Rx16 tpp tues_1230_1_worthy_2williams

Ensuring Access toQuality Treatment

Presenters:

• Stacey L. Worthy, JD, Director of Public Policy, Alliance for the Adoption of Innovations in Medicine

• Melissa Williams, MPH, Coordinator of State Government Relations, National Patient Advocate Foundation

Third-Party Payer Track

Moderator: Daniel Blaney-Koen, JD, Senior Legislative Attorney, American Medical Association Advocacy Resource Center, and Member, Rx and Heroin Summit National Advisory Board

Disclosures

Melissa Williams, MPH; Stacey L. Worthy, JD; and Daniel Blaney-Koen, JD, have disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.

Disclosures

• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

• The following planners/managers have the following to disclose:– John J. Dreyzehner, MD, MPH, FACOEM – Ownership interest:

Starfish Health (spouse)– Robert DuPont – Employment: Bensinger, DuPont &

Associates-Prescription Drug Research Center

Learning Objectives

1. Identify common barriers to addiction treatment.2. Explain federal and state patient protection and

parity laws that are intended to improve access to quality treatment for substance abuse disorders.

3. Outline strategies to improve access to quality treatment for substance abuse disorders.

4. Provide accurate and appropriate counsel as part of the treatment team.

Ensuring Access to Quality Treatment

Stacey L. Worthy, Esq.National Rx Abuse Summit

March 29, 2016

Disclosure Statement

Stacey L. Worthy has disclosed no relevant, real or apparent, personal or professional, financial relationships with proprietary entities that produce health care goods and services.

Disclosure Statement• Aimed Alliance receives funding from businesses in the

health care industry that share Aimed Alliance’s mission to improve healthcare in the U.S. through improved access to novel, evidence based treatments and technologies. Aimed Alliance’s funders are disclosed on its website.

• Aimed Alliance is managed by DCBA Law & Policy (DCBA). DCBA also provides legal and policy counsel to professionals and businesses whose activities align with Aimed Alliance’s mission. To avoid conflicts of interest, DCBA adheres to the District of Columbia Rules of Professional Conduct §§ 1.7-1.9.

Learning Objectives

• Identify common barriers to quality treatment for individuals with substance use disorders (SUDs)

• Explain federal and state patient protection and parity laws that are intended to guarantee access to quality treatment for SUDs

• Outline strategies to reduce access barriers to quality treatment for SUDs

• Provide accurate and appropriate counsel as part of the treatment team.

Theme and Preview

• Theme: Comply with new laws & policies to expand access to treatment or face enforcement actions

• Need for treatment, progress, & room for improvement

• Federal & state laws expanding access• Enforcement actions• Federal proposals & legislation • State legislation

Need for Treatment

• 27 mill. Americans used illicit drugs in past 30 days (SAMHSA, 2015)

– 4.7 mill. Americans abuse rx opioids or heroin per year (SAMHSA, 2015)

• 21.5 mill. Americans had SUDs (SAMHSA, 2015)

– 2.4 mill. Americans had opioid use disorders (SAMHSA, 2015)

• 47,055 drug overdose deaths per year (CDC, 2016)

– > 29,000 opioid-related overdose deaths in 2014 (CDC, 2015)

– Heroin-related overdose deaths tripled between 2010 and 2014 (CDC 2016)

Lack of Treatment• 80% go untreated (Johns Hopkins, 2015)

• Risks– Infectious diseases (HIV, Hep C)

• Indiana, Kentucky, Ohio, Florida– Criminal activity – Overdose – Death

• Why? (SAMHSA, 2014)

– No health coverage & could not afford cost (37.3%)– Not ready to stop using (24.5%)– Did not know where to go for treatment (9.0%)– Health plan did not cover treatment or cost (8.2%)– No transportation or inconvenient (8%)

Progress

• In 2002, 88% of plans had annual limits on outpatient visit vs. 6.5% in 2011 (HHS, 2013)

• New Hampshire (NH Insurance Dep’t Report, 2016)

– 11,650 claims for opioid treatment filed b/n Jan. 2015 & Oct. 2015 (Anthem, Cigna, Harvard Pilgrim)

