Knowledge Base Category -

CMS released the display copy of the Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) Final Rule last Wednesday September 2, 2020. As of the release of this article, you have twenty-one days to read and absorb the information as you prepare for the October 1, 2020 start of the 2021 CMS FY.  

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 highlights finalized 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.

In the proposed rule, 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.”

Clinical advisors agreed and CMS finalized their proposal 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 finalized the re-designation of these codes from O.R. to Non-O.R. procedures affecting their current MS-DRG assignment.  

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.

In the FY 2021 proposed rule, the request was again made 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 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.

In the Final Rule, CMS finalized their proposal to:  

• Assign cases reporting ICD-10-PCS procedure codes XW033C3 or XW043C3 to a 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 MS-DRG relative weight (RW) and geometric mean length of stay (GMLOS) for the BMT MS-DRGs and the 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 proposed 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 finalized the proposal to add the 6 codes as requested and the additional 36 ICD-10-PCS codes they identified as currently being in MDC 5 to the GROUPER logic for MS-DRGs 034, 035, 036 in MDC 1.

As an instructor told me when first learning about the MS-DRG system, this change permits 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.

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, CMS Clinical Advisors supported restructuring of these MS-DRGs by assigning procedures based on clinical intensity, complexity of service and resource utilization.

CMS finalized their proposals to:  

• 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).

Note, CMS refers readers to Tables 6P.2a, 6P.2b, and 6P.2.c associated with the final rule for the finalized list of procedure codes that define the logic for the finalized MS-DRGs.

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 details the current corresponding MS-DRGs for the 9 ICD-10-PCS codes describing LAAC Procedures. Note that currently the procedure map to an MS-DRG based on the approach.

CMS finalized their proposal 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. and GMLOS for FY 2021 for the four MS-DRGs as well the MS-DRG title changes for MS-DRGs 273 and 274:

‍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 excluded from this group of MS-DRGs as a result of replicating the ICD-9 based MS-DRGs.

CMS has finalized the following two proposals:

• Add 24 ICD-10-PCS code combinations for CCM devices to this group of MS-DRGs, and
• Delete 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 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 on the request and lengthy data analysis by CMS, CMS proposed and has finalized two new MS-DRGs for hip replacements due to a hip fracture.  The following table highlights the difference in R.W. and GMLOS for FY 2021:

‍Impact on the Comprehensive Care for Joint Replacement (CJR) Model

In the proposed rule CMS acknowledged that the 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 requested 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.

CMS notes in the Final Rule that “an interim final rule published in April 6, 2020 extended the CJR model through March 31, 2021, in light of the COVID-19 pandemic, to ensure the continuity of the CJR model operations in participant hospitals during the public health emergency so that we did not create any additional disruptions to the standard of care procedures hospitals have in place during this challenging time. Because the model will continue until at least March 31, 2021, we intend to adopt a policy in the CJR final rule that incorporates MS-DRG 521 and MS-DRG 522 into the CJR model as of the effective date of these new MS-DRGs. We believe such an approach would avoid disruption to the model for the remainder of PY5 (as extended) and thereafter, if our proposal to extend the CJR model to December 31, 2023 is 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 re-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).

Instead of proposing a move to a Pre-MDC MS-DRG, CMS proposed and has now finalized 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.”

Of note, CMS discussed in the proposed rule how the Pre-MDCs came into existence and that the proposal for kidney transplant procedure code to determine the MS-DRG assignment 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 indicated in the proposed rule that they believe 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 has finalized the proposed three new MS-DRGs:

• Pre-MDC MS-DRG 019 (Simultaneous Pancreas/Kidney Transplant with Hemodialysis) for cases describing the performance of hemodialysis during an admission where the patient received a simultaneous pancreas/kidney transplant, and
• MS-DRGs 650 and 651 (Kidney Transplant with Hemodialysis with MCC and without MCC respectively) for cases describing the performance of hemodialysis in an admission where the patient received a kidney transplant in MDC 11.

As part of the logic for the new MS-DRGs, CMS finalized their proposal to change the designation of the above hemodialysis codes from non-O.R. procedures to non-O.R. procedures affecting the MS-DRG.

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 noted 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.”

In the Final Rule, CMS clinical advisors concurred with commenters “that while the procedure to insert an IVC filter is not surgical in nature, procedures describing the insertion of an intraluminal device into the inferior vena cava performed via an open or percutaneous endoscopic approach could require greater resources than a procedure describing insertion of an intraluminal device into the inferior vena cave performed via a percutaneous approach.”

For this reason, CMS has indicated they will further examine relevant clinical factors and similarities in resource consumption between procedures describing the insertion of an intraluminal device into the inferior vena cava performed via an open or a percutaneous endoscopic approach.”

CMS finalized the following proposals for FY 2021: 

• ICD-10-PCD procedure code 06H03DZ designation is changing from O.R. to non-O.R. procedure, and
• For now, ICD-10-PCS procedures codes 06H00DX and 06H04DZ will maintain the O.R. designation and continue to impact MS-DRG assignment.

Moving Forward

The FY 2021 IPPS Final Rule is scheduled to be published in the Federal Register on September 18, 2020. Until then, you can access the display copy available on the FY 2021 IPPS Final Rule Home Page and watch for additional articles in the Wednesday@One.

Resources:

FY 2021 IPPS Final Rule Home Page on CMS website: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2021-ipps-final-rule-home-page#1735

CMS Fact Sheet: Fiscal Year (FY) 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Final Rule (CMS-1735-F): https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2021-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-acute-0

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

Resource Spotlight: Travel during the COVID-19 Pandemic

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

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

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

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

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

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

The Press Release provides details regarding:

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

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

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

MIS-C Cases as of September 3, 2020:

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

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

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

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

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from August 25th through the 31st.

Resource Spotlight: How to Select, Wear, and Clean Your Mask

Alabama Governor Kay Ivey has extended the state’s safer-at-home order through October 2, 2020. This order includes the following mask mandate:

• “Each person shall wear a mask or other facial covering that covers his or her nostrils and mouth at all times when within six feet of a person from another household in any of the following places: an indoor space open to the general public, a vehicle operated by a transportation service, or an outdoor public space where ten or more people are gathered.” Note, there are exceptions to the mandate, for example, the requirement does not apply when seated at a restaurant to eat or drink.
• You can read the entire Safer at Home order on the Alabama.Gov website at https://governor.alabama.gov/newsroom/covid-19/.

This week’s Resource Spotlight is on the CDC’s new COVID-19 webpage How to Select, Wear, and Clean Your Mask. Included on this page are seven ways to NOT wear a mask. If you are like me, you have been witness to each of the following ways NOT to wear a mask:

• Around your neck,
• On your forehead,
• Under your nose,
• Only on your nose,
• On your chin,
• Dangling from one ear,
• On your arm.

August 25, 2020: FDA’s Guide to Search Hand-Sanitizer Do-Not-Use List

The FDA has been urging consumers to not use certain hand sanitizer products since mid-June. Initially, the concern was methanol contamination in certain hand sanitizers. On August 12th they expanded their warning to include e 1-propanol contamination. In their guidance, the FDA indicates “1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use.”

