Healthcare Law

•Unlawful for a physician to refer a patient for designated health services if the physician has a financial relationship with the entity. •Financial Relationships - -Compensation Relationships -Ownership / Investment Interest

What is a financial relationship under STARK?

Yes, if they have "capacity"

Can the patient consent: adults and emancipated minors

STARK •Makes it unlawful for: -a physician -to refer -Federally funded patients -for designated health services -if the physician has a financial relationship with the entity.

Stark: the RULE

SCREEN STABILIZE Or, under certain conditions, TRANSFER

What are the general requirements of EMTALA on a hospital?

$50,000 civil fine per occurrence. Not covered by malpractice insurance Exclusion from Medicare participation Potential civil liability

What sanctions may follow from an EMTALA violation?

• ALE status is determined on an aggregated basis. • Penalties under employer mandate are assessed on an individual employer basis. • The reduction of the 30 employees to determine the penalty is done on a pro rata basis between aggregated entities, based on each one's number of full time employees. • Example: - Employer A employs 40 full-time employees and Employer B employs 20 full-time employees. - Employers A and B are in a parent-sub relationship and are therefore treated as a single employer. - Neither qualifies as ALE on its own. - Together, they are an ALE - with 60 employees. • Employer A does not offer its full-time employees (or their dependents) minimum essential coverage • Employer B does. - The ALE (i.e. both Employer A and Employer B) is subject to the "no coverage penalty." - The ALE is allowed one 30-employee reduction, which is allocated ratably among the ALE members. • Employer A gets reduction of 20 employees • 40 Employees - 20 employees = 20 employees • 20 employees x $2,000 = $40,000 • Because Employer B offered minimum essential coverage to its full-time employees (and their dependents), it is not subject to a penalty. - If Employer B had not offered its full-time employees (and their dependents) minimum essential coverage, it also would be subject to an assessable payment of $20,000. • 10 x $2,000 (20 full-time employees reduced by 10 (its allocable share of the 30-employee offset ((20/60) x 30 = 10)) and then multiplied by $2,000). - Employer B would be subject to an assessable payment even though it employs less than 30 full-time employees, if it had not offered minimum essential coverage.

How are penalties assessed to aggregated ALEs who violate the Mandate?

Day before 65th bday Must enroll within 6 months of 65 Continues until death Based on own earnings or those of Spouse Parent Child

Medicare Part A - Eligibility

HIPAA 18 Names Account Numbers Geographic subdivisions smaller than a state (exception re: 3 of zip) Certificate/License numbers All elements of dates (except year) directly related to an individual Vehicle identifiers, vehicle license numbers, serial numbers Fax numbers Web Universal Resource Locators (URL's) Telephone numbers Device identifiers, serial numbers E-mail addresses Internal Protocol address Numbers Social Security Numbers Biometric identifiers Medical record numbers Full face photos or comparable images Health plan beneficiary numbers Any other unique identifying number, characteristic or code (except for re-identification code)

The HIPAA 18:

Employers' four basic options: - Stay "small" and do what you want - Applicable Large Employers • Provide no coverage • Provide affordable coverage • Provide unaffordable coverage

What are Employer's four basic options in response to the Employer Mandate?

Patients' Rights Under HIPAA  Notice of Privacy Practices  Inspect/Copy PHI  Request Amendment to PHI  Request Contact in Particular Manner  Request Restriction to Uses/Disclosures  Receive Accounting of all Disclosures

What are a patient's rights under HIPAA?

Qui Tam Actions - Whistleblowers. 80% of false claim acts are brought by whistleblowers "relators" who may come as single or multiple relators (who must come at the same time). the government may intervene and join the action, decline to intervene, or settle the case before intervening. whistleblowers get money for days. (up to 15-30% of the recovery)

What are qui tam actions?

 CON granted only if Department determines:  Need exists;  Other Specific/General criteria are satisfied;  Indigent care; ( "Reasonable amount of indigent care" is defined by MDOH as: an amount which is comparable to the amount of such care offered by other providers of the requested service in the same or proximate geographic area.)  Access to indigent patients.

What must the government determine generally before granting a CON?

•Remuneration -"the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind." •Applies to any transaction where ONE PURPOSE is to induce or reward referrals. -United States v. Greber, 760 F.2d 68 (3d Cir. 1985). -Some Circuits have been more lenient, holding that there is a violation only where the PRIMARY PURPOSE of the transaction is to induce or reward referrals.

what is "renumeration" under AKS?

Practitioner Recruitment - Remuneration does not include amounts paid to induce a practitioner, who has been practicing in his specialty for less than one year to locate OR any other physician to relocate his primary place of practice into a HPSA for his specialty - Doesnt apply if you satisfy the following 9 things: 1. Set out in writing, signed, and specifies the benefits provided, the terms, and obligations of all parties 2. For Drs. leaving established practices, at least 75% of revenues at new location come from new patients 3. Benefits provided only up to three years, and are not renegotiated during that time (if area stops being a HPSA, you can still abide by agreement) 4. You cannot require referrals (can require staff membership) 5. no restriction on staff privileges elsewhere 6. benefits cannot vary based on referrals 7. recruit agrees to treat based on nondiscriminatory manner 8. at least 75% of revenues must come from patients in a HPSA, MUA, or MUP 9. Payment or exchange of anything of value must not benefit anyone in a position to make or influence referrals

AKS: recruitment safe harbor

AKS IS VIOLATED: Whenever any individual or entity  knowingly or willfully  solicits, receives, offers, or pays  any remuneration  to induce or reward referrals of items or services  payable by a federal healthcare program.