– Denial rates were 9.5%, 15%, & 28.3%– Of 64 cases deemed medically unnecessary, only 8 had

legitimate concerns– Few consumers used appeals process– Insurance Dep’t received few complaints

Progress

• MA report found expanded access & coverage in both commercial & publicly-funded plans (Center for Health Information & Analysis, 2015)

– Greater access for young adults and lower/middle income adults who previously did not qualify for MassHealth

– Hundreds of new treatment beds created in 2016 as a result of insurers complying with a new state parity law

Room for Improvement• ASAM 2013 study of Medicaid coverage found following

were common practices: – Limits on dosage– Lifetime limits on medication-assisted treatment (MAT)– Complex initial prior authorization and reauthorization – Minimal counseling coverage – Fail first criteria – No coverage of one to two of three approved medications for

MAT• Cigna pulled out of FL insurance marketplace for 2016• Improve coverage & reduce risk of liability

Parity Act

• Mental Health Parity & Addiction Equity Act (Parity Act)– Enacted in 2008; expanded under ACA in 2010;

final regs. promulgated in 2013– Expanded access to substance use treatment – Must cover SUD services at levels equivalent to

coverage of medical/surgical services

Parity Act Continued

• Applies to the following plans:– Large group plans– Small group and individual market plans (ACA)– Medicaid Managed Care, CHIP, and Medicaid

alternative benefit plans (CMS letter)

Parity Act: Financial Req. & QTLs• Financial requirements – E.g., charging higher copays – No separate cost-sharing requirements that only

apply to SUD benefits• Quantitative Treatment Limitations (QTLs)– I.e., limitations that are expressed numerically – E.g., frequency of SUD treatment, number of

visits, days of coverage, annual or lifetime visit limits

Parity Act: NQTLs• Non-quantitative treatment limitations (NQTLs) • Limitations not expressed numerically, but otherwise limit scope or duration

of benefits • 6 classifications:

– Inpatient, in-network – Inpatient, out-of-network– Outpatient, in-network– Outpatient, out-of-network– Emergency care – Prescription drugs

• 2 sub-classifications: – Office visits – All other outpatient items and services (e.g., urine drug testing)

• If plan covers one classification, it must cover all

Parity Act: NQTLs

• Examples: – Medical necessity standards– Step therapy (e.g., requiring outpatient before

inpatient)– Prior authorization– Network standards for provider reimbursement (e.g.,

sending reimbursement checks directly to patients)– Provider network criteria – Formulary design (e.g., placing all ADFs in specialty

tier)

Parity Act: Addt’l Requirements

• Additional Requirements:– Intermediate levels of care • E.g., residential or intensive outpatient treatment

– Scope of transparency • E.g., disclosure rights

– Parity for all plan standards • E.g., geographical limits, facility-type limits

Affordable Care Act

• ACA signed into law in 2010 • Purpose: – Expand access to insurance coverage – Increase consumer protections– Curb rising health care costs

ACA: Nondiscrimination Rule

• Proposed Nondiscrimination Rule (Sept. 2015) provided clarifications:– Cannot deny, cancel, limit, or refuse to issue or

renew plan or policy, or impose additional cost sharing or other limitations or restrictions

– Cannot employ marketing practices or benefit designs that discriminate (e.g., placing all HIV meds in the highest-cost specialty tier)

ACA: Nondiscrimination Law

• Nondiscrimination Provisions – No discrimination on basis of disability (e.g., SUD)– No higher premiums based on health status-

related factor – No preexisting condition exclusion– No lifetime and annual limits on dollar value for

small group or individual health plans (e.g., no lifetime limit on MAT)

State Parity Laws

• States may enact laws that are equal to or more stringent than the Parity Act

• 32 states have SUD parity laws • 16 states (California, Connecticut, Montana,

Oregon, Vermont) have fined insurers for violating state parity laws

MA Parity Law & Results

• Parity Law (effective Oct. 2015): – No prior authorization for certain SUD services– Up to 14 days of inpatient acute treatment

• Commercial plans have complied– In 2016, 100s of new treatment beds (WBUR, 2016)

