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The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule (CMS-1736-FC) was released on December 2, 2020 and is scheduled to be published in the Federal Register on December 29th. A Wednesday@One article released earlier this month highlighted changes to the Inpatient Only Procedure List and the Hospital Outpatient Department Prior Authorization Program.

This week’s article details finalized changes for supervision of outpatient therapeutic services and the Ambulatory Surgical Center (ASC) Covered Procedures List.

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 noted that a March 31, 2020 interim final rule with comment period (IFC) was issued with the intent 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 decided that these policies are appropriate outside of the PHE and proposed to adopt them for CY 2021 and beyond.

NSEDTS Level of Supervision

In the final rule, CMS finalized their proposal without modification to reduce the minimum default level of supervision for NSEDTS to general supervision. They do “note 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.”

In response to a comment from Med PAC, CMS intends to “monitor NSEDTS for safety or service quality issues that may arise from the change to general supervision as the minimum default level of supervision for the initiation period of these services.”

Direct Supervision of Pulmonary, Cardiac, and Intensive Cardiac Rehabilitation Services Using Interactive Telecommunication Technology

Several commenters expressed concerns regarding the proposed change to direct supervision for these three rehabilitation services.

Ultimately, CMS finalized their “proposed policy to permit direct supervision of these services using virtual presence only until the later of the end of the calendar year in which the PHE ends or December 31, 2021. Specifically, the required direct physician supervision can be provided through virtual presence using audio/video real-time communications technology (excluding audio-only) subject to the clinical judgement of the supervising practitioner, as discussed in IFC-1 (85 FR 19246).

When the policy to permit direct supervision through virtual presence ends, we will resume our current policy to require direct physician supervision of pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services, and that the supervising practitioner must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. This does not mean that the supervising practitioner must be present in the room when the procedure is performed.”

CMS also clarified “that, to the extent our policy allows direct supervision through virtual presence using audio/video real-time communications technology during the PHE, the requirement could be met by the supervising practitioner being immediately available to engage via audio/video technology (excluding audio-only), and would not require real-time presence or observation of the service via interactive audio and video technology throughout the performance of the procedure.”

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 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 reiterated many thoughts/beliefs about the future of ASCs included in the proposed rule. Following are some of the statements found in the final 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 total knee arthroplasty (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 the CY 2021 OPPS/ASC proposed rule, we sought to continue to promote site neutrality, where possible, between the hospital outpatient department and ASC settings, and expand the ASC CPL to include as many procedures that can be performed in the HOPD as reasonably possible to advance that goal.”

CMS finalized without modification the addition of the eleven proposed procedures to the ASC-CPL. These procedures are listed in Table 59 of the final rule.

Table 59: Final Additions to the List of ASC Covered Surgical Procedures for CY 2021

Specific to the addition of total hip arthroplasty (THA) to the ASC-CPL, CMS notes in the final rule that they “are aware that beneficiaries may incur greater cost-sharing for THA procedures in an ASC setting under our proposal, but note that this is not an occurrence that is unique to THA.” Section 4011 of the 21st Century Cures Act added the requirement that the Secretary make a searchable website available to the public, “with respect to an appropriate number of items and services, the estimated payment amount for the item or service under the OPPS and the ASC payment system and the estimated beneficiary liability applicable to the item or service.” CMS implemented this provision by providing an Outpatient Procedure Price Lookup tool available at https://www.medicare.gov/procedure-price-lookup. “This web page allows beneficiaries to compare their potential cost-sharing liability for procedures performed in the hospital outpatient setting versus the ASC setting.” CMS that this tool will include cost-sharing liability for THA in the outpatient hospital and ASC settings in the future.

At the end of the day, whether a procedure is performed in the Inpatient, Outpatient or ASC setting, 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.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from December 8th through the 14th.

Resource Spotlight: CDC December 14 Call – What Every Clinician Should Know about COVID-19 Vaccine Safety

For those that missed it, the CDC held a call about COVID-19 vaccine safety on Monday December 14th. Information shared with the clinicians during this call included:

• How to educate patients about what to expect after COVID-19 vaccination,
• The important role clinicians play in monitoring the safety of COVID-19 vaccines, and
• How to report adverse events (possible side effects) to the Vaccine Adverse Event Reporting System (VAERS).

You can access the call materials on the CDC’s webpage.

December 3, 2020: Alabama Medicaid COVID-19 Emergency Expiration Date Extended

Alabama Medicaid published an ALERT to All Providers letting them know that the new expiration date for the COVID-19 emergency is the earlier of January 31, 2021, the conclusion of the COVID-19 national emergency, or any expiration date noticed by the Alabama Medicaid Agency through a subsequent ALERT.

December 7, 2020: FDA Safety Communication: Wear Face Masks with No Metal During MRI Exams

In this FDA Safety Communication the FDA notes that they have “recently received a report that a patient’s face was burned from the metal in a face mask worn during an MRI. The FDA reminds patients and providers that patients should not wear any metal during an MRI.”

December 7, 2020: Hospital Facility-Level COVID-19 Data Published by HHS

HHS announced the release of new hospital COVID-19 capacity data at the facility level. “Previously released data about hospital capacity that had been released was aggregated at the state level. This new, more granular, data release aggregates daily hospital reports into a "week at a time" picture to protect patient privacy, while providing a view of how COVID-19 is impacting hospitals and local communities across the country.”

December 9, 2020: Alabama Governor, Kay Ivey, Extends Safer at Home Order

Alabama Governor, Kay Ivey, issued her twentieth supplemental emergency proclamation extending the Safer at Home Order until Friday, January 22, 2021 at 5:00 pm. This includes a statewide mask requirement when in public and in close contact with other people.

December 9, 2020: MLN Connects Special Edition – In Case You Missed It – Medicare Coverage of COVID-19 Antibody Treatment

CMS published a December 3rd Special Edition MLNConnects which included information about monoclonal antibody infusions. Just six days later, on December 9th, CMS published another Special Edition MLNConnects titled In Case You Missed It: CMS Announces Guidance for Medicare Coverage of COVID-19 Antibody Treatment. The following information was included in the December 9th newsletter:

“On December 9, CMS posted updates to FAQs and an infographic about coverage and payment for monoclonal antibodies to treat COVID-19. The FAQs include general payment and billing guidance for these products, including questions on different setting types. The infographic has key facts about expected Medicare payment to providers and information about how Medicare beneficiaries can receive these innovative COVID-19 treatments with no cost-sharing during the public health emergency (PHE). CMS’ November 10, 2020 announcement about coverage of monoclonal antibody therapies allows a broad range of providers and suppliers, including freestanding and hospital-based infusion centers, home health agencies, nursing homes, and entities with whom nursing homes contract, to administer this treatment in accordance with the Food & Drug Administration’s Emergency Use Authorization (EUA), and bill Medicare to administer these infusions. Currently, two monoclonal antibody therapies have received EUA’s for treatment of COVID-19.

For More Information:

• Therapeutics Coverage Infographic

• Section BB of the FAQs: billing and payment for COVID-19 monoclonal antibody treatments
• Monoclonal toolkit and program guidance”

December 9, 2020: CDC COCA Now Newsletter: Similarities in Symptoms of COVID-19 and Carbon Monoxide Poisoning

In this newsletter, the CDC notes that COVID-19 cases, hospitalizations and deaths and carbon monoxide poisoning incidence are on the rise and the symptoms may overlap. They go on to note that “The purpose of this COCA Now is to remind emergency department, urgent care, and other clinical professionals who are assessing patients for SARS-CoV-2 infection to consider the possibility of CO poisoning.” You can find additional CDC Clinician Outreach and Community Activity (COCA) Now messages related to COVID-19 on the CDC website at https://emergency.cdc.gov/coca/cocanow/index.asp.

December 9, 2020: FDA Authorizes First Direct-to-Consumer COVID-19 Test System

LabCorp’s Pixel COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer test system and does not require a prescription. Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health notes in this announcement that “This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription…While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”

December 11, 2020: FDA Issues Emergency Use Authorization (EUA) to Pfizer for COVID-19 Vaccine

Pfizer has been granted the first EUA for a COVID-19 vaccine in the United States. Acting Secretary of Defense, Christopher C. Miller, indicates in the HHS Announcement that “The massive logistical planning our military has contributed to Operation Warp Speed gives me even more pride in the talent and dedication of our service members. They have been crucial in bringing a safe and effective vaccine to the American people and in restoring the health of our country.”

December 11, 2020: FDA’s Vaccine and Related Biological Products Advisory Committee to Meet December 17th to discuss Moderna’s COVID-19 Vaccine EUA Request

Moderna’s Phase 3 clinical trial began July 27th and “was the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the U.S. and enrolled approximately 30,000 adult volunteers who did not have COVID-19. An independent data safety monitoring board overseeing the Phase 3 clinical trial reviewed the trial data and concluded that the vaccine was safe, prevented disease in 94 percent of the volunteers who received the vaccine and was generally well tolerated. The clinical studies are ongoing.”

