safe harbor provisions of the Anti-Kickback Statute

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