ICD implantation is considered medically necessary by CMS.

·        Transmittal 12104 details the codes you “shall” use on your claims when billing for services provided. To assist in understanding the codes, I recommend that you read your MAC’s related coding and billing article as it outlines codes specific to each CMS indication for coverage in the NCD.

·        For patients clinically meeting the indications for a pacemaker and an ICD, all twelve MACs have published billing and coding: single chamber and dual chamber permanent cardiac pacemaker articles related to the single and dual chamber pacemaker NCD 20.8.3.

·        This is also a good time to review a sample of claims at your hospital for documentation supporting medical necessity as well as appropriate coding.

·        Be aware that all Recovery Auditors have been approved to perform audits for medical necessity and documentation requirements for implantable automatic defibrillators in the outpatient (Issue RAC Issue 0093) and inpatient (RAC Issue 0195) setting.  

·        Last, know that the implementation date for Transmittal 12104 is July 6, 2021. However, take note that CMS indicates that MACs will not search their files for claims for ICD services between February 15, 2018, and the implementation date of this transmittal. “However, MACs should adjust those claims that are brought to their attention.”

Beth Cobb

COVID-19 in the News March 23rd through March 30th, 2021
Published on 

3/31/2021

20210331
 | Coding 
SEQUESTRATION SUSPENSION EXTENSION, COVID-19 ACCELERATED/ADVANCED PAYMENTS RECOUPMENT IS ALMOST HERE, CMS TO RESUME HOSPITAL SURVEY ACTIVITIES, CDC REPORTS ON EFFICACY OF PFIZER & MODERNA VACCINES

This week we highlight key updates spanning from March 23rd through the 30th of 2021.

March 24, 2021:  OIG Report – Hospitals Operating in Survival Mode

The OIG released the Report in Brief titled, Hospitals Reported That the COVID-19 Pandemic Has Significantly Strained Health Care Delivery. This report is a compilation of perspectives shared by front-line in hospital administrators at 320 hospitals nationwide during brief interviews conducted from February 22nd through the 26th of 2021. The OIG calls this process a “Pulse Survey.” The first Pulse Survey highlighting challenges hospitals are facing was conducted in March 2020. The OIG notes that “this pulse survey offers hospital administrators’ perspectives on the most significant strains that the response to COVID-19 has exerted on hospitals, as well as their perspectives on the longer-term implications of these strains.” The following list are examples of Hospital-Reported Challenges in this report:

  • Difficulty balancing the complex and resource-intensive care needs for COVID-19 patients with efforts resuming routine hospital care,
  • Staffing shortages have affected patient care,
  • Exhaustion and trauma have taken a toll on staff’s mental health, and
  • Challenges associated with vaccine distribution efforts and concerns about hesitancy to receive a vaccine.

March 24, 2021: FDA Consumer Update: Learn More About COVID-19 Vaccines from the FDA

In this Consumer Update, common questions about COVID-19 vaccines are answered by the FDA. The update also provides a link to a YouTube video providing four facts about COVID-19 vaccines.

March 25, 2021: COVID-19 Legislation Related to Sequestration Suspension

  • The Budget Control Act of 2011 included a 2.00% across-the-board sequestration reduction to Medicare Fee-for-Service claims payments.
  • The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended this payment adjustment from May 1, 2020 through December 31, 2020.
  • Subsequently, the Consolidated Appropriations Act, 2021, signed into law on December 27, 2020, extended this suspension to March 31, 2021.
  • On March 19, 2021, the U.S. House passed House Resolution (HR) 1868, which would extend the sequestration suspension through December 31, 2021.
  • On March 25, 2021, the U.S. Senate passed Senate Amendment SA 1410 titled, Extension of Temporary Suspension of Medicare Sequestration. Similar to HR 1868, this Amendment extends the Sequestration suspension through December 31, 2021.

