Larry D. Weiss and Jorge A. Martinez
Ever increasingly, state and federal regulations control the practice of medicine in the United States. Each state has agencies which conduct activities such as licensure, provider and institutional compliance, and disciplinary actions. In addition, Congress and federal agencies including the Drug Enforcement Agency, the Center for Medicare and Medicaid Services, and the Federal Trade Commission regulate, administer, and monitor the practice of medicine throughout the United States and oversee reimbursement for healthcare services.
THE AFFORDABLE CARE ACT
The Patient Protection and Affordable Care Act (ACA), which became effective in 2010, represents an effort by Congress and the Obama administration to significantly reform the health insurance industry in the United States (1). Congress intended these reforms to (1) provide near universal health insurance coverage, (2) improve the quality of care, and (3) lower the cost of care. Unlike many European countries which have a centrally controlled single payor system, the ACA provided a complex system of controls to reform the myriad payor systems existing in the United States. Thus, the ACA reforms payor systems in the United States while preserving the basic underlying insurance systems.
The ACA intervenes in more than 25 significant ways to improve the availability of private health insurance. It dramatically expands the government funded Medicaid insurance system for poor patients. For the first time, Medicaid will provide coverage for all poor patients with a household income of less than 133% of the federal poverty level. Even though the US Supreme Court mostly upheld the constitutionality of the ACA in a June 2012 decision, it declared that Congress could not coerce state governments to expand Medicaid in their respective states (2). Therefore, states may independently decide whether to participate in Medicaid expansion. Many commentators predict up to 20 states may elect not to initially participate when Medicaid expands on January 1, 2014.
To capture patients who earn more than 133% of the federal poverty level, but still may lack the funds to purchase traditional health insurance products, the ACA provides for the creation of state heath benefit exchanges whereby patients may select lower cost “qualified health plans” which must include a list of “essential health benefits.” Finally, the ACA provides for near universal health insurance coverage by requiring an individual “mandate” to purchase insurance by January 1, 2014. Failure to purchase insurance will result in a fine, payable on a sliding scale according to income. Those who would have to spend more than 8% of their adjusted gross income on health insurance would not have to pay a fine.
The ACA hopes to improve the quality of care and lower the cost of care primarily through the operation of Accountable Care Organizations (ACOs). A description of the functioning of ACOs lies beyond the scope of this chapter. It suffices to say that ACOs will establish quality and cost goals. If the ACO meets these goals, providers will receive cash payments through “gainsharing” rewards from the Medicare and Medicaid programs. If they fail to meet these goals, then providers must pay a penalty.
A large title of the ACA deals with workforce issues, and will have a largely negative impact on emergency medicine. This section of the ACA provides funds for the training of physician extenders and primary care physicians. However, the ACA defines primary care as general internal medicine, family practice, and general pediatrics. The ACA provides for an immediate redistribution of residency slots toward the three primary care specialties. Initially, these redistributed slots will come from two sources, (1) slots that were unfilled for 3 years, and (2) slots from closed hospitals. Thereafter, Medicare graduate medical education funds will provide for new primary care residency programs and the expansion of existing primary care residencies.
After the ACA went into effect in 2010, the various federal departments and agencies began writing regulations required by the ACA. Most of these regulations will come from the Center for Medicare and Medicaid Services (CMS). These regulations will deal with payment, quality control, ACOs, tax issues, medical education and training, and a host of other related issues. On the one hand, the ACA banned the use of “prior authorization” requirements by insurance companies for emergency department (ED) visits, and banned the use of higher copayments for ED visits, but on the other hand, a recent CMS Regulation allows insurance companies to choose a low level of reimbursement for emergency medicine providers (3). Emergency medicine advocates have an opportunity to influence the regulatory process, and a number of emergency medicine societies banded together to form lobbying groups (4).
Another area of potential difficulty in the regulatory process concerns the regulation of ACOs. In most communities, an ACO will include at least one hospital and many physicians and other providers. When the ACO contracts with insurance companies, it will have to negotiate price. This will create antitrust risk for physicians and other providers, as competitors may not discuss price, and definitely may not enter into agreements on price. Government expects all physicians in a market area to act as competitors. Two exceptions exist to this general rule, (1) physicians who practice in a group and use the same taxpayer identification number, and (2) employees. Even if an ACO includes only one emergency physician group, government investigators could consider these emergency physicians as competitors of other physicians in the ACO, such as primary care physicians, anesthesiologists, or any other physician who performs a service similar to any ED service.
