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Q:

How would you code a foreign body that is intentionally left in the body during an operation since the ICD-10-CM codes are for situations where the foreign body was unintentionally left behind?

A:

The answer to this question comes from Coding Clinic, First Quarter 2014, page 21.  We are not to assign a complication code for something left intentionally during surgery. Coding Clinic made this change to reflect The National Quality Forum revised information on Serious Reportable Events in Healthcare.

Reference:

Coding Clinic, First Quarter 2014, page 21 

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from September 28th through October 5th.

Resource Spotlight: CDC Guidance on Personal and Social Activities

Fall is my favorite time of year as there are so many opportunities to gather with friends and family. Unfortunately, this year is like no other in my lifetime. As you consider activities with friends and family, review guidance on the CDC website regarding personal and social activities which includes among other activities, hosting gatherings or cook-outs.

September 28, 2020: Alabama Medicaid COVID-19 Relief Grants

The state of Alabama is offering cash grants up to $15,000 for Alabama Health Care and Emergency Response Providers that meet eligibility requirements. Key things to note in this Alabama Medicaid Alert are:

• Disbursements will be awarded on a first-come, first-served basis up to $35 million aggregate cap,
• The application period for the Alabama Health Care and Emergency Response Provider Grant Program will be open on noon October 5, 2020 and end at noon October 16, 2020, and
• Eligible providers for this grant program include:
• Health care providers including primary care clinics, ambulance/EMS service providers, pharmacies, physician offices, dentist offices, outpatient care centers, medical and diagnostic laboratories, home health care businesses, assisted living facilities, physical therapy offices, and other provider types.
• Emergency response providers including rescue squad organizations, volunteer fire departments, 911 boards, and other provider types.

September 29, 2020: OIG Report – National Snapshot of State Agency Approaches to Child Care During the COVID-19 Pandemic

The objective of this Audit was to identify what measures Child Care and Development Fund (CCDF) program lead agencies have undertaken “to ensure access to safe child care as well as to protect the providers rendering the care in their CCDF programs in response to the COVID-19 pandemic.” The OIG compiled responses to a questionnaire and follow-up interviews conducted with State agencies between April 30 and June 16, 2020. Not surprising to parents, the OIG found that nationally about 63 percent of child care centers and 27 percent of family child care providers had closed during the COVID-19 pandemic. The OIG made no recommendations. Instead they note that the Administration for Children and Families (AFC) should “use this report to support State agencies as they work to address ongoing issues that could impede access to child care as a result of the COVID-19 pandemic.”

October 1, 2020: HHS & The Rockefeller Foundation to Share Best Practices for Increased COVID-19 Testing

HHS announced their agreement with the Rockefeller foundation “to identify and share effective approaches for using rapid point-of-care (POC) antigen tests to screen for COVID-19 in communities, with a focus on safely reopening K-12 schools.”

October 1, 2020: Remdesivir Now Available Directly from Distributor

HHS announced in a Press Release that beginning October 1, 2020, American hospitals can purchase Veklury (remdesivir) directly from the drug’s distributor. What you need to know:

• Also on October 1st, the FDA revised the Emergency Use Authorization for Veklury removing the U.S. government’s role in directing the allocation of the drug,
• The current supply of the drug exceeds the market demand,
• The cost of the drug will not change in the transition away from U.S. government oversight. Hospitals will continue to pay no more than Gilead’s wholesale acquisition price (WAC), approximately $3,200 per treatment course, and
• AmerisourceBegen will remain the sole distributor through the end of 2020 to ensure a smooth distribution process.

October 1, 2020: MLNConnects Notification – Optimizing Health Care PPE and Supplies

The Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released an Express message with new resources:  

• COVID-19: Optimizing Healthcare Personal Protective Equipment (PPE) and Supplies webinar recording: Hear from public and private sector partners

• COVID-19 Response Assistance Field Observations webpage: Learn about institutions of higher learning, K-12 schools, minority/vulnerable populations, and critical infrastructure
• Maintaining Healthcare Safety During the COVID-19 Pandemic speaker series: Listen to health care professionals share their experiences

For More Information:

• ASPR TRACIE Fact Sheet

• ASPR TRACIE website
• ASPR TRACIE Novel Coronavirus Resources webpage

October 1, 2020: $20 Billion in New Phase 3 Provider Relief Funding

The Department of Health and Human Services (HHS) announced $20 billion in new funding for providers and can begin applying for funds on Monday October 5th and can apply through November 6, 2020. Under this Phase 3 General Distribution allocation eligibility has expanded to the following:

• Providers who have already received Provider Relief Fund payments are invited to apply for additional funding,
• Previously ineligible providers, such as those who began practicing in 2020 will be invited to apply, and
• An expanded group of behavioral health providers confronting mental health and substance issues exacerbated by the pandemic will also be eligible for relief payments.

“HHS is urging all eligible providers to apply early; do not wait until the last day or week of the application period. Applying early will help to expedite HHS’s review process and payment calculations, and ultimately accelerate the distribution of all payments.”

October 2, 2020: Public Health Emergency Renewed

The Secretary of Health and Human Services, Alex M. Azar II, has renewed the Public Health Emergency (PHE) due to the COVID-19 pandemic effective October 23, 2020. The extension of the PHE means that current waivers will remain in place.

