Knowledge Base Category -

MEDICARE MLN ARTICLES & TRANSMITTALS – RECURRING UPDATES

April 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

• Article Release Date: February 23, 2021
• What You Need to Know: This article informs providers about the Average Sales Price (ASP) methodology, which is based on quarterly data manufacturers submit to CMS.
• MLN Article MM12133: https://www.cms.gov/files/document/mm12133.pdf

Quarterly Updated for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) – April 2021

• Article Release Date: February 23, 2021
• What You Need to Know: The DMEPOS CBP files are updated on a quarterly basis to implement necessary changes to HCPCS codes, ZIP codes, single payment amounts, and supplier files.
• MLN Article MM12128: https://www.cms.gov/files/document/mm12128.pdf

OTHER MEDICARE MLN ARTICLES & TRANSMITTALS

Review of Hospital Compliance with Medicare’s Transfer Policy with Resumption of Home Health Services & Other Information on Patient Discharge Status Codes

• Article Release Date: February 22, 2021
• What You Need to Know: CMS reminds providers that an accurate discharge status code is essential to assure proper payment under the Medicare Severity-Diagnosis Related Group (MS-DRG) payment system. Detailed information regarding the CMS Transfer Policy is included in this article.
• MLN Article SE21001: https://www.cms.gov/files/document/se21001.pdf

Billing for Services when Medicare is a Secondary Payer

• Article Release Date: February 23, 2021
• What You Need to Know: CMS details what to do if you think a claim was inappropriately paid and provides key reminders related to billing for services when Medicare is a secondary payer.
• MLN Article SE21002: https://www.cms.gov/files/document/se21002.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
• What You Need to Know: New HCPCS codes for 2021 that are subject to and excluded from CLIA edits are discussed in this article.
• MLN Article MM12131: https://www.cms.gov/files/document/mm12131.pdf

MEDICARE EDUCATIONAL RESOURCES

MLN Fact Sheet: Intravenous Immune Globulin (IVIG) Demonstration (Demonstration Ends on December 31, 2023)

The IVIG demonstration began in October 2014, has been extended twice, and is now set to end on December 31, 2023. This MLN Fact Sheet, dated February 2021, provides education on the IVIG demonstration and includes information on:

• Supplier eligibility and participation,
• Beneficiary eligibility and participation, and
• Billing and coding requirements.

OTHER MEDICARE UPDATES

Medicare Mid-Build Off-Campus Outpatient Department Exception Audit Results

On February 2nd CMS posted a webpage dedicated to their 21st Century Cures Act Mid-Build Audits. In overview, the Cures Act provided the criteria which off-campus departments of a provider must meet to comply with Mid-build exception requirements. CMS completed 334 provider audits that requested the mid-build exception. They found that 202 of the facilities failed to qualify for the exception. They note in the audit findings that “Providers that failed the mid-build exception audit and have been billing for the services provided by their off-campus provider-based departments under the OPPS, likely have received overpayments. Also, providers that have passed the mid-build exception audit and have not been billing for the services provided by their off-campus provider-based departments under the OPPS, likely have been underpaid.

CMS will issue audit determination letters to all affected providers on January 19, 2021. The letter will provide the final determination on meeting the exception, the appropriate point of contact information, and further instructions. The 21st Century Cures Act states that the mid-build exception audit determinations are final and may not be appealed.” The Audit Results and FAQ documents are available on this CMS webpage.

Improving Accuracy of Medicare Payments

CMS shared the following information in the Thursday February 4, 2021 Edition of MLN Connects:  

The U.S. Bureau of Labor Statistics (BLS) conducts numerous surveys of hospitals and health care providers that are used by the government to make economic decisions that affect the entire medical care system. Key users include CMS, the Federal Reserve Bank, and the U.S. Congress.  CMS uses these surveys to adjust Medicare Fee-for-Service payments each year, affecting approximately $300 billion in payments.

If you’re contacted by BLS, please participate in the survey to help ensure the data are as accurate as possible. Recently, many health care providers didn’t complete the survey, which can reduce the representativeness of the data and increase volatility in estimates. Your participation in these surveys helps address these issues and increase the validity of the data. Participation is voluntary, confidential, and the data are only used for statistical purposes.

More Information:

• BLS Survey Respondentswebpage
• BLS Confidentiality Pledge and Lawswebpage
• CMS Market Basket Datawebpage
• BLS Geographic Informationwebpage: Contact a BLS expert or get information on surveys, data, and reports”

February 22, 2021: OIG Report – $4 Million in improper payments for Spinal Facet-Joint Injections

The OIG found that 49 of 100 sampled claims were inappropriately paid by Noridian Healthcare Solutions, LLC to physicians in Jurisdiction E for spinal facet-joint injections. They note that improper payments occurred due to insufficient education to physicians and their billing staff. Based on their findings, the OIG estimated that $4.2 million was improperly paid to physicians. Recommendations for Noridian included recovering the $12,546 in improper payments found in the sampled claims, notify appropriate physicians so they can identify, report, and return any overpayments in accordance with the 60-day rule and provide annual training to physicians and their billing staff. You can read the entire report at https://oig.hhs.gov/oas/reports/region9/92003010.pdf.

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.

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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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.”

MEDICARE TRANSMITTALS – RECURRING UPDATES

Update to the Federally Qualified Health Center (FQHC) Prospective Payment System (PPS) for Calendar Year (CY) 2021 – Recurring File Update

• Article Release Date: December 4, 2020
• What You Need to Know: Since 2017 CMS has updated the FQHC PPS rate annually. Based on historical data through the second quarter of 2020, the FQHC market basket for CY 2021 is 1.7 percent increasing the FQHC PPS base payment of $173.50 in 2020 to $176.45 for 2021.
• MLN MM12046: https://www.cms.gov/files/document/mm12046.pdf

Update to Rural Health Clinic (RHC) All Inclusive Rate (AIR) Payment Limit for Calendar Year (CY) 2021

• Article Release Date: December 4, 2020
• What You Need to Know: This article provides the CY 2021 payment limit for RHCs. The CY 2021 amount has increased from $86.31 in 2020 to $87.52 effective January 1, 2021. The related Change Request (CR) 12035 was released on October 29, 2020.
• MLN MM12035: https://www.cms.gov/files/document/mm12035.pdf

Summary of Policies in the Calendar Year (CY) 2021 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, CT Modifier Reduction list, and Preventive Services List

• Article Release Date: December 4, 2020
• What You Need to Know: CR 12071 provides a summary of policies in the CY 2021 MPFS Final Rule and makes other policy changes that apply to Medicare Part B. This MLN article is a supplement to the CR.
• MLN MM12071: https://www.cms.gov/files/document/mm12071.pdf

2021 Annual Update of Per-Beneficiary Threshold Amounts

• Article Release Date: December 7, 2020
• What You Need to Know: The related Change Request (CR) 12014 updates the annual per-beneficiary incurred expenses amounts now called the KX modifier thresholds and related policy for CY 2021.
• MLN MM12014: https://www.cms.gov/files/document/mm12014.pdf

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

• Article Release Date: December 7, 2020
• What You Need to Know: Information on the data files, update factors, and other information related to the CY 2021 update to the fee schedule can be found in this article.
• MLN MM12063: https://www.cms.gov/files/document/mm12063.pdf

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

• Article Release Date: December 18, 2020
• What You Need to Know: Information provided in this article is related to CR 12080 and intended for clinical diagnostic laboratories. CR 12080 provided instructions for CY 2021 CLFS, mapping for new codes for clinical laboratory tests, and an update for laboratory costs subject to reasonable charge payment.
• MLN MM12080: https://www.cms.gov/files/document/MM12080.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.1, Effective April 1, 2021

• Article Release Date: December 23, 2020
• What You Need to Know: This article provides a background on NCCI Edits and refers to CR 12110, which provides quarterly updates to the NCCI PTP edits.
• MLN MM12110: https://www.cms.gov/files/document/mm12110.pdf

Updating Calendar Year (CY) 2021 Medicare Diabetes Prevention Program (MDPP) Payment Rates

• Article Release Date: December 23, 2020
• What You Need to Know: For organizations enrolled as MDDP suppliers, this article includes a link to the accompanying CR 12030, which contained instructions for MACs and the Railroad Specialty MAC to update the MDPP Expanded Model payment rates for CY 2021.
• MLN MM12030: https://www.cms.gov/files/document/mm12030.pdf

Quarterly Update to Home Health (HH) Grouper

• Article Release Date: December 30, 2020
• What You Need to Know: This article provides information regarding the January 2021 update to the HH Grouper software to reflect new COVID-19-related diagnosis code changes.
• MLN MM12047: https://www.cms.gov/files/document/MM12047.pdf