Anti-Kickback Statute: the RULE

Unemancipated Minors (under 18) dont have the ability to consent in MS. someone else has to consent. (they are emancipated if they get married or if they have been adjudicated by a court to be generally emancipated or specifically emancipated for medical purposes). Guardians or custodians can consent for the minor, if no guardian or custodian, then the parent, if no parent, then adult brother or sister, if none, then a grandparent. "reasonable availability". if none are reasonably available, any adult that has shown special care or concern for the minor may give consent. there are exceptions to when consent is needed for an unemancipated minor is needed: alcohol and drug treatment (15 - can give own consent to a doctor or psychiatrist) (No obligation to tell parents, but no obligation not to 41-41-14) (parents have no obligation to pay the doctor), veneral disease (can give own consent), and giving blood (own consent at 17). also any female can give her own consent in connection to pregnancy and child birth. Abortion under 18 for an unemancipated minor requires written consent of both parents or legal guardian. Theres a ton of exceptions.

Can the patient consent: Unemancipated Minors

Transferring physician obligated to identify non-responding on-call physician in transfer records Receiving hospital obligated to notify CMS of transferring hospital and on-call physician

EMTALA imposes what duties to report?

Statute of Limitations - 6 years or 3 years from when the gov should have known or knew and it can never be more than 10 years. first come first paid. filed in federal court under seal with the attoryney general and us attorney for the district where brought. employeed whistleblowers are protected from retaliation by the employer.

False Claims Act: statute of limitations

1. Prevention Your clients need to know the laws and the potential those laws have to destroy them. (STARK, anti-kickback, false claims act). And they need to know how to avoid those laws. This is called prevention. Severall important ways to prevent. A. a fraud and abuse compliance plan. This is a document that says "heres how we are going to be sure to comply with all the federal laws." if there is a state anti-kickback law, it will say how they will comply with those as well. - They are based on guidance provided by CMS on how to avoid breaking law - And will have the following things * designate a compliance officer (the guy who understands what the plan requires and prohibits, and its his job to enforce it) * provides training to all employees (ideally annually, within a designated period of time after a new hire, at times during the course of the year when needed, ie a breach, or a change of law) * provides that you perform internal audits (periodic check of whether you are obeying the compliance plan) (the plan will say how often and who will do it) * will require reporting of errors or inappropriate behavior (and protects people who come forward and report) (eliminates whistleblowers) * provides a procedure for when problems are discovered during audits or reporting > such as paying back overpayments (within 60 days, otherwise it becomes a flase claim under the false claims act) > determine how to handle discovered stark violations (the government has a provided way to report, but they dont have to go easy on you, but THEY CAN. tough spot) > details how to deal with people who are involved in the violations - what will you do with them? counseling? training? firing?

Government Investigations: PREVENTION

B. Procedure for Investigation when is it called for? - you suspect a problem - someone reports a problem - you discover a problem Who conducts it? - either the compliance officer or - outside legal counsel (esp. if the officer was involved) or - independent auditors (be careful because doing this could invite a whistleblower) Factors in considering whether to conduct an investigation: (dont not conduct one because this has never happened before, they cant afford it, they dont want to pay back money) - 35k now is better than 4 million later - 1 violation is enough to sink the ship - theyll pay back more money if they get caught Avoid disclosure by having attorney-client privilege. If you need to hire an expert, you be the one to hire the expert so that he cant go to the feds.

Government Investigations: Procedure

2. Response. Three ways the fed will start an investigation - Covert investigation through a whistleblower - Grand jury subpoena - Search warrants - what to do? a. confirm the ID of the government agents b. CALL YOU. then ask the gov to wait for you to get there. c. ask for a copy of the warrant (1 it might be improperly addressed, 2 determine the scope of the warrant and make them follow it, "it doesnt say you can go through my computer!" 3 do not agree to the government expanding the warrant) d. follow the agents around and take note of everything they do, look at, search, tough, and so on. follow every agent e. make a list of all documents reviewed or copied, and every person the gov talks to, and ask for a list of everything the government takes when it leaves f. they will want to take computers, ask to back up the computers for legitimate business purposes (you may never get it back) g. instruct all employees that they are free to talk to the gov, but not required, and that you will provide them with legal counsel if they want it h. send all nonessential personnel home on paid leave, and warn them about (g). Dont give them a room. they can issue subpoenas later. dont let them use your space. i. Dont destroy any documents or otherwise impede the investigation j. if employees get interviewed, YOU should debrief them immediately

Government Investigations: Response

requirements: 1. plain language 2. description of info to be used or disclosed 3. described in specific terms 4. which contains a name or other ID of the people authorized to make the requested use or disclosure 5. and the name or id of to whom the use or disclosure may be made 6. with an expiration date or event 7. and a statement regarding the patients right to revoke 8. which must be in writing 9. for which there are exceptions as to when you can revoke (IE when the authoree is reasonably relying on the authorization) 10. and a statement that the PHI used or disclsoed according to the authorization may be subject to redisclosure and no longer be protected 11. must be signed and dated 12. if by a rep, must include a description of the reps authority to act for the individual

HIPAA has what requirementa on authorizations?

Theres a four question test 1. are you dealing with a CE or a BA? if yes, 2. is the info PHI? if yes, 3. Does HIPAA permit or require the desired/requested disclosure/use or do you need an authorization? if HIPAA permits, 4. what amount of information may be used or disclosed?

HIPAA: the four part test

REVOCATION  AGENT DESIGNATION:  Signed writing or personal communication to healthcare provider required for revocation  EXCEPT: DIVORCE/ANNULMENT/LEGAL SEPARATION: Automatically revokes prior designation of spouse as agent.  ANY OTHER PART OF ADVANCED DIRECTIVE:  Any clearly manifested manner of revocation is sufficient.  MULTIPLE HEALTHCARE DIRECTIVES: Most recent prevails to the extent of any conflict

How can you revoke Healthcare Decision powers and how long do they last?

