1320a-7a(a)(5). . hb```@( 0icI/j:sPq[ Duttp]@X, Uq*s f :n3c`3?3NnB94+ 2H3Q @ % 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. For parties analyzing an arrangement neither set forth in writing nor signed by the parties but that otherwise fully complies with an applicable physician self-referral law exception, we advise parties to consider whether any remuneration stemming from the arrangement implicates the Federal anti-kickback statute. In addition, independent physicians who use the hospital's telehealth platform for free (i) receive no remuneration for use of the platform from the hospital (other than free access to the platform); (ii) must be responsible for appropriately maintaining any required records for patients who receive services using the platform; and (iii) independently bill and receive reimbursement from payors for professional services furnished via the platform. About half of emergency ground ambulance rides result in an out-of-network charge for people with private health insurance, potentially leaving patients at risk of getting a surprise bill, a. 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. However, Varghese Mathai, PhD, assistant professor at the University of Massachusetts Amherst and lead author of a December study published in Science Advances, says this might not be ideal for reducing transmission. 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. However, under the facts described herein, the payment of compensation by HCPs to the Organization in the form of a share of vaccine administration fees paid by third-party payors, including Federal health care programs, presents a sufficiently low risk of fraud and abuse under the Federal anti-kickback statute because of the unique circumstances of the COVID-19 public health emergency, the low risk of overutilization, and the safeguards incorporated into the arrangement, as described above. Former Senior Medic. You must choose from several ambulance companies that CIEMT is contracted with (see list below) to perform these ride-alongs. 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. 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. Although drivers for TNCs could be asked to deliver goods to and between medical facilities, they cannot move medical samples or soiled supplies between medical facilities. for which the physician is otherwise compensated, the anti-kickback statute is implicated" and explained that "[s]uch payments are suspect under the anti-kickback statute because of the implication that one purpose of the payments is to induce the physician's Federal health care program referrals." That configuration allows fresh air to flow in through the back left window and out through the front right window and helps create a barrier between the driver and the passenger. 1001.952(bb), for free or at reduced cost to obtain medically necessary items or services furnished by the eligible entity; (ii) provided only when necessary as a result of the COVID-19 outbreak and during the period subject to the COVID-19 Declaration; and (iii) not air, luxury, or ambulance-level transportation. A visitor to the southern Utah park reported to a . People are sick, losing jobs, postponing important life events, projects, losing chunks of their retirement, and living in a constant state of fear. Learn More. o The person being transported should sit in the backseat of the vehicle. The RAND Corporation is a research organization that develops solutions to public policy challenges to help make communities throughout the world safer and more secure, healthier and more prosperous. With high scalability and an existing service model available, rideshare could address transportation needs. Can a provider or supplier such as a hospital, pharmacy, or health system provide other providers and suppliers with free items and services related to COVID-19 vaccine storage, distribution, redistribution, and/or administration? For more information about the advisory opinion process, including information regarding how to submit an advisory opinion and how long it takes for OIG to process an advisory opinion request, please see https://oig.hhs.gov/faqs/advisory-opinions-faq.asp. 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. In the facts presented, the FQHC would provide the free use of space for the pharmacy to operate a vaccination clinic. 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. In addition, we recognize that the availability of COVID-19 testing may be critical to combatting the current public health emergency. Mathai explains car air ventilation flows from the back to the front window. In the case of the COVID-19 public health emergency, the Secretary has issued subsequent 90-day renewals of the original January 31, 2020, public health emergency determination. With government cooperation, the range of services rideshare drivers could provide and the number of drivers available are limited only by what is safe for the driver and logistically feasible. COVID-19 Requirements: programs offered at an independent public policy research organizationthe RAND Corporation. Drivers receive no formal medical training. With respect to a patient of the FQHC who receives a vaccine administered by the pharmacy, the FQHC would maintain a record of vaccine administration within the patient's medical record. During the time period subject to the COVID-19 Declaration, can a clinical laboratory that bills Federal health care programs for laboratory tests to diagnose COVID-19 pay a retail pharmacy a fee for certain costs that the retail pharmacy incurs related to testing collection sites? While other forms of transportation become increasingly unavailable due to quarantine, lack of access to public transit, or reserving transit for emergencies such as ambulances reserved for transferring COVID-19 patients, TNCs may be uniquely suited to current needs. This response addresses only the provision of free COVID-19 testing by the FQHC to Federal health care program beneficiaries. The pharmacy would direct and operate all aspects of the vaccination clinic, including obtaining patient consents; administering COVID-19 vaccinations to individuals, some of whom may be Federal health care program beneficiaries; observing patients after vaccination and responding to any adverse reactions; and providing all items and services related to vaccine administration (e.g., staff and equipment). 1395nn; 42 U.S.C. Transportation problems are often cited as a barrier to receiving care and medical compliance. 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. 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. Rideshares cannot offer everything, but there are things that could be done to support rideshare in doing the one thing their drivers do very well: move people and things to where they need to be. Reduced transportation options create almost impossible dilemmas. Study: Temperature and Humidity May Indicate COVID-19 Transmission Risk, Evusheld No Longer Authorized to Prevent COVID. 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? 