2021 Annual Update to the Therapy Code List

• Article Release Date: December 31, 2020
• What You Need to Know: This article provides updates to the list of codes that sometimes or always describe therapy services.
• MLN MM12126: https://www.cms.gov/files/document/MM12126.pdf

OTHER MEDICARE TRANSMITTALS

Review of Hospital Compliance with Medicare’s Transfer Policy with the Resumption of Home Health Services and the Use of Condition Codes (A-04-18-04067)

• Article Release Date: December 1, 2020
• What You Need to Know: An OIG audit report released August 2020 (report No. A-04-18-04067) identified Medicare overpayments to hospitals that did not comply with Medicare’s post-acute-care transfer policy. This MLN Special Edition article was published to remind hospitals of proper coding of the patient discharge status code and the use of condition codes 42 and 43.
• MLN SE20025: https://www.cms.gov/files/document/SE20025.pdf

FAQs on the 3-Day Payment Window for Services Provided to Outpatients Who Later Are Admitted as Inpatients

• Article Release Date: December 3, 2020
• What You Need to Know: This Special Edition MLN article is informational in nature. CMS notes that In May of this year, the OIG released the report, Medicare Made $11.7 Million in Overpayments for Nonphysician Outpatient Services Provided Shortly Before or During Inpatient Stays. This article includes FAQs to help providers avoid incorrect billing for outpatient services within 3 days before date of admission and on the date of admission.
• MLN SE20024: https://www.cms.gov/files/document/SE20024.pdf

REVISED MEDICARE TRANSMITTALS

Changed to the Laboratory National Coverage Determination (NCD) Edit Software for October 2020

• Article Release Date: July 31, 2020 – Revised November 30, 2020
• What You Need to Know: This article was revised to reflect changes made to CR 11889 issued on August 14th. CR 11889 was revised to update the codes for NCD 190.15.
• MLN MM11889: https://www.cms.gov/files/document/MM11889.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: November 9, 2020 – Revised December 2, 2020
• What You Need to Know: This is the second time that CMS has updated this MLN article. The December 2nd revisions added information for reporting the use of cinacalcet by ESRD facilities. “Beginning January 1, 2021, cinacalcet is an oral drug eligible for consideration as an ESRD outlier service. ESRD facilities should report revenue code 250 with the drug’s NDC.
• MLN MM12011: https://www.cms.gov/files/document/mm12011.pdf

New & Expanded Flexibilities for RHCs & FQHCs during the COVID-19 PHE

• Article Releases Date: April 17, 2020 – Revised December 3, 2020
• What You Need to Know: Revisions to this article includes additional guidance on telehealth services that have cost-sharing and cost-sharing waived and language changes for clarity that did not alter the substance of the article.
• MLN MMSE20016: https://www.cms.gov/files/document/se20016.pdf

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

• Article Release Date: November 4, 2020 – Revised December 10, 2020
• What You Need to Know: This article was revised due to a revised CR 12027. Revisions made did not impact the substance of this article.
• MLN MM12027: https://www.cms.gov/files/document/MM12027.pdf

Medicare Claims Processing Transmittal 10521: New Medicare Uniform Billing Committee (NUBC) Type of Bill (TOB), Condition Code and implementing Billing Codes for Opioid Treatment Programs

• Transmittal 10266 Release Date: August 6, 2020
• Transmittal 10521 Release Date: December 16, 2020
• What You Need to Know: Transmittal 10266 was rescinded and replaced by Transmittal 10266 to add the Provider Type "34", note that CAH's are paid via the OTP fee schedule, and clarification on the 2020 OTP fee schedule file (attachment 1) versus the 2021 OTP fee schedule file (new attachment 3). This correction revises business requirement 1856-4.1 and only impacts publication 100-04. All other information remains the same.
• Transmittal 10521: https://www.cms.gov/files/document/r10521cp.pdf
• Effective Date: January 1, 2021 for claims received on or after 1/1/2021

Note, a related Medicare Financial Management Transmittal 10521 revises business requirement 1856-4.1 and only impacts publication 100-04. (https://www.cms.gov/files/document/r10521fm.pdf)

Transmittal 10525: Implementation of the New Ambulatory Surgical Center (ASC) Payment Indicator “K5”

• Transmittal 10245 Release Date: July 30, 2020
• Transmittal 10525 Release Date: December 17, 2020
• What You Need to Know: Transmittal 10245 was rescinded and replaced by Transmittal 10525 to remove the word “DRAFT” from Attachment A. CMS created “a new ASC payment indicator, specifically, “K5” to identify codes that describe items, procedures, and services for which pricing information and claims data are not available, and consequently, no ASC payment will be made. This new payment indicator, effective January 1, 2021, provides the assignment, definition, and detail needed for this subset of HCPCS codes.”
• Transmittal 10525: https://www.cms.gov/files/document/r10525otn.pdf

Telehealth Expansion Benefit Enhancement Under the Pennsylvania Rural Health Model (PARHM) – Implementation

• Article Release Date: August 10, 2020 – Revised December 22, 2020
• What You Need to Know: Revisions were made due to a revised CR 11870 with updates to some denial edits.
• MLN MM11870: https://www.cms.gov/files/document/MM11870.pdf

MEDICARE COVERAGE UPDATES

December 1, 2020: CMS Updates Coverage Policies for Artificial Hearts and Ventricular Access Devices (VADs)

CMS released Decision Memo CAG-00453N on December 1st updating coverage requirements for artificial hearts and VADs. Specifically,

• Artificial Hearts: “CMS is removing the NCD at § 20.9, ending coverage with evidence development for artificial hearts and permitting Medicare coverage determinations for artificial hearts to be made by the Medicare Administrative Contractors (MACs) under § 1862(a)(1)(A) of the Social Security Act.”
• VADs: CMS notes in a related Press Release that “The final national coverage determination, which is effective today, also provides updated coverage criteria for VADs that better aligns with current medical practice and that we believe will expand coverage to a greater number of candidates who are likely to benefit from this technology. Specifically, the updated patient criteria in the NCD aligns with the inclusion criteria derived from recent large randomized controlled trials, which demonstrated improved patient outcomes.”

December 21, 2020: Proposed Updates to Coverage Policy for Autologous Blood-Derived Products from Chronic Non-Healing Wounds

CMS proposed to “update coverage of Platelet Rich Plasma (PRP) for the treatment of chronic non-healing diabetic, venous, and pressure wounds. PRP is a blood-derived product prepared from the patient’s own blood to be used as a wound covering in the management of chronic wounds. PRP is currently covered under the Coverage with Evidence Development (CED) pathway for the treatment of chronic, non-healing diabetic, venous, and pressure wounds when beneficiaries are enrolled in a clinical study. This proposed National Coverage Determination would eliminate the CED requirement and nationally cover PRP for the treatment of chronic non-healing diabetic wounds. The proposal also would provide for coverage determinations for PRP for all other chronic non-healing wounds to be made by local Medicare Administrative Contractors.”

CMS is seeking comments on the proposed national coverage determination.

MEDICARE EDUCATIONAL RESOURCES

December 10, 2020: MLN Call – Physician Fee Schedule Final Rule: Understanding 4 Key Concepts

CMS hosted a Medicare Learning Event to provide information about the following four key concepts in the 2021 PFS Final Rule:

• Extending Telehealth & Licensing Flexibilities,
• Evaluation and Management (E/M) Visits and Analogous Services,
• Quality Payment Program Updates, and
• Opioid Use Disorder/Substance Use Disorder Provisions.

You can access the Presentation on the 2020-12-10 Physician Fee Schedule webpage. 

KEPRO Case Review Connections: Acute Care Edition Winter 2020

KEPRO has released their Winter 2020 Edition of their Case Review Connections e-newsletter for Acute Care. Examples of what’s in this newsletter are the Medical Director’s Corner, a notice about them now accepting Medical Records electronically and an immediate advocacy success story.

MLN Educational Tool Medicare Preventive Services Updated in December

CMS has revised this Medicare Learning Network educational too. The tool provides information about coding, coverage and the beneficiary’s copayment/coinsurance and deductible.