OMNIBUS ACT: Four Big Rules 1. modifies Hipaas privacy and security and enforcement rules. it came out january. effective in march. enforcement rule modifications deal with the civil monetary penalities and the amounts, factors in determining amounts, calculations, etc. HOWEVER, people have 180 days, (SEPT 23rd), by which they have to have their policies and procedures updated. if you were compliant as of january, though, then you have a year past september This rule makes BAs directly liable for compliance with certain HIPAA privacy and security rules more limits on use and disclosure of phi for marketing and fundraising, prohibited the sale of phi without individual authorization expands rights to receive eloctronic copies of PHI and restrict disclosure to a health plan concerning treatment for which the patient paid out of pocket enabled access to decedent information by family 2. Adopts changes to the HIPAA enforcement rule 3. Replaces the standard for breach notification for unsecured (not encrypted) PHI (including breach of the minimum necessary standard) (secured PHI - PHI secured by the method of technology which makes the PHI unusuable or unreadable or undeicpherable to unauthorized individuals) - heightens the standard by which a breach is presumed to have occurred - so you assume a breach has occurred when an impermissible use or disclosure has occurred unless the breacher can demonstrate that there is a low probability that the PHI has been compromised - the RISK ASSESSMENT rule (the previous standard was that a breach was not found if you could show no significant risk of harm to the individual) - four factors to be considered in risk assessment 1. the nature and extent of the PHI involved, including the types of identifiers, and the likelihood of reidentification, 2. the unauthorized person who used the PHI or to whom the disclosure was made, 3. whether teh PHI was actually acquired or viewed, and 4 the extent to which the risk to the PHI has been mitigated ( a fact specific totality of the circumstances type analysis) - A breach is treated as discovered on the first day that the breach is known to the CE or by exercising reasonable diligence would have been known to the CE (reasonable diligence means the reasonable business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances) (are you trying to meet your responsibility or hide it?) (OCR recommends you look to how other CEs or BAs would act under the same circumstances) (OCR will look at 1. whether you took reasonable steps to learn of the breach, and 2. whether there were indications of breaches that a person seeking to satisfy the rule would have investigated under similar circumstances) 4. Modified privacy rule as required by GINA

How does the OMNIBUS act change HIPAA?

1. Any expenditure that exceeds the "capital expenditure threshhold," as defined by MDOH. • $1,500,000 for major medical equipment. • $2,000,000 for clinical health services • $5,000,000 for other (construction, repairs, renovations). 2. Construction, development, establishment of a new health care facility.  "Health Care Facility" includes:  Hospitals/Skilled Nursing Facilities  comprehensive medical rehab facilities  ASC's  home health agencies.  Does not include:  doctors' offices/dentists' offices  diagnostic testing facilities. 3. Relocation of a health care facility or portion thereof, or major medical equipment.  Unless within a mile; AND  Costs less than Capital Expenditure Threshhold 4. Change in bed complement 5. The following always require CON (unless already provided in last 12 mos.):  Open Heart Surgery  Cardiac Catheterization  Skilled Nursing Beds  Home Health Serv.  Comp. Inpt. Rehab. Services  Radiation Therapy  MRI/PET  ASC  LTAC Services  Invasive Diagnostics  Swing Beds  Licensed Psych./Chem. Dependency Services 6. Relocation of one or more health services (within mile, under cap. exp.) 7. Acquisition or control of "major medical equipment" 8. Change in ownership of healthcare facility. 9. Change in ownership of skilled nursing facility, intermediate care facility or intermediate care facility for mentally retarded. 10. Any activity described in 1-9 above, if that same activity would require CON approval if undertaken by a health care facility.

In Mississippi, what types of activity do you need CON approval for?

Mandatory Benefits Inpatient hospital services Outpatient hospital services Physician services Medical and surgical dental services Nursing facility services for >21 Optional Benefits Clinic services Nursing facility services for <21 Intermediate care/mentally retarded services Optometrist services/eyeglasses Prescription drugs

Medicaid: Benefits

Two tests: Income and Assets test Rules vary from state to state Categorical test Children Adults parents of dependent children pregnant women Aged Disabled Medicaid is a State Administered program You must apply - coverage starts retroactive to 3 months preceding application. Coverage ends at end of month in which a person's circumstances change. State must have a State Medicaid Plan to get federal assistance. Pregnant women Married or single. If on Medicaid when child born, child is too Children/Teenagers 18 or younger AND Limited income in family OR Child is sick enough to need nursing home care but could stay home with care there Parent or child living alone may apply States MUST provide Medicaid coverage for the following: Limited income families who meet requirements of AFDC Supplemental Security Income recipients. Infants born to Medicaid-eligible women. Children under 6 and pregnant women whose family income is <133% of Federal poverty level. Infants up to 1 year old and pregnant women with family income <185% of federal poverty level (state can set %). Certain blind, aged, disabled with incomes below poverty level. Institutionalized individuals with limited income and resources Optional targeted low-income children

Medicaid: Who is eligible?

Four parts: Part A - Hospital Insurance (HI) Part B - Supplemental Medical Insurance (SMI) Part C - Medicare Advantage Plans Part D - Prescription Drug Coverage Remember your Medicare Covered ABCD's - A - Hospital Insurance Covers 90 days each benefit period of Hospitalization (per year), + 60 days total lifetime reserve days. So 90 per year + 60 in reserve. Post hospital extended care up to 100 days. The first 20 days you pay nothing, the rest you pay a co-pay 148 dollars per day. After that you pay the full amount. Also pays for blood clotting factors and Hospice (if your life expectancy is 6 months or less if the disease runs its course. you can get recertified if you survive.) Eligibility starts the day before you turn 65, and you have to enroll within 6 months, and it continues until you die. You or your spouse has to pay into the system for at least ten years in order to not have to pay a premium (40 quarters). Changes from PPACA: increased tax rate on wages, and imposes tax on unearned income from higher taxpayers (money you dont work to get: selling a house, stocks, etc) You can buy a medicare supplement package for those long term nursing home stays. (90% of beneficiaries have this. you have to be enrolled in A and B to get a medicap policy.) - B - Supplemental Medical Insurance Basically doctors visits and anything related. Home health, out patient, physician services. After the deductible, the insurance company pays 80%. covers some ambulance, vaccines, prosthetics, braces, cancer screenings, preventative testing, and so on. Eligibility: if youre entitled to part A, or over 65, then you can enroll in part B (must be a citizen or resident alien). you have to pay the premium. Enrollment starts three months before you turn 65 and ends three months after (penalty after). The premium goes up if you make a lotta money. - C - Medicare Advantage Plans This is something else you can get to supplement A and B. You have to be enrolled in A and B to sign up (just like a medicap policy). Most people dont use Part C (they go with a medigap policy). - D - Perscription Drug Coverage Available to anyone enrolled in Medicare. There is no one single plan. Walmart, CVS, independent companies - all have part D plans that must meet certain requirements: ie, covering 75% of the cost of drugs, the deductible cant be too high, and so on.

