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 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.

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

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

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

July 28, 2020: CMS Updates COVID-19 Data

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

About the Data

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

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

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

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

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

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

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

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

The OIG is accepting questions “from the health care community regarding the application of OIG's administrative enforcement authorities, including the Federal anti-kickback statute and civil monetary penalty (CMP) provision prohibiting inducements to beneficiaries (Beneficiary Inducements CMP).”

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

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

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

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

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

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

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

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

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

For More Information:

• Laboratory tests with modified requirements (PDF)
• Interim final rule”

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

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

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

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

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

Provider counseling will include the discussion of the following:

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

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

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

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

Resources for Healthcare Providers

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

Resources for Public Health Professionals
Patient Resources:

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

Provider Resources:

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

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

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

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

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

The entire list of services being proposed are included in the calendar year (CY) 2021 Physician Fee Schedule Proposed Rule also issued on August 3rd, 2020. 

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 21st through July 27th.    

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

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

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

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

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

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

July 20, 2020: HHS Protect - Frequently Asked Questions

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

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

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

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

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

New Initiatives

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

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

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

Q&A document.

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

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

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

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

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

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

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

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

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

The ICD-10-CM Officials Guidelines “have been developed to assist both the healthcare provider and the coder in identifying those diagnoses that are reported. The important of consistent, complete documentation in the medical record cannot be overemphasized. Without such documentation accurate coding cannot be achieved. The entire record should be reviewed to determine the specific reason for the encounter and the conditions treated.”

The Guidelines for FY 2021 were released at the beginning of July and can be found on the CDC ICD-10-CM webpage as well as the 2021 ICD-10-CM CMS webpage. This article highlights changes to already current sections in the guidelines as well as new sections for EVALI and COVID-19.

Documentation by Clinicians Other than the Patient’s Provider: Social Determinants of Health (SDOH)

Over the past several years this section of the Guidelines has included more and more instances when “code assignment may be based on medical record documentation from clinicians who are not the patient’s provider.” These instances include: Body Mass Index (BMI), depth of non-pressure chronic ulcers, pressure ulcer stage, coma scale, NIH stroke scale (NIHSS), and social determinants of health codes found in categories Z55-Z65.

The 2021 Guidelines adds the following statement regarding assignment of social determinant codes:

“Patient self-reported documentation may also be used to assign codes for social determinants of health, as long as the patient self-reported information is signed-off by and incorporated into the health record by either a clinician or provider.”

Coding COVID-19

Chapter 1 of the Guidelines, Certain Infectious and Parasitic Diseases, includes a new section for Coronavirus infections. Coders are advised to “code only a confirmed diagnosis of the 2019 novel coronavirus disease (COVID-19) as documented by the provider or documentation of a positive COVID-19 test result. For a confirmed diagnosis, assign code U07.1, COVID-19. This is an exception to the hospital inpatient guideline Section II, H. In this context, “confirmation” does not require documentation of a positive test result for COVID-19; the provider’s documentation that the individual has COVID-19 is sufficient.”

If the provider documents “suspected,” “possible,” “probable,” or “inconclusive” COVID-19, do not assign code U07.1. Instead, code the signs and symptoms reports. See guideline I.C.I.g.I.g.”

This new COVID-19 section also provides guidance for the following coding issues:

• Sequencing of codes,
• Acute respiratory manifestations of COVID-19,
• Non-respiratory manifestations of COVID-19,
• Exposure to COVID-19,
• Screening for COVID-19,
• Signs and Symptoms without definitive diagnosis of COVID-19,
• Asymptomatic individuals who test positive for COVID-19,
• Personal history of COVID-19,
• Follow-up visits after COVID-19 infection has resolved, and
• Encounter for antibody testing.

New coding guidance related to COVID-19 is also included in chapters 15 and 16 (“Pregnancy, Childbirth, and the Puerperium” and “Infection in Newborn, respectively”).

