Knowledge Base - Full Library

Background

Last June CMS released a Final Decision Memo (CAG-00430R) for Transcatheter Aortic Valve Replacement (TAVR) Procedures. This procedure is for the treatment of symptomatic aortic valve stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

Final Decision Memo: What Did Not Change

Coverage under Evidence Development

The requirement that a procedure be performed under Coverage with Evidence Development (CED) did not change in the Final Decision Memo. CED means that the service is only covered in the context of a clinical trial (such as a national registry or a clinical study). This allows limited coverage for Medicare beneficiaries in a controlled environment while determining the efficacy, risks, and outcomes of the procedure. Once a new technology or procedure is proven to be safe and effective, CMS may remove the CED requirement and cover the procedure outright within set criteria.

• TAVR is covered according to CMS criteria when the procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system’s FDA approved indication and the heart team and hospital are participating in a prospective, national, audited registry.
• TAVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills criteria set forth in the decision memo.

Link to CMS TAVR CED webpage: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR

The Heart Team

• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals:
• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR; and
• TAVR must be furnished in a hospital with the appropriate infrastructure.

Final Decision Memo: What Did Change

Pre-Procedure Patient Evaluation Requirements

Historically, the TAVR National Coverage Determination (NCD) 20.32 required a face-to-face evaluation of a patient’s suitability for TAVR surgery by two cardiac surgeons. The most recent Final Decision Memo changed the requirement from two cardiac surgeons to a cardiac surgeon and an interventional cardiologist. This change is in line with the requirement of the heart team’s interventional cardiologist(s) and cardiac surgeon(s) jointly participating in the intra-operative technical aspects of TAVR. Following is specific guidance from the Final Decision Memo:

• “The heart team includes the following:
• Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:
• Independently examined the patient face-to-face, evaluated the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
• Documented and made available to the other team members the rationale for their clinical judgement.
• Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.”

Note, in general, I have seen most denials from Medicare Contractors for this procedure being due to a lack of documentation of a face-to-face encounter by two surgeons. What I have found in performing claim reviews for MMP clients is that often there was documentation from a surgeon and an interventional cardiologist which now meets the face-to-face requirement.

Hospital Specific Procedure Volumes

The prior version of the NCD and Final Decision memo both required certain volumes of procedures for the hospital and the heart team based on whether they had previous TAVR experience or not.

For example, hospitals with no previous TAVR experience, the volume of Aortic Valve Replacements has decreased while a specific volume of open heart surgeries and having at least one physician with interventional cardiology privileges has been added to the NCD. Whether or not you currently perform TAVR procedures or are in the planning phase of performing these procedures, I encourage you to review the new requirements in NCD 20.32.

August 16, 2019 FDA Announcement:  FDA Expands Indication for Several Transcatheter Heart Valves to Patients at Low Risk for Death or Major Complications Associated with Open-Heart Surgery

Last August, “the U.S. Food and Drug Administration today approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves. These transcatheter valves – Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery.

In low risk patients, open-heart surgery has been the standard-of-care for aortic valve replacement. However, the procedure to insert a transcatheter heart valve is less invasive, and involves a smaller incision and shorter recovery time than open-heart surgery. The FDA is the first medical products regulatory body in the world to expand the indication for these devices to patients at low risk for death or major complications associated with open-heart surgery.”

Final Decision Memo Changes are Now Effective

• Effective Date: June 21, 2019
• Implementation Date: June 12, 2020.

As always, with Decision Memos, the requirements are not effective until the NCD is updated and implemented. However, NCD revisions generally revert to the effective date of the Decision Memo, which is in this case June 21, 2019.

On Friday March 13th CMS published Change Request (CR) 11660  informing Medicare Administrative Contractors (MACs) that effective June 21, 2019, CMS will continue to cover TAVR under CED when the procedure is furnished for the treatment of symptomatic aortic stenosis and according to an FDA approved indication for use with an approved device, in addition to the coverage criteria outlined in the NCD manual. The Implementation date is June 12, 2020.

On Tuesday 3/24/2020 CMS published related MLN Matters Article MM11660.

TAVR Hospital “To Do” List

• Read the updated NCD carefully, making sure you are following all of Medicare’s requirements.
• Ensure your medical record contains documentation of the face-to-face patient examinations by a cardiac surgeon and an interventional cardiologist (experienced in the care and treatment of aortic stenosis) evaluated the patient’s suitability for SAVR, TAVR or medical or palliative therapy;
• Ensure your hospital has the appropriate infrastructure for the procedure;
• Assess your hospital and heart team volumes to be sure you meet the requirements for performing the procedure under the new Decision Memo; and
• Ensure the patient is under the care of a heart team and the heart team’s interventional cardiologist(s) and cardiac surgeon(s) jointly participate in the intra-operative technical aspects of TAVR.

Timeline to a New Code

The CDC announced the release of a new code specifically for reporting COVID-19 during the March 18th ICD-10-CM Coordination and Maintenance Committee Meeting. This code will be available for use on April 1st, 2020. Following is a timeline of events prompting the speed with which this code is being made available for use:

• January 30, 2020: The World Health Organization (WHO) declared the 2019 Novel Coronavirus (2019-nCoV) disease outbreak a public health emergency of international concern.
• January 31, 2020: Emergency meeting convened by WHO Family of International Classifications (WHOFIC) Network Classification and Statistics Advisory Committee (CSAC). A new ICD-10 emergency code was established by the WHO.
• 1 – 2019-nCoV acute respiratory disease
• February 11, 2020: During the January 31st meeting, the team noted “2019-nCoV” was a temporary name and likely to change. On February 11th the WHO announced the official name of the virus: COVID-19.
• March 11, 2020: The Novel Coronavirus Disease, COVID-19, was declared a pandemic by the World Health Organization (WHO).
• March 13, 2020: A National Emergency was declared in the United States concerning the COVID-19 Outbreak.
• March 18, 2020: The Coordination and Maintenance Committee Meeting met virtually. It was announced that the COVID-19 code effective date was changed from October 1, 2020 to April 1, 2020 due to the national health emergency. The code that will be effective is U07.1.

