Health LAW Outline PDF

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HEALTH LAW OUTLINE – Fall 2021BACKGROUNDPlayers:Govt3d partiesPayersProvidersWhy is Health Law important/separate from other principles?Everyone has an interest in their health or family'sScientific info - relevant to complicated principles$$$ - expensive/profitableWho pays for healthcare? M...

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HEALTH LAW OUTLINE – Fall 2021 BACKGROUND Players:  Govt  3d parties  Payers  Providers Why is Health Law important/separate from other principles?  Everyone has an interest in their health or family's  Scientific info - relevant to complicated principles  $$$ - expensive/profitable  Who pays for healthcare? Mostly o Insurers o Govt.  Medicare/Medicaid programs  Really complicated regulatory system o Significant $ spent by govt. General themes: o Quality of care regulation  What kind of systems/procedures do we have in place to try and ensure quality  A LOT  Professional licensure  How healthcare is financed - ERISA  Employer-based insurance coverage o How to protect healthcare system from fraud and abuse  So much $$ runs through that bad actors take advantage  Fraud, waste, and abuse laws Death of a Hospital article  Lots of legal issues o Turning away patients - patient abandonment o Partnership referral network  Part of economically viable plan -- economic incentive  Duty to provide quality care butting up against financial interest o Quality care  Lack of equipment  Bad internal record system  General environment/conditions  Cautionary tale about the role of big $ in healthcare o For-profit nature of healthcare o What about non-profit companies like Allina Health?  Both want $ - difference is:  For profit pays private individual  Nonprofit- pumps profit back into org operations Cases: Katskee v. Blue Cross/Blue Shield of NE

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What exactly is health? Dispute about coverage o Contract case- insurance policy

Facts:  She has a condition that suggests breast cancer - AND family history - and if not, can die. o Predisposed to awful condition  Physician recommends invasive procedure o Does it.  Insurance won't pay. Insurance opinion:  She's not sick. She didn't have cancer. What to do?  Interpret K o When terms are clear- plain meaning  If policy ambiguous - look beyond and construe against insurer. What is an illness?  Court looks at policy language, and then definitions.  Insurance definition of "medically necessary" o We cover items and services "medically necessary" as determined by us. o State can say everyone needs to cover X - insurer says" yeah, when its medically necessary" o Well, insurers behave a role in containing costs.. Managing care..  A lot of unnecessary surgeries by bad faith doctors too -o Tension within healthcare delivery Holding:  Treatment is covered  General definition of illness Fuglsang (case relied on by BC/BS)  When an illness is actually manifested.. It counts.  Here, she doesn't have a symptom, no manifestation.  COURT: this is just about whether an illness exists, not whether it IS an illness. o What about other predisposed conditions?  Depends on severity of consequence  Nature of condition and ramifications  Strength of scientific evidence  No bright line result Why wouldn't the insurers just pay?  Insurance developed in a way that sets rigid boundaries-o Even when it seems like a good idea to pay for this surgery - due to chances of increased treatment later- hard to diverge Notes:  Here, rise of genetics testing note o Ability to test for some health conditions. o Influences how insurance is paid for  NOT ERISA case. o erisa - federal law that applies to anything that is considered an employee benefit program o IF erisa, different result  ERISA imposes diff standards of review on cases like this. o In some instances, state law not federal erisa law

Practice Problem: Couple's Illness  Infertile couple wants a special treatment, Protocol 1.  Fact that they paid for it before seems relevant  Whether infertility is an illness? o Some parallels between insemination procedure and complicated Protocol 1  COULD be that insemination is just OK under policy  Insurance: condition of not being pregnant is not an illness o Needs some meaning beyond "different than normal" Holding: treatment should be covered  Functional approach- deviation from what is normal.  Sides w/ Katskee If insurance company- what to do?  Narrow the language. Specific exclusions.

PROFESSIONAL LICENSURE - Means of regulating quality of care -

Are you doing things that would require a license? Are you doing things beyond the scope of your license?