Diabetes Mellitus and the Use of Insulin, Oral Hypoglycemics, and Injectable Non-Insulin Drugs

Lately, it seems like every time I turn on the television there is a commercial for a new “long-acting” drug to treat diabetes. For this reason, it is very timely that the following guidance has been added to the FY 2021 Guidelines:

“If the patient is treated with both insulin and an injectable non-insulin antidiabetic drug, assign codes Z79.4, Long-term (current) use of insulin, and Z79.899, Other long term (current) drug therapy. If the patient is treated with both oral hypoglycemic drugs and an injectable non-insulin antidiabetic drug, assign codes Z79.84, Long-term (current) use of oral hypoglycemic drugs, and Z79.899, Other long-term (current) drug therapy.”

Note, this same guidance has been added to the section Secondary diabetes mellitus and the use of insulin or oral hypoglycemic drugs.

Mental and Behavioral Disorders Due to Psychoactive Substance Use

In the “psychoactive substance use, unspecified,” the guidelines previously advised that “as with all other unspecified diagnoses, the codes for unspecified psychoactive substance use…should only be assigned based on provider documentation and when they meet the definition of a reportable diagnosis.”

New for FY 2021, the following bolded guidance has been added:

“These codes are to be used only when the psychoactive substance use is association with a physical disorder included in chapter 5 (such as sexual dysfunction and sleep disorder), or a mental or behavioral disorder, and such a relationship is documented by the provider.”

Hypertensive Heart and Chronic Kidney Disease

FY 2020 Guidance: “If a patient has hypertensive chronic kidney disease and acute renal failure, an additional code for the acute renal failure is required.”

FY 2021 Guidance: “If a patient has hypertensive chronic kidney disease and acute renal failure, the acute renal failure should also be coded. Sequence according to the circumstances of the admission/encounter.”

Vaping-Related Disorders

It is hard to believe that this time last year the CDC, FDA, and state health authorities were diligently working to identify the cause of the national outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI). According to the CDC webpage devoted to this disease, as of February 18, 2020 a total of 2,807 hospitalized EVALI cases or deaths had been reported to the CDC from all 50 states, the District of Columbia, and two U.S. territories (Puerto Rico and U.S. Virgin Islands).

Initial vaping coding guidance was released in 2019 and a new ICD-10-CM code was implemented on April 1, 2020. Information about both can be downloaded from the CDC ICD-10-CM webpage at https://www.cdc.gov/nchs/icd/icd10cm.htm.

Specific to the Coding Guidelines, the following has been added for FY 2021:

“For patients presenting with condition(s) related to vaping, assign code U07.0, Vaping-related disorder, as the principal diagnosis. For lung injury due to vaping, assign only code U07.0. Assign additional codes for other manifestations, such as acute respiratory failure (subcategory J96.0-) or pneumonitis (code J68.0).

Associated respiratory signs and symptoms due to vaping, such as cough, shortness of breath, etc., are not coded separately, when a definitive diagnosis has been established. However, it would be appropriate to code separately any gastrointestinal symptoms, such as diarrhea and abdominal pain.”

Puerperal Sepsis

For FY 2021, the guidelines advise that “Code O85 should not be assigned for sepsis following an obstetrical procedure (See Section I.C.1.d.5.b., Sepsis due to a postprocedural infection).”

Chapter 21: Factors Influencing Health Status and Contact with Health Services (Z00-Z99) – Observation

The three observation z code categories “are for use in very limited circumstances when a person is being observed for a suspected condition that is ruled out. The observation codes are not for use if an injury or illness or any signs or symptoms related to the suspected condition are present. In such cases the diagnosis/symptom code is used with the corresponding external code cause.”

FY 2020 Guidance: “The observation codes are to be used as principal diagnosis only. The only exception to this is when the principal diagnosis is required to be a code from category Z38, Liveborn infants according to place of birth and type of delivery.”

