The healthcare field is the subject of a host of federal statutes, regulations, guidelines, informative information, and model guidance. There are a respectable number of statutes and regulations that have an impact on the delivery of healthcare services. A statute is legislative enactment that has been signed into law. A statute either directs soul to take action, grants authority to act in certain situations, or to refrain from doing so. Statutes are not self-enforcing. Someone must be authorized to do so to take action. A statute may authorize the Department of Health and Human Services to take action, and it is up to the department to implement the law. Regulations, or rules, are made by body personnel to whom legislatures have delegated such responsibilities. It is a tool for developing policies, procedures, and practice routines that track the expectations of restrictive agencies and departments. The statutory and restrictive requirements are subject to judicial interpretation.
A very important element of healthcare direction is to understand the key restrictive environment. One government statute that effects patient healthcare is the Anti-Kickback Statute. The Medicare and Medicaid Patient Protection Act of 1987 (the "Anti-Kickback Statute"), has been enacted to prevent healthcare providers from inappropriately profiting from referrals. The government regards any type of incentive for a referral as a potential violation of this law because the chance to reap business benefits may tempt providers to make referrals that are not medically necessary, thereby driving up healthcare costs and possibly putt patient's health at risk. The Anti-Kickback statute is a criminal statute. Originally enacted well-nigh 30 years ago, the statute prohibits any knowing or willful solicitation or acceptance of any type of wage to induce referrals for health services that are reimbursable by the Federal government. For example, a provider may not habitually waive a patient's co-defrayal or deductible. The government would view this as an inducement for the patient to choose the provider for reasons otherwise medical benefit. While these prohibitions originally were limited to services reimbursed by the Medicare or Medicaid programs, recent legislation enlarged the statute's reach to any Federal healthcare program. Because the Anti-Kickback statute is a criminal statute, violations of it are considered felonies, with criminal penalties of up to $25,000 in fines and five years in prison. Routinely waiving codefrayals and deductibles violates the statute and normally results in a sanction. However, a safe harbor has been created wherein a provider granting such a release supported a patient's business need would not be sanctioned. The enactment of the 1996 Health Insurance Portability and Accountability Act (HIPAA) added another level of complexity to the Anti-Kickback statute and its concomitant safe harbors. HIPAA mandated that the OIG (Office of Inspector General) render informative opinions to requesting providers that are either in an arrangement or contemplating an arrangement that may not fit squarely inside the law. For a fee, the OIG would analyze the arrangement and determine whether it could violate the law and whether the OIG would impose sanctions on the arrangement. In many of its informative opinions publicised over the past few years, the OIG has explicit that it would not impose sanctions, even though it found that the arrangement in question could violate the statute. A common reason the OIG has given for not imposing sanctions has been that the arrangement provides an overall benefit to the community. Healthcare finance professionals need to ensure that all business proceedings follow with the Anti-Kickback statute.
The Anti-Kickback statute effects the patient. The main aim of this statute is to improve patient safety, provide satisfaction and avoid risk. The result of the acquisition of a medic's practice would serve to interpose with the medic's resultant judgment of what is the most appropriate care for a patient. It would also interpose with a beneficiary's exemption of choice of providers.
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Physicians have direct patient care responsibilities. Any incentive defrayals to such medics that are either tied to overall costs of patient treatment or supported a patient's length of stay could reduce patient services. Also, the profits generated by cost nest egg may induce investor-medics to reduce services to patients. Health care programs operate the straightness and honesty of health care providers. It is important to ensure that quality services are provided at the hospital. The Anti-Kickback statute helps the government not to tolerate misuse of the reimbursement systems for business gain and hold the responsible parties causative their conduct. Such conducts can also prompt patient complaints. The hospitals and medics who are interested in structuring gainsharing arrangements power adversely affect patient care.
The Anti-Kickback statute creates a protective umbrella, a zone in which patients are protected so that the best health care is provided. This statute helps to improve efficiency, improve quality of care, and provide better information for patients and medics. The Anti-Kickback statute is not only a criminal prohibition against defrayals made purposefully to induce or reward the referral or generation of Federal health care business, it also addresses the offer or defrayal of anything of value reciprocally for purchasing, leasing, ordering of any item or service reimbursable in whole or part by a Federal health care program. It helps to promote quality and efficient delivery of health care transparency regarding health care quality and price.
