Health Care Law
Sidney Watson
Spring 2012
Licensing and Quality of Care
I. Quality of Care
A. Definitions of quality care
i. Effective care – benefits outweigh the risks such that virtually all patients with medical need should receive this care (assesses requirements of care) But, many current medical practices either are ineffective or could be replaced with less expensive substitutes
1. Physicians often select more expensive treatments because of bias, fear of litigation, or financial incentives
2. Patients would often choose different options from those recommended by their physicians if they had better information about treatment, risks, and benefits of cost
3. Much of American medical practice when exposed to controlled trials has been found unhelpful. But unnecessary care that causes harm, by Donabedian’s standards, is poor in quality, too.
4. Without more scientific testing (some coming in ACA) there are not a lot of ways to compare different procedures.
ii. Quality care – kind of care that is expected to maximize an inclusive measure of patient welfare after account of balancing the gains and losses of the process itself (assesses standards of care)
1. Institute of Medicine definition – assesses quality in terms of “outcomes” and consistency with current medical knowledge
2. Donabedian definition – assesses quality in terms of overall patient welfare
a. “Absolutist” view – doc’s management of pt’s problems in the way that the doc expects will best balance health benefits and risks
b. “Individualized” view – docs and patients share in the decision making process regarding procedures, docs provide the information and patients make an informed decision
c. “Social” view – examines the distribution of benefits within the population
iii. Error – any preventable adverse effect (whether or not it is harmful)
1. Sentinel or “never” event – an unexpected occurrence or risk involving death or severe physical/psychological injury
a. Includes: loss of functioning not related to the patient’s condition, suicide, wrong-side surgery, infant abduction, rape, and hemolytic transfusion reaction. serious and costly errors in providing healthcare services that should never happen (e.g., wrong side surgery)
b. There are 28 defined “never events” and are 100% preventable
c. The Joint commission, private accreditor of hospitals, adopted two tier reporting requirement. First reporting of sentinel events goes to Joint commission, then to patients.
d. Some states have adopted laws requiring reporting of sentinel or “never” events to the National Quality Forum.
2. Adverse Event
a. Errors that result in harm to the patient
i. Adverse Events – Clinic Effect on Patient that is perceptible to patient or health care team
ii. Patient mistakenly got the wrong drug
b. Adverse events that lead to a necessary change in the patient’s care
i. Longer hospital time
ii. More follow up visits that would have not been required
iii. Surgical procedure
c. Adverse events with a known risk of serious future health consequences – even if the risk is small
i. HIV infection
ii. Increased incidence of cancer
d. Adverse events that require treatment of procedure without the patient’s consent
i. Deviation from what the patient expected
ii. Patients have a fundamental right to be informed about what is done to them and why
3. Problem: error prevention is reactive à occurs after the error has happened, underlying causes are rarely examined
4. When to disclose errors to patients:
a. Event will have/is expected to have a clinical effect on pt that is perceptible to either the pt or healthcare team
b. Events that necessitate change in pt care (e.g., medication error that warrants observation)
c. Events with known risk of serious future health consequences (e.g., accidental exposure to toxins)
d. Events that require providing treatment or procedure without pt consent
iv. Access – to safe, effective, timely, efficient, and equitable care
1. Note: Having health insurance does not mean you have access to healthcare
B. Controlling quality
i. Professionals historically allowed to self regulate. Doctors were given strong autonomy as championed by AMA.
ii. Government regulation:
1. Made possible by the move of medical care from the home to the hospital
2. Increased use of administrative law b/c the idea that you need someone who is a good overseer of quality
3. Licensing laws
a. Statutes are broad frameworks fine tuned later by admin laws and medical boards.
iii. Market competition
1. Antitrust – prevents prices from being set by medical associations or insurance corporations.
2. Fraud and abuse law
C. Approaches to measuring quality (Donabedian method)
i. Structure – includes human, physical, financial resources needed to provide care
1. Functions to produce care or is a feature of the care environment, influences the kind of care provided
2. Not useful means of assessing quality of care because it can only indicate general tendencies, but easy to perform
a. Facilities Used
b. Medical School
c. Health of Dr.
