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

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

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

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

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

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

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

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

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

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

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

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

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

CMS Outlook for the Future of the ASC-CPL

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

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

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

Inpatient, outpatient or ASC, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed. CMS is accepting comments on the proposed rule up until 5 p.m. EST on October 5, 2020.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from August 4th through August 10th.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For More Information:

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

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

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

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

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

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

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

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

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

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

August 10, 2020: COVID-19 Laboratory Reporting Requirements

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

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

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

Complete demographic data will:  

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

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

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

Q:

Have Medicare Contractors started performing Medical Reviews again?

A:

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

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

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

American Hospital Association Letter to CMS

The American Hospital Association (AHA) expressed concern about CMS’s decision to resume medical review audits on August 3, 2020 in a July 29, 2020 letter to CMS Administrator Seema Verma. The letter ends with the AHA stating that “to be clear, we urge the agency to refrain from differentiation between medical review audits and the other flexibilities you have created, and instead ensure all of the relevant waivers remain active during the pandemic.”

Medicare Administrative Contractors (MACs) Guidance

On August 4, 2020, Palmetto GBA posted an article to their website providing additional detail about the resumption of medical reviews. Specifically,

• Beginning August 17th, the MACs are resuming post-payment reviews of items/services provided prior to March 1, 2020,
• The Targeted Probe and Educate (TPE) program will restart later, and
• MACs will continue to offer detailed review decisions and education as appropriate.

CMS included this same guidance in their August 6, 2020 MLNConnects e-newsletter.

Q:

Given the ongoing COVID-19 Public Health Emergency, has CMS extended the Testing Period for the Appropriate Use Criteria Program set to begin in Calendar Year 2020?

A:

Yes, CMS updated their Appropriate Use Criteria Program webpage on August 10, 2020 with the following Notice:

“The EDUCATIONAL AND OPERATIONS TESTING PERIOD for the AUC Program has been extended through CY 2021. There are no payment consequences associated with the AUC program during CY 2020 and CY 2021. We encourage stakeholders to use this period to learn, test and prepare for the AUC program.”

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

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

Inpatient Only Procedure List

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

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

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

Short Inpatient Hospital Stays

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

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

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

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

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

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

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

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

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

Hospital Outpatient Department Prior Authorization Program: Proposed New Service Categories

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

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

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

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

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

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

Cervical Fusion with Disc Removal

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

Implanted Spinal Neurostimulators

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

Be on the lookout for additional highlights from the proposed rule in next week’s newsletter. In the meantime, I encourage key stakeholders at your facility to take the time to review the proposed rule. For those wishing to submit comments, CMS is accepting them up until 5 p.m. EST on October 5, 2020.

Q:

Does a provider have to explicitly link a respiratory condition to COVID-19, if the COVID-19 test is positive?  For example:  Pneumonia with a positive COVID-19 test.

A:

No. A provider does not need to explicitly link the results of the COVID-19 test to the respiratory condition, as long as the positive test result itself, is part of the medical record.  For the example above, code U07.1 (COVID-19) as the principal diagnosis with code J12.89 (Other Viral Pneumonia) as a secondary diagnosis.

References:

Frequently Asked Questions Regarding ICD-10-CM Coding for COVID-19

Coding Clinic for ICD-10-CM/PCS, Second Quarter 2020: Page 3, effective May 29, 2020.

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

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

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

July 28, 2020: CMS Updates COVID-19 Data

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

About the Data

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For More Information:

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

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

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

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

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

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

Provider counseling will include the discussion of the following:

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

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

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

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

Resources for Healthcare Providers

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

Resources for Public Health Professionals
Patient Resources:

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

Provider Resources:

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

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

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

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

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

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

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

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

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

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

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

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

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

July 20, 2020: HHS Protect - Frequently Asked Questions

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

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

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

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

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

New Initiatives

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

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

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

Q&A document.

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

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

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

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

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

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

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

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

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

MEDICARE TRANSMITTALS – RECURRING UPDATES

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 26.3, Effective October 1, 2020

• Article Release Date: June 23, 2020
• What You Need to Know: Change Request (CR) 11840 providers the quarterly updates to the NCCI PTP edits.
• MLN MM11840: https://www.cms.gov/files/document/mm11840.pdf

Quarterly Update to the End Stage Renal Disease Prospective Payment System (ERSD PPS)

• Article Release Date: June 29, 2020
• What You Need to Know: CR 11835 informs providers about the twenty new diagnosis codes eligible for the ESRD PPS comorbidity payment adjustment effective October 1, 2020.
• MLN MM11835: https://www.cms.gov/files/document/mm11835.pdf

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

• Article Release Date: July 2, 2020
• What You Need to Know: This article updates the Quarterly ASP Medicare Part B Files and informs providers of revisions to prior quarterly filing prices.
• MLN MM11854: https://www.cms.gov/files/document/mm11854.pdf