Medicare ABCD's

Hospitalization and related care Inpatient hospital benefits (Up to 150 days) Post-hospital extended care (up to 100 days) SNF's (different coinsurance costs) Home Health Agency (in-home) Blood clotting factors (hemophilia pts) Hospice Provides short-term inpatient care. Must be entitled to Part A and be terminally ill.

Medicare Part A - Hospitalization

17 Requires deductible and participating provider. Supplements HI: Home health visits not available under HI Physicians' Services Services/Supplies incident to Dr.'s services Hospital services incident to Dr.'s services Diagnostic services Home dialysis supplies/equipment Outpatient PT, OT, speech therapy services Various screening tests Qualified Psychologist services

Medicare Part B

Eligibility: Must enroll during an enrollment period If entitled to HI OR are 65 or over Citizen OR resident alien who meets residency requirements Must pay required premiums Beginning Jan. 1, 2007, premium based on income. 2013 Standard premium is $104.90/month

Part B - eligibility

Also called Medicare + Choice More choices among health plans, but higher cost. Provides Part A, B and D benefits Anyone with Parts A and B is eligible, except: ESRD patients without Medicare + Choice plan at onset of disease. 13.1 million enrollees (2012)

Part C - the supplement

Part D: Drugs 21 Available to everyone on Medicare Effective 1/1/06 No single plan provided Must enroll in one of approved plans Plans vary based on drugs offered and premium required premiums from $15 to $165 in 2013 Copays and coinsurances also apply Deductible - must be $325 or less in 2013 Substantial discounts (almost 100% if you are on limited income)

Part D- Drugs

•Penalties -$15,000 - per occurrence •Plus two times the reimbursement claimed -$100,000 for knowing violations or schemes -Exclusion from Medicare Program •Strict Liability •Qui Tam Actions •False Claims Act liability

Stark Penalties

- Hospital assisting Group Practice: additional reqs. Agreement is signed by party to whom payments are directly made. Hospital may pay actual cost incurred by group in recruiting, money paid directly to recruited physician, costs allocated to group cannot exceed actualadditional incremental costs attributable to recruited physician. You have to keep records for 5 years. Remuneration from hospital is not tied to referrals. Group Practice cannot restrict physician from practicing in hospital's geographic area (a hospital CAN make the physician sign a noncompete).

Stark: Group Practice exception

Medical Staff Incidental Benefits: okay if - Items or services used on hospital's campus. - at times when docs are making rounds or otherwise benefitting hospital - Provided to ALL members of med staff in same specialty - without regard to volume or value of referrals - low value per occurence (less than $31) - no violation of AKS

Stark: Medical Staff Incidental Benefits

Non Monetary Compensation: (ie free lunch at boure) - Is okay if it does not pass 380, cannot be solicited by the doctor, not tied to referrals, cannot violate AKS (OR DOUBLE JEAPORDY!). Inadvertent overpayments are OK IF: overpayment doesnt exceed 50% of allowed (190 this year), is repaid in earlier of within 180 days, or in same calendar year, and can only be used once every three years as to the same doctor. You can have one medical staff appreciation event every year that does not count towards this limit.

Stark: Non Monetary Compensation Exception

Recruitment: - Hospital to Doctor - Must be intended to induce doctor to relocate (the dr moves his practice from outside the service area to inside and at least 25 miles, OR outside to inside and at least 75% of his revenues are gonna come from new patients) medical practice into the geographic service area (the lowest number of contiguous counties where 75% of the hospital's patients come from), in order to become member of the hospital's medical staff (which includes employees. [but not all on staff physicians are employees]). Must be in writing and signed. Not conditioned on referrals by dr. to hospital. Remuneration not tied to referrals. No restriction on staff privileges elsewhere. -Relocation does not apply if the recruit has practiced for one year or less or is a resident, or has been employed for 2 years immediately prior, with dod, va, prison, or indian health service.

Stark: Recruitment (hospital to doctor) exception

Bona Fide Employment: - You can refer to your employer IF: you refer for identifiable services, renumeration is FMV and not determined based on volume or value of referrals, the referral is commercially reasonable, and YOU CAN have productivity bonuses based on personally performed services. (No contract or writing or specified time required) - An employed doctor gets a paycheck, mere staff doctors do not have a financial relationship with the hospital. So a independent contractor staff doctor does not present a stark issue.

Stark: employment exception

Personal Services Arrangements: You can refer to one of these IF - its With Dr., Family Member, Group Practice. In writing, signed, specific about services. Covers ALL services provided to entity. Services provided are the least necessary. The contract must be for at least a year. Compensation is set in advance (FMV, not tied to referrals). - This would only apply to "directors" for our purposes

Stark: personal services arrangement exception

- Rental of Office Space or Equipment. If the rental is in writing, signed, has specified premises, is for at least a year, the space rented is only whats needed, charges are set in advance (cant get around this by bailing on the lease then making a new one within the year) (Holdovers are good for 6 months, but operate on the same terms. after that its a stark violation), is not based on volume or value of referrals, Fair Market Value, and is commercially reasonable.