• ICN: MLN006559: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/MLN-Publications-Items/CMS1243319?DLPage=1&DLEntries=10&DLFilter=preventive%20ser&DLSort=0&DLSortDir=ascending

OTHER MEDICARE UPDATES

December 1, 2020: CMS Releases 2021 Medicare Physician Fee Schedule (PFS) Final Rule

The following list highlights several of the changes found in the PFS Final Rule for 2021:

• Within the Final Rule, CMS issued two interim final rules with comment period.
• The first interim final rule is “to establish coding and payment for virtual check-in services to support the continued need for coding and payment to reflect the provisions of lengthier audio-only services outside of the PHE for COVID,19, if not as substitutes for in-person services.”
• The second interim final rule is “to establish coding and payments for PPE as a bundled service and certain supply pricing increases in recognition of the increased market-based costs for certain types of PPE.”
• Payments have been Increased to physicians and other practitioners for additional time spent with patients providing chronic disease management,
• Sixty additional services have been added to the telehealth list that will continue to be covered beyond the COVID-19 public health emergency (PHE),
• CMS established on an interim final basis a new HCPCS G-code describing 11-20 minutes of medical discussion to determine the necessity of an inpatient visit.”
• CMS commissioned a study of its telehealth flexibilities during the COVID-19 PHE,
• The increase in payment rates for office/outpatient face-to-face evaluation and management (E/M) visits finalized in 2020 goes into effect in 2021. According to a related CMS Press Release, the payment increases “support clinicians who provide crucial care for patients with dementia or manage transitions between the hospital, nursing facilities, and home,”
• Simplified coding and documentation changes for Medicare billing for E/M office visits goes into effect January 1, 2021 modernizing guidelines developed in the 1990’s,
• CMS Finalized the following workforce flexibilities that have been provided during the COVID-19 PHE:

• “Certain non-physician practitioners such as nurse practitioners and physician assistants can supervise the performance of diagnostic tests within their scope of practice and state law, as they maintain required statutory relationships with supervising or collaborating physicians.
• Physical and occupational therapists will be able to delegate “maintenance therapy” – the ongoing care after a therapy program is established – to a therapy assistant.
• Physical and occupational therapists, speech-language pathologists, and other clinicians who directly bill Medicare can review and verify, rather than re-document, information already entered by other members of the clinical team into a patient’s medical record. As a result, practitioners have the flexibility to delegate certain types of care, reduce duplicative documentation, and supervise certain services they could not before, increasing access to care for Medicare beneficiaries.”

• CMS notes in a related Fact Sheet that “direct supervision may be provided using real-time, interactive audio and video technology through the later of the end of the calendar year in which the PHE ends or December 31, 2021.”
• CMS finalized the elimination of six older National Coverage Determinations (NCDs) and noted in the final rule “that if the previous NCD barred coverage for an item or service under title XVIII (that is, national noncoverage NCD), a MAC would now be able to cover the item or service if the MAC determined that such action was appropriate under the statue…proactively removing obsolete broad non-coverage NCDs removes barriers to innovation and reduces burden for stakeholders and CMS.” The effective date for removal of the following six NCDs is on the date of the final rule:
• NCD 20.5 – Extracorporeal Immunoadsorption (ECI) Using Protein A Columns,
• NCD 30.4 – Electrosleep Therapy,
• NCD 100.9 – Implantation of Gastrointestinal Devices,
• NCD 110.19 – Abarelix for the Treatment of Prostate Cancer
• NCD 220.2.1 – Magnetic Resonance Spectroscopy, and
• NCD 220.6.16 - FDG PET for Inflammation and Infection.

December 2, 2020: OIG Fall 2020 Semiannual Report to Congress

The OIG Semiannual Report reflects work performed from April 1, 2020 through September 30, 2020. Following are some of the high-level findings from the report by the numbers:

• 97 – the number of audit reports completed
• 27 – the number of evaluation reports completed
• $337 million – the amount identified in expected recoveries,
• $446 million – costs questions by the OIG because of an alleged violations, costs not supported by adequate documentation, or the expenditure of funds where the intended purpose is unnecessary or unreasonable,
• $2 billion – potential savings identified for HHS; and
• 416 – The number of new audit and evaluation recommendations made by the OIG.

December 7, 2020: 2021 IPPS Final Rule Correction Notice Published in Federal Register

This document corrects technical and typographical errors in the September 18, 2020 issue of the FY 2021 IPPS Final Rule.

December 10, 2020: CMS Proposed Modifications to the HIPAA Privacy Rule

HHS notes in their announcement the proposed changes will “support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry.” The Summary statement in the Proposed Rule indicates that “these modifications address standards that may impede the transition to value-based health care by limiting or discouraging care coordination and case management communications among individuals and covered entities (including hospitals, physicians, and other health care providers, payors, and insurers) or posing other unnecessary burdens. The proposals in this NPRM address these burdens while continuing to protect the privacy and security of individuals’ protected health information.”

December 10, 2020: CMS Proposes New Rules to Address Prior Authorization and Reduce Burden on Patients and Providers

CMS released the following information in a December 12, 2020 Special Edition of MLNConnects:

On December 10, under President Trump’s leadership, CMS issued a proposed rule that would improve the electronic exchange of health care data among payers, providers, and patients and streamline processes related to prior authorization to reduce burden on providers and patients. By both increasing data flow and reducing burden, this proposed rule would give providers more time to focus on their patients and provide better quality care. For More Information:

• Proposed Rule (PDF): Comment period closes January 4
• Full press release
• Fact sheet
• Blog
• CMS Interoperability and Patient Access Final Rule”

December 16, 2020: CMS Report – National Healthcare Spending in 2019

“The National Health Expenditure Accounts (NHEA) are the official estimates of total health care spending in the United States. Dating back to 1960, the NHEA measures annual U.S. expenditures for health care goods and services, public health activities, government administration, the net cost of health insurance, and investment related to health care. The data are presented by type of service, sources of funding, and type of sponsor.

U.S. health care spending grew 4.6 percent in 2019, reaching $3.8 trillion or $11,582 per person.  As a share of the nation's Gross Domestic Product, health spending accounted for 17.7 percent.”

You can download the entire report on the CMS National Health Expenditure Data Historical webpage.

December 18, 2020: Special Edition MLNConnects: Monitoring for Hospital Price Transparency

CMS indicated in this Special Edition MLNConnects that they plan “to audit a sample of hospitals for compliance starting in January, in addition to investigating complaints that are submitted to CMS and reviewing analyses of non-compliance, and hospitals may face civil monetary penalties for noncompliance.” CMS also reminds providers of their Hospital Price Transparency website where they have provided several resources for hospitals as they work towards compliance with Hospital Price Transparency. 

December 31, 2020: Palmetto GBA offers Introduction to 2021 E&M Changes

Palmetto GBA included the following information in their December 31st Daily Newsletter:

“Effective January 1, 2021, the Centers for Medicare and Medicaid Services (CMS) implemented a new coding, prefatory language, and interpretive guidance framework that the American Medical Association Current Procedural Terminology Editorial Panel issued for office and outpatient E/M visits. Please review the information in this job aid and share it with your staff.” You can access this introduction education material at: https://www.palmettogba.com/palmetto/providers.nsf/ls/JJ%20Part%20B~BWSU772836?opendocument.

January 1, 2021: CMS Releases MLN Guide Titled Evaluation and Management (E/M) Services

CMS has released publication ICN: 006764 that serves as a guide to learning the principles of documentation, common sets of codes used to bill for services, and other considerations.

MEDICARE TRANSMITTALS – RECURRING UPDATES

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – October 2020 Update - Revised

• Article Release Date: August 7, 2020 – revised October 27, 2020
• What You Need to Know: Revisions reflect changes made to CR11939 where CMS added information about codes 3170F, 0599T, A4226, and the new codes 86408, 86409, 86413, and 99072.
• MLN MM11939: https://www.cms.gov/files/document/MM11939.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
• What You Need to Know: This article provides information found in the October 30, 2020 Change Request (CR) 12027 about updated ICD-10 conversions and coding updates specific to National Coverage Determinations (NCDs).
• MLN MM12027: https://www.cms.gov/files/document/mm12027.pdf

Changes to the End Stage Renal Disease (ESRD) PRICER to Accept the New Outpatient Provider Specific File Supplemental Wage Index Fields, the Network Reduction Calculation and New Value Code for Time on Machine

• Article Release Date: November 12, 2020
• What You Need to Know: This article provides information about changes to the ESRD PRICER software, the new value code required for reporting minutes of dialysis provided during the billing period and explains the ESRD Network Reduction calculations from the FIAA into the PRICER.
• MLN MM11871: https://www.cms.gov/files/document/mm11871.pdf

OTHER MEDICARE TRANSMITTALS

Special Provisions for Radiology Additional Documentation Requests

• Article Release Date: October 30, 2020
• What You Need to Know: This article discusses a pilot process enabling MACs to request pertinent documentation from treating/ordering provider during medical review, in an effort to support the necessity and payment for radiology service(s)/items(s) (billed to Medicare.”
• MLN MM11659: https://www.cms.gov/files/document/mm11659.pdf