Most recently, on August 25th, the FDA published the consumer update Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use? This update includes a “Step-by-step Search Guide” to assist consumers in accessing their Hand Sanitizer Do-Not-Use List which as of August 26th include 165 hand sanitizer products.

August 24, 2020: OCR Issues Amends June 2020 Plasma Donation Guidance

HHS announced the Office of Civil Rights (OCR) at HHS has issued amended guidance on how the HIPAA Privacy Rule permits covered health care providers and health plans to contact patients who have recovered from COVID-19 to inform them about donating their plasma containing antibodies (known as “convalescent plasma”) to help treat patients being actively treated for COVID-19.

“OCR added health plans to the June 2020 guidance that explains how HIPAA permits covered health care providers and health plans to identify and contact patients and beneficiaries who have recovered from COVID-19 for individual and population-based case management or care coordination. The guidance also emphasizes that, without individuals' authorization, the providers and health plans cannot receive any payment from, or on behalf of, a plasma donation center in exchange for such communications with recovered individuals.”

August 25, 2020: New Interim Final Rule: Impact on Nursing Homes Testing and Hospitals Reporting COVID-19 Data

CMS issued an Interim Final Rule on August 25th. In a related CMS Press Release, CMS Administrator Seema Verma noted that “These new rules represent a dramatic acceleration of our efforts to track and control the spread of COVID-19…Reporting of test results and other data are vitally important tools for controlling the spread of the virus and give providers on the front lines what they need to fight it.” Following are specific requirements specific to Nursing Homes and Hospitals.

Nursing Homes

• Revisions to infection-control regulations for long-term care facilities to no longer recommend but make it a requirement for participation in Medicare and Medicaid programs that nursing homes test their staff for COVID-19.
• Frequency of Nursing Home Staff testing will be based on community spread and CMS indicated guidance will be announced shortly.
• Nursing Homes will now be required to offer tests to residents when there is an outbreak or residents show symptoms.
• Surveyors will inspect nursing home for adherence to new testing requirements.
• Nursing Homes that do not comply will be cited for non-compliance, may face enforcement actions based on the severity of noncompliance, such as civil monetary penalties in excess of $400 per day.

Hospitals and Critical Access Hospitals

Will be required to report daily data, including, but not limited to:

• The number of confirmed or suspected COVID-19 positive patients,
• ICU beds occupied, and
• Availability of essential supplies and equipment such as ventilators and PPE.

Currently many hospitals are reporting this information voluntarily. The Interim Final Rule makes reporting data a condition of participation in Medicare and Medicaid programs. “Hospitals will face possible termination of Medicare and Medicaid payment if unable to correct reporting deficiencies.”

Note, the Interim Final Rule is applicable for the duration of the PHE for COVID-19 and addresses several other issues. For example, “this IFC also announces that with respect to the Hospital VBP Program, HRRP, HAC Reduction Program, SNF VBP Program and the ESRD QIP, if, as a result of a decision to grant a new nationwide ECE without request or a decision to grant a substantial number of individual ECEs, we do not have enough data to reliably compare national performance on measures, we may propose to not score facilities based on such limited data or make the associated payment adjustments for the affected program year.” I strongly encourage key stakeholders take the time to read this document.

August 25, 2020: American Hospitals Association Statement on the Interim Final Rule

Rick Pollack, President and CEO of the American Hospital Association (AHA), released a statement in response to the release of the CMS Interim Final Rule on behalf of the AHA. Mr. Pollack indicated the “new heavy-handed regulatory approach put forward by the Administration threatens to expel hospitals from the Medicare program.”

The statement goes on to note that the government has made at least six changes to how they want hospitals to report data since February and in spite of this “94 percent – are reporting information, according to the federal government.”

August 25, 2020: CMS Launches National Training Program to Strengthen Nursing Home Infection Control Practices

CMS announced efforts to train frontline nursing home staff and nursing home management in a Press Release. These efforts will focus on the following topics that are critical to stopping the spread of COVID-19:

• Infection control and prevention,
• Appropriate screening of visitors,
• Effective cohorting of residents,
• Safe admission and transfer of residents, and
• The proper use of personal protective equipment.

In addition to the scenario-based training called the “CMS Targeted COVID-19 Training for Frontline Nursing Home Staff and Management,” CMS and the CDC will also have subject matter experts available on biweekly webinars through January 7 from 4 to 5 pm ET, to answer questions.

August 26, 2020: Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on COVID-19 MLN Matters Article SE20011 Revised

MLN SE20011 was most revised again for the fourteenth time since its initial release in March of this year. This revision was made to add information about the HCPCS codes for OPPS, Rural Health Clinics (RHCs), FQHC, and Critical Access Hospital (CAH) billers in the Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services section.

August 26, 2020: Abbott’s 15-Minute, Easy to Use COVID-19 Test Received FDA Emergency Use Authorization (EUA)

Abbott announced the EUA authorization in a Press Release. The test approved is the BinaxNOW™ COVID-19 Ag Card rapid test which will sell for $5, “is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others.”

Along with the test, Abbott plans to launch a complimentary mobile app for iPhone and Android devices named NAVICA™. This app will:  

• Be available at no charge,
• Allow people testing negative to display the results, and
• Organizations will be able to verify the negative test result to facilitate entry into their facility.

In a related FDA News Release, the FDA likens the design of the testing card to the design of some pregnancy tests and goes on to note the “simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer.”

August 27, 2020: 150 Million Rapid COVID-19 Tests to be Deployed in 2020

One day after the FDA granted EUA for Abbott’s BinaxNow™ COVID-19 Ag Card, HHS posted a Press Release indicating that “the Administration awarded a contract for $760 million to Abbott for delivery of 150 million rapid, Abbott BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic tests to expand strategic, evidence-based testing in the United States.  Testing will be potentially deployed to schools and to assist with serving other special needs populations.”

August 27, 2020: FDA Warns Consumers about Hand Sanitizer Packaged in Food and Drink Containers

The FDA notes in a News Release , “in one recent example of consumer confusion, the FDA received a report that a consumer purchased a bottle they thought to be drinking water but was in fact hand sanitizer. The agency also received a report from a retailer about a hand sanitizer product marketed with cartoons for children that was in a pouch that resembles a snack. Drinking only a small amount of hand sanitizer is potentially lethal to a young child, who may be attracted by a pleasant smell or brightly colored bottle of hand sanitizer.”

August 27, 2020: CMS Offers Comprehensive Support for Louisiana and Texas with Hurricane Laura

The CMS announced efforts to support Louisiana and Texas in response to Hurricane Laura. CMS notes that they have “provided numerous waivers to health care providers during the current coronavirus disease 2019 (COVID-19) pandemic to meet the needs of beneficiaries and providers. The waivers already in place will be available to health care providers to use during the duration of the COVID-19 PHE determination timeframe and for the Hurricane Laura PHE.  CMS may waive certain additional Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements, create special enrollment opportunities for individuals to access healthcare quickly, and take steps to ensure dialysis patients obtain critical life-saving services.”

