Ensuring Access to Quality Treatment

1. Ensuring Access to
Quality 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

2. 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.

3. 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

4. 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.

5. Ensuring Access to Quality
Treatment
Stacey L. Worthy, Esq.
National Rx Abuse Summit
March 29, 2016

6. 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.

7. 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.

8. 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.

9. 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

10. 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)

11. 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%)

12. 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

13. 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

14. 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

15. 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

16. 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)

17. 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

18. 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

19. 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)

20. 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

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

22. 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)

23. 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)

24. 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

25. 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

26. 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.

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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.

33. 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.”

34. 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

35. Conclusion
• Contact us
– sworthy@aimedalliance.org
– Linkedin.com/in/staceyworthy
– Twitter.com/adoptinnovation
• Thank you

36. State Legislative Actions to
Address Barriers to Treatments
Melissa L. Williams, MPH
National Rx Abuse Summit
March 29, 2016

37. 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.

38. 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.

39. 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.

40. 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

41. 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

42. 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.

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

44. 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).

45. 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

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

47. 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.

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

49. 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

50. paritytrack.org 3.15.16

51. 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

52. 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

53. 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

54. 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

55. paritytrack.org 3.15.16

56. 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

57. 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).

58. 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.

59. Access to Abuse-Deterrent Formulations
http://sppan.aapainmanage.org/abusedeterrent

60. 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

61. 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

62. 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

63. Conclusion
Contact: melissa.williams@npaf.org

64. THANK YOU

65. Ensuring Access to
Quality 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