Update to Chapter 10 of Publication (Pub.) 100-08- Enrollment Policies for Home Infusion Therapy (HIT) Suppliers

• Article Release Date: October 30, 2020
• What You Need to Know: Change Request (CR) 11954 informs MACs of the policies and procedures for enrolling HIT suppliers in Medicare. MACs will accept enrollment applications beginning on or after November 1, 2020.
• MLN MM11954: https://www.cms.gov/files/document/mm11954.pdf

Manual Updates Related to the Hospice Election Statement and the Implementation of the Election Statement Addendum

• Article Release Date: November 6, 2020
• What You Need to Know: CMS is modifying the Medicare Benefit Policy Manual to include modifications to the election statement and the requirements for the hospice election statement addendum that became effective for hospice elections beginning on or after October 1, 2020.
• MLN MM12015: https://www.cms.gov/files/document/mm12015.pdf

Updates to Skilled Nursing Facility (SNF) Patient Driven Payment Model (PDPM) Claims

• Article Release Date: November 9, 2020
• What You Need to Know: This article provides updated information about claims processing instructions to adhere to current Medicare policy.
• MLN MM11992: https://www.cms.gov/files/document/mm11992.pdf

Updates to Vaccine Services Editing

• Article Release Date: November 13, 2020
• What You Need to Know: This article is for those that provide vaccines to Medicare beneficiaries and bill Medicare Administrative Contractors (MACs) for those services. Specific for hospitals related CR 11975 “modifies current editing to allow vaccines and their administration when they are the only services on a 12x claim where the service date is equal to the discharge date of an inpatient claim for the same provider and the service date is equal to the "From" date of another inpatient claim with condition code B4 for the same provider.”
• MLN MM11975: https://www.cms.gov/files/document/mm11975.pdf

Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year (CY) 2021

• Article Release Date: November 20, 2020
• What You Need to Know: Among other rates, Medicare beneficiaries without a secondary insurance will have a $1,484.00 Part A Deductible to pay if admitted as an inpatient beginning January 1, 2021.
• MLN Matters: MM12024: https://www.cms.gov/files/document/mm12024.pdf

Implement Operating Rules – Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule – Update from Council for Affordable Quality Healthcare (CAQH) CORE

• Article Release Date: November 20, 2020
• What You Need to Know: This article provides Medicare system updates based on the CORE Code Combination List to be published on or about February 1, 2021.
• MLN MM11988: https://www.cms.gov/files/document/mm11988.pdf

Implementation of Two (2) New NUBC Condition Codes. Condition Code “90”, “Service Provided as Part of an Expanded Access Approval (EA)” and Condition Code “91”, “Service Provided as Part of an Emergency Use Authorization (EUA)”

• Article Release Date: November 20, 2020
• What You Need to Know: The following two new NUBC codes will be effective for claims received on or after February 1, 2021
• “90” – To allow providers to report when the service is provided as part of an Expanded Access approval, and
• “91” – To allow providers to report when the service is provided as part of an Emergency Use Authorization (EUA).
• MLN MM12049: https://www.cms.gov/files/document/mm12049.pdf

Claim Status Category and Claim Status Codes Update

• Article Release Date: November 20, 2020
• What You Need to Know: This article informs you that all code changes approved during the January/February 2021 committee meeting shall be posted on or about March 1, 2021 with an effective date of April 1, 2021 and Implementation Date of April 5, 2021.
• MLN MM11957: https://www.cms.gov/files/document/mm11957.pdf

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

• Article Release Date: November 20, 2020
• What You Need to Know: This article updates the RARC and CARC lists and instructs the Medicare’s system maintainers to update MREP and PC Print. Note, the code update schedule is published three times a year with the next implementation date being April 5, 2021.
• MLN MM11943: https://www.cms.gov/files/document/mm11943.pdf

REVISED MEDICARE TRANSMITTALS

Penalty for Delayed Request for Anticipated Payment (RAP) Submission -- Implementation

• Article Release Date: July 31, 2020 – Revised October 27, 2020
• What You Need to Know: This article was revised to reflect changes made to CR 11855 including adding remittance advice message information.
• MLN MM11855: https://www.cms.gov/files/document/mm11855.pdf

October Quarterly Update for 2020 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

• Article Release Date: August 28, 2020 – Revised October 28, 2020
• What You Need to Know: This article was revised to reflect a revised CR11956 clarifying the claims processing jurisdiction for code K1109.
• MLN MM11956: https://www.cms.gov/files/document/mm11956.pdf

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

• Article Release Date: August 7, 2020 – Revised November 13, 2020
• What You Need to Know: This article was revised to reflect a revised CR 11880. Additions to the article include statements related to the status indicator for the G codes on the Physician Fee Schedule and noting that MACs will post HIT fees on their websites as soon as possible.
• MLN MM11880: https://www.cms.gov/files/document/mm11880.pdf

Home Health Prospective Payment System (HH PPS) Rate Update for Calendar Year (CY) 2021

• Article Release Date: November 9, 2020 – Revised November 20, 2020
• What You Need to Know: This article provides several payment updates related to the HH PPS. Note, this article was revised to reflect an updated CR 12017 that revised the Policy section and updated the Payment Rate Tables.
• MLN MM12017: https://www.cms.gov/files/document/mm12017.pdf

Overview of the Repetitive, Scheduled Non-emergent Ambulance Prior Authorization Model

• Article Release Date: May 4, 2015 – Revised November 20, 2020
• What You Need to Know: This article was revised to show the model will not end December 1, 2020. “The model no longer has an end date and will remain in effect for the nine model states.”
• MLN SE1514: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE1514.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: November 9, 2020 – Revised November 23, 2020
• What You Need to Know: This article provides information about payment rate updates and policies for CY 2021. Note, this article was revised to reflect a revised CR 12011.
• MLN MM12011: https://www.cms.gov/files/document/mm12011.pdf

MEDICARE COVERAGE UPDATES

November 13, 2020: National Coverage Determination (NCD 90.3): Chimeric Antigen Receptor (CAR) T-cell Therapy

• Article Release Date: November 17, 2020
• What You Need to Know: Effective for claims with dates of service on or after August 7, 2019, CMS covers autologous treatment for cancer T-cells expressing at least one CAR when administered at healthcare facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS) and meets specified FDA conditions. Note, this article includes billing requirements guidance.
• MLN Matters MM11783: https://www.cms.gov/files/document/mm11783.pdf

OTHER MEDICARE UPDATES

October 27, 2020: New CMS Proposals Streamline Medicare Coverage, Payment, and Coding for Innovative New Technologies and Provide Beneficiaries with Diabetes Access to More Therapy Choices

CMS published a Special Edition MLNConnects announcing a Durable Medical Equipment (DME) proposed rule aimed at reducing administrative burden for new innovative technologies.

November 2, 2020: Long-Term Services and Supports (LTSS) Rebalancing Toolkit Fact Sheet

CMS announced the release of a Long-Term Services and Supports (LTSS) Rebalancing Toolkit “to support states in their efforts to expand and enhance home and community-based services (HCBS) and to rebalance, or recalibrate, LTSS from institutional to community-based systems. You can read more about this in the CMS Press Release and related Fact Sheet.

November 2, 2020: CMS issues End-Stage Renal Disease (ESRD) Prospective Payment System Final Rule

This final rule updates payment policies and rates under the ESRD PPS for renal dialysis services furnished to beneficiaries enrolled in Original Medicare on or after January 1, 2021. It also updates the Acute Kidney Injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI and finalized changes to the ESRD Quality Incentive Program. “Medicare expects to pay $10.3 billion to approximately 7,400 ESRD facilities for the costs associated with furnishing renal dialysis services.”

For More Information:

• Final rule

• Press release
• Full text of fact sheet

November 4, 2020: HHS Proposes Unprecedented Regulatory Reform through Retrospective Review

HHS announced a notice of proposed rulemaking that would require “the Department to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA), which requires regular review of certain significant regulations. If a given regulation is subject to the RFA, the Department must review the regulation every ten years to determine whether the regulation is still needed and whether it is having appropriate impacts. Regulations will expire if the Department does not assess and (if required) review them in a timely manner.”

November 6, 2020: OIG Report – $35 Million in Overpayments for Medical Devices

Hospitals seem to continue to struggle with the Federal regulations for medical device credits as evidenced by the $35 million in overpayments reported by the OIG in this November 6, 2020 report.  