Stark: the ownership exception

- Essential Health Benefits - all plans and Medicaid, starting in January, must include: ambulatory patient services, hospitalization, emergency care, maternity and newborn care, mental health services, prescription drugs, rehab, lab, pediatrics (including dental and vision), and preventative care (with no cost sharing) (grandfathered plans are not required to include preventive care)

Under PPACA, what are the minimal essential health benefits?

•Unlawful for a physician to refer a patient for designated health services if the physician has a financial relationship with the entity. •Designated Health Services - -Clinical Laboratory Services -Physical Therapy -Occupational Therapy -Diagnostic Radiology -Radiation Therapy Services and Supplies -DME and Supplies -Parental and Enteral Nutrients, equipment and supplies -Prosthetics, orthotics and prosthetic devices -Home health services and supplies -Outpatient prescriptions drugs -Inpatient and outpatient hospital services

What are designated health services under STARK?

 Economic viability  Need, generally, for project  No significant adverse impact to existing service providers  Quality of care (existing providers)

What are the criteria, generally, for evaluating a CON's chances of success?

Four General Goals of the SHP  To prevent the unnecessary duplication of health resources  To provide cost containment  To improve the health of Mississippi residents  To increase the acceptability, accessibility, continuity and quality of health services.

What are the four goals of the State Health Plan?

• PPACA -ACA -ObamaCare -Health Reform • CON Laws • EMTALA • HIPAA • ERISA • UHCDA • STARK • ANTIKICKBACK STATUTE (AKS) • FCA

What are the main Regulatory Schemes?

•Criminal liability -Violation is a felony •Maximum fine of $25,000 •Up to 5 years in prison •BOTH -Mandatory exclusion from federal healthcare programs if convicted •Civil Monetary Penalties

What are the penalties under AKS?

Permitted Disclosures  Treatment  Payment  Healthcare Operations  When required by law  To the patient (or his legal representative)  With valid authorization

What are the permitted disclosures under HIPAA?

"comes to the emergency department" means: ›At the hospital's dedicated emergency department ("DED") requesting treatment ›On hospital property other than DED with what may be an emergency medical condition ›In a hospital-owned ambulance (anywhere) ›In a non-hospital-owned ambulance on hospital property

What does "comes to the emergency department" mean under EMTALA?

•"Physician" - -(first mention) Does not include Mid-level providers •Nurse Practitioners •Physicians Assistants •CRNAs •RPAs -(second mention) Does include immediate family members

What does "physician" mean under STARK?

"Stabilized" means: ›no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer, or ›with respect to a woman in labor, the child and placenta have been delivered

What does "stabilized" mean under EMTALA?

Security Rule 45 CFR p160 subpart (a) and (c) of p164: Administrative Safeguard - created to establish a national security standard to protect individuals created received used or maintainted by a CE PHI. three sets of safeguards: 1. administrative - security management process, assigned security responsibility, workforce security, information access management, security awareness and training, security incident procedures, and contingency plan 2. physical - how to people log in to your computer, what are the passwords, who has access, is there a fingerprint biometric scanner? etc work station security, device and media controls (role based access becoming more popular) 3. techinical safeguard - audit controls, authentification, standards promulgated, transmission standards

What duties does HIPAA impose to safeguard PHI?

• If Employer employs at least 50; AND • Provides no health ins. coverage; AND • At least one full-time employee goes to Exchange and receives a subsidy; THEN - Penalty of $2000 per employee per year • Calculated on monthly basis • First 30 employees exempt from calculation. • Penalty indexed annually for inflation • EXAMPLE: • Employer has 55 employees and provides no coverage • One employee receives a subsidy for coverage purchased on the Exchange. • Penalty= 55-30 = 25 x $2,000 = $50,000 - Or $4,166.50 for that month.

What happens if an ALE offers no coverage?

• IF 50 or more FTEs; AND • Do not offer "affordable coverage"; • To all employees and dependents; AND • At least one full time employee goes to Exchange and receives a subsidy; THEN - $3000 per employee who enrolls through the Exchange - Capped at amount of penalty that would have applied for no coverage. Example: - Employer has 55 employees and offers coverage to all employees and dependents. - Coverage is not "affordable." - Three full time employees receive subsidies toward coverage purchased on the Exchange. - Penalty = $9000 • $9000/12 per month • Example 2: - Employer has 55 employees and offers coverage to all employees and dependents. - Coverage is not "affordable." - 30 full time employees receive subsidies toward coverage purchased on the Exchange. - Penalty = 30 x $3000 = $90,000 • BUT, capped at $50,000

What if an ALE offers "unaffordable coverage"?

"Capacity" means someone determined to be capable of making health care decisions. "Capacity" - abiulity to understand the risks, benefits and alternatives to a proposed treatment, and to make and communicate a healthcare decision. The primary physician makes the determination of whether the patient has capacity. Thats either the doctor you chose or the one thats been taking care of you. When they wake up, you have to let them know you determiend they wre incapacitated.

What is "capacity"?

Basic Rule:  You may not do ANYTHING with someone else's PHI - unless:  HIPAA permits it; OR  You have a valid authorization from that person.

What is HIPAA's basic rule?

POWER OF ATTORNEY  Power of Attorney for Healthcare Decisions  Appoints Agent to make decisions  Must satisfy requirements of validity  Agents' powers are limited in time and scope POWER OF ATTORNEY  CANNOT be witnessed by:  A health care provider;  An employee of a health care provider or facility; or  The designated Agent  One witness must be someone other than:  Family member;  Person entitled to any part of

What is Power of Attorney?

 "Health Care Decision" :  Selection of healthcare providers and institutions  Approval of tests, procedures, programs of medication, orders not to resuscitate  Directions to provide, withhold or withdraw artificial nutrition and hydration and all other forms of health care.  Does not include decisions made pursuant to the Anatomical Gift Law.  Does not include consent to such things as arbitration provisions

What is a "health care decision"?

