In addition, this allows the fire department paramedics and company personnel to tend to the patient . Changes are already occurring in isolated circumstances. According to the FQHC, other than the free use of space, no remuneration would be exchanged between the parties. Is It Really Time to Take Off Your Mask on Public Transit? If you must share a car with people from outside of your household at this point in the pandemic, a new study highlights several methods to make it as safe as possible. A new study finds that rolling your windows down is more effective than car ventilation for improving air circulation and reducing airborne transmission of the coronavirus. We recognize that many physicians who prescribe extended courses of treatment such as chemotherapy, dialysis, radiation therapy, cardio/pulmonary rehabilitation treatment, or behavioral health services to beneficiaries may desire to provide transportation assistance to mitigate the effects of office closures caused by the COVID-19 outbreak or increased risk of exposure to COVID-19 for patients who use public transportation to access care. James Lacy, MLS, is a fact-checker and researcher. Riding in a car with someone outside of your home carries a risk of COVID-19 infection for yourself and others. We recognize that the donation of face masks under these circumstances presents a lower risk of fraud and abuse because it operates to protect the health and safety of the donor physician group and its treating clinicians who furnish services to the nursing home's residents during the public health emergency and who may work closely with the nursing home's staff. 1395nn; 42 U.S.C. Pilot programs allowing medication pickup by rideshares are underway, supplementing existing efforts by Doordash, Postmates, and Deliv. They also recently started delivering groceries, medical supplies, and necessary goods to medically vulnerable or transportation-disadvantaged recipients on behalf of nonprofits, government agencies, and health care organizations. Can an oncology group practice provide free in-kind local transportation to and from an established patient's home to an alternate practice location to receive medically necessary oncology care during the time period subject to the COVID-19 Declaration? Currently, the CDC recommends opening car windows or setting the air ventilation/air conditioner system to non-recirculation mode. The hospital would receive no payment from any (i) independent physician to whom it grants free access to the platform, or (ii) payor for services furnished through its telehealth platform by the independent physicians. Finally, the Organization's provision of administrative services to HCPs would not operate in conjunction with any other arrangement or agreement between and among the Organization, the HCPs, any Federal health care program beneficiary who receives vaccinations from one of the sites, or any other person or entity in a position to refer or arrange for the referral of items or services reimbursable by a Federal health care program. The paramedic or EMT performing CPR is also required to wear personal protective equipment. That can be a sign of stroke or other serious illness. Although we are making every attempt to provide an accurate response to questions posed in the context of the exigent circumstances unique to the COVID-19 public health emergency, due to the limited scope of facts presented to uswhich are not certifiedany favorable answer will not result in prospective immunity or protection from OIG administrative sanctions or prospective immunity or protection under Federal criminal law. 2023 Dotdash Media, Inc. All rights reserved, Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. In addition, we recognize that this scenario also involves potential direct or indirect financial relationships between the non-governmental donor entity providing funding, the FQHC, and Federal health care program beneficiaries, and there are different potential fraud and abuse risks with respect to those relationships. Many people who need an ambulance ride to the hospital will find themselves faced with an out-of-network bill for that service. Where do I sign my attestation? The Organization stated that it has the experience and expertise to provide reliable administrative services for vaccination sites. In contrast, if the pharmacy were to bill Federal health care programs foror otherwise were to receive Federal or State funding (e.g., through the Coronavirus Aid, Relief, and Economic Security Act) to cover the costs associated withthe items and activities for which the clinical laboratory would reimburse the pharmacy, such remuneration could constitute a problematic double payment and could evidence unlawful intent under the Federal anti-kickback statute. A complex chain of financial pressures affected state ambulance providers during the COVID-19 public health crisis. Similarly, depending on the facts and circumstances, providing free goods or services to Federal health care program beneficiaries may implicate the Beneficiary Inducements CMP. How Much Do Ventilation Systems Help Reduce COVID Transmission? People are sick, losing jobs, postponing im." Joe M Anderton on Instagram: "The effects of Covid-19 have been widely devastating. Under the unique and exigent circumstances resulting from the COVID-19 outbreak, we believe that modest, in-kind transportation assistance (e.g., a voucher or reimbursement for taxi or ridesharing services or a driver or ridesharing service paid for by the practice)-that does not otherwise