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Health Care Law
University of Mississippi School of Law
Gilchrist, Katie

Health Law Outline

Gilchrist Fall 2016

FOCUS ON STARK. NO HYPO FOR ANTIKICKBACK OR FALSE CLAIMS, JUST KNOW THE LAW AND HOW IT WORKS AND HOW YOU SHOULD ADVISE YOUR CLIENT.

Introduction to Healthcare

Outline of Our Healthcare System

Gov’t is largest insurer in the country (ex. of publicly-funded healthcare: Medicare, Medicaid, Veterans Health Association)
42 million are uninsured in U.S. of this number, 1/3 belong in households that make $50,000 or more annually, and some around age 30 opt not to purchase health insurance
How our healthcare system works:

Person who is sick or injured à Primary care physician à (referral)
Specialty physician
Hospital or Testing Facility (Diagnostic Imaging Centers: conduct MRIs, mammograms, etc.)
Pharmacy
Hopefully sick person gets well (if not, you loop back into the process)

Players in HC system

(1). Consumers

Patients, sick, injured
Quality, cost, accessibility, ability to pay matter most to consumers

(2). Types of Healthcare Providers

Hospitals (acute treatment hospital, long-term hospitals, pediatric, cardiac, etc.)
ASC’s (Ambulatory Surgical Center – surgery center patient walks in and out, don’t stay overnight; 2 types: multi-specialty and single specialty)
Public Health Clinics (publicly funded health centers)
Mental Health Centers (provide counseling, psychiatric acute facilities)
Physicians
Diagnostic Imaging Providers (radiologists practice here – 2 types: diagnostic [diagnose patients] & interventional [interact w/patients via use of scopes, etc. – these may refer])
ESRD Facilities (End Stage Renal Disease – ex: kidney dysfunction-dialysis)
Nursing Homes

Referral: A request by a physician for an item or service for which payment may be made under Medicare Part B (when one doctor sends you to another health care provider) (examples: general practitioner à cardiac surgeon; dr à hospital, MRI center; specialist à other specialist)

Primary Care (all refer): Family Practice Physicians, Pediatricians, OBGYNs, Mid-Level Providers
Specialists:

Referring: Neurosurgeons, Cardiologists, Orthopedists, Oncologists, Dermatologists;
Non-referring (not dealing directly with patients): Radiologists, Anesthesiologists, Pathologists

(3). Payors

Patients
U.S. Govt (Medicare, Medicaid, etc.): How does gov’t get most for its money?

Gov’t doesn’t bargain; they say this is what we’ll pay, period. In some states there are so many Medicaid patients, doctors/hospitals virtually have to take these patients (ex: MS – lots and lots of patients on Medicaid)

State Gov’t (participate in Medicaid)
Workers Compensation Programs [Employers (if self-insured)] Lawsuits (Damages)
Charity Care (no payment)
Insurance Companies: How does an insurance company get the most from its providers?

Insurance companies K w/physicians & hospitals and say we will direct them to you, but in order to K w/us and have access to these patients, you have to charge us less than your usual charge (basically, bargain w/the them b/c providers want access to these patients)

Most important issues to the people who are paying? Costs and effectiveness

(4). Regulators

Govt is the big regulator of health care. (fed & state).
Their biggest enforcer is Centers for Medicare and Medicaid Services (CMS)
See PP slide on regulators
What issues are important here? Over-charging patients, unnecessary treatments, unnecessary or improper referrals, etc.

Gov’t has to put restrictions on these things, so doctors and hospitals don’t take advantage of the system.

Major Regulatory Schemes: CON laws, EMTALA, HIPAA, ERISA, UHCDA (Uniform Healthcare Decisions Act – deals w/informed consent & who can consent for minors and incapacitated persons), STARK (anti-self-referral law), ANTIKICKBACK STATUTE (AKS) (prohibits doctors from getting paid for making referrals), FCA (False Claims Act)

Interrelationships

Physician/Hospital Relationship:

What is the relationship b/t physicians and hospitals?

