Health Law Outline Fall 2012
I. Chapter 1: Quality Control Regulation: Licensing of Health Care Professionals (p.1)
· State law controls licensure of health care professionals under the state’s police power. Licensing statutes govern entry into the licensed professions and disciplinary actions. Licensure also regulates the scope of health care services that licensed professionals may provide and prohibits unlicensed person from providing services reserved for the licensed professions.
· The statutes are implemented by boards that operate as state agencies but which generally are dominated by members of the licensed profession – professional self-regulation.
o Usually include lay members
o Governed by procedures and standards set in the state’s licensing statute and administrative procedures act
o Subject to judicial review in both their adjudicatory and rulemaking decisions.
· Purpose of licensing is to maintain QC
o Enforced by the state
o Board certification means you are qualified to be a consultant in the area. You can practice a specialty without being certified. It is becoming mandatory for reimbursement purposes.
o The public
o Med Mal Litigation
o Insurers providing medical malpractice
o Peer review
o Joint Commission and AHCA.
· Licensure is a privilege, not a right – it is easier to prevent someone from getting a privilege, than it is to take away (vested).
· Physician Licensure. FS 456 and 458
Florida Statute 456
· Generally describes how the DOH may regulate health professions
· Sets budgetary requirements, exec board leaders, board training
· 456.004 –
Cone v. DOH 886 So.2d 1007
· MD and DO
· Osteopathic board moved to revoke license, despite cone’s violation was not in the osteopathic realm and was conducted in a different jurisdiction
o California license was revoked, so FL DOH wanted to revoke FL license
· Court found osteopathic board does have the authority to revoke license in this case, but not for the reason that the department stated
Board Liability
· Board can be disciplined by the governor of FL
· But does not have any civil liability for mistakes made in the pursuance of board duties
Examinations
· Board and dept. may contract out exam services
· Gives them ability to set standards
· Can use national exams, but must be certified by board or dept.
· Legislature prefers national exams
· Record of exam must be kept for 2 years
· Meetings regarding exam challenges are confidential.
· Dept. Health v. Grinberg 795 so.2d 1136
o Department must provide incorrectly answered questions on exams and their answers to a person challenging their failure
o Department does not have to provide correctly answered questions
o Can challenge questions using expert witnesses
Active status vs. inactive vs. retired status
· Must have active statutes to perform services
· Active, inactive, retired statuses
· Can change status at any times
· If license goes into delinquency, license is null and licensee must apply as if applying for the first time
· If applying to be active after being inactive for 2 license cycles, may require exam
Emergencies
· Department can call for a state of medical emergency, inactive licenses can be temporarily reactivated to assist.
Information gathered
· Exempt from public disclosure laws
· Medical schools attended
· All hospitals that provide privileges
· Board certifications
· Criminal offenses
· Disciplinary action taken in past 10 years
· Other licenses
· Optional info
o Peer-review articles
o Community services
o Languages
o Participation in Medicaid
Insurance requirements
· Grants department to set malpractice insurance minimums or require “financial responsibility”
· Exceptions
o Proof of no malpractice exposure
o Employed by the state
o On medical faculty with no actual practice
o Inactive licenses
o Not practicing in state but maintains active license
Duty to report
· Any claim for damages must be reported to office of insurance regulation
Fraud
· If fraud is committed, department or board may revoke or refuse to renew it.
Grounds for discipline
· Fraud
· Violation of department rules
· Convicted felonies
· CME
· Failing to report violations committed by others
· Failing to pay student loans or other legal obligations
· Sexual misconduct
· Drug use
· …
Punishments
· Refusal to grant license
· Suspension or revocation of license
· Restriction on practice
· Fine up to 10k for each count
· Remedial education
· Letter of reprimand or concern
Repeated malpractice
· Revocation of license when practitioner commits repeated med mal
· Based on clear and convincing evidence
· May verify other states
· Repeated means 3 or more instances, must be final judgment – not settlements.
o Only leads to an investigation, not necessarily revocation
· Affects only medical doctors
1) Discipline (p.2)
a) In Re Williams(p.2)
i) Although the state medical board is not required to present expert testimony in every misconduct or standard of care hearing against a physician, there must be some reliable, probative, and substantial evidence to support the charges made.
ii) There must be clear and convincing evidence that they fell outside the standard practice
iii) If they determine that the agency’s decision is supported by “reliable, probative, and substantial evidence”, then the decision will be upheld.
iv) The rulemaking powers of the agency are generally more broad. Courts are generally not going to overturn this unless there was a very good reason.
(1) This was not the issue. The court accepted the rule, but they challenged the punishment of the physician for breaking the rule prior to the instatement of the rule.
(2) They do not grant the same broad authority of the adjudicatory aspect. Not given the same broad deference because someone’s livelihood is at stake.
b) Hoover v. The Agency for Health Care Administration(p.5)
i) A state medical board must give deference to a hearing officer’s valid findings when the hearing officer is in the best position to weigh the evidence and gauge the credibility of witnesses’ testimony in an administrative hearing against a physician.
ii) Courts try to guard against the majority view and do not want to stifle innovation by outlawing the minority view.
c) Telemedicine in Florida – Outlawed
i) Malpractice becomes an issue – where does it occur?
ii) Noninvasive vs. Invasive – if there is only an examination, the physician can come in, but if there is a chance of harm, the physician is not permitted.
d) Federal Regulation of Prescribing Practices (p. 7)
i) Physician prescribing is constricted by the FDA and DEA
ii) The FDA has the authority to approve and monitor the safety of drugs and devices
iii) The DEA more directly regulates the individual physician’s prescribing practices through its authority under the Controlled Substances Act.
