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November Legislative Update: Medicare Part B, Federal Health Reform, State Updates

Federal Legislative Update

HR 3663:  Medicare Part B DME

Good news for pharmacy!! On October 13, President Obama signed HR 3663, sponsored by Rep. Zack Space (D-Ohio), which delays Medicare Part B DME accreditation and enforcement requirements until January 1, 2010. This gives Congress a three-month window to add pharmacists to all the other health care providers exempt from the time-consuming, costly, and redundant requirement.  Please take a few minutes to call Rep. Space (202.225.6265) and thank him for his efforts on behalf of pharmacy. 

MTM Survives in All Health Care Reform Bills 

The Senate Finance Committee became the fifth and final Congressional panel to approve health care reform (HCR) legislation. Pharmacy advocates are celebrating the fact that medication therapy management (MTM) is included, in some form, in both Senate bills and three bills that are being merged in the House. The strongest MTM provisions are contained in identical language in the Senate Health, Education, Labor and Pension bill, and the bill that came out of the House Energy and Commerce Committee.

If those MTM provisions remain in the language that comes up for floor votes, pharmacy will be in prime position to maintain them during the all-important conference committee discussions.  The timeframe for final action is now towards the end of the year.

CMS Provides Clarifications on Medicare Part D Fraud, Waste and Abuse Training

On October 6, 2009, The Centers for Medicare and Medicaid Services (CMS) clarified the requirement for pharmacies participating in Medicare Part D to complete training on fraud, waste and abuse. CMS rules require each plan sponsor to adopt a comprehensive program to prevent, detect, and correct fraud, waste and abuse, and ensure that its first tier, downstream, and related entity has completed compliance training. Pharmacies are considered downstream entities.

October 6, 2009, CMS Clarifications:

1.  The October 2008 and August 2009 memorandums were not intended to supersede policy stated in the 2006 Medicare Manual, which permitted pharmacies to implement their own training or take the training offered by Part D plans.

2.  Plans bear the responsibility of ensuring that pharmacies have completed training. The August 2009 memorandum was intended to provide flexibility for plans to work with pharmacies to ensure training. CMS stated that the upcoming FAQs will address the concern that plans may demand pharmacies to use a particular training module, potentially requiring pharmacies to undergo multiple trainings.

3.  Pharmacies may continue to meet the rule by certifying or attesting to plans that the pharmacies have completed their own training. Plans may seek such attestation from pharmacies as part of their network contracts.

Please note that training programs should address the following topics listed by CMS in the August 2009 memorandum.

1.  Laws and regulations related to MA and Part D fraud, waste and abuse (i.e., False Claims Act, Anti-Kickback statute, HIPAA, etc.)                    

2.  Obligations of the first tier, downstream, and related entities to have appropriate policies and procedures to address fraud, waste, and abuse

3.  Process for reporting to the MAO or PDP sponsor suspected fraud, waste and abuse in first tier, downstream, and related entities

4.  Protections for employees of first tier, downstream, and related entities who report suspected fraud, waste and abuse

5.  Types of fraud, waste and abuse that can occur in first tier, downstream, and related entities

6.  At this time, CMS is not requiring Part D plans to attest to CMS that pharmacies have completed training. However, plans may be required to provide evidence of compliance during a plan audit. Plans may use pharmacy attestations, among others, as such evidence.

7.  Given the delay in releasing its guidance and the looming December 31, 2009, deadline, CMS has agreed to consider pharmacy's request for CMS to exercise enforcement discretion until the 2010 plan year. However, we continue to strongly urge pharmacies to meet the December 31, 2009, deadline.

State Legislative Update

HB 267:  Ohio Official Prescription Program

Rep. Clayton Luckie (D-Dayton). This bill would require prescribers to use an official Ohio prescription form, purchased from the Board of Pharmacy for $250 a year.  This would cover computer maintenance and prescription pads.  The legislation would require pharmacies to enter a serialized prescription number every time a prescription is filled, and would require additional computer software to scan prescriptions and send the information to a database. OPA opposes the computerization, or any part of the bill that would require pharmacists to input a serialized number in order to fill the prescription.

SB 119:  Pharmacy Reporting of Suspected Dispensing Errors

 Sen. Tim Grendell.  This legislation would require pharmacists, pharmacy interns, and qualified pharmacy technicians to report suspected dispensing errors to the State Board of Pharmacy.  It would require the Board to investigate all such reports and pursue disciplinary action when warranted, and to specify criminal penalties for failure to comply with the reporting requirements.

This bill is of serious concern to OPA.  We feel the best way to deal with and prevent pharmacy errors would be through a non-punitive peer- review process, much the same as that of physicians.  We have met with Sen. Grendell and the Board of Pharmacy, to ensure that the legislation addresses preventing errors and not punishing errors.

SB 154:  Pharmacy Relationship 

Primary Sponsor: Sen. Tom Patton.  This bill would prohibit pharmacy benefit managers that have a relationship with a retail pharmacy from using that relationship to the competitive disadvantage of other retail pharmacies

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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