Employment or Not? Generally, drs are not employed by the hospital; rather, they are independent contractors. Some radiologists, etc. are employed.
Medical Staff Membership Documents

Bylaws (hospitals have bylaws that tell drs how they have to behave)
Fair Hearing Plan (medical staff’s bylaws; med staff reviews drs after they have unanticipated bad outcomes from treatments or surgeries, and Fair Hearing Plan outlines how to do this)

Credentialing Process (how hospital reviews dr’s credentials before allowing them on medical staff—they look at physician’s educational background, work history, if any complaints have been filed and upheld against the physician)
Peer Review
How do hospitals/doctors get patients?

(1) Referral- dr admits patient to hospital & (2) Emergency room

How do hospitals/doctors get paid?

Employed dr gets salary & non-employed drs gets professional fee while hospital gets a technical fee.

Provider/Regulator Relationship:

What is the relationship b/t providers and regulators?

Analogy? Good drivers and law enforcement – still get nervous when you pass them even if not doing anything wrong – this is how healthcare providers feel around regulators – like they’re on edge
Governing documents

Conditions of Participation (Medicare)
Medicare Auditors (MACs, QICs)
Statutes: STARK, ANTI-KICKBACK LAW, False Claims Act

Certificate of Need Laws

What is the CON Law and why is it here?

1974: Nat. Health Planning & Resource Development Act

Intent to have major healthcare services/equipment pre-approved
If want funding from the govt, state needs to have a CON law in place. A state regulatory service needs to review CON applications and either approve or disapprove them.
All states were required to have CON laws by 1980

Legislative intent:

CON laws were originally enacted to insure quality health care by limiting supply
Insure access to indigent population
Control costs (one of primary motivating factors – state hoped to prevent expenditure of large amounts of money on health care services in areas where they weren’t really needed)

Studies after CON programs: In 1982, after CON programs were in place, statisti

heart surgery
Cardiac catheterization
Skilled nursing beds
Home health services
Comp. Inpatient Rehab services
Radiation therapy
MRI/PET (MRI good exam question)
Ambulatory Surgery Center (ASC)
LTAC (Long term acute care) Services
Invasive Diagnostics
Swing beds
Licensed psychiatric/chemical dependency services

(5). Relocation of one or more health services (unless w/in mile & under cap.)
(6). Acquisition or control of “major medical equipment”
(7). Change in ownership

If piece of equipment or facility changes ownership by 50%, must get approval by the Dept. beforehand

(8). Change in ownership of skilled nursing facility, intermediate care facility or intermediate care facility for mentally retarded
(9). Any activity described in 1-9 above, if that same activity would require CON approval if undertaken by a health care facility (ignore this one- doesn’t make sense)
(10). Any capital expenditure by or on behalf of a health care facility not covered in 1-10 above.

Med. Office Bldg. (MOB) constructed on land adjacent to health care facility
Land leased from health care facility for construction of MOB
Health care facility has option to purchase MOB or other structure
Health care facility maintains authority to approve tenants of MOB or other structure

To obtain a CON:
Satisfy the 4 general goals of the State Health Plan.

*1. To prevent the unnecessary duplication of health resources
*2. To provide cost containment
3. To improve the health of MS residents
4. To increase the acceptability, accessibility, continuity and quality of health services

Satisfy any applicable “specific standards and criteria” (set forth in State Health Plan)
Substantially comply with General Review Criteria (set forth in CON Review Manual)

The State Health Plan: Specific Standards and Criteria (Section B)

Every CON application for any of the specified facilities or services must be found to be in substantial compliance w/these standards and criteria before a CON will be issued
Examples of Specific Standards and Criteria

Open heart surgery – must show:

Minimum population base of 100,000
150 surgeries per year by end of year 3 (drs with existing patient bases or doctors willing to sign affidavit stating that they will refer at least x number of open heart patients to this hospital each year)
Other providers in area doing 150 surgeries per year for 2 yrs.
Staffing levels (personnel and proper location)
Data maintenance requirement