• Renewal of Public Health Emergency: https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.aspx
• CMS Coronavirus Waivers & Flexibilities webpage: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from September 22nd through 30th.

Resource Spotlight: FDA Video – Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

The FDA announced in their September 21, 2020 COVID-19 Daily Roundup the release of a new video, Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments, explaining “there are currently no FDA-approved drugs or vaccines to treat or prevent COVID-19. Products that fraudulently claim to cure, treat, diagnose, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness for such use, and they might be dangerous to you and your family.”

September 22, 2020: Deaths in U.S. Tops 200,000

The American Hospital, American Medical Association and American Nurses Association released a joint statement marking this “somber milestone” and urging everyone to get their flu shot early.

September 23, 2020: $200 Million from Centers for Disease Control and Prevention (CDC) to Jurisdictions for COVID-19 Vaccine Preparedness

The Department of Health and Human Services (HHS) announced the CDC’s action of providing $200 million to 64 jurisdictions for COVID-19 vaccine preparedness to help states prepare for the COVID-19 vaccine.  “Notices of Awards will be issued on September 23, 2020, and all 64 jurisdictions will receive funding, with the amount each jurisdiction receives determined by a population-based formula.”

September 23, 2020: CMS Call to Action – Drastic Decline in Care for Children in Medicaid and CHIP due to COVID-19

CMS preliminary Medicaid and Children’s Health Insurance Program (CHIP) data analysis reveals that, during the COVID-19 public health emergency (PHE), rates for vaccinations, primary and preventative services have steeply declined. Specifically, compared to the same time period in 2019:

• 22% fewer (1.7 million) vaccinations received by beneficiaries up to age 2,
• 44% fewer (3.2 million) child screening services assessing physical and cognitive development, and
• 69% fewer (7.6 million) dental services.

CMS indicates in a Press Release that they are “releasing this preliminary data to raise awareness of the vital services Medicaid and CHIP provides, and calling on stakeholders to take action to make services more readily available so that we can begin closing the gap in care for children.”

September 23, 2020: FDA Authorizes First Point-of-Care Antibody Test for COVID-19

First authorized for emergency use by certain labs in July, the FDA reissued the Emergency Use Authorization (EUA) for the Assure COVID-19 IgG/IgM Rapid Test Device for Point of Care (POC) use using finger stick blood samples. FDA Commissioner Stephen M. Hahn, M.D. noted in the FDA

News Release that “Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19.”

September 24, 2020: MLNConnects COVID-19 Resources

CMS announced in the September 24th MLNConnects newsletter that “the Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released an Express message with new resources:  

• Maintaining Healthcare Safety During the COVID-19 Pandemic: Health care professionals share their experiences
• Critical Care Load-Balancing Operational Template and Considerations for Assessing Regional Patient Effects: Resources to help jurisdictions manage Coronavirus Disease 2019 (COVID-19) patient surge
• Behavioral Health Compendium: Grants; online resources and trainings; waivers and flexibilities; and data sources for regional emergency coordinators, federal, and state planners.”

September 25, 2020: New Tools to Streamline Certification for Labs Testing for COVID-19

CMS announced the release of new tools for labs seeking Clinical Laboratory Improvement Amendments (CLIA) certification to test for COVID-19. The announcement includes a link to a quick-start guide outlining the steps that must be followed to apply for and receive CLIA certification.

CDC COVID Data Tracker – United States COVID-19 Cases

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

CMS released the display copy of the Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) Final Rule on Wednesday September 2, 2020. Time has a way of marching on as tomorrow is the start of FY 2021. This article focuses on New Technology Add-On Payments (NTAP) for FY 2021.

New Technology Add-On Payment Traditional Pathway

“A new medical service or technology may be considered for new technology add-on payment if, based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate.”

In general, there are three criteria for determining when a new medical service or technology would warrant additional payment:

• The medical service or technology must be new.
• The medical service or technology must be costly such that the DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate (Note, “no add-on payment will be made if a new technology is assigned to a DRG that most closely approximates it’s costs); and
• The service or technology must demonstrate a substantial clinical improvement over existing services or technologies.

Alternative Inpatient New Technology Payment Pathways

New for FY 2021, “certain transformative new devices and Qualified Infectious Disease Products (QIDPs) may qualify for new technology add-on payment under alternative pathway” as finalized in the FY 2020 IPPS/LTCH Final Rule.

A technology is not required to have a specified FDA designation at the time the application for NTAP is made. Instead, “CMS will review the application based on the information provided under by the applicant under the alternative pathway specified by the applicant. However, to receive approval for the new technology add-on payment under that alternative pathway, the technology must have the applicable designation and meet all other requirements in the regulations in § 412.87(c) and (d), as applicable.”

Certain Antimicrobial Products Alternative Pathway

For FY 2021, the alternative pathway for QIDPs has been expanded to include products approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) pathway. In the Final Rule, CMS finalized policy to refer more broadly to “certain antimicrobial products” rather than specifying specific FDA programs for antimicrobials (i.e. QIDPs and LPADs).

Products approved through this pathway will be considered new and not substantially similar to an existing technology and will not need to demonstrate that it meets the substantial clinical improvement criterion. However, the technology will need to meet the cost criterion.