In the March 25, 2021 Senate Congressional Record discussion, Senator Shaheen (D-NH) noted in her remarks that “this week, I heard from Wentworth-Douglass Hospital in Dover, NH. They highlighted that this legislation would result in $2.1 million in desperately needed additional revenue for the hospitals…by passing a continued moratorium through 2021, Wentworth-Douglass will be in a better place to care for those in need and respond to any future crisis affecting the health of our community.”

The American Hospital Association (AHA) released a Special Bulletin in response to passage of the Senate bill. The AHA notes in the bulletin that “the House is expected to take up the Senate-passed bill the week of April 13 when it returns to Washington D.C. It is expected that the Centers for Medicare & Medicaid Services will hold the Medicare claims until the bill is signed into law as it has done in the past.”

March 26, 2021: COVID-19 Accelerated/Advance Payments (CAAPs) Recoupment Fast Approaching

Palmetto GBA, the Medicare Administrative Contractor for Jurisdictions J and M sent the following notice regarding CAAPs to those subscribed to receive emails:

“Providers and suppliers requesting and receiving COVID-19 Accelerated/Advance Payments (CAAPs) in 2020 will receive an email in the coming days reminding them that the recoup period is fast approaching. The emails are being issued to a provider or supplier designated CAAP point of contact.

Included in the email is a copy of the October 2020 reminder email that includes details regarding any CAAPs issued to that entity. Please note the amount due as listed on the October 2020 email attachment does not reflect any amount already refunded towards that balance. There is no need to call the provider contact center. Your current amount owed can be located in eServices’ Financial Tools tab, under Overpayment Data. No offset will begin occurring unless there is still an outstanding CAAP balance for the provider, supplier or an affiliated provider with the same tax identification number.  

Resource: Accelerated and Advance Payment Repayment & Recovery Frequently Asked Questions (October 8, 2020) (PDF, 45 KB)”

March 26, 2021: CMS to Resume Hospital Survey Activities

On January 20, 2021, CMS issued a memo limiting hospital surveys for 30 days “to ensure quality of care oversight while providing hospitals the ability to focus on serving their patients and communities.” The limitations were extended on February 18, 2021 for an additional 30 days through March 22, 2021. On March 26, 2021, CMS issued the Memorandum titled Resuming Hospital Survey Activities Following 30-Day Restrictions to inform State Survey Agency Directors with their plan to resume survey activities.

March 26, 2021: Department of Justice and COVID-19 Fraud

The Department of Justice published a notice detailing actions they have taken to combat COVID-19 related fraud. They note that as of March 26th:

  • 474 defendants have been publicly charged with criminal offenses for fraud related schemes connected to the COVID-19 pandemic,
  • Cumulatively, this represents attempts to obtain over $569 million from the U.S. government and unsuspecting individuals.

Acting Assistant Attorney General Nicholas L. McQuaid of the Justice Department’s Criminal Division following message is included in this announcement: “To anyone thinking of using the global pandemic as an opportunity to scam and steal from hardworking Americans, my advice is simple – don’t…no matter where you are or who you are, we will find you and prosecute you to the fullest extent of the law.”

March 29, 2021: CDC Resource for Healthcare Providers: Caring for Patients at Higher Risks for Developing Severe Outcomes of COVID-19

The CDC has published this webpage specifically as an evidence-based resource for Healthcare Providers and notes that this page is distinct from the People with Certain Medical Conditions webpage which is intended for the general public. Following are examples of information shared on this webpage:

  • Age is the strongest risk factor for severe COVID-19 outcomes as people 65 years or older accounts for more than 80% of the U.S. COVID-19 related deaths.
  • Adults of any age with certain underlying medical conditions are at increased risk for severe illness from COVID-19. This risk increases as the number of underlying medical conditions for a person increases.
  • The most common comorbidities, based on key findings from a retrospective study of 64,781 patients with COVID-19, includes:
  • 46.7% of the patients had hypertension (HTN),
  • 28.9% of the patient patients had a diagnosis of hyperlipidemia,
  • 27.9% of the patients were a diabetic, and
  • 16.1% of the patients had a chronic pulmonary condition.

