National Health Council

National Health Council
1730 M Street NW, Suite 500, Washington, DC 20036-4561 ■ 202-785-3910 ■ www.nationalhealthcouncil.org ■ [email protected]
BOARD OF DIRECTORS
Chairperson
Nancy Brown
American Heart Association
Chairperson-Elect
Randy Beranek
National Psoriasis Foundation
Vice Chairperson
Tracy Hart
Osteogenesis Imperfecta Foundation
Secretary
Thomas Wallace
Eli Lilly and Company
Treasurer
Donald Schumacher, PsyD
National Hospice and Palliative Care
Organization
Immediate Past Chairperson
LaVarne A. Burton
American Kidney Fund
Margaret Anderson
FasterCures – The Center for
Accelerating Medical Solutions
John Castellani
PhRMA
Barbara Collura
RESOLVE: The National
Infertility Association
Elizabeth J. Fowler, PhD, JD
Johnson & Johnson
Robert Gebbia
American Foundation for Suicide Prevention
James C. Greenwood
Biotechnology Industry Organization
Larry Hausner
American Diabetes Association
Jennifer L. Howse, PhD
March of Dimes Foundation
Dan Leonard
National Pharmaceutical Council
Carolyn Levering
The Marfan Foundation
Paul Pomerantz, FASAE, CAE
American Society of Anesthesiologists
Eric Racine, PharmD
Sanofi
Amy Comstock Rick, JD
Parkinson’s Action Network
John W. Walsh
Alpha-1 Foundation
Cynthia Zagieboylo
National Multiple Sclerosis Society
Ex Officio Member
Myrl Weinberg, FASAE, CAE
Chief Executive Officer
National Health Council
June 24, 2014
Ms. Marilyn Tavenner
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
200 Independence Ave, SW
Washington, DC 20201
Re: Lack of Patient Protections for Exceptions Coverage in the Exchange
and Insurance Market Standards for 2015 and Beyond final rule
Dear Administrator Tavenner:
The National Health Council (NHC) appreciates the opportunity to submit
comments on the recently released the Exchange and Insurance Market
Standards for 2015 and Beyond final rule. We are submitting this letter to
ensure that patient protections are strengthened in the upcoming plan year.
The NHC is the only organization that brings together all segments of the
health community to provide a united voice for the more than 133 million
people with chronic diseases and disabilities as well as their family caregivers.
Made up of more than 100 national health-related organizations and
businesses, its core membership includes the nation’s leading patient advocacy
groups, which control its governance. Other members include professional
societies and membership associations, nonprofit organizations with an interest
in health, and major pharmaceutical, medical device, biotechnology, and
insurance companies.
On May 16, 2014, the Department of Health and Human Services (HHS),
released the Exchange and Insurance Market Standards for 2015 and Beyond
final rule. Among other provisions, the rule states that health insurance issuers
that provide essential health benefits must have a process to allow an enrollee
to request and gain access to clinically appropriate drugs not covered by the
health plan. In the final rule, HHS requires that this process be expedited when
necessary by requiring issuers to respond to requests within 24 hours under
exigent circumstances. While the NHC applauds HHS for including an exigent
circumstance for the exceptions process, it is vital for HHS to also ensure that
there are sufficient patient protections including an assurance of reasonable
and specified cost-sharing that counts towards the plan’s maximum out-ofpocket (MOOP) limit.
Lack of Patient Protections for Exceptions Coverage
June 24, 2014
Page 2 of 3
As noted in the final rule’s preamble, this regulation does not address cost-sharing requirements
for prescription drugs covered through the exceptions process or a requirement that cost-sharing
for these medications count towards the MOOP. This glaring lack of patient protections
regarding the affordability of drug exceptions may leave patients, especially lower income
patients, without an option to access life-saving therapies. It is critical that patients have timely
and affordable access to prescription drugs not covered on the formulary, and if patients are not
granted reasonable cost-sharing for prescriptions accessed through the exceptions process, these
prescription drugs may remain unavailable due to the high costs imposed by health plans.