Certain Transformative New Devices Alternative Pathway

Beginning in FY 2021, “if a medical device is part of FDA’s Breakthrough Devices Program and received FDA marketing authorization, it will be considered new and not substantially similar to an existing technology for purposes of the new technology add-on payment under the IPPS.” However, the new device must meet the cost criterion and must receive marketing authorization for the indication covered by the Breakthrough Device Program designation.

Additional Payment for NTAP’s

Payment for an NTAP is based on the cost to hospitals for the new medical service or technology. As set forth in § 412.88(b)(2), unless the discharge qualifies for an outlier payment, the additional Medicare payment will be limited to the following:

• For “Traditional Pathway” and “Certain Transformative New Devices”, Medicare will make an add-on payment equal to the lesser of: (1) 65 percent of the costs of the new medical service or technology; or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment.
• For Certain Antimicrobial NTAPs (QIDPs and LPADs), Medicare will make an add-on payment equal to the lesser of: (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.

Coding NTAPs

Section X is the New Technology section that was added to ICD-10-PCS effective October 1, 2015.

CMS has indicated that Section X was created in response to public comments received regarding New Technology proposals presented at ICD-10 Coordination and Maintenance Committee Meetings, and general issues facing classification of new technology procedures. The public had opposed many requests to add new codes to the existing ICD-10-PCS sections for the use of specific drugs, devices, or supplies in an inpatient setting, even when the code related to an application for New Technology add-on payments.

NTAPs for FY 2021 by the Numbers

• 10 Technologies approved for NTAP in FY 2020 which will continue in FY 2021
• 6 New technologies were approved for FY 2021 under the Traditional Pathway
• 8 New technologies were approved for FY 2021 under the Alternative Pathway of Certain Antimicrobial Products or Certain Transformative New Devices
• $874 million is CMS estimate for FY 2021 Medicare spending on NTAPs. This is nearly a 120% increase over the FY 2020 spending.

CMS Policy for Continuing NTAP Status 

“Our policy is that a medical service or technology may continue to be considered “new” for purposes of new technology add-on payments within 2 or 3 years after the point at which data begin to become available reflecting the inpatient hospital code assigned to the new service or technology. Our practice has been to begin and end new technology add-on payments on the basis of a fiscal year, and we have generally followed a guideline that uses a 6-month window before and after the start of the fiscal year to determine whether to extend the new technology add-on payment for an additional fiscal year. In general, we extend new technology add-on payments for an additional year only if the 3-year anniversary date of the product’s entry onto the U.S. market occurs in the latter half of the fiscal year (70 FR 47362).”

FY 2020 NTAPs Approved for Continued NTAP Status for FY 2021

The following Summary Table from the Final Rule highlights which NTAPs have been discontinued or continued for FY 2021.

Source: Federal Register / Vol. 85, No. 182 / Friday, September 18, 2020 / Rules and Regulations / page 58619 at https://www.govinfo.gov/content/pkg/FR-2020-09-18/pdf/2020-19637.pdf

FY 2021 Approved Applications for NTAP (Traditional Pathway)  

ContaCT

• New Technology Description: According to Viz.ai Inc., ContaCT is a radiological computer-assisted triage and notification software system intended for use by hospital networks and trained clinicians. ContaCT analyzes computed tomography angiogram (CTA) images of the brain acquired in the acute setting, sends notifications to a neurovascular specialist(s) that a suspected large vessel occlusion (LVO) has been identified, and recommends review of those images.

• ICD-10-PCS Procedure Code: 4A03X5D (Measurement of arterial flow, intracranial, external approach)

• Maximum Add-on Payment: $1,040 (65% of the costs of the new technology)

Eluvia™ Drug-Eluting Vascular Stent System (Eluvia)

• New Technology Description: Eluvia™, a drug-eluting stent for the treatment of lesions in the femoropopliteal arteries, received FDA premarket approval (PMA) September 18, 2018. According to the applicant, Boston Scientific, the Eluvia™ system is a sustained release drug-eluting stent indicated for the treatment of lesions in the femoropopliteal arteries and is designed to restore blood flow in the peripheral arteries above the knee – specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

• ICD-10-PCS Procedure Codes: See table on page 58647 of the Final Rule (total 16 codes)

• Maximum Add-on Payment: $3,646.50 (65% of the costs of the new technology)

Hemospray® Endoscopic Hemostat (Hemospray)

• New Technology Description: According to the applicant, Cook Medical, Hemospray is indicated by the FDA for hemostasis of nonvariceal gastrointestinal bleeding. Using an endoscope to access the gastrointestinal tract, the Hemospray delivery system is passed through the accessory channel of the endoscope and positioned just above the bleeding site without making contact with the GI tract wall. The Hemospray powder, bentonite, is propelled through the application catheter, either a 7 or 10 French polyethylene catheter, by release of CO2 from the cartridge located in the device handle and sprayed onto the bleeding site. According to the applicant, bentonite can rapidly absorb 5 to 10 times its weight in water and swell up to 15 times its dry volume, becoming cohesive to itself and adhesive to tissue forming a physical barrier to aqueous fluid (for example, blood). Hemospray powder is not absorbed by the body and does not require removal as it passes through the GI tract within 72 hours. Hemospray is single-use and disposable.