satisfy the conditions set forth in the existing safe harbor for local transportation-provided for free to established patients of an oncology practice would present a low risk of fraud and abuse under the Federal anti-kickback statute and the Beneficiary Inducements CMP and could improve beneficiaries' access to oncology care in certain circumstances. Lyft is delivering meals to students who normally received subsidized school meals, and to senior citizens. While having all the windows down was more beneficial than turning on the ventilation, opening specific car windows also made a difference. Under certain circumstances, such as the Federal Communications Commission distributing grants to certain providers to fund Telecommunications Technologies, the remuneration (i.e., the grant funds) from the "donor" (i.e., the Federal Government) to the provider would not implicate the Federal fraud and abuse laws. In addition, individuals would be screened for eligibility after being referred to the FQHC for case management services, but the offer or provision of gift cards would not be conditioned on the individual's past or anticipated future use of the FQHC's services reimbursable in whole or in part by Federal health care programs. It's a risk based decision, said Hahn. Your submission of a question does not obligate OIG to take action, including responding to the question, making the question public, or issuing public feedback. In your submission, please provide sufficient facts that allow for an understanding of the key parties and terms of the arrangement at issue. Both offer financial assistance to drivers self-quarantining with a doctor's note. Drawing upon decades of experience, RAND provides research services, systematic analysis, and innovative thinking to a global clientele that includes government agencies, foundations, and private-sector firms. 8. FQHCLAs deliver comprehensive primary care services to some of the country's most vulnerable individuals and families in areas where economic, geographic, or cultural barriers may limit access to affordable health care services. . Christopher Whaley is a policy researcher at RAND and a professor at the Pardee RAND Graduate School. OIG's longstanding guidance makes clear that, depending on the facts and circumstances, the provision of free or below fair market value goods or services to an actual or potential referral source may violate the Federal anti-kickback statute. Similarly, drivers cannot be used to transport patients with suspected or confirmed COVID-19, based on CDC guidance. This question is outside the jurisdiction of OIG's authorities. The Secretary may extend the [public health emergency] declaration for subsequent 90-day periods for as long as the [public health emergency] continues to exist, and may terminate the declaration whenever he determines that the [public health emergency] has ceased to exist." Section II(B)(18) of the blanket waivers protects a compensation arrangement that is neither set forth in writing nor signed by the parties but otherwise fully complies with an applicable physician self-referral law exception. Under the Ambulance Fee Schedule, Medicare Part B pays 80 percent of the approved amount, and the beneficiary is responsible for 20 percent of the approved amount as well as the applicable Part B deductible, if it has not yet been met. Medical necessity for COVID-19 patients. OIG has previously expressed concerns that such compensation arrangements could promote overutilization. The Waiver is effective retroactively to Medicare claims for services rendered on or after March 1, 2020. 0 Emergency Medicine Author has 946 answers and 1.6M answer views Updated 3 y. We also understand that some of these lodging facilities have closed as a result of the COVID-19 public health emergency. programs offered at an independent public policy research organizationthe RAND Corporation. Just like it's illegal to hold onto children and infants in your personal vehicle while it's traveling, the same holds suit in the back of an ambulance. Remuneration from an entity to a physician (or the immediate family member of a physician) resulting from a loan to the physician (or the immediate family member of the physician): (1) with an interest rate below fair market value; or (2) on terms that are unavailable from a lender that is not a recipient of the physician's referrals or business generated by the physician. Jocelyn Solis-Moreira is a journalist specializing in health and science news. Andrea Richardson @ASRichardson3, Tamara Dubowitz @TamaraDubowitz, Shanthi Nataraj, Krishna B. Kumar @kbkumar_. As with many underlying conditions, COVID-19 appears to pose an extra risk for people with kidney failure and patients undergoing dialysis, said Dr. Alan Kliger, a nephrologist at Yale. Parties must separately assess any fraud and abuse risks that may arise with respect to any direct or indirect financial relationships between the donor and the FQHC or Federal health care program beneficiaries. The letter from the ambulance. Door-to-door service involving light assistance from the driver is being explored under other new pilots. We welcome your comments as they assist us to improve our services. What are the implications, under OIG's administrative sanction authorities, of an ambulance provider or supplier waiving or discounting beneficiary cost-sharing obligations (required by the Medicare program) resulting from ground ambulance services paid for by the Medicare program under a waiver established pursuant to section 1135(b)(9) of the