HHS announced plans to purchase 100 million doses of the COVID-19 vaccine called mRNA-1273 from Moderna. This purchase brings the total doses of mRNA-1273 owned by the Federal Government to 200 million.

December 14, 2020: Special Edition MLNConnects - COVID-19 Vaccine Codes

Late in the afternoon, CMS issued the following information regarding the Pfizer-BioNTech Vaccine:

“On December 11, 2020, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older. Review Pfizer’s Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) regarding the limitations of authorized use.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for the administration of the vaccine (when furnished consistent with the EUA). Review our updated payment and HCPCS Level I CPT code structure for specific COVID-19 vaccine information. Only bill for the vaccine administration codes when you submit claims to Medicare; don’t include the vaccine product codes when vaccines are free.

Related links:

• CMS COVID-19 Provider Toolkit
• CMS COVID-19 FAQs
• CDC COVID-19 Vaccination Communication Toolkit for medical centers, clinics, and clinicians
• FDA COVID-19 Vaccines webpage”

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from December 1st through the 7th

Resource Spotlight: Starbucks Offering Free Coffee to Front-Line Responders

Starbucks is expressing thanks and providing a little holiday cheer to front-line responders by offering free coffee starting December 1 through December 31.

Offer Details:

• “Starting December 1 through December 31, any customer who identifies as a front-line responder to the COVID-19 outbreak will receive a tall brewed coffee (hot or iced) at no charge (see full eligibility list below).

• The offer can be redeemed at Starbucks U.S. company-operated locations and select licensed stores.”

Who is Eligible?

“Those eligible for the offer include front-line health care providers and first responders, including: doctors, nurses, public health workers, pharmacists, dispatchers, fire fighters, paramedics, EMTs, law enforcement officers, dentists and dental hygienists, mental health workers (therapist, psychologist, social worker, counselor, etc.), hospital staff such as janitor/housekeeping/security, military on active duty, contact tracers, vaccine and pharmaceutical researchers, pilots, flight attendants, TSA, and medical researchers.”

November 30, 2020: 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans

This new CDC webpage notes “the possibility of one or more COVID-19 vaccines becoming available before the end of the year,” and provides 10 things healthcare professionals need to know about current plans, for example one thing is the critical role healthcare providers will play in building confidence in a COVID-19 vaccination.

December 1, 2020: Letter to the American Public on COVID-19 Vaccines

The American Hospital Association (AHA), American Medical Association (AMA), and American Nurses Association (ANA) released an open letter to the American public in support of COVID-19 Vaccines. Collectively, they remind readers that as “partners in health” they are committed to the following:

• “Following the science. We are committed to supporting the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be authorized and recommended for use in the population.

• Your health and safety. We commit to establishing safe and effective processes for administering vaccine to all who are eligible and choose to get vaccinated.
• Being transparent. We will make critical information about vaccines available as it is released, working together to share plans for vaccinating communities across this country. We will share the benefits and risks of a vaccine so that you can make an informed decision for yourself and your loved ones.”

December 1, 2020: COVID-19 FAQs on Medicare Fee-for-Service Billing Updated

CMS has updated this now 159 page document twice in the past week.

• December 1st Update:
• Section QQ. Indian Health Service (IHS) Hospitals was added at the end of the document.
• December 3rd Updates:
• Section F. Hospital Inpatient Prospective Payment Systems (IPPS) Payments two new FAQs were added answering questions about the new COVID-19 treatments add-on payment (NCTAP) under the IPPS.
• Section BB. Drugs & Vaccines under Part B 12 new FAQs were added related to monoclonal antibody treatment for COVID-19.

December 1, 2020: Alabama Public Health Announces COVID-19 Vaccination Plan

State Health Officer Dr. Scott Harris is quoted as saying that “We want to assure the public that there will be equitable distribution of vaccine to all Alabamians, especially to vulnerable populations in rural and urban areas. Many external partners will have input in vaccine allocations.” A link to the complete plan is included in this announcement.

December 1, 2020: FDA Reissues Emergency Use Authorization for use of COVID-19 Convalescent Plasma

The FDA announced in their December 1st COVID-19 bulletin that they have reissued of “the August 23, 2020 Emergency Use Authorization (EUA) for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. The Letter of Authorization has been revised to add the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test to be used for the purpose of qualifying high and low titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma.”

December 2, 2020: FDA Updates Fact Sheet: Combating COVID-19 with Therapeutics

This FDA Fact Sheet includes a table of the drugs and biological products to date that have been granted Emergency Use Authorization (EUA) to treat COVID-19 and serious conditions caused by COVID-19. 

December 2, 2020: CDC Updates Quarantine Guidance

The CDC has provided updated guidance related to options to reduce quarantine from 14 to 10 days. Specifically, “CDC now recommends two additional options for how long quarantine should last. Based on local availability of viral testing, for people without symptoms quarantine can end:

• On day 10 without testing

• On day 7 after receiving a negative test result

After stopping quarantine, people should

• Watch for symptoms until 14 days after exposure.

• If they have symptoms, immediately self-isolate and contact their local public health authority or healthcare provider.
• Wear a mask, stay at least 6 feet from others, wash their hands, avoid crowds, and take other steps to prevent the spread of COVID-19.

CDC continues to endorse quarantine for 14 days and recognizes that any quarantine shorter than 14 days balances reduced burden against a small possibility of spreading the virus. CDC will continue to evaluate new information and update recommendations as needed. See Options to Reduce Quarantine for Contacts of Persons with SARS-CoV-2 Infection Using Symptom Monitoring and Diagnostic Testing for guidance on options to reduce quarantine.”

December 2, 2020: CY 2021 OPPS/ASC Final Rule COVID-19 Revised and New Reporting Requirements

CMS notes in the CY 2021 OPPS final rule (CMS-1736-FC) that “Infection prevention and control is a primary goal of hospitals and CAHs in their normal day-to-day operations, and these programs have been at the center of initiatives in hospitals and CAHs during the PHE for COVID-19.”

The current COVID-19 PHE hospital and Critical Access Hospital (CAH) Conditions of participation (CoP) reporting requirements, have been revised “to now require hospitals and CAH’s to report data elements that must include, but not be limited to the following: 1) the hospital’s (or the CAH’s) current inventory supplies of any COVID-19-related therapeutics that have been distributed and delivered to the hospital (or CAH) under the authority and direction of the Secretary; and (2) the hospital’s (or the CAH’s) current usage rate for any COVID-19-related therapeutics that have been distributed and delivered to the CAH under the authority and direction of the Secretary.”

In addition, CMS is also now requiring hospitals and CAHs “to report information with a frequency, and in such standardized format as specified by the Secretary during the COVID-19 PHE, on Acute Respiratory Illness (including, but not limited to, Seasonal Influenza Virus, Influenza-like Illness, and Severe Acute Respiratory Infection).”

“The new rules make reporting a requirement of participation in the Medicare and Medicaid programs and the required reporting is needed to support broad surveillance of COVID-19 in conjunction with other acute respiratory illnesses that may further burden and strain hospital and CAH resources.”

December 3, 2020: Special Edition MLN Connects – Steps to Widen Access to COVID-19 Antibody Treatment and Vaccine & Monoclonal Antibody Infusions – Enforcement Discretion

Bamlanivimab was the first investigational monoclonal antibody therapy granted Emergency Use Authorization (EUA) by the FDA on November 9th. Similar to Bamlanvimab, the monoclonal antibody therapy of casirivimab and Imdevimab, administered together has been granted EUA “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization.

CMS’ December 3rd Special Edition MLNConnects reminds providers that this drug combination “may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the Emergency Medical System (EMS), as necessary.” The following coding information is excerpted directly from the MLNConnects article:

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Regeneron’s Antibody Casirivimab and Imdevimab (REGN-COV2) (ZIP), EUA effective November 21, 2020.

Q0243:

Long descriptor: Injection, casirivimab and imdevimab, 2400 mg

Short descriptor: casirivimab and imdevimab

M0243:

Long Descriptor: intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

Short Descriptor: casirivi and imdevi infusion

Also included in this MLNmatters article is CMS action taken “To facilitate the efficient administration of COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is exercising enforcement discretion with respect to statutory provisions requiring consolidated billing by SNFs as well as any associated statutory references and implementing regulations, including as interpreted in pertinent guidance.”

December 3, 2020: FDA Issues Emergency Use Authorization (EUA) for Ultraviolet Light

The FDA announced in their December 4, 2020 Daily Update an EUA for the Lumin LM3000 Bioburden Reduction UV System, “the first ultraviolet-C (UV-C) light based bioburden reduction system for emergency use in bioburden reduction of certain N95 respirators when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic.”