U07.1 Coding Instructions

• This code is classified to Chapter 22: Codes for Special Purposes.
• Coding Instructions:
• Use additional code to identify pneumonia or other manifestations
• Excludes 1:
• Coronavirus infection, unspecified (B34.2)
• Coronavirus as the cause of diseases classified to other chapters (B97.2-)
• Severe acute respiratory syndrome [SARS}, unspecified (J12.81)

You can read the entire CDC announcement at: https://www.cdc.gov/nchs/data/icd/Announcement-New-ICD-code-for-coronavirus-3-18-2020.pdf

MEDICARE TRANSMITTALS – RECURRING UPDATES

International Classification of Diseases 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – July 2020 Update

• Article Release Date: February 21, 2020
• What You Need to Know: CR11655 informs providers about ICD-10 updates to specific NCDs. “Note: Coding (as well as payment) is a separate and distinct area of the Medicare Program from coverage policy/criteria. Revisions to codes within an NCD are carefully and thoroughly reviewed and vetted by CMS and are not intended to change the original intent of the NCD. The exception to this is when coding revisions are released as official implementation of new or reconsidered NCD policy following a formal national coverage analysis…MACs will adjust any claims processed in error associated with CR 11491 that you bring to their attention.”
• MLN MM11655: https://www.cms.gov/files/document/mm11655.pdf

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

• Change Request Release Date: March 3, 2020
• What You Need to Know: CR 11691 is a recurring update notification describing changes to and billion instructions for various payment policies implemented in the April 2020 OPPS update.
• CR 11691: https://www.cms.gov/files/document/r4544cp.pdf

April 2020 Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.1

• Article Release Date: March 6, 2020
• What You Need to Know: CR 11680 providers the I/OCE instructions and specifications for the I/OCE that is being updated April 1, 2020. The two new codes for COVID lab tests (U0001 and U0002) are included in this update.
• MLN MM11680: https://www.cms.gov/files/document/mm11680.pdf

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

• Change Request (CR) Release Date: March 6, 2020
• What You Need to Know: CR 11681 is a Recurring Update Notice (RUN) providing instructions for the quarterly update the clinical laboratory fee schedule with an effective date of April 1, 2020.
• CR 11681: https://www.cms.gov/regulations-and-guidanceguidancetransmittals2020-transmittals/document/r4541cp.pdf

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

• Article Release Date: March 13, 2020
• What You Need to Know: CR 11694 describes changes to and billing instructions for various payment policies implements in the April 2020 ASC payment system update.
• MLN MM11694: https://www.cms.gov/files/document/MM11694.pdf

OTHER MEDICARE TRANSMITTALS

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

• Provider Types Affected: Physicians, Providers and Suppliers
• Change Request (CR) Release Date: February 21, 2020
• What You Need to Know: CR 11638 updates RARC and CARC lists and instructs ViPS Medicare System (VMS) and Fiscal Intermediary Shared System (FISS) maintainers to update Medicare Remit Easy Print (MREP) and PC Print Software.
• MLN MM11638: https://www.cms.gov/files/document/mm11638.pdf

NCD 20.4 Implantable Cardiac Defibrillators (ICDs)

• Article Release Date: March 3, 2020
• Provider Types Affected: Physicians, Providers, and Suppliers
• What You Need to Know: This special edition article updated providers on Medicare coverage rules and policies for NCD20.4 and outlines the coding requirements (including heart failure codes) are not more restrictive than the NCD.
• MLN SE20006: https://www.cms.gov/files/document/se20006.pdf

Section 1876 and 1833 Cost Plan Enrollee Access to Care through Original Medicare

• Article Release Date: March 3, 2020
• What You Need to Know: This special edition article reinforces existing Medicare policy allowing non-network providers to bill original Medicare for services provided to Medicare cost plan enrollees.
• MLN SE20009: https://www.cms.gov/files/document/se20009.pdf

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

• Article release date: March 9, 2020
• What You Need to Know: CR11640 informs MACs about new HCPCS codes for 2020 that are subject to and excluded from CLIA edits.
• MLN MM11640: https://www.cms.gov/files/document/mm11640.pdf

The Supplemental Security Income (SSI)/Medicare Beneficiary data for Fiscal Year 2018 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long Term care Hospitals (LTCHs)

• Article Release Date: March 13, 2020
• What You Need to Know: Specific to hospitals, CR 11679 provides updates for determining Disproportionate Share (DSH) adjustment.
• MLN MM11679: https://www.cms.gov/files/document/MM11679.pdf

REVISED MEDICARE TRANSMITTALS

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – April 2020 Update

• Article Revised: February 27, 2020
• Change Request Revised: new Transmittal number R4540CP
• What You Need to Know: The MLN article was revised to reflect the revised change request date and change an MP RVU code in Table 2.
• MLN MM11661: https://www.cms.gov/files/document/mm11661.pdf

Proper Use of Modifier 59

• Special Edition MLN Article Revised March 2, 2020
• What You need to Know: This article was revised to include modifiers –X{EPSU}. All other information is unchanged.
• MLN SE1418: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1418.pdf