FY 2021 Guidance: “The observation codes are primarily to be used as a principal/first-listed diagnosis. An observation code may be assigned as a secondary diagnosis code when the patient is being observed for a condition that is ruled out and is unrelated to the principal/first-listed diagnosis (e.g., patient presents for treatment following injuries sustained in a motor vehicle accident and is also observed for suspected COVID-19 infection that is subsequently ruled out).”

Chapter 22: Codes for Special Purposes (U00-U85) NEW

This new chapter for FY 2021 includes the Vaping-related disorder code, U07.0 and COVID-19 code, U07.1. The reader is referenced back to prior sections in the Guidelines for guidance on coding both of these conditions.

While I have highlighted updates for FY 2021, I believe the Guidelines are an essential annual read for Coding and Clinical Documentation Integrity (CDI) Professionals. As I think of school systems struggling with the decision of whether to and when to reopen schools, you can consider reading the FY 2021 Coding Guidelines your required summer reading for the coming Fiscal Year.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 14th – July 20th.   

Resource Spotlight: CDC COVID-19 One-Stop Shop Toolkits

The CDC has compiled a COVID-19 One-Stop Shop Toolkits webpage where you will find videos, social media, public service announcements, print resources, checklists, FAQs, and web resources for the following audiences:

• Young Adults: 15 – 21,
• Childcare Programs & Summer Camps,
• Youth Sports,
• K-12 Schools,
• Businesses & Workplaces,
• Community & Faith-Based Organizations,
• General Public,
• Domestic Travelers,
• Shared & Congregate Housing, and
• Parks & Recreational Facilities.

July 14, 2020: FDA COVID-19 Daily Roundup – FDA Posts Hand Sanitizer Quiz

Hand sanitizer has been and continues to be a hot commodity during the COVID-19 Pandemic. Do you know where to store and not store hand sanitizer? Is hand sanitizer a drug? When should you consider a hand sanitizer to be expired? These are questions you will find answers to in a Hand Sanitizer Quiz posted by the FDA in their July 14th COVID-19 Daily Roundup. The FDA indicates the quiz provides answers to frequently asked questions and “can help consumers learn how to correctly use hand sanitizer.”

July 14, 2020: Department of Health and Human Services (HHS) Initiative for More and Faster COVID-19 Testing in Nursing Homes

HHS announced “a one-time procurement of devices and tests targeted to facilitate on-site testing among nursing home residents and staff. Through this crucial action, nursing homes will be able to augment their current capacity for coronavirus testing, bolstering their response and helping to prevent the spread of SARS-CoV-2, the virus that causes COVID-19.”

Nursing Home Numbers as of July 9, 2020 according to CMS:

• 200,000: The number of confirmed of suspected cases of COVID-19,
• 35,000: The number of COVID-19 deaths.

“The Centers for Disease Control and Prevention recommends that nursing homes perform baseline testing of all residents and staff, followed by regular screening and surveillance through routine testing to detect potential outbreak situations early and reduce morbidity and mortality.”

July 15, 2020: HHS Makes Changes to COVID-19 Daily Data Reporting for Hospitals

Vice President Pence sent a letter to hospital administrators on March 29, 2020 requesting daily data reports on testing, capacity and utilization, and patient flows be sent to the CDC National Healthcare Safety Network (NHSN) to facilitate the public health response to COVID-19.

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

CDC Director Robert Redfield indicated in a prepared remarks that the CDC’s NHSN “is an important surveillance system in our nation’s hospitals, which focuses on fighting antibiotic resistance.

In April, HHS leaders, with input from CDC, created a new system, called HHS Protect, that allows us to combine data through systems like NHSN, as well as other public and private sources. The data reported from hospitals that went into HHS Protect either came through the NHSN, directly to HHS Protect from the states, or through a system called TeleTracking.

What we have now asked is that, going forward, states provide data from hospitals directly through the TeleTracking system or directly to the HHS Protect system.”