Therefore if these physicians bargain for price with an insurance company, a government inspector could decide that these physicians engaged in price fixing, usually a criminal violation of the Sherman Antitrust Act. To avoid such potential liability, the ACO would have to evolve into a truly integrated delivery system, or the physicians would have to become employees of the hospital. Of these two options, becoming an employee would be the only sure way to avoid antitrust liability. For these reasons, unless physicians receive some regulatory antitrust relief, the development of ACOs may lead many physicians to become employees. In emergency medicine, this could threaten the viability of independent democratic groups. It could also threaten the viability of large contract management groups.
Advocacy efforts on behalf of emergency medicine should focus on influencing the regulatory process in the following areas: modification of regulations controlling payment for emergency services, antitrust relief to facilitate the development of ACOs, and modification of workforce policies that will restrict future training positions in emergency medicine. The ACA will create profound and long-lasting changes in the practice of medicine. Many of these changes will have a negative impact on emergency medicine, but many of these changes may be mitigated through appropriate advocacy during the regulatory process.
THE EMERGENCY MEDICAL TREATMENT AND ACTIVE LABOR ACT
Congress enacted the Emergency Medical Treatment and Active Labor Act (EMTALA) in 1986 to prevent financial discrimination in hospital EDs. Congress was concerned about economic dumping of uninsured patients from hospital EDs. The purpose of the Act was to prevent discrimination in the evaluation and treatment of ED patients in any form. The crux of the statute is to ensure similar and nondiscriminatory evaluation and treatment of all individuals who present to an ED, whether insured or not.
Under EMTALA, if an individual comes to an ED and a request is made on their behalf for examination or treatment, then they must receive (1) an appropriate medical screening examination (AMSE), (2) stabilization of their emergency medical condition, and (3) appropriate transfer when indicated (5). EMTALA does not define what constitutes an “appropriate medical screening examination,” but does declare that the examination must include ancillary services routinely available to determine whether an emergency medical condition exists (6). Federal courts concluded that an AMSE requires hospitals and physicians to provide an examination comparable to similarly situated patients (7).
EMTALA provides that any individual found to have an emergency medical condition (EMC), including active labor, must be stabilized before they may be transferred. Stabilization means “to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer” (8). EMTALA defines transfer as “the movement (including the discharge) of an individual outside a hospital’s facilities at the direction of any person employed by (or affiliated or associated, directly or indirectly, with) the hospital . . . It does not include such movement of an individual who has been declared dead or leaves the facility without the permission of any such person (9). EMTALA allows a physician to transfer an unstable patient to another hospital, if the medical benefits of the transfer outweigh the risks (10). Additionally, a competent patient or surrogate decision maker may also request a transfer. In either situation the transferring hospital must provide all treatment within its capabilities; must obtain the consent of the patient or surrogate for transfer; must contact the receiving hospital and secure approval for the transfer; must document that the receiving hospital accepted the patient; must send all relevant medical records, and must assure that the patient is transferred by qualified personnel with adequate equipment to complete the transfer (11).
Hospitals may not delay AMSEs to inquire about payment for services or insurance coverage (12). Furthermore, hospitals with specialized capabilities, or regional referral hospitals in rural areas, may not refuse appropriate transfers, if they have available beds and staffing (13). EMTALA obligations end once a patient with an EMC is admitted in good faith to a hospital as an inpatient (14). Plaintiffs may only file suit against a hospital, for an alleged EMTALA violation, not the physician (15). Hospitals and physicians may be fined up to $50,000 per occurrence and be excluded from Medicare for flagrant or repeated violations. Hospitals have the right to sue physicians in indemnification to recover the cost of the fines.
CMS wrote a series of regulations that interpret the EMTALA statute and guide its implementation. An individual has “come to the ED” when he arrives on hospital property (16). Hospital property is defined as (1) the area immediately adjacent to the main building, and (2) other areas owned and operated by the hospital within a 250-yard radius of the main building (16). An off-campus facility qualifies as a dedicated ED if (1) it has an ED license, (2) it holds itself out to the public as providing emergency care, or (3) during the preceding year, one-third of outpatient visits were for emergency medical conditions (16). EMTALA does not apply to inpatients, unless the hospital admits the patient in bad faith to avoid providing stabilizing treatment. Nor does it apply to scheduled outpatient visits in a hospital clinic (16). Finally, hospitals must maintain an on-call list of physicians on its medical staff based on the needs of its patients, resources available, and availability of on-call physicians. They must have written policies and procedures to respond to situations where a particular specialty is not available or the on-call physician cannot respond because of circumstances beyond the physician’s control. They must also provide that emergency services are available to meet the needs of patients if the hospital elects to permit on-call physicians to schedule elective surgery or cover concurrent on-call duties (16).