November 6, 2020: 2021 Medicare Parts A & B Premiums and Deductibles

The 2021 Monthly Medicare Parts A and B premiums, deductibles and coinsurance were announced in a CMS Press Release. Following are the changes from 2020 to 2021:

Medicare Part A Inpatient Deductible

• 2020 - $1,408
• 2021 - $1,484

Medicare Part B Enrollees Standard Monthly Premium

• 2020 - $144.60
• 2021 - $148.50

Medicare Part B Enrollees Annual Deductible

• 2020 - $198
• 2021 - $203

For a fact sheet on the 2021 Medicare Parts A & B premiums and deductibles, please visit: https://www.cms.gov/newsroom/fact-sheets/2021-medicare-parts-b-premiums-and-deductibles

November 9, 2020: Medicaid and CHIP Managed Care Final Rule Released

CMS announced the release of this final rule noting that “the purpose of the rule is to ensure state Medicaid and CHIP agencies are able to work effectively to develop and implement managed care programs that better serve each state’s growing number of Medicaid and CHIP beneficiaries.”

November 16, 2020: OIG Report – Hospitals Did Not Comply with Medicare Requirements for Reporting Cardiac Device Credits

The OIG found that hospitals did not always comply with Medicare requirements associated with reporting manufacturer credits for recalled or prematurely failed cardiac medical devices. Specifically, “911 hospitals received payments of $76 million rather than the $43 million they should have received, resulting in $33 million in potential overpayments. Medicare contractors made these overpayments because they do not have a postpayment review process that would ensure that hospitals reported manufacturer credits for cardiac medical devices.” The first of seven recommendations made by the OIG is that MAC’s should recover the portion of the $33 million overpayment that are within the reopening period.

November 17, 2020: CMS to Retire Original Compare Tools December 1st

CMS will retire the Original Compare Tools as they have been replaced with Care Compare on Medicare.gov. This new site streamlines the eight original health care compare tools. CMS notes that “Care Compare offers a new design that makes it easier to find the same information that’s on the original compare tools. It gives you, patients, and caregivers one user-friendly place to find cost, quality of care, service volume, and other CMS quality data to help make informed health care decisions.”

To learn more about the history of and what information is available go to CMS’ Hospital Compare webpage.

November 17, 2020: Medicare FFS Estimated Improper Payments Decline by $15 Billion Since 2016

In the Thursday November 19th edition of the MLNConnects Newsletter, CMS touts a “continued reduction marks fourth year Medicare FFS improper payment rate has been below 10%.” A related November 16th CMS Fact Sheet indicates that the Medicare FFS improper payment rate decreased from 7.25% in 2019 to an estimated 6.27% for 2020.

• CMS Press Release: Trump Administration Announced Medicare Fee-for-Service Estimated Improper Payments Decline by $15 Billion Since 2016
• CMS Fact Sheet: 2020 Estimated Improper Payment Rates for Centers for Medicare & Medicaid Services (CMS) Programs

November 20, 2020: Two New HHS Final Rules Advancing Value-Based Care

HHS announced the release of an OIG and CMS Final Rule, both aimed “to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system into one that pays for value and promotes the delivery of coordinated care.”

• OIG Final Rule: “Revisions to the Safe Harbors Under the Anti-Kickback Statue and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” - “OIG’s new safe harbor regulations are designed to facilitate better coordinated care for patients, value-based care, and improved cybersecurity, while also protecting against fraudulent or abusive conduct,” said Christi A. Grimm, Principal Deputy Inspector General.”

• CMS Final Rule: “Modernizing and Clarifying the Physician Self-Referral Regulations” - “The CMS final rule clarifies and modifies existing policies to ease unnecessary regulatory burden on physicians and other healthcare providers while reinforcing the physician self-referral law’s (often called the “Stark Law”) goal of protecting patients from unnecessary services and being steered to less convenient, lower quality, or more expensive services because of a physician’s financial self-interest.”

Reprinted from Kaiser Health News (CC BY-NC-ND 4.0)

Jordan Rau, Kaiser Health News  November 2, 2020

Nearly half the nation’s hospitals, many of which are still wrestling with the financial fallout of the unexpected coronavirus, will get lower payments for all Medicare patients because of their history of readmitting patients, federal records show.

The penalties are the ninth annual round of the Hospital Readmissions Reduction Program created as part of the Affordable Care Act’s broader effort to improve quality and lower costs. The latest penalties are calculated using each hospital case history between July 2016 and June 2019, so the flood of coronavirus patients that have swamped hospitals this year were not included.

The Centers for Medicare & Medicaid Services announced in September it may suspend the penalty program in the future if the chaos surrounding the pandemic, including the spring’s moratorium on elective surgeries, makes it too difficult to assess hospital performance.

For this year, the penalties remain in effect. Retroactive to the federal fiscal year that began Oct. 1, Medicare will lower a year’s worth of payments to 2,545 hospitals, the data show. The average reduction is 0.69%, with 613 hospitals receiving a penalty of 1% or more.

Out of 5,267 hospitals in the country, Congress has exempted 2,176 from the threat of penalties, either because they are critical access hospitals — defined as the only inpatient facility in an area — or hospitals that specialize in psychiatric patients, children, veterans, rehabilitation or long-term care. Of the 3,080 hospitals CMS evaluated, 83% received a penalty.

The number and severity of penalties were comparable to those of recent years, although the number of hospitals receiving the maximum penalty of 3% dropped from 56 to 39. Because the penalties are applied to new admission payments, the total dollar amount each hospital will lose will not be known until after the fiscal year ends on July 30.

“It’s unfortunate that hospitals will face readmission penalties in fiscal year 2021,” said Akin Demehin, director of policy at the American Hospital Association. “Given the financial strain that hospitals are under, every dollar counts, and the impact of any penalty is significant.”

The penalties are based on readmissions of Medicare patients who initially came to the hospital with diagnoses of congestive heart failure, heart attack, pneumonia, chronic obstructive pulmonary disease, hip or knee replacement or coronary artery bypass graft surgery. Medicare counts as a readmission any of those patients who ended up back in any hospital within 30 days of discharge, except for planned returns like a second phase of surgery.

A hospital will be penalized if its readmission rate is higher than expected given the national trends in any one of those categories.

The industry has disapproved of the program since its inception, complaining the measures aren’t precise and it unfairly punishes hospitals that treat low-income patients, who often don’t have the resources to ensure their recoveries are successful.

Michael Millenson, a health quality consultant who focuses on patient safety, said the penalties are a useful but imperfect mechanism to push hospitals to improve their care. The designers of the penalty system envisioned it as a way to neutralize the economic benefit hospitals get from readmitted patients under Medicare’s fee-for-service payment model, as they are otherwise paid for two stays instead of just one.

“Every industry complains the penalties are too harsh,” he said. “if you’re going to tell me we don’t need any economic incentives to do the right thing because we’re always doing the right thing — that’s not true.”

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MEDICARE TRANSMITTALS – RECURRING UPDATES

January 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

• Article Release Date: October 9, 2020
• What You Need to Know: This article informs providers about updates to the Quarterly ASP Medicare Part B Pricing Files and informs you of revisions, if needed to prior quarterly pricing files.
• MLN MM12020: https://www.cms.gov/files/document/MM12020.pdf

OTHER MEDICARE TRANSMITTALS

 New Waived Tests

• Article Release Date: October 5, 2020 – Revised October 15, 2020
• What You Need to Know: This article tells you of new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the FDA. CMS notes that “MACs will not search their files to either retract payment or retroactively pay claims, however, MACs should adjust claims if you bring those claims to their attention.”
• Note, this article was revised to correct a date for one of the codes for 87804QW.
• MLN Matters MM11982: https://www.cms.gov/files/document/mm11982.pdf

Ambulance Inflation Factor (AIF) for Calendar Year (CY) 2021 and Productivity Adjustment

• Article Release Date: October 16, 2020
• What You Need to Know: This article provides the CY 2021 AIF for determining the payment limit for ambulance services.
• MLN MM12031: https://www.cms.gov/files/document/mm12031.pdf

REVISED MEDICARE TRANSMITTALS

October 2020 Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.3

• Article Release Date: August 28, 2020 – Revised October 5, 2020
• What You Need to Know: This article was revised to reflect changes made to CR 11944 including adding several items to the Summary of Quarterly Release Modifications table.
• MLN Matters MM11944: https://www.cms.gov/files/document/mm11944.pdf

Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for FY 2020

• Article Release Date: August 31, 2020 – Revised September 24, 2020
• What You Need to Know: This article was revised to reflect a revised CR 11876 which changed the hourly Continuous Home Care rates in the hospice tables.
• MLN Matters MM11876: https://www.cms.gov/files/document/mm11876.pdf

Change to the Payment of Allogeneic Stem Cell Acquisition Services

• Article Release Date: July 13, 2020 – Revised October 21, 2020
• What You Need to Know: This article was revised to reflect the revised CR 11729 issued on October 20, 2020. This revision did not impact the substance of the article.
• MLN Matters: MM11729: https://www.cms.gov/files/document/mm11729.pdf

MEDICARE COVERAGE UPDATES

October 22, 2020: MCD Overview Page and Advanced Search Function Going Away

CMS has posted the following alert on the Medicare Coverage Database (MCD) Notice Board:

“On December 11, 2020, the Overview page of the Medicare Coverage Database (MCD) application will be removed in an effort to streamline the site. The website address will remain cms.gov/medicare-coverage-database but users will be directed to the Search page by default, instead of the Overview page.