August 28, 2020: Remdesivir Emergency Use Authorization Broadened to include All Hospitalized COVID-19 Patients

The FDA announced they have “broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.” This announcement includes links to Fact Sheets for health care providers and patients regarding this use of remdesivir in treating COVID-19 patients.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from August 17th through the 24th.

Resource Spotlight: OSHA Guidance on Preparing Workplaces for COVID-19

The Occupational Safety and Health Administration has published Guidance on Preparing Workplaces for COVID-19. This guide provides information about how a COVID-19 outbreak could affect workplaces, classifying worker exposure to SARS-CoV-2 and what to do to protect workers at low, medium and high or very high risk of exposure.

You can find additional guides made available by OSHA on their COVID-19 webpage at  https://www.osha.gov/SLTC/covid-19/.

August 17, 2020: Resumption of Routine Inspections, Updated Enforcement Guidance to States, and Toolkit for Nursing Homes

CMS announced in a Press Release that routine inspections of all Medicare and Medicaid certified providers and suppliers is set to resume. Inspections had been suspended in response to the COVID-19 pandemic. CMS directed the resumption of the following as soon as resources are available: 

• Onsite revisit surveys,
• Non-immediate jeopardy complaint surveys, and
• Annual recertification surveys.

Additional actions included in the press release:

• Guidance provided on resolving enforcement cases previously on hold because of survey prioritization changes, and
• Temporary expansion of the desk review policy,
• Guidance on the re-prioritization of routine state survey agency activities on Clinical Laboratory Improvement Amendments (CLIA),
• Updates to the “Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes.”

August 19, 2020: HHS Expands Access to Childhood Vaccines during COVID-19 Pandemic

In an August 19th Press Release, HHS announced that a third amendment to the Declaration under the Public readiness and Emergency Preparedness Act (PREP Act) has been issued to increase access to childhood vaccines by authorizing State-licensed pharmacists (and pharmacy interns acting under their supervision to administer vaccines to individuals ages three through eighteen years. There are several requirements the pharmacist must meet. For example, “the licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.”

HHS Secretary Alex Azar states in the announcement that “today’s action means easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic.”

August 19, 2020: FDA COVID-19 Daily Roundup: UV Lights and Lamps FAQs

In their August 19th COVID-19 Daily Roundup, the FDA announced the posting of FAQs for consumers about UV lights and lamps. The FAQs answer questions about the use of lamps for disinfection during the COVID-19 pandemic.

August 20, 2020: Kaiser Health News Article: Scam Alert: Things a COVID Contract Tracer Wouldn’t Say

This Kaiser Health News (KHN) article by Julie Appleby opens with letting readers know that, “State officials and federal agencies warn there’s a new phone scam circulating: Some callers posing as COVID-19 contact tracers try to pry credit card or bank account information from unsuspecting victims. This article provides examples of what scammers are trying and links to consumer alerts from several sources include the Federal Trade Commission and the Better Business Bureau among others.

August 21, 2020: Update to the ICD-10 Diagnosis Codes for Vaping Related Disorder and Diagnosis and Procedure Codes for the 2019 Novel Coronavirus (COVID-19) - MLN Article Revised

CMS first released MLN Matters article MM11623 on January 24, 2020. CMS revised this article on August 21, 2020. Now in its further iteration, the article has been revised to reflect an updated Change Request (CR) 11623 which updated the title, Background section and includes new procedure codes in Version 37.2 of the ICD-10 Medicare Severity - Diagnosis Related Groups (MS-DRG) Grouper and ICD-10 Medicare Code Editor (MCE). The CR release date, transmittal number and link to the transmittal also changed.

August 23, 2020: FDA Issues Emergency Use Authorization (EUA) for Investigational Convalescent Plasma to Treat COVID-19

The FDA indicated in a news release that “today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.” The EUA requires that fact sheets providing information regarding the use of convalescent plasma in COVID-19 treatment be available to health care providers and patients. 

August 24, 2020: HHS Press Release – Health Plans added to June 2020 Plasma Donation Guidance

HHS announced in a Press Release that the Office of Civil Rights (OCR) has “issued amended guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered health care providers (e.g., hospitals, pharmacies, laboratories) and health plans to contact their patients and beneficiaries who have recovered from COVID-19 to inform them about how they can donate their plasma containing antibodies (known as "convalescent plasma") to help treat others with COVID-19.” This announcement includes a link to the amended guidance.

August 24, 2020: Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment – MLN Article Revised

CMS first released MLN Matters article MM11937 on August 7, 2020. This article was revised on August 24, 2020 to reflect an updated CR 11937 that includes additional COVID-19 codes 86408, 86409, 0225U and 0226U, effective August 10, 2020. CR 11937 also added codes 0015M and 0016M, effective October 1, 2020. The CR release date, transmittal number and link to the transmittal also changed.

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1736-P) was released on August 4, 2020 and published in the Federal Register on August 12th. In last week’s article we reviewed proposals related to the Inpatient Only Procedure List and proposed new service categories subject to the Hospital Outpatient Department Prior Authorization Program.

This week we move on to proposed changes for supervision of outpatient therapeutic services and the changes to the Ambulatory Surgical Center Covered Procedures List.

Proposed Changes in the Level of Supervision of Outpatient Therapeutic Services in Hospitals and Critical Access Hospitals (CAHs)

In the 2020 OPPS Final Rule, CMS finalized their proposed policy to change the “generally applicable minimum required level of supervision for hospital outpatient therapeutic services from direct supervision to general supervision for services furnished by all hospitals and CAHs.” General supervision means that the procedure is furnished under the physician’s overall direction and control, but that the physician’s presence is not required during the performance of the procedure.

This policy became effective January 1, 2020 and will remain in place for future years unless modified by later notice and comment rulemaking.

In the 2021 OPPS Proposed Rule CMS notes that on March 31, 2020 CMS issued interim final rule with comment period (IFC) to give providers “needed flexibilities to respond effectively to the serious public health threats posed by the spread of the COVID-19.”

Specific to the level of supervision the following policies were adopted in the IFC to be effective for the duration of the Public Health Emergency (PHE) due to COVID-19:

• A policy to reduce the minimum default level of supervision for non-surgical extended duration therapeutic services (NSEDTS) to general supervision for the entire service, including the initiation portion of the service, for which CMS previously required direct supervision on initiation of the service.
• A policy indicating that the requirement for direct supervision of pulmonary, cardiac and intensive cardiac rehabilitation services includes virtual presence of the physician through audio/video real-time communications technology when use of such technology is indicated to reduce exposure risks for the beneficiary or health care provider.

CMS has decided that these policies are appropriate outside of the PHE and are proposing to adopt them for CY 2021 and beyond.

CMS reminds providers that “it is important to remember that the requirement for general supervision for an entire NSEDTS does not preclude these hospitals from providing direct supervision for any part of a NSEDTS when the practitioners administering the medical procedures decide that it is appropriate to do so. Many outpatient therapeutic services including NSEDTS may involve a level of complexity and risk such that direct supervision would be warranted even though only general supervision is required.”

Proposed Additions to the Ambulatory Surgical Center (ASC) Covered Procedures

In general procedures on the ASC covered procedure list (ASC-CPL) are those procedures that are not “expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure.”