Social Security Act? Accordingly, the arrangement implicates the Beneficiary Inducements CMP. RAND is nonprofit, nonpartisan, and committed to the public interest. Under the unique circumstances resulting from the COVID-19 outbreak, we believe that the provision of free or discounted lodging by an oncology practice to financially needy Federal health care program beneficiaries otherwise eligible for lodging at a nonprofit lodging facility presents a low risk of fraud and abuse if certain conditions are met. Not only is it dangerous to drive yourself to a hospital when you're experiencing these symptoms, but it will also take extra time that can prevent you from getting the care you need as soon as you need it. Passengers are permitted to ride in the back of a pickup or flatbed truck only if the truck bed includes a federally-approved restraint system. When you are in a confined environment, there is a risk of airborne infection, especially in ride-sharing trips that take just 15 to 20 minutes," Mathai tells Verywell. But when youre in an enclosed space like a car, theres not much opportunity to social distance, Sri Banerjee, PhD, an epidemiologist at Walden University who previously studied infectious diseases at the Centers for Disease Control and Prevention (CDC), tells Verywell. We also acknowledge that some vulnerable patient populations may not own or have access to the necessary technology or data services to facilitate these services. hbbd``b` $f F7 V$R@+ $b^X u "Hf L* ;)'3&~0 F doi:10.1126/sciadv.abe0166. However, there are exceptions to this rule such as when the patient is unconscious, a minor, intoxicated or mentally incompetent. An FQHC has received funding from a non-governmental donor to be used to provide free COVID-19 diagnostic testing to vulnerable populations that may have difficulty accessing testing due to low income, lack of transportation, or other barriers. While the group practice may be able to structure such transportation arrangements to comply with the existing safe harbor for local transportation, 42 C.F.R. Lyft and Uber have issued guidance to their drivers around safe operations, including disinfecting the in-vehicle environment and not driving when ill. Under some state and regional COVID-19 vaccine plans, providers and suppliers such as hospitals, pharmacies, and health systems play a critical role in the storage, distribution, redistribution, and administration of COVID-19 vaccines. Patients need to be advised that if they have confirmed or suspected COVID-19 and are seeking help or are experiencing a medical emergency, rideshares are not the right transportation option. TNCs can do more than just provide NEMT during the current crisis. This perspective was supported through an ongoing project on NEMT sponsored by Lyft. OIG has longstanding and continuing concerns regarding the provision of cash or cash equivalents to Federal health care program beneficiaries. While experts recommend limiting yourself to essential travel, if you have to travel in a car with a person outside of your household, its necessary to take precautions. We believe the proposed arrangement offers the possibility of substantial public health benefits through the identification of additional potential convalescent plasma donors and valuable public health information and data and would pose a sufficiently low risk of fraud and abuse, provided the proposed arrangement includes the following safeguards: (1) the physicians ordering the laboratory tests, including the free COVID-19 antibody tests, would not receive any payments or anything else of value from the clinical laboratory in connection with the free antibody testing program; (2) the patients receiving the laboratory tests would not receive any payments or anything of value, other than the free COVID-19 antibody test, from the clinical laboratory in connection with the free antibody testing program; (3) the tests would be offered only to patients receiving other medically necessary blood tests as part of a medically necessary exam or treatment; (4) no payor, including the patient, a commercial insurance company, or a Federal health care program, would be billed for or pay any costs in connection with the COVID-19 antibody tests; and (5) the antibody tests are cleared or approved by the U.S. Food and Drug Administration (FDA) or are subject to an FDA-issued Emergency Use Authorization. Study: Temperature and Humidity May Indicate COVID-19 Transmission Risk, Evusheld No Longer Authorized to Prevent COVID. Because each vehicle is designed differently, a study design would need to be customized to apply to the specific dimensions of the vehicle. See U.S. Department of Health and Human Services, Determination that a Public Health Emergency Exists (Jan. 31, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx (COVID-19 Declaration). We recognize that FQHCs deliver care to some of the nation's most vulnerable individuals and families, including Federal health care program beneficiaries. on the guidance repository, except to establish historical facts. Within airplanes, theres a lot of areas for air to circulate, so theres not as much risk of repeat exposure to the same virus. We encourage parties to review the recent guidance published by the Office for Civil Rights regarding the use of audio or video communication technology to furnish telehealth services during the COVID-19 public health emergency: "Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency. Before sharing sensitive information, make sure youre on a federal government