December 3, 2020: HHS Amends Public Readiness and Emergency Preparedness Act (PREP Act) to Expand Access to Countermeasures against COVID-19

HHS announced their fourth amendment to the PREP Act “to increase access to critical countermeasures against COVID-19.” One example provided in the announcement is authorizing the provision of COVID-19 covered countermeasures via telehealth across state lines noting that “many states have already authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of COVID-19; this action will ensure that COVID-19 Covered Countermeasures can be provided via telehealth across state lines.” 

December 4, 2020: FDA Approves Home Test to Detect COVID-19 and Influenza A and B (Flu)

The FDA announced they have authorized the first diagnostic test for at home collection of patient samples to detect COVID-19 and influenza A and B. The test was developed by Quest Diagnostics and is the RC COVID-19 + Flu RT-PCR test.

December 4, 2020: CDC Morbidity and Mortality Weekly Report (MMWR): Guidance to Address the High Level of COVID-19 Cases

The CDC indicates in this MMWR Report that “with colder weather, more time spent indoors, the ongoing U.S. holiday season, and silent spread of disease, with approximately 50% of transmission from asymptomatic persons (2), the United States has entered a phase of high-level transmission where a multipronged approach to implementing all evidence-based public health strategies at both the individual and community levels is essential.” Specific strategies outlined in this article includes:

• Universal face mask use,
• Maintaining physical distance from other persons and limiting in-person contacts,
• Avoiding nonessential indoor spaces and crowded outdoor spaces,
• Increasing testing to rapidly identify and isolate infected persons,
• Promptly identifying, quarantining, and testing close contacts of persons with known COVID-19,
• Safeguarding persons most at risk for severe illness or death from infection,
• Protecting essential workers with provisions of adequate personal protective equipment (PPS) and safe work practices,
• Postponing travel,
• Increasing room air ventilation and enhancing hand hygiene and environmental disinfection, and
• Achieving widespread availability and high community coverage with effective COVID-19 vaccines.

CDC COVID Data Tracker – United States COVID-19 Cases

The Calendar Year (CY) 2021 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule (CMS-1736-FC) was released on December 2, 2020. This article focuses on changes to the Medicare Inpatient Only Procedure (IPO) List including medical reviews of procedures being removed from the list and additions to the Hospital Outpatient Prior Authorization Program that went into effect July 1, 2020.

Inpatient Only Procedure List

Currently, there are approximately 1,740 services on the IPO List. In the proposed rule, CMS proposed the following changes for CY 2021: 

• 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.

They also requested 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.”

Not surprisingly, CMS has finalized their proposal to phase out the IPO list by CY 2024. For CY 2021, 298 services are being removed from the IPO list and can be found in Table 48 of the final rule. This list includes:

• 266 musculoskeletal related services,
• 16 anesthesia codes related to the musculoskeletal procedures being removed, and
• 16 additional procedures that were recommended for removal by the Hospital Outpatient Panel (HOP).

“All 298 services that are being removed from the IPO list beginning in CY 2021 are assigned status indicator “J1” and will receive payment through C-APCs, except for 34 services that are assigned status indicator “N”, which indicates that payment for the service is packaged into payment for other services and there is no separate APC payment, and two services assigned status indicator “Q1) which indicates conditionally packaged payment. CPT code 44314 (Revision of ileostomy; complicated (reconstruction in-depth) (separate procedure)), is the only code to be removed from the IPO list that is assigned status indicator “T”, indicating that it is a separately paid procedure. The vast majority of the procedures being removed from the IPO list for CY 2021 are assigned to C-APCs or packaged into payment for other services, which will result in beneficiaries paying one copayment amount.”

“Commenters urged CMS to develop national guidelines outlining beneficiaries who are appropriate candidates for the inpatient vs outpatient setting, particularly for services that generally have a short length of stay (i.e. do not meet 2-midnight benchmark).”

In response, CMS again stated that this decision is a complex medical judgment and should be based on a “beneficiary’s individual clinical needs.” However, they did note that they “agree with the commenters that, in the near term, in light of the elimination of the IPO list over a three-year period, physicians and providers could benefit from having access to general considerations for physicians regarding the types of services that may continue to be more appropriately performed in the inpatient setting for Medicare beneficiaries. Therefore, in the future, we plan to provide information on appropriate site of service selection to support physicians’ decision-making. We note that these considerations will be for informational or educational purposes only and will not supersede physicians’ medical judgment about whether a procedure should be performed in the inpatient or outpatient hospital setting.”

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

The Two-Midnight Rule, as finalized in the FY 2014 IPPS Final Rule, clarified when an inpatient admission is to be considered reasonable and necessary for purposes of Medicare Part A payment. Per CMS “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.”

Additionally, CMS has consistently indicated 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.”

So, what exactly does this mean? It means that when a surgical procedure has been removed from the IPO List, if you admit a patient as an inpatient for a surgical procedure not on the IPO list, documentation in the record must support the need for the inpatient admission.

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

Ultimately, CMS finalized a policy where procedures removed from the IPO list beginning January 1, 2021 “will be indefinitely exempted from site-of-service claim denials under Medicare Part A, eligibility for Beneficiary and Family-Centered Care-Quality Improvement Organization (BFCC-QIO) referrals to Recovery Audit Contractors (RACs) for noncompliance with the 2-midnight rule, and RAC reviews for “patient status.”

CMS plans to maintain this exemption until they “have Medicare claims data indicating that the procedure is more commonly performed in the outpatient setting than the inpatient setting.”

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). Ultimately, irrespective of site-of-service, a short stay claim can still be denied for lack of documentation supporting medical necessity of the surgical 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 blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty, and vein ablation all required a prior authorization.  

CMS indicates in the CY 2021 OPPS final rule that they received over 100 comments to their proposal to add cervical fusion with disc removal and implanted spinal neurostimulators to this program effective for services provided on or after July 1, 2021.

Several commenters expressed the concern “that the MACs have not demonstrated the ability to handle the volume of prior authorization requests since the OPD process began July 1, 2020. These commenters stated that MACs have taken longer than the 10 days specified for communicating the results of prior authorization requests.” CMS responded by acknowledging “there have been occasions when a few of the MACs were not able to issue decisions within this timeframe, as they adjusted to this new workload.” They went on to indicate they have worked with the MACs to ensure outstanding requests were resolved as soon as possible and “as this program continues, we will continue tracking MAC timeliness metrics and are confident that the MACs will be able to meet the required review and decisions timeframes so as not to cause additional burden for OPD providers or delay medically necessary services.” Only time will tell.

Ultimately, CMS finalized their proposal without modifications. Table 74 of the final rule includes the overall list of outpatient department services that will require a prior authorization. Following are the new procedure codes effective July 1, 2021.

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

Timely to the concerns raised about this Medicare Fee-for-Service prior authorization program, on December 2nd, the American Hospital Association (AHA) published the document Addressing Commercial Health Plan Abuses to Ensure Fair Coverage for Patients and Providers.  The AHA notes that “Inappropriate use of prior authorization can negatively impact the quality of care. A survey of more than 1,000 physicians found that more than 90 percent of respondents said prior authorization “had a significant or somewhat negative clinical impact, with 28 percent reporting that prior authorization had led to a serious adverse event such as a death, hospitalization, disability or permanent bodily damage, or other life-threatening event for a patient in their care.”

Resources:

December 2, 2020 CMS Press Release: https://www.cms.gov/newsroom/press-releases/trump-administration-finalizes-policies-give-medicare-beneficiaries-more-choices-around-surgery

December 2, 2020 CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cy-2021-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0

CMS Prior Authorization for Certain Hospital Outpatient Department (OPD) Services webpage: https://www.cms.gov/research-statistics-data-systems/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives/prior-authorization-certain-hospital-outpatient-department-opd-services‍

NEW RISK AREA - TOTAL KNEE REPLACEMENT

Last Wednesday December 2nd, the Program for Evaluating Payment Patterns Electronic Report (PEPPER) Team sent out a notice to list serve recipients informing them that the Q3 Fiscal Year 2020 PEPPER Report for Short-Term Acute Care Hospitals was recently completed. It is important to note that your hospital specific report will only be available for download until December 14, 2020 as the QualityNet file transfer service will be decommissioned on December 15th. If you do not download the report before the deadline, the report will not be available until the next release scheduled for March 8, 2021.

This article focuses on the Short-Term Acute Care Hospitals PEPPER. Specifically, the changes in the recently released Fiscal Year (FY) 2020 Q3 Short-Term Acute Care PEPPER and an analysis of Palmetto JJ Total Knee claims. But first, for those not familiar with the PEPPER, let’s take a look at what it is and why it is a valuable resource for hospitals.  

Background

What is PEPPER?