New Medicare Beneficiary Identifier (MBI) Get It, Use It

• Special Edition MLN Article Revised March 19, 2020
• What You Need to Know: This article was revised to clarify that you need the beneficiary’s first name, last name, date of birth, and SSN to use MBI look-up tool.
• MLN SE18006: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE18006.pdf

MEDICARE COVERAGE UPDATES

NCD (20.32) Transcatheter Aortic Valve Replacement (TAVR)

• Change Request: 11660
• What You Need to Know: The purpose of this Change Request (CR) is to inform MACs that effective June 21, 2029, CMS will continue to cover TAVR under Coverage with Evidence Devlopment (CED) when the procedure is furnished for the treatment of symptomatic aortic stenosis and according to an FDA approved indication for use with an approved device, in addition to the coverage criteria outlined in the NCD manual.
• CR 11660: https://www.cms.gov/files/document/r217ncd.pdf

MEDICARE PRESS RELEASES AND FACT SHEETS

February 20, 2020: Comprehensive Care for Joint Replacement Model Three Year Extension and Changed to Episode Definition and Pricing (CMS 5529 P)

CMS issued a proposed rule in the Federal Register proposing a three year extension, changes to the  definition of an episode, and changes in pricing in the Comprehensive Care for Joint Replacement (CJR) Model. This model began April 1, 2016 and has a current end date of December 31, 2020. Since this model began total hip and total knee procedures have been removed from the Medicare Inpatient Only Procedure List. Consequently, one proposal being made is to incorporate outpatient hip and knee replacements in the episode of care definition. Comments on the proposed rule must be received no later than 5 p.m. EST on April 24, 2020.

• CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/comprehensive-care-joint-replacement-model-three-year-extension-and-changes-episode-definition-and
• Proposed Rule: https://www.federalregister.gov/documents/2020/02/24/2020-03434/medicare-program-comprehensive-care-for-joint-replacement-model-three-year-extension-and-changes-to
• CJR Model webpage on CMS Innovation Center: https://innovation.cms.gov/initiatives/CJR

CMS Press Release: CMS Administrator Seema Verma at the 2020 CMS Quality Conference

https://www.cms.gov/newsroom/press-releases/speech-remarks-cms-administrator-seema-verma-2020-cms-quality-conference

https://www.beckershospitalreview.com/patient-safety-outcomes/cms-revamps-quality-strategy-5-things-to-know.html?origin=QualityE&utm_source=QualityE&utm_medium=email&oly_enc_id=1461H5080234E6F

MEDICARE EDUCATIONAL RESOURCES

MLNconnects March 19, 2020 Newsletter: Provider Minute Video: The Importance of Proper Documentation

CMS has med this Provider Minute video available discussing how proper documentation affects items/services, claim payment and medical review by discussing the following:

• Top five documentation errors,
• How to submit documentation for a Comprehensive Error Rate Testing (CERT) review, and
• How your Medicare Administrative Contractor (MAC) can help.

https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2020-03-19-mlnc#_Toc35426083

OTHER MEDICARE UPDATES

February 19, 2020: Medicare Advantage Denial Notice

CMS has posted the following information to the CMS MA Denial Notices webpage:

“The Office of Management and Budget (OMB) has approved revisions to the Notice of Denial of Medical Coverage (or Payment), also known as the Integrated Denial Notice (IDN). The expiration date is different on this renewed notice. Plans should begin using the revised IDN as soon as possible, but no later than April 1, 2020. Both the previous and new versions of the notice are acceptable for use through March 31, 2020. Significant revisions made to the notice and instructions include:

• Addition of adjudication timeframes for Part B drugs.
• Removal of language regarding State Fair Hearing as first level of appeal.
• Removal of option to add state specific Medicaid appeal filing timeframe.
• New determination option if an item, service, Part B drug, or payment is partially approved.
• New language notifying enrollees they cannot request an expedited appeal for a request for payment.
• New language informing enrollees they may ask for a good cause extension and should include their reason for being late.
• Option to add information for submitting appeal via plan website.”

March 9, 2020: HHS Finalized Two Transformative Rules Giving Patients Unprecedented, Safe, Secure Access to Their Health Data

Two rules issued by the HHS Office of the National Coordinator for Health information Technology (ONC) and CMS implement interoperability and patient access provisions of the bipartisan 21st century Cures Act (Cures Act) and support the MyHealthEData initiative. 

“The CMS final rule established a new Condition of Participation (CoP) for all Medicare and Medicaid participating hospitals, requiring them to send electronic notifications to another health care facility or community provider or practitioner when a patient is admitted, discharge, or transferred.”  For More Information:

• ONC Cures Act Final Rule website: View the rule,
• CMS Interoperability and Patient Access Final Rule webpage: View the rule,
• CMS Interoperability and Patient Access Fact Sheet,
• Register for Medicare Learning Network call on April 7,
• See the full text of this excerpted CMS Press Release (issued March 9).

March 2020: New OIG Work Plan Item: Medicare Hospital Payments for Claims Involving the Acute- and Post-Acute-care Transfer Policies

The OIG indicated they will review Medicare hospital discharges that were paid a full DRG payment when the patient was transferred to a facility covered by the acute and post-acute transfer policies where Medicaid paid for the service. Under the acute- and post-acute transfer policies, these hospital inpatient stays should have been paid a reduced amount. Additionally, we will assess the transfer policies to determine if they are adequately preventing cost shifting across healthcare settings.

https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000445.asp

This week should have marked the 31st Annual Health Information Professionals (HIP) Week; however, with many of our valued HIM professionals focused on work involving COVID-19, AHIMA has decided to postpone HIP week. The MMP team would still like to acknowledge and celebrate health information professionals at your facility, no matter when your celebration takes place.