CMS has proposed to continue to apply the revised definition of “surgery” adopted in the CY 2019 OPPS/ASC Final Rule that includes procedures that are “surgery-like” procedures that are assigned outside the CPT surgical range, for CY 2021 and subsequent years.

CMS Outlook for the Future of the ASC-CPL

CMS has posed many thoughts/beliefs about the future of ASCs in the proposed rule. Following are some of the statements found in the proposed rule:

• CMS believes “that significant advancements in medical practice, surgical techniques, medical technology, and other factors have allowed certain ASCs to safely perform procedures that were once too complex, including those involving major blood vessels and other general exclusion criteria.
• CMS acknowledges “that ASCs and hospitals have different health and safety requirements. Despite this fact, ASCs often undergo accreditation as a condition of state licensure and share some similar licensure and compliance requirements with hospitals as well as meet Medicare conditions for coverage (see 42 CFR 416.40 through 416.54).”
• CMS reminds the reader that “in recent years, we have added procedures to the ASC-CPL that were largely considered hospital inpatient procedures in the past, such as TKA and certain coronary intervention procedures.”
• “Many procedures that are currently only payable as hospital outpatient services under Medicare fee-for-service are safely performed in the ASC setting for other payors.”
• CMS recognizes “that non-Medicare patients tend to be younger and have fewer comorbidities than the Medicare population.” However, “careful patient selection can identify Medicare beneficiaries who are suitable candidates for these services in the ASC setting.”
• “Medicare Advantage plans are not obligated to adopt the ASC-CPL as it exists in Medicare fee-for-service and…many MA enrollees have had services performed in the ASC setting that are not currently payable under Medicare fee-for-service.”
• “The COVID-19 pandemic has highlighted the need for more healthcare access points throughout the country…Looking ahead to after the pandemic, it will be more important than ever to ensure that the health care system has as many access points and patient choices for all Medicare beneficiaries as possible. Because the pandemic has forced many ASCs to close, thereby decreasing Medicare beneficiary access to care in that setting, we believe allowing greater flexibility for physicians and patients to choose ASCs as the site of care, particularly during the pandemic, would help to alleviate both access to care concerns for elective procedures as well as access to emergency care concerns for hospital outpatient departments.”
• “In this CY 2021 OPPS/ASC proposed rule, we are seeking to continue to promote site neutrality, where possible, between the hospital outpatient department and ASC settings, and expanding the ASCCPL to include as many procedures that can be performed in the HOPD as reasonably possible will advance that goal.”

Table 40. - Proposed Additions to the List of ASC Covered Procedures for CY 2021

Inpatient, outpatient or ASC, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed. CMS is accepting comments on the proposed rule up until 5 p.m. EST on October 5, 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 August 11th through August 17th.

Resource Spotlight: KFF’s Kaiser Health News (KHN) and Guardian U.S. New Interactive Database

In an August 11, 2020 KFF News Release, KHN announced a new interactive database from KHN and Guardian US. This “interactive tool — the nation’s most comprehensive independent database of health care workers who have lost their lives — can be searched by factors such as race and ethnicity, age, occupation, location and whether the workers had adequate access to protective gear. The database is freely available to help local news organizations profile workers in their communities who have lost their lives fighting the pandemic. The profiles include 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.”

August 10, 2020: CDC Data - Total Cases, Total Deaths and Wearing Masks

On the CDC’s webpage Cases in the U.S. you will find the total number of cases and deaths in the U.S. due to COVID-19. This information is updated daily based on data confirmed at 4:00pm ET the day before. The August 10th updated data indicates that the U.S. has had 5,023,649 total cases (48,690 new cases compared to August 9th) and 161,842 total deaths (558 new deaths compared to August 9th.)

The CDC also has a COVID-19 webpage dedicated to information About Masks. I share this with you because the Physician’s Office in the building where I work has posted signs telling patients that masks with valves or vents are not allowed in the building. The CDC has posted the following information on their About Masks webpage providing an answer to why they are not allowed: 

“The purpose of masks is to keep respiratory droplets from reaching others to aid with source control. Masks with one-way valves or vents allow exhaled air to be expelled out through holes in the material.  This can allow exhaled respiratory droplets to reach others and potentially spread the COVID-19 virus. Therefore, CDC does not recommend using masks if they have an exhalation valve or vent.”

August 10, 2020: COVID-19 Laboratory Reporting Requirements

The CDC posted the following Clinician Outreach and Community Activity (COCA) Now Alert about COVID-19 laboratory reporting requirements:

“The public health response to COVID-19 depends on comprehensive laboratory testing data. The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the HHS Laboratory Data Reporting Guidance released on June 4, 2020 require every COVID-19 testing site to report specific data elements for every diagnostic and screening test performed to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody). The data are to be reported to the appropriate state or local public health department, based on the individual’s residence.

Healthcare providers also have a critical role in collecting several of the data elements when ordering a COVID-19 laboratory test, particularly demographic information such as the patient’s age, sex, race, and ethnicity. Beginning August 1, 2020, testing sites should make every reasonable effort to report these demographic data to state and local health departments using existing public health reporting channels (in accordance with state law or policies).

Complete demographic data will:  

• Ensure that all groups have equitable access to testing, 
• Allow an accurate determination of the burden of infection on vulnerable groups, and  
• Help improve decision-making to better prevent or mitigate further COVID-19 illness among Americans.

Below are some additional resources for more information about this COVID-19 laboratory reporting requirement:

• CDC’s How to Report COVID-19 Laboratory Data website
• HHS’s CARES Act Section 18115 Laboratory Data Reporting Guidance
• HHS Press Release: HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing
• HHS’s Frequently Asked Questions: Laboratory Data Reporting for COVID-19 Testing”

August 10, 2020: New CPT Codes to Streamline COVID-19 Testing Currently Available in the United States

An August 10, 2020 AMA announcement includes a summary of SARS-Co-V-2 related CPT codes that have been approved and published for the 2021 CPT code set. The most recent new codes are effective August 10, 2020 and includes:

• 86408 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (COVID-19) screen,
• 86409 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (COVID-19) neutralizing antibody titer.
• New Proprietary Laboratory Analysis (PLA) code 0225U: Infectious disease (bacterial or viral respiratory tract infection) pathogen-specific DNA and RNA, 21 targets, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), amplified probe technique, including multiplex reverse transcription for RNA targets, each analytic reported as detected or not detected
• New PLA code 0226U Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), ELISA, plasma, serum

The AMA included the following statement in the announcement of these codes:

“Please note that, per the standard early release delivery process for CPT codes, you will need to manually upload these code descriptors into your EHR system. These CPT codes will arrive as part of the complete CPT code set in the data file for 2021 later this year.” You can find links to downloads for all of the new codes related to COVID-19 in this announcement.

August 12, 2020: FDA says Help Stop the Spread of Coronavirus and Protect Your Family

The FDA posted an infographic and details about the simple steps that can and should be taken to slow the spread of COVID-19 and protect everyone. I believe the key takeaway from this guidance is the very first sentence:

“The COVID-19 pandemic requires that we remain vigilant in our everyday lives.”

