RESUMEN

The United States spends more of its wealth on healthcare than any other developed country, and that share is rising. Supporters of the free market system point to the regulatory burden on the healthcare industry. Estimates of the regulatory costs of US healthcare range from dollars 58 billion to dollars 339 billion. A recent report indicates that approximately dollars 8 billion of the US healthcare budget of dollars 1.9 trillion is spent on physicians' extra income derived from their ownership in outpatient facilities, such as ambulatory surgery centers, diagnostic imaging centers, and diagnostic testing and procedure laboratories. It is essential for an interventionalist to understand fraud and abuse, self-referrals, and the implications of the Stark law and anti-kickback statutes, among a maze of other regulations. It is important for interventionalists to understand and also be able to invest in protected and approved investments and also be involved in business dealings which are within the law. Various reasons include: decreasing reimbursements by Medicare, Medicaid, managed care, and all other third-party payors; increased competition in providing interventional pain management; increasing costs of overhead and doing business; the popularity of interventional pain management, leading each and every pain physician to want to provide the service; concerns in multiple settings, including offices, ambulatory surgery centers (ASCs), hospitals, private practices, and academic settings; and finally, the failure to develop strategies to remove oneself from questionable investments and business associations. Self-referrals occur when physicians refer to medical facilities in which they have financial interest. Multiple concerns related to self-referral, including conflict of interest and increased costs to the Medicare program, resulted in a ban on self-referral arrangements for clinical laboratory services under the Medicare program in 1989 known as Stark I. In 1993, the Stark I prohibition on self-referrals by physicians expanded to include 10 additional healthcare services known as designated health services or DHS. The 1993 expansion of Stark I was enacted in 1995 as Stark II. In 2007, CMS adopted Phase III of the regulations interpreting Stark II. Phase III made multiple changes and clarified many previous issues, and it becomes effective December 4, 2007. While it is mandatory to obtain expert legal advice and this manuscript in no way provides the extensive navigation required through the maze of Stark laws and other anti-kickback statutes, it is incumbent on interventionalists in all settings of practice to have appropriate knowledge of the Stark laws and exceptions and of the anti-kickback statute and safe harbors. Penalties for violating the Stark laws are severe, including fines of up to dollars 15,000 per service and the economic threat of exclusion from participation in federal healthcare programs, which may result in exclusion of any type of healthcare program and loss of privileges at hospitals and surgery centers. This manuscript reviews physician practices in general, physician payments, and self-referral patterns in particular, the evolution of the Stark law and regulations and its implications for physician practices. This article is not, and should not be, construed as legal advice or an opinion on specific situations.

Asunto(s)

Honorarios Médicos/legislación & jurisprudencia , Inversiones en Salud/legislación & jurisprudencia , Propiedad/legislación & jurisprudencia , Auto Remisión del Médico/legislación & jurisprudencia , Administración de la Práctica Médica/legislación & jurisprudencia , Servicios de Diagnóstico/economía , Servicios de Diagnóstico/estadística & datos numéricos , Honorarios Médicos/ética , Fraude/economía , Fraude/legislación & jurisprudencia , Regulación Gubernamental , Costos de la Atención en Salud , Humanos , Reembolso de Seguro de Salud , Inversiones en Salud/ética , Laboratorios/economía , Laboratorios/estadística & datos numéricos , Responsabilidad Legal/economía , Medicare/legislación & jurisprudencia , Propiedad/ética , Dolor/prevención & control , Auto Remisión del Médico/ética , Administración de la Práctica Médica/economía , Centros Quirúrgicos/economía , Centros Quirúrgicos/estadística & datos numéricos , Estados Unidos

RESUMEN

Physician practices that transmit any health information in electronic form in connection with a transaction covered by the HIPAA transactions and code sets rule will be required to comply with the rule no later than October 16, 2003. Under the rule, if certain transactions, such as the filing of claims, are conducted electronically, they must contain certain data content and be formatted in a particular way. On and after October 16, 2003, Medicare will require claims to be submitted electronically unless a physician practice has less than 10 full-time equivalent employees. Practices with fewer than 10 FTEs can continue to submit paper claims to Medicare without any further action on their part. At a minimum, physician practices must have the ability to capture the data required by the rule for covered transactions conducted electronically, and either use a clearinghouse to translate the data to X12N format or obtain a translator and electronic connectivity to ensure that the practice can send electronically compliant claims by October 16, 2003. Trading partner agreements may specify the duties and responsibilities of each party to the agreement in conducting a covered transaction electronically, but they are not required under HIPAA. Business associate agreements are required under HIPAA if a practice chooses to use a business associate (a person who performs an activity falling under the rule on behalf of the practice), including a health care clearinghouse, to conduct electronic covered transactions for it, and the agreement must comply with the HIPAA transactions and code sets rule, the privacy rule, and the security rule. This article is not, and should not be construed as, legal advice or an opinion on specific situations.

RESUMEN

On February 20, 2003, the Department of Health and Human Services (HHS), pursuant to its authority under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), issued the final rule on Security Standards for electronic protected health information (PHI). The rule addresses the duties of providers who conduct electronic transactions covered under the HIPAA transactions and code sets rule to address the security issues surrounding the storage and transmission of electronic PHI. Providers who are required to comply with the security rule must do so by April 20, 2005. While this may seem like a long time, the compliance requirements are lengthy and burdensome, so providers would be well advised to start compliance efforts now. Appointing a security officer and beginning a risk analysis should be the first priorities of any practice. While the security officer will be integral in a practice's compliance, it is ultimately the burden of the practice to ensure compliance with the rule. Penalties for non-compliance are stiff: civil money penalties of up to a $100 fine for every violation of each requirement or prohibition, capped at $25,000 per year for all violations of an identical requirement or prohibition. Criminal penalties must be imposed if a person knowingly and in violation of the security rule: obtains individually identifiable health information relating to an individual or discloses individually identifiable information to another person. This article is not, and should not be construed as, legal advice or an opinion on specific situations.

RESUMEN

Over the past several months, the Department of Health and Human Services (DHHS) has issued new final and proposed rules pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The privacy rule was finalized on August 14, 2002. Changes made to the original rule were in general beneficial to providers. Consent forms will no longer be required for treatment, although providers may choose to continue to use them. Physicians will still be required to use and disclose only the "minimum necessary" protected health information (PHI) to accomplish the purpose for which the information is being used or disclosed, but the new final rule excludes some situations in which the minimum necessary requirement will apply. A model business associates contract is provided in the final rule, making it easier for providers to comply with the rule's requirement that they have written business associate contracts with vendors who need access to the provider's PHI to perform tasks on behalf of providers. Researchers now only need to provide one form for consent and authorization, instead of two. There are also proposed changes in the transaction rule. Certain data elements that were required by the final rule are now situational in the proposed rule. Unnecessary data elements have been removed. Certain items, like special program indicator codes, will now be able to be reported via external code sets rather than as data elements in a transaction. The proposed rule also adopts requests from the industry by adding data elements, codes, or loops to enable covered entities to perform certain business functions in the standardized transactions, such as cross-referencing two subscriber IDs (e.g., surviving spouse and dependents). A final rule was published in May 2002 that created a standard employer identifier. The Employer Identifier Number (EIN) that is already in use by the IRS will be the standardized unique employer identifier number. A proposed rule to cease using the National Drug Codes in transactions for nonretail pharmacy transactions was published in May 2002. DHHS developed the proposal in response to widespread industry concern over the tremendous cost of implementing the National Drug Codes (NDC). The NDC will either not be replaced at all, or will be replaced by the HCPCS. This article is not, and should not be construed as, legal advice or an opinion on specific situations.