Transcription

Fraud, Waste,and Abusein the Context ofJANUARY 2022

The Healthcare Fraud Prevention Partnershipwould like to thank participating Partnersfor their contributions.This paper was prepared in collaboration with Annika M. Dries,Neera Ahuja, Jason Hom, and Tina Hernandez-Boussard.For questions related to this white paper,please email [email protected]

TABLE OFCONTENTSExecutive Summary.2Introduction and Objectives.3HFPP and Fraud, Waste, and Abuse Prevention.3Objectives.3COVID-19 and its Impact on Healthcare.6COVID-19 Introduction.6Testing.7Treatments and Vaccines. 9Personal Protective Equipment (PPE).11Changes to Practices and Policies.12Waivers and Policy Adjustments.12Billing Codes.15Telehealth. 18Prescriptions.19COVID-19 Public Health Emergency Fraud, Waste, and Abuse Schemes.21Billing Potentially Unnecessary Services.21Respiratory Pathogen Panels (RPPs). 21Other Lab Testing.22Evaluation of Cardiac MRI for COVID-19 Patients.22Non-Evidence-Based Treatments.22Incorrect Coding and Billing. 23Direct Solicitation and Identity Theft.24Fraud, Waste, and Abuse Detection, Enforcement, Prevention,and Mitigation Methods.26Detection.26Collaborative Efforts.26Data Analysis.27Enforcement.29Prevention and Mitigation.29Conclusions and Future Directions.31References.33Addendum – Useful Articles, Resources, and Sites. 371The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.

EXECUTIVESUMMARYSince early 2020, coronavirus disease 2019 (COVID-19), caused by the severeacute respiratory syndrome coronavirus 2 (SARS-CoV-2), has significantly shapedpublic life and healthcare delivery in the United States. The novel anddevastating virus led to necessary and comprehensive changes in the nation’shealthcare system. As in any rapidly developing healthcare situation, potentialvulnerabilities for healthcare fraud, waste, and abuse arose for bad actors tocapitalize upon. To mitigate these actions, stakeholders, including federal, state,and local agencies, private payers, law enforcement, and healthcare anti-fraudassociations, responded and collaborated extensively.This white paper outlines background information on COVID-19 and its impacton healthcare delivery, frequently observed, pandemic-related fraud, waste, andabuse schemes, and the methods used to prevent schemes. During this time,traditional fraud schemes were modified and appeared with new entry pointsto the system: COVID-19 testing, services, and treatments. Expedited due to thepandemic and social distancing measures, the transition to increasedtelemedicine services provided an avenue for bad actors to adapt previouslyexisting fraud schemes to take advantage of patients. This evolution inhealthcare delivery is a topic of growing concern, with action taken by the U.S.Department of Justice (DOJ) Criminal Division Fraud Section’s Health CareFraud Unit in September 2020 identifying 4.5 billion in allegedly false andfraudulent claims related to telemedicine fraud.Balancing the delivery of necessary healthcare services with the needed fraud,waste, and abuse controls is vital for the healthcare system to be resilient to theimpact of the COVID-19 pandemic. Within this context, this paper will describeevents relating to the Public Health Emergency (PHE), suspect and fraudulentschemes, and methods to address acts of fraud, waste, and abuse observedduring 2020 and the beginning of 2021.2The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.

