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1201 - PHSA Section 2709: Coverage for Individuals Participating in Approved Clinical Trials

 
Implementation Status 
Statutory Text 

Summary

Added by section 10103 of the Manager’s Amendment. Provides that group or individual plans may not deny individuals participation in a clinical trial, deny or limit coverage for routine costs or discriminate on the basis of such participation.

Specifies conditions for inclusion of routine patient costs and defines qualified individual and approved clinical trial. Notes that a plan or issuer may require that a qualified individual participate in the trial through an in-network participating provider if the provider will accept the individual, adding that the section’s protections nonetheless apply to a qualified individual participating in an approved clinical trial that is conducted outside the State in which the qualified individual resides.

Effective for plan years beginning on or after January 1, 2014.

Last updated: (October 31, 2016)  #Insurance Reform

Implementation Status

 
Summary 
Statutory Text 

2013

On April 29, 2013, DOL, Treasury and HHS issued FAQs clarifying that waivers from the annual limit requirements will expire on the approved expiration date, notwithstanding any modifications that plans may make to their plan or policy years. The FAQs also clarify that the ACA’s provider non-discrimination and clinical trial coverage provisions are self-implementing and that no regulations are expected “in the near future.” The Departments note that the Qualified Health Plan transparency reporting requirements under section 1311(e)(3) will take effect “only after QHPs have been certified as QHPs for one benefit year,” adding that outside-the-Exchange reporting requirements under PHSA 2715A will not take effect sooner than this.

On Nov. 14, coinciding with the President’s remarks on the Administration’s pursuit of an administrative fix for those receiving policy cancellations and following his apology for those facing such cancellations, CCIIO released a letter to state Insurance Commissioners (White House fact sheet) laying out a transitional policy under which insurers “may choose to continue coverage that would otherwise be terminated or cancelled, and affected individuals and small businesses may choose to re-enroll in such coverage” – without complying with 2014 market reforms detailed on p. 2 of the letter – under a set of specified parameters (see p. 2 of the letter). Prior to the announcement, on Nov. 9, CMS also had released a fact sheet on policy cancellation letters and Marketplace options.

On Nov. 21, the Center for Consumer Information and Insurance Oversight released guidance and standard notices for health plans to use in the individual and small group markets under the Administration’s transitional policy for – with state insurance commissioner approval – extending into 2014 non-ACA compliant plans that otherwise would or already have been canceled. Also see a White House blog post and CCIIO Q&A on notices. On Nov. 20, President Obama met with Insurance Commissioners regarding the policy.

On Dec. 2, Rep. Darrell Issa (R-CA), chairman of the House Oversight and Government Reform Committee, wrote to 15 insurers asking about, among other issues, ACA-related plan cancellations and providers no longer in networks. On Dec. 4, the House Ways and Means Health Subcommittee held a hearing that addressed, in part, plan cancellations; among those testifying was the Washington state insurance commissioner. On Dec. 6, the House Oversight and Government Reform Committee held an Arizona-based field hearing, “ObamaCare Implementation, The Broken Promise: If You Like Your Current Plan You Can Keep It” (details).

2014

On Jan. 3, CCIIO released Q&As clarifying eligibility for hardship exemption from the individual mandate for policyholders whose plans have been canceled, noting that “in order to receive [the exemption] and be able to purchase catastrophic coverage, you must submit the hardship exemption form and should submit supporting documentation showing your health insurance policy was cancelled to an issuer offering catastrophic coverage in your area.” CCIIO indicates that the agency may contact those not including such documentation; the exemption can be revoked if this substantiation is not provided.

2015

On Mar. 16, HHS, DOL and Treasury issued a final rule amending the definition of excepted benefits and establishing two pilot programs through which employers may provide certain limited wraparound coverage to individual plans, including those purchased in Marketplaces. One pilot enables limited wraparound coverage only for ACA Multi-State Plans, while the other permits it for “part-time workers who enroll in an individual health insurance policy or in Basic Health Plan coverage for low-income individuals established under the Affordable Care Act.

On July 1, IRS issued a notice providing transition relief and interim guidance on the applicability of certain ACA provisions to expatriate coverage.

2016

On Apr. 20, HHS, DOL, and the Treasury issued joint FAQs regarding implementation of ACA market reform provisions, the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), and the Women’s Health and Cancer Rights Act of 1998 (WHCRA). Specific market reforms made by the ACA, including emergency services protections, coverage of preventive services, prohibition on rescissions, coverage of individuals participating in approved clinical trials, and limitations on cost sharing, are all addressed.

On Oct. 31, Treasury, DOL, and CMS issued a final rule on short-duration plans, among other topics, that takes effect on Dec. 30, 2016. It applies to group plans and health insurance issuers “beginning on the first day of the first plan year (or, in the individual market, the first day of the first policy year) beginning on or after Jan. 1, 2017.”

