Home' The Source : Second Quarter 2017 Contents The 340B Drug Pricing Program requires drug
manufacturers participating in Medicaid to provide out-
patient drugs at significantly reduced prices to eligible
healthcare organizations or covered entities, such as safety-
net hospitals. This program was originally set up in 1992
to provide support to safety-net hospitals that take care of a large
number of the poor and indigent in their communities to stretch
scarce dollars to help take care of those patients. The 340B program
was expanded under the A ordable Care Act (ACA), adding eligibility
for critical access hospitals, sole community hospitals, rural referral
centers and freestanding cancer hospitals, explains Vincent Jackson,
PharmD, vice president of HealthTrust's pharmacy services group.
In early January, the U.S. Health Resources and Services
Administration (HRSA) published a final rule updating the price
structure for the 340B Drug Pricing Program. The rule, known
as "340B Mega Guidance," was set to become e ective in March.
However, on Jan. 30, President Trump instituted an executive order
banning new government regulations and 340B Mega Guidance
The rule would have provided clarifications regarding enrolled
cover entities, patient and physician eligibility, drug manufacturer
participation and participating contract pharmacies, Jackson says.
Since it has been withdrawn, further guidance could potentially be
issued through Apexus (HRSA-designated vendor for the program),
HRSA O ce of Pharmacy A airs or HRSA audit findings.
While the Mega Guidance rule was under review, some hospitals
raised concerns about the proposal, and the American Hospital
Association argued that redefining patient eligibility for the 340B
program would have inappropriately narrowed the number of drugs
that qualify for 340B pricing. "It's anybody's guess whether [the
Mega Guidance rule] will ever come out, and if it does, it could be
totally di erent from what we thought it might be," says Michael
Bonck, R.Ph., pharmacy manager at CHI Franciscan Health's
St. Joseph Medical Center in Tacoma, Washington.
For now, the rule is o the table, but with the new administration's
call to repeal and replace the ACA, the future shape of 340B could
still be in question. In the meantime, covered entities are focused
on maintaining compliance and communicating the value of the
program to decision-makers.
In recent years, the 340B program has been the subject of increased
scrutiny, with the O ce of Pharmacy A airs (OPA) undertaking over
500 audits of covered entities since 2013, Bonck says. More compli-
ance audits are planned.
Participating in the program o ers hospitals deep discounts on
drugs for qualifying patients, but it also requires multiple levels of
reporting and compliance. For instance, on a regular basis, covered
entities must undertake internal audits to ensure that their data clearly
separates medications used for eligible patients of GPO hospitals
from eligible 340B patients of non-GPO hospitals, Bonck says.
The program originally permitted covered entities to use one
contract pharmacy, but in 2010 that expanded to as many as needed
to best serve their patient population. "Some have over 100 contract
pharmacies, which can increase their risk if they're not auditing each
of those," Bonck says. "If 340B contract pharmacy buy-backs are
purchased incorrectly through the 340B entity's TPA administrator,
the contract pharmacy or the TPA administrator is not at risk; the
covered entity is at risk since it's ultimately responsible for any errors."
In addition, every new clinic operating under a 340B-eligible
entity must be registered with OPA, a process that can take up to 18
months. If a "child site" (e.g., outpatient center or clinic operating
under a parent hospital) is not properly registered and is using 340B,
the parent site will be in breach of regulations.
SOURCEBOOK UNDER THE MICROSCOPE
The 340B Drug
Pharmacy Leaders Face Reimbursement
and Compliance Challenges
Continued on page 22
20 The Source | Second Quarter 2017
Links Archive First Quarter 2017 Third Quarter 2017 Navigation Previous Page Next Page