– Fraud & profiteering

NY Parity Law• Requires insurers to cover detox and rehabilitation services

– 60 outpatient visits; 20 therapeutic outpatient services for family members

– Insurers cannot mandate step therapy – Denials must be processed w/in 24 hours

• Number of denials reduced significantly• New York aggressively enforcing state parity law

– NY AG Schneiderman investigated & settled 5 cases – Beacon Health Options allegedly denied coverage for SUD services at 2x

rate of denied med/surg. services; settled for $900K– Excellus Health Plan denied inpatient addiction treatment 7x as often as

inpatient medical services. Settlement requires reform to claims review process. Could result in up to $9 mill. for patients.

Results

• 3rd party payers “have taken tremendous steps to implement these changes and requirements in a way that is affordable to patients” – Clare Krusing, AHIP

• Parity Act broadened access to SUD services w/o increasing costs (Health Affairs 2015)

– 8.7% increase for out-of-network inpatient SUD services– 4.3% increase for out-of-network outpatient SUD

services

Results

• Lack of access to in-network treatment (Health Affairs, 2015)

• Pattern of denials show exploitation of loopholes– E.g., frequent utilization review, step therapy

requirements, and applying stricter medical necessity criteria (Health Affairs, 2015)

– 25% of two unnamed state marketplace plans appeared to be inconsistent with Parity Act (NAMI, 2015)

• Increase in lawsuits and enforcement actions

Cases & Enforcement Actions• Violations of Parity Act & ACA:– Dep’t of Labor & IRS have authority over ERISA plans– States & HHS share authority over most other plans

• New York State Psychiatric Assoc. v. UnitedHealth Group (Aug. 2015)– Individuals can sue third-party plan administrators

directly under Parity Act– Provider associations can sue on patients’ behalf– Could increase litigation

Parity Cases• Utah 2016: Plan excluded residential treatment but covered skilled nursing facility services.

Restriction was NQTL. If plan chooses to cover MH/SUD services, those services must be on par with med./surg. services. Joseph F. v. Sinclair Servs. Co.

• North Dakota 2015: Plaintiffs could proceed w/punitive class action complaint claiming plan administrator breached duty by using more rigorous standards than general accepted standards of care for SUD outpatient treatment. Alexander v. United Behavioral Health

• Washington state 2015: Two class action suits. Insurers improperly denied medically necessary autism treatment. Settled for $6 million. K.M. v. Regence; R.H. v. Premera Blue Cross

• Oregon 2014: Insurer violated law by placing cap on number of hours per week for autism services. Law has little meaning if insurers can cover health condition but exclude coverage for medically necessary services “related to” that condition. A.F. v. Providence Health Plan

• California 2013: Kaiser Permanente investigated for multiple violations (e.g., denying members access to critical info about SUD benefits); comply with corrective action plan or face fines.

• Washington state 2012: Plan imposed age restriction for certain speech therapies. Defendant insurer attempted to correct violation by applying same restrictions to med./surg. benefits. Parity Act was intended to “bolster” coverage, and not “weaken or supplant . . . baseline coverage.” Z.D. ex rel. J.D. v. Grp. Health Coop

Enforcement Actions: DOL Report

• Gov’t is enforcing parity & investigating violations (Dep’t of Labor, 2016)

• Oct. 2010 to Dec. 2015: 1,515 investigations, 171 violations found (58% were NQTLs)

• DOL worked with issuers to ensure corrections

ACA Cases

• Florida 2015: Investigation found 4 insurers discriminated against consumers with HIV/AIDs by placing all meds in highest cost specialty tier • Humana fined $500K for impeding investigation

• Oregon 2015: Physician association sued insurer for refusing to cover preventative services required under ACA. Oregon Assoc’ of Naturopathic Physicians v. Health Net Plan (ongoing)– Seeking reimbursement, repayment of profits, etc.

