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. 1395nn; 42 U.S.C. 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. The ride-alongs are scheduled outside of class time . A member of the victim's family said the situation is 'still so raw.' Both offer financial assistance to drivers self-quarantining with a doctor's note. Drivers receive no formal medical training. authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically I am an eligible provider who received a distribution through the CARES Act Provider Relief Fund. We also acknowledge that 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. o The car windows should be open for the entire trip. 8. 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. 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. The site is secure. Mathai explains car air ventilation flows from the back to the front window. 0 Mathai says that while his study looks at how to improve air flow in a car if you must, it is by no means a recommendation to ride in a car with another passengers from outside your household. Cars dont have the same air filtration system as airplanes, which may be slightly safer because of their HVAC ventilation. In addition, in the context of ground ambulance services performed prior to the issuance of the Waiver, ambulance providers and suppliers would have had no expectation that the Medicare program would reimburse for services that did not involve an actual transport, and there was no expectation on the part of the beneficiaries receiving services that they would have incurred cost-sharing obligations. This could help Uber, Lyft, and taxis in knowing which windows to open for the safety of the passenger, Mathai says. If rideshare drivers are going to continue to work, everyone, from the TNCs to the customers, must ensure this remains a safe occupation. The OIG's advisory opinion process remains available to interested parties. For parties analyzing referrals by physicians for designated health services to entities under sections II(B)(12)-(17) of the blanket waivers under the Federal anti-kickback statute, we advise parties to consider whether such referrals would result in remuneration that implicates the Federal anti-kickback statute. 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. 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 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. 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. The Waiver is effective retroactively to Medicare claims for services rendered on or after March 1, 2020. Transportation Network Companies (TNCs) like Lyft and Uber have been providing NEMT, since 2016 and 2018 respectively, through a ride-share model. This could include an expanded service into remote, rural areas. They can deliver (and as of April 15th are delivering) food to individuals in medical quarantine or who are unable to safely shop for themselves, supplementing existing grocery delivery services who are currently overwhelmed. That can be a sign of stroke or other serious illness. 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. 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 the unique circumstances resulting from the COVID-19 outbreak, we believe that these scenarios likely would present a low risk of fraud and abuse under the Federal anti-kickback statute and the Beneficiary Inducements CMP provided the services being offered are (i) necessary to meet patient care needs as a result of staffing shortages directly connected to the COVID-19 outbreak; (ii) provided for free or at a reduced cost only when necessary as a result of the COVID-19 outbreak; (iii) limited to the period subject to the COVID-19 Declaration; and (iv) not contingent on 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. U.S. Department of Health & Human Services 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. 1001.952(b). o PPE worn during transport should be thrown out by placing it directly into a plastic garbage bag, We stated that if the services for which the laboratory compensated the physician were paid for by a third party through other means, any payment by the laboratory to the physician for the physician's services could constitute double payment that evidenced unlawful intent under the Federal anti-kickback statute. 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. A non-provider philanthropic organization (the Organization) wishes to provide certain administrative services, described further below, to support the development and operation of COVID-19 vaccination sites. An official website of the United States government. incorporated into a contract. This way they can be properly secured with a seat belt. It is incumbent on the parties to determine a fair market value payment for the actual and necessary items and services furnished by the retail pharmacy; we express no opinion regarding the fair market value for such items and services. A Federally Qualified Health Center (FQHC) received from a private foundation a $15,000 COVID-19 relief grant designated for emergency cash assistance for financially needy individuals. Laura Fraade-Blanar is an associate policy researcher at the nonprofit, nonpartisan RAND Corporation. Can a federally qualified health center (FQHC) with a location in a rural area provide free space to a retail pharmacy that administers COVID-19 vaccinations to FQHC patients and the general public (including Federal health care program beneficiaries)? 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. Please have your government issued ID with you when you report for your ride-along. COVID-19 Requirements: 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. Changes are already occurring in isolated circumstances. When Can I Use Public Transportation Again After Being Fully Vaccinated? 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. /content/admin/rand-header/jcr:content/par/header/reports, /content/admin/rand-header/jcr:content/par/header/blogPosts, /content/admin/rand-header/jcr:content/par/header/multimedia, /content/admin/rand-header/jcr:content/par/header/caseStudies, Don't Be Fooled by China's Mask Diplomacy, Leading with the Proper Use of Scientific Evidence Is Better Than Hiding Behind It, Solving the Mental Health Crisis: Tackling Psychiatric Bed Shortages in California, Great-Power Competition Outside the Indo-Pacific and Europe, The Problems Facing VA Modernization Are Bigger Than Its Software Systems, Violence in Sudan, Alcohol Use, North Korea: RAND Weekly Recap, Russian Military Operations in Ukraine in 2022 and the Year Ahead. 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. 