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

• Article Release Date: July 2, 2020
• What You Need to Know: This article provides FY 2020 Updates to the SNF PPS payment rates, as required by statue.
• MLN MM11859: https://www.cms.gov/files/document/mm11859.pdf

Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes – July 2020 Update

• Article Release Date: July 6, 2020
• What You Need to Know: Change Request (CR) 11769 released on June 23, 2020 updates the HCPCS code set for codes related to drugs and biologicals effective July 1, 2020. The related MLN article MM11769 provides links to the updated quarterly HCPCS complete code set.
• MLN MM11769: https://www.cms.gov/files/document/mm11769.pdf

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2020

• Article Release Date: July 10, 2020
• What You Need to Know: This article announced changes included in the October 2020 quarterly release of the edit module for clinical diagnostic laboratory services.
• MLN MM11889: https://www.cms.gov/files/document/MM11889.pdf

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

• Article Release Date: July 10, 2020
• What You Need to Know: This article informs you of the availability of payment allowances for the seasonal influenza virus vaccines as updated on an annual basis, effective August 1 each year.
• MLN MM11882: https://www.cms.gov/files/document/mm11882.pdf

Other Medicare Transmittals

Revising Chapters 3 and 5 of Publication (Pub.) 100-08, to Reflect the Recent Final Rule CMS-1713-F

• Article Release Date: July 1, 2020
• What You Need to Know: CR 11599, released June 19, 2020, revises the Medicare Program Integrity Manual, Chapters 3 (Verifying Potential Errors and Taking Corrective Actions) and 5 (Items and Services Having Special DMEPOS Review Considerations) to include finalized regulatory updates, including those related to face-to-face encounter and written order requirements.
• MLN Matters MM11599: https://www.cms.gov/files/document/mm11599.pdf

Change to the Payment of Allogeneic Stem Cell Acquisition Services

• Article Release Date: July 13, 2020
• What You Need to Know: Currently payment for this service is included in the MS-DRG payment for allogeneic hematopoietic stem cell transplants when transplants occurred in the inpatient setting. Change Request (CR) Transmittal R10218CP provides instructions to pay inpatient hospital Allogeneic Stem Cell Acquisition services on a reasonable cost basis.
• MLN Matters MM11729: https://www.cms.gov/files/document/mm11729.pdf

Revised Medicare Transmittals

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)—July 2020 Update

• Article Release Date: February 25, 2020 – Revised June 22, 2020
• What You Need to Know: This MLN article was revised to reflect a revised Change Request (CR) 11655 in which CMS removed the CPT code 0048U from the business requirement for NCD 90.2 Next Generation Sequencing (NGS) and corresponding removals of CPT 0048U and its associated diagnosis codes from the NCD 90.2 NGS spreadsheet. Changes were made due to the CPT code not meeting the policy criteria in NCD 90.2 for NGS.
• MLN MM11655: https://www.cms.gov/files/document/mm11655.pdf

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

• Article Release Date: June 8, 2020 – Revised July 2, 2020
• What You Need to Know: This article was revised to reflect updates in the related CR R10207CP. Updates include the following:
• Added CPT code 99458 with status indicator "B".
• "New Separately Payable Procedure Codes – Surgical Procedures" has been updated with corrected APC assignment for HCPCS code C9760.
• "OPPS PRICER Logic and Data Changes for the July 2020 Update" has been removed. There is also a new, "Inadvertent Deletion of CPT code 0126T" added.
• Therefore, the existing section 16 "Changes to the Wage Index" has become section 15. Table 1 has been updated by adding a new PLA COVID-19 code, 0202U.
• Table 2 has been updated by adding CPT code 99458 with status indicator "B".
• Table 21 has been updated by changing APC number for HCPCS code C9760 from APC 1591 to APC 1589. We also changed the CR release date, transmittal number and link to the transmittal. All other information is unchanged.
• MLN MM11814: https://www.cms.gov/files/document/mm11814.pdf

July 2020 Update of the Ambulatory Surgical Center (ASC) Payment System

• Article Release Date: June 24, 2020 – Revised July 2, 2020
• What You Need to Know: This article describes changes to and billing instructions for various payment policies implemented in the July 2020 ASC payment system update. This notification also includes HCPCS updates. The July 2nd revision was made to correct the last section in Section 6.e, on page 10. CMS notes it should have stated, “C9058 is replaced by Q5120 effective July 1, 2020.”
• MLN MM11842: https://www.cms.gov/files/document/mm11842.pdf

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

• Article Release Date: May 4, 2015 – Revised July 24, 2020
• What You Need to Know: This article was revised to provide information on transportation information for beneficiaries in the Additional Information section of this article.
• MLN SE1514: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1514.pdf

