Knowledge Base Category -

At least annually, MS-DRG classifications and relative weights are adjusted to reflect changes in treatment patterns, technology, and other factors that may change the relative use of hospital resources. This week is the first article in a series of article about the 2021 IPPS Proposed Rule. This week highlights proposed changes to specific MS-DRG Classifications.

Pre-MDC: Bone Marrow Transplants

Surgical vs. Medical MS-DRGs

Currently, the Bone Marrow Transplant (BMT) MS-DRGs (MS-DRG 014 (Allogeneic Bone Marrow Transplant), MS-DRG 016 (Autologous Bone Marrow Transplant with CC/MCC or T-Cell Immunotherapy), and MS-DRG 017 (Autologous Bone Marrow Transplant without CC/MCC) are designated as surgical MS-DRGs.

A request was made to re-designate these three MS-DRGs as medical MS-DRGs as a Bone Marrow Transplant does not involve a surgical procedure or require the use of an O.R. The requestor noted that this change “would clinically align with the resources utilized in the performance of these procedures.

CMS clinical advisors agreed and the proposal has been made to re-designate MS-DRGs 014, 016, and 017 as medical MS-DRGs effective October 1, 2020.

BMT Procedures Designation O.R. vs. Non-O.R.

The requestor also noted that MS-DRGs 016 and 017 includes ICD-10-PCS procedures codes designated as Non-O.R. while the following eight procedures are designated as O.R. Procedures:

• 30230AZ: Transfusion of embryonic stem cells into peripheral vein, open approach
• 30230G0: Transfusion of autologous bone marrow into peripheral vein, open approach
• 30230X0: Transfusion of autologous cord blood stem cells into peripheral vein, open approach
• 30230Y0: Transfusion of autologous hematopoietic stem cells into peripheral vein, open approach
• 30240AZ: Transfusion of embryonic stem cells into central vein, open approach
• 30240G0: Transfusion of autologous bone marrow into central vein, open approach
• 30240X0: Transfusion of autologous cord blood stem cells into central vein, open approach
• 30240Y0: Transfusion of autologous hematopoietic stem cells into central vein, open approach.

CMS is proposing to re-designate these codes from O.R. to Non-O.R. procedures effective October 1, 2020.

Chimeric Antigen Receptor (CAR) T-Cell Therapies: New MS-DRG

In the FY 2020 IPPS Proposed Rule, a request was made to create new MS-DRGs for CAR T-cell therapy. The requestor noted this would improve payment in the inpatient setting. CMS did not believe enough data was available to make a change at that time. However, CMS did seek comments on payment alternatives for CAR-T cell therapies.

In the FY 2020 Final Rule CMS finalized the continuation of the new technology status and add-on payments for FY 2020 for this therapy.

There were several requests made, in the FY 2021 proposed rule, to create a new MS-DRG as this therapy will no longer be eligible for the new technology add-on payment (NTAP) for FY 2021. CMS has responded by noting they now have enough data to consider the development of a new MS-DRG. Further, CMS clinical advisors found a vast discrepancy in resource consumption and clinical differences warranting the creation of new MS-DRG.

CMS is proposing to do the following:

• Create new MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell immunotherapy, and
• Revise the MS-DRG 016 title to “Autologous Bone Marrow Transplant with CC/MCC.”

The following table highlights the proposed MS-DRG relative weight (RW) and geometric mean length of stay (GMLOS) for the BMT MS-DRGs and the proposed new CAR T-Cell MS-DRG:

‍MDC 1: Diseases and Disorders of the Nervous System

Carotid Artery Stent Procedures: Background

In FY 2020 CMS finalized their proposal to reassign 96 ICD-10-PCS procedures describing dilation of carotid artery with an intraluminal device(s):

• From MS-DRGs 037, 038, and 039 (Extracranial Procedures with MCC, with CC, and without CC/MCC respectively)
• To MS-DRGs 034, 035, and 036 (Carotid Artery Stent Procedures with MCC, with CC, and without CC/MCC respectively)

Carotid Artery Stent Procedures: FY 2021 Proposals

In response to a request, CMS is proposing to reassign the following six ICD-10-PCS codes describing dilation of carotid artery with drug eluting intraluminal device(s) using an open approach from MS-DRGs 037, 038, and 039 to MS-DRGs 034, 035, and 036:

• 037H04Z: Dilation of right common carotid artery with drug-eluting intraluminal device, open approach
• 037J04Z: Dilation of left common carotid artery with drug-eluting intraluminal device, open approach
• 037K04Z: Dilation of right internal carotid artery with drug-eluting intraluminal device, open approach
• 037L04Z: Dilation of left internal carotid artery with drug-eluting intraluminal device, open approach
• 037M04Z: Dilation of right external carotid artery with drug-eluting intraluminal device, open approach
• 037N04Z: Dilation of left external carotid artery with drug-eluting intraluminal device, open approach

CMS further reviewed to see if any of the six codes were included in MS-DRGs outside of MDC 1. They found a total of 36 ICD-10 PCS codes for procedures describing dilation of the carotid artery with an intraluminal device with an open approach that are currently assigned to MS-DRG 252 (Other Vascular Procedures with MCC) in MDC 5 (Diseases and Disorders of the Circulatory System). Interestingly, they found 8 claims with one of these 36 ICD-10-PCS codes and a Principal Diagnosis in MDC 1 causing the claims to group to the Extensive O.R. Procedure Unrelated to Principal Diagnosis MS-DRG Group (981, 982, and 983).

CMS is proposing to add the 36 ICD-10-PCS codes currently in MDC 5 to the GROUPER logic for MS-DRGs 034, 035, 036 in MDC 1. As my instructor told me when first learning about the MS-DRG system, this change will permit cases with a Principal Diagnosis in MDC 1 to “remain in the family.”

MDC 3: Diseases and Disorders of Ear, Nose, and Throat

Temporomandibular Joint Replacements

A request was made to reassign ICD-10-PCS procedures 0RRC0JZ (Replacement of right temporomandibular joint with synthetic substitute, open approach), and 0RRD0JZ (Replacement of left temporomandibular joint with synthetic substitute, open approach):

• From MS-DRGs 133 and 134 (Other Ear, Nose, Mouth and Throat O.R. Procedures with and without CC/MCC, respectively)
• To MS-DRGs 131 and 132 (Cranial and Facial Procedures with and without CC/MCC, respectively) in MDC 03.

The requestor stated that it is inaccurate for these two codes that involve the excision of the TMJ and replacement with a prosthesis to Group to MS-DRGs 133 and 134 when the codes for the TMJ excision alone (0RBC0ZZ (Excision of right temporomandibular joint, open approach) and 0RBD0ZZ (Excision of left temporomandibular joint, open approach) group to the higher weighted MS-DRGs 131 and 132.

The requestor also recommended analysis of all procedures involving the mandible and maxilla and consider reassignment of these procedures codes describing procedure performed on facial and cranial structure:

• From MS-DRGs 129 (Major Head and Neck Procedures with CC/MCC or Major Device) and 130 (Major Head and Neck Procedures without CC/MCC)
• To MS-DRGs 131 and 132.

CMS undertook a comprehensive review of all procedures currently assigned to MS-DRGs 129, 130, 131, 132, 133, and 134. Based on data analysis and this comprehensive review, the Clinical Advisors support restructuring of these MS-DRGs by assigning procedures currently assigned to these MS-DRGs based on clinical intensity, complexity of service and resource utilization.

Additional Findings as a result of this comprehensive review included:

• CMS noting the current special logic defined as “Major Device Implant” for MS-DRG 129 that identified procedures describing the insertion of a cochlear implant or other hearing device. “Clinical advisors supported the removal of this special logic from the definition for assignment to any proposed modifications to the MSDRGs, noting the costs of the device have stabilized over time and the procedures can be appropriately grouped along with other procedures involving devices in any restructured proposed MS-DRGs.”
• CMS identified 338 procedure codes that were inadvertently assigned to MS-DRGs 133 and 134 as a result of replication during the transition from ICD-9 to ICD-10 based MS-DRGs. This list of codes is available in Table 6P.2c.

As a result of their review, CMS has proposed the following:

• Delete the three MS-DRGs groups with a two-way severity level subgroup (129 & 130, 131 & 132, and 133 & 134)
• Create two new base MS-DRGs with a three-way severity level split:
• MS-DRGs 140, 141, and 142 (Major head and Neck Procedures with MCC, with CC, without CC/MCC respectively), and
• MS-DRGs 143, 144, and 145 (Other Ear, Nose, Mouth, and Throat O.R. Procedures with MCC, with CC, without CC/MCC respectively).

MDC 5: Diseases and Disorders of the Circulatory System

Left Atrial Appendage Closure (LAAC)

Requests were made to create a new MS-DRG for the LAAC procedure or to map all LAAC procedures to a different MS-DRG with payment rates aligned with procedural costs.  The following table shows the current corresponding MS-DRGs for the 9 ICD-10-PCS codes describing LAAC Procedures

As detailed in the table, ICD-10-PCS procedures currently map to an MS-DRG based on the approach. CMS has proposed to reassign the ICD-10-PCS procedure codes for an open approach to MS-DRGs 273 and 274. “Clinical advisors stated this reassignment would allow all LAAC procedures to be grouped to the same MS-DRGs and improve clinical coherence. The following table highlights the difference in R.W., GMLOS and national average payment in FY 2020:

‍Potential Impact by the Numbers

With the national payment rate for MS-DRGs 273 and 274 being significantly higher than MS-DRG 250 and 251, I wanted to see what the potential volume of claims and payment impact this change might have. To answer these questions I pulled Medicare fee-for-service paid claims data from RealTime Medicare Data (RTMD). Specifically, all claims with one of the 9 ICD-10-PCS procedure codes for LAAC for Alabama, Georgia and Tennessee in Calendar Year (CY) 2019. Following is what I found “by the numbers:”

• 314: The number of LAAC procedures performed in CY 2019.
• 1: The volume of claims grouping to MS-DRG 250.
• 8: The volume of claims grouping to MS-DRG 251.
• $74,166.95: The increase in payment for this group of 9 MS-DRGs based on FY 2020 national average payment.

Insertion of Cardiac Contractility Modulation Device

A request was made to review the MS-DRG assignment for cases identifying patients receiving a cardiac contractility modulation (CCM) device system for CHF. “CCM is indicated for patients with moderate to severe heart failure resulting from either ischemic or non-ischemic cardiomyopathy. CCM utilizes electrical signals which are intended to enhance the strength of the heart and overall cardiac performance. CCM delivery device systems consist of a programmable implantable pulse generator (IPG) and three leads which are implanted in the heart. One lead is implanted into the right atrium and the other two leads are inserted into the right ventricle.”

Reasons for this request:

• MS-DRGs 222, 223, 224, 225, 226, and 227 (Cardiac Defibrillator Implant with and without Cardiac Catheterization with and without AMI/HF/Shock with and without MCC, respectively include “code pairs” describing the insertion of contractility modulation devices.
• Currently, GROUPER logic requires the combination of the CCM device codes and a left ventricular lead to map to this group of MS-DRGs.
• Per the requestor, a CCM device is contraindicated in patients with a left ventricular lead. Consequently, no case involving insertion of the CCM system can be appropriately mapped to this group of MS-DRGs.
• Currently, CCM system insertion maps to MS-DRG 245 (AICD Generator Procedures).
• Requester noted to date this procedure has been performed on an outpatient bases but expects that some Medicare patients will receive CCM devices as an inpatient.

CMS analysis found that the ICD-10-PCS procedure code combinations for right ventricular and/or right atrial lead insertion with insertion of CCM devices were inadvertently excludes from this group of MS-DRGs as a result of replicating the ICD-9 based MS-DRGs. Based on their analysis, CMS is making the following two proposals:

• Add 24 ICD-10-PCS code combinations for CCM devices to this group of MS-DRGs, and
• Delete the 12 clinically invalid code combinations from the GROUPER logic of this MS-DRG group describing the insertion of CCM device and the insertion of a cardiac lead into the left ventricle.

MDC 6: Diseases and Disorders of the Digestive System

Acute Appendicitis

A request was made to add K35.20 (Acute appendicitis with generalized peritonitis, without abscess) to the list of complicated Principal Diagnoses grouping to MS-DRGs 338, 339, and 340 (Appendectomy with Complicated Principal Diagnosis with MCC, with CC, without CC/MCC, respectively) so that all ruptured/perforated appendicitis codes in MDC 6 would groups to these MS-DRGs.

Clinical Advisors agreed that the “presence of an abscess would clinically determine whether a diagnosis of acute appendicitis would be considered a complicated principal diagnosis.” However, since K35.20 is “without an abscess,” CMS did not make a proposal to add K35.20 to this MS-DRG group.

The requestor had also noted that K35.32 (Acute appendicitis with perforation and localized peritonitis, without abscess) currently groups to MS-DRGs 338, 339, and 340. Subsequently, CMS identified all diagnosis codes describing acute appendicitis under subcategory K35.2 and K35.3 to review MS-DRG assignments for clinical coherence. As a result of this review, CMS is making the following proposals specific to diagnosis code K35.32:

• Reassign diagnosis code from MS-DRGs 338, 339 and 340 to MS-DRGs 341, 342, and 343; and
• Remove diagnosis code from the complicated principal diagnosis list in MS-DRGs 338, 339, and 340.

MDC 8: Diseases and Disorders of the Musculoskeletal System and Connective Tissue

Hip and Knee Joint Replacements

A requestor recommended restructuring MS-DRGs for total joint arthroplasty that utilize oxidized zirconium bearing surface implants in total hip and total knee replacements. They went on to offer three options for restructuring the MS-DRGs. Based this request and lengthy data analysis by CMS, CMS is proposing to create two new MS-DRGs for FY 2021:

• MS-DRG 521: Hip Replacement with Principal Diagnosis of Hip Fracture with MCC, and
• MS-DRG 522: Hip Replacement with Principal Diagnosis of Hip Fracture without MCC.