(1) Schedule V – lowest potential for addiction – Schedule 1 – highest potential, not allowed to be prescribed by physicians.
(2) May revoke a permit or pursue criminal actions
iv) At the time of the Hoover case, there was strong evidence that the medical boards had not adjusted their standards to reflect medical evidence that supported the use of opioids for treatment over the long term and in higher doses than had been customary.
v) Intractable pain acts – state enacted legislation-limiting agencies from taking action against physicians in certain circumstances.
2) Complementary and Alternative Medicine (CAM) (p.12)– group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine as practiced by MDs or Dos or Allied health practitioners. 4 Domains – Whole Medical Systems, Mind-body medicine, biologically based practices that use substances found in nature, and energy medicine.
a) State Board of Registration for the Healing Arts v. McDonagh(p.12)
i) The appropriate standard of care to determine whether a physician’s actions constitute “repeated negligence” is that same degree of skill and learning used by members of the profession in similar circumstances.
3) Unlicensed Providers – The state medical board has the primary responsibility for enforcing the prohibition against the unauthorized practice of medicine by unlicensed providers. This is enforced by criminal sanctions against the unlicensed practitioner and license revocation against any physician who aids and abets the unlicensed practitioner.
a) State Board of Nursing and State Board of Healing Arts v. Ruebke(p.19)
i) Providing medical services without a medical degree comparable to medical services provided by someone with a medical degree will not be automatically classified as a practice of medicine.
ii) The court in Ruebke concluded that the midwife was operating within a common exception to the prohibition against the unauthorized practice of medicine by performing works delegated by a physician
b) Notes and questions
i) Courts have adopted many approaches to analyzing whether services provided in assistance at childbirth constitute the unauthorized practice of medicine.
4) Scope of Practice Regulation (P.26) – Licensed nonphysician health care providers cannot legally practice medicine, but practices that fall within their own licensures are not considered the practice of medicine.
a) Sermchief v. Gonzales (p.26)
i) Under Missouri law, a nurse does not engage in the unauthorized practice of medicine if she performs certain medical procedures within her field of professional nursing so long as they are consistent with her specialized education, judgment, and skill.
b) Notes and questions
i) PAs are educated in a medical model of care and view themselves as practicing medicine through physician delegation of tasks under the supervision of physicians
ii) Nurse Practitioners view themselves as operating from a nursing model of health acting as specialists
II. Chapter 2: Quality Control Regulation of Health Care Institutions (p.
nd visitation rights
(e) Equal quality of care
b) Survey and Inspection (p.51)
i) An effective quality control regulatory system requires an effective inspection process that, with an acceptable degree of accuracy, detects and documents violations of the standards.
ii) Several studies have concluded that state and federal surveys seriously understate deficiencies, failing to cite deficiencies or categorizing cited deficiencies as less serious than they are
c) Sanctions (p.52)
i) The development of intermediate sanctions was a major effort among the states in the late 1970s and 1980s, and was adopted by the federal government in OBRA 1987.
ii) OBRA allows the HHS to choose from intermediate sanctions when disciplining facilities in hopes of preventing the “yoyo” effect that occurs with the more harsh sanctions.
iii) The most frequently litigated questions are the determination of ‘immediate jeopardy’, which triggers the most severe sanctions, and the appropriateness of the sanction chosen
iv) Broad deference is warranted where the regulation concerns a complex and highly technical regulatory program, like Medicare, in which the identification and classification of relevant criteria necessarily require significant expertise and entail the exercise of judgment grounded in policy concerns.
5) Private Accreditation of Health Care Facilities (54)
a) The Joint Commission (JCAHO), which offers accreditation programs for hospitals, nursing homes, home health, and other facilities, and the National Committee on Quality Assurance (NCQA), which accredits managed care plans and other providers, are two of the leading accreditation organizations of health care entities.
b) All hospitals with more than 25 beds are accredited by JCAHO.
c) Both state and federal governments rely on accreditation in their hospital licensure and Medicare/Medicaid hospital certification programs.
d) Under the Medicare statute, JC accredited hospitals are deemed to have met requirements of Medicare certification. Although, the Secretary retains a look-behind authority, the JC substitutes for the routine surveillance process.
e) The federal government’s reliance on private accreditation as a substitute for routine government surveillance has expanded considerably and now extends to clinical laboratories and home health care.
f) Private accreditation programs traditionally have engaged in practices that encourage voluntary subscription and the standards are dominated by professionals in the industry rather than consumer groups.
g) The JC began performing unannounced inspections in spring 2006.
6) Hospital Licensure, see ppt.
III. Chapter 3: The Professional-Patient Relationship (p.57)
· Once you have an existing relationship, you cannot abandon the patient. You have to follow a set of procedures to terminate a relationship – in writing by certified mail.
o You don’t have to speak directly to or touch a patient to establish a relationship. It is based on reliance – once the patient relies on a licensed physician, a relationship is established. The care can be managed or directed by a physician. Holds true for any licensed provider.
o Good Samaritan statute is not worth much. You are held to the standards of a licensed provider, not just an average citizen.
o There are two states with an affirmative duty to rescue.
o Generally, no relationship is established when it is a family seeking advice.
o Is there a relationship when there is a phone call to a secretary? No.
§ Every time a nurse answers the phone, she is accepting liability and should counsel the patient to be seen and/or call 911.
o Can you decline a patient in Florida? Yes, but you cannot give a reason for why you are declining.
· Respondeat Superior – employer is always responsible for the acts of the employees, regardless of who it is.
o The only way around this, is if they go beyond the scope of practice that is permitted by the employer. The employer can then sue you.
o Staff privileges are not being an employee of a hospital.
o If you are on call, and you don’t answer your page, the physician and the hospital are responsible, even if there is no employment relationship.