As you have probably heard many times by now but continue to see examples of noncompliance on a daily basis, the simple steps to stop the spread includes washing your hands, covered you mouth and nose with a cloth face covering or non-surgical mask when around others, and avoid crowds and practice social distancing (stay at least 6 feet apart from others).

August 14, 2020: CDC Morbidity and Mortality Weekly Report: COVID-19-Associated Multisystem inflammatory Syndrome in Children MIS-C) – United States, March – July 2020

This August 14, 2020 Weekly Morbidity and Mortality Report was written by Godfred-Cato S, Bryant B, Leung J, et al, and indicates that as of July 29, 2020:

• A total of 570 MIS-C patients with onset dates from March 2 to July 18, 2020, had been reported from 40 state health departments, the District of Columbia, and New York City.
• The median patient age was 8 years (range = 2 weeks–20 years); 55.4% were male,
• 5% were Hispanic or Latino (Hispanic), 33.1% were non-Hispanic black (black), and 13.2% non-Hispanic white (white).
• Obesity was the most commonly reported underlying medical condition, occurring in 30.5% of Hispanic, 27.5% of black, and 6.6% of white MIS-C patients.

August 17, 2020: MLN Article Update - New COVID-19 Policies for IPPS Hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) due to Provisions of the CARES Act

MLN article SE20015, initially released on April 15, 2020, has been updated on August 17th to add an update regarding the implementation of Section 3710 of the CARES Act for IPPS hospitals to address potential Medicare program integrity risks. Specifically, “effective with admissions occurring on or after September 1, 2020, claims eligible for the 20 percent increase in the MS-DRG weighting factor will also be required to have a positive COVID-19 laboratory test documented in the patient’s medical record. Positive tests must be demonstrated using only the results of viral testing (i.e., molecular or antigen), consistent with CDC guidelines. The test may be performed either during the hospital admission or prior to the hospital admission… The Pricer will continue to apply an adjustment factor to increase the MS-DRG relative weight that would otherwise be applied by 20 percent when determining IPPS operating payments for discharges that report the ICD‑10‑CM diagnosis code U07.1 (COVID-19). CMS may conduct post-payment medical review to confirm the presence of a positive COVID-19 laboratory test and, if no such test is contained in the medical record, the additional payment resulting from the 20 percent increase in the MS-DRG relative weight will be recouped.”

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1736-P) was released on August 4, 2020.

CMS estimates “that total OPPS payments for CY 2021, including beneficiary cost-sharing, to the approximately 3,628 facilities paid under the OPPS (including general acute care hospitals, children’s hospitals, cancer hospitals, and CMHCs) would increase by approximately 1.6 billion compared to CY 2020 payments, excluding our estimated changes in enrollment, utilization, and case-mix.”

Inpatient Only Procedure List

In years past, this is where I would remind you that CMS has specific criteria for determining whether or not a procedure should be removed from the Inpatient Only (IPO) List and assigned to an Ambulatory Payment Category (APC) group. However, not this year because this year CMS is proposing to:  

• Eliminate the IPO list over a three-year transitional period with the list completely phased out by CY 2024, and
• Begin with the removal of nearly 300 musculoskeletal-related services,

CMS is requesting comments on “whether three years is an appropriate time frame for transitioning to eliminate the IPO list; other services that are candidates for removal from the IPO list for CY 2021; and the sequence in which to remove additional clinical families and/or specific services from the IPO list in future rulemaking.”

Short Inpatient Hospital Stays

The Two-Midnight Rule, as finalized in the FY 2014 IPPS Final Rule, clarified when an inpatient admission is considered reasonable and necessary for purposes of Medicare Part A payment. This policy established a benchmark for when a patient is considered appropriate for inpatient hospital admission and payment.

CMS also clarified that “when a beneficiary enters a hospital for a surgical procedure not designated as an inpatient-only (IPO) procedure as described in 42 CFR 419.22(n), a diagnostic test, or any other treatment, and the physician expects to keep the beneficiary in the hospital for only a limited period of time that does not cross 2 midnights, the services would be generally inappropriate under Medicare Part A.”

In the CY 2016 OPPS/ASC Final Rule CMS “finalized a proposal to allow for case-by case exceptions to the 2-midnight benchmark, whereby Medicare Part A payment may be made for inpatient admissions where the admitting physician does not expect the patient to require hospital care spanning 2 midnights, if the documentation in the medical record supports the physician’s determination that the patient nonetheless requires inpatient hospital care.” The following criteria are relevant to making this determination:

• Complex medical factors such as history and comorbidities;
• The severity of signs and symptoms;
• Current medical needs; and
• The risk of an adverse event.

Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2021 and Subsequent Years (2-Midnight Rule)

Once a surgical procedure has been removed from the IPO List, documentation in the record must support the need for the inpatient admission. CMS once again reminds providers in this proposed rule that “removal of a service from the IPO list has never meant that a beneficiary cannot receive the service as a hospital inpatient – as always, the physician should use his or her complex medical judgment to determine the generally appropriate setting.”

In the CY 2020 OPPS Final Rule, CMS finalized a two-year exemption from site-of-service claim denials, Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO) referrals to RACs, and RAC reviews for “patient status” (that is, site-of-service) for procedures that are removed from the IPO list under the OPPS beginning on January 1, 2020.

For CY 2021, CMS is proposing to continue the two-year exemption for procedures removed from the IPO list beginning on January 1, 2021. They are also requesting comments on whether this continues to be the appropriate time frame, or if a longer or shorter period may be warranted.

As a provider, it is important to be mindful that this exemption is specific to site-of-service claim denials. This exemption does not include medical necessity based on a National or Local Coverage Determinations (NCDs and LCDs) meaning irrespective of site-of-service, a short stay claim can still be denied for lack of documentation supporting medical necessity of the procedure.

Hospital Outpatient Department Prior Authorization Program: Proposed New Service Categories

With the CY 2020 OPPS/ASC Final Rule (CMS-17-17-FC), CMS established the nationwide prior authorization process and requirements for certain hospital outpatient department (OPD) services.  Effective July 1, 2020 the following services now require prior authorization:

• Blepharoplasty,
• Botulinum toxin injections,
• Panniculectomy,
• Rhinoplasty, and
• Vein Ablation.

As part of their responsibility to protect the Medicare Trust Funds, CMS routinely monitors the utilization of services. Through claims analysis, CMS notes in the proposed rule that they have identified an increase in volume of cervical fusion with disc removal procedures and implanted spinal neurostimulator procedures that was significantly higher than overall trends for all OPD services.

CMS notes they “researched possible causes for the increase in volume that would indicate the services are increasingly necessary.” However, CMS notes that “after reviewing all available data, we found no evidence suggesting other plausible reasons for the increases, which we believe means financial motivation is the most likely cause. We believe utilizing codes because of financial motivations, as opposed to medical necessity reasons, has resulted in an unnecessary increase in volume.”

CMS continues to believe prior authorization “is an effective mechanism to ensure Medicare beneficiaries receive medically necessary care while protecting the Medicare Trust Funds from unnecessary increased in volume by virtue of improper payments, without adding onerous new documentation requirements.”