Request for Comment

CMS noted that the Comprehensive Care for Joint Replacement (CJR) model includes episodes triggered by MS-DRG 469 with hip fracture and MS-DRG 470 with hip fracture. Given the proposal for new MS-DRGs for hip fracture, CMS is seeking comments on the effect this proposal would have on the CJR model and whether to incorporate the new MS-DRGs into the model if finalized.

MDC 11: Diseases and Disorders of the Kidney and Urinary Tract

Kidney Transplants

Currently, Kidney Transplants group to MS-DRG 652 (Kidney Transplant) in MDC 11. There was a request to designate kidney transplants as Pre-MDC MS-DRGs similar to other organ transplants. CMS analysis found that all kidney transplants in MS-DRGs 981 and 982 reported a principal diagnosis in MDC 5 (Diseases and Disorders of the Circulatory System). CMS is proposing an alternate option “to modify the GROUPER logic for MS-DRG 652 by allowing the presence of a procedure code describing transplantation of the kidney to determine the MS-DRG assignment independent of the MDC of the principal diagnosis in most instances.”

CMS goes on to discuss how the Pre-MDCs came into existence and that the proposal for kidney transplant represent a “first step in investigating” how they may consider shifting transplants out of Pre-MDCs as their clinical advisors have noted that while once considered as being very resource intensive, “treatment practices have shifted since the inception of Pre-MDCs.”

Kidney Transplants and Dialysis during an Inpatient Stay

An additional request was made to create a new MS-DRG for kidney transplant cases where a patient receives dialysis during the inpatient stay and after the date of the transplant. The following three ICD-10-PCS procedure codes identify the performance of hemodialysis:

• 5A1D70Z: Performance of urinary filtration, intermittent, less than 6 hours per day
• 5A1D80Z: Performance of urinary filtration, prolonged intermittent, 6-18 hours per day
• 5A1D90Z: Performance of urinary filtration, continuous, greater than 18 hours per day

CMS believes that creating separate MS-DRGs when hemodialysis is performed either before or after a kidney transplant or simultaneous pancreas/kidney transplant “would appropriately address the differential in resource consumption consistent with the President’s Executive Order on Advancing American Kidney Health (see https://www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/). CMS is proposing the following three new MS-DRGs:

• Proposed new Pre-MDC MS-DRG 019 (Simultaneous Pancreas/Kidney Transplant with Hemodialysis),
• CMS is proposing to add the procedure codes from current Pre-MDC MS-DRG 008 to the proposed new Pre-MDC MS-DRG 019 with the procedure codes describing a hemodialysis procedure.
• Proposed new MS-DRG 650 (Kidney Transplant with Hemodialysis with MCC) and
• Proposed new MS-DRG 651 (Kidney Transplant with Hemodialysis without MCC).
• Similarly, CMS is also proposing to add the procedure codes from current MS-DRG 652 to the proposed new MS-DRGs 650 and 651 with the procedure codes describing a hemodialysis procedure.

Hemodialysis procedure codes are currently “designated as Non-O.R. procedure, therefore, as part of the logic for these proposed new MS-DRGs, we are also proposing to designate these codes as non-O.R. procedures affecting the MS-DRG.”

Proposed Addition of Diagnoses to MS-DRGs 673, 674, and 675 (Other Kidney and Urinary Tract Procedure Logic

In response to a request, CMS reviewed the GROUPER logic for this MS-DRG group including the special logic for certain MDC 11 diagnoses reported with procedures codes for the insertion of tunneled or totally implantable vascular access devices. Based on their review, CMS is making several proposals for code reassignment to this MS-DRG group.

MDC 17: Myeloproliferative Diseases and Disorders, Poorly Differentiated Neoplasms

Inferior Vena Cava Filters

A requestor noted that currently when the procedure code describing the placement of an inferior vena cava (IVC) filter (06H03DZ – Insertion of intraluminal device into inferior vena cava, percutaneous approach) is also reported with the codes describing the introduction of a high dose chemotherapy agent or report a chemotherapy principal diagnosis with a secondary diagnosis describing acute leukemia, the cases are assigned to a lower weighted MS-DRG group than when the IVC filter code is not on the claim.

CMS notes in the proposed rule that “our clinical advisors believe that, given the similarity in factors such as complexity, resource utilization, and lack of a requirement for anesthesia administration between all procedures describing insertion of a device into the inferior vena cava, it would be more appropriate to designate these three ICD-10-PCS codes describing the insertion of an intraluminal device into the inferior vena cava as Non-O.R. procedures. Therefore, we are proposing to remove ICD-10-PCS procedure codes 06H00DZ, 06H03DZ, and 06H04DZ from the FY 2021 ICD-10 MS-DRG Version 38 Definitions Manual in Appendix E--Operating Room Procedures and Procedure Code/MS-DRG Index as O.R. procedures. Under this proposal, these procedures would no longer impact MS-DRG assignment.”

Review of Procedure Codes in MS-DRGS 981 through 983 and 987 through 989

Adding Procedures Codes Currently Grouping to MS-DRGS 981 – 983 and 987 – 989 into MDCs

Annually, CMS conducts a review of procedures resulting in assignment to the O.R. and non-extensive O.R. Procedures Unrelated to Principal Diagnosis MS-DRG Groups (981-983 and 987-989). This review is done on the basis of volume, by procedure, to see if it is more appropriate to move a procedure to a surgical MS-DRG for the MDC where the Principal Diagnosis falls.

There are several proposals being made to move diagnosis and procedures codes back into a specific MDC for FY 2021. For those interested, you can find these proposals on pages 32526 – 32542 of the Proposed Rule.

MMP strongly encourages key stakeholders at your facility take the time to review this proposed rule and submit comments. CMS is accepting comments through 5 p.m. EDT on July 10, 2020.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from May 12th through May 15th.  

Resource Spotlight This Week:

This week’s spotlight is on a May 4th pdf document titled COVID-19 Regulations & Waivers to Enable Health System Expansion highlighting how CMS has enabled significant health system flexibility during the COVID-19 Public Health Emergency (PHE) through Medicare 1135 blanket waivers and the passage of two interim final rules. You can also find this presentation on the CMS Coronavirus Waivers and Flexibilities webpage. 

May 12, 2020: Price Transparency Requirement to Post Cash Prices Online for COVID-19 Diagnostic Testing

In a May 12 Special Edition MLNConnects newsletter, CMS noted the following regarding Price Transparency Requirements:

“The Coronavirus Aid, Relief, and Economic Security (CARES) Act includes a number of provisions to provide relief to the public from issues caused by the pandemic, including price transparency for COVID -19 testing. Section 3202(b) of the CARES Act requires providers of diagnostic tests for COVID-19 to post the cash price for a COVID-19 diagnostic test on their website from March 27 through the end of the public health emergency. For more information, see the FAQs. (PDF).”

CMS has also posted a Q&A Document specific to the Price Transparency Requirement.

May 13, 2020: CMS Issues Nursing Homes Best Practices Toolkit to Combat COVID-19

This Toolkit includes recommendations and best practices from front line health care providers, governors’ COVID-19 task forces, associations, organizations and experts. It is intended to provide a catalogue of resources dedicated to address challenges facing nursing homes in the fight against COVID-19. You can read more in a related CMS Press Release.

May 14, 2020: FDA Informs Public about Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test for COVID-19

The FDA Alert indicates that early data suggests potential inaccurate results from using this point-of-care to diagnose COVID-19. Specifically, the test may return false negative results. They will continue to work with Abbott and communicate any updates publicly.

May 14, 2020: FDA Health Advisory Issued: Multisystem Inflammatory Syndrome in Children (MIS-C) Association with COVID-19

The CDC issued an official Health Advisory alert providing background information on several cases of a recently reported MIS-C associated with COVID-19 and a case definition of the syndrome. “CDC recommends healthcare providers report any patient who meets the case definition to local, state, and territorial health departments to enhance knowledge of risk factors, pathogenesis, clinical course, and treatment of this syndrome.”

The Case Definition for MIS-C includes the following:

• An individual aged <21 years presenting with fever, laboratory evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (>2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological); AND
• No alternative plausible diagnoses; AND
• Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of symptoms

May 14, 2020: Health Affairs Research Article: Strong Social Distancing Measures in the United States Reduced the COVID-19 Growth Rate

Economists at the University of Kentucky evaluated the impact of imposed social distancing measures on growth rate of confirmed COVID-19 cases across US counties in March and April of 2020. The end date of this study was April 27 as this date coincided with the re-opening of restaurants and other entertainment facilities in Georgia. Results of this study imply there would have been more than 35 times greater spread of the disease without any of the social distancing measures having been put into place.

May 15, 2020: American College of Surgeons (ACS) Post-COVID-19 Readiness Checklist for Resuming Surgery

The ACS developed this checklist “to help surgeons ultimately communicate to their patients the important items they want to know. You can read the full announcement and download a print-friendly version of the checklist on the ACS website at https://www.facs.org/covid-19/checklist.

May 15, 2020: OCR Bulletin: Ensuring the Rights of Persons with Limited English Proficiency (LEP) in Health Care During COVID-19

This OCR Bulletin reminds health care providers that they “must take reasonable steps to provide meaningful access to individuals with LEP eligible to be served or likely to be encountered in their health programs and activities. This longstanding obligation is not waived during a National Emergency.” You will find suggestions for providing meaningful access for persons with LEP and links to several available resources.

May 15, 2020: Special Edition MLNConnects: Deadline Approaching for Nursing Homes to Report Confirmed and Suspected COVID-19 Cases

The April 30th Interim Final Rule with Comment Period requires nursing homes to begin reporting data to the CDC no later than Sunday May 17th. Facilities have to enroll in the CDC’s National Healthcare Safety Network (NHSN) to report data. “As nursing homes report this data to the CDC, CMS will be taking swift action and publicly posting this information so all Americans have access to accurate and timely information on COVID-19 in nursing homes. More information on the CDC’s NHSN COVID-19 module can be found here.”

May 15, 2020: Special Edition MLNConnects: Telephone Evaluation and Management Visits

“The March 30 Interim Final Rule with Comment Period added coverage during the Public Health Emergency for audio-only telephone evaluation and management visits (CPT codes 99441, 99442, and 99443) retroactive to March 1. On April 30, a new Physician Fee Schedule was implemented increasing the payment rate for these codes. Medicare Administrative Contractors (MACs) will reprocess claims for those services that they previously denied and/or paid at the lower rate.

There are also a number of add on services (CPT codes 90785, 90833, 90836, 90838, 96160, 96161, 99354, 99355, and G0506) which Medicare may have denied during this Public Health Emergency. MACs will reprocess those claims for dates of service on or after March 1.

You do not need to do anything.”

May 17, 2020: New CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again – May 2020

This CDC Document was posted to the CDC website on May 17th. In addition to highlighting CDC activities and initiatives, this document includes the following appendices:

• Appendix A: Surveillance for COVID-19,
• Appendix B:Healthcare System Surveillance,
• Appendix C: Guidance on Infection Control and Contact Tracing,
• Appendix D: Guidance on Test Usage (Asymptomatic Populations and Serology),
• Appendix E: Assessing Surveillance and Hospital Gating Indicators, and
• Appendix F: Setting Specific Guidance.

Appendix F offers interim guidance for child care programs, interim guidance for schools and day camps, interim guidance for employers with workers at high risk, interim guidance for restaurants and bars, and interim guidance for mass transit administrators. The CDC notes the guidance in Appendix F is meant to assist establishments as they open. Further, they will update guidance as more is learned about COVID-19 and best practices to prevent its spread.

Last week’s Wednesday@One included an article providing details about the CMS Prior Authorization Program for certain hospital outpatient department (ODP) services. As a reminder this program will begin for services provided on or after July 1, 2020. We have continued to follow Medicare Administrative Contractor (MAC) websites for news about the program. This article provides details about which MACs have scheduled provider education. Also included in this article, are tables posted on two different MACs websites that provide links to applicable Local Coverage Determinations (LCDs) and Articles.

J15 MAC: CGS Administrators, LLC (CGS)
Jurisdiction Area: Kentucky, Ohio

CGS is providing a webinar to introduce the new prior authorization program for certain hospital outpatient services on Thursday May 21, 2020 at 11:00 a.m. Eastern Time. You can go to the CGS Part A Calendar of Events to register for this webinar.

CGS has also created an OPD Prior Authorization webpage in the Medical Review section of their website. Currently you will find a list of applicable HCPCS codes. Also, Process and Results are “coming soon!” to this webpage.

JN MAC: First Coast Service Options, Inc.
Jurisdiction Area: Florida, Puerto Rico, U.S. Virgin Islands

On May 4th First Coast reminded providers that the CMS is implementing a prior authorization program for the following hospital outpatient department services for dates of service on or after July 1, 2020:

• Blepharoplasty, eyelid surgery, brow lift, and related services,
• Botulinum toxin injections,
• Panniculectomy, excision of excess skin and subcutaneous tissue (including lipectomy), and related services,
• Rhinoplasty and related services, and
• Vein ablation and related services.

First Coast will be hosting two webcasts in which they will review the guidelines for submitting a Prior Authorization Request (PAR) and the potential results and options available. Specialists will be present to answer questions relating to the process. The dates for the webcasts are Thursday, May 28th and Thursday, June 11th. To register for a webcast you can go to the First Coast events calendar under their Education Section of their website (https://medicare.fcso.com/index.asp). To learn more the Prior Authorization Program you can look under the Medical Review section of the website.

First Coast JN: Documentation Guidance

First Coast has posted the following table on their website to provide more information on coverage and documentation requirements.

