Key Federal Healthcare Regulatory Requirements
Emergency Transfer and Active Labor Act (EMTALA)
The purpose of the Emergency Medical Treatment and Active Labor Act
(EMTALA), or Federal “anti-dumping” law, is to fight hospitals transferring,
discharging, or refusing to treat indigent patients coming to the emergency
department because of cost factors. The Act protects anyone coming to a
hospital seeking emergency medical services and imposes strict penalties
including fines and exclusion from the Medicare program for violations of the Act.
In part, the Act requires Medicare participating hospitals providing emergency
medical services to:




provide an appropriate medical screening exam to anyone coming to the
emergency department seeking medical care,
treat and stabilize the emergency medical condition, or the hospital must
transfer the individual; for anyone that comes to the hospital and the
hospital determines that the individual has an emergency medical
condition,
stabilize an individual with an emergency medical condition prior to
transfer unless several conditions are met including affecting an
appropriate transfer, and
maintain an on-call list in a manner that best meets the needs of the
hospital's patients who are receiving services required under EMTALA, in
accordance with the capability of the hospital, including the availability of
on-call physicians.
Medicare does not set requirements on how frequently on call physicians are
expected to be available to provide on call coverage. This is up to the hospital
and the physicians on its on-call roster. In order to comply with this law, the
hospital must have an on-call list of physician specialists and sub-specialists,
routinely available to the Emergency Department, including the date and time
when those physicians are on call. This on-call list is typically produced and
maintained by the medical staff office. Medical staff bylaws, rules and
regulations, or policies and procedures should clearly define who must take call
and the responsibility of on-call physicians to respond, examine and treat
patients with emergency medical conditions. Physicians, hospitals, or both, may
be responsible under the EMTALA statute to provide emergency care if a
physician who is on the on-call list fails to or refuses to appear within a
reasonable period of time. Physicians are not required to be on call at all times,
but the hospital must have policies and procedures to be followed when a
particular specialty is not available or the on-call physician cannot respond
because of situations beyond his or her control.
Health Insurance Portability and Accountability Act of 1996 (HIPAA).
HIPAA legislation requires the United States Department of Health and Human
Services (DHHS) to develop standards and requirements for maintenance and
Page 1 of 4
NAMSS Certification Prep Workshop
9/2014
Key Federal Healthcare Regulatory Requirements
transmission of health information that identifies individual patients. HIPAA
regulations are divided into four Standards or Rules: (1) Privacy, (2) Security, (3)
Identifiers, and (4) Transactions and Code Sets.
The Privacy Rule sets standards for how protected health information (PHI) "in
any form or medium" should be controlled. All healthcare organizations, including
health plans and healthcare providers, are prohibited from using or disclosing
health information except as authorized by the patient or specifically permitted by
the regulation and must inform their patients/beneficiaries of their business
practices concerning the use and disclosure of health information.
The Identifiers Rule sets a standard for a national health care provider identifier
(NPI) and requirements concerning its use. The purpose of the National Provider
Identifier (NPI) is to uniquely identify a health care provider in standard
transactions, such as health care claims. NPIs may also be used to identify
health care providers on prescriptions, in internal files to link proprietary provider
identification numbers and other information, in coordination of benefits between
health plans, in patient medical record systems, in program integrity files, and in
other ways. HIPAA requires that covered entities (i.e., health plans, health care
clearinghouses, and those health care providers who transmit any health
information in electronic form in connection with a transaction for which the
Secretary of Health and Human Services has adopted a standard) use NPIs in
standard transactions. The NPI is a 10-position, intelligence-free numeric
identifier (10-digit number). This means that the numbers do not carry other
information about healthcare providers, such as the state in which they live or
their medical specialty.
The Security Rule requires protection against unauthorized use or disclosure
and requires processes to assure the integrity and availability of electronic PHI. It
includes provisions for data backup, disaster recovery and emergency operations
and conducting risk assessments and development of security plans to protect
this information.
The Transactions and Code Sets Rule addresses uniform electronic
interchange formats.
MSPs often deal with peer review issues that contain patient information,
physician health information on applications, and patient complaints. Care
should be taken not to disclose patient health information without obtaining
appropriate consent and release.