July 16, 2020: CDC Webinar: Clinical Management of Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with COVID-19

Previously, the CDC provided a Clinician Outreach and Communication Activity (COCA) MIS-C with COVID-19 call on May 19, 2020. That call focused on providing clinicians information about clinical characteristics of MIS-C, how cases have been diagnosed and treated, and how clinicians have responded to recently reported cases associated with COVID-19. This past Thursday July 17, 2020, a second webinar was held focusing on the clinical management of this patient population. The CDC has provided a recording and slide deck for both webinars.   

July 16, 2020: July 2020 Updated of the Hospital Outpatient Prospective Payment System (OPPS) MLN Article MM11814 Revised

Now in its third iteration, CMS updated MLN Article MM11814 on July 16th. Revisions made reflect the revised Change Request (CR) 11814. Specific revisions include:

• Update to the section on “COVID-19 Laboratory Tests and Services and Other Laboratory Tests Coding Update,”
• Table 1 updated to add 3 new COVID-19 codes: 87426, 0223U, and 0224U,
• HCPCS code Q5112 status indicator was changed from SI=E2 to SI=K, effective April 15, 2020 through September 30, 2020 and section 9 “Drugs, Biologicals, and Radiopharmaceuticals” has been updated by adding new subsections j and k to reflect the change.

July 16, 2020: FDA Closes its COVID-19 Industry Hotline

In the FDA’s Daily Roundup for July 16th they announced that as of 8:00 PM on Friday July 17th they would be closing their COVID-19 Industry Hotline. Moving forward to meet current needs, the FDA will be “providing support for industry and laboratory questions about COVID-19 and medical devices through this directory Contacts for Medical Devices During the COVID-19 Pandemic.”

July 17, 2020: HHS Distributing $10 Billion in Additional Funding to Hospitals in High Impact COVID-19 Areas

The Department of Health and Human Services (HHS) indicated in a July 17th announcement that they are set to begin distributing $10 billion in a second round of high impact COVID-19 area funding to hospitals this week.  In this second round of funding, amounts to be distributed “was based on a formula for hospitals with over 161 COVID-19 admissions between January 1 and June 10, 2020, or one admission per day, or that experienced a disproportionate intensity of COVID admissions (exceeding the average ratio of COVID admissions/bed). Hospitals will be paid $50,000 per eligible admission.” The HHS announcement provides links to a list of hospital recipients of funds as well as a state-by-state breakdown on the funding.

In a related statement by AHA President and CEO Rick Pollack, he thanked HHS for this additional relief but went on to note that “since this distribution of funding for “hot spots” does not take into account the latest spike in cases and hospitalizations in some parts of the country, we look forward to working with the Administration to ensure that additional relief will be distributed to ‘hot spots’ and all hospitals."

July 17, 2020: Medicare Fee-for-Service (FFE) Response to the Public Health Emergency on COVID-19 MLN Article Revised

It seems on an almost weekly basis now MLN SE20011 is being revised. The latest revision updates information on CDC nursing home patients/residents testing and adds clarifying language to the Skilled Nursing Facility (SNF) Benefit Period Waiver – Provider information section.

July 17, 2020: Alabama Medicaid Extends COVID-19 Emergency Expiration Date

Alabama announced in this Alert that “All previously published expiration dates related to the Coronavirus (COVID-19) emergency are once again extended by the Alabama Medicaid Agency (Medicaid). The new expiration date is the earlier of August 31, 2020, the conclusion of the COVID-19 National emergency, or any expiration date noticed by the Alabama Medicaid Agency through a subsequent ALERT.”

July 20, 2020: Office of Civil Rights (OCR) Issues Guidance on Civil Rights Protections Prohibiting Race, Color, and National Origin Discrimination During COVID-19

The OCR announced in a Press Release that they are “issuing guidance to ensure that recipients of federal financial assistance understand that they must comply with applicable federal civil rights laws and regulations that prohibit discrimination on the basis of race, color, and national origin in HHS-funded programs during COVID-19. This Bulletin focuses on recipients' compliance with Title VI of the Civil Rights Act of 1964 (Title VI).”