This year’s theme, “Connecting People, Systems, and Ideas,” highlights the unique skills, abilities, experiences, and actions at the heart of the health information profession. Health Information Management (HIM), an allied health profession, leads efforts to ensure the availability, accuracy, integrity, and security of all data related to patient healthcare encounters, thus achieving better clinical and business decisions that enhance healthcare quality. HIM professionals work in multiple settings, including hospitals, clinics, physician offices, government and health insurance agencies, and other organizations. They play a key role in the effective management of health data to deliver quality healthcare to the public.

“As our healthcare ecosystem continues to evolve, health information professionals remain committed to the principles of delivering the best in patient care through the use of high-quality data that transforms health and healthcare,” said AHIMA CEO Wylecia Wiggs Harris, PhD, CAE. “HIP Week is an opportunity to celebrate the HIM profession and the dedicated HIM professionals who carry out AHIMA’s mission -- empowering people to impact health.”

Resource: AHIMA.org 

For over thirty years, Medical Management Plus has made it our mission to help healthcare make sense for our clients. This weekly newsletter is one platform we use to provide what we believe to be current and relevant news to our client base. As the potential of Coronavirus (COVID-19) has turned into a reality we are being forced as a nation to come to grips with a new “normal” which includes among other things social distancing, actually washing our hands for a full 20 seconds with soap and water, and for hospitals preparing for the potential onslaught of patients presenting with COVID-19.

There is a wealth of information about COVID-19 and it is being updated and added to on a daily basis. Finding the time to sort through what is available while carrying out your daily responsibilities can be a challenge. To that end, this article is meant to provide our readers with key information and links to additional resources. The entire staff at MMP appreciates all of the dedicated healthcare workers on the front lines of this pandemic and will continue to monitor the situation and share key updates with you our readers.

February 27, 2020: American Heart Association News: What Heart Patients Should Know About Coronavirus

In this article, the American Heart Association highlights reasons why the Coronavirus is more concerning for individuals with a Cardiac history. With a mother, spouse, and friends who are heart patients, it was concerning to me to learn that in people with known fatty buildup of plaque in their arteries, “evidence indicates similar viral illnesses can destabilize these plaques, potentially resulting in the blockage of an artery feeding blood to the heart, putting patients at risk of heart attack.”

March 4th, 2020: MLN Connects Special Edition: CMS Announces Actions to Address Spread of Coronavirus

On March 4, the Centers for Medicare & Medicaid Services (CMS) announced several actions aimed at limiting the spread of the Novel Coronavirus 2019 (COVID-19). Specifically, CMS issued a call to action to health care providers across the country to ensure they are implementing their infection control procedures, which they are required to maintain at all times. Additionally, CMS announced that, effective immediately and, until further notice, State Survey Agencies and Accrediting Organizations will focus their facility inspections exclusively on issues related to infection control and other serious health and safety threats, like allegations of abuse – beginning with nursing homes and hospitals. The shift in approach allows inspectors to focus their energies on addressing the spread of COVID-19.” This announcement went on to describe memorandums as well as links to each one as follows: To view each memo, please visit:

• Suspension of Survey Activities
• Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge
• Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in nursing homes

March 6th, 2020: Defending Against COVID-19 Cyber Scams

The Cybersecurity and Infrastructure Security Agency (CISA) published a notice warning people to remain vigilant for scams related to COVID-19 which included specific precautions that should be taken. For example, avoid clicking on links in unsolicited emails and be wary of email attachments.

March 9th, 2020: Hospital ED Screening for COVID-19 and Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications

CMS published a Press Release urging hospitals to screen all patients for Coronavirus and published a related Memorandum to provide information in response to questions from hospitals and critical access hospitals (CAHs) regarding implications of COVID-19 and their compliance with EMTALA. Note, this guidance applies to both Medicare and Medicaid providers. This memorandum specifically addresses EMTALA screening obligation and EMTALA stabilization, transfer and recipient hospital obligations.

March 10th, 2020: Memorandum to MA Organizations related to COVID-19

This Memorandum was issued to Medicare Advantage Organizations and Part D Sponsors to inform them of the obligations and permissible flexibilities related to disasters and emergencies resulting from COVID-19. The flexibilities include:

• Waiving cost-sharing for COVID-19 tests,
• Waiving cost-sharing for COVID-19 treatments in doctor’s offices or emergency rooms and services delivered via telehealth,
• Removing prior authorizations requirements,
• Waiving prescription refill limits, Relaxing restrictions on home or mail delivery of prescription drugs, and
• Expanding access to certain telehealth services.

CMS also provided a related Press Release.

March 13, 2020: COVID-19 Emergency Declaration Health Care Providers Fact Sheet

CMS provided a Fact Sheet in response to their announcement about the steps taken through 1135 waivers. One key blanket waiver is for Skilled Nursing Facilities (SNFs). Specifically, “CMS is waiving the requirement at Section 1812(f) of the Social Security Act for a 3-day prior hospitalization for coverage of a skilled nursing facility (SNF) stay provides temporary emergency coverage of (SNF services without a qualifying hospital stay, for those people who need to be transferred as a result of the effect of a disaster or emergency. In addition, for certain beneficiaries who recently exhausted their SNF benefits, it authorizes renewed SNF coverage without first having to start a new benefit period.” A word of caution, a patient must still have a skilled need.

March 13, 2020: Guidance for Infection Control and Prevention of COVID-19 in Nursing Homes Revised

In a Revised Memorandum to State Survey Agency Directors, CMS advised facilities to “restrict visitation of all visitors and non-essential health care personnel, except for certain compassionate care situations, such as end-of-life situation.”

