Legislative

1
Legislative Regulatory Update

• 38th Annual Southeastern
• Pharmacy Officers Conference
• Biloxi, Mississippi
• August 2, 2008

2
Medicaid Tamper-Resistant Rx Requirements

• Iraqi Supplemental Bill (P.L. 110-28)
• Beginning with prescriptions executed October 1,
  2007 all handwritten, outpatient Medicaid
  prescriptions must be written on a
  tamper-resistant prescription pad
• Expected to save 150 million over 5 years by
  reducing fraud

3
Medicaid Tamper-Resistant Rx Requirements

• August 17, 2007 CMS provided its initial
  guidance, defining tamper-resistant as
  industry-recognized features designed to prevent
• Unauthorized copying
• Erasure or modification
• Counterfeit prescription forms
• CMS exempted
• Electronic, faxed and phoned-in prescriptions
• Prescriptions for which managed care is the payer
• Medications reimbursed in specified institutional
  settings
• Refills for prescriptions written before
  implementation date
• More information available at www.pharmacist.com/t
  amperissuebrief

4
Medicaid Tamper-Resistant Rx Requirements

• APhA attempts to delay implementation Congress
  reluctant
• Pharmacy should have caught it
• It is the Administrations screw uplet CMS fix
  it
• Patient and Pharmacy Protection Act of 2007 (H.R.
  3090)
• Limit to Schedule II Controlled Substances
• Patient and Pharmacy Protection Act of 2007 (S.
  2013)
• Limit to CIIs beginning 0ctober 1, 2007
• Apply to all medications March 31, 2009
• September 29, 2007 President signed 6-month delay
  
• (P.L. 110-90)
• New Implementation Timeline
• April 1, 2008 1 of 3 features required (Phase 1)
• October 1, 2008 3 of 3 features required (Phase
  2)

5
Medicaid Tamper-Resistant Rx Requirements

• APhA efforts to facilitate Phase 1 of
  implementation
• Sent coalition letter urging State Medicaid
  Directors to clarify state-specific requirements
  to key stakeholders
• Worked with NCPDP to develop pharmacy-friendly
  recommendations of tamper-resistant features for
  State Medicaid Directors
• Resulted in CMS clarification that prescribers
  cant alter prescription pads/paper to make
  tamper-resistant (e.g. embossing,
  spelling out number of pills)
• Participated in NCPDP task force to develop
  educational materials for prescribers,
  pharmacists and patients
• Secured NASMD as the clearing house for state
  information and educational materials

6
Medicaid Tamper-Resistant Rx Requirements

• APhA efforts to facilitate Phase 2 of
  implementation
• Participated in conference calls with CMS to
  share feedback from Phase 1
• Participated in NCPDP focus group meeting
  regarding lessons learned from Phase 1
• Resulted in CMS clarification that prescriptions
  printed from a computer (EMR/eRx application) do
  not need to be printed on special paper, security
  requirements can be incorporated through printing
  of the prescription
• Cosigned NCPDP focus group letter urging State
  Medicaid Directors to facilitate Phase 2
  implementation
• Worked within the NCPDP focus group to update and
  develop additional educational materials for
  prescribers, pharmacists and patients

7
Compounding

• Traditional pharmacy compounding
• FDA historically has deferred to the States
  regarding the regulation of traditional
  compounding
• FDAs concerns
• Activities that are more representative of a
  drug manufacturer (manufacturing disguised as
  compounding)
• Copies or near copies of FDA-approved,
  commercially available drugs
• Adulterated and misbranded products
  unsubstantiated claims (safety/efficacy/superiorit
  y not demonstrated)
• Active ingredients not components of FDA-approved
  drug products
• May lack procedures to prevent contamination or
  to ensure proper drug strength, quality,
  purity/sterility (particular concern with
  inhalation drugs)

8
Compounding Recent Activity

• FDA issued warning letters January 2008
• Bio-identical hormone replacement therapy (BHRT)
• Misbranded unsubstantiated claims efficacy
  superiority
• bio-identical
• Unapproved new drug estriol not a component of
  an FDA-approved drug under CPG
• FDA released guidance on the required IND for
  estriol July 2008
• Court case 5th Circuit Court of Appeals issued
  its decision on July 18, 2008, that
• Compounded products are new drugs under FDCA
• The Food and Drug Administration Modernization
  Act of 1997 (FDAMA) creates limited exemptions
  from new drug requirements for compounded
  products that comply with conditions within FDAMA

9
Compounding Recent Activity

• Unclear what the future FDA enforcement
  activities will be related to compounding with
  estriol
• 5th Circuit estriol allowed (Louisiana,
  Mississippi, Texas)
• 9th Circuit estriol not allowed (Alaska,
  Arizona, California, Guam, Hawaii, Idaho,
  Montana, Nevada, Oregon, Washington)
• APhA and other pharmacy stakeholders continue to
  work with FDA
• To secure clarification regarding enforcement
• Dont support IND process because it moves the
  regulation of compounding from the states to the
  FDA

10
Health Care Reform - The Big Picture

• Increasing health care costs
• Less than optimal health outcomes
• Need for improved patient safety quality
• Despite insurance coverage, patients are not
  getting healthier
• To secure the value of our health care system,
  need to
• Move away from just discussing coverage
• Begin discussing making the provided services work

11
The Problems

• Lack of adherence to medication regimen
• Society unaware that all medications have risk,
  particularly when combined
• Society sees pharmacy as a commodity
• Lack of patient understanding of their health
  condition or their medications
• Personal importation
• Challenges to securing the drug supply
• Increasing reliance on pharmacist to troubleshoot
  at point of service
• Lack of patient empowerment

12
Suggested Solutions

• Make quality and safety a priority
• Empower patients to care for themselves
• Utilize the clinical knowledge, pharmaceutical
  expertise, and accessibility of pharmacists
• Allow a collaborative practice design that is
  based on providing proper incentives to payers,
  patients, and providers
• Provide patients access to pharmacist services
  through payment under Medicare Part B

13
Suggested Solutions (cont.)

• Improve Medicare Part D MTM
• Create incentives for small businesses to pay for
  pharmacist services
• Support a behind-the-counter (BTC) category of
  drugs
• Improve compliance and drug tracking programs
• Standardizations
• Measure administrative and financial burdens on
  pharmacists ability to provide clinical services
• Monitor administrative compliance of the other
  stakeholders (payers, prescribers)
• Decrease formulary management burden

14
Potential OutcomesA Net Positive

• Reduced
• Overall health care costs
• Employer/payer costs
• Emergency Department visits and hospitalizations
• Increased
• Medication adherence
• Physician visits
• Pharmacy related costs
• Drug products
• Pharmacist services

15
Health Care Reform Possibilities

• Pharmacists providing direct patient care have
  and can make a difference
• Increased access to pharmacist provided patient
  care services
• Better patient understanding of their disease,
  empowered to provide their own care, better
  health outcomes, financial incentives (lower
  co-payments)
• Improved patient safety
• Lower costs, fewer workers compensation claims,
  fewer sick days

16
Medicare Payment for Pharmacist Services

• Leadership for Medication Management (LMM)
• Medicare Part D require Part D plans to include
  in their MTM programs a once-yearly medication
  therapy review and assessment by a pharmacist
• Medicare Part B Authorize payment for pharmacist
  services
• For Medicare beneficiaries not enrolled in
  Medicare Part D
• For Medicare Part D beneficiaries who are not
  expected to meet the eligibility criteria for MTM
  services required under their Part D plan
• Requires referral from a prescriber
• Comparative Cost-Effectiveness Study
• Part D MTM vs Part B MTM for those not in Part D

17
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18

• Marcie Bough, Director, Federal Regulatory
  Affairs
• 202.429.7538 MBough_at_APhAnet.org
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• 202.429.7572 WGaitwood_at_APhAnet.org
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  Affairs
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• 202.429.7521 AWiley_at_APhAnet.org