HIPAA AND HITECH
Access to a patient’s health information (HI) is essential to provide appropriate and comprehensive medical care. During treatment, a patient’s HI is exposed to numerous healthcare providers, support personnel, and payers. A major concern is that persons not involved in a patient’s medical care may gain unauthorized access or exposure to HI inadvertently or intentionally and divulge it to third parties.
In response Congress enacted the Health Insurance Portability and Accountability Act (HIPAA) in 1996. The intent of the Act was to guarantee that individuals retain access and control of their HI and to ensure that healthcare providers treat HI in a confidential manner. HIPAA applies to all HI, whether communicated, stored, or transmitted in oral, written, or electronic form. This includes oral conversations, telephone calls, faxes, letters, e-mails, text messaging, computer drives, and data centers.
The principal part of HIPAA affecting the ED is the Administrative Simplification section, 45 CFR Parts 160, 162, 164 (1996). It contains privacy and security regulations which (1) describes how an individual’s HI may be used and disclosed, (2) incorporates privacy and security standards to safeguard the integrity, confidentiality, and availability of HI, and (3) provides specific patient rights concerning their HI; and creates national standards for electronic healthcare transactions, including data and transaction formats and specific code sets for diagnosis, procedures, and medications. The law compels privacy and security measures to prevent unauthorized disclosure, access, alteration, destruction, or release of HI. It also establishes unique identifiers for providers and third-party payers, and details sanctions for violations.
A covered entity (CE) under HIPAA may use protected health information (PHI) for treatment, payment, and healthcare operations (17). CEs are not required to obtain an individual’s authorization to use PHI. HIPAA requires a CE to obtain an individual’s written authorization before it may disclose PHI outside of the CE (18). Exceptions allowing PHI to be disclosed without prior authorization involve public health matters.
On February 13, 2009, Congress passed the Health Information Technology for Economic and Clinical Health Act (HITECH). Through HITECH Congress instituted incentives for the meaningful use of electronic health records (EHRs). It also expanded HIPAA’s privacy and security provisions directly to business associates, revised civil monetary penalties for violations, and mandated accountings for disclosures made for payment, treatment, or healthcare operations via an EHR.
Civil penalties are tiered based on severity of the violations. The minimum fine is $100; the maximum fine is $50,000 per individual violation. Maximum civil penalties for multiple violations range from $25,000 to $1.5 million per year (19). Moreover, criminal sanctions may be imposed against CEs and persons within the CE. If the PHI is obtained or disclosed without authorization, the fine is $50,000 and/or incarceration for up to 1 year.
Common Pitfalls
• The Affordable Care Act and its Regulations contains many pitfalls for the specialty of emergency medicine including limitations on reimbursement for emergency services, antitrust risks for physicians in ACOs, and future financial limitations on emergency medicine training programs.
• Failure to provide an AMSE for every individual who seeks care in an ED.
• Failure to provide stabilizing treatment to the maximum capability of the hospital before transferring patients.
• Failure to obtain proper authorization prior to the release of protected health information.
• Failure to establish administrative, physical, and technical safeguards to protect the privacy and integrity of health information.
REFERENCES
1. Pub Law 111 Congr 148; 124 Stat 119 (2010). To be codified in various sections of 42 U.S.C.
2. NFIB v. Sebelius, 567 U.S. ___ (2012).
3. 45 CFR §147.138(b)(3).
4. See, e.g.: www.acep.org/emactionfund.
5. 42 USC §1395 dd.
6. 42 USC §1395 dd (a).
7. Summers v. Baptist Medical Center, Arkadelphia, 69 F.3 d 902 (8th Cir 1995), rev on reh 91 F.3 d 1132(1996).
8. 42 USC §1395 dd (b).
9. 42 USC §1395 dd (e)(4).
10. 42 USC §1395 dd (c).
11. 42 USC §1395 dd (c)(2).
12. 42 USC §1395 dd (h).
13. 42 USC §1395 dd (g).
14. Harry v. Marchant, 291 F.3 d 767 (11th Cir. 2002).
15. Baber v. Hospital Corporation of America, 977 F.2 d 872 (4th Cir. 1992).
16. 42 CFR §489.24.
17. 45 CFR §164.502.
18. 45 CFR §164.508.
19. 42 USC §1320 d-5.