July 28, 2020 – Save the Date: CDC Webinar: COVID-19 and Diabetes: The Importance of Prevention, Management, and Support

My husband, mother and brother all have adult onset diabetes. This puts each one of them at higher risk for severe illness if they were to contract COVID-19. On Tuesday, July 28, 2020 the CDC is hosting a COCA call where presenters will focus on current information available about this increased risk and the importance of diabetes prevention, management and support. Information for participating in this webinar is available on the CDC website at https://emergency.cdc.gov/coca/calls/2020/callinfo_072820.asp?deliveryName=USCDC_1052-DM32990.

New England Journal of Medicine (NEJM): COVID-19 Rx: Treatment Solutions

Although this free resource was released on May 19th, in keeping with the education offerings from the FDA Hand Sanitizer Quiz and CDC webinars, I wanted to make you aware of this education resource from the NEJM Group. According to the May NEJM Group anouncement, this series of five COVID-19 interactive cases was “designed to teach clinicians on the frontlines of the pandemic, the detailed cases feature clinical information on each of the five fictional patients. In one, the patient is a young woman who arrives to the emergency room with fever and cough. In another, an elderly man with probable Covid-19 and respiratory distress and a history of hypertension and COPD was transferred to the ICU from an outside hospital.”

Welcome to this month’s MAC Talk article. Before diving into updates from the MACs, there are two issues I want to alert readers about. First, a reminder about the updated ABN form. Second, CMS’ indication that Medicare Contractor can resume medical reviews as of August 3, 2020.

New Fee-For-Service (FFS) Advanced Beneficiary Notice of Noncoverage (ABN) Form CMS-R-131

On June 24th the FFS ABN CMS webpage was modified to add the following statement:

“The ABN, Form CMS-R-131, and form instructions have been approved by the Office of Management and Budget (OMB) for renewal.  The use of the renewed form with the expiration date of 06/30/2023 will be mandatory on 8/31/2020.  The ABN form and instructions may be found in the download section.”

Link to webpage: https://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN

Medical Review during the COVID-19 Public Health Emergency

On July 6, 2020, CMS released the document Coronavirus Disease 2019 (COVID-19) Provider Burden Relief Frequently Asked Questions (FAQs). The very first FAQ addresses Medicare Fee-for-Service medical reviews.

Q. Is CMS suspending most Medicare Fee-For-Service (FFS) medical review during the Public Health Emergency (PHE) for the COVID-19 pandemic?

A. On March 30 CMS suspended most Medicare Fee-For-Service (FFS) medical review because of the COVID-19 pandemic. This included pre-payment medical reviews conducted by Medicare Administrative Contractors (MACs) under the Targeted Probe and Educate program, and post-payment reviews conducted by the MACs, Supplemental Medical Review Contractor (SMRC) reviews and Recovery Audit Contractor (RAC). As states reopen, and given the importance of medical review activities to CMS’ program integrity efforts, CMS expects to discontinue exercising enforcement discretion beginning on August 3, 2020, regardless of the status of the public health emergency. If selected for review, providers should discuss with their contractor any COVID-19-related hardships they are experiencing that could affect audit response timeliness. CMS notes that all reviews will be conducted in accordance with statutory and regulatory provisions, as well as related billing and coding requirements. Waivers and flexibilities in place at the time of the dates of service of any claims potentially selected for review will also be applied.

Link to document: https://www.cms.gov/files/document/provider-burden-relief-faqs.pdf

July MAC Talk: The Local Scene

June 16, 2020: Palmetto GBA Article: Botulinum Toxin Injections

In this article, Palmetto provides detail from their Local Coverage Determination (L33458) including dosage and frequency of botulinum toxin injections, documentation expectations for coverage of the services provided, and a checklist to ensure documentation requirements are in the medical record.

