OIG's longstanding guidance makes clear that, depending on the facts and circumstances, the provision of free space to an actual or potential referral source likely implicates the Federal anti-kickback statute and would not satisfy the requirements of the space rental safe harbor, 42 C.F.R. Babies and children younger than 2 years old Anyone who has trouble breathing or is unconscious Anyone who is incapacitated or otherwise unable to remove the mask without help Masks are meant to protect other people in case the wearer is unknowingly infected but does not have symptoms. As the number of positive COVID-19 cases continues to grow in the Hudson Valley, a new directive for EMS workers is put in place to help prevent the spread of the disease. Riding in a car with someone outside of your home carries a risk of COVID-19 infection for yourself and others. 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. 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. In your submission, please provide sufficient facts that allow for an understanding of the key parties and terms of the arrangement at issue. The informal feedback here applies only to arrangements in existence solely during the time period subject to the COVID-19 Declaration. This way they can be properly secured with a seat belt. In light of these EMS protocols, on May 5, 2021, pursuant to section 1135(b)(9) of the Social Security Act, the Secretary of Health and Human Services waived certain statutory requirements relating to Medicare payments for ground ambulance services furnished in response to a 911 call (or the equivalent in areas without a 911 call system) in cases in which an individual would have been transported to a destination permitted under Medicare regulations but such transport did not occur as a result of communitywide EMS protocols established due to the public health emergency (the Waiver). The FAQ is a favorable response related to ambulance providers and suppliers waiving or discounting beneficiary cost-sharing obligations resulting from ground ambulance services paid for under the CMS waiver waiving certain statutory requirements relating to Medicare payment for ground ambulance services. If, after such analysis, the parties remain concerned about OIG pursuing administrative enforcement authority in connection with remuneration related to such referrals or arrangement, we invite the parties to submit questions to OIGComplianceSuggestions@oig.hhs.gov. Its important to note that this work was looking at airborne infectionlooking at how air flowsnot how you cough and the respiratory droplets that can be released, Mathai says. 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. An ambulance ride costs an average of $1,300 in the United States. Both are working to distribute cleaning supplies to drivers. The only way I could describe the feeling would be a steamroller starting at the bottom of my lungs. OIG's longstanding guidance makes clear that, depending on the facts and circumstances, providing free or discounted goods or services to an actual or potential referral source may violate the Federal anti-kickback statute. 1396b(s). At least three states removed regulatory barriers to allow rideshares to provide NEMT in the last few weeks, some using the 1135 waivers (PDF) under the Stafford Act to exercise greater flexibility. However, we believe that the provision of free items and services related to COVID-19 vaccine storage, distribution, redistribution, and administration would pose a low risk of fraud and abuse under the Federal anti-kickback statute. Final. If you have to ride in a car with someone who has not been in your household during the . %%EOF Cars dont have the same air filtration system as airplanes, which may be slightly safer because of their HVAC ventilation. In the circumstances described in the 2014 Alert, the Medicare program reimbursed physicians for processing and packaging specimens for transport to a clinical laboratory through a bundled payment reported under a particular Current Procedural Terminology code. Patients who. 1001.952(b). These services continue to be needed during a pandemic, especially among the chronically ill, a group which may already face greater transportation barriers than the general public. In the facts presented, the FQHC would provide the free use of space for the pharmacy to operate a vaccination clinic. Theres a risk of the coronavirus on surfaces, but a majority of transmissions are not from it.. 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). Accordingly, the arrangement implicates the Beneficiary Inducements CMP. This could include an expanded service into remote, rural areas. 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? However, there are exceptions to this rule such as when the patient is unconscious, a minor, intoxicated or mentally incompetent. Generally, the service has yielded positive results; studies found patients using rideshare-based NEMT had fewer missed primary care appointments, a lower average wait time, a higher rate of on-time pickup compared to those using other types of NEMT, and lower costs. Reduced transportation options create almost impossible dilemmas. Similarly, we received a question about a SNF or other long-term-care provider filling patient-care needs as a result of staffing shortages with, for example, community dentists or podiatrists who otherwise are not practicing at full capacity during the current public health emergency and are willing to offer their services for free or at a reduced rate to the SNF's patients on a temporary basis. 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. We wanted to understand how the air flows in the car and how to improve this.". 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? 185 0 obj <>stream She holds a Masters in Psychology concentrating on Behavioral Neuroscience. Federal government websites often end in .gov or .mil. David Tan, M.D., president of the National Association of EMS Physicians, explains the precautions being taken by EMTs to keep non-COVID patients safe and help them get the care they need. Still, people have to obtain non-emergency but necessary medical care, including kidney dialysis, chemotherapy, and prenatal care visits. 