On April 30, 2021, the Advanced Search function of the MCD application will be removed. All features related to the Advanced Search were incorporated into the new Search function, which was released on September 3, 2020. The new Search function is both faster and easier to use than the Advanced Search, so please switch to the new Search if you haven't already. Bookmarks to advanced-search.aspx and search-results.aspx will no longer work after April 30, 2021.”

MEDICARE EDUCATIONAL RESOURCES

September 28, 2020: MLN Fact Sheet: ICD-10-CM, ICD-10-PCS, CPT, and HCPCS Code Sets

• What You Need to Know: CMS released this educational tool to give “health care providers, suppliers, medical coders, billing and claims staff an easy reference to information on the code sets used to bill Medicare claims.” CMS advises using this tool when submitting inpatient and outpatient diagnoses, procedures, and supplies on Medicare claims.
• ICN MLN900943 September 2020: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCS-Code-Sets-Educational-Tool-ICN900943.pdf

October 2020: Medicare Quarterly Provider Compliance Newsletter

This CMS quarterly newsletter provides information on how to avoid common billing errors and includes top issues of a particular quarter. The October 2020 edition of the newsletter highlights Recovery Auditor Findings related to the following two issues:

Issue #0070: Critical Care Billed on the Same Day as Emergency Room Services: Unbundling

• Provider Types Affected: Physicians and Non-Physician Practitioners (NPPs)
• Problem: “Hospital emergency department services are not payable for the same calendar date as critical care services when billed for the same beneficiary, on the same date of service and by the same service provider (based on Tax ID and Provider Specialty Code).
• Affected Codes: 99281, 99282, 99283, 99284, 99285
• Type of Review: Automated Review

Issue #0131: Pneumatic Compression Device (PCD): Medical Necessity and Documentation Requirements.

• Provider Types Affected: Durable Medical Equipment (DME) Suppliers, including physicians who supply DME
• Problem: When providing PCDs to patients, be sure the patient meets all Medicare coverage criteria.
• Affected codes: E0650, E0651, E0652, E0656, E0657, E0667, E0668, E0669 and E0670.
• Type of review: Complex Review

Link to newsletter: https://www.cms.gov/outreach-and-educationmedicare-learning-network-mlnmlnproductsmln-publications/mln5230120

OTHER MEDICARE UPDATES

September 28, 2020: CMS Guidance Related to the Emergency Preparedness Testing Exercise Requirements – COVID-19

CMS posted a Memo to State Surveyors on their website which included the following summary statements and a link to the memorandum:

“CMS regulations for Emergency Preparedness require specific testing exercises be conducted to validate the facility’s emergency program. During or after an actual emergency, the regulations allow for an exemption to the testing requirements based on real world actions taken by providers and suppliers.

This worksheet presents guidance for surveyors, as well as providers and suppliers, with relevant scenarios on meeting the testing requirements in light of many of the response activities associated with the COVID-19 Public Health Emergency (PHE).”

September 28, 2020: CY 2021 Annual Amount In Controversy (AIC) Adjustments

CMS published the AIC Adjustments for CY 2021 in the Federal Register:

• Administrative Law Judge (ALJ) hearings AIC threshold: $180, and
• Judicial Review AIC threshold: $1,760.

October 5, 2020: Compliance with Residents’ Rights Requirement related to Nursing Home Residents’ Right to Vote

CMS sent this Memorandum to State Survey Agency Directors on October 5, 2020. Following are the three Memorandum Summary bullets:

• The Centers for Medicare & Medicaid Services (CMS) is affirming the continued right of nursing home residents to exercise their right to vote.
• While the COVID-19 Public Health Emergency has resulted in limitations for visitors to enter the facility to assist residents, nursing homes must still ensure residents are able to exercise their Constitutional right to vote.
• States, localities, and nursing home owners and administrators are encouraged to collaborate to ensure a resident’s right to vote is not impeded.

Additionally, CMS has published a letter to be sent to nursing home residents or family members.

October 8, 2020: CMS Press Release: Medicare Advantage and Medicare Part D Quality Ratings

CMS indicates in this Press Release that “according to the latest data, quality ratings of Medicare Advantage and Medicare Part D drug plans remain strong. Most Medicare beneficiaries – about 77 percent – who enroll in Medicare Advantage plans with drug coverage will be in plans with four or more stars in 2021.”

October 9, 2020: New National Action Plan for Combating Antibiotic-Resistant Bacteria

The CDC announced the release of the next National Action Plan for Combating Antibiotic-Resistant Bacteria for 2020-2025. They note in the announcement that antibiotic-resistant infections kill more than 35,000 people in the United States each year.

October 19, 2020: Palmetto GBA Outpatient Department (OPD) Prior Authorization (PA) Alert!

Palmetto GBA included in the following Alert in their October 21, 2020 Daily eNewlsetter:

“As of October 9, 2020, if you are a physician/NPP (Part B provider), you are required to provide two (2) fax numbers to receive your Outpatient Department (OPD) Prior Authorization (PA) decision. If a second fax number is not provided, your OPD PA will be rejected. 

If the requestor is a representative of the Hospital Outpatient Facility, only one (1) fax number is required.

Did you know?
...that the when requesting an OPD PA you must include both the hospital and the requestor’s fax number if the requestor is the physician/NPP (Part B provider)? If not, your PA will be rejected.

Did you know?
...that if the requestor is a representative of the Hospital Outpatient Facility, only one fax number is required.”

October 21, 2020: CMS Announcement, Radiation Oncology Model Delayed

CMS posted the following update to the CMS Radiation Oncology Model webpage:

“UPDATE: (10/21/2020) - CMS has received feedback from a number of stakeholders about the challenges of preparing to implement the RO Model by January 1, 2021. Based on this feedback, CMS intends to delay the RO Model start date to July 1, 2021. We are pursuing rulemaking to make this change.” Note, slides for two recent events related to this model as well as an FAQ document are also available on the Radiation Oncology Model webpage.

October 2020 C2C Innovative Solutions, Inc. Quarterly Newsletter Released

C2C Innovative Solutions Inc. (C2C), the Qualified Independent Contractor (QIC) for Medicare Part A for 26 eastern states, Washington D.C. and two U.S. territories, has released its quarterly newsletter.

October 21, 2020: Alabama Medicaid Alert: National Changes for Office Visit Procedure Codes

The Alabama Medicaid Agency issued an Alert reminding providers about the upcoming changes for Evaluation and Management (E&M) Procedure Codes effective January 1, 2021. This Alert includes links to National Information and Additional Resources about the changes.

Pre-orders have started for Apple’s soon to be released iPhone 12. Imagine what it would be like for devoted iPhone fans if the time from placing a pre-order to when you could actually hold one in your hands followed the CMS timeline for approval for new healthcare technologies. This would definitely not be the timeline for creating and maintaining a consumer base of people wanting the latest technology available in an iPhone.

In September, 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.”

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.

Current Medicare Coverage Pathways

The MCIT pathway is being 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 details current Medicare coverage pathways in this proposed rule. Each pathway is highlighted in the following table. 

‍Proposed MCIT Coverage Pathway

The MCIT Coverage Pathway would be specifically for Medicare coverage of devices that are designated as part of the FDA Breakthrough Devices Program and are FDA market authorized. The pathway would involve a coordinated effort by CMS, the FDA and manufacturers as medical devices move through the FDA regulatory process for Breakthrough devices. This simultaneous effort will ensure Medicare coverage on the date of FDA market authorization for all devices that fall within a Medicare benefit category.

