in Healthcare

Lisa English Hinkle, Esq.

Health Reform and

Accountable Care

• The current culture of medicine which has been built into our health care systems for decades is experiencing a transformational change

• This transformational change will require strong partnerships between payors and providers to meet the new demands of the marketplace

Historical Culture of Medicine • Competitive • Volume-based • Individualistic

Evolving Culture • Patient centered • Quality • Value-based • Collaborative

GOALS 3

• Affordable Care Act

• Provisions for 2014

• Kentucky’s Health Benefit Exchange

• Miscellaneous

• Accountable Care Organization

• Paying for Quality

• Kentucky’s Solution to Prescription Drug Abuse

Per Capita Health Expenditures of 10

Selected Countries in the OECD

Higher Mortality and Inferior

Health in the United States

• The Institute of Medicine recently reported that there is a “strikingly persistent and pervasive pattern of higher mortality and inferior health in the United States when compared with other high-income countries. We believe that this poor correlation between spending and outcomes should prompt a reevaluation of current cost-containment efforts.”

Affordable Care Act

• Expansion of Access to Health Insurance

▫ Health Benefit Exchanges

• Expansion of Medicaid Eligibility

• New Payment Mechanisms ▫ Quality

▫ Integration/Coordination of Care

• Fraud and Abuse Tools

2014: The Watershed Year

• January 1, 2014 ▫ Expanded Medicaid Coverage ▫ Presumptive Eligibility for Medicaid ▫ Individual Requirement to Have Insurance ▫ Health Insurance Exchanges ▫ Health Insurance Premium and Cost Sharing Subsidies ▫ Guaranteed Availability of Insurance ▫ No Annual Limits on Coverage ▫ Essential Health Benefits ▫ Multi-State Health Plans ▫ Temporary Reinsurance Program for Health Plans ▫ Basic Health Plan ▫ Employer Requirements ▫ Medicare Advantage Plan Loss Ratios ▫ Wellness Programs in Insurance ▫ Fees on Health Insurance Sector ▫ Medicare Payments for Hospital-Acquired Infections

• January 15, 2014

▫ Medicare Independent Payment Advisory Board Report (Jan. 15)

ACA’s Tax Penalties for

Lack of Insurance

• Individuals

• Employers

Individuals

• Shared responsibility payment for each month without insurance

• Flat dollar or % of income ▫ $95 for 2014 ▫ $325 for 2015 ▫ $695 for 2016 ▫ Household income minus exemptions

1% - 2014 2% - 2015 2.5% - 2016

Employer Pay or Play Penalties

• What is a Large Employer? ▫ 50+ employees (Aggregated)

▫ Fulltime – 30 hours 30 hours per week

130 hours monthly

No Coverage Penalty

• No minimum essential coverage to 95% of full-time employees and children

• Any full-time employee receives

premium tax credit or cost-sharing reduction for purchasing insurance through the exchange

No Coverage Penalty

• $2000 multiplied by the number of Full-time Employees (“FTE’s) minus 30, divided by 12

EXAMPLE:

($2000 x (90-30 FTE’s))/12

$2000 x 60/12

$120,000/12

$10,000 per month

Insufficient Coverage

Penalty

•Offers Health Insurance

▫ Does not provide minimum value

▫ The coverage is not affordable

Insufficient Coverage

Penalty •The lesser of:

▫ $3000 x # of FTE’s receiving subsidy divided by 12; or

▫ The “No Coverage Penalty” Amount

Coverage must have

Minimum Value

•Plan covers at least 60% of total allowed costs of benefits

Coverage Must be Affordable

•Coverage must not exceed: ▫ 9.5% of W-2 Wages

▫ 9.5% of Federal Poverty Line for a Single Individual

$11,490 (or $1,100)

Who is a Full-Time

Employee?