Statutory Text

 
Implementation Status 
Summary 

‘‘SEC. 2709 [42 U.S.C. 300gg–8]. COVERAGE FOR INDIVIDUALS PARTICIPATING
IN APPROVED CLINICAL TRIALS.
[Section added by section 10103(c)]
‘‘(a) COVERAGE.—
‘‘(1) IN GENERAL.—If a group health plan or a health insurance
issuer offering group or individual health insurance coverage
provides coverage to a qualified individual, then such
plan or issuer—
‘‘(A) may not deny the individual participation in the
clinical trial referred to in subsection (b)(2);
‘‘(B) subject to subsection (c), may not deny (or limit
or impose additional conditions on) the coverage of routine
patient costs for items and services furnished in connection
with participation in the trial; and
‘‘(C) may not discriminate against the individual on
the basis of the individual’s participation in such trial.
‘‘(2) ROUTINE PATIENT COSTS.—
‘‘(A) INCLUSION.—For purposes of paragraph (1)(B),
subject to subparagraph (B), routine patient costs include
all items and services consistent with the coverage provided
in the plan (or coverage) that is typically covered for
a qualified individual who is not enrolled in a clinical trial.
‘‘(B) EXCLUSION.—For purposes of paragraph (1)(B),
routine patient costs does not include—
‘‘(i) the investigational item, device, or service,
itself;
‘‘(ii) items and services that are provided solely to
satisfy data collection and analysis needs and that are
not used in the direct clinical management of the patient;
or
‘‘(iii) a service that is clearly inconsistent with
widely accepted and established standards of care for
a particular diagnosis.
‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one or more participating
providers is participating in a clinical trial, nothing
in paragraph (1) shall be construed as preventing a plan or
issuer from requiring that a qualified individual participate in
the trial through such a participating provider if the provider
will accept the individual as a participant in the trial.
‘‘(4) USE OF OUT-OF-NETWORK.—Notwithstanding paragraph
(3), paragraph (1) shall apply to a qualified individual
participating in an approved clinical trial that is conducted
outside the State in which the qualified individual resides.
‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For purposes of subsection
(a), the term ‘qualified individual’ means an individual who
is a participant or beneficiary in a health plan or with coverage described
in subsection (a)(1) and who meets the following conditions:
‘‘(1) The individual is eligible to participate in an approved
clinical trial according to the trial protocol with respect to
treatment of cancer or other life-threatening disease or condition.

‘‘(2) Either—
‘‘(A) the referring health care professional is a participating
health care provider and has concluded that the individual’s
participation in such trial would be appropriate
based upon the individual meeting the conditions described
in paragraph (1); or
‘‘(B) the participant or beneficiary provides medical
and scientific information establishing that the individual’s
participation in such trial would be appropriate based
upon the individual meeting the conditions described in
paragraph (1).
‘‘(c) LIMITATIONS ON COVERAGE.—This section shall not be construed
to require a group health plan, or a health insurance issuer
offering group or individual health insurance coverage, to provide
benefits for routine patient care services provided outside of the
plan’s (or coverage’s) health care provider network unless out-of-network
benefits are otherwise provided under the plan (or coverage).

‘‘(d) APPROVED CLINICAL TRIAL DEFINED.—
‘‘(1) IN GENERAL.—In this section, the term ‘approved clinical
trial’ means a phase I, phase II, phase III, or phase IV
clinical trial that is conducted in relation to the prevention, detection,
or treatment of cancer or other life-threatening disease
or condition and is described in any of the following subparagraphs:

‘‘(A) FEDERALLY FUNDED TRIALS.—The study or investigation
is approved or funded (which may include funding
through in-kind contributions) by one or more of the following:

‘‘(i) The National Institutes of Health.
‘‘(ii) The Centers for Disease Control and Prevention.

‘‘(iii) The Agency for Health Care Research and
Quality.
‘‘(iv) The Centers for Medicare & Medicaid Services.

‘‘(v) cooperative group or center of any of the entities
described in clauses (i) through (iv) or the Department
of Defense or the Department of Veterans Affairs.

‘‘(vi) A qualified non-governmental research entity
identified in the guidelines issued by the National Institutes
of Health for center support grants.
‘‘(vii) Any of the following if the conditions described
in paragraph (2) are met:
‘‘(I) The Department of Veterans Affairs.
‘‘(II) The Department of Defense.
‘‘(III) The Department of Energy.
‘‘(B) The study or investigation is conducted under an
investigational new drug application reviewed by the Food
and Drug Administration.
‘‘(C) The study or investigation is a drug trial that is
exempt from having such an investigational new drug application.

‘‘(2) CONDITIONS FOR DEPARTMENTS.—The conditions described
in this paragraph, for a study or investigation conducted
by a Department, are that the study or investigation
has been reviewed and approved through a system of peer review
that the Secretary determines—
‘‘(A) to be comparable to the system of peer review of
studies and investigations used by the National Institutes
of Health, and
‘‘(B) assures unbiased review of the highest scientific
standards by qualified individuals who have no interest in
the outcome of the review.
‘‘(e) LIFE-THREATENING CONDITION DEFINED.—In this section,
the term ‘life-threatening condition’ means any disease or condition
from which the likelihood of death is probable unless the course of
the disease or condition is interrupted.
‘‘(f) CONSTRUCTION.—Nothing in this section shall be construed
to limit a plan’s or issuer’s coverage with respect to clinical trials.
‘‘(g) APPLICATION TO FEHBP.—Notwithstanding any provision
of chapter 89 of title 5, United States Code, this section shall apply
to health plans offered under the program under such chapter.
‘‘(h) PREEMPTION.—Notwithstanding any other provision of this
Act, nothing in this section shall preempt State laws that require
a clinical trials policy for State regulated health insurance plans
that is in addition to the policy required under this section.’’.

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