MCIT Pathway Proposals:

• The pathway would be voluntary and be initiated when a manufacturer notifies CMS of its intention to utilize the MCIT pathway.
• To be part of the MCIT Pathway, the device must be used in accordance with its FDA approved or cleared indication for use.
• Unlike the pathways in the above table, CMS is proposing that that MCIT Pathway would 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.
• If CMS has issued an NCD for a specific breakthrough device, it would not be eligible for the MCIT pathway.
• Coverage would continue for up to 4 years, unless CMS determines the device does not have a Medicare benefit category as determined as part of the pathway process.
• Reasons that the MCIT pathway may end prior to 4 years includes circumstances where a device becomes subject to an NCD, regulation, statute, or if the device can no longer be lawfully marketed.

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.

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. They are also seeking comments on whether or not a National Coverage Analysis should be opened if a MAC has not issued an LCD within 6 months of the expiration date of the MCIT period.

MCIT Device Eligibility

CMS is proposing that devices having received Breakthrough Device designation within 2 years of the date this proposed rule is finalized will be eligible for coverage for claims submitted on or after the effective date of the final rule. This group of devices would not be eligible for all 4 years of MCIT coverage as the 4 year period starts on the date of FDA market authorization. CMS anticipates 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.

Proposal to Codify Definition of “Reasonable and Necessary”

In addition to the proposed MCIT Pathway, CMS is proposing 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.”

Proposal: “An item or service would be considered ‘‘reasonable and necessary’’ if it is— (1) safe and effective; (2) not experimental or investigational; and (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is:

• 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;
• Furnished in a setting appropriate to the patient’s medical needs and condition;
• Ordered and furnished by qualified personnel;
• One that meets, but does not exceed, the patient’s medical need; and
• At least as beneficial as an existing and available medically appropriate alternative.”

Proposal: An item or service would be “appropriate for Medicare patients” under (3) if it is covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals.

Proposal: An item or service deemed appropriate for Medicare coverage based on commercial coverage would be covered on that basis without also having to satisfy the bullets listed above.

CMS Seeking Comments to the Proposed Rule

In the world of CMS proposed rules, this one makes for a quick read at just 13 pages in the Federal Register. CMS is seeking comments on many aspects of this proposed rule and comments must be received by CMS no later than 5 p.m. on November 2, 2020.

Resources

CMS Press Release: CMS Acts to Spur Innovation for America’s Seniors https://www.cms.gov/newsroom/press-releases/cms-acts-spur-innovation-americas-seniors

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

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

Proposed Rule (CMS-3372-P)

https://www.federalregister.gov/documents/2020/09/01/2020-19289/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and

MEDICARE TRANSMITTALS – RECURRING UPDATES

October 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: August 31, 2020
• What You Need to Know: This article informs providers about changes to and billing instructions for various payment policies implemented in the October 2020 OPPS update.
• MLN MM11905: https://www.cms.gov/files/document/mm11905.pdf

October 2020 Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.3

• Article Release Date: August 28, 2020
• What You Need to Know: This article provides information about the October 2020 version of the I/OCE instructions and specifications that Medicare uses.
• MLN MM11944: https://www.cms.gov/files/document/mm11944.pdf

Annual Clotting Factor Furnishing fee Update 2021

• Article Release Date: August 28, 2020
• What You Need to Know: The annual clotting factor furnishing fee for 2021 is $0.238 per unit.
• MLN MM11932: https://www.cms.gov/files/document/mm11932.pdf

2021 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments

• Article Release Date: August 28, 2020
• What You Need to Know: Section 413(b) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 mandated an annual update to the automated HPSA bonus payment file. This article lets providers know that CMS will provide MACs with files for the automated payments of HPSA bonuses for dates of service January 1, 2021 through December 31, 2021.
• MLN MM11852: https://www.cms.gov/files/document/mm11852.pdf

October Quarterly Update for the 2020 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

• Article Release Date: August 28, 2020
• What You Need to Know: This article provides details about the changes to the DMEPOS fee schedules that Medicare updates quarterly, when necessary, to implement fee schedule amounts for new and existing codes, as applicable, and apply changes in payment policies. Specific to the ongoing Public Health Emergency (PHE) due to the COVID-19 pandemic, “the October 2020 DMEPOS and PEN fee files continue to include the non-rural contiguous non-CBA 75/25 blended fees required by Section 3712(b) of the CARES Act signed into law on March 27, 2020.
• MLN MM11956: https://www.cms.gov/files/document/mm11956.pdf

Implement Operating Rules - Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule - Update from Council for Affordable Quality Healthcare (CAQH) CORE

• Article Release Date: August 28, 2020
• What You Need to Know: This article informs providers that Medicare will update its claims processing systems based on the Committee on Operating Rules for Information Exchange (CORE), Code Combination List, which will be published on or about October 1, 2020.
• MLN Matters MM11881: https://www.cms.gov/files/document/mm11881.pdf

Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice PRICER for FY 2021

• Article Release Date: August 31, 2020 – Revised September 10, 2020
• What You Need to Know: This article provides updates in Change Request (CR) 11876 to hospice payment rates, wage index, PRICER, and aggregate cap amounts for Fiscal Year (FY) 2021. Note, this article was revised on September 10th to correct two typos. All other information remained the same.
• MLN Matters MM11876: https://www.cms.gov/files/document/mm11876.pdf

Claim Status Category and Claim Status Codes Updates

• Article Release Date: August 28, 2020
• What You Need to Know: This article informs providers of updates to the Claim Status and Claims Status Category Codes used for the Accredited Standards Committee (ASC) X12 276/277 Health Care Claim Status Request and Response and ASC X12 277 Health Care Claim Acknowledgement transactions. Code changes during the September/October 2020 National Code Maintenance Committee (NCMC) meeting will be posted on or about November 1, 2020.
• MLN Matters MM11796: https://www.cms.gov/files/document/mm11796.pdf

2021 Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing facility (SNF) Consolidated Billing (CB) Update

• Article Release Date: September 16, 2020
• What You Need to Know: This articles provides information regarding changes to HCPCS codes and Medicare Physician Fee Schedule (MPFS) designations that Medicare uses to revise Common Working File (CWF) edits to allow MACs to make appropriate payments.
• MLN Matters MM11968: https://www.cms.gov/files/document/mm11968.pdf

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

• Article Release Date: September 22, 2020
• What You Need to Know: This article provides FY 2021 update to the IPPS and LTCH PPS.
• MLN MM11879: https://www.cms.gov/files/document/mm11879.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.0, Effective January 1, 2021

• Article Release Date: September 25, 2020
• What You Need to Know: CR 11984 provides quarterly updates to the NCCI PTP edits. A test file will be available around November 2, 2020 with a final file available on or about November 17, 2020.
• MLN MM11984: https://www.cms.gov/files/document/mm11984.pdf

OTHER MEDICARE TRANSMITTALS

Updates to Chapter 23 – Fee Schedule Administration and Coding Requirements

• Change Request Release Date: August 28, 2020
• What You Need to Know:
• CR 11941 (Transmittal 10320): https://www.cms.gov/files/document/r10320cp.pdf
• Effective Date: December 1, 2020
• Implementation Date: December 1, 2020

Internet Only Manual Update to Pub. 100-04, Chapter 16, Section 60.1.2 and Pub. 100-04, Chapter 26, Section 10.4, Item 19

• Article Release Date: September 4, 2020
• What You Need to Know: CMS has removed the reference to Electrocardiogram (EKG) services in the Medicare Claims Processing Manual, Chapter 16, Section 60.1.2 and Chapter 26, Section 10.4, Item 19. This change only clarifies existing content.
• MLN Matters MM11935: https://www.cms.gov/files/document/mm11935.pdf

Update to the Medicare Claims Processing Manual

• Article Release Date: September 18, 2020
• What You Need to Know: This article provides information regarding updated to the Medicare Claims Processing Manual, Chapters 12 and 23.
• MLN Matters MM111958: https://www.cms.gov/files/document/mm11958.pdf

REVISED MEDICARE TRANSMITTALS

National Coverage Determination (NCD 30.3.3): Acupuncture for Chronic Low back Pain (cLPB)

• Article Release Date: May 13, 2020 – Revised September 1, 2020
• What You Need to Know: This MLN article was revised to reflect an updated Change Request (CR) 11755 that provides revised messaging (page 3 in the article). It also revised the Claims Processing Manual at Section 410.4.
• MLN Matters MM11755: https://www.cms.gov/files/document/MM11755.pdf

Update to the Model Admission Questions for Providers to Ask Medicare Beneficiaries

• Article Release Date: September 4, 2020 – Revised September 15, 2020
• What You Need to Know: This article provides information about CMS modifying and streamlining the model admission questions for providers to ask Medicare beneficiaries or authorized representatives upon admission or start of care.
• Note, this article was revised on September 15th to reflect the CR revision adding part of sentence that had been left out of manual Section 20.2.2 of the Medicare Secondary Payer Manual.
• MLN Matters MM11945: https://www.cms.gov/files/document/mm11945.pdf

October 2020 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: September 11, 2020 – Revised September 24, 2020
• What You Need to Know: This article is based on Change Request (CR) 11963 which provides information about changes to and billing instructions for various payment policies implemented in the October 2020 ASC payment system update.
• Note, this article was revised to reflect the updated CR revision to HCPCS code C9066 in Table 2 in the CR.
• MLN MM11963: https://www.cms.gov/files/document/mm11963.pdf

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

• Article Release Date: August 7, 2020 – Latest Revision September 24, 2020
• What You Need to Know: This article informs laboratories of changes from the quarterly update to the clinical laboratory fee schedule. Now in its third iteration, this article was most recently updated to add new COVID-19 code (86413) and ADLT code (0090U).
• MLN MM11937: https://www.cms.gov/files/document/mm11937.pdf

Change to the Payment of Allogeneic Stem Cell Acquisition Services

• Article Release Date: July 13, 2020 – Revised September 24, 2020
• What You Need to Know: This article was revised to reflect a revised CR issued on September 24, 2020. All other information remains the same.
• MLN MM11729: https://www.cms.gov/files/document/mm11729.pdf

October 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Article Release Date: August 31, 2020 – Revised September 25, 2020
• What You Need to Know: This article has been revised to reflect an updated CR 11960 that made several changes including adding a new COVID-19 CPT code, 86413, to Table 1.
• MLN MM11960: https://www.cms.gov/files/document/mm11960.pdf

MEDICARE COVERAGE UPDATES

National Coverage Determination (NCD 90.2): Next Generation Sequencing (NGS) for Medicare Beneficiaries with Germline (Inherited) Cancer

• Article Release Date: September 15, 2020
• What You Need to Know: CMS “has determined that NGS, as a diagnostic laboratory test, is reasonable and necessary and covered nationally for patients with germline (inherited) cancer when performed in a CLIA-certified laboratory, when ordered by a treating physician, and when specific requirements are met.
• NCD Implementation Date: November 13, 2020
• NCD Effective Date: January 27, 2020
• MLN MM11837: https://www.cms.gov/files/document/mm11837.pdf

OTHER MEDICARE UPDATES

August 27, 2020: OIG Report – Medicare Contractors Were Not Consistent in How They Reviewed Extrapolated Overpayments in the Provider Appeals Process

• Link to Report: https://oig.hhs.gov/oas/reports/region5/51800024.pdf

Proposed Rule: Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations Extension of Timeline for Publication of Final Rule

Link to notice in Federal Register: https://www.govinfo.gov/content/pkg/FR-2020-08-27/pdf/2020-18867.pdf

September 2, 2020: FY 2021 IPPS Final Rule released.

September 3, 2020: Medicare Preventive Services Tool and Poster Revised

CMS noted in their September 3rd edition of MLNConnects that the Medicare Preventive Services Medicare Learning Network Educational Tool and Poster have been revised. The tool is extremely useful to understand Coding, Coverage, and Copayment/coinsurance and deductible requirements for Preventative Services covered by Medicare.

• Link to Revised Tool: Medicare Preventive Services
• Link to Revised Poster: Medicare Preventive Services Poster

September 10, 2020: OIG Report: Billions in Estimated Medicare Advantage Payments from Diagnoses Reported Only on Health Risk Assessments Raise Concerns

The OIG performed this review due to concerns that Medicare Advantage Organizations may use Health Risk Assessments (HRAs) to inappropriately increase risk adjusted payments. The key takeaway highlighted in the Report Brief is that “billions in estimated risk-adjusted payments supported solely through HRAs raise concerns about the completeness of payment data, validity of diagnoses on HRAs, and quality of care coordination for beneficiaries.”

September 11, 2020: Community Health Access and Rural Transformation (CHART) Model CMS Fact Sheet

CMS announced the CHART Model in a Fact Sheet, indicating that “the approximately 57 million Americans living in rural communities, including millions of Medicare and Medicaid beneficiaries, face unique challenges when seeking health care services, such as limited transportation options, shortages of health care services, and an inability to fully benefit from technological and care-delivery innovations.” CMS goes on to highlight the following three items to be accomplished through this model:

• “Increase financial stability for rural health care providers through multiple new funding approaches, including the use of up-front investments and predictable, capitated payments that pay for quality and patient outcomes over volume;

• Provide the necessary operational and regulatory flexibilities to allow health care providers and CMS to test the Model in their local communities and successfully transform themselves; and
• Support local rural communities’ transformation efforts by being directly engaged at CMS, offering real-time technical expertise and other learning when needed to foster success.”

New Understanding Your Remittance Advice Reports MLN Booklet (MLN8788099)

CMS has published a new MLN Booklet providing information to:

• Help you learn which types of Remittance Advice (RA) are available,
• What information is included in an RA,
• How to view an RA, and
• Frequently Asked Questions.

Checking Medicare Eligibility MLN Booklet (MLN8816413 September 2020)

CMS advises providers, in this MLN Booklet, “to ensure you are billing appropriately for Medicare-covered supplies and services, check for eligibility. Regularly review your patients’ eligibility information.” This booklet provides guidance on who may be eligible for Medicare and how to check for eligibility.

September 15, 2020: New Roadmap for States to Accelerate Adoption of Value-Based Care (VBC) through Medicaid

CMS sent a letter to State Medicaid Directors on September 15, 2020 “to provide information on how states can advance value-based care (VBC) across the healthcare systems, with a particular emphasis on Medicaid populations, and to share pathways for adoption of such approaches with interested states.

CMS noted in a related Fact Sheet, that just as they have made a “strong commitment to advancing VBC in Medicare for its 61.7 million enrollees” guidance released on September 15, 2020 “is designed to ensure that this same commitment can be made at the state level through Medicaid with its nearly 74 million beneficiaries.”

September 18, 2020: CMS Announces New Model of Care for Medicare Beneficiaries with Chronic Kidney Disease

CMS has finalized the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model, “to improve or maintain the quality of care and reduce Medicare expenditures for patients with chronic kidney disease” (CKD). CMS notes in a Press Release that the model is set to be implemented January 1, 2021, will impact approximately 30 percent of kidney care providers, and the estimated savings from the model is $23 million over five and half years.

September 18, 2020: CMS Announced Radiation Oncology Model

CMS has finalized the Radiation Oncology (RO) Model which is “expected to improve the quality of care for cancer patients receiving radiotherapy and reduce Medicare expenditures through bundled payments that allow providers to focus on delivering high-quality treatments.” CMS notes in a Press Release that the RO Model is set to begin January 1, 2021 and the estimated savings is $230 million over five years.

September 21, 2020: OIG Report (A-07-17-01176) Incorrect Acute Stroke Diagnosis Codes Increased Payments to Medicare Advantage Organizations

In this audit, the OIG focused on Medicare eligible patients who were covered under traditional Medicare one year and the following year chose a Medicare Advantage Plan. Data mining enabled them to identify several diagnosis codes at high risk of being miscoded. Specifically for this audit, the OIG focused on the acute stroke diagnosis codes reported on one physician’s claim without being reported on the corresponding inpatient claim. The objective being to determine if selected acute stroke codes submitted by physicians under traditional Medicare were later used by CMS to make payments to MA organizations complied with Federal Requirements. The OIG found that in 580 of 582 claims, the record did not support the acute stroke diagnosis codes. In turn, this meant the ischemic stroke codes used as HCC’s were not valid. CMS estimated just over $14.4 million inaccurate payments were made to MA Plans.

September 22, 2020: CMS Expands Ambulance Program Integrity Model Nationwide

CMS announced the expansion of the Medicare Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) nationwide. CMS notes in the Press Release that the model has saved Medicare $650 million over four years.

The initial model began for transports on or after December 15, 2014 and is scheduled to end in all model states on December 1, 2020, based on date of service. You can read more about this model in Special Edition MLN article SE1514. Information is also available on the Prior Authorization of Repetitive, Scheduled Non-Emergent Ambulance Transport CMS webpage.

September 24, 2020: Importation of Prescription Drugs FDA Final Rule

This Final Rule was issued “to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. Under this final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit importation program proposals to the Food and Drug Administration (FDA, the Agency, or we) for review and authorization…The purpose of the final rule is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to the public’s health and safety.”

• Final Rule 4164.01-P: https://www.hhs.gov/sites/default/files/importation-final-rule.pdf
• FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-takes-actions-help-lower-us-prescription-drug-prices?utm_medium=email&utm_source=govdelivery