‍JK and J6 MAC: National Government Services, Inc. (NGS)
JK Jurisdiction Area: Connecticut, New York, Main, Massachusetts, New Hampshire, Rhode Island, Vermont
J6 Jurisdiction Area: Illinois, Minnesota, Wisconsin

As of Monday May 18th, MMP was unable to find any information about this program or planned provider education on the NGS website.

JE and JF MAC: Noridian Healthcare Solutions, LLC (Noridian)
JE Jurisdiction Area: California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands
JF Jurisdiction Area: Alaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming

Noridian will be hosting webinars on the following dates:

• May 28, 2020,
• June 4, 2020,
• June 10, 2020,
• June 18, 2020, and
• June 24, 2020.

This Provider Outreach and Education (POE) webinar will include the following:

• Overview,
• Authorization Process,
• Submitting Prior Authorization Request,
• Services Requiring Prior Authorization,
• Advanced Beneficiary Notice of Noncoverage (ABN)
• Cosmetics, and
• Resources

Link to Webinar Announcement on JE website: https://med.noridianmedicare.com/web/jea/article-detail/-/view/10521/prior-authorization-for-certain-hospital-outpatient-department-opd-services-webinars

Link to Webinar Announcement on JF website: https://med.noridianmedicare.com/web/jfa/article-detail/-/view/10529/prior-authorization-for-certain-hospital-outpatient-department-opd-services-webinars

JH and JL MACs: Novitas Solutions, Inc. (Novitas)
JH Jurisdiction Area: Arkansas, Colorado, New Mexico, Oklahoma, Texas, Louisiana, Mississippi 
JL Jurisdiction Area: Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania

Novitas will be hosting a webinar on Thursday May 28, 2020. This webinar will review the details and submission guidelines for the Prior Authorization (PA) program for certain hospital outpatient department (OPD) services being implemented by the Centers for Medicare & Medicaid Services (CMS) effective June 17, 2020, for dates of service on or after July 1, 2020, nationwide. CMS believes prior authorization for certain hospital OPD services will ensure that Medicare beneficiaries continue to receive medically necessary care while protecting the Medicare trust fund from improper payments and keeping the medical necessity documentation requirements unchanged for providers. You can register for this webinar on the Novitas Medicare Part A Educational Event Calendar webpage at: https://www.novitas-solutions.com/webcenter/portal/MedicareJH/pagebyid?contentId=00008010

Novitas JH and JL: Documentation Guidance:

Similar to First Coast, Novitas has posted the following table on their website providing more information on coverage and documentation requirements.

‍JJ and JM MAC: Palmetto GBA, LLC (Palmetto)
JJ Jurisdiction Area: Alabama, Georgia, And Tennessee
JM Jurisdiction Area: North Carolina, South Carolina, Virginia, West Virginia

On May 13th Palmetto release an article letting providers know they will be providing a two-part webcast on May 26, 2020 regarding the Outpatient Department (OPD) Prior Authorization (PA) program. The first session will be an overview of the program and begins at 10 a.m. ET. The second session will begin at 1 p.m. ET and will discuss “Medical Necessity.” These webcasts are available for Medicare Part A and Part B providers. Links to register for both sessions are included in the Article.  

The next day on May 14th, Palmetto included in their Daily Newsletter the following article specific to the procedures in this program:

• Blepharoplasty and Blepharoptosis Repair
• Panniculectomy
• Rhinoplasty
• Vein Ablation and Related Services 

All of the articles include details about documentation requirements and a procedure specific Documentation Checklist.

J5 and J8 MAC: Wisconsin Physician Service Government Health Administrators (WPS)
J5 Jurisdiction Area: Iowa, Kansas, Missouri, Nebraska
J8 Jurisdiction Area: Indiana, Michigan

WPS has scheduled a teleconference that will cover the new prior authorization process, the services specific to this process, and the responsibilities of both the physician and the facility. This training is intended for J5 and J8 Part A/B providers billing on a UB-04/CMS-1500 or electronic equivalent. There will be two different sessions both held on June 10, 2020. The first teleconference will be from 10:00 AM – 11:30 AM CT and the second session will be from 1:00 PM – 2:30 PM CT. You can sign up for these sessions on the WPS Learning Center at: http://wpsghalearningcenter.com/login.

Welcome to the fifth edition of our monthly MAC Talk article. This month before diving into updates from the MACs there are a couple of updates that have come about due to the current COVID-19 Public Health Emergency (PHE) that I wanted to share. Specifically, an NGS update about telehealth and an MLN Connects announcement regarding who can certify a home health plan of care.

Medicare Telehealth versus Telemedicine

On April 22, 2020 NGS included the following post in their Latest COVID-19 News:

“We have received many questions that have indicated confusion between telehealth and telemedicine, and which rules apply to which services within these two benefit categories. While there is a perceived relation between these types of services they are distinctly different.

Telemedicine refers to a group of services that may be provided to a patient without any physical patient contact. Services may be provided via a telephone (audio) connection, or via some type of online communication such as a patient/provider portal or via email interactions between the patient and practitioner. Typically, most telemedicine services are non-covered by Medicare. However, CMS has opened some of the codes for coverage during the COVID-19 public health emergency (PHE).

Telehealth refers to a distinct level of established services that have traditionally been performed via a face-to-face interaction between the patient and practitioner. This group of services has been grouped together in a distinct policy that allows this limited amount of traditional face-to-face services to be performed via an audio and video connection as a replacement to the in person, face-to-face interaction. Telehealth allows the interaction to still occur face-to-face; however, it can be achieved via the audio and video connection.

This benefit was set apart as a specific addition to Medicare policy in SSA 1834(m). The criteria requires real time communication between the patient and practitioner (audio and video), the patient geographic location is in a rural or non-metropolitan statistical area (based on ZIP Code eligibility), and patient consent is required. 

The site where the patient is located is considered the originating site and may bill Q3014 to cover the cost of a professional to set up the audio and video communication system and assist with the service provided, if required. The site where the practitioner is rendering the telehealth service is known as the distant site. The practitioner will bill for the service s/he provides based on the list of approved telehealth services. All telehealth services in the benefit are professional services.

CMS issued the MLN Telehealth Booklet which explains the coverage criteria, provides a listing of eligible originating sites, and eligible distant site practitioners that may perform services via telehealth. The booklet also contains a listing of applicable procedure codes that are allowed to be performed via telehealth and information on the appropriate geographic location of the patient that is allowed for telehealth services. During the PHE, the list of services allowed to be performed via telehealth have been temporarily expanded. The MLN Telehealth Booklet includes the complete list of codes, with those that are temporarily identified as such.”

May 7, 2020: MLNConnects Home Health Plans of Care: NPs, CNSs and PAs Allowed to Certify

Section 3708 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. No. 116-136) amended sections 1814(a) and 1835(a) of the Social Security Act to allow Nurse Practitioners (NPs), certified Clinical Nurse Specialists (CNSs), and Physician Assistants (PAs) to certify beneficiaries for eligibility under the Medicare home health benefit and oversee their plan of care. This is a permanent change that will continue after the Public Health Emergency.

Effective for claims with dates of service on or after March 1, 2020, these non-physician practitioners may bill the following codes:

• G0179: Physician re-certification for Medicare-covered home health services under a home health plan of care (patient not present), including contacts with home health agency and review of reports of patient status required by physicians to affirm the initial implementation of the plan of care
• G0180: Physician certification for Medicare-covered home health services under a home health plan of care (patient not present), including contacts with home health agency and review of reports of patient status required by physicians to affirm the initial implementation of the plan of care
• G0181: Physician supervision of a patient receiving Medicare-covered services provided by a participating home health agency (patient not present) requiring complex and multidisciplinary care modalities involving regular physician development and/or revision of care plans

The descriptors of the three codes will be revised at a later date to include the non-physician practitioner specialties.

May MAC Talk: The Local Scene

April 22, 2020: Palmetto GBA JJ Posts TPE Progress Updates

In last month’s MAC Talk article, we included TPE Progress Updates that had been posted by Palmetto GBA for Jurisdiction M and J. Since then Palmetto GBA has posted additional articles. Following is a list of specific TPE articles released to date by Palmetto GBA JJ:

• March 25, 2020: HBO Therapy G0277,
• March 25, 2020: JJ Part A Skilled Nursing Facility (SNF),
• March 25, 2020: Therapeutic Exercise 97110,
• April 3, 2020: DRG 885 Psychoses; and
• April 3, 2020: DRG 470 Major Joint Replacement,
• April 10, 2020: Manual Therapy 97140,
• April 10, 2020: Inpatient Rehabilitation Facility (IRF) Ao604-D0604
• April 10, 2020: Pegfilgrastim J205,
• April 10, 2020: DRGs 291 and 292: Heart Failure and Shock with MCC and with CC,
• April 11, 202: Rituximab J9310,
• April 11, 2020: Infliximab J1745,
• April 11, 2020: Denosumab J0897,
• April 11, 2020: Bevacizumab J9035, and
• April 20, 2020: DRGs 682/683 – Renal Failure.

Links to all of the articles can be found on Palmetto GBA’s JJ Target Probe and Educate webpage.

April 24, 2020: Palmetto GBA Daily Newsletter: Provider Contact Center FAQs and Reminder of Suspended Sequestration

• Palmetto GBA is publishing the following Frequently Asked Questions (FAQ) based upon data analytics identifying topics generating a high volume of telephone inquiries from January 1, 2020, through March 31, 2020. We hope the answers to the questions below help you maximize your time by reducing your need to contact the Provider Contact Center (PCC). https://www.palmettogba.com/palmetto/providers.nsf/ls/JJ%20Part%20A"BNYKJU2621?opendocument
• Providers are reminded that Section 3709 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act temporarily suspends the 2% payment adjustment currently applied to all Medicare Fee-For-Service (FFS) claims due to sequestration. The suspension is effective for claims with dates of service from May 1 through December 31, 2020.  https://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/BNYMSN1444?opendocument

April 23, 2020: Palmetto GBA Daily Newsletter: Clarification of Negative Reimbursement

Palmetto GBA’s April 23rd Daily Newsletter included an article about negative reimbursement. The article opens with the following: “Negative reimbursement happens when the beneficiary cost sharing, such as coinsurance and/or deductible, exceeds the reimbursement due to the provider. Medicare Administrative Contractors (MACs) are instructed to withhold payments if the Medicare deductible/coinsurance is more than the reimbursement rate. For example, if the set deductible for an inpatient stay is $100 and the reimbursement for the stay is $95, Medicare will show a negative $5 for the reimbursement amount. Further examples are provided in this article.”

April 28, 2020: Noridian Announcement: Outpatient Therapy A/B Physical, Occupational, and Speech Language Pathology Webinar – May 28, 2020

The Noridian Provider Outreach and Education (POE) staff announced they are hosting this webinar on May 28, 2020. This webinar includes:

• Certification and Re-certification,
• Coding and Billing,
• Maintenance Services,
• CMS and Noridian Resources.

They advise providers that you can sign up for this webinar and other events of interest by visiting the Noridian Schedule of Events.

April 29, 2020: WPS GHA Medicare eNews: June 9, 2020 Hospital Notices of Non-Coverage Webinar

WPS announced they will be hosting this webinar that will cover the different notices of non-coverage issued by hospitals and clarifies when to issue each. The following notices will be covered during this presentation:

• Hospital-Issued Notices of Noncoverage (HINNs) 1, 10, 11, and 12
• Important Message from Medicare (IM) and the Detailed Notice of Discharge (DND) (CMS-R-193 and CMS-10066)
• Medicare Outpatient Observation Notice (MOON) (CMS-10611)
• Advance Beneficiary Notice of Noncoverage (ABN) (CMS-R-131)

You can sign up for this course through the WPS Learning Center.

May 4, 2020: WPS GHA eNews: Procedure Code 94762 – Are You Billing Correctly?

In their May 4th eNews, WPS noted that procedure code 94762 represents a continuous overnight pulse oximetry service. Further, they have 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. WPS encourages 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.

May 4, 2020: Palmetto GBA Daily eNewsletter: CERT Task Force Education Material

Palmetto GBA reminds provider that the Medicare A/B Contractor CERT Task Force is a joint effort of the Part A/B MACs to communicate national issues of concern regarding improper payments to the Medicare Program. They also encourage providers to review the CERT Task Force Educational Material available on their website and share with your staff.

May 5, 2020: Palmetto GBA Daily eNewsletter: Spring Virtual Tour

Palmetto GBA announced they will be presenting their first ever Medicare Part A Spring Virtual Tour for Jurisdictions J and M. There will be two days of sessions with presenters from the following:

• The Provider Outreach and Education (POE) Team,
• The Appeals Department,
• Medical Review, Audit and Reimbursement,
• MCG Health, and
• C2C Solutions.

You can read more about this event and select sessions you would like to register for on the JJ/JM Part A Springing into Summer Virtual Tour 2020: June 8-9, 2020 webpage.

May 8, 2020: Noridian JF: Sleep Lab Credentialing: Polysomnography and Other Sleep Studies Retirement – Effective May 14, 2020

Noridian provided the following Notice in their daily eNewsletter. Even though they are retiring this article (A57698), Noridian cautions against a change in your current practice.

This coverage article has been retired under contractor numbers: 02101 (AK), 02201 (ID), 02301 (OR), 02401 (WA), 03101 (AZ), 03201 (MT), 03301 (ND), 03401 (SD), 03501 (UT), and 03601 (WY).

Effective Date: May 14, 2020
Summary: Coverage articles may be retired due to lack of evidence of current problems or CMS may have issued guidance regarding national coverage. The Noridian guidance in the retired article may still be helpful in assessing medical necessity. Where providers have adjusted their billing and coding practices to correspond to the guidance in a coverage article, they will want to be very careful in departing from these practices just because the article is retired. Provider offices remain responsible for correct performance, coding, billing, and medical necessity under Medicare. This responsibility for correct claims submission is unchanged whether or not there is a coverage article in place.

