Knowledge Base Category -

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

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

To paraphrase a Barbara Mandrell song, I was a pumpkin spice latte fan before pumpkin spice was cool. In fact, two weeks ago I drank my first pumpkin spice latte for 2020. Did you know that one grande pumpkin spice latte from Starbucks has about 150mg of caffeine? That is enough caffeine to be equivalent to about two shots of expresso. To keep with musical references, Amy Grant once referred to expresso as being a “nap in a can” on one of her live albums. 

So why the focus on caffeine? The October 1st start date of the 2021 CMS Fiscal Year is just 22 days from today and CMS has been publishing updates effective October 1st at a pace worthy of a shot or two of expresso to keep you energized as you prepare for these changes. This article highlights recently released MLN articles providing guidance on updates effective October 1st.

Modify Edits in the Fee for Service (FFS) System when a Beneficiary has a Medicare Advantage (MA) Plan

• Article Release Date: July 21, 2020 – Revised July 21, 2020
• What You Need to Know: This article is “for providers, especially hospitals, submitting claims to Medicare Administrative Contractors (MACs) for Part A services provided to Medicare beneficiaries when a beneficiary’s Medicare Advantage (MA) plan becomes effective during the inpatient admission.”
• MLN MM11580: https://www.cms.gov/files/document/mm11580.pdf
• Change Request 11580: https://www.cms.gov/files/document/r10229CP.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020
  

Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Code 87426

• Article Release Date: July 24, 2020
• What You Need to Know: This article provides information about the addition of the QW modifier to HCPCS code 87426 [(Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIAhttps://www.cms.gov/files/document/mm11927.pdf">https://www.cms.gov/files/document/mm11927.pdf
• Change Request 11927: https://www.cms.gov/files/document/r10231OTN.pdf
• Effective Date: June 25, 2020
• Implementation Date: October 5, 2020
  

New Waived Tests

• Article Release Date: July 28, 2020
• What You Need to Know: This article provides information about five new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests that have been approved by the FDA. These tests are marketed immediately after approval so CMS must notify the MACs of the new tests for accurate claims processing. “Note: MACs will not search their files to either retract payment or retroactively pay claims. However, MACs should adjust claims if you bring those claims to their attention.
• MLN Matters MM11916: https://www.cms.gov/files/document/mm11916.pdf
• Change Request 11916: https://www.cms.gov/files/document/r10230CP.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020
  

July 31, 2020: CMS Releases Inpatient Psychiatric Facility (IPF), Skilled Nursing Facilities (SNF), and Hospices FY 2021 Final Rules

CMS announced in a News Alert that they are “finalizing three Medicare payment rules that further advance our efforts to strengthen the Medicare program by better aligning payments for inpatient psychiatric facilities (IPF), skilled nursing facilities (SNF) and hospices.”   For fact sheets on each final rule, visit:

• IPF PPS – https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2021-final-medicare-payment-and-policy-changes-inpatient-psychiatric-facilities-cms-1731
• SNF PPS – https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2021-payment-and-policy-changes-medicare-skilled-nursing-facilities-cms-1737-f
• Hospices PPS -- https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2021-hospice-payment-rate-update-final-rule-cms-1733-f

Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year 2021

• Article Release Date: August 21, 2020
• What You Need to Know: This article provides updates related to the IPF PPS FY 2021 Final Rule including information about:
• Market Basket Update,
• FY 2021 Wage Index Update,
• IPF Quality Reporting Program,
• PRICER Updates,
• ICD-10 CM/PCS Updates,
• Cost of Living Adjustment (COLA) Adjustment, and
• Rural Adjustment.
• MLN MM11949: https://www.cms.gov/files/document/mm11949.pdf
• Change Request 11949: https://www.cms.gov/files/document/r10312CP.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020