Fed. Activity to Expand Treatment • DOD proposed rule: eliminate 60-day limit on partial

hospitalization, and annual and lifetime limits for SUD treatment for vets (Feb., 2016)

• CMS “Advance Notice & Draft Call Letter”(Feb., 2016)– Medicare Advantage plans must ensure access to MAT– “Given requirements imposed by [DATA 2000] and [REMS] for

buprenorphine-contained products for MAT, Part D sponsors should not impose prior authorization criteria that simply duplicate these requirements.”

– “Part D formulary and plan benefit designs that hinder access, either through overly restrictive utilization management strategies or high cost-sharing, will not be approved.”

Federal Legislation

• H.R. 4276 – Behavioral Health Coverage Transparency Act of 2015 – Fed. bill introduced in Dec. 2015 by U.S. Rep. Joe

Kennedy III – Would require insurers to disclose how often and

why they deny SUD claims– In response to National Alliance on Mental Illness – Not yet reintroduced

Conclusion

• Contact us– [email protected] – Linkedin.com/in/staceyworthy – Twitter.com/adoptinnovation

• Thank you

State Legislative Actions to Address Barriers to Treatments

Melissa L. Williams, MPHNational Rx Abuse Summit

March 29, 2016

Disclosure Statement

Melissa L. Williams has disclosed no relevant, real or apparent, personal or professional, financial relationships with proprietary entities that produce health care goods and services.

Disclosure Statement• The National Patient Advocate Foundation (NPAF) serves as

the patient voice for patients with chronic, debilitating illnesses who need access to affordable, high quality health care.

• NPAF, a 501(c)4, is the sister organization and advocacy affiliate to Patient Advocate Foundation, a 501(c)3, which provides direct case management services to patients who have trouble affording or accessing treatments.

• NPAF helps translate the individual experiences of PAF patients to federal and state legislative or regulatory policies.

Learning Objectives

• Identify common barriers to addiction treatment.• Explain federal and state patient protection and parity

laws that are intended to improve access to quality treatment for substance abuse disorders.

• Outline strategies to improve access to quality treatment for substance abuse disorders.

• Provide accurate and appropriate counsel as part of the treatment team.

Background

Federal Parity Law protects patients from treatment limits: Non-quantitative treatment limitations (NQTL)-• Medical necessity standards• Step therapy• Prior authorization• Network standards for provider reimbursement• Provider network criteria• Formulary design - Adverse tiering

Background

Federal Parity Law protects patients from treatment limits: Non-quantitative treatment limitations (NQTL)-• Medical necessity standards• Step therapy• Prior authorization• Network standards for provider reimbursement• Provider network criteria• Formulary design - Adverse tiering

Prior Authorization

• Patient needs to get pre-approved for coverage of a treatment or medication.

• An insurance plan may not pay for care if the patient’s condition does not meet certain standards.

• Insurance company may not approve a drug or service until the patient’s provider gives notes and/or lab results describing the patient’s condition and treatment history.

http://www.csro.info/PriorAuthorization 3.15.16

Prior Authorization

Uniform prior authorization forms:(a) Not exceed 2 pages,(b) Be made electronically available; and(c) Be capable of being electronically accepted by the

payer after being completed

Requires PA requests to be deemed approved if insurer has not responded within the required timeframe (24h/48h).

Step Therapy

• A requirement that a patient try a less expensive treatment first before he gets approval for the treatment his provider orders.

• Also referred to as Fail First Protocol

http://www.csro.info/failfirst 3.15.16

Step Therapy(a) Clinical review criteria must be used to establish step therapy protocol;

(b) Insurer must have an override / exception protocol;

(c) Exemption determination process shall be easily accessible on health plan issuer’s or utilization review organization’s website;

(d) The step therapy protocol may not require failure on the same medication on more than one occasion for patients continuously enrolled in any health plan offered by the carrier.

Adverse Tiering

• Moving all drugs of the same class to the highest cost-sharing tier.

Adverse Tiering(a) No insurance company, hospital service corporation, medical service corporation, health care center or other entity delivering, issuing for delivery, renewing, amending or continuing an individual health policy or contract that provides coverage for prescription drugs may:

(1) Place all prescription drugs in a given class in the highest cost-sharing tier of a tiered prescription drug formulary.

