Knowledge Base - Full Library

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

REVISED MEDICARE MLN ARTICLES & TRANSMITTALS

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

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• What You Need to Know: Transmittal 10546, dated December 31, 2020, has been rescinded and replaced by Transmittal 10557 to correct Attachment B with the addition of missing existing HCPCS J0390, J0745, J2560, 0583T, and Q5118.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

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

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• What You Need to Know: Transmittal 10360, dated September 18, 2020, has been rescinded and replaced with Transmittal 10571 to correct a value in section G. Updating the PSF for Wage Index, Reclassifications and Redesignations and Wage Index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

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

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• What You Need to Know: Transmittal 10496, dated November 25, 2020, has been rescinded and replaced with Transmittal 10572 to update the background section and to add business requirements 12062.6 and 12062.3.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

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

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

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

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

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

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

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

MEDICARE COVERAGE UPDATES

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

Following is the summary information from this Final Decision Memo: 

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

The patient is:

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

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

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

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

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

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

MEDICARE EDUCATIONAL RESOURCES

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

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

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

OTHER MEDICARE UPDATES

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Background:

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

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

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

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

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

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

January 20, 2021: CMS Memorandum – Hospital Survey Priorities

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

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

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

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

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

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

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

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

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

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

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

January 19, 2021: CGS Article – Redetermination Submission Checklist

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

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

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

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

Removed from List:

• Denosumab (J0897)

Added to List:

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

Changes to Jurisdiction M Part A LOB

Removed from List:

• Denosumab (J0897)

Added to List:

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

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

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

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

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

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

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

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

Insufficient Documentation

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

DRGs 266 & 267: Endovascular Cardiac Valve Replacement

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

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

DRGs 273 & 274: Percutaneous Intracardiac Procedures

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

DRGs 226 & 227: Cardiac Defibrillator without Cardiac Cath

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

Cardiac Defibrillator Shared Decision Making

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

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

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

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

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

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

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

Moving Forward

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

In September 2020, CMS released the proposed rule Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Proposed Rule (CMS-3372-P). Per a related CMS Press Release, “Under current rules, FDA approval of a device is followed by an often lengthy and costly process for Medicare coverage. The lag time between the two has been called the “valley of death” for innovative products, with innovators spending time and resources on FDA approval, only to be forced to spend additional time and money on the Medicare coverage process.” Further, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar, stated that “this new proposal would give Medicare beneficiaries faster access to the latest lifesaving technologies and provider more support for breakthrough innovations by finally delivering Medicare reimbursement at the same time as FDA approval.”

CMS issued Final Rule (CMS-3372-F) on January 12th which was published in the Federal Register on January 14, 2021. This Final Rule will take effective on March 15, 2021. CMS notes in a related Press Release that “after the final rule takes effect, upon manufacturer request, Medicare may cover through MCIT eligible breakthrough devices the FDA has approved, including breakthrough devices that received FDA marketing authorization approval within two calendar years prior to the final rule’s effective date, giving Medicare beneficiaries access to these innovative and potentially life-saving devices.”

Current Medicare Coverage Pathways

The MCIT pathway was proposed because the prescribed statutory timeframes for the National Coverage Determination (NCD) process limits CMS’ ability to institute immediate national coverage policies for new, innovative medical devices. NCDs and Local Coverage Determinations (LCDs) take, on average, 9 to 12 months to finalize.

CMS detailed current Medicare coverage pathways in the proposed rule. Each pathway is highlighted in the following table. 

FDA Breakthrough Devices Program

The Breakthrough Devices Program is specifically for medical devices and device-led combination products meeting the following two criteria:

• The device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
• The device must satisfy one of the following elements:
• It represents a breakthrough technology;
• No approved or cleared alternatives exist; or
• It offers significant advantages over existing approved or cleared alternatives.

MCIT Coverage Pathway

CMS will coordinate with FDA and manufacturers as medical devices move through the FDA regulatory processes to ensure seamless Medicare coverage. This simultaneous effort will ensure Medicare coverage on the date of FDA market authorization for all devices that fall within a Medicare benefit category.

Unlike the pathways in the above table, the MCIT Pathway will allow for immediate national coverage upon the date of FDA market authorization (that is the date the medical device received Premarket Approval (PMA); 510K clearance; or the granting of a De Novo classification request) for the breakthrough device.

Medical Device Eligibility

The MCIT Coverage Pathway is available only to medical devices that meet all of the following:

• A device is an FDA-designated breakthrough device,
• A device that was FDA market authorized two years prior to the effective date of the final rule (March 15, 2021) and thereafter,
• A device is used according to their FDA approved or cleared indication for use,
• A device that falls within a Medicare benefit category,
• A device that is not the subject of a Medicare national coverage determination, and
• A device that is not otherwise excluded from coverage through law or regulation.

