Outpatient speech-language pathology services. The laws were enacted to ensure physicians make medical decisions for their patients based on the best interests of the patient and not the financial interests of the physician. Hence, CMS administers the nations healthcare programs such as Medicare and Medicaid. Stark Law essentially prohibits a physician from making referrals to a patient for a particular designed healthcare service that is payable by Medicare or Medicaid to an entity. 1395nn, "Limitation on certain physician referrals"). Business entities should: Create a database of all healthcare employment contracts and ensure they meet the safe harbor provisions listed below. The Stark Law contains several exceptions, including physician services, in-office ancillary services, ownership in publicly traded securities and mutual funds, rental of office space and equipment, and bona fide employment relationship. 1395nn, referrals are limited to certain types of medical services, such as lab testing, hospital services, prescription drugs, and durable medical equipment, defined as designated health services. In addition, the Stark Law applies only to relationships with physicians. Calling All Community Banks: CDFI Fund Opens Applications for FY 2023 Bank USCIS Removes Form I-693 Signature Requirement, Simplifying the Green Card New York State Adopts Updates to Model Sexual Harassment Prevention Policy, Life Sciences Lifeline - Medical Countermeasures for Biodefense, McDermott Deal Academy 2023 Photovoltaik, Critical Wage & Hour Developments for 2023: New Minimum Wage Laws, Paying Day Rates, and DOL Focus on Pay Equity. 1395nn). The court found BB&J made direct compensation arrangements with its shareholder physicians for designed healthcare services such as physical therapy, X-rays and MRIs. The choice of a lawyer or other professional is an important decision and should not be based solely upon advertisements. i{Wj$hl +VjtVbsTXrSfe{9rEZY"[>K3F&VgihrW;d0LG tNRf*tY&3 In healthcare, many kickbacks take the form of: Paying physicians excessively high speaker fees, Sending physicians and their families on vacations, Paying for accommodations or offering free rent. The new regulations limit how far Stark Law can reach to inpatient services that increase the amount Medicare pays. 2014 saw some of the largest Stark Law violation settlements to date. In the case of the Stark Law, proof that an improper referral was made is enough to impose liability, whether or not the physician knew of a potential financial or familial conflict. The Stark Law is defined as a set "Novartis coordinated with three co-pay foundations to funnel money through the foundations to patients taking Novartis own drugs," said U.S. Attorney Andrew E. Lelling for the District of Massachusetts. In 2020, the US Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) authorized changes to these two referral laws. Importantly, the Stark Law is a strict liability law. Intra-Family Rural Referral allows physicians to refer patients to a DHS entity if no other healthcare provider can furnish needed services within 25 miles or 45 minutes from the patients home. FDA Publishes Implementation Policy Regarding Cybersecurity HHS OCR Delivered Annual Reports to Congress, Challenges to IP Protections in Fast-Paced Cloud Environments. 3) Halifax Hospital Medical Center: This medical center was accused of intentionally violating the False Claims Act and the Stark Law by entering into illegal contracts with medical providers. Can the MSO Legally Brand the name of a Medical Clinic? Emerging Healthcare Technologies A whistleblower reports fraudulent activities, graft and corruption, and organization abuses that affect the publics welfare. Medicare fraud is not only attacking the lives of the healthy and wealthy, but also, it is damaging the state of our elderly patients, patients with disabilities, persons living with HIV, patients suffering from autoimmune diseases, and many others. Hence, improper payments may result in the billing of unnecessary medical services and treatment. Functional Medicine Wellness Practices Gain Legal Traction, https://cohenhealthcarelaw.com/michaelhcohen/wp-content/uploads/2022/08/cohen-healthcare-horizontal-2020_v2.webp, Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law, https://cohenhealthcarelaw.com/michaelhcohen/wp-content/uploads/2022/02/doctor-putting-bribe-into-her-pocket-2021-08-26-20-16-07-utc-1920.jpg, Compliance Issues for Durable Medical Equipment Companies, The Good Faith Estimate Requirement of the No Surprises Act Part One, Fraud & Abuse (Anti-Kickback, Fee-Splitting, Stark), M&A (Acquisitions & Sales of Healthcare Businesses), Management Services Organizations (MSO) Issues, Medical Device & Mobile Medical App Issues, ANTI-AGING & FUNCTIONAL MEDICINE PRACTICES, BEHAVIORAL & MENTAL HEALTHCARE PROVIDERS AND LIFE COACHES, COMPLEMENTARY & INTEGRATIVE MEDICINE PROVIDERS, CONCIERGE & DIRECT PRIMARY CARE MEDICAL PRACTICES, DIETARY SUPPLEMENT & NUTRACEUTICAL COMPANIES, HEALTHCARE FACILITIES (HOSPITALS, LABS, DME, IMAGING), ANTI-KICKBACK STATUTE AND STARK LAW SETTLEMENTS WORTH MILLIONS. The National Law Review - National Law Forum LLC 3 Grant Square #141 Hinsdale, IL 60521 Telephone (708) 357-3317 ortollfree(877)357-3317. June 11, 2021. (vi) Communicating the results of tests or procedures for the entity furnishing the items, devices or supplies. The new Stark and AKS