March 29, 2021: CDC Study Confirms Protective Benefits of mRNA COVID-19 Vaccines

The CDC announced in a Press Release the findings of a new study which “provides strong evidence that mRNA COVID-19 vaccines are highly effective in preventing SARS-CoV-2 infections in real-world conditions among health care personnel, first responders, and other essential workers.”  Results among study participants revealed the following:

  • Following a single dose of the Pfizer-BioNTech or Moderna mRNA vaccines the risk of infection with SARS-CoV-2 was reduced by 80% two or more weeks after vaccination, and
  • Following the second dose of vaccine, risk of infection was reduced by 90% two or more weeks after vaccination.

March 30, 2021: Special Edition MLN Connects: Temporary Claims Hold

CMS released the following notice in a Special Edition MLN Connects regarding the pending congressional action to extend the Sequestration Suspension:

“In anticipation of possible Congressional action to extend the 2% sequester reduction suspension, we instructed the Medicare Administrative Contractors (MACs) to hold all claims with dates of service on or after April 1, 2021, for a short period without affecting providers’ cash flow. This will minimize the volume of claims the MACs must reprocess if Congress extends the suspension; the MACs will automatically reprocess any claims paid with the reduction applied if necessary.”

Beth Cobb

March 2021 Medicare Transmittals and Other Updates
Published on 

3/31/2021

20210331

MEDICARE MLN ARTICLES & TRANSMITTALS – RECURRING UPDATES

April 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.1

  • Article Release Date: March 8, 2021
  • What You Need to Know: Included in this MLN article are changes to the April 2021 version of the I/OCE instructions and specifications for the I/OCE that Medicare uses under the OPPS and non-OPPS for hospital outpatient departments, community mental health centers, all non-OPPS providers, limited services when provided in a home health agency not under the HH PPS, and for a hospice patient for treating a non-terminal illness.
  • MLN MM12187: https://www.cms.gov/files/document/mm12187.pdf

Clinical Laboratory Fee Schedule – Medicare Travel Allowance Fees for Collection of Specimens

  • Article Release Date: March 9, 2021
  • What You Need to Know: Changes to CY 2021 travel allowances bill per mileage basis (HCPCS P9603) and on a flat rate basis (HCPCS P9604) are included in this article. Note, “Medicare Part B allows payment for a specimen collection fee and travel allowance, when medically necessary, for a laboratory technician to draw a specimen from either a nursing home patient or homebound patient under Section 1833(h)(3) of the Act. Payment for these services is made based on the Clinical Laboratory Fee Schedule (CLFS).”
  • MLN MM12140: https://www.cms.gov/files/document/mm12140.pdf

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

  • Article Release Date: March 9, 2021
  • What You Need to Know: This MLN Article provides notice of changes that CMS is making for the April 2021 update of the FY 2021 Inpatient Prospective Payment System (IPPS). CMS notes that MACs will be reprocessing certain claims as explained in this article.
  • MLN MM12062: https://www.cms.gov/files/document/mm12062.pdf

April 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

  • Article Release Date: March 8, 2021
  • What You Need to Know: Related CR 12175 describes changes to and billing instructions for various payment policies implemented in the April 2021 Outpatient Prospective Payment System (OPPS) update. The April 2021 Integrated Outpatient Code Editor (I/OCE) will reflect the HCPCS, Ambulatory Payment Classification (APC), HCPCS Modifier, and Revenue Code additions, changes, and deletions identified in CR 12175.
  • MLN MM 12175: https://www.cms.gov/files/document/mm12175.pdf

Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

  • Article Release Date: March 10, 2021
  • What You Need to Know: Quarterly updates to the Clinical Laboratory Fee Schedule (CLFS) are detailed in this MLN article, including a table of new codes effective April 1, 2021.
  • MLN Article MM12178: https://www.cms.gov/files/document/mm12178.pdf