• ICD-10-PCS Procedure Codes:
• XW0G886 (Introduction of mineral-based topical hemostatic agent into upper GI, via naturel or artificial opening endoscopic, new technology group 6), and
• XW0H886 (Introduction of mineral-based topical hemostatic agent into lower GI, via natural or artificial opening endoscopic, new technology group 6)

• Maximum Add-on Payment: $1,625.00 (65% of the costs of the new technology)

IMFINZI® (durvalumab) and TECENTRIQ® (Atezolizumab)

• New Technology Description: Two manufacturers, AstraZeneca PLC and Genentech, Inc., submitted separate applications for new technology add-on payments for FY 2021 for IMFINZI® (durvalumab) and TECENTRIQ® (atezolizumab), respectively. Both of these technologies are programmed deathligand 1 (PD-L1) blocking antibodies used for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

The applications were considered separately in the Proposed Rule. Since then, CMS has determined the two are substantially similar and as such evaluated both technologies as one application for NTAP.

• ICD-10-PCS procedure codes for TECENTRIQ®
• XW033D6 (Introduction of atezolizumab antineoplastic into peripheral vein, percutaneous approach, new technology group 6), and
• XW043D6 (Introduction of atezolizumab antineoplastic into central vein, percutaneous approach, new technology group 6)
• ICD-10-PCS procedure codes for IMFINZI®
• XW03336 (Introduction of durvalumab antineoplastic into peripheral vein, percutaneous approach, new technology group 6), and
• XW04336 (Introduction of durvalumab antineoplastic intro central vein, percutaneous approach, new technology group 6)

• Maximum Add-on Payment: $6,875.90 (65% of the costs of the new technology)

Soliris® (eculizumab)

• New Technology Description: Soliris® is approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. According to the applicant, Alexion, Inc., NMOSD is a rare and severe condition that attacks the central nervous system without warning. The applicant explained that NMOSD attacks, also referred to as relapses, can cause progressive and irreversible damage to the brain, optic nerve and spinal cord, which may lead to long-term disability, and in some instances, the damage may result in death.

• ICD-10-PCS Procedure Codes:
• XW033C6 (Introduction of eculizumab into peripheral vein, percutaneous approach, new technology group 6), and
• XW043C6 (Introduction of eculizumab into central vein, percutaneous approach, new technology group 6).
• Maximum Add-on Payment: $21,199.75 (65% of the costs of the new technology)

The SpineJack® Expansion Kit (SpineJack® System)

• New Technology Description: The applicant, Stryker, Inc., describes the SpineJack® system as an implantable fracture reduction system, which is indicated for use in the reduction of painful osteoporotic vertebral compression fractures (VCFs) and is intended to be used in combination with Stryker VertaPlex and VertaPlex High Viscosity (HV) bone cement.

• ICD-10-PCS Procedure Codes:
• XNU0356 (Supplement lumbar vertebra with mechanically expandable (paired) synthetic substitute, percutaneous approach, new technology group 6), and
• XNU4356 (Supplement thoracic vertebra with mechanically expandable (paired) synthetic substitute, percutaneous approach, new technology group 6)
• Maximum Add-on Payment: $3,654.72 (65% 0f the costs of the new technology)

FY 2021 Approved NTAP Alternative Pathway for Breakthrough Devices

BAROSTIME NEO® System

• New Technology Description: According to the applicant, CV Rx, the BAROSTIM NEO® System is indicated for the improvement of symptoms of heart failure – quality of life, six-minute hall walk and functional status – for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

• ICD-10-PCS Procedure codes:
• 0JH60MZ (insertion of stimulator generator into chest subcutaneous tissue and fascia, open approach) in combination with
• 03HK0MZ (Insertion of stimulator lead into right internal carotid artery, open approach), OR
• 03HL0MZ (Insertion of stimulator lead into left internal carotid artery, open approach).

• Maximum Add-on Payment: $22,750 (65% of the average cost of the technology)

Optimizer® System (QFV)

• New Technology Description: Impulse Dynamics submitted an application for The Optimizer® System (QFV). It is intended for the treatment of chronic heart failure in patients with advanced symptoms that have normal QRS duration and are not indicated for cardiac resynchronization therapy.

• ICD-10-PCS Procedure codes to identify the Optimizer System
• 0JH60AZ (Insertion of contractility modulation device into chest subcutaneous tissue and fascia, open approach),
• 0JH63AZ (Insertion of contractility modulation device into chest subcutaneous tissue and fascia, percutaneous approach),
• 0JH80AZ (Insertion of contractility modulation device into abdomen subcutaneous tissue and fascia, open approach), and
• 0JH83AZ (Insertion of contractility modulation device into abdomen subcutaneous tissue and fascia, percutaneous approach)

• Maximum Add-on Payment: $14,950 (65% of the average cost of the technology)

FY 2020 Approved NTAP Alternative Pathway Certain Antimicrobial Products (i.e. QIDPs and LPADs)

Cefiderocol (Fetroja)

• Product Description: Cefiderocol is an injectable β-lactam antibiotic indicated for the treatment of complicated urinary tract infections (cUTI), including Pyelonephritis, caused by the following susceptible Gram-negative (GN) pathogens: Escherichia coli (including with concurrent bacteremia), Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Citrobacter freundii, Enterobacter cloacae, Morganella morganii, and Serratia marcescens.

Per the applicant, Shionogi & Co. Ltd (Company), Cefiderocol should be used to treat infections where limited or no alternative treatment options are available and where Cefiderocol is likely to be an appropriate treatment option, which may include use in patients with infections caused by documented or highly suspected carbapenem-resistant (CR) and/or multidrug-resistant GN pathogens.