Coverage Period

The pathway is a voluntary, opt-in model and will begin when a manufacturer notifies CMS of its intention to utilize the MCIT pathway. CMS finalized that manufacturers may opt-in using no more than an email from the manufacturer to CMS indicating a desire to opt-in and the requested start date of MCIT coverage.

A manufacturer’s requested start date must be no early than the date a device receives market authorization and no later than 2 years after the date of market authorization.

In the proposed rule, CMS indicated that they anticipate two MCIT pathway participants in the first year based on the number of medical devices that received FY 2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles.

MCIT Pathway End Date

MCIT coverage will expire four years after the date of FDA approval, irrespective of when the manufacturer requested activation of their MCIT coverage, at which point, the manufacturer may request CMS to undertake an NCD for the breakthrough device.

Reasons that the MCIT Pathway may End Prior to 4 years

• The manufacturer withdraws the breakthrough device from the MCIT pathway,
• The device becomes subject to an NCD,
• The device becomes non-covered through law, regulation, or at the discretion of the Secretary subsequent to an FDA medical device safety communication or warning letter, or
• The FDA removes authorization of a device.

When an MCIT Coverage Pathway Ends, What Next?

At the end of the 4-year MCIT pathway, coverage of a device would be subject to one of the following three possible outcomes:

• NCD affirmative coverage, which may include facility or patient criteria;
• NCD non-coverage; or
• MAC discretion (claim-by-claim adjudication or NCD).

CMS encourages interested manufacturers to submit an NCD request during the third year of MCIT to allow time for NCD development.

Definition of “Reasonable and Necessary” Codified

In addition to the MCIT Pathway, CMS proposed and has finalized their intent to “codify in regulations the Program Integrity Manual definition of ‘‘reasonable and necessary’’ with modifications, including to add a reference to Medicare patients and a reference to commercial health insurer coverage policies.”

Reasonable and Necessary Definition

An item or service would be considered ‘‘reasonable and necessary’’ if it is— (i) safe and effective; (ii) not experimental or investigational; and (iii) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it meets all of the following criteria:

(A) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;

(B) Furnished in a setting appropriate to the patient’s medical needs and condition;

(C) Ordered and furnished by qualified personnel;

(D) Meets, but does not exceed, the patient’s medical needs; and

(E) Is at least as beneficial as an existing and available medically appropriate alternative.

(F) “Not later than March 15, 2022, CMS will issue guidance on the methodology of which commercial insurers are relevant based on the measurement of majority of covered lives. For national and local coverage determinations, which have insufficient evidence to meet paragraphs (b)(3)(i) through (v) of this section, CMS will consider coverage to the extent the items or services are covered by a majority of commercial insurers. As part of CMS’ consideration, CMS will include in the national or local coverage determination its reasoning for its decision if coverage is different than the majority of commercial insurers.”

CMS intends to list MCIT pathway covered devices on the CMS website to ensure all stakeholders will be aware of what is covered through this pathway.

Resources

CMS Press Release: CMS Unleashes Innovation to Ensure our Nation’s Seniors have Access to the Latest Advancements

 https://www.cms.gov/newsroom/press-releases/cms-unleashes-innovation-ensure-our-nations-seniors-have-access-latest-advancements

CMS Fact Sheet: Medicare Coverage of Innovative Technology (CMS-3372-F)

https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-innovative-technology-cms-3372-f

Final Rule (CMS-3372-F)

https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00707.pdf

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

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

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

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

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

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

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

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

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

Updated: 1/7/21”

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

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

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

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

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

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

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

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

CDC COVID Data Tracker – United States COVID-19 Cases

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CDC COVID Data Tracker – United States COVID-19 Cases

Monthly, MMP provides a summary of Medicare Transmittals, related MLN Articles, Coverage Updates, CMS education resources and any other Medicare updates we believe to be pertinent to our readers. With the holiday season, December’s updates were released in last week’s Wednesday@One article. Since then, CMS has released additional MLN articles with updates effective early in January. For this reason, following is a list of pertinent updates that providers need to know before the end of January when our usual monthly article is published.