• 30 hours or more weekly

• 130 hours monthly

• Seasonal/variable hourly ▫ Test period of 3 - 12 months

• Standard measurement period chosen by employer

Why a Health Insurance Penalty May

Look Tempting

New York Times – June 22, 2013

▫ Average employer contribution to healthcare insurance is $11,429 per employee

▫ Penalty $2,000

ACA’s Essential

Health Benefits

• Health plans offered in individual and small group markets are required to offer comprehensive coverage of Essential Health Benefits

ACA’s Essential Health Benefits

• Ambulatory patient services • Emergency services • Hospitalization • Maternity & newborn care

• Mental health & substance use disorder services, including behavioral health treatment, Rehabilitative and Habilitative Prescription drugs

• Rehabilitative & habilitative services and devices • Laboratory Services • Preventive & wellness services and chronic disease

management • Pediatric services, including oral & vision care

Kentucky’s Health

Benefit Exchange

• The Kentucky Health Benefit Exchange website describes an exchange as “an online marketplace where individuals and employees of small businesses can comparison shop for health insurance based on cost, benefits and quality. It will also allow individuals and businesses to apply for premium subsidies and tax credits. Through the Exchange, an individual can also apply and have eligibility determined for Medicaid and the Kentucky Children's Health Insurance Program (KCHIP). http://healthbenefitexchange.ky.gov/Pages/home.aspx

Travelocity for

Healthcare Insurance!!!

• On Monday, June 24th, 2013, the Obama administration kicked off the Health Insurance Marketplace education effort with a new, consumer-focused HealthCare.gov website and the 24-hours-a-day consumer call center to help Americans prepare for open enrollment and ultimately sign up for private health insurance. The new tools will help Americans understand their choices and select the coverage that best suits their needs when open enrollment in the new Health Insurance Marketplace begins October 1.

Kentucky’s Health Exchange

• 900 KAR 10:010E – May, 2013

• Exchange participation requirements

• Certification of Qualified Health and Dental Plans

▫ KHBE – Clearinghouse

▫ DOI – rate approvals

Qualified Insurance Issuers

• Must be accredited by:

▫ Utilization Review Accreditation Commission

▫ National Committee for Quality Assurance

▫ HHS Approved

Participation in the KBHE

• 900 KAR 10:010E: Exchange Participation Requirements and Certification of Qualified Health Plans and Qualified Dental Plans was issued as an emergency regulation on May 13, 2013 and promulgated as an ordinary regulation as well. The following requirements must be met to be a Qualified Health Plan Issuer:

▫ Hold Certificate of Authority

▫ Execute KHBE Participation Agreement

▫ Offer certified QHP in the Individual or SHOP markets

▫ Meet benefit design standards 45 CFR 156.20

Metal levels of coverage

Bronze with actuarial value of 60%

Silver with actuarial value of 70%

Gold with actuarial value of 80%

Platinum with actuarial value of 90%

▫ Cover essential health benefits, pediatric dental health benefits or both

▫ Implement/Report on quality improvement consistent with 42 USC 18031(g)

▫ Offer required types of QHP for Individual or SHOP exchanges

▫ Meet service area requirements

▫ Not discriminate based on race, ethnicity, language, health status, or factor that excludes a high utilizing, high cost or medically underserved population

▫ Meet network adequacy standards for essential community providers of 20% and offer a contract to at least one essential community provider in each category for each service

▫ Rates: Premium rates inside and outside the KHBE for the same QHP shall be the same

▫ Implement required enrollment/termination processes

Mandated Transparency

▫ Claims payment policies and practices

▫ Periodic financial information

▫ Enrollment/Disenrollment information

▫ Data on denied claims

▫ Data on rating practices

▫ SBC

▫ Cost-sharing information for out-of-network claims

▫ Information on enrollee rights

Essential Health Benefits

for Kentucky

• KHIE

▫ Anthem Preferred Provider Organization

(PPO)as Benchmark Plan

▫ KCHP as Pediatric Dental and Vision Supplement Benchmark Plan

Open For Business

Open Enrollment Dates

• KBHE ▫ October 2013 – January 1, 2014

• QHP ▫ January 2013

MISCELLANEOUS

• ACA Essential Benefits expands coverage

▫ Mental Health and Substance Use Disorder

▫ Comply with Federal Mental Healthcare Parity Act

ACA: Making Insurers Accountable

• Medical Loss Ratios (“MLR”) – 2011

▫ Health Insurers in individual and small group markets must spend 80% on medical care and quality improvements

▫ Large Market – 85%

News

• 2011

▫ HHS reported $1.1 billion rebates to 12.8 million consumers

• 2012

▫ HHS reported $504 million rebates to 8.5 million consumers

2012

• $192 million - individual market

• $203 million – small market

• $109 million – large group market

• Average Rebate: $100 per family

Changing the Payment System -

What is an “ACO”?