• ICD-10-PCS Procedure Codes:
• XW03366 (Introduction of Lefamulin Anti-infective into Peripheral Vein, Percutaneous Approach, New Technology Group 6), or
• XW04366 (Introduction of Lefamulin Anti-infective into Central Vein, Percutaneous Approach, New Technology Group 6)

• Maximum Add-on Payment: $7,919.86 (75% of the average cost of the technology)

CONTEPO™ (fosfomycin for injection)

• Product Description: IV fosfomycin for injection (ZTI-01) is for the treatment of patients 18 years and older with cUTI including Acute Pyelonephritis (AP) caused by designated susceptible bacteria. The applicant, Nabriva Therapeutics, notes that once approved, CONTEPO will represent the first FDA-approved IV epoxide antibiotic in the United States.

• ICD-10-PCS Procedure Codes:
• XW033K5, (Introduction of Fosfomycin anti-infective into peripheral vein, percutaneous approach, new technology group 5), and
• XW043K5 (Introduction of Fosfomycin anti-infective into central vein, percutaneous approach, new technology group 5)

• Maximum Add-on Payment: $2,343.75 (75% of the average cost of the technology)

NUZYRA® for injection (omadacycline)

• Product Description: According to the applicant, Paratek Pharmaceuticals, NUZYRA® for Injection is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
• Community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus methicillin susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
• Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (methicillin susceptible and resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.

• ICD-10-PCS Procedure Codes:
• XW033B6 (Introduction of omadacycline anti-infective into peripheral vein, percutaneous approach, new technology group 6), or
• XW043B6 (Introduction of omadacycline anti-infective into peripheral vein, percutaneous approach, new technology group 6).

• Maximum Add-on Payment: $1,552.50 (75% of the average cost of the technology)

RECARBRIO™

• Product Description: RECARBRIOTM is a fixed-dose combination of imipenem, a penem antibacterial; cilastatin, a renal dehydropeptidase inhibitor; and relebactam, a novel β-lactamase inhibitor (BLI). According to the applicant, Merck, RECARBRIOTM is intended for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) for patients 18 years of age and older. RECARBRIOTM is administered via intravenous infusion. Per RECARBRIOTM’s prescribing information, the recommended duration of treatment with RECARBRIOTM is 4 days to 14 days.

• ICD-10-PCS Procedure Codes:
• XW033U5 (Introduction of imipenem-cilastatin-relebactam anti-infective into peripheral vein, percutaneous approach, new technology group 5) or
• XW043U5 (Introduction of imipenem-cilastatin-relebactam antiinfective into central vein, percutaneous approach, new technology group 5)

• Maximum Add-on Payment: $3,532.78 (75% of average cost of the technology)

XENLETA

• Product Description: Nabriva Therapeutics submitted an application for XENLETA, a pleuromutilin antibacterial agent representing the first intravenous (IV) and oral treatment option from a novel class of antibiotics for community-acquired bacterial pneumonia (CABP). XENLETA is indicated for the treatment of adults with CABP caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. Per the applicant, XENLETA also has in vitro activity against methicillin resistant Staphylococcus aureus.

• ICD-10-PCS Procedure Codes:
• XW03366 (Introduction of lefamulin anti-infective into peripheral vein, percutaneous approach, new technology group 6),
• XW04366 (Introduction of lefamulin anti-infective into central vein, percutaneous approach, new technology group 6) or
• XW0DX66 (Introduction of efamulin anti-infective into mouth and pharynx, external approach, new technology group 6)

• Maximum Add-on Payment: $1,275.75 (75% of the average cost of the technology)

ZERBAXA® (ceftolozane and tazobactam)

• Product Description: ZERBAXA® is a combination of ceftolozane, a cephalosporin antibacterial; and tazobactam, a β-lactamase inhibitor (BLI), indicated in patients 18 years or older for the treatment of the following infections caused by designated susceptible microorganisms:
• Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole;
• Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis;
• Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP).

Note, CMS has indicated that the NTAP for FY 2021 is specific to treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) is eligible for NTAP for FY 2021, because the other indications approval is beyond the 3-year newness period.

• ICD-10-PCS Procedure Codes:
• XW03396 (Introduction of Ceftolozane/Tazobactam Anti-infective into Peripheral Vein, Percutaneous Approach, New Technology Group 6), or
• XW04396 (Introduction of Ceftolozane/Tazobactam Anti-infective into Central Vein, Percutaneous Approach, New Technology Group 6)

• Maximum Add-on Payment: $1,836.98 (75% of the average cost of the technology)

Appendix A – Effects of Policies Relating to New Medical Service and technology Add-On Payments (page 2056)

CMS estimates the payment amounts for new technology add-on payments in the Final Rule based on the applicant’s estimates. This amount and the estimated number of patients is highlighted in the following table: 

‍Moving Forward

The number of new technologies has increased from 18 in FY 2020 to 24 in FY 2021. With this increase, the estimated number of patients to receive a new technology during an inpatient stay has increased from 71,659 in FY 2020 to 259,101 for FY 2021. Identifying and coding new technologies is an opportunity not to be missed for those hospitals providing these services. That said, some questions come to mind for you to think about:

• Is your hospital providing any of these medical services or technology?
• Who needs to be aware of what the new technologies are? (i.e. Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
• What process do you have in place to alert your Coding Staff of the need to code the new technologies?