The PEPPER contains statistics for specific “Target Areas” that have been identified as being “at risk for improper payment due to billing, coding and/or admission necessity issues.” The Centers for Medicare & Medicaid Services (CMS) approves the Short Term PEPPER target areas.

The PEPPER compares you to other hospitals in your state, Medicare Administrative Contractor (MAC) Jurisdiction and to the nation. “Comparisons enable a hospital to determine if it is an outlier, differing from other short-term acute care hospitals.” Reports are delivered to a hospital electronically, are hospital specific, and provide the most recent twelve federal fiscal quarters for each target area.

In addition to your hospital specific report, the PEPPER Resources National-level Data Reports webpage includes a Target Area Analysis that provides claims volume, average length of stay and average Medicare Payment for each of the target areas.

Why is this a Valuable Resource for your Hospital?

The PEPPER User’s Guide notes that the Office of Inspector General (OIG) “encourages hospitals to develop and implement a compliance program to protect operations from fraud and abuse. As part of a compliance program, a hospital should conduct regular audits to ensure charges for Medicare services are correctly documented and billed.”

It is important to understand that “PEPPER does not identify the presence of payment errors, but it can be used as a guide for auditing and monitoring efforts. A hospital can use PEPPER to compare its claims data over time to identify areas of potential concern:

• Significant changes in billing practices,
• Possible over- or under-coding,
• Changes in lengths of stay.”

PEPPER User’s Guide, 31st Edition, effective with Q3FY 2020 Release, What’s New?

The 31st Edition of the PEPPER User’s Guide includes a new target area called Total Knee Replacement. Following are the Total Knee Target Area definitions for the numerator and denominator in the User’s Guide:

• Numerator: the count of discharges with at least one of the ICD-10-PCS knee replacement procedures codes in Appendix 6 of the User’s Guide.
• Denominator: the count of discharges with at least one of the ICD-10-PCS knee replacement procedure codes plus outpatient claims with CPT® code 27447.

The CY 2018 OPPS Final Rule finalized the removal of this procedure from the Medicare Inpatient Only (IPO) List. This new target area will monitor the proportion of all knee surgeries that are performed on an inpatient basis in short-term acute care hospitals.

The User’s Guide indicates that high outlier hospitals may have “unnecessary admissions related to the use of outpatient observation or inappropriate use of admission screening criteria associated with total knee replacement procedures. A sample of medical records for these procedures should be reviewed to determine whether care could have been provided more efficiently on an outpatient basis. Documentation should support the need for an inpatient admission.”

RealTime Medicare Data (RTMD) Analysis of Total Knee Claims

In addition to total knee procedures being a new PEPPER Target Area, Total Knee Arthroplasty Medical Necessity and Documentation Requirements Reviews became an approved RAC Issue (0185) on August 3, 2020. The RACs will be performing complex medical reviews for inpatient hospital, outpatient hospital, ambulatory surgical center and professional services.

Given that Total Knee Claims seem to be an ongoing review for Medicare Contractors, I turned to our sister company, RTMD, to perform an analysis of Total Knee claims for Palmetto GBA Jurisdiction J which includes Alabama, Georgia and Tennessee. Specifically parameters of my analysis included:

• Claims with dates of service from January to June for calendar years 2017 (the year prior to total knee procedures being removed from the Medicare Inpatient Only (IPO) list) through 2020.
• Total knee inpatient claims with the list of ICD-10-PCS knee replacement codes found in Appendix 6 of the User’s Guide, and
• Total knee outpatient claims with a CPT® code 27447, again as per the parameters of the PEPPER Review Target. This is important to keep in mind as the RAC issue also includes additional knee procedure CPT® codes 27445, 27486 and 27487.

Key Findings

• While there were outpatient claims in all three states in 2017, in general hospitals received no payment for CPT 27447.
• All three states have seen a shift from inpatient to outpatient total knee claims with the most significant shift being in Georgia.
• Inpatient volumes appear to have been impacted more as a result of the COVID-19 pandemic.

Potential Next Steps

• Download your PEPPER Report prior to December 15, 2020.
• Whether or not you are an outlier, consider reviewing a sample of claims for documentation supporting the billing patient status and medical necessity of the surgical procedure.
• Prior to reviewing a sample of claims, determine whether or not your MAC has created a Local Coverage Determination (LCD) and Local Coding and Billing Coverage Article (LCA) for total knee procedures.
• I encourage you to spend some time on the PEPPER Resources website where you can find a copy of the most recent User’s Guide, Training and Resources available to you including testimonials and training sessions.
• One last resource, at the same time Total Knee Procedure became an approved issue for the RACs, CMS released an updated Major Joint Replacement (Hip or Knee) MLN Booklet in August. This is a useful tool as it provides information related to documentation, coverage requirements and coding major joint replacements.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from November 19th through the 30th.  

Resource Spotlight: Accessing COVID-19 Lab Testing and Vaccine CPT Codes

The American Medical Association (AMA) announced on November 10th new codes for immunizations for COVID-19. Note, the “CPT codes are unique for each of two coronavirus vaccines as well as administration codes unique to each such vaccine. The new CPT codes clinically distinguish each coronavirus vaccine for better tracking, reporting and analysis that supports data-driven planning and allocation.” From this AMA webpage (https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance) you can access a file with the new CPT codes for testing and vaccine products and vaccine administrations.

November 19, 2020: FDA Authorizes Drug Combination for Treatment of COVID-19

The FDA announced in a News Release  that an emergency use authorization (EUA) has been issued for the drug baricitinib (Olumiant), in combination with remdesivir (Veklury), for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).”

November 19, 2020: Alabama Board of Nursing Emergency Rule for Administering Vaccines

The Alabama Board of Nursing (ABN) announced emergency rule ABN Administrative Code §610-X-4-.16 ER allowing nurses with a retired or lapsed licenses “to administer vaccines during a declared state or national pandemic, provided that the individual nurse’s license was otherwise in good standing at the time of lapse or retirement. A permanent version of the same rule, which is intended to assist the healthcare community in rapidly deploying vaccinations for COVID-19 and any subsequent pandemics, will be published for public comment on November 30, 2020, after which the Board will certify the permanent change.”

November 20, 2020: New Condition Codes for Services Provided as Part of Expanded Access (EA) Approval and Emergency Use Authorization (EUA)

CMS Change Request (CR) 12049 implements the newly created condition code “90” in order to allow providers to report when the service is provided as part of an Expanded Access approval and condition code “91” in order to allow providers to report when the service is provided as part of an Emergency Use Authorization (EUA). The new codes will be effective for claims received on or after February 1, 2021.

November 20, 2020: Palmetto posts COVID-19 Allowances for Laboratory Test Codes

Palmetto GBA notes that CMS established new codes for lab test for COVID-19 and provided pricing for codes U0001 and U0002. However, MACs were instructed to develop the allowance for the remaining codes. This Palmetto GBA article includes a listing of the codes and the code allowance.

November 21, 2020: EUA for Casirivimab and Imdevimab

The FDA posted a News Release regarding an EUA “for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 poundshttps://www.federalregister.gov/documents/2020/11/24/2020-25795/effective-and-innovative-approachesbest-practices-in-health-care-in-response-to-the-covid-19">Request for Information (RFI) in the Federal Register and will be accepting comments through their portal no later than midnight Eastern Time (ERT) on December 24, 2020. The summary statement in this document indicates that HHS is seeking “to gain a comprehensive understanding of the impact of changes adopted by health care systems and health care providers in response to the COVID-19 pandemic. Many healthcare systems and clinicians have rapidly reengineered their policies and programs to improve access, safety, quality, outcomes including mortality and morbidity, cost, and value for both COVID-19 and non-COVID-19 related medical conditions. HHS plans to identify and learn from effective innovative approaches and best practices implemented by non-HHS organizations in order to inform HHS priorities and programs.”

November 24, 2020: FDA Publishes New Webpage – Face Masks, Surgical Masks, and Respirators for COVID-19

The FDA indicated in their November 24 Daily Update that this new webpage is “a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks and respirators.

November 25, 2020: CMS’ Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge

CMS announced “comprehensive steps to increase the capacity of the American health care system to provide care to patients outside a traditional hospital setting amid a rising number of coronavirus disease 2019 (COVID-19) hospitalizations across the country.” One example is the expansion of Hospitals without Walls to include an innovative Acute Hospital Care At Home program. The CMS Press Release announcing these steps also includes links to the Acute Hospital Care At Home initiative and application, a link to more ambulatory surgical center flexibilities, comments from hospitals already participating in the Acute Hospital Care at Home program and a link to related FAQs.