site. However, we believe that there are scenarios in which an HHA and an assisted living facility could work together to fill critical gaps caused by the COVID-19 outbreak to provide necessary health care services to vulnerable beneficiaries residing in an assisted living facility. Narrator: Simultaneously, the paramedics are checking the patient's overall condition, looking at their airway, breathing, and circulation. Can mental health and substance use disorder providers accept donations from public entities (i.e., local, State, or Federal government entities), private charitable foundations, or health plans to fund cell phones, service or data plans, or both for patients who are financially needy or who do not own their own cell phone for the purpose of furnishing medically necessary services while in-person care is disrupted during the COVID-19 outbreak? In particular, we believe such transportation assistance would present low risk so long as the transportation assistance is: (i) provided by an "eligible entity" to an "established patient," as those terms are defined under 42 C.F.R. Toll Free Call Center: 1-877-696-6775, https://oig.hhs.gov/faqs/advisory-opinions-faq.asp, https://oig.hhs.gov/compliance/alerts/index.asp, OIG Policy Statement Regarding Application of Certain Administrative Enforcement Authorities Due to Declaration of Coronavirus Disease 2019 (COVID-19) Outbreak in the United States as a National Emergency, Blanket Waivers of Section 1877(g) of the Social Security Act (the Act), https://www.hhs.gov/provider-relief/index.html, Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency, https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx, https://www.phe.gov/Preparedness/legal/Pages/phe-qa.aspx#faq7. For example, under some State plans certain providers and suppliers assume responsibility for storing COVID-19 vaccines in cold or ultracold storage and redistributing (which includes, in certain instances, transporting) vaccines to other providers and suppliers, some of which may be actual or potential referral sources. In general, a patient is permitted to refuse medical assistance and if they do, providers cannot force the patient to accept any services. James received a Master of Library Science degree from Dominican University. You also should call 911 if you have trouble seeing and . Providing free testing to individuals who are not Federal health care program beneficiaries would be unlikely to implicate the Federal anti-kickback statute or Beneficiary Inducements CMP. The "OIG Policy Statement Regarding Application of Certain Administrative Enforcement Authorities Due to Declaration of Coronavirus Disease 2019 (COVID-19) Outbreak in the United States as a National Emergency" does not incorporate sections II(B)(12)-(18) of the blanket waivers of the physician self-referral law as issued by the Secretary. The school nurse checked Brasfield's pulse, found it too fast to count and called 911 for an ambulance. Can a home health agency's (HHA) staff members furnish free blood draws-provided that such blood draws are within the scope of the staff's licenses-to assisted living facility residents who are Federal health care program beneficiaries and are not patients of the HHA? The TNC must be able to work within the state statutes on NEMT, and within the state dictated operating model, such as working with health plans, transportation brokers, and/or state agencies to coordinate service. The Office of Inspector General (OIG) recognizes that, in the current public health emergency resulting from the outbreak of the COVID-19, the health care industry must focus on delivering needed patient care.1 As part of OIG's mission to promote economy, efficiency, and effectiveness in HHS programs, we are committed to protecting patients by ensuring that health care providers have the regulatory flexibility necessary to adequately respond to COVID-19 concerns. Typically, one family member or friend can ride to the hospital with the patient. The Organization also explained that the COVID-19 vaccines administered at the sites would be approved by the U.S. Food and Drug Administration (FDA) or subject to an FDA-issued Emergency Use Authorization. Cars dont have the same air filtration system as airplanes, which may be slightly safer because of their HVAC ventilation. In your submission, please provide sufficient facts to allow for an understanding of the key parties and terms of the arrangement at issue.3 OIG will update the FAQ site as we respond to additional frequently asked questions. Can a non-provider philanthropic entity contract to provide certain administrative services to a health care provider relating to the operation of COVID-19 vaccination sites and be compensated on a per-vaccine basis? authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically California Consumer Limit the Use of My Sensitive Personal Information, California Consumer Do Not Sell or Share My Personal Information. Ticket Fines for Riding in the Bed of a Truck in California. Patients who. The laboratory's stated purpose for the arrangement is to increase patient awareness of antibodies to promote donations of COVID-19 blood plasma, which could be used for certain experimental convalescent plasma therapy treatments for COVID-19. Documentation to support medical necessity and the qualifying communitywide EMS protocols must be maintained by the ambulance providers and suppliers and provided to CMS contractors, such as part of a medical review, upon request. Sitting in the back of the car and opening the window farthest