Note: Noridian JE also announced the retirement of their Polysomnography and Other Sleep Studies Article (A57697) effective May 14, 2020.

May 15, 2020: Palmetto GBA Daily Newsletter: Medical Review (MR) Hot Topic Targeted Probe and Educate (TPE) Webcast

Palmetto will be hosting this webcast on June 1, 2020. Their Medical Review subject matter experts will be available to discuss and answer questions about the current TPE model. This announcement includes a link for you to register for this event.

May 15, 2020: Palmetto GBA Daily Newsletter: Appeals and Clerical Error Reopenings Module 

Palmetto notes this “updated module provides education on correcting incomplete and/or invalid submissions, correcting claims with medically denied lines, clerical error reopening, and redetermination requests. There is also a further explanation on the submission of documentation for a clerical error reopening (bilateral procedure) and on adding late charges during the appeal process. A new section, Correcting Inpatient Discharge Status, was added to the module. Please review the updated module and share it with your staff.”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates that span from May 5th through May 11th.

May 5, 2020: Advanced Persistent Threat (APT) Groups are Exploiting the COVID-19 Pandemic

The United States Department of Homeland Security (DHS) Cybersecurity and Infrastructure Security Agency (CISA) and the United Kingdom’s National Cyber Security Centre (NCSC) released a Joint Alert highlighting ongoing activity by APT groups against organizations involved in national and international COVID-19 responses. In addition to this alert including a link to a graphical summary of joint alerts, the May 5th alert also includes information about the following:

• COVID-19 Related Targeting,
• Targeting of pharmaceutical and research organizations, and
• COVID-19 Related Password Spraying Activity.

May 5, 2020: FDA Continues to Update FAQs on Testing for SARS-CoV-2

The FDA has recently added several FAQs to their growing list of questions related to Testing for SARS-CoV-2. As of May 5th, FAQs Topics available on this webpage include the following:

• What Laboratories and Manufacturers are Offering Tests for COVID-19?
• General FAQs
• What If I Do Not Have...?
• Clinical Laboratory Diagnostic Test FAQs
• Test Kit Manufacturer Diagnostic Test FAQs
• Serology/Antibody Test FAQs

The FDA plans to update this page regularly and provides the opportunity for you to sign up for email alerts.

May 5, 2020: OCR Issues Guidance on Covered Health Care Providers and Restrictions on Media Access to Protected Health Information (PHI) about Individuals in Their Families

This Guidance was issued to remind covered health care providers that the HIPAA Privacy Rule does not permit giving media and film crews access to facilities where patients’ PHI will be accessible without the patients’ prior authorization. Per the OCR Director Roger Severino, “The last thing hospital patient’s need to worry about during the COVID-19 crisis is a film crew walking around their bed shooting ‘B-roll…Hospitals and health care providers must get authorization from patients before giving the media access to their medical information, obscuring faces after the fact just doesn’t cut it.”

May 6, 2020: Memorandum (QSO-20-29-NH): Interim Final Rule Updating Requirements for Notification of Confirmed and Suspected COVID-19 Cases Among Residents and Staff in Nursing Homes

In addition to CMS indicating an interim Final Rule is to be published May 8, 2020, the Memorandum Summary also included the following:

• COVID-19 Reporting Requirements: CMS is requiring NHs to report COVID-19 facility data to the CDC and to residents, their representatives, and families of residents in facilities.
• Enforcement: failure to report in accordance with 42 CFR 483.80(g) can result in an enforcement action.
• Updated Survey Tools: CMS has updated survey for Nursing Homes to reflect COVID-19 reporting requirements.
• COVID-19 Tags:
• F884: COVID-19 Report to CDC
• F885: COVID-19 Reporting to Residents, their Representatives, and Families
• Transparency: CMS will begin posting data from the CDC National Healthcare Safety Network (NHSN) for viewing by facilities, stakeholder, or the general public. The COVID-19 public use fill will be available on https://data.cms.gov/.

Enforcement Actions specific to COVID-19 Tag F885: If it is determined that facility failed to comply with the requirement to report COVID-19 related information to the CDC, this will result in an enforcement action. Regulations require a minimum of weekly reporting, and noncompliance with this requirement will receive a deficiency citation and results in a civil monetary penalty (CMP) imposition.

• Facilities will have an initial two-week grace period to begin reporting cases in the NSHN system (period ends 11:59 p.m. on May 24, 2020).
• Facilities that fail to being reporting after the third week (by 11:59 p.m. on May 31st) will receive a warning letter reminding them to begin reporting required information to the CDC.
• Facilities that have not started reporting in the NSHN system by 11:59 p.m. on June 7th, CMS will impose a per day (PD) CMP of $1,000 for one day for failure to report that week.
• For each subsequent week that a facility fails to submit the required report, the noncompliance will results in an additional one-day PD CMP imposed at an amount increased by $500.

May 7, 2020: New YouTube Video with Guidance for Certifying Deaths Due to COVID-19

The National Centers for Health Statistics (NCHS) is responding to COVID-19 with new resources to monitor and report deaths. On April 2nd the document Guidance for Certifying Deaths Due to Coronavirus Disease 2019 (COVID-19) was posted on the CDC’s National Vital Statistics System (NVSS) Coronavirus Disease (COVID-19) Death Data and Reporting Guidance webpage. This document provides guidance to death certifiers on proper cause-of-death certification for cases where confirmed or suspected COVID-19 infection resulted in death. You can also find provisional death counts for COVID-19 (updated daily Monday through Friday) and NVSS COVID-19 Alerts on this webpage.

On May 8th the CDC announced that to supplement the previous published guidance, the CDC and NCHS has released a short video via the NCHS YouTube channel. The video runs about three minutes and can be accessed here. 

May 7, 2020: MLNConnects: COVID-19 Modified Ordering Requirements for Laboratory Billing

During the COVID-19 Public Health Emergency, CMS is relaxing billing requirements for laboratory tests (PDF) required for a COVID-19 diagnosis. Any health care professional authorized under state law may order tests. Medicare will pay for tests without a written order from the treating physician or other practitioner:

• If an order is not written, an ordering or referring National Provider Identifier (NPI) is not required on the claim
• If an order is written, include the NPI of the ordering or referring professional, consistent with current billing guidelines

For More Information:

• Laboratory Tests (PDF) with modified requirements
• Interim Final Rule

May 7, 2020: MLNConnects: New Coronavirus Specimen Collection Code

To identify and pay for specimen collection for COVID-19 testing, CMS established a new Level II HCPCS code for billing Medicare under the Outpatient Prospective Payment System (OPPS).

The new code, C9803, Hospital outpatient clinic visit specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19]), any specimen source, is effective for services provided on or after March 1, 2020. 

OPPS claims received on or after May 1, 2020, with Coronavirus Specimen Collection HCPCS Codes G2023 and G2024 will be returned to you with edit W7062. Resubmit returned claims as a packaged service to include Code C9803, when appropriate.

May 8, 2020: OIG Updates FAQs – Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to the COVID-19 Public Health Emergency

On May 8th the following question was answered on the OIG’s COVID-19 FAQs webpage:

• During the time period subject to the COVID-19 Declaration, can a clinical laboratory that bills Federal health care programs for laboratory tests to diagnose COVID-19 pay a retail pharmacy a fee for certain costs that the retail pharmacy incurs related to testing collection sites?

The OIG is accepting inquiries from the health care community regarding the application of OIG's administrative enforcement authorities, including the Federal anti-kickback statute and civil monetary penalty (CMP) provision prohibiting inducements to beneficiaries (Beneficiary Inducements CMP).2 If you have a question regarding how OIG would view an arrangement that is directly connected to the public health emergency and implicates these authorities, please submit your question to OIGComplianceSuggestions@oig.hhs.gov.

May 8, 2020: Medicare Pharmacies and Other Suppliers May Temporarily Enroll as Independent Clinical Diagnostic Laboratories to Help Address COVID-19 Testing

Special Edition MLN Matters article SE20017 provides information for Pharmacies and other suppliers on how to enroll temporarily as an independent clinical diagnostic laboratory during the COVID-19 Public Health Emergency (PHE). This opportunity is open to Pharmacies and other suppliers currently enrolled in Medicare and those who are not currently enrolled in Medicare.

May 8, 2020: Telehealth Video: Medicare Coverage and Payment of Virtual Services

CMS has posted an updated video providing answers to common questions about the expanded Medicare telehealth services benefit under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act.

May 8, 2020: MLN Matters MM11784: Extension of Payment for Section 3712 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)

Information in MM11784 affects supplies billing MACs for DMEPOS items and services provided to Medicare beneficiaries. Specifically, this article provides information about the implementation of the new April 2020 DMEPOS fee schedule amounts based on changes mandated by Section 372 (b) of the CARES Act.

May 11, 2020: Expanded Ability for Hospitals to Offer Long-term Care Services (“Swing Beds”)

On May 11th, CMS added additional blanket waivers to their COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers. CMS has indicated which blanket waivers are new since the 4/30 release of this document. Following is the details enabling hospitals to provide “swing bed” services:

Expanded Ability for Hospitals to Offer Long-term Care Services (“Swing-Beds”) for Patients Who do not Require Acute Care but do Meet the Skilled Nursing Facility (SNF) Level of Care Criteria as Set Forth at 42 CFR 409.31. (New since 4/30 Release)

Under section 1135(b)(1) of the Act, CMS is waiving the requirements at 42 CFR 482.58, “Special Requirements for hospital providers of long-term care services (“swing-beds”)” subsections (a)(1)-(4) “Eligibility”, to allow hospitals to establish SNF swing beds payable under the SNF prospective payment system (PPS) to provide additional options for hospitals with patients who no longer require acute care but are unable to find placement in a SNF.

In order to qualify for this waiver, hospitals must:

• Not use SNF swing beds for acute level care.
• Comply with all other hospital conditions of participation and those SNF provisions set out at 42 CFR 482.58(b) to the extent not waived.
• Be consistent with the state’s emergency preparedness or pandemic plan.

Hospitals must call the CMS Medicare Administrative Contractor (MAC) enrollment hotline to add swing bed services. The hospital must attest to CMS that:

• They have made a good faith effort to exhaust all other options
• There are no skilled nursing facilities within the hospital’s catchment area that under normal circumstances would have accepted SNF transfers, but are currently not willing to accept or able to take patients because of the COVID-19 public health emergency (PHE);
• The hospital meets all waiver eligibility requirements; and
• They have a plan to discharge patients as soon as practicable, when a SNF bed becomes available, or when the PHE ends, whichever is earlier.

This waiver applies to all Medicare enrolled hospitals, except psychiatric and long term care hospitals that need to provide post-hospital SNF level swing-bed services for non-acute care patients in hospitals, so long as the waiver is not inconsistent with the state’s emergency preparedness or pandemic plan. The hospital shall not bill for SNF PPS payment using swing beds when patients require acute level care or continued acute care at any time while this waiver is in effect. This waiver is permissible for swing bed admissions during the COVID-19 PHE with an understanding that the hospital must have a plan to discharge swing bed patients as soon as practicable, when a SNF bed becomes available, or when the PHE ends, whichever is earlier.”

Following is a list of the additional new blanket waivers since the 4/30 release of this CMS document:

• Hospitals Classified as Sole Community Hospitals (SCHs): CMS is waving distance requirements, “market share” and bed requirements for the duration of the Public Health Emergency.
• Hospitals Classified as Medicare-Dependent, Small Rural Hospitals (MDHs): CMS is waiving the eligibility requirement that the hospital has 100 or fewer beds during the cost reporting period and the requirement that at least 60 percent of the hospital’s inpatient days or discharges were attributable to individuals entitled to Medicare Part A benefits during the specified hospital cost reporting period.
• Paid Feeding Assistance: CMS is modifying the minimum training timeframe requirements from 8 hours to 1 hour in length.
• Occupational Therapists (OTs), Physical Therapists (PTs) and Speech Language Pathologists (SLPs) to Perform Initial and Comprehensive Assessment for all Patients
• Furnishing Dialysis Services on the Main Premises: CMS is waiving the requirement that dialysis facilities provide services directly on its main premises or on other premises that are contiguous with the main premises.
• Specific Life Safety Code (LSC) for Multiple Providers: CMS is waiving and modifying requirements related to Alcohol-based Hand-Rub (ABHR) Dispensers, Fire Drills, and Temporary Construction.

MMP encourages you to read about all of the new blanket waivers.

Jig-Saw Puzzles: Gathering all of the Pieces

Depending on the size of a jig-saw puzzle, putting it together successfully can be a very simple or daunting task. Keys to success include having a clear picture of what the puzzle is supposed to look like and not being left with missing pieces.

CMS finalized a Prior Authorization Program for certain hospital procedures in the Outpatient Prospective Payment System (OPPS)/Ambulatory Surgery Center (ASC) CY 2020 Final Rule. Since then I have been waiting for sub-regulatory guidance to provide additional “puzzle pieces” needed for Provider success with this Program.

CMS released the first puzzle piece on April 24, 2020 in the form of a One-Time Notification (Transmittal 10061/Change Request (CR) 11671) titled Provider Education for Required Prior Authorization (PA) of Hospital Outpatient Department (OPD) Services. This CR provides Medicare Administrative Contractors (MACs) with instructions for provider education regarding this Program. The CR also includes a template letter to be sent to Providers, a template letter to be sent to Practitioners, and a table of the HCPCS procedure codes included in this Program. The effective and implementation date of this CR is May 26, 2020.

So now we wait for additional puzzle pieces from the MACs. While we wait, this article is meant to equip you with additional puzzle pieces from the Final Rule, data analysis for Alabama, Georgia and Tennessee utilizing RealTime Medicare Data (RTMD) Medicare Fee-for-Service paid claims data and leave you with potential next steps for implementing a process at your hospital.