CDC COVID Data Tracker – United States COVID-19 Cases

MEDICARE TRANSMITTALS – RECURRING UPDATES

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

• Article Release Date: August 7, 2020 – revised October 27, 2020
• What You Need to Know: Revisions reflect changes made to CR11939 where CMS added information about codes 3170F, 0599T, A4226, and the new codes 86408, 86409, 86413, and 99072.
• MLN MM11939: https://www.cms.gov/files/document/MM11939.pdf

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

• Article Release Date: November 4, 2020
• What You Need to Know: This article provides information found in the October 30, 2020 Change Request (CR) 12027 about updated ICD-10 conversions and coding updates specific to National Coverage Determinations (NCDs).
• MLN MM12027: https://www.cms.gov/files/document/mm12027.pdf

Changes to the End Stage Renal Disease (ESRD) PRICER to Accept the New Outpatient Provider Specific File Supplemental Wage Index Fields, the Network Reduction Calculation and New Value Code for Time on Machine

• Article Release Date: November 12, 2020
• What You Need to Know: This article provides information about changes to the ESRD PRICER software, the new value code required for reporting minutes of dialysis provided during the billing period and explains the ESRD Network Reduction calculations from the FIAA into the PRICER.
• MLN MM11871: https://www.cms.gov/files/document/mm11871.pdf

OTHER MEDICARE TRANSMITTALS

Special Provisions for Radiology Additional Documentation Requests

• Article Release Date: October 30, 2020
• What You Need to Know: This article discusses a pilot process enabling MACs to request pertinent documentation from treating/ordering provider during medical review, in an effort to support the necessity and payment for radiology service(s)/items(s) (billed to Medicare.”
• MLN MM11659: https://www.cms.gov/files/document/mm11659.pdf

Update to Chapter 10 of Publication (Pub.) 100-08- Enrollment Policies for Home Infusion Therapy (HIT) Suppliers

• Article Release Date: October 30, 2020
• What You Need to Know: Change Request (CR) 11954 informs MACs of the policies and procedures for enrolling HIT suppliers in Medicare. MACs will accept enrollment applications beginning on or after November 1, 2020.
• MLN MM11954: https://www.cms.gov/files/document/mm11954.pdf

Manual Updates Related to the Hospice Election Statement and the Implementation of the Election Statement Addendum

• Article Release Date: November 6, 2020
• What You Need to Know: CMS is modifying the Medicare Benefit Policy Manual to include modifications to the election statement and the requirements for the hospice election statement addendum that became effective for hospice elections beginning on or after October 1, 2020.
• MLN MM12015: https://www.cms.gov/files/document/mm12015.pdf

Updates to Skilled Nursing Facility (SNF) Patient Driven Payment Model (PDPM) Claims

• Article Release Date: November 9, 2020
• What You Need to Know: This article provides updated information about claims processing instructions to adhere to current Medicare policy.
• MLN MM11992: https://www.cms.gov/files/document/mm11992.pdf

Updates to Vaccine Services Editing

• Article Release Date: November 13, 2020
• What You Need to Know: This article is for those that provide vaccines to Medicare beneficiaries and bill Medicare Administrative Contractors (MACs) for those services. Specific for hospitals related CR 11975 “modifies current editing to allow vaccines and their administration when they are the only services on a 12x claim where the service date is equal to the discharge date of an inpatient claim for the same provider and the service date is equal to the "From" date of another inpatient claim with condition code B4 for the same provider.”
• MLN MM11975: https://www.cms.gov/files/document/mm11975.pdf

Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year (CY) 2021

• Article Release Date: November 20, 2020
• What You Need to Know: Among other rates, Medicare beneficiaries without a secondary insurance will have a $1,484.00 Part A Deductible to pay if admitted as an inpatient beginning January 1, 2021.
• MLN Matters: MM12024: https://www.cms.gov/files/document/mm12024.pdf

Implement Operating Rules – Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule – Update from Council for Affordable Quality Healthcare (CAQH) CORE

• Article Release Date: November 20, 2020
• What You Need to Know: This article provides Medicare system updates based on the CORE Code Combination List to be published on or about February 1, 2021.
• MLN MM11988: https://www.cms.gov/files/document/mm11988.pdf

Implementation of Two (2) New NUBC Condition Codes. Condition Code “90”, “Service Provided as Part of an Expanded Access Approval (EA)” and Condition Code “91”, “Service Provided as Part of an Emergency Use Authorization (EUA)”

• Article Release Date: November 20, 2020
• What You Need to Know: The following two new NUBC codes will be effective for claims received on or after February 1, 2021
• “90” – To allow providers to report when the service is provided as part of an Expanded Access approval, and
• “91” – To allow providers to report when the service is provided as part of an Emergency Use Authorization (EUA).
• MLN MM12049: https://www.cms.gov/files/document/mm12049.pdf

Claim Status Category and Claim Status Codes Update

• Article Release Date: November 20, 2020
• What You Need to Know: This article informs you that all code changes approved during the January/February 2021 committee meeting shall be posted on or about March 1, 2021 with an effective date of April 1, 2021 and Implementation Date of April 5, 2021.
• MLN MM11957: https://www.cms.gov/files/document/mm11957.pdf

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

• Article Release Date: November 20, 2020
• What You Need to Know: This article updates the RARC and CARC lists and instructs the Medicare’s system maintainers to update MREP and PC Print. Note, the code update schedule is published three times a year with the next implementation date being April 5, 2021.
• MLN MM11943: https://www.cms.gov/files/document/mm11943.pdf

REVISED MEDICARE TRANSMITTALS

Penalty for Delayed Request for Anticipated Payment (RAP) Submission -- Implementation

• Article Release Date: July 31, 2020 – Revised October 27, 2020
• What You Need to Know: This article was revised to reflect changes made to CR 11855 including adding remittance advice message information.
• MLN MM11855: https://www.cms.gov/files/document/mm11855.pdf

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

• Article Release Date: August 28, 2020 – Revised October 28, 2020
• What You Need to Know: This article was revised to reflect a revised CR11956 clarifying the claims processing jurisdiction for code K1109.
• MLN MM11956: https://www.cms.gov/files/document/mm11956.pdf

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

• Article Release Date: August 7, 2020 – Revised November 13, 2020
• What You Need to Know: This article was revised to reflect a revised CR 11880. Additions to the article include statements related to the status indicator for the G codes on the Physician Fee Schedule and noting that MACs will post HIT fees on their websites as soon as possible.
• MLN MM11880: https://www.cms.gov/files/document/mm11880.pdf

Home Health Prospective Payment System (HH PPS) Rate Update for Calendar Year (CY) 2021

• Article Release Date: November 9, 2020 – Revised November 20, 2020
• What You Need to Know: This article provides several payment updates related to the HH PPS. Note, this article was revised to reflect an updated CR 12017 that revised the Policy section and updated the Payment Rate Tables.
• MLN MM12017: https://www.cms.gov/files/document/mm12017.pdf

Overview of the Repetitive, Scheduled Non-emergent Ambulance Prior Authorization Model

• Article Release Date: May 4, 2015 – Revised November 20, 2020
• What You Need to Know: This article was revised to show the model will not end December 1, 2020. “The model no longer has an end date and will remain in effect for the nine model states.”
• MLN SE1514: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE1514.pdf

Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2021

• Article Release Date: November 9, 2020 – Revised November 23, 2020
• What You Need to Know: This article provides information about payment rate updates and policies for CY 2021. Note, this article was revised to reflect a revised CR 12011.
• MLN MM12011: https://www.cms.gov/files/document/mm12011.pdf

MEDICARE COVERAGE UPDATES

November 13, 2020: National Coverage Determination (NCD 90.3): Chimeric Antigen Receptor (CAR) T-cell Therapy

• Article Release Date: November 17, 2020
• What You Need to Know: Effective for claims with dates of service on or after August 7, 2019, CMS covers autologous treatment for cancer T-cells expressing at least one CAR when administered at healthcare facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS) and meets specified FDA conditions. Note, this article includes billing requirements guidance.
• MLN Matters MM11783: https://www.cms.gov/files/document/mm11783.pdf

OTHER MEDICARE UPDATES

October 27, 2020: New CMS Proposals Streamline Medicare Coverage, Payment, and Coding for Innovative New Technologies and Provide Beneficiaries with Diabetes Access to More Therapy Choices

CMS published a Special Edition MLNConnects announcing a Durable Medical Equipment (DME) proposed rule aimed at reducing administrative burden for new innovative technologies.

November 2, 2020: Long-Term Services and Supports (LTSS) Rebalancing Toolkit Fact Sheet

CMS announced the release of a Long-Term Services and Supports (LTSS) Rebalancing Toolkit “to support states in their efforts to expand and enhance home and community-based services (HCBS) and to rebalance, or recalibrate, LTSS from institutional to community-based systems. You can read more about this in the CMS Press Release and related Fact Sheet.