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

• Article Release Date: August 7, 2020 – Revised August 24, 2020
• What You Need to Know: This article provides information about the quarterly update to the clinical laboratory fee schedule. On August 24th it was updated to reflect changes to Change Request (CR) 11937 that includes additional COVID-19 codes 86408, 86409, 0225U, 0226U, effective August 10, 2020. This CR also added codes 0015M and 0016M, effective October 1, 2020.
• MLN MM11937: https://www.cms.gov/files/document/mm11937.pdf
• Change Request 11937: https://www.cms.gov/files/document/r10318CP.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020

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

• Article Release Date: August 7, 2020
• What You Need to Know: This article provides information about the issuance of updated payment files in October of the 2020 MPFS.
• MLN MM11939: https://www.cms.gov/files/document/mm11939.pdf
• Change Request 11939: https://www.cms.gov/files/document/r10288cp.pdf
• Effective Date: January 1, 2020
• Implementation Date: October 5, 2020
  

October 2020 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files – REVISED

• Article Release Date: July 2, 2020 – Revised August 14, 2020
• What You Need to Know: Changes made on August 14th were a revised Change Request (CR) release date, transmittal number and web address. All other information remained the same.
• MLN MM11854: https://www.cms.gov/files/document/MM11854.pdf
• Change Request 11854: https://www.cms.gov/files/document/r10306CP.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020
  

Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2021

• Article Release Date: July 2, 2020 – Revised August 19, 2020
• What You Need to Know: This article was revised to reflect a revised CR 11859 which “shows that effective for Fiscal Year (FY) 2021, a 5 percent cap will be adopted and applied to all Skilled Nursing Facility providers on any decrease to a provider’s FY 2021 final wage index from that provider’s final wage index of the prior fiscal year (FY 2020).”
• MLN MM11859: https://www.cms.gov/files/document/MM11859.pdf
• Change Request 11859: https://www.cms.gov/files/document/r10314CP.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020
  

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

• Article Release Date: August 28, 2020
• What You Need to Know:
• MLN MM11960: https://www.cms.gov/files/document/mm11960.pdf
• Change Request 11960: https://www.cms.gov/files/document/r10331CP.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020
  

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

• Article Release Date: August 28, 2020
• What You Need to Know: This article provides information about the October 2020 version of the I/OCE instructions and specifications that Medicare uses.
• MLN MM11944: https://www.cms.gov/files/document/mm11944.pdf
• Change Request 11944: https://www.cms.gov/files/document/r10332cp.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020

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

• Article Release Date: August 28, 2020
• What You Need to Know: This article provides details about the changes to the DMEPOS fee schedules that Medicare updates quarterly, when necessary, to implement fee schedule amounts for new and existing codes, as applicable, and apply changes in payment policies. Specific to the ongoing Public Health Emergency (PHE) due to the COVID-19 pandemic, “the October 2020 DMEPOS and PEN fee files continue to include the non-rural contiguous non-CBA 75/25 blended fees required by Section 3712(b) of the CARES Act signed into law on March 27, 2020.
• MLN MM11956: https://www.cms.gov/files/document/mm11956.pdf
• Change Request 11956: https://www.cms.gov/files/document/r10334CP.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020

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

• Article Release Date: August 31, 2020
• What You Need to Know: This article provides updates in Change Request (CR) 11876 to hospice payment rates, wage index, Pricer, and aggregate cap amounts for Fiscal Year (FY) 2021.
• MLN Matters 11876: https://www.cms.gov/files/document/mm11876.pdf
• Change Request 11876: https://www.cms.gov/files/document/r10338cp.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020

Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) PRICER Changes for FY 2020

• Article Release Date: September 3, 2020
• What You Need to Know: This article is meant to notify IRFs about a new IRF PRICER software package to be released prior to October 1, 2020.
• MLN Matters: 11858: https://www.cms.gov/files/document/mm11858.pdf
• Change Request 11858: https://www.cms.gov/files/document/r10321cp.pdf
• Effective Date: October 1, 2020
• Implementation Date: October 5, 2020

As if all of this isn’t expresso worthy, the FY 2021 Inpatient Prospective Payment System Final Rule was released last Wednesday September 2nd. So grab yourself a pumpkin spice latte and enjoy while reading about MS-DRGs changes in the IPPS Final Rule discussed in a related article in this week’s edition of Wednesday@One.

