Category Archives: Risk Management Program Development

The EMTALA Primer

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EMTALABy: Dave Davidson

In 1986 President Ronald Reagan signed the Emergency Medical Treatment and Active Labor Act (EMTALA) into law.  Since then, the application of the law has been expanded and refined.  It was one of the first laws giving the government the authority to dictate certain operations of a hospital.  While other laws and regulations such as the Anti-Kickback Statute and the Stark Law have become more of a focus for health care providers, EMTALA remains an area of active enforcement.  All providers with hospital privileges should therefore be aware of its application.

The policy behind the law is fairly straightforward.  Hospitals with emergency departments should not be able to turn away patients needing care because of their inability to pay (no more “wallet biopsies” as part of triage).  Likewise, hospitals should not be able to “dump” patients on other facilities for reasons other than for advanced care.

The requirements of the law are also very basic.  If a patient comes to an emergency department and requests an examination or treatment for a medical condition, the hospital must provide an appropriate medical screening exam, within its capability, to determine whether or not the patient has an emergency medical condition.  The screening provided goes beyond simple triage, and must be performed by a clinical provider such as a physician, nurse practitioner, or physician’s assistant. Continue reading →

Governing Boards in Healthcare Organizations – Making Compliance Your Priority

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compliance manualBy: Jackie Bain

Does your healthcare entity have a governing Board? How involved is that Board in overseeing your business? Would your Board members be able to respond to questions about your business’ compliance-related activities? Recently, the Office of the Inspector General (“OIG”), in conjunction with a host of non-profit healthcare associations, released guidance on achieving compliance for healthcare governing boards. The guidance is not based on abstract principals of compliance, instead it points to applicable federal law, OIG guidance, case law, and sentencing guidelines.

Each and every healthcare organization, whether or not it accepts reimbursement from government payors, must have in place regulatory compliance measures designed to protect the population it serves, and the persons paying for and providing those services. All levels of a healthcare organization must be cognizant of their roles in the organization’s continuing commitment to compliance. Even Board members, who often do not experience the inner-workings of the entities they represent, have an obligation and duty to the organization to act in a manner that stressed compliance. Applicable federal and state laws, how they apply to an organization, and how the organization reacts to its obligations imposed by those laws, must be of paramount importance to a governing Board.

The OIG compliance guidance for healthcare Boards tracks 4 areas over which boards should have specific oversight: Continue reading →

The 7 Essential Elements of an Effective Compliance Plan

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020513-Succession-Planning-ChecklistBy: Jackie Bain

When a healthcare provider cares for a patient, many times, the provider will set out directives for the patient to follow in order to live a healthier life.  These changes may include changes in lifestyle, eating habits, and obedience in taking medications.  A patient’s compliance with these directives instructs the provider on how to care for the patient in the future.  A patient who does not follow these directives may suffer health consequences.

Similarly, the government sets out legal regulations for healthcare providers.  The government expects healthcare providers to comply with its regulations, and providers who don’t can suffer consequences as a result.  The regulations governing health care providers are vast and dynamic.  In order to keep abreast of the changes in law, and to evidence an intent to comply with law, healthcare providers should strongly consider instituting compliance programs in their businesses.

Compliance with healthcare laws is important.  Any number of consequences can result in the event that a healthcare provider is out of compliance—the most devastating being that the Department of Health and Human Services Office of the Inspector General (“OIG”) has the authority to exclude healthcare providers from participation in Medicare and other federal health care programs.  Ignorance of the law does not absolve a healthcare provider of liability. Continue reading →

Collect Now…or Pay Later

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bonus calculationBy: Karina P. Gonzalez

Though it can be tempting to offer help to patients in this era of sky high healthcare costs, out-of-network physicians must remember that they should not only be collecting copayments and deductibles from their patients at the time of service and before they leave the office, but also that collecting these payments is their obligation. For physicians and other providers who engage in the practice of failing to collect payments there is a significant legal exposure under federal and state laws including civil litigation brought by commercial health plans, managed care organizations and medical benefit managers regarding routine waiver of these payments. Continue reading →

Physician Joint Ventured Pharmacies Require Guidance

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Final-ACO-RulesFlorida physicians are being approached to become owners of pharmacies to which they may refer, often compounding pharmacies, but may be unaware of the regulatory issues involved.  Physicians need to be aware of the core laws that apply, which include the Florida Patient Self Referral Act (FPSRA), the Florida Anti Kickback Statute, the Patient Brokering Act and the Federal Investment Interest Safe Harbor. Continue reading →

Florida Clinical Labs Must Now Give Patients Direct Access to Their Laboratory Test Results

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lab testingBy: David Hirshfeld 

In an effort to help individuals access their health information so that they can become more actively involved in managing their own health care, several agencies within the Department of Health and Human Services promulgated a rule that modifies the Clinical Laboratory Improvement Amendments (“CLIA”) and the Health Insurance Portability and Accountability Act (“HIPAA”) in a way that supersedes Florida State laws governing the disclosure of laboratory test results directly to patients.

Continue reading →

HIPAA Stings Dermatology Practice

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HIPAAThe US Department of Health and Human Services, Office of Civil Rights is the chief enforcer of HIPAA.  The Office’s recent enforcement of HIPAA with respect to a Massachusetts derm practice is illustrative of how the government views HIPAA and how vulnerable medical practices are.  Continue reading →

Blue Cross Lawsuit Against Avee Attacks Point of Care Testing

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bcbs lawsuitA recent lawsuit by Horizon Blue Cross/Blue Shield of New Jersey has the potential to cripple point of care testing arrangements often employed by drug and alcohol treatment centers.  At risk is not only the roughly $36 Million sought to be recouped by BC/BS, but also perhaps the many millions more which may be claimed by other payers as well.

BC/BS is making serious allegations against Avee Laboratories, Alere, Inc., and a number of recovery centers.  The factual allegations include: Continue reading →

Board of Medicine: New Rule Regarding Adequacy of Medical Records for Compounded Medication

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gavelThe Florida Board of Medicine reviewed Rule 64B8-9.003, Florida Administrative Code which provides standards for the adequacy of medical records.  The underlined portions below are the new standards required for medical records as it relates to compounded medications.  These standards are effective September 9, 2013. Continue reading →

Is The End of Stark (and IOAS) Near?

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Background

Since its passage in 1989, the now ubiquitous federal law known as the Stark Law has driven the business behavior of health care providers of many kinds.  Recent developments, however, make us wonder whether the end of Stark is near, and if so, whether that’s a good thing.

By way of background, the Stark law has two components:  part one, a self referral prohibition, generally forbids physicians from referring to a provider of any “designated health service” (DHS) (e.g. MRI, PT, clinical lab) if the physician or his/her immediate family member has a financial relationship (including ownership interest) with the provider of the service.  Part two mandates that certain compensation arrangements between healthcare providers meet certain requirements.  Things like medical director agreements, management agreements, employment and independent contractor arrangements have been regulated by the law since its inception.  Most notably, for purposes of this article, one provision (the “In Office Ancillary Services” exception or “IOAS”, also known as the “Group Practice Exception”) has allowed medical practices to provide all sorts of “ancillary services” to their own patients.  That is the key aspect of the law that is lately coming under serious attack. Continue reading →