This was timely information in advance of the July 1, 2020 implementation date for the Prior Authorization Program for Certain Hospital Outpatient Department (OPD) Services.

June 29, 2020: CGS J15

CGS posted the following information to their website on June 29th:

On April 6, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment (CMS-1744-IFC) instructing the DME MACs to suspend or not enforce various requirements found in local coverage determinations and related policy articles. On May 8, 2020, CMS published CMS-5531-IFC extending non-enforcement of the clinical indications for coverage to therapeutic continuous glucose monitors (CGMs). These changes are effective for claims with dates of service on or after March 1, 2020 and for the duration of the COVID-19 Public Health Emergency (PHE). Please see the full details regarding DME MAC implementation of CMS-1744-IFC and CMS-5531-IFC in the article here.”

July 2, 2020: Noridian JF Article: The Difference Between and Appeal and a Rebuttal

“When a provider does not agree with an overpayment determination, they may appeal the decision. An appeal disputes the overpayment and provides documentation to show medical necessity for the procedures in question. The limitation on recoupment provision mandates that no recoupment begins when a valid and timely request for a first level or second level appeal is received.

A rebuttal does not dispute the amount of the overpayment, nor does it dispute the overpayment determination. A rebuttal permits the provider a vehicle to indicate why the proposed recoupment should not be taken at the designated time. This allows providers to submit a statement advising if the recoupment occurs, it will cause financial hardship for their facility. The contractor, based on the rebuttal statement, determines whether to delay or begin recoupment. The rebuttal process is not an appeal and does not change anything regarding the debt owed.”

Internet Only Manual, (IOM), Publication 100-06, Chapter 3, Section 200.1.4: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/fin106c03.pdf 

Link to Noridian JF webpage: https://med.noridianmedicare.com/web/jfa/article-detail/-/view/10529/the-difference-between-an-appeal-and-a-rebuttal

July 6, 2020: WPS GHA eNews - Prior Authorization (PA) for Hospital Outpatient Department Services Facts

Effective June 17, 2020, providers billing on a 13x Type of Bill (TOB) should submit a PA request to their MAC before providing the following services:

• Blepharoplasty

• Botulinum toxin injections
• Panniculectomy
• Rhinoplasty
• Vein Ablation 

Providers should note the following:

• Prior authorization requests for botulinum toxin injections are only for injection CPT codes 64612 and 64615

• Prior authorization requests for botulinum toxin injections must include both the administration site and drug CPT codes
• Units of service for botulinum toxin injections should include the expected units of waste
• Each date of service requires its own prior authorization request
• CPT code 21235 no longer requires a prior authorization request
• Prior authorization is for dates of service July 1, 2020, and after
• Expedited requests must include justification that the standard review time for making a decision would seriously risk the health of the beneficiary
• Requests are not valid if they do not have the facility PTAN and NPI for the Hospital Outpatient Department 

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

July 6, 2020: Noridian JF to Host ABN Webinar – August 6, 2020

Noridian announced they will be hosting an ABN webinar on August 6th at 11 a.m. CT. This event includes:

• The new ABN form
• ABN Basics
• ABN Completion
• ABN Tips
• ABN Resources
• Noteworthy information

The Noridian announcement provides a link to sign up for this webinar.

July 9, 2020: New and Improved ST PEPPER Format for Short-Term (ST) Acute Care Hospital PEPPER

The PEPPER Team sent a notice about a “new and improved” format for the PEPPER Report. Hospitals will notice changes with the release of the Q1FY20 report scheduled to be available on July 15th.

The PEPPER Team noted in the announcement that “while all of the data and information that you are used to seeing in your PEPPER will still be available, the new format will include the following improvements:

• Greater accessibility
• Cleaner presentation
• Improved readability.

To help introduce Providers to the new format of PEPPER, the PEPPER Team prepared a recorded webinar demonstration of the new PEPPER, which is available on the PEPPER website.