November 2, 2020: CMS issues End-Stage Renal Disease (ESRD) Prospective Payment System Final Rule

This final rule updates payment policies and rates under the ESRD PPS for renal dialysis services furnished to beneficiaries enrolled in Original Medicare on or after January 1, 2021. It also updates the Acute Kidney Injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI and finalized changes to the ESRD Quality Incentive Program. “Medicare expects to pay $10.3 billion to approximately 7,400 ESRD facilities for the costs associated with furnishing renal dialysis services.”

For More Information:

• Final rule

• Press release
• Full text of fact sheet

November 4, 2020: HHS Proposes Unprecedented Regulatory Reform through Retrospective Review

HHS announced a notice of proposed rulemaking that would require “the Department to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA), which requires regular review of certain significant regulations. If a given regulation is subject to the RFA, the Department must review the regulation every ten years to determine whether the regulation is still needed and whether it is having appropriate impacts. Regulations will expire if the Department does not assess and (if required) review them in a timely manner.”

November 6, 2020: OIG Report – $35 Million in Overpayments for Medical Devices

Hospitals seem to continue to struggle with the Federal regulations for medical device credits as evidenced by the $35 million in overpayments reported by the OIG in this November 6, 2020 report.  

November 6, 2020: 2021 Medicare Parts A & B Premiums and Deductibles

The 2021 Monthly Medicare Parts A and B premiums, deductibles and coinsurance were announced in a CMS Press Release. Following are the changes from 2020 to 2021:

Medicare Part A Inpatient Deductible

• 2020 - $1,408
• 2021 - $1,484

Medicare Part B Enrollees Standard Monthly Premium

• 2020 - $144.60
• 2021 - $148.50

Medicare Part B Enrollees Annual Deductible

• 2020 - $198
• 2021 - $203

For a fact sheet on the 2021 Medicare Parts A & B premiums and deductibles, please visit: https://www.cms.gov/newsroom/fact-sheets/2021-medicare-parts-b-premiums-and-deductibles

November 9, 2020: Medicaid and CHIP Managed Care Final Rule Released

CMS announced the release of this final rule noting that “the purpose of the rule is to ensure state Medicaid and CHIP agencies are able to work effectively to develop and implement managed care programs that better serve each state’s growing number of Medicaid and CHIP beneficiaries.”

November 16, 2020: OIG Report – Hospitals Did Not Comply with Medicare Requirements for Reporting Cardiac Device Credits

The OIG found that hospitals did not always comply with Medicare requirements associated with reporting manufacturer credits for recalled or prematurely failed cardiac medical devices. Specifically, “911 hospitals received payments of $76 million rather than the $43 million they should have received, resulting in $33 million in potential overpayments. Medicare contractors made these overpayments because they do not have a postpayment review process that would ensure that hospitals reported manufacturer credits for cardiac medical devices.” The first of seven recommendations made by the OIG is that MAC’s should recover the portion of the $33 million overpayment that are within the reopening period.

November 17, 2020: CMS to Retire Original Compare Tools December 1st

CMS will retire the Original Compare Tools as they have been replaced with Care Compare on Medicare.gov. This new site streamlines the eight original health care compare tools. CMS notes that “Care Compare offers a new design that makes it easier to find the same information that’s on the original compare tools. It gives you, patients, and caregivers one user-friendly place to find cost, quality of care, service volume, and other CMS quality data to help make informed health care decisions.”

To learn more about the history of and what information is available go to CMS’ Hospital Compare webpage.

November 17, 2020: Medicare FFS Estimated Improper Payments Decline by $15 Billion Since 2016

In the Thursday November 19th edition of the MLNConnects Newsletter, CMS touts a “continued reduction marks fourth year Medicare FFS improper payment rate has been below 10%.” A related November 16th CMS Fact Sheet indicates that the Medicare FFS improper payment rate decreased from 7.25% in 2019 to an estimated 6.27% for 2020.

• CMS Press Release: Trump Administration Announced Medicare Fee-for-Service Estimated Improper Payments Decline by $15 Billion Since 2016
• CMS Fact Sheet: 2020 Estimated Improper Payment Rates for Centers for Medicare & Medicaid Services (CMS) Programs

November 20, 2020: Two New HHS Final Rules Advancing Value-Based Care

HHS announced the release of an OIG and CMS Final Rule, both aimed “to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system into one that pays for value and promotes the delivery of coordinated care.”

• OIG Final Rule: “Revisions to the Safe Harbors Under the Anti-Kickback Statue and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” - “OIG’s new safe harbor regulations are designed to facilitate better coordinated care for patients, value-based care, and improved cybersecurity, while also protecting against fraudulent or abusive conduct,” said Christi A. Grimm, Principal Deputy Inspector General.”

• CMS Final Rule: “Modernizing and Clarifying the Physician Self-Referral Regulations” - “The CMS final rule clarifies and modifies existing policies to ease unnecessary regulatory burden on physicians and other healthcare providers while reinforcing the physician self-referral law’s (often called the “Stark Law”) goal of protecting patients from unnecessary services and being steered to less convenient, lower quality, or more expensive services because of a physician’s financial self-interest.”

The Office of Inspector General (OIG) added several new items to their Work Plan in November. Today we focus on one posted in late November, CMS Oversight of the Two-Midnight Rule for Inpatient Admissions. This type of review is not new for the OIG. In fact, targeting “short inpatient stays” has been on the OIG’s radar since before the Two-Midnight Rule.

OIG Report prior to the implementation of the Two-Midnight Rule

In July 2013, the OIG posted the completed report Hospitals' Use of Observation Stays and Short Inpatient Stays for Medicare Beneficiaries. One reason cited by the OIG for performing this review was CMS’ concern “about improper payments for short inpatient stays when the beneficiaries should have been treated as outpatients.” At that time the OIG noted that “to address these concerns, CMS recently proposed policy changes-through a Notice of Proposed Rulemaking (NPRM)-that, if promulgated as proposed, would substantially affect how hospitals bill for these stays.”

Key Findings in the OIG Report  

• Short inpatient stays were often for the same reason as observation stays, but Medicare paid nearly three times more for a short inpatient stay than an observation stay, on average.
• Beneficiaries also paid far more for short inpatient stays than for observation stays, on average
• Hospitals varied widely in their use of short inpatient and observation stays.
• Some beneficiaries had hospital stays that lasted three nights or more, but did not qualify for SNF services under Medicare.

October 1, 2013 Implementation of Two-Midnight Rule

With the implementation of the Two-Midnight Rule, in addition to scrutiny by the OIG, several Medicare Contractors have been tasked with performing short stay reviews as highlighted in the following timeline.

Timeline of Short Stay Inpatient Reviews

• October 1, 2013: As part of the FY 2014 IPPS Final Rule the Two-Midnight Rule went into effect. Initially Medicare Administrative Contractors (MACs) were tasked with performing short stay pre-payment reviews under the then new Probe and Educate Program process.
• October 1, 2015: The responsibility for short stay reviews shifted to the Beneficiary and Family Centered Care Quality Improvement Organizations (BFCC-QIO). Unlike the MACs, BFCC-QIO’s conducted post-payment reviews.
• May 4, 2016: Short stay reviews were temporarily paused. At that time CMS indicated that they “took this action in an effort to promote consistent application of the medical review of patient status for short hospital stays.” In simple terms, CMS needed time to re-educate the educators.
• September 12, 2016: BFCC-QIOS resumed short stay reviews after the following tasks were completed:
• BFCC-QIOs completed re-training on the Two-Midnight policy;
• BFCC-QIOs completed a re-review of claims that were previously formally denied;

• CMS examined and validated the BFCC-QIOs peer review activities related to short stay reviews;
• The BFCC-QIOs performed provider outreach on claims impacted by the temporary suspension; and
• The BFCC-QIOs initiated provider outreach and education regarding the Two-Midnight policy.

• May 8, 2019: BFCC-QIO short stay reviews were put on hold as CMS planned to procure a new BFCC-QIO contractor who would perform short stay reviews and higher-weighted-DRG reviews on a national basis. CMS anticipated awarding this contract by the 3rd quarter of calendar year 2019. To date, no contract has been awarded.

CERT Annual Supplemental Improper Payment Data

The Comprehensive Error Rate Testing (CERT) Program calculates improper payment rates for the Medicare Fee-for-Service program. Annually, the CERT publishes a report of their findings along with Medicare Fee-for-Service Supplemental Improper Payment data.

Since the Two-Midnight Rule was implemented, the annual data has included a table comparing improper payment rates for Part A hospital claims by Length of stay. While the Improper Payment Rate has dropped for “0 or 1 day” LOS claims, this group of claims continues to have the highest improper payment rate and from 2018 to 2019 seems to be going in the wrong direction.