Patient Self-Determination Act
This act requires that patients be allowed to participate in treatment decisions
including the use of advance directives. Advanced directives are documents that
allow a person to give directions about future medical care or to designate
Page 2 of 4
NAMSS Certification Prep Workshop
9/2014
Key Federal Healthcare Regulatory Requirements
another person(s) to make medical decisions if the individual loses decisionmaking capacity. Advance directives include living wills, durable powers of
attorney for healthcare decisions, do-not-resuscitate (DNRs) orders, right to die,
or similar documents expressing the individual's preferences.
Sherman Anti-trust Act
The Sherman Act provides: "Every contract, combination in the form of trust or
otherwise, or conspiracy, in restraint of trade or commerce among the several
States, or with foreign nations, is declared to be illegal". The Act also provides:
"Every person who shall monopolize, or attempt to monopolize, or combine or
conspire with any other person or persons, to monopolize any part of the trade or
commerce among the several States, or with foreign nations, shall be deemed
guilty of a felony.” Hospitals must take precaution not to violate the Sherman
Antitrust Act when making medical staff appointment or privileging decisions,
when making referrals to physicians or other health care practitioners, and when
contemplating joint rate setting with other healthcare organizations.
Healthcare Quality Improvement Act of 1986
The purpose of the HCQIA is to encourage good faith professional review
activities. It includes provisions for expectation to protect hospitals and medical
staff members participating on peer review committees from potential liability in
the form of money damages due to legal action taken after the revocation of a
physician’s hospital privileges. In addition, the Act includes standards for
conducting professional review actions (hearings). It also created the National
Practitioner Data Bank (NPDB) and specifies the querying and reporting
requirements for the NPBB.
Stark Law
The Stark law prohibits a physician who has a financial relationship with an entity
from referring Medicare or Medicaid patients to that entity for the provision of a
designated health service. There are eleven categories of designated health
services including but not limited to inpatient hospital services, home care, etc.
Violation of physician recruiting laws and regulations can lead to serious
penalties, including loss of a hospital's tax-exempt status and exclusion from
Medicare and Medicaid.
The Civil Rights Act of 1964
This law was enacted to “enforce the constitutional right to vote, to confer
jurisdiction upon the district courts of the United States to provide injunctive relief
against discrimination in public accommodations, to authorize the attorney
General to institute suits to protect constitutional rights in public facilities and
public education, to extend the Commission on Civil Rights, to prevent
Page 3 of 4
NAMSS Certification Prep Workshop
9/2014
Key Federal Healthcare Regulatory Requirements
discrimination in federally assisted programs, to establish a Commission on
Equal Employment Opportunity, and for other purposes.” It applies to
discrimination in the medical staff application process.
Americans with Disabilities Act (ADA)
The Americans with Disabilities Act (ADA) is a federal civil rights law that
prohibits discrimination based on disability and bars discrimination against a
qualified individual due to the disability. State and local court opinions vary
regarding whether ADA applies only to employees only or includes medical staff
members. It is up to individual hospitals to determine how the ADA applies to its
privileging and credentialing processes. If the organization employs the medical
staff member, the ADA applies.
The Patient Safety and Quality Improvement Act of 2005 (PSQIA)
Final Rule, 42 C.F.R. Part 3, was published on November 21, 2008, and is
effective on January 19, 2009. PSQIA establishes a voluntary reporting system
designed to enhance the data available to assess and resolve patient safety and
health care quality issues. To encourage the reporting and analysis of medical
errors within health care systems, PSQIA provides Federal privilege and
confidentiality protections for patient safety work product. Patient safety work
product includes patient, provider and reporter identifying information that is
collected, created or used for patient safety activities. Civil money penalties
(CMPs) may be imposed for knowing or reckless impermissible disclosures of
patient safety work product.
Patient Protection and Affordable Care Act
The law puts in place comprehensive health insurance reforms. The act created
a provision for Accountable Care Organizations (ACOs). An ACO refers to a
group of providers and suppliers of services (e.g., hospitals, physicians, and
others involved in patient care) that will work together to coordinate care for the
patients they serve with Original Medicare (that is, those who are not in a
Medicare Advantage private plan). The goal of an ACO is to deliver seamless,
high quality care for Medicare beneficiaries. The ACO would be a patientcentered organization where the patient and providers are true partners in care
decisions. ACOs create incentives for health care providers to work together to
treat an individual patient across care settings – including doctor’s offices,
hospitals, and long-term care facilities. The Medicare Shared Savings Program
will reward ACOs that lower growth in health care costs while meeting
performance standards on quality of care and putting patients first. Patient and
provider participation in an ACO is purely voluntary.
Page 4 of 4
NAMSS Certification Prep Workshop
9/2014