March 16, 2020: Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19)

As follow-up to the March 13th Emergency Declaration Health Care Providers Fact Sheet, CMS indicated in this Special MLN article (SE20011) that they have issued blanket waivers consistent with those issues for past public health emergencies (PHE) declarations. “These waivers prevent gaps in access to care for beneficiaries impacted by the emergency. You do not need to apply for an individual waiver if a blanket waiver is issued.”

March 16, 2020: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp

The FDA announced they have issued Emergency Use Authorization (EUAs) to Hologic for its Panther Fusion SARS-COV-2 Assay, and LabCorp for its COVID-19 RT-PCR test.

March 16, 2020: COVID-19 & HIPAA

On March 16th HHS released this Bulletin providing information about a Limited Waiver of HIPAA Sanctions and Penalties during a Nationwide Public Health Emergency.

March 17, 2020: CMS Coronavirus Partner Virtual Toolkit

CMS released a Virtual Toolkit to help you stay up-to-date on CMS materials available on COVID-19. CMS encourages you to bookmark the webpage and check back often. 

March 17, 2020: CMS Expands Medicare Telehealth Coverage & the OIG Releases Waiving Telehealth Cost-Sharing Policy Statement

Expanded Medicare telehealth coverage was announced that will “enable beneficiaries to receive a wider range of healthcare services from their doctors without having to travel to a healthcare facility.

• Medicare Telemedicine Health Care Provider Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet
• Telehealth FAQs: https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf

At the same time, the OIG released a Policy Statement regarding Physicians and Other Practitioners that reduce or waive amounts owed by the beneficiary during the COVID-19 outbreak.

• OIG Policy Statement: https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/policy-telehealth-2020.pdf
• OIG Fact Sheet: https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/factsheet-telehealth-2020.pdf

The Office of Civil Rights published a related Notification of Enforcement Discretion for Telehealth in which they indicated the following:

• They “will exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency.  This notification is effective immediately.”
• They are “exercising its enforcement discretion to not impose penalties for noncompliance with the HIPAA Rules in connection with the good faith provision of telehealth using such non-public facing audio or video communication products during the COVID-19 nationwide public health emergency.  This exercise of discretion applies to telehealth provided for any reason, regardless of whether the telehealth service is related to the diagnosis and treatment of health conditions related to COVID-19.
• Under this Notice, covered health care providers may use popular applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA Rules related to the good faith provision of telehealth during the COVID-19 nationwide public health emergency. 
• Providers are encouraged to notify patients that these third-party applications potentially introduce privacy risks, and providers should enable all available encryption and privacy modes when using such applications. 
• Under this Notice, however, Facebook Live, Twitch, TikTok, and similar video communication applications are public facing, and should not be used in the provision of telehealth by covered health care providers.

March 17, 2020: Medicaid Telehealth

As a companion piece to the Medicare Telehealth Guidance, CMS released a Medicaid Telehealth Guidance to states document. Additionally, Medicaid.gov has a webpage dedicated to Telemedicine.

March 18, 2020: CMS Releases Recommendations on Surgeries & Procedures during COVID-19 Response

CMS announced in a Press Release that all elective surgeries, non-essential medical, surgical, and dental procedures be delayed during the 2019 Novel Coronavirus (COVID-19) outbreak. This CMS Press Release includes a link to specific tiered recommendations. For example, Tier 1a has an action to Postpone procedure or surgery and provides specific examples of carpal tunnel release, EGD, colonoscopy and cataracts.

March 18, 2020: Updated COVID-19 FAQs for State Medicaid and CHIP Agencies

In an effort to protect the health and safety of providers and patients, including those covered by Medicaid and the Children’s Health Insurance Program (CHIP), CMS provided an updated FAQ Document.

March 18, 2020: Kaiser Family Foundation (KFF) New COVID-19 Tool:

KFF has developed a New Tool providing the Latest State-Level Data on COVID-19 Cases and Deaths, Provider Capacity and the various policy actions that states have taken to combat the crisis. Information will be updated regularly.

March 18, 2020: Medicare Fee-for-Service (FFS) Response to Public Health Emergency on the Coronavirus (COVID-19) MLN Article Revised

• What You Need to Know: This article was revised to include information about the Telehealth waiver.
• MLN Matters SE20011: https://www.cms.gov/files/document/se20011.pdf

March 22, 2020: CMS Press Release Relief for Quality Reporting Programs

CMS announced “unprecedented relief for clinicians, providers, and facilities participating in Medicare quality reporting programs…Specifically, CMS announces it is granting exceptions from reporting requirements and extensions for clinicians and providers….with respect to upcoming measure reporting and data submission for those programs.” This action is in response to 2019 Novel Coronavirus (COVDI-19). This Press Release includes a table detailing the specific extensions being granted.

March 23, 2020 OIG Releases Fraud Alert

The OIG has released “a COVID-19 Fraud Alert to warn about several health care fraud scams that harm patients and the federal programs designed to serve them.  This alert has general information about these schemes and how to protect yourself and your community against bad actors.”

Alabama Public Health: COVID-19 Webpage

The Alabama Public Health Department has created a COVID-19 webpage which includes guidance for healthcare providers, what to do if you suspect you have COVID-19, a current “Situation Summary,” and lists several resources available from the Alabama Department of Public Health, the CDC, CMS and additional resources such as the World Health Organization and American Veterinary Medical Association (AVMA).

CDC Handouts & Posters

The CDC has made available Handouts and Posters in English, Spanish and simplified Chinese. Topics available includes:

• Share Facts About COVID-19,
• What You Need to Know,
• What to do if you are sick,
• Stop the spread of germs poster, and
• Symptoms of Coronavirus Disease 2019 poster.