• The ACA requires the ACO’s meet the following requirements:

1. Be accountable for quality, cost and care of Medicare beneficiaries

2. Commit to participating in the program for at least three years

3. Have a formal legal structure to receive and distribute payments for shared savings

4. Must include sufficient primary care

beneficiaries 5. Have a leadership and management structure

including clinical and administrative systems 6. Develop processes to promote evidence-based

medicine and patient engagement to report on quality and cost measures and to coordinate care through appropriate technologies; and

7. Demonstrate that it meets patient-centeredness criteria by HHS

Injecting Quality Measures

into Payment

• Federal Government’s Readmission Penalties

▫ Effective: October 1, 2012

Readmission

• Readmission occurs if a patient is admitted within 30 days of initial hospitalization regardless of the cause of readmission

Physician Practice Reporting

• Physicians must report information about practice or face a penalty reduction in Medicare reimbursement by 2015

Value-Based Purchasing Program

for Hospitals

• Establish a fund to make payments to hospitals that demonstrate high quality by withholding 1% from DRG’s

• Pay rewards based on Quality

Hospital-Acquired Conditions

“HAC”

• 2015 – Hospitals with highest HAC rate will have Medicare payments reduced by 1%

Never Events • For specified events, CMS disallows

payments:

▫ Artificial insemination with the wrong donor egg

▫ Unintended retention of a foreign body in a patient after surgery or other procedure

▫ Patient death or serious disability associated with patient elopement (disappearance)

▫ Patient death or serious disability associated with a medication error

▫ Patient death or serious disability associated with a hemolytic reaction due to administration of ABO/HLA-incompatible blood or blood products

▫ Patient death or serious disability associated with an electric shock or elective cardioversion while being cared for in a healthcare facility

▫ Patient death or serious disability associated with a fall while being card for in a healthcare facility

▫ Surgery performed on the wrong body part

▫ Surgery performed on the wrong patient

▫ Wrong surgical procedure performed on patient

▫ Intraoperative or immediately post-operative death in an ASA Class I patient

▫ Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility

▫ Infant discharged to the wrong person

▫ Patient suicide, or attempted suicide resulting in serious disability, while be cared for in a healthcare facility

▫ Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility

▫ Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility

▫ Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates

▫ Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility

▫ Patient death or serious disability due to spinal manipulative therapy

▫ Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances

▫ Patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility

▫ Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a healthcare facility

▫ Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider

▫ Abduction of a patient of any age

▫ Sexual assault on a patient within or on the grounds of the healthcare facility

▫ Death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of the healthcare facility.

Prescribing Controlled

Substances in Kentucky • One of the most important public health trends of

the last 10 years is the shifting pattern of drug abuse from heroin, cocaine and marijuana to prescription drugs that are opioid-based. To address this problem, the Kentucky General Assembly passed sweeping legislation that established strict new standards for prescribing controlled substances and directed licensing boards to issue regulations addressing prescribing standards.

• The Kentucky Board of Medical Licensure (“KBML”) followed suit and issued extremely conservative regulations for physicians prescribing controlled substances. The statute and implementing regulations are the most restrictive in the country.

In 2012, HB 1:

- Established new procedures for the Board of Medical Licensure

- Established new requirements for physicians

- Required specific sanctions for certain conduct

- Required Board to set out prescribing/dispensing standards in regulations

- Established ownership and other requirements for pain management facilities

Regulation of Pain Clinics

KRS 218A.175

• A Pain Management Facility means a facility where the majority of the patients receiving treatment from the practitioners at the facility are provided treatment for pain that includes the use of controlled substances and

▫ (i) The facility’s practice component is the treatment of pain; or

▫ (ii) The facility advertises in any medium for any type of pain management services.