away from you may also improve air circulation and reduce exposure to aerosol droplets. Other NEMT options, such as family or friends driving, ambulances or handivans picking up individuals, become difficult in a pandemic as resources become scarce and people isolate themselves by necessity. This could help Uber, Lyft, and taxis in knowing which windows to open for the safety of the passenger, Mathai says. A Canadian woman had to be resuscitated by rescue teams after losing her pulse while clinging on to a log in Zion National Park's Virgin River. While any type of traveling can increase your chances of COVID-19 exposure, riding in a car is especially risky because passengers are in a confined space. This is to limit the spread of Covid-19 and to keep patient . OIG's longstanding guidance makes clear that, depending on the facts and circumstances, the provision of free goods or services to an actual or potential referral source of Federal health care program business may implicate the Federal anti-kickback statute. Researchers from the University of Massachusetts at Amherst and Brown University performed computer models on the likelihood of airborne transmission from one occupant in a car to another. Providing free laboratory testing to Federal health care program beneficiaries implicates the Federal anti-kickback statute because the clinical laboratory would be providing something of value for free to beneficiaries who could self-refer to the laboratory for items and services reimbursable by a Federal health care program. 5Note that "[a public health emergency] declaration lasts until the Secretary declares that the [public health emergency] no longer exists or upon the expiration of the 90-day period beginning on the date the Secretary declared a [public health emergency] exists, whichever occurs first. Understanding how to reduce COVID-19 transmission in the air is important in preventing future infections. How Long Is COVID-19 Contagious? The most surprising finding was that if one occupant could potentially infect the other, opening the window next to you might not necessarily be the best option, Mathai says. I am an eligible provider who received a distribution through the CARES Act Provider Relief Fund. Specifically, based on the facts included in the question submitted to us, the distribution of grant funds would be administered through one of the FQHC's social services programs, and the FQHC would: (1) screen for financial need (demonstrated by an individual's enrollment in Medicaid or by an uninsured individual's attestation of annual income); (2) screen for COVID-19-related financial need to confirm that an individual has lost more than 50 percent of his or her income due to the COVID-19 public health emergency; (3) document each individual's satisfying of the two-pronged financial need criteria; (4) explain to a recipient, and require a signed acknowledgment from each recipient, that eligibility for the cash assistance is not tied to becoming a patient of the FQHC, or for individuals who are the FQHC's patients continuing to receive care from the FQHC; (5) limit any cash-equivalent gift card to $100 to $200 (depending on family size); (6) track to ensure a patient receives gift card assistance only once; and (7) refrain from advertising the program. So even if someone isnt showing symptoms, they can still spread the virus. Such efforts could be necessary if rideshare drivers and TNCs are going to be depended upon to provide essential services at this time. The only way I could describe the feeling would be a steamroller starting at the bottom of my lungs. 3OIG plans to review all submissions, develop responses as appropriate to FAQs, and make such responses publicly available on its website by updating this site. "Ambulance officers across the country have been directed to only transport family members with patients in exceptional circumstances. Can the FQHC furnish cash-equivalent gift cards, in specified amounts, to address social determinants of health for financially needy individuals, including Federal health care program beneficiaries who meet certain criteria? In the limited context of the COVID-19 outbreak and in light of certain flexibilities in coverage for various telehealth and other virtual services payable by Federal health care programs, we believe the provision of a cell phone, service or data plan, or both (individually or collectively, "Telecommunications Technologies") by a mental health or substance use disorder provider to a patient likely presents a sufficiently low risk of fraud and abuse so long as the arrangement includes the following safeguards: (i) the provider determines in good faith that the patient is in financial need in advance of providing the Telecommunications Technologies; (ii) the provider determines in good faith that the patient requires Telecommunications Technologies to access medically necessary services related to his or her mental health or substance use disorder treatment; (iii) all services furnished using the Telecommunications Technologies are medically necessary, which lowers the risk of overutilization or inappropriate utilization; (iv) the provider uses the third party's funding solely for Telecommunications Technologies; (v) the provider does not market the Telecommunications Technologies (e.g., offer or provide free phones to generate business); (vi) the provider offers the Telecommunications Technologies only to "established patients" as that term is defined under 42 C.F.R.

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