States that have taken action: TX, LA, MD, DE, NY, AZ, ME, OK, NM, VT, CA

paritytrack.org 3.15.16

Prior Authorization Legislation• CT SB 1160 (2013) - Enacted Changes to state insurance law

regarding utilization review:• Inpatient care, partial hospitalization services, residential

treatment, and intensive outpatient services for behavioral health could be part of an “urgent care request”

• All utilization reviews for SUD to use Patient Placement Criteria from the ASAM

• Hawaii Parity Law - Enacted Includes requirements of utilization review agents who perform behavioral health service reviews

paritytrack.org

Prior Authorization Legislation• IL HB 1 (2015) - Enacted Requires IL Medicaid plans to cover

any Rx for SUD; no prior authorization required for these medications and any utilization management follow ASAM criteria.

• Maryland Parity Law - Enacted “Processes, strategies, evidentiary standards, or other factors used to determine coverage” for behavioral health coverage cannot be “applied more stringently” than they are for other medical coverage.

• Missouri Parity Law - Enacted Administrative and clinical procedures should “not serve to reduce access to medically necessary treatment.”

paritytrack.org

Prior Authorization Legislation

• Rhode Island Parity Law - Enacted Requires Dept of Health to develop reporting requirements for insurance plans’ utilization review programs for compliance with the Federal Parity Law and ACA.

• Virginia Parity Law - Enacted Medical necessity reviews must be conducted “in the same manner” as reviews for other medical services.

• VT H 101 (2015) - Pending Requires plans to use same prior authorization procedures for behavioral health services and other medical services.

paritytrack.org

Step Therapy Legislation

• MD HB 1233/SB 622 (2014) - Enacted Gives MD Health Care Commission authority to work with health providers to cancel out step therapy protocols required within insurance plans.

• WI AB 458 (2014) - Enacted Requires Medicaid to cover in-home services without requiring fail-first protocol

paritytrack.org

paritytrack.org 3.15.16

Opportunities

• ID parity law is not comprehensive; makes clear that SUDs do not count as serious emotional disorders.

• ID HCR 54 (2016) - Requesting a report on the strategic plan for improving behavioral health treatment from the Dept of Health and Welfare

Adverse Tiering - HIV

• In May 2014, a formal complaint was filed with the Department of Health and Human Services which contended that FL insurers had structured their drug formularies to discourage people with HIV from selecting their plans. Insurers had categorized all HIV drugs, including generics, in the specialty tier (The AIDS Institute).

Adverse Tiering - Hepatitis

• In 2015, 8 out of the 12 major insurers offering qualified health plans in FL placed drug treatments for Hepatitis B and C on the highest cost sharing tier, charging beneficiaries coinsurance as high as 30 to 50 percent (The AIDS Institute).

• Their findings revealed that discriminatory plan design is much more widespread for people accessing Hepatitis B and C drugs than HIV drugs.

Access to Abuse-Deterrent Formulations

http://sppan.aapainmanage.org/abusedeterrent

Access to Abuse-Deterrent Formulations

• Pharmaceutical manufacturers have developed new formulations of frequently-abused opioid pain relievers that deter tampering.

• Barriers to accessing ADFs:– Subjected to prior authorization or “fail

first” policies– High cost-sharing requirements

Implications

• Utilization review practices may reduce medication expenditures, but these requirements may also have unintended consequences of reducing use of medication and access to treatment.– Non-adherence– Relapse

Recommendations

• Implement policies that:– Preserve the patient-provider relationship;– Adopt protocols that are consistent with

clinical review criteria;– Do not discriminate against patients with

SUDs

Conclusion

Contact: [email protected]

THANK YOU

Ensuring Access toQuality Treatment

Presenters:

• Stacey L. Worthy, JD, Director of Public Policy, Alliance for the Adoption of Innovations in Medicine

• Melissa Williams, MPH, Coordinator of State Government Relations, National Patient Advocate Foundation

Third-Party Payer Track

Moderator: Daniel Blaney-Koen, JD, Senior Legislative Attorney, American Medical Association Advocacy Resource Center, and Member, Rx and Heroin Summit National Advisory Board