The term “payment for referral” strikes fear in the hearts of health care providers throughout the country because of the significant prohibitions under the federal Anti-Kickback Statute (AKS). And, Florida’s Patient Brokering Act (PBA) casts an even bigger shadow over arrangements involving payment in exchange for referrals. There are other statutory restrictions as well, which may apply depending upon the services for which a referral is being made. Those include but are not limited to statutes prohibiting physician fee-splitting and the federal Eliminating Kickbacks in Recovery Act (EKRA) (applicable to referrals to recovery homes, clinical treatment facilities, or laboratories in an effort to stave off growing opioid-related fraud), and the potential collateral damage of a false claim under the federal False Claims Act (FCA) if any of the above statutes are violated.
So, is there any scenario where a payment may be made by a health care provider in exchange for referrals? The answer is yes- there is a safe harbor under the AKS (42 U.S. C. §1320a-7b(b)) specifically for such arrangements. This safe harbor is not commonly used and likely means revision to existing arrangements to come into compliance with its specific requirements. But it may be worth considering if the referral (and payment for that referral) is not otherwise prohibited as noted above.
COVID-19 has devastated the US economy, including many parts of our Healthcare sector. The Federal Government, along with most States, have begun to respond with various financial incentives, ranging from straight out grants to loans, and everything in between. The following is an overview of some of the assistance that is currently available for the Healthcare community, along with some tips that may assist your company in applying, and what you need to do if you are lucky enough to receive some money:
The CARES Act
Paycheck Protection Program (the “PPP”). Essentially a grant from the Federal Government for payroll, employee benefits, rent/mortgage, utilities for 8 weeks. This program is available for all small businesses, and is managed through banks and private financial institutions.
Apply with multiple financial institutions, and whoever comes through first take the loan/grant;
If you receive the money keep excellent records;
You can only use the money for W-2 employees, not 1099 contractors;
There are strict rules with respect to the number of employees, and their maximum salary. The NUMBER of employees before and after the loan is critical, not the actual employee, so if you laid off someone, you don’t have to hire back that particular person, you can use the money for a new employee who fills the same position; and
If you don’t use all the money for payroll etc, don’t worry, you can either pay it back in a lump sum, or pay it back over time at 1% interest.
The newest relief for small business and health care providers was passed by the Senate on April 21st, by the House on April 23rd, and became law on April 24, 2020. This new Act, provides for $484 billion in additional relief to small businesses and healthcare providers. $100 billion of the relief has been allocated to the Department of Health and Human Services and of that amount $75 billion is earmarked “to reimburse health care providers for health related expenses or lost revenues that are attributable to the coronavirus outbreak.” The remaining $25 billion will be used for expenses to research, develop, validate, manufacture, purchase, administer, and expand capacity for COVID-19 test to effectively monitor and suppress COVID-19.
The $75 billion provided under the Act will remain available until expended and will be used to prevent, prepare for, and respond to coronavirus to reimburse necessary expense or lost revenues incurred as a result of COVID-19. However, if a health care provider has already had expenses or lost revenues incurred due to COVID-19 reimbursed from other sources or that other sources are obligated to reimburse (like the CARES Act), any funds received from the $75 billion cannot be used as a “double dip” by that health care provider.
A big difference for health care providers with this Act, is that unlike the CARES Act that provided a direct deposit to health care providers based on Medicare fee for services reimbursement, no application necessary, this Act requires the health care provider to apply for relief funds. Eligible health care providers include public entities, Medicare or Medicaid enrolled suppliers and providers, profit and not-for-profit entities that provide diagnoses, testing, or care for individuals with possible or actual cases of COVID-19 (so as to accommodate the “lost revenues” provision, this could mean any patient treated since January 31, 2020, and is not necessarily limited to patients treated for COVID-19 symptoms without testing confirmation). Health care providers should act quickly and apply for funds as soon as possible as the HHS Secretary will review applications and make payments on a rolling basis. Payment may be a pre-payment, prospective payment, or a retrospective payment as determined by the HHS Secretary. Health care providers must submit an application that includes statements justifying the need of the provider for the payment. The provider must have a valid tax id number (could be an individually enrolled physician). As with the CARES Act, HHS will have the ability to audit how relief funds are expended and must start reporting obligations of funds to the House and Senates Committees on Appropriations within 60 days from the date of enactment of this Act. Reporting will continue every 60 days thereafter.