Puzzle Piece: CMS Data Analysis

A significant “piece” of CMS’ responsibility to protect the Medicare Trust Funds is data analysis. Specific to the Prior Authorization Program, CMS noted in the Final Rule that they had conducted a compare of “the total number of Medicare beneficiaries served by providers to help ensure the continued appropriateness of payment for services furnished in the hospital outpatient department (OPD).” Following are highlights from CMS’ data analysis in the CY 2020 OPPS/ASC Final Rule:

• CMS “targeted services that represent procedures that are likely to be cosmetic surgical procedures and/or are directly related to cosmetic surgical procedures that are not covered by Medicare, but may be combined with or masquerading as therapeutic services.”
• Over 1.1 billion OPD claims were reviewed during the 11-year period from 2007 through 2017.
• On average, the overall rate of OPD claims submitted for payment increased annually by an average rate of 3.2 percent.
• The 3.2 percent increase equated to an increase in claims submitted for payment from approximately 90 million in 2007 to approximately 118 million in 2017.
• On average, the annual rate-of-increase in the Medicare allowed amount (“the amount that Medicare would pay for services regardless of external variables, such as beneficiary plan differences, deductibles, and appeals”) was 8.2 percent.
• The 8.2 percent equated to an increase in the total Medicare allowed for OPD services claims from $31 billion in 2007 to $65 billion in 2017.
• The 8.2 percent increase exceeded the average per year overall health care spending increase of 5.8 percent during 2007 through 2017.
• During this same time, the average annual increase in the number of Medicare beneficiaries per year was only 1.1 percent.
• Higher than expected volumes were found in five general categories of services (blepharoplasty, Botulinum toxin injections, panniculectomy, rhinoplasty, and vein ablation).

CMS believes “the increases in volume associated with certain covered OPD services described…are unnecessary because the data show that the volume of utilization of these services far exceeds what would be expected in light of the average rate-of-increase in the number of Medicare beneficiaries.”

Puzzle Piece: Program Definitions

• Prior Authorization Request (PAR): a process through which a request for provisional affirmation of coverage is submitted to CMS or its contractors for review before the service is provided to the beneficiary and before the claim is submitted.
• Provisional Affirmation: A preliminary finding that a future claim for the service will meet Medicare’s coverage, coding, and payment rules.
• List of Services: The list of hospital outpatient department services requiring prior authorization. This list includes blepharoplasty, Botulinum toxin injections, panniculectomy, rhinoplasty, and vein ablation.

Puzzle Piece: About the Program

• The implementation date for this program is July 1, 2020.
• Prior authorization for the five categories of services listed above will be a condition of Medicare payment.
• A PAR will need to include all documentation necessary to show the service meets applicable Medicare coverage, coding and payment rules.
• Claims submitted that require prior authorization that have not received a provisional affirmation of coverage will be denied.
• A provisional affirmation does not preclude a claim being denied due to a technical requirement that could only be evaluated after the claim has been submitted for formal processing or information not available at the time of the prior authorization request is received.
• MACs will be the Contractor reviewing PARs for compliance with applicable Medicare coverage, coding, and payment rules.
• An issuance of Affirmation or Non-Affirmation is to be issued by the MAC within 10 business days of a request.
• The Program will allow a PAR for an “expedited review when a delay could seriously jeopardize the beneficiary’s life, health, or ability to regain maximum function.” Documentation to support this must be submitted with the request.
• Expedited reviews are to be completed by the MAC within 2 business days.
• If a provider receives a Non-Affirmation they are allowed to resubmit a request with additional relevant documentation.
• Non-affirmations are not appealable, but the provider will receive a detailed explanation as to why the request was non-affirmed can resubmit an unlimited number of requests.
• When a claim is submitted without provisional affirmation, it will be denied. The denial is considered an initial determination and the provider may submit a redetermination request.
• Claims associated with or related to a service for which a claim denial is issued will also be denied. These associated services include, but are not limited to, services such as anesthesiology services, physician services, and/or facility services. The associated claims would be denied whether a non-affirmation was received or the provider did not request a prior authorization request.

Puzzle Piece: Potential Provider Exemption

• CMS may elect to exempt a provider from the PA process if a provider demonstrates compliance with Medicare coverage, coding, and payment rules.
• Providers achieving a prior authorization provisional affirmation threshold of at least 90 percent during a semiannual assessment would be exempted.
• An exemption would remain in effect until CMS elects to withdraw the exemption.
• CMS anticipates that exemptions will take approximately 60 calendar days to effectuate.
• If evidence becomes available based on claims reviews that a provider has begun to submit claims not payable based on Medicare’s coverage, coding and payment rules then CMS might withdraw an exemption.
• If the rate of non-payable claims submitted becomes higher than 10 percent during a semiannual assessment, CMS will consider withdrawing an exemption.

Puzzle Piece: CMS Response to Comments

• Why the Prior Authorization Program is limited to Hospital ODPs: At this time, this process is limited to hospital OPDs as the program is being adopted as part of the OPPS Final Rule. CMS will monitor data and consider additional program integrity oversight if shifts to other settings for these procedures occur (i.e., Ambulatory Surgery Centers).
• Why Choose the Prior Authorization Process? CMS believes “that the use of prior authorization in the OPD context will be an effective tool in controlling unnecessary increases in the volume of covered OPD services by ensuring that the correct payments are made for medically necessary OPD services.”
• Who is Responsible for Obtaining Prior Authorization? CMS indicated that “in light of the different arrangement that could exist I different hospitals, we determined that enabling either the physician or the hospital to submit the prior authorization request on behalf of the hospital outpatient department was the best approach, though the hospital ultimately remains responsible for ensuring this condition of payment is met.”
• Communicating Prior Authorization Decisions as Unique Tracking Number (UTN): All PARs submitted will be assigned a UTN. The UTN must be included on any claim submitted for the services listed. The UTN will be used to verify compliance with the prior authorization process.
• Claim Denials to Include Associated Claims: “Any claims associated with or related to a service that requires prior authorization for which a claim denial is issued would also be denied. These associated services include, but are not limited to, services such as anesthesiology services, physician services, and/or facility services.”
• Claims could still be reviewed by CERT and OIG: It is possible for a claim subject to prior authorization to fall within a CERT sample. In this situation, the claim would not be protected from the CERT audit. In addition, the Office of Inspector General’s (OIG) authority to audit claims is not impacted by the protection from future audits provided by the provisional affirmation prior authorization decision.
• Non-Affirmations: Impact on Care for the Beneficiary: With regard to the impact on care for those beneficiaries for which hospitals receive non-affirmations, CMS specifically chose services that are often cosmetic and believes that it is appropriate to deny such services in the case of a non-affirmation, because a non-affirmation would indicate that Medicare’s coverage, coding, and/or payment rules for the service are not being met.
• How often are Prior Authorization Requests Affirmed? Our experience in our other prior authorization and pre-claim review processes has been that approximately 95 percent of submissions are affirmed within two requests, and that the impact of non-affirmation decisions has been minimal for necessary, covered services.
• Prior Authorization for a Specific Course of Treatment: CMS acknowledged that there are circumstances when a prior authorization could apply for a specific course of treatment such a botulinum toxin injections and will allow for prior authorization requests for a number of treatments over a specific period of time.

Puzzle Piece: RealTime Medicare Data (RTMD) Claims Analysis

As I so often do, I turned to our sister company RTMD to have an understanding of the actual volume of claims that will be impacted by this Program. Specifically, I reviewed all paid claims for the applicable HCPSC codes for calendar year 2019 for the Jurisdiction J MAC (Alabama, Georgia, and Tennessee).

Puzzle Piece: CMS March 2020 MLN Booklet – Hospital Outpatient Prospective Payment System (ICN MLN006820)

This MLN Booklet was updated in March of this year. In the Innovation section of the booklet, CMS informs the reader that beginning July 1, 2020, you must request prior authorization for the outpatient department services in the Program and that medical necessity documentation requirements remain the same. So, unless something unforeseen happens between now and July 1, it appears the Prior Authorization requirement is a go.

Missing Puzzle Piece: CMS Additional Resources

CMS informs Providers and Physicians in the template letters to be sent by the MACs that “To facilitate open and ongoing dialogue with both patients and physician/practitioners, and to support program transparency, CMS has established a dedicated website for prior authorization program for Certain Hospital Outpatient Department (OPD) Services with comprehensive information for patients, suppliers, and physician/practitioners at: https://www.cms.gov/research-statistics-data-systems/medicare-fee-service-compliance-programs/prior-authorization-initiatives/prior-authorization-certain-hospital-outpatient-department-opd-services.”

CMS has indicated that they will post additional information about this program on this website. However, at the time this article was written, the last time this webpage was modified was January 17, 2020. I encourage you to check this webpage often for any additional information.

Missing Puzzle Piece: MAC Provider and Physician Education

Also, at the time this article was written, First Coast Services the JN MAC for Florida was the only MAC to have posted information about this program on their website.

The first “piece” of information was a May 1st article under the Part A Medical Review section of their website that includes a background and general information about the program and a table of applicable Local Coverage Determinations and Local Articles for the procedures included in this program.

The second “piece” of information was an announcement to participate in one of two webcasts to learn about the prior authorization program. (Thursday, May 28 or Thursday, June 11). Providers can access information about this event under the Education section of their website.

Putting the Puzzle Pieces Together

Now that you are equipped with many of the “pieces” for success and July 1st is less than two months away following are things to consider as you put your processes in place:

• Decide who the key stakeholders are that need to be involved in this process? (i.e., Outpatient Department Nurse Manager, Scheduling, Physicians performing these procedures, Physician Advisor, etc.)
• Work with your IT Department to understand the anticipated volume at your hospital and identify which Physicians are performing these procedures.
• Several other insurance plans already requires prior authorization for these procedures. With that in mind, determine who is currently completing this process at your hospital. Is it feasible for them to incorporate prior authorization for Medicare claims in their process?
• Who needs to receive education about this program (i.e. Physicians performing the procedures, Outpatient Department Staff, Chief Medical Officer, and Physician Advisors)?
• How will the Prior Authorization UTN be communicated to the Physician Office and Hospital Billing Department?
• Identify applicable Medicare Coverage Determinations (NCDs, LCDs, and Articles) specific for the procedures included in this program?
• Who will be responsible for the Appeals Process if a claim is denied?

MMP has sent a question to Palmetto GBA the JJ and JM MAC to find out what their plan is for education. In the meantime we will continue to monitor the CMS and MAC websites and provide you with any additional “puzzle pieces” in future Wednesday@One newsletters. 

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates that span from April 23rd through April 30th.  

Coronavirus.gov Website

This week’s COVID-19 resource spotlight is the Coronavirus.gov website at

https://www.coronavirus.gov/. Specifically, there are two resources available on this website that I want to point out. First is the COVID-19 Screening Tool.  This tool can help you understand what to do next about COVID-19. Second, is the State Information where you can choose a state to see COVID-19 specific guidance from that state’s health department. Both of these resources can be found by clicking “Check for Symptoms” on the homepage.  

April 23, 2020: COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing – Updated

On April 9, 2020 CMS announced in Special Edition MLN Connects that the COVID-19 FAQs have been updated. They advise that you check this resource often as it is updated on a regular basis. They noted that a date is added at the end of an FAQ when it is new or the content has been updated. As of Thursday April 23th this document is now 41 pages. The following list highlights the newest FAQ topics in the document:

• Payment for specimen collection for purposed of COVID-19 testing,
• Diagnostic laboratory services,
• Hospital services,
• Ambulance services,
• Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs),
• NEW: Expansion of Virtual Communication Services for FQHCs/RHCs,
• NEW: Revision of the Home Health Agency Shortage Area Requirement for Visiting Nursing Services Furnished by RHCs and FQHCs,
• Medicare telehealth. (CMS notes this document does not include flexibilities that might be exercised under the CARES Act),
• Physician Services
• Home Infusion Services,
• Accountable Care Organizations (ACO),
• Opioid Treatment Programs,
• Inpatient Rehabilitation Facility services,
• Skilled Nursing Facility services,
• General billing requirements,
• Home Health,
• Drugs and Vaccines under Part B,
• NEW: National Coverage Determinations (NCD),
• Medicare payment to facilities accepting government resources,
• Oxygen,
• NEW: Temporary Department of Defense Sites, and
• NEW: Military Treatment Facilities (MTFs).

April 24, 2020: Alabama Medicaid Alert

Alabama Medicaid indicated in a Provider Alert that all previously published expiration dates related to the COVID-19 emergency are being extended with a new expiration date of May 30, 2020 or at the conclusion of the COVID-19 National emergency, whichever occurs first.

Also included in this Alert is the reminder that “during the COVID-19 emergency, it is important to file claims as quickly as possible to ensure payment from Medicaid is made to Medicaid providers close to the date of service. The Centers for Medicare and Medicaid Services has increased the federal matching percentage for the emergency time frame, but states can only receive the increased match on claims that are paid during the emergency. Providers should include appropriate COVID-19 diagnosis code(s) on claims submitted to help with tracking of COVID-19.”

You can view a listing of prior Provider Alerts and all actions in response to the COVID-19 National emergency on the Agency’s COVID-19 at: https://medicaid.alabama.gov/news_detail.aspx?ID=13729

April 27, 2020: HHS Launches COVID-19 Uninsured Program Portal

In an April 27th media release, the U.S. Department of Health and Human Services (HHS) announced that they have “launched a NEW COVID-19 Uninsured Program Portal, allowing health care providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 to submit claims for reimbursement.”