July 13, 2020: First Coast JN Prior Authorization for Certain Hospital Outpatient Department Services Tips and Reminders

First Coast has posted the following information on their website regarding this program:

The PA team has been receiving and processing prior authorization requests (PAR) for certain hospital OPD services. View the following reminders prior to submitting your request:

• Providers are reminded that the PAR must include a PAR coversheet along with appropriate documentation. 
• Providers are asked to make sure the PAR hospital outpatient procedures Medicare fax/mail coversheet is being used and that all fields on the PAR coversheet are completed.
• Remember that PA is only required for procedures on the CMS list

• The PA is only required for the hospital outpatient department (OPD) who will be billing on the type of bill (TOB) 13X
• PA for hospital OPD does not apply to Ambulatory Surgical Centers (ASCs)

• PAR resubmissions must include the following:
• A copy of the initial PAR cover sheet and all documentation from the initial submission
• Any additional information/documentation

Click here to view additional information related to the prior authorization program.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from July 6th through July 13th.   

Resource Spotlight This Week: National Institute on Aging Provides Government COVID-19 Resources for Older Adults

The National Institutes of Health (NIH) National Institute on Aging has developed a webpage to provide Government COVID-19 Resources for Older Adults. Guidance and Information available on this page includes:

• Federal Resources on Caregiving during COVID-19,
• COVID-19 Financial & Housing Resources for Families,
• Health Information on Coronavirus,
• COVID-19 and Healthcare,
• COVID-19 Safety and Emergency Response,
• COVID-19 Resources for Veterans, and
• Employment Resources for COVID-19

July 6, 2020: EPA Approves First Surface Disinfectant Products Tested on the SARS-CoV-2 Virus

The Environmental Protection Agency (EPA) announced in a News Release that they have approved two products that safely and effectively kill the novel coronavirus, SARS-CoV-2, on surfaces.

• Lysol Disinfectant Spray (EPA Reg. No. 777-99), and
• Lysol Disinfectant Max Cover Mist (EPA Reg. No. 777-127)

July 6, 2020: New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) During the COVID-19 Public Health Emergency MLN Article Revised

MLN SE20016 was initially issued on April 17, 2020. Now in the third iteration, this article was revised on July 6th to include:

• Additional guidance on telehealth services that have cost-sharing waived and additional claims examples, and
• An additional section on the RHC Productivity Standard.

July 7, 2020: HHS Launches ‘Surge’ COVID-19 Testing in Hospital Jurisdictions in Florida, Louisiana and Texas

HHS Announced free COVID-19 testing in Jacksonville, Florida; Baton Rouge, Louisiana; and Edinburg, Texas to “temporarily increase federal support to communities where there has been a recent and intense level of new cases and hospitalizations related to the ongoing outbreak.” HHS, in partnership with eTrueNorth plans to offer 5,000 tests per-city per-day at no charge to people being tested. “The temporary surge testing sites will be live anywhere from five to 12 days.”

July 8, 2020: MLN SE20011 Medicare Fee-for-Services Response to Public Health Emergency on COVID-19 Revised Again

MLN SE20011 article has once again been updated. This most recent revision was to add a row at the end of the Waiver/Flexibility table (page 7) to address services provided by the hospital in the patient’s home as a provider-based outpatient department when the patient is registered as a hospital outpatient.

CMS also added the new section Teaching Physicians and Residents: Expansion of CPT Codes that May Be Billed with the GE Modifier.

July 8, 2020: Department of the Treasury and the Small Business Administration Releases the Paycheck Protection Program (PPP) Loan Data

The PPP was established by the CARES Act and was meant to provide small businesses with funds to pay up to 8 weeks of payroll costs including benefits. On Monday July 8th the Department of Treasury and Small Business Administration released a summary of cumulative PPP data. As of July 8th almost 5 million loans have been approved with the average loan size being $106,542. Downloaded data is available for loans above and below $150,000 by state.