regulations from CMS and the OIG are now effective. In addition, the center overpaid certain neurosurgeons for admitting patients who did not truly need to be admitted, just to increase Medicare billings. Other penalties such as exclusion from any federal healthcare programs (administrative) or incarceration (criminal) would have to be further evaluated by the Department of Justice. Any HCP, healthcare system, or hospital found at fault could be required to refund all payments for the improper amounts collected; to pay up to $15,000 per improper referral, and be excluded from all federal healthcare programs. Enter your email to sign up. The Office of the Inspector General (OIG) is tasked to investigate suspected healthcare fraud activities and report cases to the U.S. Department of Justice (DOJ) for criminal or civil actions. 0000001396 00000 n Physicians, medical practices, ancillary companies, and MSOs should contact Cohen Healthcare Law Group, PC to discuss Stark Law, AKS, and other laws that affect any type of referrals. A safe harbor provision is a law or series of compliance steps that, if followed, will limit or eliminate liability if a violation is reported. Those 0000103457 00000 n Under the purposes of the Stark Law, the following medical professionals are considered physicians: medical doctors, osteopathy, optometry, dental medicine, dental surgery, podiatric medicine, plus chiropractors. The Stark Violation Case of Baldwin Bone & Joint, P.C. Multiple technology solutions exist that specifically automate physician time logging and eliminates Stark Law violation risk. Whether you work in a doctor's office, in a billing department of a healthcare group or insurance provider, you may be able to report on your employer and be protected against possible retaliation. Reducing administrative burdens that increase costs so the money can be spent on patient care. It seeks to ban the abusive practices of physicians and other health care service providers. The federal government instituted the Anti-Kickback Statute and Stark Law in an effort to eliminate healthcare fraud and abuse. The Stark Law, also known as the physician self-referral rule, is in Section 1877 of the Social Security Act (42 U.S.C. Three government agencies collaborate in enforcing Stark Law including the Center for Medicare and Services (CMS), the Office of the Inspector General (OIG), and the Department of Justice (DOJ). The new regulation does not apply to outpatient hospital services. "[1] A "financial relationship" includes ownership, investment interest, and compensation arrangements.[1]. As the cost of healthcare and Medicare fraud activities continues to increase, the quality of healthcare that we receive and mostly rely on plummets alongside it. xbbbd`b``3D? In case any assistance is needed for Medicare billing or submitting claims to private insurance carriers, contact us at, Importance of A/R Follow up in Medical Billing, Avoiding False Claim Billing for your Practice, Ambulance Transportation Billing Services, Skilled Nursing Facilities Billing Services. In case any assistance is needed for Medicare billing or submitting claims to private insurance carriers, contact us at info@medicalbillersandcoders.com/ 888-357-3226. But all in all, almost all offenders faced monetary (civil) penalties. In addition, they believe that it would create a captive referral system, which limits competition by other providers. Multiple federal entities oversee enforcement of Stark Law. Radiology and certain other imaging services. Some of these changes may directly impact how the MSO operates and the relationship between the physician/practice and the MSO. Essentially, the more risk the physician is taking, the less medical scrutiny. Statement in compliance with Texas Rules of Professional Conduct. For example, if you invest in an imaging center, the Stark law requires the resulting financial relationship to fit within an exception or you may not refer patients to the facility and the entity may not bill for the referred imaging services. These were considered improper claims, and the company was required to pay $1.2 million to resolve the matter. Electronic Health Records Items and Services. Originally, Stark I intended to abolish any physicians financial scheme in sending patients for unnecessary testings. Finalizing the guidance physicians need regarding self-referral law exceptions. WHEN USING A MANAGEMENT SERVICES ORGANIZATIONS (MSO) IS THE RIGHT CHOICE FOR YOUR MEDICAL PRACTICE, Medical Spa Laws Specify Doctor Supervision Level, How MSOs Help Medical Practices with Office and Equipment Rental, Medical Spa Laws Detail Physician vs. Nurse Authority, Terms of Use, Disclaimer, and Privacy Policy. Fair Market Value Exception should be consistent with the General Market Value. Financial relationships include both ownership/investment interests and compensation arrangements. Attorney Advertising Notice: Prior results do not guarantee a similar outcome. The Stark Law is a strict liability statute, meaning that proof of specific intent to break the law is not required. Under certain state laws the following statements may be required on this website and we have included them in order to be in full compliance with these rules. The Stark Law is defined as a set of regulations that prohibit the self-referral of physicians under federal law. 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