About the Program

• Where to Access the Portal
• HHS’ Health Resources and Services Administration (HRSA) COVID-19 Claims Reimbursement to Health Care Providers and Facilities Testing and Treatment of the Uninsured webpage at: https://www.hrsa.gov/coviduninsuredclaim
• HHS’ HRSA has contracted with UnitedHealth Group to administer this program.
• Approximately $1 billion is available to reimburse providers. This money was appropriate through the Families First Coronavirus Response Act.
• Program Timeline:
• April 22: Program Details Launch
• April 27: Sign up period begins for the program
• April 29: On Demand training starts
• May 6: Begin submitting claims electronically
• Mid-May: Begin receiving reimbursement
• Services Eligible for reimbursement:
• Specimen collection, diagnostic and antibody testing.
• Testing-related visits including in the following settings: office, urgent care or emergency room or via telehealth.
• Treatment, including office visit (including via telehealth), emergency room, inpatient, outpatient/observation, skilled nursing facility, long-term acute care (LTAC), acute inpatient rehab, home health, DME (e.g., oxygen, ventilator), emergency ground ambulance transportation, non-emergent patient transfers via ground ambulance, and FDA-approved drugs as they become available for COVID-19 treatment and administered as part of an inpatient stay.
• FDA-approved vaccine, when available.
• For inpatient claims, date of admittance must be on or after February 4, 2020.
• How to learn more:
• HRSA has indicated the Program website will be updated with much more information starting April 27 and to check back often.

April 27, 2020: MLN Matters MM11765: Addition of the QW Modifier to HCPCS Code U0002 and 87635

Provider Types affected by information in MLN MM11765 are facilities with a current Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver. Specifically, the article advised the need for the addition of the QW modifier to:

• HCPCS code U0002 (2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC), and
• 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.]

Medicare will permit the use of Codes U0002QW and 87635QW for claims submitted by facilities with a valid, current CLIA certificate of waiver with dates of service on or after March 20, 2020. The official instruction, CR 11765, issued to your MAC regarding this change is available at https://www.cms.gov/files/document/r10066OTN.pdf.

April, 28 2020: AHA and AHIMA FAQs Regarding ICD-10-CM Coding for COVID-19 Revised

The American Hospital Association and American Health Information Management Association released this joint FAQs regarding ICD-10-CM Coding for COVID-19 document on March 24, 2020. Since then several FAQs have been added with the most recent additions being on April 28, 2020.

MMP encourages you to visit the AHA COVID-19 FAQ webpage often for new information that can be downloaded and shared with your Coders and Clinical Documentation Integrity (CDI) Specialists.

April 28, 2020: Alabama Hospitals allowed to Resume Medical Procedures

Alabama’s Safer At Home Order signed on April 28, 2020 amended the Order of the State Health Officer Suspending Certain Public Gathering Due to the Risk of Infection by COVID-19 document. This is good news for Alabama hospitals as the following information for hospitals regarding resuming medical procedures was included in the amended document:

“Medical procedures. Effective April 30, 2020, at 5:00 P.M., dental, medical, or surgical procedures may proceed unless the State Health Officer or his designee determines that performing such procedures, or any category of them (whether statewide or regionally), would unacceptably reduce access to personal protective equipment or other resources necessary to diagnose and treat COVID-19. Providers performing these procedures shall follow all applicable COVID-19-related rules adopted by a state regulatory board or by the Alabama Department of Public Health. In the absence of such rules, providers should take reasonable steps to comply with applicable COVID-19-related guidelines from the Centers for Medicare and Medicaid Services (CMS) and the CDC, including “Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I” from CMS, available at https://www.cms.gov/files/document/covid-flexibility-reopen-essential-non-covid-services.pdf, and “Infection Control Guidance for Healthcare Professionals about Coronavirus (COVID-19)” from the CDC, available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control.html.”

April 28, 2020: CMS Issues Letter to Clinicians Regarding New COVID-19 Clinical Trials Improvement Activity to the MIPS

In a letter thanking clinicians for their efforts to treat patients and combat COVID-19, CMS provided additional details on the new Merit-Based Incentive Payment System (MIPS) improvement activity.

Letter (PDF)

April 29, 2020: First Coast eNews: COVID-19: Allowances for Lab Test Codes U0001-U0004 and 87635

In this announcement, First Coast reminds providers that CMS established new codes for lab tests for the novel coronavirus (COVID-19). Further, CMS provided pricing for codes U0001 and U0002, and instructed MACs to develop the allowance for the remaining codes. The following table highlights the Allowance for each code:

‍April 29, 2020: The HHS Office of Civil Rights (OCR) Webinar on HIPAA Privacy and Security Issues Related to COVID-19

In an April 29th announcement the OCR indicated they had hosted a webinar on April 24, 2020, for health IT stakeholders on HIPAA privacy and security issues related to COVID-19 and recent OCR actions related to the pandemic. The following topics were included in this webinar:

• COVID-19 and Permissible Disclosures under the HIPAA Privacy Rule
• Enforcement Discretion and Guidance for Telehealth Remote Communications
• Guidance for Disclosures to First Responders and Public Health Authorities
• Enforcement Discretion for Business Associates to Use and Disclose PHI for Public Health and Health Oversight Activities
• Enforcement Discretion for Community-Based Testing Sites

A recording of this webinar is now available on YouTube: https://youtu.be/2C6iOdS_FR0. 

The slides from this presentation may be viewed at:  https://go.usa.gov/xvExS. 

For more information related to HIPAA and COVID-19, visit the HIPAA, Civil Rights, and COVID-19 webpage.

April 30, 2020: Second Round Sweeping Changes to Support U.S. Healthcare System During COVID-19 Pandemic

In an April 30th Press Release the CMS announced “another round of sweeping regulatory waivers and rule changes to deliver expanded care to the nation’s seniors and provide flexibility to the healthcare system as America reopens.” The CMS indicates “today’s actions are informed by requests from healthcare providers as well as by the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act.”  Included in the Press Release is the reminder that you do need to apply for the blanket waivers and providers and states can begin using the flexibilities immediately. Following are a few of the actions being taken:   

COVID-19 Diagnostic Testing for Medicare and Medicaid Beneficiaries:

• During the Public Health Emergency, COVID-19 test may be covered when ordered by any healthcare professional authorized to do so under state law. To provide broad access to testing related to COVID-19, a written practitioner’s order is no longer required for the COVID-19 test for Medicare payment purposes.
• CMS will pay hospitals and practitioners to assess beneficiaries and collect lab samples for COVID-19 testing, and make separate payment when that is the only service the patient receives.
• CMS announced they will be “covering certain serology (antibody) tests, which may aid in determining whether a person may have developed an immune response and may not be at immediate risk for COVID-19 reinfection. Medicare and Medicaid will cover laboratory processing of certain FDA-authorized tests that beneficiaries self-collect at home.”

CMS Hospitals Without Walls

CMS provided the following examples of ways hospitals are being provided flexibility to increase beds for COVID-19 patients and receive stable Medicare payments:

• Teaching hospitals can increase the number of temporary beds without facing reduced payments for indirect medical education.
• Inpatient Psychiatric and inpatient rehabilitation facilities (IRFs) can admit more patients to alleviate pressure on acute-care hospital capacity without facing reduced teaching status payments.
• Specific for freestanding IRFs, CMS is excepting certain requirements to enable them to accept patients from acute-care hospitals experiencing a surge, even if they do not require rehabilitation care.
• Hospital systems with rural health clinics (RHCs) can increase bed capacity without affecting the RHCs payments.

Outpatient Hospital Services

• Under current law, most provider-based hospital outpatient departments that relocate off-campus are paid at lower rates under the Physician Fee Schedule, rather than the Outpatient Prospective Payment System (OPPS). CMS will allow certain provider-based hospital outpatient departments that relocate off-campus to obtain a temporary exception and continue to be paid under the OPPS. Importantly, hospitals may also relocate outpatient departments to more than one off-campus location, or partially relocate off-campus while still furnishing care at the original site.

Additional flexibilities being made are related to increasing the Healthcare Workforce, decreasing administrative burden for providers, and further expanding telehealth.

You can read more about the new flexibilities and waivers in a related CMS Fact Sheet or the Medicare and Medicaid Interim Final Rule with Comment (IFC): Additional Policy and Regulatory Revisions in Response to COVID-19 Public Health Emergency (CMS-5531 IFC) that can be found on the CMS COVID-19 flexibilities webpage: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers. 

April 30, 2020: MLN SE20016 New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) During the COVID-19 Public Health Emergency (PHE) Revised

MLN SE20016 was revised to provide the following:

• Additional claims submission and processing instructions,
• Information on cost-sharing related to COVID-19 testing,
• Additional information on telehealth flexibilities, and
• Information on provider-based RHCs exemption to the RHC payment limit.

April 30, 2020: New FAQs on the Emergency Medical Treatment and Labor Act (EMTALA)

CMS has issued FAQs to clarify requirements and considerations for hospitals and other providers related to EMTALA during the COVID-19 pandemic. FAQ topics includes the following:

• Patient Presentation to the Emergency Department,
• Where Does EMTALA Apply,
• Qualified Medical Professionals (QMPs),
• Medical Screening Exam (MSE),
• Transfer and Stabilization of a Patient,
• Telehealth,
• Waivers Under Section 1135 of the Social Security Act, and
• FAQs falling under “Other.”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates that span from April 20th through April 27th.  

April 20, 2020: FDA’s Daily Roundup: Serological (Antibody) Tests Guidance

On April 20th the Food and Drug Administration (FDA) issued the following information on the use or serological (antibody) tests to help identify people potentially exposed to the SARS-CoV-2 virus or have recovered from the infection:

• Letter to Health Care Providers: Important Information on the use of serological (antibody) tests for COVID-19. This letter opens with the following important statement: “The U.S. Food and Drug Administration (FDA) recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Health care providers should also be aware of the limitations of these tests and the risks to patients and the community if the test results are used as the sole basis to diagnose COVID-19.”
• FDA Fact Sheet: Serological Testing for Antibodies to SARS-CoV-2 Infection; and
• New Serology/Antibody Test FAQs in the FAQs on Diagnostic Testing for SARS-CoV-2 Infection.

April 20, 2020: CMS Announces Clinicians Can Earn Credit in the Merit-Incentive Payment System (MIPS) when Participating and Attesting to the New COVID-19 Clinical Trials Improvement Activity

In an April 20th Press Release, CMS announced that clinicians who participate in the CMS Quality Payment Program (QPP) may now earn credit in the MIPS for participation in a clinical trial and reporting clinical information by attesting to the new COVID-19 Clinical Trials improvement activity. CMS noted “this action will provide vital data to help drive improvement in patient care and develop innovative best practices to manage the spread of COVID-19 within communities.”

How You Will Receive Credit for Participation

“Clinicians must attest that they participate in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with a COVID-19 infection and report their findings through a clinical data repository or clinical data registry for the duration of their study.”

More about this Improvement Activity

• There is flexibility in the type of clinical trial, which could include the traditional double-blind placebo-controlled trial, to an adaptive or pragmatic design that flexes to workflow and clinical practice.
• Clinicians who report this activity will automatically earn half of the total credit needed to earn a maximum score in the MIPS improvement activities performance category, which counts as 15 percent of the MIPS final score.
• You can view a database of privately and publicly funded clinical studies currently being conducted on COVID-19 at https://clinicaltrials.gov/

April 21, 2020: COVID-19 Update: FDA Authorizes First Test for Patient At-Home Sample Collection

The U.S. FDA announced  that they had re-issued the emergency use authorization (EUA) for the LapCorp COVID-10 RT-PCR Test to permit testing of samples self-collected by patients at home using LapCorp’s Pixel by LabCorp COVID-19 Test home collection kit. FDA Commissioner Stephen M. Hahn, M.D., notes they “worked with LapCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

The FDA makes it clear this authorization only applies to this LapCorp test and is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home.

April 21, 2020: CMS Releases Additional Blanket Waivers for Long-Term Care Hospitals, Rural Health Clinics, Federally Qualified Health Center and Intermediate Care Facilities

Additional blanket waivers released on April 21st were related to care for patients in LTCHs, temporary expansion locations of Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs), staffing and training modifications in Intermediate Care Facilities for individuals with Intellectual disabilities, and the limit for substitute billing arrangements (locum tenens). Blanket waiver guidance can be found in the COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers document.

April 21: Memorandum to State Survey Agency Directors: Guidance for Freestanding EDs during COVID-19 Public Health Emergency

According to the Memorandum Summary, “CMS is creating additional flexibilities to allow licensed independent freestanding emergency departments (EDs) to participate in Medicare and Medicaid to help address the urgent need to increase hospital capacity to provide care to patients. The following ways to participate include:

• Becoming affiliated with a Medicare/Medicaid-certified hospital under the temporary expansion 1135 emergency waiver.
• Participating in Medicaid under the clinic benefit if permitted by the State, or
• Enrolling temporarily as a Medicare/Medicaid-certified hospital to provide hospital services.”

April 22, 2020: New Toolkit to Help States Navigate COVID-19 Health Workforce Challenges

An April 22nd CMS Press Release announced that the CMS and the Assistant Secretary of Preparedness and Response (ASPR) released the COVID-19 Healthcare Workforce Toolkit to help state and local healthcare decision makers maximize workforce flexibilities when confronting COVID-19 in their communities. This work was developed by the Healthcare Resilience Task Force and provides helpful information on funding flexibilities, liability protections, and workforce training. It also provides up-to-date best practices making it a go-to resource for decision makers to find out what has been implemented in the field and how it’s working.