MEDICARE TRANSMITTALS – RECURRING UPDATES

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

• Article Release Date: January 5, 2021
• What You Need to Know: The following major changes made in Change Request (CR) 12120 are highlighted in this MLN article:
• COVID-19 Laboratory Tests and Services Coding Update,
• CPT Proprietary Laboratory Analyses (PLA) coding changes effective October 6, 2020,
• Monoclonal antibody therapy product and administration codes for drugs granted emergency use authorizations (EUAs) to treat mild to moderate cases of COVID-19,
• New COVID-19 CPT vaccines and administration codes,
• New device pass-through categories, device offset from payment, transitional pass-through payments for designated devices, and alternative pathway for devices that have a Food and Drug Administration (FDA) Breakthrough Device designation,
• New HCPCS code describing the administration of subretinal therapies requiring vitrectomy,
• New HCPCS code describing nasal endoscopy with cryoablation of nasal tissue(s) and/or nerve(s),
• New HCPCS code describing peripheral intravascular lithotripsy (IVL) procedures,
• Comprehensive APCs (C-APCs) updates,
• Changes to the Inpatient-Only List (IPO) for CY 2021,
• Removals of selected National Coverage Determinations (NCDs) Effective January 1, 2021,
• Changes to some Opioid Treatment Program (OTP) – related codes,
• Change to the Status Indicator for HCPCS code P9099 (blood component or product not otherwise classified) from SI “ER” to SI “R,”
• Drugs, Biologicals, and Radiopharmaceuticals updates,
• Skin Substitutes,
• Reporting for certain Outpatient Department services (that are similar to Therapy Services)(“Non-therapy outpatient department services”) and are Adjunctive to Comprehensive APC Procedures,
• Payment Adjustment for Certain Cancer Hospitals Beginning CY 2021,
• Method to control for unnecessary increased in utilization of outpatient services /G0463 with Modifier PO,
• Changes to OPPS Pricer Logic,
• Updates to the Outpatient Provider Specific File (OPSF),
• Wage Index Policies in the CY 2021 OPPS,
• Coverage Determinations reminder, and
• General Supervision of Outpatient Hospital Therapeutic Services currently assigned to the Non-Surgical Extended Duration Therapy Services (NSEDTS) level of supervision.
• MLN Article MM12120: https://www.cms.gov/files/document/mm12120.pdf

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

• Article Release Date: January 5, 2021
• What You Need to Know: This article details changes and billing instructions for policies implemented in the January 2021 Ambulatory Surgical Center (ASC) update. Following are key points from the related Change Request (CR) 12129 included in this MLN article are:
• Three new device pass through categories,
• Device offset from Payment,
• Device Pass-Through Payments,
• New HCPCS code describing the administration of subretinal therapies requiring vitrectomy,
• New HCPCS code describing nasal endoscopy with cryoablation of nasal tissue(s) and/or nerve(s),
• Four new HCPCS code describing peripheral intravascular lithotripsy (IVL) procedures,
• Removal of five National Coverage Determinations (NCDs) effective January 1, 2021 as stated in the CY 2021 Physician Fee Schedule (PFS) final rule.
• The one existing and fifteen new HCPCS codes for certain drugs and biologicals in the ASC setting that will start to receive separate payment beginning January 1, 2021.
• Retroactive payment for HCPCS J1097 (Phenylep ketorolac opth soln), brand name Omidria. This code became separately payable October 1, 2020. However, there was no available payment rate for MACs. “Consequently, ASCs that may have submitted claims for this drug, may not have been paid correctly…suppliers who think they may have previously received an incorrect payment or incorrect disposition associated with this correction for J1097, for claims beginning October 1, 2020, may request their MAC adjust the previously processed claims.”
• Drugs and Biologicals with payments based on Average Sales Price (ASP),
• Drugs and Biologicals based on ASP methodology with restated payment rates, and
• Skin substitute procedure edits.

CMS ends this MLN article with the following statement about Coverage Determinations:

“Assignment of an HCPCS code and payment rate under the ASC payment system to a drug, device, procedure, or service doesn’t imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the program. MACs determine whether a drug, device, procedure, or other service meets all program requirements for coverage. For example, MACs determine that it is reasonable and necessary to treat the beneficiary’s condition and whether it’s excluded from payment.”

• MLN Article MM12129: https://www.cms.gov/files/document/mm12129.pdf

January 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.0

• Article Release Date: January 5, 2021
• What You Need to Know: This article details changes to the January 2021 version of the Integrated Outpatient Code Editor (I/OCE) instructions and specifications for the Integrated OCE that Medicare uses:
• Under the OPPS and Non-OPPS for hospital outpatient departments, community mental health centers and all non-OPPS providers,
• For limited services when provided in a Home Health Agency (HHA) not under the Home Health Prospective Payment System, and
• For a hospice patient for the treatment of a non-terminal illness.
• MLN Article MM12114: https://www.cms.gov/files/document/mm12114.pdf

REVISED MEDICARE TRANSMITTALS

Billing for Home Infusion Therapy Services on or After January 1, 2021

• Article Release Date: August 7, 2020 – Revised December 31, 2020
• What You Need to Know: A revised Change Request (CR) 11880 was issued on December 31, 2020. This MLN Article was revised to reflect the CR where two codes (J1559 JB and J7799 JB) were added in Table 3.2 on page 7 of this article.
• MLN MM11880: https://www.cms.gov/files/document/MM11880.pdf

MEDICARE EDUCATIONAL RESOURCES

Hospital Price Transparency Webcast: Audio Recording & Transcript

CMS provided the following information in their Thursday, January 7, 2021 edition of MLN Connects: “An audit recording, transcript, and clarification are available for the December 8 Medicare Learning Network webcast on Hospital Price Transparency. Effective January 1, each hospital operating in the United States is required to provide clear, accessible pricing information online. Learn about resources to help you prepare for compliance.”