Missed Class Cases: Ruebke Case - Midwifery (alternate healthcare)  Example of a dispute that happens throughout the country w/ respect to boundaries and who gets to do what Issue:  Whether Reubke (lay midwife) guilty of nursing Rel. Laws/stats: definition of the "healing arts"  Broad definition  Statute first talks in a very general sense - and then narrows a bit. o If you hold yourself out as physician OR  Prescribe, perform surgery  Core issue: is the definition void be/c too vague Facts:  Ruebke = lay midwife (head of midwives assoc.) o Unlicensed. Practical experience dealing w/ childbirth.  Turf battle (competition (theme in course))  OB testified that R's practice is OB treatment  Nurse testified that R's work is like her own o Licensure for nurse midwives  No harm to patients alleged Board argument:  Have to show inherent risks  Really, just didn't have a strong case Opinion:  Detail about midwife history and fact that its existed forever  Dr's start to crowd the field and childbirth BECOMES a medical thing  Childbirth different than other forms of medical care (theme in case)

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b/c not abnormality; natural condition (what is illness?) -- unsatisfying part of opinion in prof's opinion (and mine) Even if she is doing healing arts, she is fine be/c under the supervision of physician

 Notes:  What are appropriate role of licensing board?

Sermchief v. Gonzales (scope of nursing)  Asking the court to weigh in on legal action that effects your rights. (nurses and physicians) Facts:  Agency provides general health services to low-income patients o Medicaid/Medicare $ o With only 2 physicians and lots of nurses - can provide lots of service to low-income people  Nature of services: related to STDs and reproductive health services o (maybe some political motivation to shut them down) Board's argument that nurses are practicing outside of scope:  Not always supervised  Allegation: nature of services are going beyond traditional nursing services Laws involved:  Stat. o Former and updated definition  "under supervision and direction of physician" Court:  Inferring that legislature intended to expand role of nurses and to create accessible healthcare Notes:  Some legal risks w/ arrangement where a single physician and # of allied practitioners o How many people are being overseen (accountability problems) o One of the things to point out are realistic risks of this kind of practice and here are the things you can do to reduce:  Limitations on what nurses can do  Implement practices that mitigate risk Practice Problem: Physicians, PAs, and Nurses - p.73  Level of uncertainty w/ some of these q's Facts:  2 physicians w/ practice in broad family healthcare.  Want to expand into new underserved area  Want to employ Nurse and PA o PA w/ trauma experience  1/week visits  Want to include midwife (mayo) Discussion:  Starting office in Tessa: o How to advise in terms of legal compliance:  Geographic proximity - not clear so look @ case law, comments, sub regulatory guidance  Daily oversight.  Ellis (PA) o Stop giving blank & signed prescription pads o Concept of PA prescribing seems to be OK -- BUT need daily review

 Expectation of oversight that isn't happening Can delegate prescribing authority to PA, BUT  w/in scope of PA's training Mayo (lay midwife) o Supervised by OB, but patients admitted by dif. Internist  What she does is in spirit of statute, but loose ends Can't delegate to a PA something you don't know about o Meant to oversee - if you don't have experience in that field, then you can't oversee. o

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REGULATED INSTITUTIONS (as opposed to individuals) Regulatory Systems: - Federal Govt:  Power of the purse o "He who shows up with bucks gets the donut."  Nursing homes super controlled from fed. Govt o Also must abide by state (can be licensed, but fed is where $ comes from for most)  Only those who accept Medicare or Medicaid funding must abide Examples of institutions:  Hospitals  Nursing homes  *regulation must be different for different types of institutions Standards developed by Fed. Govt.: 1. Structural a. Staffing i. (why would you not require each facility to include a staff member dedicated to compliance-- job is to make sure they are meeting standards AND documenting.) b. Building c. Equipment 2. Processes a. Set of policies and procedures that exist b. Do you have a plan in place that is intended to guide operations in a way that is designed to make sure what you're doing will render quality services 2. Outcomes a. Results of care b. How is the patient's health status actually impacted c. Hard to measure i. Surveys are subjective ii. Say, quality measured comes out - ex: going to measure nursing homes by looking at following measures and one is making sure residents are bathed 1. All nursing homes are going to be focused on bathing 2. Homes get too focused on quality measures and less on what the patients actually need Structural differences  Hospital: o Physicians are directing care o Advocacy and awareness by patients  NH have old patients only o Concept of choice more real

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 Harder in NHs When you think about how to regulate quality – different