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.

MEDICARE TRANSMITTALS – RECURRING UPDATES

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

• Article Release Date: August 4, 2020
• What You Need to Know: This article informs providers about updated ICD-10 conversions and coding updates specific to National Coverage Determinations (NCDs). Change Request 11905 includes coding changes for the following NCDs:
• NCD 20.4 Implantable Cardiac Defibrillators (ICDs)
• NCD 50.3 Cochlear Implants
• NCD 90.2 Next Generation Sequencing (NGS)
• NCD 220.6.17 Positron Emission Tomography (FDG) for Oncologic Conditions
• MLN MM11905: https://www.cms.gov/files/document/mm11905.pdf

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

• Article Release Date: August 7, 2020
• What You Need to Know: This article provides information about the issuance of updated payment files in October of the 2020 MPFS.
• MLN MM11939: https://www.cms.gov/files/document/mm11939.pdf

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

• Article Release Date: August 7, 2020
• What You Need to Know: This article informs laboratories of changes resulting from the quarterly update to the clinical laboratory fee schedule. With the ongoing Public Health Emergency (PHE) this quarterly update includes changes made due to the COVID-19 pandemic.
• MLN MM11937: https://www.cms.gov/files/document/mm11937.pdf

Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2021

• Article Release Date: August 21, 2020
• What You Need to Know: This article identifies changes required as part of the annual IPF PPS update. Changes are applicable to discharges occurring from October 1, 2020, through September 30, 2021 (FY 2021). The related Change Request (CR) applies to the Medicare Claims Processing Manual (CLM), Chapter 3, Section 190.4.3.
• MLN 11949: https://www.cms.gov/files/document/mm11949.pdf

OTHER MEDICARE TRANSMITTALS

New Waived Tests

• Article Release Date: July 28, 2020
• What You Need to Know: This article provides information about five new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests that have been approved by the FDA. These tests are marketed immediately after approval so CMS must notify the MACs of the new tests for accurate claims processing. “Note: MACs will not search their files to either retract payment or retroactively pay claims. However, MACs should adjust claims if you bring those claims to their attention.
• MLN Matters MM11916: https://www.cms.gov/files/document/mm11916.pdf

Update to Osteoporosis Drug Codes Billable on Home Health Claims

• Article Release Date: August 7, 2020
• What You Need to Know: Change Request (CR) adds instructions for billing and payment of additional codes for osteoporosis drugs under the home health benefit.
• MLN MM11846: https://www.cms.gov/files/document/mm11846.pdf

Correction to Editing Update for Vaccine Services

• Article Release Date: August 7, 2020
• What You Need to Know: This article informs you that Medicare is changing the Common Working File (CWF) to bypass line-item dates of service for vaccines reported on inpatient Part B claims with Type of Bill (TOB) 12X and 22X when the dates of service (DOS) equal a posted outpatient TOB 73X or 77X service dates, or if present, occurrence span code visit date, regardless of the date of service.
• MLN MM11867: https://www.cms.gov/files/document/mm11867.pdf

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

• Article Release Date: August 7, 2020
• What You Need to Know: This article provides guidance, for qualified Home Infusion Therapy (HIT) suppliers who bill Medicare Part B MACs, about claims processing systems changes necessary to implement Section 5012(d) of the 21st Century Cures Act. Changes will be effective on or after January 1, 2021.
• MLN Article: MM11880: https://www.cms.gov/files/document/mm11880.pdf

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

• Article Release Date: August 10, 2020
• What You Need to Know: This article provides information about the PARHM and the “Transformation Plans” for participating hospitals. CR 11870 expands the allowable telehealth services for Model-participant hospitals. Without this CR, some hospitals may fail to meet healthcare transformation goals set by the Model. Make sure your billing staffs are aware of these changes.
• MLN Article MM11870: https://www.cms.gov/files/document/mm11870.pdf