The toolkit is housed on the ASPR Technical Resources, Assistance Center, and Information Exchange (TRACIE). This is a healthcare emergency preparedness information gateway ensuring all stakeholders have access to the information. To view the COVID-19 Healthcare Workforce Toolkit, visit: https://asprtracie.hhs.gov/Workforce-Virtual-Toolkit

April 23, 2020: COVID-19 Telehealth Toolkit to Accelerate State Use of Telehealth in Medicaid and CHIP

The Trump Administration announced in a Press Release the release of a new toolkit for states to help accelerate adoption of broader coverage policies in the Medicaid and Children’s Health Insurance Program (CHIP) during the COVID-19 pandemic. The toolkit includes the following issues for states to consider when evaluating their need to expand telehealth capabilities and coverage policies:

• Patient populations eligible for telehealth,
• Coverage and reimbursement policies,
• Providers and practitioners eligible to provide telehealth,
• Technology requirements,
• Pediatric considerations; and
• A compilation of FAQs.

April 23, 2020: Guidance for Infection Control and Prevention Concerning COVID-19 in Home Health Agencies (HHAs) and Religious Nonmedical Healthcare Institutions (RNHCIs)

This guidance was initially released on March 10, 2020 and was subsequently updated on April 23, 2020 to include RNHCI Guidance on COVID-19. The following information was added to the Memorandum Summary:

• HHA Guidance now includes additional information about CMS waivers and regulations, and CDC guidance was added for optimizing personal protective equipment and return to work criteria for healthcare personnel with confirmed or suspected COVID-19.
• Recommendations for Visitation in Residential Facilities not Certified by Medicare: CMS is providing recommendations to home health care personnel who care for patients in residential settings such as assisted and independent living facilities.
• Medicare Participating Religious Nonmedical Healthcare Institutions (RNHCIs) and Actions – CMS is providing additional guidance for RNHCIs related to addressing potential and confirmed COVID cases and mitigating transmission including screening, treatment, and transfer to higher level of care (when appropriate).

April 24, 2020: Nursing Home Five Star Quality Rating System Updates, Nursing Home Staff Counts, and Frequently Asked Questions

An April 24, 2020 Memorandum to State Survey Agency Directors indicates CMS’ commitment to ensuring nursing homes are prepared to respond to the threat of COVID-19. Specific steps outlined in the memorandum summary includes the following:

• The inspection domain of the Nursing Home Compare Five Star Quality Rating System will be held constant temporarily due to the prioritization and suspension of certain surveys, to ensure the rating system reflects fair consumer information.
• CMS will post a list of the surveys conducted after the prioritization of certain surveys, and findings, through a link on the Nursing Home Compare website.
• CMS is publishing a list of the average number of nursing and total staff that work onsite in each nursing home, each day. This information can be used to help direct adequate (PPE) and testing to nursing homes.
• A list of FAQs is being released to clarify certain actions that CMS has taken related to visitation, survey, waivers, and other guidance.

April 26, 2020: CMS Reevaluates Accelerated Payment Program and Suspends Advance Payment Program

On April 26, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. The agency made this announcement following the successful payment of over $100 billion to health care providers and suppliers through these programs and in light of the $175 billion recently appropriated for health care provider relief payments. You can read more about this in the April 26th CMS Press Release.

April 27, 2020: WPS GHA Medicare eNews: Modifier CS and COVID-19 Testing

The following reminder was included in the April 27th edition of WPS’ Medicare eNews:

“A new law waives cost-sharing under Medicare Part B for certain outpatient COVID-19 testing-related services. The CS modified signals the MACs to pay 100% for these services. This applies for claims with dates of service on or after March 18, 2020. Claims submitted without the modifier may be resubmitted.

To learn more, refer to "Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services"   in the CMS MLN Connects Special Edition – Tuesday, April 7, 2020.”

Kaiser Health News and Guardian US Partner to Honor American Health Care Workers Lost on the Frontline of the COVID-19 Pandemic

In recent COVID-19 updates articles MMP has highlighted the Institute for Health Metrics and Education (IHME) COVID-10 Projection Models (link to Project: https://covid19.healthdata.org/projections

) and the Johns Hopkin’s Coronavirus Resource Center where you will find world and U.S. specific numbers as well as critical trends.

This week I want to make our readers aware of the Lost on the Frontline Project that was officially launched on April 15th by KFF’s Kaiser Health News (KHN) and Guardian US. This special project aims to document the life of every health care worker in America who has died from COVID-19 during the pandemic. According to the KHN Announcement, “this includes medical professionals like doctors, nurses and paramedics, and others working at hospitals, nursing homes and other medical facilities, including aides, administrative employees and cleaning and maintenance staff.”

Note, when you go to the Lost on the Frontline website, you are encouraged to share the story of colleagues or loved ones that you know who have died from COVID-19.

KHN and The Guardian are inviting news organizations across the country to partner in the effort. The project will link to local news stories on health care worker deaths, and all content from the series will be available free to other news organizations to republish. The project will reflect the rich diversity of the U.S. health care workforce. The lead partners will translate selected stories into multiple languages and make them available for publication by ethnic media outlets to ensure they reach the many communities in America affected by the pandemic. 

April 10, 2020: AMA Announces Expedited Updates to CPT for COVID-19 Antibody Tests

The CPT Editorial Panel expedited the review of proposed changes and approved them on April 10th. In the Announcement AMA President Patrice A. Harris, M.D., M.A. said that “The expedited approval of new CPT codes for COVID-19 antibody tests is an important step that enhances the reporting of innovative tools now available to advance medicine's overarching goals of reducing the COVID-19 disease burden, improving health outcomes and reducing long-term care costs.”

• Code 86328 has been established for antibody testing using a single step method immunoassay.
• Code 86769 has been established for antibody testing using a multiple step method.

Prior to these two new Category I CPT codes approval, the CPT Editorial Panel approved a new code to report molecular testing to detect the SARS-CoV-2 virus:

• Code 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: All AMA COVID-19 Coding Guidance to date is available on the AMA’s COVID-19 Coding and Guidance webpage. 

April 13, 2020: CMS Provides COVID-19 Long-Term Care Transfer Scenarios

CMS released a Memorandum to State Survey Agency Directors. This memorandum provides supplemental information for transferring or discharging residents between facilities for the purpose of cohorting residents based on COVID-19 status (i.e., positive, negative, unknown/under observation). This guidance includes graphics explaining the various scenarios.

April 14, 2020: Novo Nordisk® Offering Free 90-Day Insulin Supply to People Experiencing Financial Hardship due to COVID-19

Novo Nordisk, Inc. announced on April 14th that diabetics using Novo Nordisk insulin who have lost health insurance coverage because of a change in job status due to the COVID-19 pandemic may now be eligible for enrollment in their Diabetes Patient Assistance Program and receive a 90 day supply of insulin free of charge.

April 15, 2020: Special Edition MLNConnects: IPPS Hospitals, LTCHS: Reprocessing Claims for CARES Act

Sections 3710 and 3711 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act implemented changes to increase payments to IPPS Hospitals and Long-Term Care Hospitals (LTCHs). When you submit an IPPS claim for discharges on or after January 27, 2020, or an LTCH claim for admissions on or after January 27, 2020, and we receive it:

• April 20, 2020, and earlier, Medicare will reprocess. You do not need to take any action.
• On or after April 21, 2020, Medicare will process in accordance with the CARES Act.

For more information, see MLN Matters Special Edition Article SE20015.

April 15, 2020: CMS Increases Medicare Payment for High-Production Coronavirus Lab Tests

In a CMS Press Release CMS announced that Medicare will nearly double payments for certain lab tests that use high-throughput technologies to rapidly diagnose large numbers of COVID-19 cases. CMS Administrator Seema Verma said “this is an absolute game-changer for nursing homes, where the risk of Coronavirus infection is high among our most vulnerable.”

Key Facts from this Announcement

• Medicare will pay the higher payment of $100 for COVID-19 clinical diagnostic lab tests making use of high-throughput technologies developed by the private sector.
• High-throughput lab tests can process more than 200 specimens daily.
• High-throughput lab tests use highly sophisticated equipment requiring specially trained technicians and more time-intensive processes to assure quality.
• This increased payment rate became effective April 14, 2020, through the duration of the COVID-19 National Emergency.
• Local Medicare Administrative Contractors (MACs) will continue to be responsible for other COVID-19 lab tests.
• MACs are currently paying approximately $51 for those tests.

CMS reminds readers that for a complete and updated list of  CMS actions, and other information specific to CMS, please visit the Current Emergencies Website.

For more information on this payment announcement, please visit: https://www.cms.gov/files/document/cms-2020-01-r.pdf

April 17, 2020:  MLN SE20016: New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) During the COVID-19 Public Health Emergency (PHE)

Special Edition Article SE20016 highlights changes made to the RHC and FQHC requirements and payments for the duration of the PHE. Also included in this article is a link to the RHC/FQHC COVID-19 FAQs.

April 17, 2020: CDC’s Clinical Outreach & Communications Activity (COCA) Webinar: COVID-19 in the United States: Insights from Healthcare Systems

This past Friday the CDC provided a webinar focused on insights from healthcare care systems in response to the COVID-19 PHE. Specifically, David Reich, MD, President, and Chief Operating Officer of The Mount Sinai Hospital in New York and Amy Compton-Phillips, MD, Executive Vice President, Chief Clinical Office of Providence St. Joseph Health in Washington shared their healthcare systems experience. A replay of the webinar and the transcript and slide presentation are available on the CDC’s COCA Calls/Webinars - 2020. 

Drug Enforcement Administration: Diversion Control Divisions’ Response to COVID-19

The Diversion Control Division of the DEA has been working closely with “Federal partners, DEA registrants, and their representative association to assure that there is an adequate supply of controlled substances in the United States. The DEA will also work to assure that patients will have access to controlled substances.” All of their actions to date are available on their COVID-19 Information Page. Following is one Q&A available on this page regarding drug distribution to “pop-up” hospitals. 

Question: Distributors are being inundated with requests to deliver to what distributors are referring to as "pop-up" hospital/triage locations that are located in a variety of locations, including parking lots, hotels, and convention centers – essentially wherever additional space can be found to set up treatment centers. Distributors are concerned that these alternate locations do not comply with the CSA and the DEA regulations regarding the delivery of controlled drugs. How can distributors obtain expedited approval to deliver to an alternate address for their customers in the event that a pharmacy or healthcare facility is shut down for quarantine or cleaning?

Answer: Before addressing this question, we wish to emphasize that DEA is making every effort to expeditiously review any application for an emergency DEA registration number and intends to expedite the pre-registration process when warranted. The DEA registrant requesting to establish an alternate site should submit a request to DEA's national disaster email, natural.disaster@usdoj.gov, for an emergency DEA registration number for each designated alternate location. The email must include the following information for the alternate location: physical address; security measures; and, the name and complete contact information of the person who will be responsible for the controlled substances at this location.

Please also see the answer to the question and answer regarding what alternate delivery methods will be considered compliant with 21 CFR 1305.13(c) and 1305.22(f) during the COVID-19 public health emergency. In addition, to address the scenario in which, due to COVID-19 related considerations, the purchaser that has recently set up location for which the purchaser's DEA-222 forms do not yet reflect its new location, DEA is issuing an exception to the regulations. This exception is posted at DEA's COVID-19 guidance webpage

April 19, 2020: New Nursing Homes COVID-19 Transparency Efforts

CMS announced new regulatory requirements for nursing homes in a Sunday April 19th Press Release.

New Requirements:

• Nursing homes will be required to inform residents, their families and representatives of COVID-19 cases in their facilities.
• As part of President Trump’s Opening Up America, nursing home will now be required to report COVID-19 case directly to the CDC in accordance with existing privacy regulations and statute.
• Nursing homes will be required to fully cooperate with CDC surveillance efforts around COVID-19 spread. The CDC will be providing a reporting tool to nursing homes that will support Federal efforts to collect nationwide data to assist in COVID-19 surveillance and response. CMS plans to make the data publicly available.

April 19, 2020: Guidelines for Opening Up America Again

In an April 19th Press Release, the CMS announced the issuance of new recommendations specifically targeted to communities that are in Phase 1 of the Guidelines for President Trump’s Opening Up America Again with low incidence or relatively low and stable incidence of COVID-19 cases. The recommendations update earlier guidance provided by CMS on limiting non-essential surgeries and medical procedures. The new CMS guidelines recommend a gradual transition and encourage health care providers to coordinate with local and state public health officials and to review the availability of Personal Protective Equipment (PPE) and other supplies, workforce availability, facility readiness, and testing capacity when making the decision to re-start or increase in-person care.

The new recommendations can be found here: https://www.cms.gov/files/document/covid-flexibility-reopen-essential-non-covid-services.pdf

The Guidelines for Opening Up America Again can be found here: https://www.whitehouse.gov/openingamerica/#criteria 

Medical Review Administrative Relief Related to the Novel Coronavirus (COVID-19) Pandemic

Palmetto GBA has posted the following Notice on their website:

The Centers for Medicare & Medicaid Services (CMS) has authorized nationwide waivers under §1812(f) of the Social Security Act retroactive to March 1, 2020, for those impacted by COVID-19. Medicare Fee-For-Service (FFS) operations will implement the following policies and procedures for all claims, not just for the COVID-19 diagnoses.

Additional Documentation Requests (ADRs)

• For ADRs that have already been issued, Medicare contractors will release the claims for payment and not issue claim denials; providers should not respond to any pending claims as all claims will be released for relief efforts.
• Any claims auto-denied for non-response of an ADR from March 1, 2020, until March 26, 2020, will have the denial reversed and allow payment if an appeal has not been filed. If an appeal has been filed, normal appeals processes will be followed.
• As of March 26, 2020, future ADRs will not be sent until further notice from CMS

Targeted Probe and Education (TPE)

• All current TPE reviews and associated edits are suspended and selected claims released for payment
• MACs will allow TPE medical review education sessions to be rescheduled upon provider request

Note: Providers must resume compliance with normal Medicare fee-for-service rules and regulations as soon as they are able. The waivers or modifications a provider was operating under are no longer available after the termination of the emergency period.