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

• Article Release Date: May 1, 2020 – Revised July 21, 2020
• What You Need to Know: This article was revised to reflect revisions in Change Request (CR) 11850 also issued on July 21, 2020. This CR reflects additional sections to the Medicare Claims Procession Manual – Chapter 32 – Billing Requirements for Special Services. Section 66.2 of the chapter identifies CAR-T as having significant costs for Medicare Advantage. Due to the significant cost Providers may bill the A/B MAC for this NCD service provided to a MA beneficiary.
• MLN MM11580: https://www.cms.gov/files/document/mm11580.pdf

Medicare Coverage Updates

MLN Booklet: How to Use the Medicare Coverage Database (MCD)

• Booklet Release Date: June 2020
• What You Need to Know: This MLN education booklet provides information on what the MCD is, why you would use it, a background about Medicare coverage and coverage determinations, how up-to-date is the MCD and how to search the MCD.
• ICN MLN901347 June 2020: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/MedicareCvrgeDatabase_ICN901346.pdf

National Coverage Determination (NCD) 160.18 Vagus Nerve Stimulation (VNS) MLN Article Revised

• MLN Article Revised: June 23, 2020
• What You Need to Know: This article was revised to reflect the revised CR11461 issued on June 23, 2020. The revised CR clarifies instructions for the MACs and changed the implementation date to July 22, 2020.
• MLN MM11461: https://www.cms.gov/files/document/mm11461.pdf

Medicare Compliance Tips

MLN Booklet: How to Use the Medicare National Correct Coding Initiative (NCCI) Tools

• Booklet Release Date: June 2020
• What You Need to Know: This MLN education booklet provides information on what is the Medicare NCCI, why would you use it, how up to date are the NCCI tables and manual, how to locate the NCCI tables and manual and using the NCCI tools.
• ICN 901346 June 2020: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/How-To-Use-NCCI-Tools.pdf

Medicare Quarterly Provider Compliance Newsletter

• Newsletter Release Date: July 2020
• What You Need to Know: This newsletter is released on a quarterly basis to share Medicare Contractor Audit Findings and provide information on how to address and avoid top issues in a particular quarter. The July 2020 edition includes information from the following three RAC Auditor Reviews:
• New Issue #0099 – Skilled Nursing Facility Consolidated Billing: Outpatient Facility – Not Separately Payable Services: Unbundling,
• New Issue #0129 – Hyperbaric Oxygen Therapy for Diabetic Wounds: Medical Necessity and Documentation Requirements, and
• New Issue #0103 – Urological Supplies: Medical Necessity and Documentation Requirements.
• ICN MLN5829840 July 2020: https://www.cms.gov/files/document/medicare-quarterly-provider-compliance-newsletter-volume-10-issue-4.pdf

Other Medicare Updates

CMS Announces the Creation of the Office of Burden Reduction and Health Informatics

In a June 23rd Press Release, CMS announced a new Office of Burden Reduction and Health Information meant “to unify the agency’s efforts to reduce regulatory and administrative burden and to further the goal of putting patients first.” CMS Administrator Seema Verma said in the announcement that “The Office of Burden Reduction and Health Informatics will ensure the agency’s commitment to reduce administrative costs and enact meaningful and lasting change in our nation’s health care system…Specifically, the work of this new office will be targeted to help reduce unnecessary burden, increase efficiencies, continue administrative simplification, increase the use of health informatics, and improve the beneficiary experience.”

June 25, 2020: CMS Issues Home Health PPS Proposed Rule [CMS-1730-P] CY 2021

In addition to updating payment rates and wage index for calendar year 2021, “this proposed rule proposes to permanently finalize the changes to §409.43(a) as finalized in the first COVID-19 PHE IFC (85 FR 19230), to state that the plan of care must include any provision of remote patient monitoring and other services furnished via a telecommunications system and describe how the use of such technology is tied to the patient-specific needs as identified in the comprehensive assessment and will help to achieve the goals outlined on the plan of care.”

• Related CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cms-proposes-calendar-year-2021-payment-and-policy-changes-home-health-agencies-and-calendar-year

June 26, 2020: HHS Submits Status Report on Medicare Appeals Backlog at the ALJ Level

In this June 26th report, HHS indicated that they have reduced that “By the end of the second quarter of 2020, a total of 242,995 appeals remain pending at OMHA, which is a 43% reduction from the starting number of appeals identified in the Court’s order (426,594 appeals).”

https://www.aha.org/system/files/media/file/2020/06/alj-delay-status-report-6-26-2020.pdf

AHA Announcement: https://www.aha.org/news/headline/2020-06-26-result-aha-lawsuit-hhs-continues-reduce-appeals-backlog

July 6, 2020: CMS Issues End Stage Renal Disease (ESRD) Prospective Payment System (PPS) Calendar Year (CY) 2021 Proposed Rule (CMS-1732-P)

In addition to proposed updates to payment policies and rates, this rule is also proposing updates to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI and proposes changes to the ESRD Quality Incentive Program (QIP).

• CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-proposes-medicare-payment-changes-support-innovation-and-increased-access-dialysis-home-setting
• CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/end-stage-renal-disease-esrd-prospective-payment-system-pps-calendar-year-cy-2021-proposed-rule-cms

July 15, 2020: OIG Report: Hospitals Overbilled Medicare $1 Billion by Incorrectly Assigning Severe Malnutrition Diagnosis Codes to Inpatient Hospital Claims

This is not the first time the OIG has focused on malnutrition diagnosis codes and based on their findings I do not anticipate this will be the last time. The parameters of the OIG audit included:

• Focusing on Diagnosis Codes E41 (Nutritional marasmus) and E43 (Unspecified severe protein calorie malnutrition), and
• Auditing a random sample of 200 claims with a discharge date in Fiscal Year 2016 or 2017.

OIG Findings:

• 173 of the 200 records reviewed were not correctly billed by the hospitals
• 9 of the 173 incorrectly coded claims the removal of the malnutrition code did not impact DRG assignment or payment.
• The 164 claims that were incorrectly coded results in net overpayments of $914, 128
• The OIG extrapolated their sample and estimated that hospitals received overpayments of$1 billion for FYs 2016 and 2017.

Based on OIG recommendations, “CMS stated that it will instruct its contractors to review a sample of claims in the sampling frame to determine whether they were billed correctly. Based on the findings of the sample review, CMS will determine the appropriate course of action. CMS will recover, as appropriate, any identified overpayments associated with the reviews consistent with agency policy and procedures.” You can read the entire report at https://www.oig.hhs.gov/oas/reports/region3/31700010.pdf.

July 15, 2020: Contract Award for A/B MAC Jurisdiction 6

CMS posted the following information on the CMS MAC What’s New webpage:

“On July 15, 2020, the Centers for Medicare & Medicaid Services (CMS) awarded National Government Services, Inc. (NGS) a new contract for the administration of Medicare Part A and Part B Fee-for-Service (FFS) claims for Illinois, Minnesota, and Wisconsin (Jurisdiction 6). This contract will also administer Medicare Home Health and Hospice (HH+H) FFS claims for Alaska, American Samoa, Arizona, California, Guam, Hawaii, Idaho, Michigan, Minnesota, Nevada, New Jersey, New York, Northern Mariana Islands, Oregon, Puerto Rico, US Virgin Islands, Wisconsin and Washington. As NGS is the incumbent contractor for this A/B MAC jurisdiction, CMS anticipates that implementation of the new contract will go smoothly, with few, if any, service issues for Medicare beneficiaries and providers. Learn more about this at A/B MAC Jurisdiction 6 Award Fact Sheet (PDF).”

July 17, 2020: The Joint Commission’s (TJC’s) Continued Approval of its Hospital Accreditation Program Limited to 2 Years

CMS published their decision to approve TJC for continued recognition as a national accrediting organization for hospitals participating in the Medicare and Medicaid Programs in the Federal Register on July 17, 2020. CMS can approve an accrediting agency for up to 6 years. However, the Final Notice indicated the TJCs continued approval is effective for only two years from July 15, 2020 through July 15, 2022. The following excerpt from the Federal Register outlines CMS reasons for this shorter term of approval:

“This shorter term of approval is based on our concerns related to the comparability of TJC’s survey processes to those of CMS, as well as what CMS has observed of TJC’s performance on the survey observation. Some of these concerns stem from the level of detail TJC provides in the daily briefings it provides to facilities, as well as TJC’s processes surrounding its staff interview practices. Additionally, we are concerned about TJC’s review of medical records and surveying off-site locations, in particular for the Physical Environment condition of participation. Based on these observations and review of TJC’s processes as discussed at section V.A. (Differences Between TJC’s Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements), we remain concerned about the thoroughness of review conducted within the facilities. While TJC has taken action based on the findings annotated in section V.A., as authorized under §488.8, we will continue ongoing review of TJC’s survey processes across all their approved accrediting programs to ensure that all our recommended changes have been implemented. In keeping with CMS’s initiative to increase AO oversight, and ensure that our requested revisions by TJC are complied with, CMS expects more frequent review of TJC’s activities to avoid any continued inconsistencies.”

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

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

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

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

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

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

Coding COVID-19

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

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

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

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

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

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

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

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

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

Mental and Behavioral Disorders Due to Psychoactive Substance Use

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

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

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

Hypertensive Heart and Chronic Kidney Disease

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

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

Vaping-Related Disorders

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

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

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

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

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

Puerperal Sepsis

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

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

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

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

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

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

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

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