The Intravenous Immune Globulin (IVIG) Demonstration: Demonstration is ending on December 31, 2020

• Article Release Date: August 21, 2020
• What You Need to Know: This article is notification of the IVIG Demonstration ending December 31, 2020.
• MLN MM11877: https://www.cms.gov/files/document/mm11877.pdf

REVISED MEDICARE TRANSMITTALS

Influenza Vaccine Payment Allowances – Annual Update for 2020-2021 Season

• Article Release Date: July 10, 2020 – Revised July 31, 2020
• What You Need to Know: This MLN article was revised to reflect an updated Change Request (CR) 11882 that extended the implementation date to no later than October 1, 2020 and for mass adjustments no later than November 1, 2020.
• MLN MM11882: https://www.cms.gov/files/document/mm11882.pdf

October 2020 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files – REVISED

• Article Release Date: July 2, 2020 – Revised August 14, 2020
• What You Need to Know: Changes made on August 14th were a revised Change Request (CR) release date, transmittal number and web address. All other information remained the same.
• MLN MM11854: undefined

Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2021

• Article Release Date: July 2, 2020 – Revised August 19, 2020
• What You Need to Know: This article was revised to reflect a revised CR 11859 which “shows that effective for Fiscal Year (FY) 2021, a 5 percent cap will be adopted and applied to all Skilled Nursing Facility providers on any decrease to a provider’s FY 2021 final wage index from that provider’s final wage index of the prior fiscal year (FY 2020).”
• MLN MM11859: https://www.cms.gov/files/document/MM11859.pdf

MEDICARE COVERAGE UPDATES

CMS Transmittal 10228 (Change Request 11884): Updates to Chapters 1-8, 10, and 11 to Publication 100-08 (Medicare Program Integrity Manual)

• Transmittal Release Date: July 27, 2020
• What You Need to Know: The purpose of Change Request (CR) 11884 is to update all references of Program Safeguard Contractor (PSC) and Zone Program Integrity Contractor (ZPIC) to Unified Program Integrity Contractor (UPIC) within Chapters 1-8, 10, 11, and Exhibits in the Medicare Program Integrity Manual (Publication 100-08).
• CR11884: https://www.cms.gov/files/document/r10228pi.pdf

CMS Proposes Updates to Coverage Policy for Artificial Hearts and Ventricular Assist Devices (VADs)

CMS announced in an August 12, 2020 Press Release their proposed updates to coverage policies for artificial hearts and VADs, “both of which are used to treat patients with life-threatening advanced heart failure.” The proposed decision memorandum would:

• Eliminate the coverage with evidence development (CED) requirement for artificial hearts,
• MACs would become responsible for providing coverage determinations for artificial hearts, and
• Providers updated coverage criteria for VADs “that better aligns with current medical practice and provides additional flexibility for patients and providers to choose the most appropriate treatments.”

CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-proposes-updates-coverage-policy-artificial-hearts-and-ventricular-assist-devices-vads

OTHER MEDICARE UPDATES

July 31, 2020: CMS Releases Inpatient Psychiatric Facility (IPF), Skilled Nursing Facilities (SNF), and Hospices FY 2021 Final Rules

CMS announced in a News Alert that they are “finalizing three Medicare payment rules that further advance our efforts to strengthen the Medicare program by better aligning payments for inpatient psychiatric facilities (IPF), skilled nursing facilities (SNF) and hospices.”   For fact sheets on each final rule, visit:

• IPF PPS – https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2021-final-medicare-payment-and-policy-changes-inpatient-psychiatric-facilities-cms-1731
• SNF PPS – https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2021-payment-and-policy-changes-medicare-skilled-nursing-facilities-cms-1737-f
• Hospices PPS -- https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2021-hospice-payment-rate-update-final-rule-cms-1733-f

