IACP Meets with the Government Accountability Office to discuss Animal Drug Compounding
At the request of the Government Accountability Office (GAO), IACP met with staff from the GAO, today, to discuss animal drug compounding. It is expected that the Agency will release a report based upon the Agency’s meetings and discussions with all opponents and proponents of compounding for animal use.
The lengthy meeting centered around questions from GAO including the U.S. Food & Drug Administration's (FDA’s) authority to oversee animal drug compounding; accreditation of veterinary pharmacies; safety and effectiveness of drug compounding for animal use; state regulatory practices regarding compounding for animal use; adverse events reporting and data available on such events; and drug approval process at FDA for animal drug compounding.
As IACP previously reported, FDA stated within its annual Appropriations justification to Congress, that funds are needed by the Agency to develop guidance addressing animal compounding. With increased efforts by FDA to address animal compounding, IACP has worked with the American Veterinary Medical Association (AVMA) to establish Veterinary Task Forces that will work to address any regulatory and/or legislative efforts to restrict animal compounding. IACP has met with AVMA and the AVMA Veterinary Task Force several times in the past months and looks forward to working with GAO, Congress, AVMA, and all stakeholders to provide insight into the benefit that animal compounding provides.
House Ways and Means Committee Solicits Comments from the Public on Released Draft Bill Addressing Medicare Fraud
House Ways and Means Subcommittee on Health Chairman Kevin Brady (R-TX) released a discussion draft addressing Medicare Fraud, Waste, and Abuse, the Protecting Integrity in Medicare Act of 2014 (PIMA). The draft legislation follows an April 2014 Ways and Means Health Subcommittee hearing with the Medicare Payment Advisory Commission (MedPAC) where MedPAC estimated that $44 billion of the $574 billion paid to providers under Medicare in 2012 was improperly paid claims or fraudulent activity.
Comments on the discussion draft can be submitted by September 1, 2014 to firstname.lastname@example.org.
Sections impacting pharmacists include:
• Beginning in 2015, Medicare Administrative Contractor (MAC) claims processing edits must be established that prevent payments for incarcerated, unlawfully present, and deceased individuals. Recovery Audit Contractors (RACs) will review claims and recoup any payments that are made despite these edits.
• Expands individuals that may document the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) face-to-face requirement to include in addition to physicians, nurse practitioners and physician assistants as allowed by State law.
• Centers for Medicare and Medicaid Services (CMS) will require each MAC to establish an improper payment outreach and education program to provide information to providers of services and suppliers in the contractor’s region. This information will include the provider’s or supplier’s most frequent and expensive payment errors, a notice of new topics that have been approved for audits by the RACs, and specific instructions to correct and avoid errors and audit issues in the future.
• Requires CMS to use the National Prescriber Identifiers (NPIs) as the only allowed prescriber identifier for the Medicare prescription drug program.
• Requires each claim under Medicaid and the Children’s Health Insurance Program (CHIP) to include a valid identification number of an individual who is verified and eligible to receive benefits.
• Establishes a penalty for an individual or entity that voluntarily discloses a technical violation of the Stark self-referral laws submitted through existing Self-Referral Disclosure Protocol. The penalty will be capped at $5,000 if submitted within the year of the noncompliance and $10,000 thereafter.
• Allows Health and Human Services (HHS) to bid MAC contracts every 10 years instead of the 5 years currently allowed.
• Creates a high-risk beneficiary drug management program under the supervision of a Part D plan sponsor. Beneficiaries determined to be high-risk can be locked in, as they are able to be currently in the Medicaid program, into one physician and one pharmacy for certain opioids and other high-risk drugs.
• Requires providers convicted of defrauding Medicare to lose their eligibility for Medicare benefits and grants the ability to earn back the entitlement by working 40 honest quarters.
• Requires HHS to include Vacuum Erection Systems (VES) in the Durable Medical Equipment (DME) Competitive Bidding Program by 2016.
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