3. Examples: the number of nurses, the facilities, the medical school, years of experience, gender. Concept includes the human, physical, and financial resources that are needed to provide medical care.
4. Characteristics of structure:
a. Relatively stable
b. Functions to produce care or is a feature of the environment of care
c. Influences the kind of care that is provided
d. Relevant to quality in that it increases or decreases the probability of good performances
ii. Process – set of activities that go on between patients and practitioners (primary objective of healthcare measurement)
1. direct observation or review of records can be used for judging quality
2. Drs. can set standards for care and establish spectrum of acceptable practice before research complete.
3. Factors
a. Years of experience
b. Interpersonal relationship (patients like fuzzy feel-goods)
c. # of preventative tests carried out (generally well-done but large discrepancies in U.S. based upon race)>
iii. Outcome – includes improvement to social and psychological function and physical and psychological aspects of healthcare
1. Provides flexible approach that focuses on what works and on integrated care that includes consideration of a patient’s contribution.
a. Hard to specify but some factors are:
i. Malpractice and
ii. Readmission rates.
D. Principles of quality improvement philosophy (Total Quality Management – Intermountain)
i. Quality is defined in terms of meeting the needs of customers, but if patients can’t assess the quality of medical care, they cannot define it
ii. Efforts are better directed at improving the system through which care is directed rather than looking for incompetent workers
iii. Data are important for driving and shaping improvement; systems as well as improvements must be monitored
om pursuing alternative treatments even if legitimate
iv. Payer certification – certain minimum standards required to receive funding (usually Medicare/Medicaid); always requires licensing and often gives deemed status for accreditation
1. “Deemed status” – payer (Medicaid/medicare) certification standards are generally “deemed” to have been met if the organization is privately accredited (e.g., by JC)
v. Regulation – requires public comment period, more lengthy documents; binding on agency/organization, enforceable in court, promulgated by agency. Think NHA.
vi. Guideline/Policy – can be put through pure quickly, no public input; don’t have the force of law
B. Licensing via law and regulatory issues
i. State/Federal Prescribing practices
1. Read the applicable statute – what does it say you have to be licensed for and what can you do under the license?
2. Levels: state medical boards à public/private payers (e.g., Medicaid) à FDA/DEA
3. FDA authority – to approve and monitor the safety of drugs and devices
4. No authority to restrict Drs in proscribing drug after it is approved for a purpose (off-label use)
5. DEA authority – regulates individual Dr’s Proscribing practices through Controlled Substances Act
a. Drs receive permits from DEA to prescribe scheduled drugs
6. Controlled Substances Act (CSA) – gives feds ability to govern production and distribution of drugs that have abuse/addiction potential
a. Drugs categorized into 1-5 with 5 having low abuse likelihood and 1-2 having very high abuse likelihood.
i. (Level 1 – have no therapeutic benefit and have very high abuse potential (e.g., heroin)
b. Level 2 has some therapeutic value and can be allowed with prescription.
7. State/Federal drug policy conflict
a. Diverge with respect to relative emphasis on ensuring availability of pain meds to those who need them
b. States instituted legislation that protected docs who issued meds for chronic pain in some cases
c. DEA initially followed suit but later retracted saying that previous attempts had departed from standards set by Federation of State Medical Boards
C. Standard for judicial review of licensing agency hearing decisions (doctor decisions)
i. “In an appeal from an administrative agency a reviewing court is bound to uphold the agency’s order if it is…supported by reliable, probative and substantial evidence and is in accordance with the law…”
1. In re Williams [117] – Rx’d drugs that were later deemed prohibited for the use Dr was Proscribing. Where doctor was giving prescriptions for diet pill for longer periods than supposed to be prescribed and for longer uses.
a. Question: Whether the minority use of the drug may be supplanted by the preferred use by the medical board (even if in other states the minority use is approved by other boards).
b. Court stated that when there are two established schools of thought, board cannot use its own preference as evidence of substandard care
c. Further, where there is a body of expert opinion in support of a practice (minority view, for instance) it does not cut against the statute or the board’s rulemaking authority.
d. Court stated you do not need an expert witness to testify to standard of care when a specific regulation/statute has been violated