Business associate means, with respect to a covered entity, a person who: (i) On behalf of CE, but not as a workforce member of the CE, creates, receives, maintains, or transmits protected health information (PHI) for a function or activity regulated by HIPAA; OR (ii) Provides services to or for the CE involving the disclosure of PHI. A covered entity may be a business associate of another covered entity. Omnibus Rule expanded BA definition to include: Health Information Organization, E-prescribing Gateway, or other person that provides data transmission services with respect to PHI to a CE and that requires access on a routine basis to such PHI. A subcontractor that creates, receives, maintains, or transmits protected health information on behalf of the business associate. Excludes: disclosures of PHI by a CE to the provider concerning the treatment of the individual.

What is a Business Associate under Hipaa?

Hospital Medical Staff - includes doctors (either employees and independent contractors) - credentialing process - comprised of doctors of all different specialties which make up the medical staff: cardiologists, anesthesiologists, radiologists, etc - the process by which the staff is vetted before being a-okayed to be on the staff, at which point the "privileges" are decided, where the hospital says what all the doctor can do (most commonly how many patients he can admit. different levels of privileges exist. larger privileges also come with increased responsibility - ie, being on call) - both employed and IC doctors have to undergo the credentialing process - employed doctors have contracts, independent doctors who mutually benefit because the doctor cant do the surgery without the venue, and the hospital cant perform the surgeon itself

What is a hospital medical staff?

•Referral - -A request by a physician for an item or service for which payment may be made under Medicare Part B -NOT - Personally Performed Services

What is a referral under STARK?

What is a "referral"? Any time somebody sends a patient to another person or place/facility or entity to get treatment, evaluation, treatment, drugs, any goods or services related to healthcare.

What is a referral?

A reverse false claim is when you know you got paid when you shouldnt have and you dont give it back. ie when your client gets overpaid by medicare and doesnt pay it back within the timeframe the law gives.

What is a reverse claim?

• Affordable Coverage - If the employee's required contribution does not exceed 9.5% of the employee's household income for the taxable year. • Safe Harbors Provided: - Form W-2 safe harbor - Rate of pay safe harbor - Federal poverty line safe harbor

What is affordable coverage?

"Appropriate transfer" means: ›transferring hospital provides medical treatment within its capacity to minimize risks to the individual's health and, in the case of a woman in labor, the health of the unborn child. › receiving hospital has available space and qualified medical personnel for treatment of the individual; and has agreed to accept transfer of the individual and to provide appropriate medical treatment

What is an "appropriate transfer" under EMTALA?

Dedicated Emergency Department ›Any department or facility of the Hospital that is: Licensed by the State as an emergency department; OR Held out to public as providing emergency treatment; OR Actually provided emergency treatment on 1/3 of the visits to that department in the preceding calendar year.

What is an "emergency department" under EMTALA?

ADVANCED DIRECTIVES  Consent or refuse any treatment  Designate healthcare providers  Approve or disapprove of tests or lifesustaining mechanisms  Artificial nutrition and hydration issues

What is an Advanced Directive?

Conducted by qualified medical personnel Purpose - to determine whether an emergency medical condition exists Must be provided regardless of diagnosis, financial status, race, color, national origin and/or disability. May be requested by a minor child

What is an Appropriate Medical Screening under EMTALA?

"Emergency Medical Condition" means: A medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in— •placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; •Serious impairment to bodily functions; or •Serious dysfunction of any bodily organ or part.

What is an Emergency Medical Condition under EMTALA?

•Unlawful for a physician to refer a patient for designated health services if the physician has a financial relationship with the entity. •Entity - -Clinic -Hospital / Nursing Home -DME provider / Lab / Pharmacy -Non profit foundation / HMO -The referring physician is not an entity

What is an Entity under STARK?

Informed consent means that the doctor has warned the patient of known risks of the treatment or surgery, so that the patient is able to make an intelligent decision about whether to go forward. treatment without informed consent is battery. There are exceptions: EMERGENCIES. An emergency is a situation where the proposed treatment is immediately necessary, and the delay due to getting consent would put at risk the life, limb, or health of the patient, permanent disfigurement, or impairment of faculty. Another exception is infectious disease - if the doctor determines that testing for infectious disease is necessary for the safety of the patient, the doctor, staff, or other patients.

What is informed consent?

 "Protected Health Information" (PHI)  All Individually identifiable health information  Subset of health information collected from an individual  Created or received by a CE  Relates to past, present, future physical or mental health, or condition of an individual, or provision of health care that:  Identifies the individual; or  Reasonable basis to believe it could be used to identify the individual  Transmitted or maintained by a CE  Form of PHI does not matter (i.e., paper, electronic, verbal

What is protected by HIPAA:

Stabilization Requirement ›If any individual comes to the hospital and has an emergency medical condition, the hospital must either: Stabilize the medical condition with the staff and facilities available at the hospital, or Arrange for an appropriate transfer of the individual to another medical facility

What is the "stabilization" requirement of EMTALA?

The Employer Mandate • Offer Affordable Coverage that provides at least Minimum Value, or else (sort of). - Minimum Essential Coverage: includes coverage under an eligible employer-sponsored plan - Minimum Value = if the plan's share of the total allowed costs of benefits provided by the plan is equal to or greater than 60% of those costs.

What is the Employer Mandate?

 Minimum Necessary Standard: provide only the minimum necessary information to accomplish the purpose of the use or disclosure.  Applies to most uses and disclosures, except:  Treatment  Law Enforcement Needs (some)  Authorization

What is the minimum necessary standard under HIPAA?

Medical Screening Requirement: In the case of a hospital that has an emergency department, if an individual comes to the emergency department, the hospital must provide an appropriate medical screening examination, including ancillary services routinely available to the emergency department, to determine whether an emergency medical condition exists.

