2021.2.1: pol/healthcare/
safe harbor provisions of the Anti-Kickback Statute:
to the HHS Office of Inspector General (OIG):
https://www.regulations.gov/comment?D=HHSIG_FRDOC_0001-0440
Thank you for the opportunity to provide comments on
abuse of safe harbors to the anti-kickback statute (AKS).
. this letter is a revision of the aapsonline response.
https://aapsonline.org/alert-and-special-legislative-update-pharmacy-benefits-managers/
Physicians Against Drug Shortages estimates that
http://www.physiciansagainstdrugshortages.com/
safe harbor facilitated kickbacks increase
"annual supplies costs by at least 30%,
or upwards of $100 billion
... and the prices of drugs ...
by at least $100 billion annually as well."
I urge HHS to move forward with the Part D rebate rule
instead of delaying it further.
. that regulation would replace protections for
drug rebates in Medicare Part D
with protections for discounts
provided directly to consumers.
. the Biden administration agreed to delay this rule
in response to suit challenging it brought by
the Pharmaceutical Care Management Association.
https://www.fiercehealthcare.com/payer/a-win-for-pbms-biden-administration-delays-rebate-rule
It is past time that discounts on drugs
are passed along directly to patients
instead of being kicked back to middlemen.
In addition, the Office of Inspector General (OIG)
must not sidestep its responsibility to investigate and end
abuse of current AKS safe harbors,
for example 42 CFR § 1001.952(j) and related regulations.
This safe harbor for Group Purchasing Organizations (GPOs)
has unleashed an epidemic of kickbacks
in the medical supply chain
which has spread into pharmaceuticals
through similar exploitation by
Pharmacy Benefits Managers (PBMs).
HHS should further work to stop both
GPO and PBM misuse of safe harbors
by encouraging Congress to repeal 42 U.S.C. § 1320a-7b(b)(3)(C),
a key statute that shelters harmful schemes.
Shortages, unaffordability, and improper steering of patients
to the most profitable product, instead
of the one that best meets patients' needs,
are driven in part by this AKS safe harbor.
For example,
sole-source contracts, facilitated by kickbacks,
are an anti-competitive feature of
many GPO arrangements with hospitals and manufacturers,
which increase the risk of shortages and push prices higher.
For more details see
http://jpands.org/vol23no2/singleton.pdf
-- This year the comment window is open until
February 16 at 5pm Eastern.
my Comment Tracking Number: 1k5-9lk3-v0h4