INTRODUCTIONAND OBJECTIVESHFPP and Fraud, Waste, and Abuse PreventionThe Healthcare Fraud Prevention Partnership (HFPP) is a voluntary,public-private partnership between the federal government, state and localgovernment agencies, law enforcement, private health insurance plans,employer organizations, and anti-fraud organizations that seeks to identify andreduce fraud, waste, and abuse across the healthcare sector.1 To advance thiseffort, HFPP Partners regularly collaborate, share information and data, andconduct studies using a unique cross-payer data set. Additionally, the HFPP’sbroad membership provides a platform to discuss emerging healthcare issues.As a part of its mission, the HFPP publishes white papers focused on relevantand emerging fraud, waste, and abuse topics. These publications are a methodof revealing fraud, waste, and abuse schemes, as well as highlighting importantstrategies and actions HFPP Partners and other healthcare stakeholders cantake to counter them. Previous white papers have reviewed opioids, clinicallaboratory testing, and genetic testing. For example, the white paper, GeneticTesting Fraud, Waste, and Abuse,2 recently brought together new informationfor commonly observed fraud, waste, and abuse schemes and best practicesinvolved in the expansion of genetic testing services.ObjectivesCoronavirus disease 2019 (COVID-19), caused by the severe acute respiratorysyndrome coronavirus 2 (SARS-CoV-2), has significantly impacted public life andhealthcare delivery. Beginning in January 2020, the World Health Organization(WHO) and Centers for Disease Control and Prevention (CDC) took note of thevirus and the rapidly developing healthcare situation, and by the end of themonth, both organizations declared a PHE.3 The virus and its impacts quicklyspread – from the declaration of the PHE on January 31, 2020 through February2021, there were over 27 million cases of COVID-19 in the United States, with over500,000 deaths attributed to the virus.4,5 In response, numerous waivers andpolicy changes were implemented within the first months of the PHE to providethe flexibility needed for healthcare providers and payers to address the drasticshift in healthcare needs stemming from COVID-19.3The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.

As these necessary changes were implemented, bad actors repurposed andmodified fraud, waste, and abuse schemes to adapt to the evolving healthcarelandscape. For example, telemarketing schemes involving direct solicitationhave evolved since the early 1990’s and have historically been associated withlaboratory testing, genetic testing, and the unnecessary sale of durable medicalequipment and back braces, among others.2,6,7,8 To fit within the context of thePHE, fraudsters have now modified this scheme to include COVID-19 testing. Assuch, this paper outlines how fraud schemes have adapted to the changedhealthcare environment.In fiscal year 2020, the Department of Justice (DOJ) opened 1,148 newhealthcare fraud investigations, consistent with the number of yearlyinvestigations observed over the past decade.9 Although healthcare fraudschemes occurred prior to the PHE, fraudsters have adjusted to COVID-19, andtherefore, efforts to prevent and mitigate healthcare fraud must also adapt. Toaddress these concerns, this paper describes the vigorous response of federal,state, and local agencies, private payers, healthcare anti-fraud associations, andlaw enforcement, who worked together to combat this adapted fraud, waste,and abuse by collaborating extensively, anticipating vulnerabilities associatedwith various healthcare flexibilities and waivers, and working to actively mitigatethose vulnerabilities.The primary goal of this white paper is to provide an overview of fraud, waste,and abuse associated with COVID-19 testing, prevention, treatment, and care.Insights gained from HFPP Partners during interviews conducted in the fall of2020, additional feedback provided through January 2021, as well as a review ofavailable literature, contribute to meeting the following objectives:1) Provide background information on the COVID-19 PHE and highlightareas of focus for healthcare payers2) Describe fraud, waste, and abuse schemes related to the delivery ofcare for COVID-19, as well as schemes that capitalize upon the PHE3) Identify methods used to detect, take enforcement action against,mitigate, and prevent fraud, waste, and abuse schemes in the contextof the COVID-19 PHE4The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.

The following sections outline COVID-19 related fraud, waste, and abuse in thecontext of the COVID-19 PHE from a healthcare payer perspective. Robustanti-fraud practices related to COVID-19 (e.g., monitoring for fraudulentadvertisements of medical products claiming inaccurate COVID-19 preventionand treatment abilities) occurred in addition to efforts described within thescope of this white paper.10 The fact that the PHE is ongoing at the time of thiswhite paper’s publication, as well as other limitations regarding collection ofdata (e.g., in many health plans, delays between when services are furnishedand when claims may be submitted), creates certain constraints. Therefore, thispaper is intended to provide a snapshot of HFPP Partners’ experiences fromearly 2020 through January 2021, along with relevant events that occurredacross approximately the same timeframe, to inform best practices to reducefraud, waste, and abuse during both the COVID-19 pandemic and potentialfuture healthcare emergencies.5The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.