 OIG Focus on Short Inpatient Stays after implementation of the Two-Midnight Rule

One year after implementation of the Two-Midnight Rule, the OIG included the item: New Inpatient Admission Criteria in their FY 2015 Work Plan. Specifically, the OIG indicated that they “will determine the impact of new inpatient admission criteria on hospital billing, Medicare payments, and beneficiary copayments. This review will also determine how billing varied among hospitals in FY 2014. Previous OIG work identified millions of dollars in overpayments to hospitals for short inpatient stays that should have been billed as outpatient stays. Beginning in FY 2014, new criteria state that physicians should admit for inpatient care those beneficiaries who are expected to need at least 2 nights of hospital care (known as the “two midnight policy”). Beneficiaries whose care is expected to last fewer than 2 nights should be treated as outpatients. The criteria represent a substantial change in the way hospitals bill for inpatient and outpatient stays.”  

For the FY 2016 Work Plan, the OIG followed up with a slightly different look at short stay reviews, the item, Hospitals’ use of outpatient and inpatient stays under Medicare’s two-midnight rule. The OIG noted that they “will determine how hospitals’ use of outpatient and inpatient stays changed under Medicare’s two-midnight rule, as well as how Medicare and beneficiary payments for these stays changed, by comparing claims for hospital stays in the year prior to the effective date of the two-midnight rule to stays in the year following the effective date of that rule. We will also determine the extent to which the use of outpatient and inpatient stays varied among hospitals. CMS implemented the two-midnight rule on October 1, 2013. This rule represents a substantial change to the criteria that hospital physicians are expected to use when deciding whether to admit beneficiaries as inpatients or treat them as outpatients.

On December 19, 2016, the OIG published the Report Vulnerabilities Remain Under Medicare's 2-Midnight Hospital Policy. They noted in the report that while they “found that the number of inpatient stays decreased, the number of outpatient stays increased since the implementation of the 2-midnight policy. Further, short inpatient stays decreased more than long outpatient stays. Despite these changes, vulnerabilities still exist.

• Hospitals are billing for many short inpatient stays that are potentially inappropriate under the policy; Medicare paid almost $2.9 billion for these stays in FY 2014.
• Medicare pays more for some short inpatient stays than for short outpatient stays, although the stays are for similar reasons.
• Hospitals continue to bill for a large number of long outpatient stays.
• An increased number of beneficiaries in outpatient stays pay more and have limited access to SNF services than they would as inpatients.
• Hospitals continue to vary in how they use inpatient and outpatient stays.”

Here we are in December of 2020 and hospitals have been put on notice as the OIG once again targets short stay reviews. They note in this new Work Plan item that “Prior OIG audits identified millions of dollars in overpayments for inpatient claims with short lengths of stay. Instead of billing the stays as inpatient claims, they should have been billed as outpatient claims, which usually results in a lower payment. To reduce inpatient admission errors, CMS implemented the Two-Midnight Rule in fiscal year 2014. Under the Two-Midnight Rule, CMS generally considered it inappropriate to receive payment under the inpatient prospective payment system for stays not expected to span at least two midnights. The only procedures excluded from the rule were newly initiated mechanical ventilation and any procedures appearing on the Inpatient Only List. Revisions were made to the Two-Midnight Rule after its implementation. We plan to audit hospital inpatient claims after the implementation of and revisions to the Two-Midnight Rule to determine whether inpatient claims with short lengths of stay were incorrectly billed as inpatient and should have been billed as outpatient or outpatient with observation. We also plan to review policies and procedures for enforcing the Two-Midnight Rule at the administrative level and contractor level. While OIG previously stated that it would not audit short stays after October 1, 2013, this serves as notification that the OIG will begin auditing short stay claims again, and when appropriate, recommend overpayment collections.” The expected issue date of their findings is FY 2021.

Moving Forward: Compliance with Short Stay

In general, for any given review target, hospitals with high volume and or high paid claims tend to be subject to medical review. Questions to ask and find answers to moving forward:

• Do you track your short stay volume overall, by MS-DRG or Physician over time?
• Do you know what percentage of your Medicare Fee-for-Service inpatient claims are for short stays?
• If so, is this subset of your overall claims increasing year over year at your facility?
• Does the documentation in short stay medical records support a short stay inpatient admission?
• Do you know if your hospital is an outlier?
• Where can you look to find these answers?

PEPPER

One resource available to hospitals is the Short-Term Acute Care PEPPER (Program for Evaluating Payment Patterns Electronic Report). The PEPPER is made available to hospitals on a quarterly basis and compares your hospital to your state, MAC Jurisdiction and the nation. One-day Stays for Medical and Surgical MS-DRGs are two of the “Target Areas” at risk for improper payments included in this report.

The PEPPER Short-Term Acute Care Hospitals User's Guide provides the following suggested interventions for high One-day Stays Hospitals: 

“This could indicate that there are unnecessary admissions related to inappropriate use of admission screening criteria or outpatient observation. A sample of same- and/or one-day stay cases should be reviewed to determine if inpatient admission was necessary or if care could have been provided more efficiently on an outpatient basis (e.g., outpatient observation). Hospitals may generate data profiles to identify same- and/or one-day stays sorted by DRG, physician or admission source to assist in identification of any patterns related to same- and/or one-day stays. Hospitals may also wish to identify whether patients admitted for same- and/or one- day stays were treated in outpatient, outpatient observation or the emergency department for one or more nights prior to the inpatient admission. Hospitals should not review same- and/or one- day stays that are associated with procedures designated by CMS as “inpatient only.”

RealTime Medicare Data

Another source that can help assist you is our sister company, RealTime Medicare Data (RTMD). RTMD collects over 1.2 billion Medicare claims annually from 48 states and the District of Columbia, and allows for searching of over 10 billion historical claims and counting.

In response to the “Two-Midnight” Policy, RTMD has available in their suite of Inpatient Hospital reports a One Day Stay Report. To give you a true picture of your “at risk” volume, this report excludes claims with a discharge status for Expired (20), left against medical advice (07), hospice (50 & 51) and /or were transferred to another Acute care facility (02). This report enables a hospital to view one day stay paid claims data by DRG and Physician to direct where audits should be focused. For further information on all that RTMD has to offer you can visit their website at https://rtmd.org.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from November 9th through the 12th.

Resource Spotlight: Celebrating Thanksgiving

As we quickly close in on Thanksgiving Day, the CDC has posted a webpage filled with information on how to safely celebrate Thanksgiving. This page opens with the statement that “traditional Thanksgiving gatherings with family and friends are fun but can increase the chances of getting or spreading COVID-19 or the flu…The safest way to celebrate Thanksgiving this year is to celebrate with people in your household. If you do plan to spend Thanksgiving with people outside your household, take steps to make your celebration safer.”

November 9, 2020: ORCHID Trial Debunks Effectiveness of Hydroxychloroquine in Adults Hospitalized with COVID-19

In a November 9, 2020 Press Release, the National Institutes of Health (NIH) announced findings from the trial called Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with Symptomatic Disease (ORCHID). The ORCHID Trial enrolled participants between April 2 and June 19, 2020 who were a median age of 57. “At day 14, those who received hydroxychloroquine and those who received a placebo had a similar health status, with most participants in both groups discharged from the hospital and able to perform a range of activities.”

Per Wesley Self, M.D., M.P.H., emergency medicine physician at Vanderbilt University, “The finding that hydroxychloroquine is not effective for the treatment of COVID-19 was consistent across patient subgroups and for all evaluated outcomes, including clinical status, mortality, organ failures, duration of oxygen use, and hospital length of stay,”

November 10, 2020: OIG Posts Information about Operation CARE

The OIG has posted details about Operate CARE (Caring, Awareness, & Resources for Elders). With a long history of protecting the health and well-being of HHS beneficiaries they note that “Unfortunately, during the COVID-19 pandemic, we have seen a spike in the number of reports of elder harm and neglect.”

The OIG Operation CARE webpage includes resources (i.e., awareness posters) available to the public to also advocate for this population by reporting patient safety and fraud concerns.

November 12, 2020: COVID-19 Non-Physician Practitioner Billing for CPT Codes 98966-98968

In the Thursday November 12th edition of MLNConnects, CMS reminders non-physician practitioners that “During the COVID-19 Public Health Emergency (PHE), non-physician practitioners who are eligible to bill Medicare directly, including registered dietitians and nutrition professionals, may bill for audio-only telephone assessment and management services:

• CPT codes 98966-98968

• Dates of service on or after March 1 until the end of the PHE”

November 12, 2020: CMS Guidance - COVID-19 Vaccine Shots

CMS added the following new webpages to CMS.gov website regarding COVID-19 Vaccine Shots:

• Enrollment for Administering COVID-19 Vaccine Shots,
• Coding for COVID-19 Vaccine Shots,
• Medicare COVID-19 Vaccine Shot Payment,
• Medicare Billing for COVID-19 Vaccine Shot Administration,
• Beneficiary Incentives for COVID-19 Vaccine Shots, and
• CMS Quality Reporting for COVID-19 Vaccine Shots

November 12, 2020: CMS Monoclonal Antibody COVID-19 Infusion

In addition to information about COVID-19 Vaccine Shots, CMS has added a Monoclonal Antibody COVID-19 Infusion webpage which includes information on the following topics:

• Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction,
• Coding for Monoclonal Antibody COVID-19 Infusion,
• Medicare Payment for Monoclonal Antibody COVID-19 Infusion, and
• Billing for Monoclonal Antibody COVID-19 Infusion Administration.