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – April 2021 Update

  • Article Release Date: March 10, 2021
  • What You Need to Know: This MLN article provides highlights from Change Request (CR) 12155 which includes April 2021 updates to the 2021 MPFS. CMS notes in the article that “MACs won’t search their files to either retract payment for claims already paid or to retroactively pay claims. However, MACs will adjust claims that you bring to their attention.”
  • MLN MM12155: https://www.cms.gov/files/document/mm12155.pdf

One-Time Transmittal 10599 (Change Request 12089): HIPAA Electronic Data Interchange (EDI) Front End Updates for July 2021

  • Transmittal Release Date: March 11, 2021
  • What You Need to Know: The purpose of this Change Request (CR) is to provide the July 2021 Combined Common Edits/Enhancements Module (CCEM) edits for the Part A and Part B Medicare Administrative Contractors (A/B MACs) and the Common Electronic Data Interchange (CEDI) contractor. Additionally, this CR directs Shared Systems to appropriately update the CCEM.
  • Change Request 12089: https://www.cms.gov/files/document/r10599otn.pdf

April Quarterly Update for 2021 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) & PC Print Update

  • Article Release Date: March 12, 2021
  • What You Need to Know: This article details updates to the RARC and CARC lists and instructs Medicare’s Shared System Maintainers (SSMs) to update MREP and PC Print.
  • MLN MM12102: https://www.cms.gov/files/document/mm12102.pdf

Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2021

  • Article Release Date: March 17, 2021
  • What You Need to Know: Included in this article are the Calendar Year 2021 rate updates and policies for the ESRD PPS. Of note, the January 2021 ESRD PRICER did not apply the network reduction to Intermittent Peritoneal Dialysis (IPD) revenue code 0831 and ultrafiltration revenue code 0881 in error. The revised PRICER is correcting this error.
  • MLN MM12188: https://www.cms.gov/files/document/mm12188.pdf

April 2021 Quarterly Update to HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement

  • Article Release Date: March 25, 2021
  • What You Need to Know: Updates to lists of HCPCS codes subject to the consolidated billing provision of the SNF Prospective Payment System (PPS) are provided in this MLN article.
  • MLN MM12212: https://www.cms.gov/files/document/mm12212.pdf

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2021

  • Article Release Date: March 23, 2021
  • What You Need to Know: This article and related Change Request (CR) 12171 announced changes in the July 2021 quarterly release of the edit module for clinical diagnostic laboratory services.
  • MLN MM12171: https://www.cms.gov/files/document/mm12171.pdf

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

Updated Billing Requirements for Home Infusion Therapy (HIT) Services on or after January 1, 2021

  • Article Release Date: March 15, 2021
  • What You Need to Know: Following is an excerpt from this article regarding new changes to Medicare claims processing for HIT services on or after January 1, 2021:
  • “As described in the 21st Century Cures Act, Medicare will make a separate payment for HIT services under the permanent HIT benefit to qualified home infusion suppliers, effective January 1, 2021. Home infusion drugs are assigned to three payment categories, as determined by the HCPCS J-code:
  • Payment Category 1: Includes certain intravenous antifungals and antivirals, uninterrupted long-term infusions, pain management, inotropic, and chelation drugs
  • Payment Category 2: Includes subcutaneous immunotherapy and other certain subcutaneous infusion drugs
  • Payment Category 3: Includes certain chemotherapy drugs. MLN Matters article MM11880 lists the home infusion therapy service G-codes and corresponding home infusion therapy drug J-codes.
  • MLN MM12108: https://www.cms.gov/files/document/mm12108.pdf

Common Working File (CWF) Edits for Medicare Telehealth Services and Manual Update

  • Article Release Date: March 18, 2021
  • What You Need to Know: This article is for physicians, non-physician practitioners, nursing facilities, and other providers submitting telehealth claims to MACs for nursing facility services.
  • MLN MM12068: https://www.cms.gov/files/document/mm12068.pdf

Update to Rural Health Clinic (RHC) Payment Limits

Update to the Manual for Telephone Services, Physician Assistant (PA) Supervision, and Medical Record Documentation for Part B Services