COVID-19 AND ITS IMPACTON HEALTHCARECOVID-19, discussed in detail below, created several concerns in the healthcaredomain, including for healthcare payers. As the virus spread, the need fortesting, treatment, and personal protective equipment (PPE) increased.Additionally, changes to policies and practices addressing billing codes,telehealth, and prescriptions, among other areas, were swift andcomprehensive. These developments triggered the concern that the changescould lead to modified healthcare fraud, waste, and abuse.COVID-19 IntroductionCOVID-19 is caused by SARS-CoV-2 (an RNA virus).11 Symptoms, shown in Figure 1below, can include one or more of the following: fever or chills, cough, shortnessof breath or difficulty breathing, fatigue, muscle or body aches, headache, loss oftaste or smell, sore throat, congestion or runny nose, nausea or vomiting, and/ordiarrhea. Symptoms may appear between 2 and 14 days after exposure to thevirus, or infected individuals may remain asymptomatic.12 There is a widespectrum of clinical presentations in symptomatic patients, with some patientsexperiencing transient and self-limited cold-like symptoms and other patientspassing away from sepsis, acute hypoxic respiratory failure, or otherlife-threatening conditions.12,13 Research indicates that various risk factors,including increased age and underlying medical conditions (e.g., cancer, chronickidney disease, heart conditions, immunocompromised state, obesity,pregnancy, sickle cell disease, smoking, and Type 2 diabetes mellitus), canincrease the risk for COVID-19 and shape disease severity.14 Evidence alsosuggests Hispanic, Black, and American Indian/Alaska Native patients bear adisproportionate burden of COVID-19 risk factors and are more susceptible toserious complications.15,16,176The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.

COVID-19 SYMPTOMSRUNNY NOSEFEVERBODY ACHESDIFFICULTY BREATHINGSORE THROATFigure 1: COVID-19 SymptomsMutations in the virus identified in late 2020 led to various new strains, includingsome with demonstrated increased transmission rates, also being a concern.18After rapid increases of COVID-19 in certain geographic regions during late 2020,genomic surveillance unveiled several new variants of SARS-CoV-2. For example,the B.1.1.7 lineage, originating in the United Kingdom, has been shown to spreadmore easily and quickly than other variants. The B.1.351 lineage was originallydetected in October 2020 in South Africa and was discovered in the UnitedStates in late January 2021 with initial evidence indicating one of the spikeprotein mutations may affect neutralization by some polyclonal and monoclonalantibodies. During the same timeframe, the P.1 lineage, originating in Brazil, wasalso detected in the United States and notably contains a set of additionalmutations that may impede its ability to be recognized by antibodies, aconsideration for potential for reinfection and further evaluation of vaccineefficacy.TestingThroughout the PHE, there has been a focus on COVID-19 testing in order todetect, treat, and limit the spread of the virus. During the early global spread ofthis virus, the lack of accessible testing hampered the possibility for healthcareprofessionals, policymakers, and citizens to mitigate community spread.Additionally, increased demand for testing led to the presence of fraudulent testkits for COVID-19 being sold online.19 Over the course of the PHE, testing hasbecome more readily available and there have been several efforts to publiclytrack the testing results. For example, the Johns Hopkins Coronavirus Centercaptured daily figures including positive case and death rates across countriesglobally, as well as critical trends such as state hospitalization rates in the UnitedStates, which emerged as an important resource for HFPP Partners, physicians,and the public.207The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.

There are two main categories of laboratory tests available for COVID-19:1) Diagnostic testing through detection of genetic or protein material forcurrent infection including nucleic acid amplification tests (NAATs), suchas reverse transcription polymerase chain reaction (RT-PCR), and antigentesting, a more rapid result test, which are both types of lab assays thatdetect the SARS-CoV-2 virus directly; and2) Antibody testing, which uses a blood sample to identify antibodiesmade by the immune system in response to the virus SARS-CoV-2typically measurable 7 to 14 days after illness onset, indicates a priorinfection, and has been shown to have highly variable sensitivity andspecificity.Nasopharyngeal swab testing (Figure 2) was first evaluated for routine RT-PCRdiagnostic testing,21 followed by the development of additional nasal and salivaswab specimen collections for diagnostic testing. Antigen tests are generally lesssensitive than NAATs. For the detection of the SARS-CoV-2 virus, antigen testingperforms better among symptomatic individuals within 5 to 7 days of symptomonset than asymptomatic individuals.22,23,24COVID-19 TESTINGDIAGNOSTIC TESTING(I.E. RT-PCR)Uses genetic or proteinmaterial collected bynasopharyngeal swaband also by saliva andnasal swab testing options.ANTIBODY TESTINGUses a blood sample toidentify antibodies madeby the immune system inresponse to a threat;for example the virusSARS-CoV-2.Figure 2: COVID-19 TestingIn this description, sensitivity represents the proportion of true positives that arecorrectly identified, while specificity measures the proportion of true negativesthat are accurately identified. In the context of a COVID-19 diagnosis, a falsenegative could lead to further viral community spread, while a false positivecould lead to unnecessary quarantine and additional testing and public healthmeasures. The U.S. Food and Drug Administration (FDA) maintains a list of invitro diagnostic tests that have been issued an Emergency Use Authorization(EUA).258The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.