2020. p.eabe0166. Essentially it's just guidance for first responders to follow, said Kurt Hahn, the deputy EMS coordinator for Orange County Department of Emergency Services To make any efforts on scene for about 20 minutes, and then to make a decision as far as if transportation to hospital, be prudent, or if termination of resuscitation would be the ultimate decision on scene.. In response to the COVID-19 public health emergency, various State, local, or municipal authorities (including hospitals, but only where a hospital has the requisite legal authority) have established communitywide emergency medical service (EMS) protocols that require or allow, with patient consent, ambulance providers and suppliers to treat certain patients, including Medicare beneficiaries, "in place" who otherwise, but for the COVID-19 public health emergency, would have been transported to a Medicare covered destination (such as a hospital). 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. 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? "If you have all your windows closed, you are germinating in a closed space without a lot of circulation. 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). In the unique circumstances resulting from the COVID-19 outbreak, we believe that these facts likely would present a low risk of fraud and abuse under the Federal anti-kickback statute and the Beneficiary Inducements CMP provided the free blood draw services being offered by an HHAthrough its staff membersto Federal health care program beneficiaries who are not patients of the HHA and reside in an assisted living facility are: (1) within the scope of practice of the HHA's staff; (2) limited to the period subject to the COVID-19 Declaration; and (3) not contingent upon referrals for any items or services that may be reimbursable in whole or in part by a Federal health care program, either during or after the COVID-19 Declaration period. Therefore, a retroactive waiver of cost-sharing obligations by ground ambulance providers and suppliers for instances in which no ambulance transport was provided but for which the Medicare program retroactively reimburses for these specified services is unlikely to induce the use of those or any other services in the future. 149 0 obj <> endobj on the guidance repository, except to establish historical facts. As such, and except as provided in the last paragraph below, OIG would not take enforcement action against a provider or supplier that furnishes free or discounted goods or services related to COVID-19 vaccine storage, distribution, redistribution, and/or administration. 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 may violate the Federal anti-kickback statute; similarly, depending on the facts and circumstances, the provision of free goods or services to Federal health care program beneficiaries may implicate the Beneficiary Inducements CMP. Final. Ambulances are being told not to transport trauma patients - victims of heart attacks, gunshot wounds, car crashes - to the hospital if they can't be resuscitated in the field. The .gov means its official. The Secretary has issued subsequent 90-day renewals of that original determination. COVID can worsen quickly at home. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. On the fence about calling an Uber to get to an appointment? Except for one bill: $3,000 for an ambulance ride from my local hospital to a larger medical center that my doctors thought was better equipped to treat me. Routine waivers of cost-sharing obligations implicate the Federal anti-kickback statute and the civil monetary penalty provision prohibiting inducements to beneficiaries and may result in overutilization or inappropriate utilization of items and services reimbursable by Federal health care programs. Non-Emergency Medical Transportation (NEMT), transportation to medical appointments, pharmacies, lab visits, and other types of routine care for the transportation-disadvantaged, aims to reduce this barrier. It is our understanding that many FQHCLAs and other providers face financial strain in light of the COVID-19 public health emergency due to shifting demands for health care items and services and, consequently, decreased revenue. Normally the family member or friend will ride in the front cab passenger seat of the ambulance. During the current pandemic, movement has slowed as people shelter in place. For example, the oncology group practice may desire to provide transportation assistance for patient safety reasons to prevent the risk of COVID-19 exposure to patients while using public transportation. We also acknowledge that it may be possible for parties to structure a program to meet the Promotes Access to Care exception to the Beneficiary Inducements CMP (see, e.g., OIG Advisory Opinion 19-02), but we are unable to make this determination without all the relevant facts, and we further note that there is no parallel safe harbor for protection under the Federal anti-kickback statute. 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 protocol is intended to protect EMS workers and to limit the number of people that could potentially be exposed by a possibly infected person. In this role, providers and suppliers may furnish free items and services (e.g., vaccine cold or ultracold storage, staff time, and supplies) to other providers and suppliers that are actual or potential Federal health care program referral sources. The following limitations apply to these FAQs: While an ambulance provider or supplier waiving or discounting beneficiary cost-sharing obligations 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 would implicate the Federal anti-kickback statute and Beneficiary Inducements CMP, OIG believes that such discounts or waivers would represent a sufficiently low risk of fraud and abuse under those statutes, provided the ground ambulance services are billed in accordance with the waiver described further below. NEMT, covered by Medicaid and certain Medicare Advantage plans, is associated with greater use of preventive and primary health care, lower use of emergency services and inpatient services, and timely medical care among certain health conditions. The factors relevant to this assessment include, but are not limited to, the unique circumstances of the COVID-19 public health emergency, the key role of providers and suppliers under current plans related to distribution of COVID-19 vaccines approved or authorized by the Food and Drug Administration (FDA), and that such items and services are furnished consistent with a state or regional COVID-19 vaccine plan submitted to the Centers for Disease Control and Prevention, or are otherwise furnished at the direction of or in coordination with Federal, state, or local public health officials. This question is outside the jurisdiction of OIG's authorities. Ph.D. Student, Pardee RAND Graduate School, and Assistant Policy Researcher, RAND, A rideshare driver wears gloves and a mask while driving following the outbreak of COVID-19, in New York City, March 15, 2020, by Laura Fraade-Blanar and Christopher M. Whaley. During the COVID-19 public health emergency, some patients who receive care from FQHCs may be experiencing additional financial hardships. Can health care providers and practitioners furnish services, not to exceed their scope of practice, for free or at a reduced rate, to assist skilled nursing facilities (SNFs) or other long-term-care providers that are facing staffing shortages due to the COVID-19 outbreak?
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