  • Article Release Date: March 24, 2021
  • What You Need to Know: This article serves as notice regarding updates made to Chapter 15 of the Medicare Benefit Policy Manual for Physician Supervision for Physician Assistant (PA) Services and Medical Record Documentation for Part B services.
  • MLN MM11862: https://www.cms.gov/files/document/mm11862.pdf

New Provider Enrollment Administrative Action Authorities

  • Article Release Date: March 24, 2021
  • What You Need to Know: This Special Edition MLN article provides information about the CMS Final Rule titled Program Integrity Enhancement to the Provider Enrollment Process. This Final Rule was issued on September 10, 2019. Included in this MLN article is the following note, “In light of the pandemic and various other factors, we will not begin updating the Form CMS-855 applications with affiliation disclosure for at least another 12 months.”
  • MLN SE21003: https://www.cms.gov/files/document/se21003.pdf

REVISED MEDICARE MLN ARTICLES & TRANSMITTALS

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

  • Article Release Date: September 22, 2020 – Revised March 9, 2021
  • What You Need to Know: In CR 11879, CMS changes the 25th percentile wage index value from 0.8465 to 0.8649. This MLN article reflects this change.
  • MLN MM11879: https://www.cms.gov/files/document/mm11879.pdf

Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits

  • Article Release Date: February 23, 2021 – Revised March 9, 2021
  • What You Need to Know: This MLN article was revised to reflect the revised CR 12131, which changed the date CMS added HCPCS code 87428 to the correct date of November 10, 2020.
  • MLN MM12131: https://www.cms.gov/files/document/mm12131.pdf

MEDICARE COVERAGE UPDATES

OIG Reports and Guidance regarding Polysomnography Services

MACs paid providers approximately $885 million for selected polysomnography services provided to Medicare beneficiaries from January 1, 2017 through December 31, 2018. The OIG identified in prior audits payments being made with inappropriate diagnosis codes, without documentation supportive of the services provided and to providers exhibiting questionable billing patterns. These findings in combination with increased spending as noted above prompted the OIG to conduct additional audits. This month, the OIG has released reports for two polysomnography audits.

  • OIG Report: Peninsula Regional Medical Center: Audit of Medicare Payments for Polysomnography
  • 10 of 100 randomly selected beneficiary claims included 12 lines of service that did not comply with Medicare requirements. Based on the net overpayments of $17,499, the OIG estimated that Peninsula received at least $66,647 in overpayments for polysomnography services during the audit period.
  • OIG Report: North Mississippi Medical Center: Audit of Medicare Payments for Polysomnography
  • 12 of 100 randomly selected beneficiary claims included 13 lines of services that did not comply with Medicare requirements. Based on the next overpayments of $7,624, the OIG estimated that North Mississippi received at least $67,038 in overpayments for polysomnography services during the audit period.

CMS included the following additional resources for Providers related to correct billing for Polysomnography services in the March 18, 2021 edition of their weekly eNewsletter, MLN Connects:

Claims Processing Instructions for National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs)

MEDICARE EDUCATIONAL RESOURCES

MLN Booklet: Behavioral Health Integration Services

MLN Booklet: Evaluation and Management Service Guide

January 2021 Medicare Quarterly Compliance Newsletter

CMS Posted a link to this newsletter in the March 18, 2021 MLN Connects eNewsletter. In this quarter’s newsletter you can learn about:

  • Prefabricated and custom-fabricated knee orthoses: medical necessity and documentation requirements, and
  • Ankle-foot orthoses and knee-ankle foot orthoses within the reasonable useful lifetime: excessive units.

March 15, 2021” Medicare Learning Network® (MLN) Provider Compliance Products

CMS published a list of Provider Compliance Education Products. These products provide education on how to avoid common coverage and coding/billing errors (i.e. Complying with Medical Record Documentation Requirements (MLN909160), Complying with Medicare Signature Requirements (MLN905364), and Provider Compliance Tips for Polysomnography (Sleep Studies) (MLN4013531)).