The required volume of testing for patients, and rapid changes to healthcarepolicies during the PHE, generated concerns about the potential for fraud,waste, and abuse. Key policies and examples of testing fraud schemes are foundin the Changes in Practices and Policies and the PHE Fraud, Waste, and AbuseSchemes sections of this paper.Treatments and VaccinesNumerous treatments for COVID-19 were investigated through clinical trialsthroughout 2020, and preventive vaccines were researched and tested for safetyand efficacy. Several medications were issued EUAs by the FDA for patientshospitalized with COVID-19, including remdesivir (a SARS-CoV-2 nucleotideanalog RNA polymerase inhibitor) in May 2020 and baricitinib (selective inhibitorof Janus kinase [JAK] 1 and 2) in combination with remdesivir in November 2020.Notably, remdesivir received FDA approval for the treatment of COVID-19 inOctober 2020, and clinical trial data demonstrated shorter time to recovery inhospitalized patients with evidence of lower respiratory disease who receivedremdesivir compared to those who received a placebo.26 National Institutes ofHealth (NIH) COVID-19 treatment guidelines also recommendeddexamethasone (corticosteroids) in certain contexts.27 For treatment of mild tomoderate COVID-19, casirivimab and imdevimab (REGEN-COV) administeredtogether showed effectiveness and reduction of viral load that supported FDAcriteria for EUA in November 2020. Specifically, the REGEN-COV treatment hasbeen granted an EUA by FDA for the treatment of mild to moderate COVID-19 inadults and pediatric patients (12 years of age and older weighing at least 40 kg)with positive results of direct SARS-CoV-2 viral testing, and who are at high riskfor progressing to severe COVID-19 and/or hospitalization.28 Bamlanivimab andetesevimab administered together were also granted an EUA in February 2021for the same use as REGEN-COV. 29,*Additionally, two vaccines, using mRNA, showed promising data in Phase IIIclinical trials performed in 2020, demonstrating safety and efficacy in preventingsymptomatic COVID-19 in adults.30 In mid-December 2020, the FDA grantedEUAs to allow two mRNA vaccines (developed by Pfizer-BioNTech andModernaTX, Inc.) to be administered to individuals 16 years of age and older(Pfizer-BioNTech), and to individuals 18 years of age and older (ModernaTX, Inc.).†*Bamlanivimab alone was revoked in April 2021 due to the sustained increase of viral variants in the US that were resistant tobamlanivimab alone treatment. Updates to FDA COVID-19 Emergency Use Authorizations can be found on the FDA website.website.†In May of 2021, FDA expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine for use in adolescents12 to 15 years of age. Updates to FDA COVID-19 Emergency Use Authorizations can be found on the FDA website.The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.9