April MAC Talk: The Local Scene

March 17th, 2020: Palmetto GBA JM Posts TPE Progress Updates

It seems a little ironic that in March Palmetto GBA JM began releasing Targeted Probe and Educate (TPE) Progress Updates. Medical Review specific articles include the dates of services reviewed, the volume of probes performed, the charge denial rates, top denial reasons, tips for preventing denials, next steps, and references.

In regards to “Next Steps,” Palmetto GBA indicates that Providers found to be non-compliant (major risk category/denial rate of 21–100%) at the completion of TPE Probe 1 will advance to Probe 2 at least 45 days from completion of the 1:1 post probe education call date. Palmetto GBA offers education at any time for providers. Providers do not have to be identified for TPE to request education.

Following is a list of the specific TPE articles released to date by Palmetto GBA JM:

• March 17, 2020: DRG 682/683 Renal Failure with MCC/CC,
• March 17, 2020: DRG 470 – Major Joint Replacement,
• March 18, 2020: Inpatient Rehab Facility A0604, B0604, C0604 and D0604,
• March 18, 2020: DRG 885 Psychoses,
• March 19, 2020: Therapeutic Exercise 97110,
• March 19, 2020: Skilled Nursing Facility (SNF),
• March 23, 2020: Rituximab J9310/J9312,
• March 23, 2020: Pegfilgrastim J2505,
• March 23, 2020: Neuromuscular Re-education – 97112,
• March 23, 2020: Manual Therapy – 97140,
• March 23, 2020: Infliximab J1745,
• March 23, 2020: HBO Therapy G0277,
• March 23, 2020: DRG 291 Heart Failure and Shock with MCC and DRG 292 Heart Failure and Shock with CC,
• March 23, 2020: Denosumab J0897, and
• March 23, 2020: Bevacizumab J0935.

Links to all of the articles can be found on Palmetto GBA’s JM Target Probe and Educate webpage.

March 20, 2020: First Coast Revises Articles A52571 and A57778

Article A52571: Self-Administered Drug Exclusion List

Effective May 3, 2020, First Coast (JN) has added the following drugs to the self-administered drug (SAD) list:

• Tremfya® (guselkumab) (J1628), and
• Stelara® (ustekinumab) subcutaneous (J3357).

This announcement includes a link to their entire list of SADs.

Article A57778: Billing and Coding Intravenous Immune Globulin

First Coast has added the new FDA approved drug Panzyga® (immune globulin intravenous, human – IFAS) (HCPCS codes C9399 and J1599) to the CPT®/HCPCS Codes/Group 1 Paragraph:/Group 1 codes:” and “ICD-10 Codes that Support Medical Necessity/Group 1 Paragraph:” section.

This change is effective for claims processed on or after March 16, 2020, for services rendered on or after August 2, 2018.

March 24, 2020: Palmetto GBA Daily Newsletter: Self-Administered Drug Exclusion List Article Changes

Palmetto GBA posted information about revisions made to their Self-Administered Drug Exclusion List

Article A53066.

These changes will be effective 4/20/2020. They encourage providers to share this information with their staff.

• Revision 23 (R23): Under Excluded CPT/HCPCS Codes – Table Format the previous revision (R22) that added HCPCS Code J3358 – Stelara®, ustekinumab for intravenous injection, 1mg should be disregarded as this code was inadvertently added. HCPCS code J3557 – Stelara®, ustekinumab for subcutaneous injection, 1mg has been added.

March 25, 2020: Palmetto GBA JJ Posts TPE Progress Updates

A little over a week after Palmetto GBA released TPE Progress Updates for Jurisdiction M they began posting findings for Jurisdiction J. Review specific articles follow the same format as articles released for JM. Following is a list of specific TPE articles released to date by Palmetto GBA JJ:

• March 25, 2020: HBO Therapy G0277,
• March 25, 2020: JJ Part A Skilled Nursing Facility (SNF),
• March 25, 2020: Therapeutic Exercise 97110,
• April 3, 2020: DRG 885 Psychoses; and
• April 3, 2020: DRG 470 Major Joint Replacement,
• April 10, 2020: Manual Therapy 97140,
• April 10, 2020: Inpatient Rehabilitation Facility (IRF) A0604-D0604
• April 10, 2020: Pegfilgrastim J205,
• April 10, 2020: DRGs 291 and 292: Heart Failure and Shock with MCC and with CC,
• April 11, 202: Rituximab J9310,
• April 11, 2020: Infliximab J1745,
• April 11, 2020: Denosumab J0897, and
• April 11, 2020: Bevacizumab J9035.

Links to all of the articles can be found on Palmetto GBA’s JJ Target Probe and Educate webpage.

March 30, 2020: CGS Posts Notice Medical Review Update

On January 31, 2020, Secretary Azar of the Department of Health & Human Services (HHS) declared a nationwide public health emergency.  On March 13, 2020, Secretary Azar authorized waiver and modifications under §1135 of the Social Security Act retroactive to March 1, 2020. CGS understands the effect of COVID-19 on our provider community. In response to questions received regarding Medical Review Additional Document Requests (ADRs) and Targeted Probe and Educate (TPE) activity, at this time, CGS has temporarily suspended TPE reviews. Our medical review and provider outreach and education staff will continue to be available to conduct education sessions and provide answers to questions to ensure that providers understand regulatory guidelines to prevent improper payment. To reschedule a TPE educational session, request an educational session related to medical review topics, or for medical review general TPE questions please contact us at one of the email addresses below or contact the appropriate provider contact center (PCC) at: https://www.cgsmedicare.com/help/index.html.

• Part A Medical Review: J15AprobeandEducation@cgsadmin.com
• Part B Medical Review: J15BPROBEANDEDUCATION@cgsadmin.com
• HHH Medical Review: J15HHprobeandEducation@cgsadmin.com

April 1, 2020: NGS News COVID-19 Update: Important Information Regarding Part A and B Second-Level Appeals
NGS provided the following “information at the request of the Qualified Independent Contractor (QIC), C2C Innovative Solutions, Inc. (C2C). C2C conducts second-level Medicare Part A and B Fee-for-Service claims appeals submitted in Jurisdiction K Part A and B as well as Jurisdiction 6 home health and hospice for New York, New Jersey, Puerto Rico and the U.S. Virgin Islands. If you appeal to C2C as the Part A and B East QIC, they are limiting their on-site mail room operations in response to the COVID-19 public health emergency. During this public health emergency, providers and Medicare beneficiaries falling into the above categories are encouraged to submit new second-level Medicare appeals and related correspondence via fax or the electronic portal. For additional information including the QIC fax numbers and a link to their portal, please visit the C2C website.”

April 6, 2020: NGS Posts Update Regarding Pricing of HCPCS G2066

NGS News and Alerts

On 3/12/2020 NGS posted an article on their website regarding a fee adjustment for HCPCS G2066 (Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular physiologic monitor system, implantable loop recorder system, or subcutaneous cardiac rhythm monitor system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results).

While NGS recognizes its authority to periodically review and adjust pricing as warranted of any “Contractor Priced“ codes, the adjustment in payment for HCPCS G2066 will not go into effect during this PHE, as scheduled on April 24, 2020.

HCPCS G2066 was created by the CMS for 2020 to replace the retired code of CPT 93299. Therefore, the fee for G2066 will remain the same as the prior 2019 fee for CPT 93299.

At such time as the PHE is deemed over, HCPCS G2066 will be reviewed for pricing based on other MAC fees; a thorough review of this service; and further input from stakeholders.

April 8, 2020: Palmetto GBA Claims Payment Issue: Medically Unlikely and Procedure-to-Procedure Edit Updates Due to COVID-19

Palmetto GBA identified the following Issue on April 3, 2020:

As a result of the CMS expansion of telehealth services in response to COVID-19, CMS updated certain Medically Unlikely Edits (MUEs) and Procedure-to-Procedure (PTP) edits for CPT and HCPCS codes, retroactive to January 1, 2020. Palmetto GBA advises that they will implement the CMS replacement files and adjust affect claims with dates of service on or after March 6, 2020. Additionally, any appeals already started by Palmetto GBA that related to MUE or PTP denials will be prioritized for review using the replacement files for claims with dates of service on or after March 6, 2020.

April 9, 2020: NGS Daily News: A Message from Our Medical Review Team: Targeted Probe and Educate Medical Reviews
In the wake of the public health emergency related to COVID-19, National Government Services (NGS) is in the process of pausing Targeted Probe and Educate (TPE) Medical Reviews. At this time, they are unable to provide additional clarity on when or how TPE reviews will resume, but will share information as it’s made available. They will work with providers who previously scheduled educational sessions to reschedule them.

NGS is contacting providers to let them know claims were released and there is no need to respond to an additional development request (ADR) for medical records. Effective 3/1/2020, claims that auto-denied for nonresponse or late response to the ADR will be reversed and allowed for payment unless an appeal has already been filed. In that case, the appeal will follow the normal appeals process.

NGS’ dedicated email address remains available for questions specific to medical reviews

• Jurisdiction 6 Part A:  j6probeandeducate@anthem.com
• Jurisdiction 6 Part B: J6Bprobeandeducate@anthem.com
• Jurisdiction K Part A: ngs-jkmedicalreview@anthem.com
• Jurisdiction K Part B: educate@anthem.com">Jkbprobe&educate@anthem.com

April 9, 2020: Palmetto GBA Update: MACs to Host Multi-jurisdictional Contractor Advisory Committee (CAC) Meeting Regarding Facet Joint & Medical Nerve Branch Procedures on May 28, 2020 from 1-3 p.m. CT

Due to the COVID-19 Pandemic, the decision has been made to hold the meeting via Teleconference/Webinar ONLY. All other information remains the same.

The purpose of the meeting is to obtain advice from CAC members and subject matter experts (SMEs) regarding the strength of published evidence on Facet Joint and Medial Nerve Branch Procedures. In addition to discussion, the CAC and SME panel will vote on pre-distributed questions. The public is invited to attend as observers.

The meeting will be hosted by seven Medicare Administrative Contractors and will be held via Teleconference/Webinar. There will be a panel of experts discussing the Facet Joint and Medial Nerve Branch Procedures. CAC panels do not make coverage determinations, but MACs benefit from their advice.

Complete details will be available by May 14, 2020 (background material, questions, and agenda).

Link to Announcement:
https://www.palmettogba.com/palmetto/providers.nsf/DocsR/JJ-Part-A"BMYQLA2250

April 13, 2020: WPS J8A Medical Review (MR) Targeted Probe & Educate (TPE) Quarterly Update

WPS provided the common errors identified by their Medical Review staff throughout the first quarter of 2020. Specific for hospitals was the following guidance regarding wound care.

• Wound Care (CPT 11042): Denials for Documentation Not Supporting Sharp Debridement: WPS reminds Providers that documentation should provide a clear rationale for the excisional debridement. Additionally, the documentation should include a certified plan of care that includes the potential to heal and goals. The WPS Local Coverage Determination (LCD) L37228outlines coverage criteria for wound care.

April 13, 2020: WPS eNews: Inpatient Psychiatric Facility (IPF) – CERT Errors

A WPS Announcement indicated that the Comprehensive Error Rate Testing (CERT) Contractor has assessed for errors for IPF services and found that in most cases there was missing documentation to support payment based on Medicare guidelines. The announcement details information that should be submitted in a response to a Medicare request and provides a link to additional information in Chapter 2: Inpatient Psychiatric Hospital Services of the Medicare Benefit Policy Manual.

April 13, 2020: OIG Releases Report : An Estimated 87 Percent of Inpatient Psychiatric Facility Claims with Outlier Payments Did Not Meet Medicare’s Medical Necessity or Documentation Requirements

The OIG focus for this audit was claims resulting in outlier payments with an objective of determining whether Inpatient Psychiatric Facilities (IPFs) complied with Medicare coverage, payment, and participation requirements. OIG Findings from the 160 sampled claims:

• 25 claims did not meet Medicare medical necessity requirements,
• 142 claims had missing or inadequate medical record elements, including physician certification, and
• 12 of the 142 claims did not clearly support that the IPF had protected the patient’s right to make informed decisions regarding care.

Ultimately, the OIG estimated that Medicare overpaid IPFs $93 million for FYs 2014 and 2015 for stays that were non-covered or partially non-covered and resulted in outlier payments. 

April 16, 2020: CGS Announces Retirement of LCD L34093: Chemotherapy and Biologicals

• Effective June 7, 2020: CGS will be retiring LCD L34093: Chemotherapy and Biologicals
• Effective June 8, 2020: LCD L34093 will be replaced with Article A58113: Off-Label Use of Anti-Cancer Drugs and Biologicals
• CGS Notes in the announcement that, “This is a change from how we currently handle chemotherapy and biological drugs. While there will no longer be a local policy in place with attached billing and coding articles, we will be using the coverage indications as listed in the Centers for Medicare & Medicaid Services (CMS) Internet Only Manual (IOM) 100-02, Chapter 15, section 50.4.1 and 50.4.5 which is the basis for the current policy. CGS will cover these types of drugs based on FDA label indications and for off label use if listed in one of the five CMS approved compendia’s (NCCN, Micromedex Drug DEX, Lexi-Drugs, AHFS, or Clinical Pharmacology).”
• You can read the entire announcement at:   https://www.cgsmedicare.com/parta/pubs/news/2020/04/cope16807.html

April 17, 2020: First Coast eNews: TPE Announcement

“Targeted probe and educate (TPE) reviews have been temporarily postponed due to the public health emergency (PHE) declared as a result of the 2019 novel coronavirus (COVID-19). We encourage providers to focus on patient care and defer discussions related to these reviews after the PHE. First Coast will reach out to providers after the pandemic to offer education based upon prior reviews. In the event providers would like to receive education during this time, we are prepared to provide educational sessions. Please feel free to reach out to the nurse assigned to your case to arrange an educational call.”