OTHER MEDICARE UPDATES

Happy National Nutrition Month®

CMS included the following information in the March 4th edition of MLN Connects:

“Did you know that Medicare covers the following preventive services for nutrition-related health conditions like diabetes, chronic kidney disease, and obesity?

  • Medical nutrition therapy
  • Diabetes screening
  • Diabetes self-management training
  • Intensive behavioral therapy for obesity
  • Intensive behavioral therapy for cardiovascular disease
  • Annual wellness visit

During National Nutrition Month®, encourage your patients to develop healthy eating patterns and make food choices to meet their individual nutrient needs, goals, backgrounds, and tastes. More Information:

Information for your patients on nutritional therapy services, diabetes screenings, diabetes self-management training, obesity behavioral therapy, cardiovascular behavioral therapy, and yearly “wellness” visits

MLN Fact Sheet: Health Professional Shortage Area Physician Bonus Program

This fact sheet explains how the Medicare Health Professional Shortage Area (HPSA) Physician Bonus Program works. It has information about how to get bonus payments when you deliver Medicare-covered services to patients in a geographic HPSA. Key Takeaways noted in this Fact Sheet includes:

  • HPSAs are geographic areas of populations that lack enough health care providers to meet the health care needs of that population.
  • CMS pays a 10 percent bonus payment when health care providers deliver Medicare-covered services to patients in a geographic HPSA.
  • CMS pays HPSA bonuses quarterly based on the amount paid for professional services.

Link to MLN Fact Sheet (ICN MLN903196) February 2021: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/HPSAfctsht.pdf

March 17, 2021: American Hospital Association (AHA) Response to the American Rescue Plan Act of 2021 (ARP)

President Biden signed this $1.9 trillion coronavirus relief plan into law on March 11, 2021. In a related American Hospital Association Legislative Advisory, AHA notes their concern “that the law does not include an extension of relief from Medicare sequester cuts, which will go back into effect at the beginning of next month, and also fails to provide loan forgiveness for Medicare accelerated payments for hospitals.”

You can read more about the ARP Act of 2021 in related HHS and CMS Fact Sheets:

March 12, 2021: CMS Published Lists of Participants for Emergency Triage, Treat and Transport (ET3) Model

Link to Model CMS webpage:
link to Press Release: https://www.cms.gov/newsroom/press-releases/cms-announces-final-participants-emergency-triage-treat-and-transport-et3-model-furthers-commitment

March 18, 2021: MLN Connects Clinical Laboratory Data Reporting Delayed Until 2022 Reminder

CMS included the following information regarding the Protecting Access to Medicare Act of 2014 (PAMA) data collection and reporting periods:

For Clinical Diagnostic Laboratory Tests that are not Advanced Diagnostic Laboratory Tests, the requirement for you to report private payor data between January 1 and March 31, 2020, was delayed 2 years.  You must report data from the original collection period. Reporting will resume on a 3-year cycle beginning in 2025. (Section 3718 of the Coronavirus Aid, Relief, and Economic Security Act). Current timeline:

  • Collect Data for January 1 through June 30, 2019
  • Report data between January 1 and March 31, 2022

For more information, see the PAMA Regulations webpage.

March 17, 2021: Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule Delayed

CMS published an interim final rule in the Federal Register in keeping with the January 20, 2021 “Regulatory Freeze Pending Review” Memorandum. The Final Rule is being delayed until May 15, 2021. CMS is seeking public comments through April 16, 2021. In addition to operational practicalities cited by CMS as making them incapable of implementing the MCIT program on March 15, 2021, CMS notes the following additional reasons:

  • “The higher than anticipated volume of devices receiving FDA breakthrough device designation exponentially complicates the operational concerns that we have identified. Further, public comments highlighted the importance of the agency having the ability to not only cover an FDA-designated breakthrough device expeditiously, but also to be able to have coding and payment levels established at the same time.”

Beth Cobb

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