A Wash Your Hands poster is also available in English, Spanish, French, Arabic, Bengali, Chinese, Portuguese, and Urdu.

World Health Organization (WHO): COVID-19 Advice for the Public: Myth Busters

The WHO has posted several Facts about the Coronavirus that can be downloaded and shared as a graphic. A few of the facts available are:

• Taking a hot bath does not prevent the new coronavirus,
• Vaccines against pneumonia do not provide protection against the new coronavirus, and
• There is no evidence that regularly rinsing the nose with saline has protected people from infection with the new coronavirus.

Additional Websites Providing COVID-19 Resources:

• Palmetto GBA Coronavirus (COVID-19) Resources at: https://www.palmettogba.com/COVID-19
• gov Coronavirus Disease 2019 (COVID-19) at: https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/covid19/index.html
• AMA COVID-19 at: https://www.ama-assn.org/search?search=COVID+19
• Environmental Protection Agency (EPA) Coronavirus Disease 2019 (COVID-19) at: https://www.epa.gov/coronavirus
• Note: Included on this page is a link to a List of disinfectants for use against Coronavirus (COVID-19).

March 13, 2020: AMA Announces New CPT Code to Report Novel Coronavirus Test

The CPT editorial panel expedited approval of a unique CPT code to report laboratory testing services that diagnose the presence of the novel coronavirus.

• CPT code and long descriptor: 87635 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique
• Note, the code is effective immediately for use for reporting of tests for the novel coronavirus.

Press Release: https://www.ama-assn.org/press-center/press-releases/new-cpt-code-announced-report-novel-coronavirus-test

Link to further guidance from the AMA regarding the CPT including a CPT Fact Sheet: https://www.ama-assn.org/practice-management/cpt/cpt-releases-new-coronavirus-covid-19-code-description-testing

Getting to Know the MACs

Welcome to the third edition of MMP’s MAC Talk article. Before jumping in to “The Local Scene” I wanted to provide general information about MACs in the form of questions and answers.

Question: What is a MAC?
Answer: A CMS contractor that processes Medicare Part A and Part B (A/B) benefit claims or Durable Medical Equipment (DME) claims for a designated jurisdiction. CMS relies on a network of MACs to serve as the primary operational contact between the Medicare Fee-for-Service (FFS) program and the health care providers and suppliers enrolled in the FFS program.

Question: What types of claims does an A/B MAC process?
Answer: A/B MACs process claims for both institutional and non-institutional providers for a designated geographic jurisdiction. Currently, there are 12 A/B MACs that process about 95% of all FFS claims. Four of the twelve MACs also specialize in handling claims for home health and hospice providers.  Seven different companies hold the prime contracts (CGS, FCSO, NGS, Noridian, Novitas, Palmetto and WPS).

Question: What are the primary functions of the MACs?
Answer: MACs perform the following functions:

• Process Medicare FFS claims,
• Enroll providers in the Medicare FFS program,
• Respond to provider inquiries,
• Handle Redetermination requests (1st stage of the appeals process),
• Review medical records for selected claims,
• Perform provider reimbursement services,
• Review and audit institutional provider cost reports,
• Educate providers about Medicare FFS billing requirements,
• Establish Local Coverage Determinations (LCDs) and Articles,
• Support CMS demonstration projects (e.g., prior authorization, new payment models), and
• Coordinate with CMS and other FFS contractors.

March MAC Talk: The Local Scene

February 18, 2020 Palmetto GBA Article for No Orders for Inpatient Admission (5J503)

In this article, Palmetto GBA offers tips to preventing a denial for lack of an inpatient order. The first tip in the article is as follows:

• “Physician’s order to admit to inpatient services should be clearly identified in the medical records. This order may be located within the history and physical, progress note, emergency room report and/or verbal order signed and dated by the physician.”

https://www.palmettogba.com/palmetto/providers.nsf/DocsR/Providers"JJ%20Part%20A"Medical%20Review"Medical%20Review%20Denials"BLWHMM2865?open

February 26th, 2020: Palmetto GBA Posts FAQs from February 13th Part A Ask the Contractor Teleconference

The transcript includes a welcome and brief discussion about Medicare Comprehensive Error Rate Testing (CERT) Program. Specific questions ranged from interrupted stays to waiving a Medicare patient’s coinsurance, deductible and copays to asking if Medicare Advantage Plans adhere to local and national coverage determinations.

https://www.palmettogba.com/palmetto/providers.nsf/ls/JJ%20Part%20A"BM5SZ43042?opendocument

February 26, 2020: National Government Services (NGS) Posts Guidance for Amending Medical Records

NGS reminds providers that “occasionally, certain entries related to services provided are not properly documented. In this event, the documentation will need to be amended, corrected or entered after rendering the service.” The post goes on to provide guidance on how to comply with amending a medical record as outlined in the Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.5.

https://tinyurl.com/vz8sahe

March 2nd, 2020: NGS Posts News Alert about QIO Improvement Initiatives

In this Alert, NGS encourages providers to reach out to your Quality Improvement Networks – Quality Improvement Organization (QIN-QIO) to see if what resources may be available “to assist you with your local healthcare priorities and needs.”

https://tinyurl.com/yx6zav5n

March 4th, 2020: Palmetto GBA Posts JJ and JM Part B Ask the Contractor Teleconference Q&As

Even though in general MMP focuses on Part A Services, there were a couple of interesting Q&A’s in this release, for example:

• Question: If we have questions regarding a national coverage determination, is there anyone to contact for additional information and/or a better understanding of the criteria that is required?
• Answer: As a Medicare contractor, Palmetto GBA interprets national coverage determinations (NCD) as outlined by CMS. Your first call should be to the Palmetto GBA provider contact center for general information. If you disagree with the NCD and would like to request CMS to consider making changes, you should send your request to NCDrequest@CMS.hhs.gov.