In late February 2021, the FDA issued an EUA for a third vaccine for theprevention of COVID-19 caused by SARS-CoV-2. The vaccine, developed byJanssen Biotech, Inc. (Johnson & Johnson), uses an adenovirus mechanism andwas shown to be safe and effective in preventing moderate to severe COVID-19disease. The Johnson & Johnson vaccine is packaged as a one-dose vaccine(versus two spaced doses for the mRNA vaccines) and does not require the sameultra-low temperature storage as the mRNA vaccines.31,32,‡,§Since vaccinations began in December 2020, the CDC has released ongoingrecommendations with respect to the prioritization of vulnerable populations tohelp guide states and localities in the distribution of vaccines. One challenge ofdistribution for mRNA vaccines has been their initial ultra-low temperaturestorage requirements, which led to some vaccine distribution sites havingthawed doses of vaccines at the end of the day that could not be restored forlater distribution.The vaccine distribution process may be vulnerable to fraud, waste, and abuse inparticular from false offers of vaccines available at various vaccination sites. Dailycomplaints have appeared across the United States regarding potentialvaccine-related scams. In Florida for example, there have been complaints ofscammers taking money in exchange for COVID-19 vaccine reservations.Nationwide, there have been concerns that the older adult population that wasprioritized for COVID-19 vaccinations may also be more susceptible to scamcalls.33In light of potential vaccine scams, the Federal Bureau of Investigation (FBI), U.S.Department of Health and Human Services (HHS), and the Centers for Medicare& Medicaid Services (CMS) released a vaccine scam alert on December 21, 2020;these agencies also urged people to consult their state health departmentswebsite for up-to-date information about authorized vaccine distributionchannels and only obtaining the vaccine through such channels.34 This alertparticularly highlighted the reports they have received of scammers using thepublic’s interest in COVID-19 vaccines to obtain personally identifiableinformation and compensation through various schemes.‡On April 13, 2021, the CDC and FDA recommended a pause in the use of Johnson & Johnson’s COVID-19 vaccine. Of the nearly 7million doses administered by this date in the Unites States, a small number of reports of a rare and severe type of blood clot havebeen reported in people after receiving Johnson & Johnson’s COVID-19 vaccine. Following a thorough safety review, the FDA andCDC determined that the recommended pause regarding the use of Johnson & Johnson’s COVID-19 Vaccine in the U.S. should belifted and use of the vaccine should resume. The FDA amended the EUA for the COVID-19 vaccine to include information about thevery rare and serious type of blood clot in people who receive the vaccine. The most up to date information and frequently askedquestions regarding the Johnson & Johnson COVID-19 vaccine can be found on the FDA website.§Based on a review of data submitted by Pfizer Inc., in May of 2021, FDA authorized undiluted, thawed Pfizer-BioNTech COVID-19Vaccine vials to be stored in the refrigerator at 2 C to 8 C (35 F to 46 F) for up to 1 month. Previously, thawed, undiluted vaccinevials could be stored in the refrigerator for up to 5 days.The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. The Secretary or the Secretary’s designees will make the final policies or other decisions.10

The alert from the FBI National Press Office outlined the following indicators forfraudulent activity:34 Advertisements or offers for early access to a vaccine upon payment of adeposit or fee Requests asking you to pay out of pocket to obtain the vaccine or to putyour name on a COVID-19 vaccine waiting list Offers to undergo additional medical testing or procedures whenobtaining a vaccine Marketers offering to sell and/or ship doses of a vaccine, domestically orinternationally, in exchange for payment of a deposit or fee Unsolicited emails, telephone calls, or personal contact from someoneclaiming to be from a medical office, insurance company, or COVID-19vaccine center requesting personal and/or medical information todetermine recipients’ eligibility to participate in clinical vaccine trials orobtain the vaccine Claims of FDA approval for a vaccine that cannot be verified Advertisements for vaccines through social media platforms, email,telephone calls, online, or from unsolicited/unknown sources Individuals contacting you in person, by phone, or by email to tell you thegovernment or government officials require you to receive a COVID-19vaccinePersonal Protective Equipment (PPE)In addition to limited testing availability, the lack of PPE supplies became acentral problem of the pandemic and continues to be a challenge for healthcaresystems and under-resourced healthcare settings. Surgical masks, N95respirators, face shields, goggles, gloves, and contact isolation gowns areexamples of PPE that have risen in demand to help mitigate the spread of thevirus – mainly by protecting against contact, droplet, and airborne transmission.During interviews for the preparation of this white paper, several HFPP Partnersdescribed PPE as a potential inroad for bad actors to obtain member orbeneficiary information. Demand for PPE was high during the beginning of thepandemic, as suppliers were still ramping up production of masks and adequate11The following disclaimer applies: 42 U.S.C. 1320a–7c(a) (6) authorizes the HFPP. All HFPP activities are purely voluntary.HFPP-sponsored communications and activities are to be used solely as avenues by which individual members may share facts,information, or individual input. T

COVID-19, discussed in detail below, created several concerns in the healthcare domain, including for healthcare payers. As the virus spread, the need for testing, treatment, and personal protective equipment (PPE) increased. Additionally, changes to policies and practices addressing billing codes,