Therefore, CMS is proposing to add cervical fusion with disc removal and implanted spinal neurostimulators to this program effective for services provided on or after July 1, 2021. Following are the specific procedure codes being proposed for inclusion in this program:

Cervical Fusion with Disc Removal

• 22551: Fusion of spine bones with removal of disc at upper spinal column, anterior approach, complex, initial, and
• 22552: Fusion of spine bones with removal of disc in upper spinal column below second vertebra of neck, anterior approach, each additional interspace

Implanted Spinal Neurostimulators

• 63650: Implantation of spinal neurostimulator electrodes, accessed through the skin,
• 63685: Insertion or replacement of spinal neurostimulator pulse generator or receiver, and
• 63688: Revision or removal of implanted spinal neurostimulator pulse generator or receiver

Be on the lookout for additional highlights from the proposed rule in next week’s newsletter. In the meantime, I encourage key stakeholders at your facility to take the time to review the proposed rule. For those wishing to submit comments, CMS is accepting them up until 5 p.m. EST on October 5, 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 August 4th through August 10th.

Resource Spotlight: COVID-19 “Long Hauler” Symptoms Survey Report

It seems that surviving COVID-19 is not the end of the story and that symptoms can linger long after recovery from the acute illness. Dr. Natalie Lambert & Survivor Corps have released a report titled COVID-19 "Long Hauler" Symptoms Survey Report. In this report Survivor Corps is described as “a grassroots movement connecting, educating and mobilizing COVID-19 survivors with the medical, scientific and academic research community to help stem the tide of this pandemic and assist in the national recovery.” You will find in this report which of the 50 most common symptoms reported by Long Hauler in the survey with the 12 symptoms recognized by the CDC. 

August 3, 2020: OIG Releases Two Toolkits for Health Care Providers and Community Responders

The OIG released two emergency response toolkits designed to help health care providers and community responders in their response to the COVID-19 pandemic and other emergencies as they arise.

Toolkit: Insights for Communities from OIG’s Historical Work on Emergency Response

This toolkit includes past OIG reports published from 2004 to 2020 about community emergency preparedness and response that are separated out into the following topics:

• Funding,
• Training,
• Laboratory Testing,
• Vaccination Programs, and
• Emergency Planning.

Link to toolkit: https://go.usa.gov/xfV3p

Toolkit: Insights for Health Care Facilities from OIG's Historical Work on Emergency Response

This toolkit includes past OIG reports published from 2002 to 2020 about health care facility emergency preparedness and response that are separated out into the following topics:

• Facility Operations,
• Facility Staffing,
• Facility Coordination with Community, and
• Facility Emergency Planning.

Link to toolkit: https://go.usa.gov/xfV3G

August 4, 2020: OIG Updates FAQs – Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to COVID-19 Public Health Emergency

MMP’s August 5, 2020 COVID-19 in the News article included information about the most recent FAQ answered by the OIG. On August 4th, the OIG has provided an answer to the question of whether or not clinical laboratories can offer free COVID-19 antibody testing to Federal health care program beneficiaries who are contemporaneously receiving other medically necessary blood tests during the COVID-19 public health emergency.

You can read the answer to this and all other questions posted on the OIG website at https://oig.hhs.gov/coronavirus/authorities-faq.asp.

August 6, 2020: Telemedicine, Clinical Experiences, Resources for Hospitals and Urgent Care Centers

CMS include the following information in their Thursday August 6th edition of MLNConnects:

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

• Use of Telemedicine in Alternate Care Sites Webinar Recording: Hear from speakers in operations and management
• COVID-19 and Clinical Experiences from the Field: Reports and findings from journal and news articles, clinical rounds presentations, and webinars
• COVID-19 Hospital Resource Compilation: Guidance on hospital surge, crisis standards of care, workforce protection, and resumption of services
• COVID-19 and Urgent Care Centers: Lessons Learned for the Future: Urgent Care Association shares their experiences and plans to work with local medical communities

For More Information:

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

August 7, 2020: HHS Announced Allocation of CARES Act Provider Relief Fund for Nursing Homes

The Department of Health and Human Services (HHS) announced in a press release that the Provider Relief Fund (PRF) “distribution will total approximately $5 billion, and will be used to protect residents of nursing homes and long-term care facilities from the impact of COVID-19.” They go on to note that approximately $2.5 billion will be used for upfront funding to support increased testing, staffing, and PPE needs.

August 7, 2020: HHS Fact Sheet: Explaining Operation Warp Speed

On August 7th, HHS released the Fact Sheet: Explaining Operation Warp Speed (OWS). In answer to the question of the goal of this operation, HHS indicates that OWS “aims to deliver 300 million doses of a safe, effective vaccine for COVID-129 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as counter measures).” This Fact Sheet also provided answers to the following questions about OWS:

• How will the goal be accomplished?
• What’s the plan and what’s happened so far?
• Who’s leading Operation Warp Speed?
• What is being done to make these products affordable for Americans?
• How is Operation Warp Speed being funded?

August 10, 2020: CDC Data - Total Cases, Total Deaths and Wearing Masks

On the CDC’s webpage Cases in the U.S. you will find the total number of cases and deaths in the U.S. due to COVID-19. This information is updated daily based on data confirmed at 4:00pm ET the day before. The August 10th updated data indicates that the U.S. has had 5,023,649 total cases (48,690 new cases compared to August 9th) and 161,842 total deaths (558 new deaths compared to August 9th.)

The CDC also has a COVID-19 webpage dedicated to information About Masks. I share this with you because the Physician’s Office in the building where I work has posted signs telling patients that masks with valves or vents are not allowed in the building. The CDC has posted the following information on their About Masks webpage providing an answer to why they are not allowed: 

“The purpose of masks is to keep respiratory droplets from reaching others to aid with source control. Masks with one-way valves or vents allow exhaled air to be expelled out through holes in the material.  This can allow exhaled respiratory droplets to reach others and potentially spread the COVID-19 virus. Therefore, CDC does not recommend using masks if they have an exhalation valve or vent.”

August 10, 2020: COVID-19 Laboratory Reporting Requirements

The CDC posted the following Clinician Outreach and Community Activity (COCA) Now Alert about COVID-19 laboratory reporting requirements:

“The public health response to COVID-19 depends on comprehensive laboratory testing data. The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the HHS Laboratory Data Reporting Guidance released on June 4, 2020 require every COVID-19 testing site to report specific data elements for every diagnostic and screening test performed to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody). The data are to be reported to the appropriate state or local public health department, based on the individual’s residence.

Healthcare providers also have a critical role in collecting several of the data elements when ordering a COVID-19 laboratory test, particularly demographic information such as the patient’s age, sex, race, and ethnicity. Beginning August 1, 2020, testing sites should make every reasonable effort to report these demographic data to state and local health departments using existing public health reporting channels (in accordance with state law or policies).

Complete demographic data will:  

• Ensure that all groups have equitable access to testing, 
• Allow an accurate determination of the burden of infection on vulnerable groups, and  
• Help improve decision-making to better prevent or mitigate further COVID-19 illness among Americans.