There are millions of uninsurable patients who are unable to pay their hospital bills. Giving a discount on hospital charges to an uninsurable patient does not entail the Federal Anti-Kickback statute. Most need-based discounting policies are aimed at making health care more cut-price for the millions of uninsurable citizens who are not referral sources for the hospital. For discounts offered to these uninsurable patients, the Anti-Kickback statute simply does not apply. It is fully supported that a patient's business need is not a roadblock to health care. Furthermore, OIG legal regime permit hospitals and others to offer bonafide discounts to uninsurable patients and to Medicare or Medicaid beneficiaries who cannot afford their health care bills. The Anti-Kickback statute is concerned about improper business incentives that often lead to abuses, such as overutilization, enlarged program costs, corruption of medical-decision making, and unfair competition.
There are risk direction implications of this statute. There are risks associated with the Anti-Kickback statute and its good to prevent them. Rather than be an imposing and discouraging challenge to understand, the outcome can be development of risk direction systems to guide the delivery of health care. This fact is recognized that such statutes are an important attribute of the risk direction professional. For example there are potential risks under the Anti-Kickback statute arising from hospital relationships. In case of joint ventures there has been a long-standing concern about arrangements between those in a position to refer or generate Federal health care program business and those providing items or services reimbursable by Federal health care programs. In the context of joint ventures, the chief concern is that wage from a joint venture power be a covert defrayal for past or future referrals to the venture or to one or more of its participants. The risk direction should be done by having a knowledge of the manner in which joint venture participants are elite and retained, the manner in which the joint venture is structured and the manner in which the investments are supported and profits are distributed. Another area of risk is the hospital's compensation arrangements with medics. Although many compensation arrangements are legitimate business arrangements, but may violate the Anti-Kickback statute if one purpose of the arrangement is to compensate medics for past or future referrals. Risk direction is to follow the general guideline that any wage flowing between hospitals and medics should be at fair market price for actual and necessary items rendered or services.
Risk direction is also required in entities such as in cases where a hospital is the referral source for other providers or providers. It would be discreet for the hospital to scrutinize cautiously any wage flowing to the hospital from the provider or provider to ensure compliance with the Anti-Kickback statute. Also, many hospitals provide incentives to recruit a medic or other health care professional to join the hospital's medical staff and provide medical services to the encompassing community. When accustomed bring required medics to an underserved community, these arrangements can benefit patients. However, enlisting arrangements pose substantial fraud and abuse risk. This can be prevented by having knowledge of the size and value of the enlisting benefit, the duration of payout of the enlisting benefit, the practice of the existing medic and the need for the enlisting. Another area where risk direction is to be applied is when the discounts are given. The Anti-Kickback statute contains an exception for discounts offered to customers that submit claims to the Federal health care programs. The discounts should be properly disclosed and accurately reported. The regulation provides that the discount must tend at the time of sale or, in certain cases, it should be set at the time of sale. This will help in risk direction. It is also required in medical staff credentialing and malpractice insurance subsidies.
The key areas of potential risk under the Federal Anti-Kickback statute also arise from pharmaceutical manufacturer relationships with 3 groups: purchasers, medics or other health care professionals, and gross sales agents. Activities that pose potential risk admit discounts and other terms of sale offered to purchasers, product conversion, consulting and informative defrayals. The pharmaceutical manufacturers and their employees and agents should be aware of the constraints the Anti-Kickback statute places on the marketing and promoting of products paid for by federal and state health care programs. To that end, the draft guidance recommends pharmaceutical manufacturers ensure that such activities fit squarely inside one of the safe harbors under the Anti-Kickback statute. The Department of Health and Human Services has publicised safe harbor regulations that protect certain specific arrangements from prosecution under the Anti-Kickback Statute.
Healthcare being one the most regulated of all sectors of commerce, it is important that all facts and circumstances with respect to the statutes and regulations are evaluated.