You can also access this date and read more about this program on the U.S. Department of Treasury website at https://home.treasury.gov/policy-issues/cares/assistance-for-small-businesses.

Note, larger companies across the nation applied for and received funding from this program. However, since then, the Department of Treasury has indicated in an FAQ document that “it is unlikely that a public company with substantial market value and access to capital markets will be able to make the required certification in good faith, and such a company should be prepared to demonstrate to SBA, upon request, the basis for its certification.” These companies were given the option to repay the money without penalty and have done just that. COVID Stimulus Watch, a public service of Good Jobs First has made available a list of awards, a list of funds that were later refunded.

July 8, 2020: MLN Article MM11815 Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment – REVISED

MLN Article MM11815 was initially released June 12, 2020. This article was updated on July 9, 2020 to reflect a revision to related Change Request (CR) 11815. The revision added information on COVID-19 codes 87426, 0223U and 0224U. The effective date for all three of these new codes was June 25, 2020.

July 9, 2020: Medicare Part A & B Provider Outreach and Education Multi-MAC Collaboration Group Published Modifiers Used During COVID-19 Table

The Provider Outreach and Education A/B MAC Workgroup has developed a table titled Modifiers Used during the COVID-19 Public Health Emergency (PHE). Information included in the table includes the following:

• The Type of Bill (TOB) the modifier would be used on Part A (UB04) or Part B (1500),
• Details about each modifier,
• Links to reference materials for each modifier, and
• When applicable, any exception/special usage for the modifier.

July 9, 2020: HHS Awards More Than $21 Million to Support Health Centers’ COVID-19 Response

HHS indicates in this News Release the awarding of more than $21 million to support health centers’ COVID-19 response efforts noting “the majority of this investment - $17 million – supports 78 Health Center Program look-alikes (LALs) with funding to expand capacity for COVID-19 testing.” Included in this announcement are links to the award recipients as well as links to where you can find more information about the following:

• Health center capacity and the impact of COVID-19 on health center operations, patients, and staff,
• Health Center Program look-alikes, and
• Health Center Controlled Networks.

July 10, 2020: HHS Announces Over $4 Billion in Additional Relief Payments to Healthcare Providers Impacted by the Coronavirus Pandemic

HHS through the Health Resources and Services Administration (HRSA) announced:

• Approximately $3 billion in funding to hospitals serving an large percentage of vulnerable populations on thin margins, and
• Approximately $1 billion to specialty rural hospitals, urban hospitals with certain rural Medicare designations, and hospitals in small metropolitan areas.

HHS is also opening the provider portal to allow dentists to apply for relief. You can read the full announcement on the HHS website at https://www.hhs.gov/about/news/2020/07/10/hhs-announces-over-4-billion-in-additional-relief-payments-to-providers-impacted-by-coronavirus-pandemic.html.

July 10, 2020: HHS Releases May and June COVID-19 State Testing Plans

HHS announced that they have made available May and June COVID-19 Testing plans from all states, territories, and localities. Plans include details on response to surge cases and how to reach vulnerable populations including minorities, immunocompromised individuals and older adults.

Assistant Secretary for Health AMD Brett P. GIroir, M.D. noted in the announcement that “Overall, the plans submitted by the states were very good to excellent; and all will be improved by the ongoing collaboration of states with federal experts. Testing is not just about numbers – it is about targeting testing to the right people at the right time, and incorporation of testing into a comprehensive state plan for COVID-19…We are pleased at what nearly every state has achieved to date, and look forward to continuing to expand SARS-CoV-2 testing capacity in the U.S."

July 10, 2020: Additional Resources Directed to Nursing Homes in COVID-19 Hotspot Areas

In a June 10th Press Release, CMS announced their plan to deploy Quality Improvement Organizations (QIOs) nationwide to provide immediate assistance to nursing homes in hotspot areas as identified by the White House Coronavirus Task Force with an end goal of protecting vulnerable Americans.