Below are some additional resources for more information about this COVID-19 laboratory reporting requirement:

• CDC’s How to Report COVID-19 Laboratory Data website
• HHS’s CARES Act Section 18115 Laboratory Data Reporting Guidance
• HHS Press Release: HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing
• HHS’s Frequently Asked Questions: Laboratory Data Reporting for COVID-19 Testing”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 27th through August 3rd.

Resource Spotlight: CDC Toolkit for Young Adults: 15 to 21

As parents across the country are facing the dilemma of whether or not to send their child back to school or attend school “remotely,” the CDC has developed a series of Factsheets for Young Adults covering a variety of topics related to COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/communication/toolkits/young-people-15-to-21.html

July 28, 2020: CMS Updates COVID-19 Data

In a CMS Press Release, they announced the first monthly update of data providing a snapshot of the impact of COVID-19 on the Medicare population.

About the Data

• For the first time the data included information for American Indian/Alaskan Native Medicare beneficiaries,
• The data confirms “that the COVID-19 public health emergency is disproportionately affecting vulnerable populations, particularly racial and ethnic minorities,”
• The data is based on COVID-19 cases and hospitalizations from January 1, 2020 to June 20, 2020,
• The data is based on Medicare claims and encounter data CMS received by July 17, 2020,
• Key data points about the data are that black beneficiaries, beneficiaries eligible for both Medicare and Medicaid and beneficiaries with end-stage renal disease (ESRD) are being hospitalized at a higher rate, and
• “CMS paid $2.8 billion in Medicare fee-for-service claims for COVID-related hospitalizations, on an average of $25,555 per beneficiary.”

July 28, 2020: CDC Clinician Outreach and Communication Activity (COCA) Call: COVID-19 and Diabetes

For those that were unable to attend the July 28th session, the CDC hosted a call focused on current information about the impact and increased risk for COVID-19 complications in people with diabetes and the importance of diabetes prevention, management, and support. The CDC has made available a video recording, slides and transcript of this call.  

July 28, 2020: Dramatic Trends in Medicare Beneficiary Telehealth Utilization and COVID-19

The U.S Department of Health and Human Services (HHS) issued a Press Release announcing the release of a “new report showing the dramatic utilization trends of telehealth services for primary care delivery in Fee-for-Service (FFS) Medicare in the early days of the coronavirus disease 2019 (COVID-19) pandemic…Even after Medicare in-person primary care visits resumed in May, there continues to be steady demand for telehealth visits which are now more broadly available to Medicare beneficiaries and providers during the PHE. This suggests there will be continued interest in telehealth post-pandemic for millions of Medicare beneficiaries.”

July 29, 2020: Palmetto GBA FAQs: COVID-19 Accelerated/Advance Payment (AAP) Repayment FAQ

Palmetto GBA, the JJ and JM MAC has posted an FAQ document “to help providers understand the process and options of repaying accelerated/advance payments (AAPs) issued for COVID-19.”

July 29, 2020: OIG Updates FAQs – Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to COVID-19 Public Health Emergency

The OIG is accepting questions “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).”

The most recent addition to this document was on July 29th when the OIG answers the question of whether or not “an oncology practice can offer free or discounted lodging to its financially needy patients who are Federal health care program beneficiaries if, prior to the COVID-19 public health emergency, such patients would have had access to free or discounted housing at a nonprofit lodging facility while receiving chemotherapy or radiation treatment?”

You can read the answer to this and all other questions posted on the OIG website at https://oig.hhs.gov/coronavirus/authorities-faq.asp.

July 29, 2020: FDA Posts FAQs about Antibody (Serology) Testing During COVID-19 PHE

The FDA announced the release of FAQs for patients and consumers about antibody (serology) testing during the COVID-19 pandemic in their July 30th Edition of the COVID-19 Update: Daily Roundup. Topics reviewed in the FAQs includes:

• Antibodies and antibody testing: the basics,
• Understanding antibody test results,
• Practical information on antibody tests: who needs them where to get them; and
• Additional Resources where you are provided to the CDC webpage Using Antibody Tests for COVID-19.

July 30, 2020: CMS MLNConnects Newsletter: COVID-19 Lab Claims Requiring the NPI of the Ordering/Referring Professional – Update

The following information was included in the July 30, 2020 edition of CMS MLNConnects eNewsletter: “During the COVID-19 Public Health Emergency (PHE), CMS relaxed requirements for a limited number of laboratory tests required for a COVID-19 diagnosis. These tests do not require a practitioner order during the PHE. We added a new test to this list (PDF): CPT 87426 (Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [COVID-19]).

Any health care professional authorized under state law may order these tests. Medicare will pay for these tests without a written order from the treating physician or other practitioner:

• If an order is not written, you do not need to provide the National Provider Identifier (NPI) of the ordering or referring professional 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 with modified requirements (PDF)
• Interim final rule”

July 30, 2020: National Public Health Experts to America: Donate Plasma

The HHS Press Office announced the release of a series of public service announcements (PSAs) to Americans seeking to “dramatically increase donations of convalescent plasma by the end of August in the whole-of-America fight against the coronavirus disease 2019 (COVID-19) pandemic.” Messaging in the PSAs to Americans includes the following three points:

• If you have recovered from COVID-19 after a confirmed test for the virus and have had no symptoms for at least two weeks, find a location and donate plasma;
• There are thousands of locations around the country where you can donate, and
• Donation locations can be found by visiting gov.

July 30, 2020: CMS and CDC Announces Provider Reimbursement for Counseling Patients to Self-Isolate at Time of COVID-19 Testing

In a July 30th Special Edition MLNConnects eNewsletter, CMS and the CDC announced “that payment is available to physician and health care providers to counsel patients, at the time of Coronavirus Disease 2019 (COVID-19) testing, about the importance of self-isolation after they are tested and prior to the onset of symptoms.”

Provider counseling will include the discussion of the following:

• Immediate need for isolation, even before test results are available,
• The importance to inform their immediate household that they too should be tested for COVID-19,
• Review the signs and symptoms and services available to them to aid in isolating at home, and
• If a patient tests positive for COVID-19, they will be counseled to wear a face mask at all times, that they will be contacted by public health authorities to provider information for contact tracing, and to tell immediate household and recent contacts in case it is appropriate for them to also be tested for COVID-19 and self-isolate.

MLN SE20011 was revised on July 30th to add information about Counseling and COVID-19 Testing and how to bill for the counseling services.

July 31, 2020: CDC and CMS COVID-19 Counseling Reimbursement Resources

The CDC’s Clinician Outreach and Community Activity (COCA) issued a COCA Now email about COVID-19 Counseling Reimbursement noting that “counseling can help slow the spread of the virus and keep families and communities safe.” In the announcement the CDC provides links for Healthcare Providers and Public Health Professionals to CDC and CMS developed resources. 