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. 1001.952(bb); and (vii) the provision of the Telecommunications Technologies is limited to the time period subject to the COVID-19 Declaration, requiring the return of the cell phone, cessation of payment for the patient's service or data plan, or both, after the time period subject to the COVID-19 Declaration. Under the facts described herein, the provision of free COVID-19 diagnostic testing to Federal health care program beneficiaries presents a sufficiently low risk of fraud and abuse under the Federal anti-kickback statute and Beneficiary Inducements CMP because, as described, the program includes the following safeguards: (1) free COVID-19 testing is offered to all patients who request it, regardless of the patient's insurance coverage or lack thereof; (2) beneficiaries who received positive test results would not be referred to the FQHC or to any other specific provider; (3) the FQHC would not offer special discounts or any other free or discounted items or services to beneficiaries who received free COVID-19 testing; (4) no payor, including the beneficiary, a commercial insurance company, or a Federal health care program, would be billed for or pay any costs in connection with the COVID-19 testing services; and (5) the COVID-19 tests are cleared or approved by the Food and Drug Administration (FDA), are subject to an FDA-issued Emergency Use Authorization, or are covered by the Medicare program. 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? 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. In light of the unique circumstances of the current public health emergency, the Secretary has offered regulatory flexibilities to health care entities similar to those requested here via Blanket Waivers of Section 1877(g) of the Social Security Act (the Act), issued March 30, 2020 (the Blanket Waivers). 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 provider or patient. 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. They looked at the differences in air flow when specific windows were open versus when all of the windows were open versus being closed. According to the FQHC, other than the free use of space, no remuneration would be exchanged between the parties. Drivers receive no formal medical training. This response addresses only the provision of free COVID-19 testing by the FQHC to Federal health care program beneficiaries. 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. Patients and physicians would be able to access COVID-19 antibody testing results through the laboratory's patient portal, and the results from the antibody testing program also would be reported to the Centers for Disease Control and Prevention and State public health agencies to further support COVID-19 surveillance and response efforts. Typically, one family member or friend can ride to the hospital with the patient. In light of such guidance, a physician group's provision of free or reduced-cost masks to nursing homes where they provide care to Federal health care program beneficiaries could raise concerns under the anti-kickback statute. In a simulation of two people in a car, the results suggest that better air circulation and less exposure to airborne contaminants were most effective when the passenger sat in the back of the vehicle. The Organization stated that it has the experience and expertise to provide reliable administrative services for vaccination sites. 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. 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. Both offer financial assistance to drivers self-quarantining with a doctor's note. The Centers for Disease Control and Prevention (CDC) also recommends that people with COVID-19 avoid public transportation, ride-sharing, or taxis. hbbd``b` $f F7 V$R@+ $b^X u "Hf L* ;)'3&~0 F By Jocelyn Solis-Moreira According to reports, Diana's ambulance ride to the hospital should have been five to 10 minutes but took 40 minutes because, applying standard French emergency procedures, they drove extremely. We recognize, however, that beneficiary obligations that arise as a result of billing by ambulance providers or suppliers under the Waiver could result in the perception of "surprise billing," particularly with respect to retroactive billing for services that were provided prior to the issuance of the Waiver. Transportation problems are often cited as a barrier to receiving care and medical compliance. Under the state protocol, if EMTs are unable to restart the heart or revive an adult cardiac patient using CPR, defibrillators, medication and other techniques at the scene then they are not to transport them to the hospital. 169 0 obj <>/Filter/FlateDecode/ID[<6B14081871CC16478E0EB20B77719C21>]/Index[149 37]/Info 148 0 R/Length 95/Prev 109230/Root 150 0 R/Size 186/Type/XRef/W[1 2 1]>>stream 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. "Ambulance officers across the country have been directed to only transport family members with patients in exceptional circumstances. As compensation for the enumerated administrative services, each HCP would share a portion of the vaccine administration fees the HCP collects from third-party payors, including Federal health care programs, with the Organization as follows: After the HCP retains a certain amount per hour for the HCP's compensation and to cover the staffing costs associated with the clinicians who administer the vaccine under the HCP's supervision, the HCP would distribute the remaining vaccine administration fee amounts to the Organization. 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. You also should call 911 if you have trouble seeing and . 