Resources:

CMS September 2, 2020 Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2021-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-acute-0

FY 2021 IPPS CMS webpage: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2021-ipps-final-rule-home-page

MM11879 – Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) PPS Changes: https://www.cms.gov/files/document/mm11879.pdf

Welcome to this month’s MAC Talk article. This month before diving into updates from the MACs, I want to highlight Kepro’s  Fall 2020 Case Review Connections newsletter for acute care. The following items are included in this issue:

• Medical Director’s Corner with a focus on the Important Message from Medicare (IM),
• Appeals: Delivering the IM to a Representative,
• A link to KEPRO’s COVID-19 resource page,
• An Immediate Advocacy Success Story,
• FAQs related to the IM,
• Beneficiary Care Management Program, and
• Outreach: Focus on State Health Insurance Assistance Programs.

Note, the Post-acute Care Edition of Case Review Connections provides information about giving a Medicare beneficiary the Notice of Medicare Non-coverage (NOMNC).

September MAC Talk: The Local Scene

September 8, 2020: WPS GHA Medicare eNews: Prior Authorization for Hospital Outpatient Department Services Unique Tracking Number (UTN) Facts

WPS GHA published the following in their September 8th edition of their Medicare eNews:

“WPS assigns a UTN to each request submitted under the Prior Authorization for HOPD Services program. Providers should keep the following points in mind about the UTN:

• Part A HOPD providers shall include the UTN when submitting their claims for payment. Part B physicians do not need to include it on their claims.
• Once a Nurse Analyst renders a prior authorization decision, the UTN is valid for 120 days.
• The UTN is valid for one-time use.
• If the anticipated date of service changes but remains within the 120 days the UTN is valid, the provider does not need to seek a new UTN for that service.”

September 8, 2020: WPS GHA Medicare eNews: Prior Authorization for Hospital Outpatient Department Services Tips and Reminders

WPS GHA published the following information in their September 8th edition of their Medicare eNews:

“We continue to find errors and omissions on prior authorization requests. These errors and omissions may result in processing delays. Providers should note the following:

• Prior Authorization Request Form
• To be valid the prior authorization request must:
• Include the facility PTAN and NPI
• Include the correct Medicare Beneficiary Identifier (MBI)
• Include medical documentation for review
• Include an applicable CPT or HCPCS code
• Be legible
• To prevent processing delays due to rejections, we encourage providers to use our Prior Authorization (PA) Request Form

• Botulinum Toxin
• Prior authorization requests are only for injection CPT codes 64612 and 64615
• Prior authorization requests must include both the administration site and drug CPT codes
• Units of service for botulinum toxin injections should include the expected units of waste

• Vein Ablation
• Prior authorization requests should clearly identify which extremity and vein(s) the request is for

• Blepharoplasty
• Prior authorization requests should clearly identify which eye the request is for
• Photographs should include patient identifiers 

For additional information, see Prior Authorization for Hospital Outpatient Department Services (HOPD) Overview. Please select J5A or J8A to see the full article.”

September 8, 2020: Palmetto GBA – Medicare Advantage (MA) Plan Overpayments – Update

Palmetto noted on September 8th that CMS has extended the deadline for accepting the agency’s settlement offers to resolve the MA overpayments by several months. You will also find a link to FAQs on their MA Plans Overpayments Update web page. 

September 18, 2020: Kepro Joins YouTube

Kepro, announced their new BFCC-QIO YouTube channel aimed at providing education for providers and Medicare beneficiaries. Here are the first three videos available on their channel:

• Using Kepro's Medical Records Bar Code Fax Cover Sheet: This video talks about the importance of using this cover sheet when you fax medical records to Kepro.
• How to Fill Out and Deliver the Notice of Medicare Non-Coverage: This video will review this Centers for Medicare & Medicaid Services form, which is used for skilled service termination appeals. We will go over how the form must be delivered and how to fill it out.
• Medical Record Documentation for Medicare Hospital Discharge and Skilled Service Termination Appeals: This video will provide you with tips about documentation requirements to help ensure that medical records are complete and contain the appropriate level of documentation to ensure the appropriate appeal outcome.

Palmetto GBA JJ/JM Part A MACtoberfest October 20th and 21st Goes Virtual

Palmetto GBA has announced their first-ever virtual MACtoberfest® - “Shelter in Place. We are Coming to You.” The Palmetto team will be providing the latest information regarding the current state of Medicare. Note, you must sign up for each day separately. Following are just a few of the sessions being offered:

• Discharge Planning – Working with other Entities,
• The Latest COVID-19 News and Reminders,
• Hospital Outpatient Department (OPD) Prior Authorization, and
• Part A Medical Review – Signed, Sealed, and Documented.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from September 15th through 22nd.

Resource Spotlight: Billing Guidance for Hospitalization without a Positive COVID-19 Test

CMS first released MLN SE20015 on April 15, 2020. This article was revised for the third time on September 11, 2020 to add guidance on how providers notify their MAC when there is no evidence of a positive laboratory test documented in the patient’s medical record.