Resources for Healthcare Providers

• 3 Key Steps to Take While Waiting for Your COVID-19 Test Result
• Infographic describing what to expect during contact tracing
• Health care provider Q&A about reimbursement for counseling
• Provider-patient counseling talking points
• Provider counseling checklist  

Resources for Public Health Professionals
Patient Resources:

• 3 Key Steps to Take While Waiting for Your COVID-19 Test Result
• Infographic describing what to expect during contact tracing

Provider Resources:

• Health care provider Q&A about reimbursement opportunity
• Provider-patient counseling talking points
• Provider counseling checklist
• CMS Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19)

You can sign up for future COCA Now Messages on the CDC website at undefined.

August 3, 2020: Proposed Expansion of Telehealth Benefits Permanently Beyond the COVID-19 Public Health Emergency (PHE)

CMS announced in a Press Release proposed changes to expand telehealth permanently simultaneous to an Executive Order on Improving Rural Telehealth Access signed by President Trump.  “Before the public health emergency (PHE), only 14,000 beneficiaries received a Medicare telehealth service in a week while over 10.1 million beneficiaries have received a Medicare telehealth service during the public health emergency from mid-March through early-July.”

CMS is proposing to permanently allow some of the 135 services added, during the PHE, to the list of services that can be paid when delivered by telehealth, “including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home), and certain types of visits for patients with cognitive impairments. CMS is seeking public input on other services to permanently add to the telehealth list beyond the PHE in order to give clinicians and patients time as they get ready to provide in-person care again.” CMS is also proposing to extend payment for other telehealth services, such as emergency department visits, through the calendar year in which the PHE ends.

The entire list of services being proposed are included in the calendar year (CY) 2021 Physician Fee Schedule Proposed Rule also issued on August 3rd, 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 July 21st through July 27th.    

Resource Spotlight: CDC Natural Disasters, Severe Weather, and COVID-19

Earlier this month the CDC launched the new webpage Natural Disasters, Severe Weather, and COVID-19.  They note that “planning and preparing for hurricanes and other natural disasters can be stressful, even more so during the COVID-19 pandemic. Know how the COVID-19 pandemic can affect disaster preparedness and recovery, and what you can do to keep yourself and others safe.”

You can find guidance on the following topics is available on this webpage:

• Preparing for Hurricanes & COVID-19; Follow tips to help you and your family stay safe during hurricane season this year,
• Public Disaster Shelters & COVID-19: Follow tips to help you prepare and lower your risk of getting sick with COVID-19 while staying in a shelter, and
• Professionals & Emergency Workers: Know how to keep your community safe during and after a natural disaster amid the COVID-19 pandemic.

July 15, 2020: Resuming Elective Orthopedic Surgery During the COVID-19 Pandemic

This article can be found in the July 15, 2020 Issue of The Journal of Bone and Joint Surgery. The guidelines for resuming elective surgery was developed by the International Consensus Group (ICM). Specifically, seventy-seven expert physicians in orthopaedic surgery, infectious disease, microbiology and virology, and anesthesia were involved in this effort. The stated purpose for providing this list of recommendations is to reduce the COVID-19 “pathogen transfer during the reintroduction of elective orthopaedic surgical procedures.” At the outset of this article the authors acknowledge the guidelines are based on current available scientific evidence and may require being altered as new evidence emerges.

July 20, 2020: HHS Protect - Frequently Asked Questions

For a while now, to facilitate the public health response to COVID-19, hospitals have been reporting daily data reports on testing, capacity and utilization, and patient flows. Initially hospitals were advised to send this information to the CDC National Healthcare Safety Network (NHSN). 

Effective July 15, 2020 reporting to the NHSN was no longer an option. Instead, hospitals were to begin submitting data directly to the Federal Government through one of the methods outlined in the COVID-19 Guidance for Hospital Reporting document that was updated on July 10, 2020.

In a July 20, 2020 Press Release, HHS provides Frequently Asked Questions about HHS Protect, “a secure data ecosystem powered by eight commercial technologies for sharing, parsing, housing, and accessing COVID-19 data and driven by four principles: transparency, sharing, privacy, and security.”

July 22, 2020: New Resources to Protect Nursing Home Residents Against COVID-19

Several new initiatives designed to protect nursing home residents was announced in a July 22nd CMS Press Release. CMS Administrator Seema Verma indicates “as caseloads continue to increase in areas around the country, it has never been more important that nursing homes have what they need to maintain a sturdy defense against the virus. These measures will help them do exactly that.”

New Initiatives

• New Funding: HHS will devote $5 billion of the Provider Relief Fund authorized in the CARES Act to Medicare-certified long term care facilities and state veterans’ home (“nursing homes”), to build nursing home skills and enhance nursing response to COVID-19, including infection control.
• Enhanced Testing: Rapid point-of-care diagnostic testing devices will be distributed to nursing homes. Along with the deployment of more than 15,000 testing devices over the next few months, “CMS will being requiring, rather than recommending, that all nursing homes in states with a 5% positivity rate or greater test all nursing home staff each week.”
• Additional Technical Assistance and Support:
• Task Force Strike Teams were deployed in 18 nursing homes in Illinois, Florida, Louisiana, Ohio, Pennsylvania and Texas between July 18 and July 20 with a focus on the following four key areas of support:
• Keeping COVID-19 out of facilities,
• Detecting COVID-19 cases quickly,
• Preventing transmission, and
• Managing staff.
• Nursing Home COVID-19 Training: An online, self-paced, on-demand Nursing Home COVID-19 Training consisting of 23 modules will be made available to all 15,400 nursing homes nationwide. In order for nursing homes to be able to receive additional funding from the Provider Relief Fund Program, participation in this Training is required.
• Weekly Data on High Risk Nursing Home: “The White House and CMS will release a list of nursing homes with an increase in cases that will be sent to states each week as part of the weekly Governor’s report.”

July 23, 2020: COVID-19 Public Health Emergency Declaration to Renew on July 25th

Alex M. Azar II, Secretary of Health and Human Services declared an initial Public Health Emergency due to the COVID-19 pandemic on January 31, 2020. A PHE lasts for the duration of the emergency or 90 days and may be extended by the Secretary. On July 25, 2020, the PHE due to COVID-19 has been extended for the second time. You can learn more about Public Health Emergency Declarations in a CMS

Q&A document.

July 24, 2020: Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Code 87426

MLN Article MM11927 provides information about the addition of the QW modifier to HCPCS code 87426] (Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiqualitative, multiple-step method; severe acute respiratory syndrome coronavirus 9eg, SARS-CoV, SARS-CoV-2 [COVID-19]]/

At the end of this MLN article CMS includes the following note:

“Providers should be aware that MACs will not search their files to either retract payment for claims already paid or to retroactively pay claims. However, MACs will adjust claims that you bring to their attention.”

July 24, 2020: Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19)

MLN Article SE20011 has now been revised for the eleventh time. In this latest revision, CMS has added clarifying language to the Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services section to show it applies to lab tests regardless of the HCPCS codes used to report those tests.

July 27, 2020: FDA Reiterates Warning about Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

In a Press Announcement, FDA Commissioner Stephen M. Hahn, M.D. notes that “Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products….We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers.”

The agencies do-not-use list of dangerous hand sanitizer products is being updated regularly. It is important to note that the FDA has indicated that “In most cases, methanol does not appear on the product label.”