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. Emergency Medicine Author has 946 answers and 1.6M answer views Updated 3 y. However, providers may find more information about the CARES Act Provider Relief Fund and reach the attestation portal here: https://www.hhs.gov/provider-relief/index.html. authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically Officials say one way a person who dials 911 for a loved one or someone in distress can protect themselves from the virus is by taking a shirt or towel and covering the patient's mouth and nose while you initiate compression only CPR. Riding in a car with someone outside of your home carries a risk of COVID-19 infection for yourself and others. 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. 149 0 obj <> endobj Some studies show that the novel coronavirus can live in the air for up to three hours, so leaving your car's windows open between rides for . Officers, paramedics and an air ambulance attended, but the woman - believed to be in her 30s - was pronounced dead at the scene. OIG expresses no opinion regarding the liability of any party under the Federal False Claims Act, Federal criminal law, or other legal authorities for any improper billing, claims submission, cost reporting, or related conduct. 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. Ticket Fines for Riding in the Bed of a Truck in California. Second, the TNC must have the logistical capabilities to provide NEMT to transportation-vulnerable Medicare and Medicaid recipients. The letter from the ambulance. Understanding how to reduce COVID-19 transmission in the air is important in preventing future infections. Orange County paramedics are on the frontlines for the coronavirus outbreak and with positive cases rising to more than 6,000 the Hudson Valley Regional EMS Council has adopted the states Cardiac Arrest Standard of Care during the COVID-19 Pandemic. 442 U.S.C. We also understand that some of these lodging facilities have closed as a result of the COVID-19 public health emergency. 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. Within airplanes, theres a lot of areas for air to circulate, so theres not as much risk of repeat exposure to the same virus. Helping Coastal Communities Plan for Climate Change, Measuring Wellbeing to Help Communities Thrive, Assessing and Articulating the Wider Benefits of Research, >Non-Emergency Medical Transportation in the Time of COVID-19, confirmed or suspected COVID-19 and are seeking help or are experiencing a medical emergency, medically vulnerable or transportation-disadvantaged recipients, In Pittsburgh: Feeding the Needy, and Protecting Workers on the Front Lines of the Pandemic, Protecting Household Employers and Workers During the COVID-19 Pandemic, What Autonomous Vehicles Could Mean for American Workers. 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. Although drivers can bring a transportation-vulnerable individual to a pharmacy anywhere across the country, they don't have scaled capabilities to pick up the prescription and deliver it to the individual's home. We note that the same factors would not be present for providers, suppliers, or other individuals and entities that distribute, redistribute, or administer adulterated, counterfeit, or fraudulent COVID-19 vaccines, or that otherwise attempt to induce or generate Federal health care program business by providing free items and services in connection with COVID-19 vaccines or other medical countermeasures not approved or authorized by the FDA. If PPE supplies were sufficient to satisfy the needs of medical providers, rideshare drivers, as public-facing essential personnel, may be appropriate recipients of masks. 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. We also acknowledge that it may be possible for parties to structure the provision of free or reduced-cost lodging to meet the Promotes Access to Care exception to the Beneficiary Inducements CMP (see, e.g., OIG Advisory Opinion 17-01), 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. Upon arrival for your ride-along shift, you will be required to sign a liability waiver and agree to a routine wants and warrants check by the on-duty watch commander. hb```@( 0icI/j:sPq[ Duttp]@X, Uq*s f :n3c`3?3NnB94+ 2H3Q @ % 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. We understand that Federal health care program beneficiaries with cancer, who are receiving chemotherapy or radiation treatment, sometimes qualify for free or discounted housing at a nonprofit lodging facility near treatment sites while receiving treatment. People are sick, losing jobs, postponing important life events, projects, losing chunks of their retirement, and living in a constant state of fear. We further understand that some patients with cancer, including Federal health care program beneficiaries, must travel longer distances from their homes to receive chemotherapy or radiation treatment because of practice closures or consolidation of practice sites resulting from the COVID-19 public health emergency. In addition, this allows the fire department paramedics and company personnel to tend to the patient . Each breath was going to be a . This question is outside the jurisdiction of OIG's authorities. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Andrea Richardson @ASRichardson3, Tamara Dubowitz @TamaraDubowitz, Shanthi Nataraj, Krishna B. Kumar @kbkumar_. The Pardee RAND Graduate School (PardeeRAND.edu) is home to the only Ph.D. and M.Phil. Traditional NEMT options have narrowed or disappeared as public transportation and paratransit stop or operate at reduced schedules, and family and neighbors become less willing to provide transit (lest the infection spread, as occurred in New Rochelle, New York, where an ill individual infected the neighbor providing transportation to the hospital). While having all the windows down was more beneficial than turning on the ventilation, opening specific car windows also made a difference. 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. 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. Laura Fraade-Blanar is an associate policy researcher at the nonprofit, nonpartisan RAND Corporation.