Physician Owned

• After July 20, 2012, only a physician who is currently licensed to practice medicine or osteopathy shall have an ownership or investment interest in a pain management facility that is formed or comes into existence after April 24, 2012.

Exceptions • Hospitals, hospice programs, ambulatory surgery

centers, or long term care facilities (nursing homes) are not pain management facilities.

Registration or Licensure of Pain

Management Facilities

• On or before August 1, 2012 and each August 1 of each

succeeding year, every pain management facility operating as a private office or clinic of a physician within the Commonwealth of Kentucky shall register with the Kentucky Board of Medical Licensure. Pain Management Facilities owned by non-physicians were grandfathered in and must be licensed by the Office of Inspector General pursuant to 902 KAR 20:420 and also inspected every year.

New Requirements for Doctors –

KASPER Registration

• To lawfully prescribe a controlled substance in Kentucky:

1. Must have valid DEA permit AND

2. Be registered to use KASPER system

• Sanctions:

1. Each prescription is violation and basis for action

2. Emergency Order of Restriction until registered

Dispensing Restriction

• For Schedule II controlled substances and Schedule III controlled substances with hydrocodone, shall not dispense more than a 48-hour supply to any patient

• May not avoid limit by prescribing on consecutive or multiple occasions

Exception: Dispensing is part of licensed narcotic treatment program.

NOTE: Dispensing is not Prescribing

Prescribing/Dispensing Standards -

Exceptions

Standards do not apply: • To patient as part of hospice/end-of-life care • To patient admitted to hospital as part of

expected course of care at hospital • To patient for pain/treatment of cancer • To registered patient of long-term-care facility • To Schedule V substances • In single dose to relieve anxiety, pain or

discomfort related to diagnostic test/procedure

Standards for Documentation

• Each prescriber/dispenser must obtain/record all relevant info in patient record:

- in a legible manner

- in sufficient detail for Board to determine whether physician is conforming to standards

• For Schedule II and III w/hydrocodone, accurate, readily accessible and complete with, as appropriate:

Standards for Documentation

• Medical history and physical/mental health evaluation

• Diagnostic, therapeutic and lab results • Evaluations and consultations • Treatment objectives • Discussion of treatment x risks, benefits and

limitations • Treatments • Medications – date, type, dosage, amounts • Instructions and agreements • Periodic reviews

Standards – Initial Prescribing for

Treatment of Pain Prior to initial prescribing/dispensing of

controlled substances for treatment of pain or other symptoms of same primary medical complaint, first prescriber/dispenser shall:

a. Obtain appropriate medical history relevant to medical complaint, including HPI;

b. Conduct physical exam or mental health evaluation appropriate to medical complaint

Standards – Initial Prescribing for

Treatment of Pain c. Obtain and review KASPER for 12 months prior

to visit and appropriately use info

d. After appropriate risk-benefit analysis, including non-treatment, make deliberate decision that it is medically appropriate to prescribe/dispense amount specified

e. Not prescribe/dispense long-acting or controlled-release opioid not directly related to and close in time to specific surgical procedure

Standards – Initial Prescribing for

Treatment of Pain f. Explain to patient that use of controlled

substance for acute pain is for time-limited use, and to discontinue use when condition requiring controlled substance use has resolved

g. Explain to patient how to safely use and properly dispose of any unused controlled substance

Standards – Initial Prescribing for

Treatment of Pain • Schedule II and III w/hydrocodone:

- written plan with treatment objectives and further diagnostic exams required AND

- Informed consent after risk-benefit discussion

UNLESS script written in first 7 days to same patient for same condition AND doctor:

- Cancels any refills on initial prescription

- Requires patients to dispose of unused meds

Standards – Decision to Extend

Treatment of Pain Beyond 3 months Before continuing to prescribe/dispense to 16

years or older for treatment of pain and related symptoms for more than 3 months, physician shall:

a. Obtain and document complete history:

1. HPI

2. Past medical history

3. History of substance use/treatment for pt, and history of abuse for first-degree relatives

Standards – Before Beyond 3 month

4. Past family history of relevant illness/treatment

5. Psychosocial history

b. Obtain appropriate physical exam sufficient to support long-term use of cs

c. Perform appropriate baseline assessments to establish and monitor treatment plan

d. Obtain prior records if review is necessary to justify long-term use of cs

Standards – Before Beyond 3 month

e. Promptly establish working diagnosis

f. If unable to formulate working diagnosis, despite best efforts, physician shall:

1. consider usefulness of other information

2. only prescribe long-term after establishing use at specific level is indicated/appropriate

g. If functional improvement is expected, prepare treatment plan with specific/verifiable goals and schedule for periodic evaluations

Standards – Before Beyond 3 months

h. Obtain baseline drug screen

i. Screen for other conditions that may impact cs use and for potential for illegal diversion

j. If reasonable likelihood patient is suffering from substance use disorder of mental health condition, facilitate appropriate referral

k. If risk of diversion, use prescribing agreement

l. If doctor determines patient will use cs illegally, cannot prescribe/dispense

Standards – Before Beyond 3 months

j. Obtain informed consent, after risk-benefit discussion with patient

k. To extent possible, initially attempt or document prior attempt of trial of non-controlled modalities and lower doses of cs in increasing order to treat condition, before continuing at given level.

Standards – Before Beyond 3 months

Standards may be accomplished by different practitioners in single group practice at direction of or on behalf of prescribing physician if:

- each has lawful access to patient record

- there is compliance with all standards AND

- each is acting within legal scope of practice

*** This also applies to standards for long-term prescribing.

Standards – Long-Term Prescribing

If physician continues to prescribe/dispense to patient 16 yo or older for pain and related symptoms beyond 3 months, physician shall:

a. Ensure patient is seen at least monthly at first

b. May move to less frequent visits after:

1. cs titrated to appropriate level;

2. cs not causing unacceptable side effects

3. sufficient monitoring in place to prevent inappropriate/illegal use or diversion

Standards – Long-Term Prescribing

c. At appropriate intervals:

1. obtain appropriate history

2. conduct focused physical exam

3. perform appropriate measurable exams

4. evaluate working diagnosis and treatment plan and modify, as appropriate

d. If patient presents significant risk of abuse/diversion, discontinue cs use or justify continued use in patient record

Standards – Long-Term Prescribing

e. If improvement expected, but not seen, obtain appropriate consults to determine if there are undiagnosed conditions that need to be addressed

f. If patient exhibits symptoms of mood, anxiety or psychotic disorder, obtain consult for intervention if appropriate

g. At least annually, ensure patient receives preventive health screening/exam appropriate to patient’s status.

Standards – Long-Term Prescribing

h. If patient reports breakthrough pain,

1. attempt to identify trigger(s)

2. try to treat with non-controlled therapy

3. take appropriate steps to minimize risk of improper/illegal use, after risk-benefit choice

i. Obtain and review KASPER quarterly

j. Immediately obtain KASPER if report of illegal/improper use or diversion

Standards – Long-Term Prescribing

k. If KASPER shows doctor-shopping, notify other prescribers

l. Obtain specialist assistance if appropriate

m. If appropriate, conduct random pill counts

n. Use drug screens, appropriate to substance and condition, at appropriate times, in random and unannounced manner

o. If indication patient is non-compliant:

1. do controlled taper

Standards – Long-Term Prescribing

2. Immediately stop use of cs; OR

3. Make appropriate referral of patient

p. Discontinue cs use and refer to addiction management if:

1. No improvement where expected

2. CS therapy has produced significant adverse side effects, OR

3. Patient exhibits inappropriate drug-seeking behavior or diversion

Standards - Prescribing in ER

In addition to meeting standards for initial prescribing, ER prescriber must not routinely:

a. Administer IV cs for relief of acute pain unless that is only appropriate means of delivery;

b. Provide replacement cs prescription for one that was lost, stolen or destroyed

c. Provide replacement dose of methadone, suboxone or subutex for patient in treatment program

Standards – Prescribing in ER

d. Prescribe long-acting or controlled release cs or replacement dose of such cs

e. Administer Meperidine to patient, or

f. Prescribe/dispense more than minimum necessary to treat patient until patient can be seen by primary or other physician. If longer than 7 day supply, must justify in record.