NURSING HOMES Considerations for quality regulation o NH's are largely for-profit o Functions are more sensitive (ADLs) o Proof problems  Don't have reliable witnesses  Dealing w/ very frail population  States license nursing homes  Regulation is much more top-down  *Regulatory systems need to be able to adapt and change depending on the landscape  $$ reimbursement for these institutions are really low o Lot of reliance on govt programs Licensure of Nursing Home  Dept of health issues licenses o Extensive rules about nurse training, hygiene, o Can conduct inspections Fed govt  Exercise lots of control when it comes to nursing homes o Basically b/c paying for it -- financial reliance of NH on fed healthcare programs that allow the fed govt in having a substantial role 

Nursing home regulatory reform  Driven by scandal o Nursing home horror stories o What's the problem w/ regulations being drive by scandal?  Reacting as opposed to proactive o Reactive regulation can go too far sometimes o Scandal -->  Overlayed big regulatory scheme on it  If not, could take different approach

Cases: Smith v. Heckler Facts: - started out as class action lawsuit brought on behalf of nursing home residents against dept. of hum services  Main point of case: challenge how nursing homes are being overseen o Π fundamental contention/complaint: categories of standard  Overly focused on structural things (facility-oriented) and allows paper compliance  Survey q's were extensive -- so on paper, they look very compliant.. But in reality, all it did was allow nursing homes to quickly check off the list. -- just show that you've the theoretical ability to provide quality care o Actual req: HHS has to design and implement a system that ensures patients/residents get optimal medical and psychological care  HHS has ability to do implementing regs -- and then agency, you can implement through regulation

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Problem w/ HHS implementation. - kind of missing the point  They made a bunch of regulations that didn't actually ensure or focus on actual care  Only measuring stuff like size of room, doors, etc.

Holding:  Court agrees w/ π's  Relief: basically require HHS to develop a new approach o Significant to have a court order a state agency like HHS to start over and to tell them they aren't doing their job. That they need to make sure standards meet regulation. One part is to make sure care is right. Your regulatory scheme falls short Notes:  Went from really high level stuff to NOW very detailed requirements o Does create challenges for long-term care facilities and those advising them Background:  Medicaid = state insurance o Covers lower income and certain categories of disability o Medicaid expansion and additional eligibility o In MN, administered by dept. of human services o States accepting substantial amount of federal funding -- with strings attached  Must have state plan  (so THIS is why red states don't like Medicaid expansion -- favor limited govt. expansion would require them to be highly regulate) -poor Edwina. Getting used by politicians.  Compliance to federal standards  Survey process o By the time you enter nursing homes, you've most likely depleted your assets and rely on Medicaid. Most in nursing homes are on Medicaid.  Medicare o Some are duo-eligible for both this and ^  Case shows state-federal play about how healthcare is regulated Sunshine Haven Procedure:  Super complex  Several levels of administrative appeal Facts:  Survey 1: 11/5/2008  Initiated by complaint  Mom said SH wasn't bathing her daughter  Surveyor based conclusion on records (facility's own documentation got them in trouble)  Residents didn't look unkempt  No clear actual harm  If your handbook says X, and you don't do it; you're in trouble.  Survey 2: focused on restraints  Survey 3: transfer techniques in noncompliance  Survey 4: February  Smoke alarms. Lack of cameras.  Structural complaints  Results in all these correction orders.  In some instances, SH actually corrects and complies.

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Penalty imposed: Deny new patient admission funds Terminate provider agreement (major) Rationale: Under regulations you HAVE to terminate if 6 mo. Of noncompliance  Stringing together various deficiencies - Overlap of deficient and correction.  Starts in Nov. and continues to have problems -- every survey chained together to result in long period of non-compliance SH argues:  Surveyor told them K's in place were good enough to satisfy.  BUT you should have been im compliance anyway.  Surveyor was unqualified (lol)  All arguments lost b/c of OWN documentation and manuals  They don't meet standard Notes: How does burden of proof work?  Initial burden - CMS has burden of production - prima facie case  Once met, burden shifts to SH - preponderance of evidence  Set up to favor govt. Background: Required lots of resources from both parties

Practice Problems: Residents’ Rights – p. 94 Ms. Kaitze  Restraints:  Falling does not warrant that kind of restraint o Only under physician order that medically necessary- and MUST include detailed circumstances and duration  Why health law is interesting to pursue?  Lawyers don't know everything out the gate. BUT know where to look  Need to find reqs and then marry with how to run a nursing home.  Encourage facility to figure out from overall standpoint - how do we ensure restraints are provided consistent w/ regulations  Nursing home residents usually don't have the chance to advocate for themselves and relies on family to advocate Mr. Scott Problem Can’t be discharged/transferred  Must not unless:  Welfare can’t be met at facility  Significant health improvements  Threatened others safety/health  Unless you can document reasons why transfer is necessary for this person's welfare  Can’t restrict visiting hours (friends) 