You can read more about the first Monoclonal Antibody drug to received Emergency Use Authorization for treating COVID-19 in a related FAQ in this week’s newsletter. 

November 12, 2020: Special Edition MLN Connects – COVID-19 Vaccine Codes and PC-ACE Software Update

CMS noted the following in this Special Edition of MLN Connects:

“In anticipation of the availability of a vaccine(s), for the novel coronavirus (SARS-CoV-2) in response to the coronavirus disease 2019 (COVID-19), the American Medical Association (AMA), working with the Centers for Medicare & Medicaid Services (CMS), created new codes for the vaccine and the administration of the vaccine.  To prepare for the vaccine administration claims, the PC-ACE software is also updated and ready for providers to download.

If you intend to administer the COVID-19 vaccines when they become available, or the new monoclonal antibody bamlanivimab, especially if you intend to roster bill these codes, please download and install the new release of PC-ACE. This release includes the coding structure, currently comprised of both a HCPCS Level I CPT code structure issued by the American Medical Association (AMA) and a HCPCS Level II code structure issued by CMS. Together, these codes support the administration of the COVID-19 vaccines and the monoclonal antibody infusions, as they become available; this structure includes the codes for bamlanivimab. This code structure was developed to facilitate efficient claims processing for any COVID-19 vaccines and monoclonal antibody infusions that receive FDA EUA or approval. CMS and the AMA are working collaboratively regarding which codes to submit for COVID-19 vaccines and administration.  Most of these codes are not currently effective and not all codes will be used.  We will issue specific code descriptors in the future.  Effective dates for the codes for Medicare purposes will coincide with the date of the FDA EUA or approval.”

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from November 3rd through November 9th.

Resource Spotlight: Telehealth Information for Providers and Patients

Telehealth.HHS.GOV offers resources for Providers and Patients.

Telehealth Resources for Providers: Content available on the Telehealth for Providers webpage includes:

• Getting Started,
• Planning your telehealth workflow,
• Preparing patients for telehealth,
• Policy changes during the COVID-19 Public Health Emergency,
• Billing and Reimbursement during the COVID-19 Public Health Emergency, and
• Legal Considerations

Telehealth Resources for Patients: Content available on the Telehealth for Patients webpage includes:

• Understanding telehealth,
• Telehealth during the COVID-19 emergency,
• Finding telehealth options, and
• Preparing for a video visit.

November 4, 2020: Provider-Specific Fact Sheets on New Waivers and Flexibilities Updated

CMS updated almost all of the Provider-Specific Fact Sheets on News Waivers and Flexibilities to include information from the October 28, 2020 Interim Final Rule (IFC) to ensure all Americans have access to a COVID-19 vaccine when one becomes available. Of note, “for calendar years 2020 and 2021, Medicare will pay directly for the COVID-19 vaccine and its administration for beneficiaries enrolled in Medicare Advantage (MA) plans. Providers should submit COVID-19 claims to Original Medicare for all patients enrolled in MA in 2020 and 2021. MA plans will not be responsible for reimbursing providers to administer the vaccine during this time. MA beneficiaries also pay nothing for COVID-19 vaccines and their copayment/coinsurance and deductible are waived.” All of the Face Sheets can be accessed on the CMS Coronavirus waivers and flexibilities webpage. Note, the Toolkit for States to Mitigate COVID-19 in Nursing Homes found on the COVID-19 Current Emergencies webpage was also updated on November 4th to include the vaccine information.

November 5, 2020: Governor Ivey Extends Safer at Home order until December for the State of Alabama

The Safer at Home order has been extended until December 11, 2020 and include the mask ordinance requiring masks be worn in schools and in public when interacting within 6 feet of someone from another household. Following are two new amendments to the order:

• Occupancy Rates: Emergency occupancy rates will be removed from retailers, gyms and fitness centers, and entertainment venues.
• Use of Partitions: An exception to social-distancing rules will be allowed for many businesses – including barber shops, hair salons, gyms, and restaurants – if people are wearing masks and separated by an “impermeable” barrier.

You can read the Press Release and access Safer at Home Information Sheets on the Alabama Governor’s Newsroom webpage.

November 5, 2020: Preparing to Administer COVID-19 Vaccine when it’s Available

CMS included the following information in their Thursday November 5th edition of MLNConnects:

“Get ready to administer the COVID-19 vaccine when it’s available. Read the enrollment section of our COVID-19 provider toolkit to see if you need to take action now:

• Many Medicare-enrolled providers don’t have to take any action until a vaccine is available – make sure your provider-type enrollment is all set
• Some Medicare-enrolled providers must also separately enroll as a mass immunizer to administer and bill for COVID-19 vaccines when they’re available – find out if you must also enroll as a mass immunizer
• If you’re not a Medicare-enrolled provider, you must enroll as a mass immunizer or other Medicare provider type that can bill for administering vaccines

Enrolling over the phone a mass immunizer is easy and quick — call your MAC-specific enrollment hotline (PDF) and give your valid legal business name, national provider identifier, tax identification number, practice location, and state license, if applicable.”

November 6, 2020: CDC Report: Telework before Illness Onset of COVID-19

The CDC’s Morbidity and Mortality Weekly Report (MMWR) for November 6th focused on employees working in the office versus telework and positive COVID-19 test. Following are answers to questions in the summary section of this report.

“What is added by this report? Adults who received positive test results for SARS-CoV-2 infection were more likely to report exclusively going to an office or school setting in the 2 weeks before illness onset, compared with those who tested negative, even among those working in a profession outside of the critical infrastructure.

What are the implications for public health practice? Businesses and employers should promote alternative work site options, such as teleworking, where possible, to reduce exposures to SARS-CoV-2. Where telework options are not feasible, worker safety measures should continue to be scaled up to reduce possible worksite exposures.”

November 6, 2020: OIG Audit – Office of Refugee Resettlement (ORR) Preparedness to Respond to COVID-19 Pandemic

The OIG released their report where they conducted a communicable disease preparedness audit of 11 selected facilities from March through June 2020 during the COVID-19 pandemic in the United States. They found that the facilities selected for review followed preparation requirements and were prepared to respond to the pandemic. The OIG report contains no recommendations.

“ORR officials stated that, since 2006, ORR has had a policy in place that required its facilities to prepare for and respond to a communicable disease outbreak; therefore, the facilities were generally able to quickly pivot to respond to the COVID-19 pandemic.”

November 6, 2020: FDA Authorizes First Test to Detect Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

Previously issued Emergency Authorization Use (EUAs) for antibody (serology) tests only detect the presence of binding antibodies. The EUA issued to GenScript USA Inc. for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit is “the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.”

In the FDA’s press announcement they caution “against using the results from this test, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work. The FDA also wants to remind patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies that the immune system develops in response to the virus, not the virus itself.”

November 9, 2020: FDA Authorizes Monoclonal Antibody Treatment

The FDA announced the issuance of an emergency use authorization (EUA) for Bamlanivimab which is an investigational monoclonal antibody therapy. This drug is not authorized for patients already hospitalized due to COVID-19. Instead, it is to be given in an outpatient setting and  “is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.”

According to the Scope of Authorization in the emergency use authorization (EUA):

• Distribution of the authorized drug will be controlled by the U.S. Government,
• Again, it is authorized for use only by healthcare providers in an outpatient setting,
• The drug may only be administered in a setting where health care providers have immediate access to medications to treat a severe infusion reaction, and
• Use of the drug covered by the authorization must be in accordance with the dosing regiments in the authorized Fact Sheets.

You can also read more about the EUA in a related Lilly Investors announcement.

November 9, 2020: Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) MLN Matters Article Revised

MLN Matters Article SE20011  was originally released March 16, 2020. The most recent iteration of this article includes revisions to clarify the billing instructions in the Skilled Nursing Facility (SNF) Benefit Period Waiver – Provider Information section.

November 9, 2020: Pfizer Announces Vaccine Against COVID-19

In an early Monday morning Press Release, Pfizer announced the success of a joint effort with BioNTech in the development of a vaccine. Specifically, Pfizer indicated that the “vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.” Once the required safety milestone has been achieved Pfizer is planning to submit for Emergency Use Authorization (EUA) to the FDA. At the time of the Press Release the expectation for reaching that milestone was this week.

CDC COVID Data Tracker – United States COVID-19 Cases