CY 2021 Physician Fee Schedule (PFS) Proposed Rule with Comment Period

CMS announced the release of this proposed rule in an August 3, 2020 CMS Fact Sheet. A few of the proposals highlighted in the Fact Sheet includes:

• A proposed CY 2021 PFS conversion factor of $32.26 which is down $3.83 from the CY 2020 PFS conversion factor of $36.09,
• Proposal to add several services to the Medicare telehealth list on a Category 1 basis,
• Proposal to create a third temporary category of criteria for adding services to the Medicare telehealth services list. Category 3 describes services added during the PHE for the COVID-19 pandemic that will remain on the list through the calendar year in which the PHE ends. The PHE determination as a result of COVID-19 was most recently renewed on July 23, 2020,
• Proposal to make permanent following the COVID-19 PHE, the same policy that was finalized under the May 1st COVID-19 IFC, for the duration of the COVID-19 PHE. This proposal would allow nurse practitioners (NPs), clinical nurse specialists (CNSs), physician assistants (PAs) and certified nurse-midwives (CNMs) to supervise the performance of diagnostic tests in addition to physicians, and
• Proposal to make permanent our Part B policy for maintenance therapy services that we adopted on an interim basis for the PHE in the May 1st COVID-19 IFC that grants a physical therapist (PT) and occupational therapist (OT) the discretion to delegate the performance of maintenance therapy services, as clinically appropriate, to a therapy assistant – a physical therapist assistant (PTA) or an occupational therapy assistant (OTA). 

August 2020 OIG Report: Inadequate Edits and Oversight Caused Medicare to Overpay More Than $267 Million for Hospital Inpatient Claims with Post-Acute-Care Transfers to Home Health Services

The OIG’s objective in performing this audit was to determine whether Medicare properly paid acute-care hospital inpatient claims subject to the transfer policy when hospitals:

• Did not code the claims as a discharge to home with home health services when the beneficiary resumed home health services within 3 days of discharge,
• Applied condition code 43 indicating that the home health services were not provided within 3 days of discharge, or
• Applied condition code 42 indicating that the home health services were not related to the inpatient hospital services.

The OIG audit 150 inpatient claims with dates of service in fiscal years 2016 and 2017 and found that 147 claims were improperly paid with $722,288 in overpayments. Based on the sample the OIG estimated that Medicare improperly paid $267 million during the 2-year period when services should have been paid at a graduated per diem rate.

• OIG Report Number A-04-18-04067: https://oig.hhs.gov/oas/reports/region4/41804067.pdf

CMS Announces Initiative to Transform Rural Health

CMS announced new funding opportunities to increase access and improve quality. The Community Health Access and Rural Transformation (CHART) Model “also ties payment to value, increase choice and lowers cost to patients.

Link to August 11, 2020 Press Release: https://www.cms.gov/newsroom/press-releases/trump-administration-announces-initiative-transform-rural-health

Link to CHART Model webpage: https://innovation.cms.gov/innovation-models/chart-model

OIG’s Top Unimplemented Recommendations: Solutions to Reduce Fraud, Waste, and Abuse in the HHS Program

The OIG released their annual publication of this report on August 11th. The top 25 recommendations made are based on audits and evaluations issued through December 31, 2019. Seven of the top twenty-five recommendations are related to Medicare Parts A and B. One of the seven recommendations is that CMS re-evaluate the Inpatient Rehabilitation Facility (IRF) payment system.

The U.S. government’s PaymentAccuracy website “is dedicated to ensuring the American people that its government is addressing…and taking concrete steps on prevention and recovery of improper payments.” According to the Department of Health and Human Services Q4 2019 Payment Scorecard, IRF medical necessity errors resulted in overpayments of $6,740M. Program goals include continuing to educate IRF providers through the Targeted Probe and Educate (TPE) program and approve IRF issues for Recovery Audit Contractor (RAC) review, as appropriate.

Link to PaymentAccuracy website: https://www.paymentaccuracy.gov/about-payment-accuracy/

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.

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 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 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”

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.