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Smith has right to privacy w/ regard to accommodations (shower) and visits (friends). C(1)(a)(iii)  Right to participate in social activities  Right to receive visitors when he wants  Access and visitation rights  Must allow to be seen by anyone he consents to see  Can’t require staff assistance in shower  Reasonable accommodation of his preferences – doesn’t endanger anyone  Self-determination - "42 C.F.R. § 483.10 Resident rights" (f)(1)  Right to choose activities and schedule Also not proper for restraints. Advice to client:  Establish some limitations that are reasonably tailored to what you want to accomplish  I guess you can implement a bunch of policies that are tailored… like no alcohol in NH

CORPORATE PRACTICE OF MEDICINE (CPM) DOCTRINE Corporate Practice of Medicine (CPM)  Similar to licensure and authority to deliver healthcare services o In order to practice medicine; need license; must stay w/in scope of license  Found in state law that prohibits corporations from practicing medicine  Derived from licensure standards Overview:  Origins  Policy rationale for CPM Prohibition  Exemptions from CPM doctrine  Where does it arise? o Litigation ex  Current CPM trends - direction Origins  Rise of medical profession 1800's  1846 - American Medical Association  AMA's first "Code of Ethics" est. 1847 o Promoted superiority of physicians over "irregulars" - (generally faith healers) o Legal controls  Early 1900's - new medical business models begin to emerge o Entrepreneurs o Hiring physicians to deliver healthcare services o Profit involved o 1912 - physicians passed code of ethics that said physicians should prioritize patients and thus not be driven by $ -CPM Doctrine - where does it appear  State licensure framework  State legislation  Case law

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Where most of development is found Started in CA in 1930's  Parker Dental Case  P = non-dentist who owned a bunch of dental offices across state  Got shut down Sub-regulatory guidance o Proclaims the way corporate practice doctrine should work in that state

CPM Exemptions (vary by state)  Professional firms act o Many states has a version of this o Allows professionals to form corporations o Requirement is that the corp. must be under the control of those professionals  Doctors have to be the shareholders  Nonprofit hospitals  Other non-profit charitable health care entities  Govt health care entities  State agencies o Dept of corrections  Health Maintenance Orgs (HMOs) CPM Trends  States continue to have diff approaches  State guidance o Accountable care organization (ACO)  Can be governed by state laws to allow physician employment  Reactive policymaking o Retail clinics (CVS)  Reigned in by state law  Strong advocacy around issue Is CPM still relevant?  Some states don't recognize it; on other hand, some pursue CPM doctrine  Commentators/critics o Policy arguments don't make sense anymore considering changes in health care o Other avenues of oversight Cases/Litigation Trends:  Hospital Internists of Austin, PA v. TeamHealth o Alleged unlawful control over the actual delivery of healthcare services o Case still active  Andrew Corothers v. Progressive o NY case o Any medical corp w/ physician that cedes too much control to management violates NY CMP prohibition  *lots of cases come up when insurance tries to wiggle out of paying. They cite the violation as reason for void. Isles Wellness v. Progressive Northern (2005) Background:

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CPM doctrine used by insurance clinic to get out of paying for services. o No-fault insurance  Coverage levels $20-25k if you're in a car accident. No questions asked; insurance co. will cover.

Facts:  3 clinics under one shareholder (no license) o Massage therapy, physical therapy, chiropractor Arguments:  Prog.: They have no authority to render services in the first place. All bills null and void.  Clinic: o there's no CPM in MN. Never has been; and even if it does exist, it shouldn't and it doesn't apply. Let's take this time to get rid of it. o Some MN statutes that get pretty specific about bans Rationale:  Granger v. Adson o Layman offered a "health audit" to subscribers for free o Seems more a case about individual guy going out and doing things w/o medical license  But court kind of mentions corporations in dicta  Williams v. Mack o Allowed corporate employment of optometrist o This court: it's ok for glasses to be sold in retail and a specific statute recognizes that an optometrist can take part in that  Public policy rationale for having CPM prohibition o The threat of profit motive  If...