Gives doctors,
patients price information at time of prescribing
WASHINGTON -- The
Centers for Medicare & Medicaid Services has finalized a rule aimed
at making prices more transparent with Medicare Part D drug plans and allowing
plan sponsors to use cost-cutting tools such as step therapy under certain
circumstances.
"CMS is
delivering on price transparency, because patients have a right to know the
cost of their healthcare services before they receive them," CMS
Administrator Seema Verma said in a statement Thursday
afternoon. "Today's rule requires Part D plans to adopt tools that provide
clinicians with information that they can discuss with patients on
out-of-pocket costs for prescription drugs at the time a prescription is
written. By empowering patients with information on the cost of their
prescription drugs, today's rule will ensure that pharmaceutical companies have
to compete on the basis of price. This effort builds on new requirements for
hospitals to disclose chargemaster prices and other agency initiatives to
promote price transparency."
The rule doesn't
require physicians to use the tool every time they prescribe a drug to a
Medicare patient, but does give them the option to do it when appropriate,
Verma said when the rule was proposed.
For the six
"protected" classes of drugs that each Part D plan is required to
cover -- antidepressants; antipsychotics; anticonvulsants; immunosuppressants
for treatment of transplant rejection; antiretrovirals; and antineoplastics --
the rule also continues the current policy on step therapy, in which a health
plan can require patients to try and fail a less expensive drug or therapy for
a particular condition before being covered for a more expensive treatment.
"Under current
policy, Part D sponsors are only permitted to impose prior authorization and
step therapy requirements for beneficiaries initiating therapy (i.e., new
starts) for 5 of the 6 protected classes, with no prior authorization or step
therapy allowed for antiretrovirals," the agency said in a fact sheet on
the final rule. "The final regulatory provision codifies this existing
policy, which has been in effect since 2006."
The rule also permits
step therapy for Medicare Advantage (MA) plans who also cover drugs under
Medicare's Part B program, which applies to drugs administered in the
physician's office. "We believe that use of step therapy as a utilization
management tool will better enable MA organizations to ensure that Medicare
beneficiaries pay less overall or per unit for Part B drugs," CMS said in
the fact sheet. However, the agency noted that there would be some safeguards
for step therapy: "[It] may only apply to new starts of medication, must
be reviewed and approved by the plan's pharmacy and therapeutics committee, and
when patients request coverage of or appeal a denial of a Part B drug, a plan's
decision-making timeframe will be shorter and mirror current Part D
rules."
CMS decided, however,
against allowing Part D plans to exclude protected-class drugs when their prices
rise faster than overall inflation. "We received many comments regarding
this proposal, including commenters that supported this proposed exception, and
agreed with CMS that this flexibility would allow plans more negotiation power
with manufacturers on protected class Part D drugs," CMS noted in the
final rule. "However, we also received many comments urging us not to
finalize this proposed exception highlighting concerns with beneficiary access,
and inability to adequately address rising launch prices, among other concerns.
Based on the comments and responses summarized below, we are not finalizing
this proposed exception."
The final rule also
implements a statutory requirement, recently signed by President Trump, that
prohibits pharmacy gag clauses in Part D. "This provision supports the
President's initiative to help lower out-of-pocket costs of prescription drugs
for Medicare beneficiaries by helping inform them about lower cost
alternatives," the fact sheet noted.
Healthcare
organizations were generally pleased with the final rule. "We appreciate
the administration taking steps to allow for greater use of PBM [pharmacy
benefit manager] tools in Medicare's so-called 'protected classes,'" J.C.
Scott, president and CEO of the Pharmacy Care Management Association, a trade
group for PBMs, said in a statement. "PBMs agree that price transparency
is needed for enhanced communication regarding drug costs among payers,
prescribers, and beneficiaries. Providing real-time prescription benefit
information empowers patients and their physicians to make better health care
decisions."
"The National
Kidney Foundation thanks ... CMS for its decision to not finalize changes to
its protected class policy that would have made it more challenging for some
transplant recipients to access immunosuppressive drugs that they need to
prevent organ rejection when they are covered under Medicare Part D," the
foundation said in a statement. "As initially proposed by CMS, the
policies would have created broad exceptions to requirements that all
immunosuppressive drugs be covered by Part D formularies. Since 2008, this
requirement has ensured the safety of transplant recipients, nearly every one
of whom depends on a tailored combination of immunosuppressive medications that
must be taken every day to prevent organ rejection. By maintaining its
protected class coverage policy for immunosuppressives prescribed under Part D,
CMS is putting patient safety at the forefront."
One group was slightly
more muted in its praise. "Current cancer patients will be relieved to
hear their access to innovative new drug therapies will not be in question
under this finalized rule," said Lisa Lacasse, president of the American
Cancer Society's Cancer Action Network, in a statement, noting that oncology
drugs "are rarely interchangeable."
"Concern remains,
however, over how this [rule] may affect patients starting new therapies,"
she continued. "We will closely monitor implementation of this rule
working to make sure all cancer patients have timely access to the therapies
best suited to treat their disease."
https://www.medpagetoday.com/publichealthpolicy/medicare/79903
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