What is the screening requirement?

 Step 1: Notice of Intent to Apply for CON  (30 days before filing Application)  Step 2: File CON Application with MDOH  CON applications considered on schedule of "review cycles"  Filing dates December 1, March 1, June 1, September 1.  Filing fee: .5% of proposed capital expenditure  Not less than $1000 or more than $25,000.  Additional fee: .25% of proposed capital expenditure  Not less than $250 or more than $50,000.  Step 3: Application must be "deemed complete" by Department's Division of Health Planning and Resources.  30 Days from Filing  Opportunity to Submit additional information  Step 4: Comment Period  30 Days - Letters accepted from Affected Parties  Step 5: Department issues its "Staff Analysis"  First indication of whether application will be approved or disapproved.  Generally take Application as true on its face.  Step 6: "Affected Parties" may request a Hearing on the application.  Called a Hearing During the Course of Review.  Must be requested within 20 days after issuance of the Staff Analysis.  The Applicant may request a Hearing IF the Application is recommended for disapproval.  Step 7: Hearing w/in 90 days of Staff Analysis.  Presided over by Hearing Officer (employee of AG Office).  Transcript 30 days after last hearing date.  Parties submit Proposed Findings w/30 days of transcript.  Step 8: Hearing Officer's Findings/Conclusions.  Step 9: State Health Officer (Dr. Mary Currier) announces the Department's decision at the next monthly CON announcement meeting.  First Appeal to Chancery Court  Appeal w/in 20 days of decision.  Second Appeal to Ms. Sup. Court.  Appeal w/in 30 days from Chancery decision.  Oral argument granted if requested. ( Standard of Review  Same at Chancery and Supreme Court levels.  Presumption that Hearing Officer and State Health Officer are correct in their decisions.)

What is the step-by-step procedure for obtaining a CON?

Each hospital must maintain an on-call list of physicians on its medical staff. ›HOSPITAL has ultimate responsibility for ensuring adequate on-call coverage. ›List to be maintained in manner that will best meet the needs of patients, in view of hospital's resources. ›Physician group names are not sufficient. Must have individual names.

What requirements does EMTALA place on hospital staffs?

A physician who does not come to the hospital when called, but repeatedly or typically directs the patient to be transferred to another hospital where he can treat the patient, may have violated EMTALA ›Surveyors will assess facts prior to making recommendation whether physician violated EMTALA ›Surveyors will consider individual needs and physician circumstances A physician may be on call simultaneously for more than one hospital Physicians may perform elective surgery while on call. Liability for selective response to call by physician. ›Physician may be liable. ›Hospital may be liable for permitting. Response time of on-call physicians. ›The expected response time should be stated in minutes in the hospital policies ›Terms such as "reasonable" or "prompt" are not enforceable by the hospital and therefore inappropriate in defining physician's response time. ›Always want your personnel to note the time of notification and the response (or transfer) time.

What requirements does EMTALA place on physicians?

To Obtain a CON. . .  Satisfy the Four General Goals of the State Health Plan.  Satisfy any applicable "specific standards and criteria."  Substantially comply with General Review Criteria (set forth in CON Review Manual).

What three general things must you do to obtain a CON?

• Small Business Tax Credit - 25 or fewer full-time employees [defined]; and - average annual wages of less than $50,000 - 10 or fewer full time employees [defined]; and - average annual wages of less than $25,000 • Employers must pay for at least 50% of the employee's premium.

What's the Small Business Tax Credit and how can it be obtained?

• Exists when one organization (parent) owns at least 80% of another (subsidiary) - Ex. The ABC partnership (40 full-time employees) owns 80 percent of S corporation (30 full-time employees). • Standing alone, neither organization would be an ALE. • However, because they are in a parent-sub relationship, their employees are counted together for purposes of determining ALE status. - The organizations collectively employ 70 full-time employees. - Therefore, these organizations are an ALE. • It does NOT matter if the organizations serve two entirely different industries.

When are "parent-subsidiaries" aggregated for Mandate purposes?

• Generally, these are organizations that are largely owned by the same small group of people. - Exists when the same five or fewer persons own 80 percent or more in each organization, and - Those same persons are in "effective control" of each organization. • "Effective control" is a complex term not discussed here

When are brother-sister organizations aggregated for Mandate purposes?

When you violate the STARK or AKS, and then ask the government for money for a tainted referral, you have made a false claim. This lumps on top of that 5.5-11k per claim. 31 USC 3729 - You are liable if you knowingly (actual or reckless disregard or deliberate ignorance, does not require specific intent to defraud. deliberate ignorance means ignorance of the law youre expected to know) make a claim for money that never happened or violates STARK or AKS, claims for work done by someone else, by unlicensed professionals, or even unreasonable costs, or "upcoding" (as in the case we read.)

When are you liable under the false claims act?

A hospital that has specialized capabilities or facilities shall not refuse to accept an appropriate transfer of an individual who requires such specialized capabilities or facilities if the hospital has the capacity to treat the individual

When can a hospital with specialized facilities and staff refuse transfer of a patient who needs their specialized help?

Reasons of Conscience Contrary to Policy of Institution

When can a provider refuse to comply with a patient's directions?

Upon determination that no emergency medical condition exists. Upon determination that emergency medical condition exists and individual is appropriately transferred. Upon determination that emergency medical condition exists and individual is admitted to the hospital.

When does duty under EMTALA end?

• Mandate is Satisfied IF: - Minimum Essential/Affordable Coverage is offered to all employees (and dependents starting 2015). • 95% Rule: OK if 95% of employees (or all but five if that is more than 5%) and dependents are offered affordable coverage. - Spouses do not count as dependents. • Employee must have an effective opportunity to elect to enroll in coverage no less than once during the plan year.

When has the ALE satisfied the mandate?