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. An ambulance ride costs an average of $1,300 in the United States. 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. For highly vulnerable populations, like older adults living independently, using public transportation-NEMT involves either risking potential infection to travel to the places they need to go, or possibly risking other adverse health outcomes by not traveling to necessary medical care. RAND is nonprofit, nonpartisan, and committed to the public interest. 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. Because each vehicle is designed differently, a study design would need to be customized to apply to the specific dimensions of the vehicle. This question is outside the jurisdiction of OIG's authorities. 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.. 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. Emergency Medicine Author has 946 answers and 1.6M answer views Updated 3 y. 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. 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. The Organization stated that it has the experience and expertise to provide reliable administrative services for vaccination sites. 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." Thank you. 2023, Charter Communications, all rights reserved. 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. In addition, no party may bill or otherwise shift the costs of free blood draws to Federal health care programs. 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. Issued by: Office of Inspector General (OIG). Thank you. This may allow for cross-ventilation in the cabin.. Permitting a passenger to unlawfully ride in the bed of a pickup truck carries a $100 fine for either the driver or passenger. The proposed arrangement also implicates the Beneficiary Inducements CMP because the free COVID-19 antibody testing could reasonably influence a Medicare or State health care program beneficiary to selector to cause his or her physician to selectthe clinical laboratory for other medically necessary blood testing that is reimbursable by Medicare or a State health care program, in order to qualify for the free COVID-19 antibody testing. %%EOF 2Section 1128B(b) of the Social Security Act (Act), 42 U.S.C. For this reason, Banerjee warns that a passenger not taking proper precautions can potentially lead to community spread, which is dangerous because of the difficulty to contact trace. 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. In your submission, please provide sufficient facts that allow for an understanding of the key parties and terms of the arrangement at issue. According to the facts presented in the question we received, during the timeframe subject to the COVID-19 Declaration, the hospital would provide free access to a web-based telehealth platform to independent physicians on its medical staff. Learn More. 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. According to the facts presented, an oncology group practice has temporarily closed a particular office due to actual or potential patient and staff exposure to COVID-19. 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. Mathai and his team are looking at applying similar simulations to improving airflow in other confined spaces, from helicopters to restaurants. 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. California Consumer Limit the Use of My Sensitive Personal Information, California Consumer Do Not Sell or Share My Personal Information. Ambulance Victoria is a critical link in Victoria's healthcare system. People are sick, losing jobs, postponing important life events, projects, losing chunks of their retirement, and living in a constant state of fear. This is especially relevant for long car rides where aerosol droplets can build up in concentration over time, like in an hour-long ride. Last year, Congress abandoned its attempt . 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. OIG has longstanding and continuing concerns regarding the provision of cash or cash equivalents to Federal health care program beneficiaries. 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. 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? 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. Because the facts presented here differ from those in the 1994 Alert and the 2014 Alert, we believe that the proposed arrangement between the clinical laboratory and retail pharmacy, in the context of the COVID-19 public health emergency, would be sufficiently low risk under the following circumstances: (i) the retail pharmacy incurs costs in operating the testing collection sites; (ii) the payment is fair market value for the items and services furnished by the retail pharmacy in running the sites; and (iii) the retail pharmacy is not submitting claims to Federal health care programsor directly or indirectly receiving other Federal or State fundingthat reimburse it, in whole or in part, for the items and services furnished by the retail pharmacy in running the sites for which the laboratory reimburses the pharmacy. It's possible to spread the virus. Uber has pledged free rides and free meals for health care providers internationally. And if you have a confirmed case of COVID-19 . If you have to ride in a car with someone who has not been in your household during the . We recognize that FQHCs deliver care to some of the nation's most vulnerable individuals and families, including Federal health care program beneficiaries. You can ride in a car with anyone who has been in quarantine with you as long as you're both feeling well. In-kind transportation services offered by an oncology group practice to Federal health care program beneficiaries for free constitutes remuneration that may violate the Federal anti-kickback statute if the requisite intent to induce referrals is present. 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. With high scalability and an existing service model available, rideshare could address transportation needs. By clicking Accept All Cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. This remuneration also could reasonably influence a patient to select the group practice to receive federally reimbursable items and services. "It's like . BUMSONTHESADDLE on Instagram: "INSTAGRAM LIVE ANNOUNCEMENT We are . In addition, this allows the fire department paramedics and company personnel to tend to the patient . 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. 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.

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