https://www.palmettogba.com/palmetto/providers.nsf/ls/JJ%20Part%20B"BMDJKB7554?opendocument

March 9th, 2020: WPS Posts Notice about Expiring ABN Form CMS-R-131

“The Advance Beneficiary Notice of Noncoverage (ABN) Form CMS-R-131 expiration date is March 2020. CMS has not notified us of a new form. In addition, CMS has not instructed us to assess errors for the current form during medical review. The form is still acceptable until CMS notifies us otherwise, even after March 2020. We will publish more information when it becomes available.”

https://www.wpsgha.com/wps/portal/mac/site/claims/news-and-updates/form-cms-r-131/

March 9th, 2020: WPS Post Notice about Procedure Code 94762 – Are You Billing Correctly?

Procedure code 94762 represents a continuous overnight pulse oximetry service. WPS GHA recently evaluated claim data for this service. The analysis compared Jurisdiction 5 (J5) and Jurisdiction 8 (J8) claim submission rates to national data. The data showed J5 providers billing Type of Bill 12X submitted this code twice as often providers in the rest of the country. We encourage all providers to review their records to ensure they are billing the procedure correctly. You can find information in our resource Continuous Overnight Pulse Oximetry (CPT 94762) – Evaluate Use.

https://www.wpsgha.com/wps/portal/mac/site/claims/news-and-updates/procedure-code-94762-are-you-billing-correctly/

March 10th, 2020: Noridian Posts Notice Regarding Improper Payment for IMRT

In a recent report, the Office of Inspector General (OIG) determined that payments for outpatient Intensity Modulated Radiation Therapy (IMRT) did not comply with Medicare billing requirements. Specifically, hospitals billed separately for complex stimulations when they were performed as part of IMRT planning. Overpayments occurred because hospitals are unfamiliar with or misinterpreted CMS guidance. Use the following resources to bill correctly:

• IMRT Planning Services Editing  MLN Matters Article
• July 2016 Update of the Hospital Outpatient Prospective Payment System  MLN Matters Article
• Medicare Improperly Paid Hospitals Millions of Dollars for IMRT Planning Services  OIG Report
• Medicare Claims Processing Manual, Chapter 4 , Section 200.3.1

Source: CMS MLN Connects dated September 19, 2019

https://med.noridianmedicare.com/web/jfa/article-detail/-/view/10529/improper-payment-for-intensity-modulated-radiation-therapy-planning-services

MMP Note: Palmetto GBA JM recently added a Review of Outpatient Claims for CPT Codes 77301 and 77338 IMRT Planning and MLC Devices to their TPE Medical Review list. You can view the entire Medical Review list at: https://www.palmettogba.com/palmetto/providers.nsf/DocsCat/Providers"JM%20Part%20A"Medical%20Review"General"9NNJBX6701?open.

March 10th, 2020: NGS Posts their March 2020 Provider Education: Social Determinants of Health

This three page document defines Social Determinants of Health (SDOH), discusses effort within the government to increase the understanding and impact of SDOH on healthcare and healthcare outcomes, and provides resources for Provider to help identify and address gaps in SDOHs for Medicare beneficiaries.

https://www.ngsmedicare.com/ngs/wcm/connect/ngsmedicare/905372ca-f30a-477e-8aa7-837625f11f82/2222_sd_mar2020_final_508.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=ROOTWORKSPACE.Z18_69MIG982N05UD0QGR5I7CS2000-905372ca-f30a-477e-8aa7-837625f11f82-n2s35TX

March 16th, 2020: WPS Posts CERT Denials for Laboratory Services

Claim reviews performed by the Comprehensive Error Rate Testing (CERT) contractor have noted error findings for insufficient documentation for laboratory services. Documentation to support medical necessity, a valid physician order (or note of intent), and laboratory report(s) were often missing.

The following will help providers responding to CERT claim reviews. Documentation should include:

• The ordering physician or non-physician (physician assistant, nurse practitioner, or clinical nurse specialist) progress note that documents the medical necessity for the laboratory services.
• A signed and dated physician or non-physician order (a registered nurse (RN) cannot sign an order) or progress notes documenting intent.
• All laboratory reports to support the procedure code(s) billed. 

For more information, refer to the Medicare Learning Network (MLN) Fact Sheet, "Complying with Documentation Requirements for Laboratory Services."

Q:

When Medicare changes the status indicator for separately payable drugs, do we have to revise the related modifiers assigned to these drugs in the chargemaster (CDM) / pharmacy system?

A:

Yes. If your hospital purchased the drug through the 340B Program, you must bill the applicable modifier JG or TB for the drug to Medicare. This is specific to drugs / biologicals assigned status indicator G or K in Addendum B under the Outpatient Prospective Payment System (OPPS).

If the drug is assigned status indicator K, Medicare wants to reduce your reimbursement for the drug if it was purchased through 340B.  In that scenario, it is your responsibility to bill the drug to Medicare with modifier JG. If you purchase a status indicator K drug through the 340B program, but do not bill the drug with modifier JG, you will be overpaid.

Modifier TB should be billed for drugs assigned status indicator G which are purchased through the 340B program.  Even though modifier TB is for informational purposes, it is still required, just like modifier JG. This modifier does “not” trigger a reduced payment from Medicare.

If a drug /biological was “not” purchased through a 340B program, modifier JG / TB should not be billed.