May only transfer an individual with emergency condition who has not been stabilized IF: ›The individual requests transfer to another facility in writing; OR ›A physician has signed a certification that the medical benefits expected from the provision of medical treatment at another facility outweigh the increased risks to the individual and in the case of labor, to the unborn child

When may a hospital transfer without stabilizing under EMTALA?

1. Individual instruction, or 2. Advanced Directive, (must be signed, dated, and witnessed. ); then 3. Power of Attorney, (designated agent) (signed, written, dated, and either witnessed by two people, or notarized. power of attorney only applies while the principal does not have capacity. the document does not implicitly allow the person to put you in a mental institution. a power of attorney doc cant be witnessed by a health care provider, an employee thereof, the designated agent. one of the witness has to not be family/someone who is a beneficiary.) 4. Guardians, 5. Surrogates, (in this order: spouse, adult child, a parent, an adult sibling. if there is more than one of the category you go with, you go with the majority opinion. if there is a draw (among siblings for example), you go to court. (you cant be a surrogate and a healthcare employee unless related by blood or marriage)) 6. Court Order

Who and in what order makes healthcare decisions when the patient does not have capacity?

Payors: • Patients • Insurance • Employers (self-insured) • Workers Compensation Programs (Employers) • Lawsuits (Damages) • Charity Care • United States Government - Medicare - Medicaid • State Governments - Medicaid 1. Consumers - chronic disease, trauma, defects, illness 3. Providers - hospitals (sometimes Critical Access Hospitals which are deregulated for rural areas), - Nursing homes (Skilled Nursing Facilities - SNF), - ESRD facilities (dialysis), - Diagnostic Imaging Providers (Radiologists, MRIs), - (ambulatory surgery center - walk in and out surgery. it used to be that surgery could only happen at a hospital. ASCs have special rules about how far under they can put you under. ASCs are also owned by doctors more frequently.) ASCs, - public health clinics, - mental health centers, - physicians, - NPPs (non-physician practitioners: physician assistants, nurses, nurse-practitioners) 4. Regulators and Enforcers - The various forms of the government - what do they care about? - getting care to the people who need it without discrimination, preventing fraud and abuse

Who are the main players in healthcare?

•Patients - -Include federally funded patients -Non-federally funded patient referrals are not actionable under Stark

Who are the patients under STARK?

Who can refer? Doctors, nurse practitioners, physician assistants, RNs,. Some doctors are always referral sources. Ie general practitioners. Some are never referral sources, ie pathologists, who only provide a service. Others, ie, anesthesiologists or radiologists, who dont often, but sometimes do, provide referrals. You can know whether a doctor is a source of referrals by two facts, his practice area, and the context.

Who can Refer?

Covers: Most Americans 65 or older. Under 65 and disabled ESRD (1972) Lou Gherig's disease.

Who does Medicare cover?

Applicable Large Employers • The employer mandate applies to "applicable large employers" • 50 or more FTE employees • How do you count? - Full-time employees - Part-time employees - Seasonal employees • What if you're a new employer? - FTEs determined on expected employment (good faith) 1. Count Full-Time. 2. Calculate any additional FTEs 1. Total number of service hrs. per week for all part-time, including seasonal and ÷ 120 3. Add Full-Time and FTEs for each of the 12 months in prior year. 4. Total 12 months and ÷ by 12. 5. IF result is 50 or more, determine if Seasonal exemption applies Seasonal Exemption • Not an ALE if: - Employer had 50+ full time employees for 120 days or less; but - Employees in excess of 50 were seasonal workers employed 120 days or less. • 120 days (or 4 months) need not be consecutive

Who does the Employer Mandate apply to and who meets the criteria?

Enforcement  HIPAA is enforced by the U.S. Department of Health and Human Services (HHS), Office for Civil Rights  Complaint-driven process.  Covered Entities must have a process to receive and investigate complaints.

Who enforces HIPAA?

 Covered Entities  Business Associates  Covered "Transaction" means the transmission of information between two parties to carry out financial or administrative activities related to health care.  Examples: (1) Health care claims; (2) Health care payment (3) Coordination of benefits. (4) claim status. (5&6) Enrollment and eligibility in a health plan, (7) premium payments, (11) Health care electronic funds transfers (EFT) and remittance advice. (12) Other transactions that the Secretary may prescribe by regulation. the test for a covered entity is 1. is the person business or agency furnish bill or receive payment for healthcare in the normal course of business? 2. does the person business or agency transmit ie send any covered transactions? (typicall a trans involving the exhcnage of electronic info about a patient for the purpose of healthcare - claims, benefits, claim status, enrollment and eligibility, payments, electronic fund transfers, and remittance), 3 and are any of these covered transactions transmitted in electronic form? (hard drives, removable or transportable digital memory medium) (transmission media include the internet, dial up lines, private lines, the actual physical movement of data in the medium) (important distinctions: transmissions like scanned paper does not count because it didnt originally exist as electronic data) IF ALL THREE prongs are a yes, then its a covered healthcare provider. Providers are covered regardless of their size if they fulfill the test.

Who is covered under HIPAA?

- Who is eligible? 140%-200 something% of the poverty level - The gov will pay directly to the policy the amount it is going to assist you - Supposed t start exchanges on January 1st. it is uncertain if that will be running by then - No one can be required to pay more than 9.5 percent of their adjusted gross income for health insurance. Theres a sliding scale for where you are on the federal poverty level. Suppose you have a family of four at 48k per year - that puts you at 200% of the fed poverty level - and the fed says at that level you cant be required to pay more than 6% of your income on health insurance, which is 3k. so if the second lowest silver plan is 14k (the standard for whatever reason), the fed will cough up 11k.

Who is eligible to receive a subsidy on the exchange?

 Are you a Health Care Facility?  Capital Expenditure?  Covered Equipment, Service?  Relocation?  If not a HCF -  Covered Equipment or Service?  Relocation of covered equipment?  Determination of Reviewability

Who needs to get CON approval?