HHS has already designed and implemented an appropriate model for these exact scenarios
under Medicare Part D. In the exceptions process in Medicare Part D, enrollees are granted
specific cost-sharing guidelines for therapies covered under the exceptions. As stated in the
Medicare Prescription Drug Benefit Manual Chapter 18, Section 30.2.2.4: “a plan sponsor has
the flexibility to determine what level of cost-sharing will apply for non-formulary drugs
approved under the exceptions process. However, a plan sponsor is limited to choosing a single
cost-sharing level that applies to one of its existing formulary tiers. For example, a plan sponsor
may apply the non-preferred level of cost-sharing for all non-formulary drugs approved under
the exception process. Part D sponsors may also elect to apply a second, less expensive level of
cost-sharing for approved formulary exceptions for generic drugs, so long as the second level of
cost-sharing is associated with an existing formulary tier and is uniformly applied to all approved
formulary exceptions for generic drugs.” i This level of cost-sharing specificity applied to nonformulary drugs approved under the exceptions protections ensures that patients maintain timely
and affordable access to prescriptions drugs.
Additionally, as stated in the Medicare Prescription Drug Benefit Manual, costs that are incurred
can be added to an enrollee’s True Out-of-Pocket (TrOOP). More specifically the Medicare
Prescription Drug Benefit Manual, Chapter 5, Section 30.1 notes: “Costs are considered incurred
costs and can be added to an enrollee’s TrOOP balance if the following conditions are met:
•
•
Costs are incurred against any annual deductible, any applicable cost-sharing for costs
above the deductible and up to the initial coverage limit, and any applicable cost-sharing
for costs above the initial coverage limit and up to the annual out-of-pocket threshold.
Costs are incurred with respect to covered Part D drugs that are either included in a PDP or
MA-PD plan’s formulary or treated as being included in a plan’s formulary as a result of a
coverage determination, redetermination, or appeal under chapter 18.” ii This same
protection should also be applied to MOOP limits for enrollees in exchanges and will allow
patients living with chronic conditions to access life-saving therapies with reasonable
patient cost-sharing expectations that count towards the MOOP.
The NHC strongly suggests that HHS release additional guidance clarifying cost-sharing for
prescription drugs covered through the exceptions process and including language to ensure that
any spending on prescription drugs accessed through the exceptions process would be included
in MOOP. We ask that HHS issue a rule or sub-regulatory guidance requiring plans to make
these changes, clarifying the policy to match the stated patient protections currently available in
Medicare Part D.
Lack of Patient Protections for Exceptions Coverage
June 24, 2014
Page 3 of 3
We appreciate the efforts the HHS has made to improve patient protections for those who are
served through the exchange market. However, we believe that it is important to increase
protections for vulnerable patient populations, particularly those living with chronic diseases and
conditions trying to access non-formulary drugs in a timely and affordable manner. As the voice
for people with chronic conditions, the NHC believes that broad patient protections are critical to
the success of qualified health plans and exchanges. As HHS works to clarify and issue further
guidance on exchanges and insurance market standards moving forward, the NHC strongly
encourages the agency to include the above-referenced levels of patient protections supported in
our previous communications with the agency.
We would like to thank you for this opportunity to share our comments. The NHC supports your
efforts to ensure that exchange plans meet the intended objectives of improving and
standardizing health care coverage. Please do not hesitate to contact Eric Gascho, our Assistant
Vice President of Government Affairs, if you or your staff would like to discuss these issues in
greater detail. He is reachable by phone at 202-973-0545 or via e-mail at
[email protected]. You may also reach me on my direct, private line at 202-973-0546 or
via e-mail at [email protected].
Sincerely,
Myrl Weinberg, FASAE, CAE
Chief Executive Officer
i
ii
Medicare Prescription Drug Benefit Manual, Section 30.2.2.4, Chapter 18
Medicare Prescription Drug Benefit Manual, Section 30.1, Chapter 5

Download Report