This creates a challenge for CDM coordinators, because this type of CDM maintenance is absolutely essential to compliant Medicare billing of these items. You should expect some status indicator changes quarterly. We acknowledge some hospitals manage pharmacy modifiers in a pharmacy system separate from the CDM.

Take a look at the upcoming status indicator changes listed in the  April 2020 OPPS Update, excerpted below – effective April 1, 2020. Keep in mind, modifiers JG and TB must be date specific to match the status indicator assigned for respective dates of service on the outpatient Medicare claim.

New CY 2020 HCPCS Codes Effective April 1, 2020 for Certain Drugs, Biologicals, and Radiopharmaceuticals

Currently Existing HCPCS Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals receiving pass-through status Effective April 1, 2020

HCPCS Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals with Pass-Through Status Ending Effective March 31, 2020

For more information about billing 340B modifiers under the OPPS, refer to the CMS FAQ document published April 2018. 

March is National Professional Social Work Month. This year’s the National Association of Social Workers (NASW) is celebrating its 65th anniversary with the theme “Social Workers: Generations Strong.” The NASW notes that “as we enter a new decade it is important to look back and honor the powerful, positive impact the social work profession has had on our society for generations.”

A few of the highlights available on NASW’s website for your 2020 Social Work Campaign include:

• A Social Work Month 2020 video highlighting who social workers are;
• Several different Infographics that can be used to educate people about the different types of Social Work; and
• A document highlighting the theme and rationale for Social Work Month.

I want to acknowledge and thank all of the wonderful social workers that I have worked with or who have been an invaluable resource in my own life when family members have been hospitalized.

The transition of care from a hospital to a post-acute setting can be a very stressful time. As MMP has done in years past, we are providing an updated list of resources to assist with discharge planning.

• Resources for You:
• Medicare Costs at a Glance for 2020
• Medicare and Medicaid Basics MLN Booklet
• Long-Term Care Hospital Prospective Payment System MLN Booklet
• Inpatient Rehabilitation Facility Prospective Payment System MLN Booklet
• Skilled Nursing Facility Prospective Payment Fact Sheet Booklet
• Swing Bed Services Fact Sheet
• The Medicare Home Health Benefit
• Home Health Prospective Payment System
• Hospice Payment System Fact Sheet
• Medicare Ambulance Transports
• Home Oxygen Therapy
• Power Mobility Devices MLN Booklet

• Resources for your patients
• Taking Care of Myself: A Guide for When I Leave the Hospital
• Discharge Planning Protects You
• Your Discharge Planning Checklist

From all of us at MMP, Happy Social Work Month!

Additional Code for Coronavirus Lab Test

Included in MMP’s February Coding Corner was news about CMS developing a new Healthcare Common Procedure Coding System (HCPCS) code for providers and laboratories testing patients for SARS-CoV-2.

In a March 5th Press Release, CMS announced a second HCPCS code has been developed “that can be used by laboratories to bill for certain COVID-19 diagnostic tests to help increase testing and track new cases. In addition, CMS released new fact sheets that explain Medicare, Medicaid, Children’s Health Insurance Program, and Individual and Small Group Market Private Insurance coverage for services to help patients prepare as well.”

• February 2020 HCPCS code U0001 is to be used specifically for CDC testing laboratories to test patients for SARS-CoV-2.
• March 2020 HCPCS U0002 allows laboratories to bill for non-CDC laboratory tests for SARS-CoV-2/2019-nCoV (COVID-19).

The Press Release also notes the Food and Drug Administration issued a new, streamlined policy on February 29th for certain laboratories to develop their own validated COVID-19 diagnostics. This second HCPCS code may be used for tests developed by these additional laboratories when submitting claims to Medicare and health insurers.

The Medicare claims processing systems will be able to accept these codes starting April 1, 2020 for dates of service on or after February 4, 2020.

Medicare Fact Sheet: Inpatient Hospital Quarantines

As mentioned above, included in the press release about a second HCPCS code were fact sheets. Following is an excerpt from the Medicare Fact Sheet specifically about Inpatient Hospital Quarantines:

“There may be times when beneficiaries with the virus need to be quarantined in a hospital private room to avoid infecting other individuals. These patients may not meet the need for acute inpatient care any longer but may remain in the hospital for public health reasons. Hospitals having both private and semiprivate accommodations may not charge the patient a differential for a private room if the private room is medically necessary. Patients who would have been otherwise discharged from the hospital after an inpatient stay but are instead remaining in the hospital under quarantine would not have to pay an additional deductible for quarantine in a hospital.

If a Medicare beneficiary is a hospital inpatient for medically necessary care, Medicare will pay hospitals the diagnosis-related group (DRG) rate and any cost outliers for the entire stay, including any the quarantine time when the patient does not meet the need for acute inpatient care, until the Medicare patient is discharged. The DRG rate (and cost outliers as applicable) includes the payments for when a patient needs to be isolated or quarantined in a private room.”

https://www.cms.gov/newsroom/press-releases/cms-develops-additional-code-coronavirus-lab-tests

Cigna Adopts Sepsis-3

Cigna announced in their First Quarter 2020 Cigna Network News that “As part of our effort to promote the accurate diagnosis and treatment of sepsis, and use the appropriate billing and coding, we have adopted the Third International Consensus Definitions or Sepsis and Septic Shock (Sepsis-3), effective immediately.” https://www.cigna.com/sites/email/2020/937483-2020-q1-network-news.pdf

What this means to you

“If after reviewing a patient’s medical record and the Sepsis-3 criteria a Cigna Medical Director determines that sepsis was not present, a diagnosis-related group (DRG) claim assignment may be adjusted because sepsis treatment services should not have been included as part of the claim. In these cases, covered claims will be processed with the appropriate revised DRG supported in the medical record.”