As a reminder, for admissions on or after September 1, 2020 to be eligible for the 20 percent increase in the MS-DRG weighting factor there must be a positive COVID-19 laboratory test documented in the patient’s medical record. The following guidance was added to the September 11th update:

“To notify your MAC when there is no evidence of a positive laboratory test documented in the patient’s medical record, enter a Billing Note NTE02 “No Pos Test” on the electronic claim 837I or a remark “No Pos Test” on a paper claim.”

A word of caution, CMS also indicates in the MLN article that they may conduct post-payment medical review and if no documentation is in the medical record they will recoup the additional payment. In fact, in late August, the OIG added auditing whether payments made by Medicare for COVID-19 inpatient discharges billed by hospitals complied with Federal requirements to their Active Work Plan Items. 

September 15, 2020: Bipartisan COVID Relief Framework

The Problem Solvers Caucus (PSC), a group of 25 Democrats and 25 Republicans, released their "March to Common Ground" Bipartisan COVID Relief Framework. With an objective of inspiring negotiators to return to the table, this document addresses the following topics related to COVID-19 by indicating the problem and providing solutions:

• Testing and Healthcare,
• Support for individuals and Families,
• Unemployment Assistance,
• Small Business & Non-Profits,
• Schools and Child Care,
• State and Local Aid,
• Election Aid,
• Broadband, Agriculture, USPS, & Census; and
• Worker and Liability Protections.

September 16, 2020: Report from the Independent Coronavirus Commission for Safety and Quality in Nursing Homes (Commission)

CMS announced they had received the final report from the Commission. “To help CMS inform immediate and future actions as well as identify opportunities for improvement, the Commission was created to conduct an independent review and comprehensive assessments of confronting COVID-19. The Commission’s report contains best practices that emphasize and reinforce CMS strategies and initiatives to ensure nursing home residents are protected from COVID-19.”

September 16, 2020: COVID-19 Vaccine Distribution Strategy Released

HHS and the Department of Defense (DoD) announced the release of two documents “outlining the Trump Administration’s detailed strategy to deliver safe and effective COVID-19 vaccine doses to the American people as quickly and reliably as possible.” The Operation Warp Speed, “From the Factory to the Frontlines” document details requirements for vaccine distribution, administration, monitoring, and engagement with a nationwide network of partners. 

September 17, 2020: COVID-19 Lessons Learned & Infectious Disease Surge Annex Template

CMS indicated in the Thursday September 17 edition of MLNConnects that the Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) have released the following resources related to COVID-19 lessons learned as well as an infectious disease surge annex template:

• “The Exchange, Issue 11: COVID-19 Lessons Learned: Resources on managing patient surge, safety and staff health, operations, telehealth, and what’s next 

• Healthcare Coalition Infectious Disease Surge Annex Template: Voluntary template for developing a surge annex 
• Interim Guidance: SARS-CoV-2 (COVID-19) and Field Trauma Triage Principles: How COVID-19 impacts triage for first responders

For More Information: 

• ASPR TRACIE Fact Sheet
• ASPR TRACIE website 
• ASPR TRACIE Novel Coronavirus Resources webpage”

September 17, 2020: New Guidance for Safe Visitation in Nursing Homes During COVID-19 Public Health Emergency

CMS has issued revised guidance on ways for nursing homes to safely facilitate visitation during the ongoing COVID-19 pandemic. “CMS recognizes that physical separation from family and other loved ones has taken a significant toll on nursing home residents. In light of this, and in combination with increasingly available data to guide policy development, CMS is issuing revised guidance to help nursing homes facilitate visitation in both indoor and outdoor settings and in compassionate care situations.”

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from September 8th through the 15th.

Resource Spotlight: COVID-19 Public Reporting Tip Sheets

CMS has created COVID-19 public reporting tip sheets to explain the strategy for CMS quality data exempted from public reporting due to COVID-19 and the impact on Compare website refreshes. Tip Sheets are available for:

• Home health (PDF),
• Hospice (PDF),
• Inpatient Rehabilitation Facility (IRF (PDF)),
• Long-Term Care Hospital (LTCH (PDF)), and
• Skilled Nursing Facility (SNF (PDF)).

September 8, 2020: AMA Announces New COVID-19 Related CPT Codes

The American Medical Association (AMA) announced in a Press Release that they have published an update to the CPT® Code Set which “includes two code additions for reporting medical services sparked by the public health response to the COVID-19 pandemic.”

New Category I CPT codes and long descriptors

• CPT 99072: Additional supplies, materials, and clinical staff time over and above those usually included in an office visit or other non-facility service(s), when performed during a Public Health Emergency as defined by law, due to respiratory-transmitted infectious disease
• 86413: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) antibody, quantitative

The AMA notes that they have worked with “50 national medical societies and other organizations” to compile data regarding the costs involved in maintaining a safe medical office during the public health emergency and have provided this information to CMS “to inform payment of code 99072.”

Both codes are effective immediately. In addition to the Press Release you can find additional information about the two new codes, including a clinical example in a CPT® Assistance Special Edition: September Update.  

September 9, 2020: Expanding Access to COVID-19 Vaccines

The U.S. Department of Health and Human Services issued a Press Release highlighting the issuance of guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines. “This guidance authorizes state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older, subject to certain requirements.”

September 17 CDC Call: Testing and Treatment of 2020-2021 Seasonal Influenza During the COVID-19 Pandemic

The CDC is hosting a Clinician Outreach and Communication Activity (COCA) Call on Thursday, September 17th from 2:00 pm – 3:00 pm (ET). In the announcement, the CDC indicated the following four objectives that participants will be able to accomplish at the conclusion of the call:

• Review influenza activity since the onset of the COVID-19 pandemic.