The Secretary of Health and Human Services issued blanket waiver of the Stark Law on March 30th in order to facilitate COVID related medical services. The waivers apply only to financial relationships and referrals related to COVID. The circumstances and conditions under which the waivers apply are strictly and narrowly described. Moreover, the waivers have no impact in the presence of fraud or abuse. With respect to physicians wanting to provide designated health services (e.g. clinical lab services) related to COVID detection and treatment, for instance–
the federal requirement that the DHS be provided in the same building as the physician office is waived; and
the financial relationship limitations between the physician (or family member) and the DHS provider is waived.
The waiver also contains specific examples of waived interactions between providers and hospitals, including—
CMS has rolled out a telehealth/telemedicine tool kit to assist medical professionals with health care delivery during the current COVID-19 public health emergency.
The toolkit contains information and links concerning:
1135 Waivers – allows the Secretary of HHS to temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure sufficient health care services and items are available to meet the needs of individuals enrolled in Social Security Act programs during the emergency and that providers who provide services in good faith can be reimbursed and exempted from sanctions (provided there is no determination of fraud and abuse). 1135 waiver or modifications include:
Conditions of participation and other certification requirements;
Program participation and similar requirements;
State licensing requirements where services are rendered as long as the provider has equivalent licensing in another State (for Medicare, Medicaid, CHIP reimbursement only; State licensing still controls whether a non-Federal provider may provide services in a state he/she is not licensed in);
EMTALA sanctions for redirection for medical screening, as long as redirection is not the result of discrimination on the basis of a patient’s source of payment or ability to pay;
Stark self-referral sanctions;
Adjustment (not waiver) to performance deadlines and timetables;
Limitations on payment to permit Medicare enrollees to use out of network providers in an emergency situation.
On March 16, 2020, Florida became the first state to receive a Medicaid waiver from CMS in response to the COVID-19 national emergency. These provider enrollment emergency relief efforts also apply to the Children’s Health Insurance Program (CHIP), as applicable. With this waiver, Florida Medicaid, and Medicaid providers, will have greater flexibility in treating covered patients. Pursuant to the Florida waiver:
The Centers for Medicare & Medicaid Services (CMS) contracts with private companies also known as sponsors to provide Medicare services and benefits under Parts C and D. However, when a sponsor fails to comply with program and/or contract requirements, sponsors are subject to a wide range of enforcement action by CMS. Enforcement and contract actions available to CMS include intermediate type sanctions (i.e., suspension of payment, marketing or enrollment), termination, and most notably, civil monetary penalties (CMPs). Historically, the majority of enforcement action taken involve the imposition of CMPs. Thus, plan sponsors are strongly encouraged to adopt an aggressive compliance plan that includes mock periodic audits in order to prevent potential deficiency findings by CMS.
It is not news that Hurricanes Harvey and Irma have rocked Texas and the Florida mainland, and Irma has left unimaginable damage throughout the Caribbean and Florida Keys. During both hurricanes, considerable media attention was directed to how well hospitals and other sub-acute care providers in the affected areas were prepared for and responded to these events. When coupled with the loss of multiple lives occurring at the Rehab Center at Hollywood Hills, seemingly due, at least in part, to exposure to extremely elevated temperatures during an extended power outage, emergency readiness should be near the top of every health care provider and supplier agenda. Providers and suppliers should also be mindful of a rapidly approaching regulatory deadline Medicare requirement for continued participation on the topic of emergency preparedness.
Earlier this year, the Florida legislature passed prohibitions against balance billing by out-of-network providers for emergency services and where the patient goes to a contracted facility but does not have an opportunity to choose a provider such as emergency room physicians, pathologists, anesthesiologists and radiologists.
Specific reimbursement requirements went into effect on October 1, 2016 for certain out-of-network providers of emergency and non-emergency services, where a patient has no opportunity to choose the provider.
Under these circumstances, an Insurer must pay the greater amount of either:
(a) The amount negotiated with an in-network provider in the same community where services were performed;
(b) The usual and customary rate received by a provider for the same service in the community where service was provided; or
The Supreme Court of the United States in the case of Universal Health Services v. United States ex rel. Escobar (decided 6/16/2016) extended the reach of the False Claims Act (FCA) to cover implied false certifications made “in certain circumstances” by healthcare providers in requesting payment for goods and services.
At issue was a theory of liability known as the “implied false certification theory” and whether this theory was valid under the FCA. The implied false certification theory treats a payment request as an implied certification of compliance with relevant statutes, regulations or contract requirements that are a material condition of payment and treats a failure to disclose a violation as a misrepresentation that renders the claim false or fraudulent.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.