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Sept. Leg. Update: PBM Audit Reform, Drug Disposal Act, MTM Act, AMP Update

This month’s legislative update will be devoted to Federal issues.  For your convenience, links are included for more detail.

 Congress is Coming to Your Town

Your elected members of Congress will be in their home districts in September campaigning for the November election.  Call their district offices to set up appointments now to invite them into your practices!  Take action while they are home to make sure they understand the importance of pharmacy in your community. Go to: for help finding your member of Congress and information on their district offices.

 In September you can:
1. meet with your members of Congress;
2. attend local town halls and other events with your elected officials in your community;
3. send a message to your member of the U.S. House of Representatives today on the following critical pending legislation.

H.R. 5234:  PBM Audit Reform and Transparency Act of 2010

This bill was recently introduced by Reps. Weiner (D-NY) and Moran (R-KS). This legislation expands the new PBM transparency requirements included in the health care reform bill to all plans, both public and private plans. It is also the first federal legislation to try and reform PBM’s abusive auditing practices.

H.R. 5235:  Medicare Access to Diabetes Supplies Act

This legislation, recently introduced by Reps. Welch (D-VT) and Rogers (R-MI), would exclude diabetic supplies provided by small pharmacies from DME competitive bidding. The bill defines small pharmacies using the SBA definition of $7 million or less in annual sales. Excluding these supplies from competitive bidding is important for small pharmacies because they will unlikely be able to effectively participate in the competitive bidding program. That will reduce beneficiaries’ access to diabetes testing supplies.


H.R. 5809:  Safe Drug Disposal Act of 2010

Introduced by Chairman Stupak (D-MI) and Rep. Jay Inslee (D-WA), this bill would provide for take-back disposal of controlled substances. The legislation was marked up in the House Energy and Commerce Health Subcommittee now moves to the full committee for consideration.


S. 3397:  Secure and Responsible Drug Disposal Act 

In August the Senate passed the S. 3397 introduced by Sen. Klobuchar (D-MN), a bill that would amend the Controlled Substances Act to provide for take-back disposal of controlled substances in certain instances. Specifically, the bill would allow the ultimate user (the patient) of a controlled substance to deliver unused or expired drugs to a non-DEA registered person for disposal if the person is authorized to engage in such activities and the disposal takes place according to regulations to prevent drug diversion. The bill would also authorize long-term care facilities to dispose of controlled substances on behalf of a patient who resides in the facility. Lastly, the bill would increase the penalty for persons convicted of a drug offense involving receipt of a controlled substance for disposal.


S. 3543:  Medication Therapy
Management (MTM) Expanded Benefits Act of 2010

This bill, introduced by Sens. Hagen (D-NC) and Franken (D-MN), would expand Medicare beneficiary access to MTM services.  The legislation would do the following.

•Expand the list of conditions used to determine eligibility for MTM services. •Allow pharmacists or other qualified providers to help determine who may benefit from MTM services.
•Require any MTM program to offer both comprehensive and targeted medication reviews at the time of initial enrollment and at a transition of care.
•Require PDP sponsors to offer any willing pharmacy in its network, and any other health care provider, the opportunity to provide MTM services.
•Require PDP sponsors to reimburse pharmacies or other qualified health care providers furnishing MTM services based on the resources used and the time required to provide such services.
•Provide pharmacies and other entities that furnish MTM services with additional incentive payments based on their performance in meeting quality measures established under this Act. 

AMP Update

Under the health care reform law, manufacturers are supposed to start calculating revised AMPs (reflecting only prices paid by retail pharmacies) starting October 2010, even if a final regulation is not published. Indications are CMS will start using AMP data to publish FULs for generics, possibly as early as the end of December or early next year. States will likely have up to 30 days to implement the new FULs for generics. AMP data may be made public at the same time.  OPA will continue to update you as information becomes available.

If you have any questions or comments about the issues mentioned in this article, please contact Kelly Vyzral, Director of Government Affairs, at 614.586.1497 or

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