1. Provide background on influenza tests and antivirals for influenza.
2. Describe influenza testing guidance for patients with acute respiratory illness for the 2020-2021 season, including during community co-circulation of influenza viruses and SARS-CoV-2.
3. Describe antiviral treatment recommendations for patients with suspected or confirmed influenza for the 2020-2021 season, including during community co-circulation of influenza viruses and SARS-CoV-2.

Additional information about the call and how to join in the session can be found on the CDC website at https://emergency.cdc.gov/coca/calls/2020/callinfo_091720.asp?deliveryName=USCDC_1052-DM37672.

September 8, 2020: CDC COVID Data Tracker – United States COVID-19 Cases

• Total Cases: 6,287,362,
• Total Deaths: 188,688
• Deaths per 100,000 people: 57
• Cases in last 7 days: 282, 919
  

September 14, 2020: CDC COVID Data Tracker – United States COVID-19 Cases

• Total Cases: 6,503,030
• Total Deaths: 193,705
• Deaths per 100,000 people: 59
• Cases in last 7 days: 241,814

Link to CDC COVID Data Tracker: https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases

In a September 3, 2020 Press Release, CMS announced the launch of a new website call Care Compare. “Care Compare provides a single user-friendly interface that patients and caregivers can use to make informed decisions about healthcare based on cost, quality of care, volume of services, and other data. With just one click, patients can find information that is easy to understand about doctors, hospitals, nursing homes, and other health care services instead of searching through multiple tools.”

Care Compare Features:

• One click to find information about doctors, hospitals, nurses, nursing homes, home health service, hospice care, inpatient rehabilitation facilities, long-term care hospitals and dialysis facilities,
• Tool is optimized for mobile and tablet use,
• Updated maps,
• New filters to help you identify the providers right for you, and
• “Consistent design that makes it easier to compare providers and find the information that’s most important to you.”

CMS Administrator Seema Verma noted in the Press Release that “By aggregating all eight of CMS’ quality tools into a single interface, patients can easily research different providers and facilities before they entrust themselves to their care. Today’s launch of Care Compare is the next step in fulfilling our eMedicare promise. Our Administration is committed to ensuring our tools are robust and beneficial to patients.”

While CMS gathers feedback and considers additional improvements to the tool, you will still be able to use the original eight compare tools.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from September 1st through the 8th.

Resource Spotlight: Travel during the COVID-19 Pandemic

The CDC’s Travel during the COVID-19 Pandemic webpage provides information about:

• Reasons you should not travel,
• Considerations prior to travel,
• What to do if you do travel,
• Considerations for types of travel (i.e., air, bus, care, RV),
• Tips to avoid getting and spreading COVID-19 in common travel situations (i.e., bathrooms and rest stops),
• Anticipating your travel needs, and
• What to do after you have traveled.

September 1, 2020: Provider Relief for Assisted Living Facilities (ALFs)

HHS announced that ALFs may now apply for funding under the Provider Relief Fund Phase 2 General Distribution allocation. This funding was made possible through the CARES Act and the Paycheck Protection Program and Healthcare Enforcement Act.

September 3, 2020: $2 Billion Provider Relief Fund Nursing Home Incentive Payment Plans

HHS announced “details of a $2 billion Provider Relief Fund (PRF) performance-based incentive payment distribution to nursing homes. This distribution is the latest update in the previously announced $5 billion in planned support to nursing homes grappling with the impact of COVID-19. Last week, HHS announced it had delivered an additional $2.5 billion in payments to nursing homes to help with upfront COVID-19-related expenses for testing, staffing, and personal protective equipment (PPE) needs. Other resources are also being dedicated to support training, mentorship and safety improvements in nursing homes.”

The Press Release provides details regarding:

• Qualifications to participate in the Program,
• The performance and payment cycle, and
• Methodology to measure a facilities performance. Specifically, nursing homes will have their performance measured on their ability to keep new COVID infection rates low among residents and ability to keep COVID mortality low among residents.

September 3, 2020: Reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States

The CDC has been tracking reports of MIS-C since mid-May 2020. According to the CDC, this is “a rare but serious condition associated with COVID-19. MIS-C is a new syndrome, and many questions remain about why some children develop it after a COVID-19 illness or contact with someone with COVID-19, while others do not.”

MIS-C Cases as of September 3, 2020:

• 792 confirmed cases and 16 deaths in 42 states,
• Most cases are in children between 1 and 14 years old with an average age of 8,
• More than 70% of reported cases have occurred in children who are Hispanic/Latino (276 cases) or Non-Hispanic Black (230 cases),
• 99% of cases (783) tested positive for COVID-19 while the remaining 1% were around someone with COVID-19,
• Most children developed MIS-C 2-4 weeks after COVID-19 infection, and
• 54% of reported cases have been male.

The CDC MIS-C webpage provides additional information about the disease, what they are doing, and information for healthcare professionals.

September 8, 2020: CDC COVID Data Tracker – United States COVID-19 Cases

• Total Cases: 6,287,362,
• Total Deaths: 188,688
• Deaths per 100,000 people: 57
• Cases in last 7 days: 282, 919
• Link to CDC COVID Data Tracker: https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases