Coverage of Compounded Medications in Minnesota

Compound Drugs Revised: 01-23-2012 Compound Drugs A compound drug consists of two or more ingredients. The quantity at the line level should reflect the way the NDC is normally billed. Example: if the NDC is normally billed per milliliter, the quantity at the line should be the total number of milliliters dispensed for the entire prescription – not the number of containers of normal saline used. Pharmacies will be paid only for the ingredients which are normally covered by DHS. Commercially Available Products If room stable commercially available products are compounded, reimbursement is limited to the rate of the commercially available product (WAC plus 2% or the SMAC plus dispensing fee). Compounded Products, Preparations, and Oral Drugs Compounded liquid oral drugs (e.g., solutions, suspensions, emulsions) are covered only for children and for aphagic adult recipients, and only when a commercial liquid version of the drug is not available. Compounded capsules are covered only if a tablet or capsule commercial version of the drug is not available in the strength prescribed, and if the appropriate strength cannot be achieved using half or quarter tablets. Compounded Topical Products Compounded topical products are not covered when a product that contains the same combination of active ingredients in the same strengths is commercially available from a pharmaceutical manufacturer, regardless of the package size that is commercially available. Example: If the prescription is for 15 grams of an ointment and the commercially available version is available only in 30 gram tubes, MHCP will not cover 15 grams of the compounded product. Compounded Intravenous (IV) & Total Parenteral Nutritional (TPN) Drugs Compounded IV and TPN drugs are covered according to FDA guidelines regarding approved indications and preparation.

Alabama Medicaid Physician Administered Drugs: When will Compounded Drugs for Non-Pharmacy Providers be Covered

Compound Drugs for Non-Pharmacy Providers
The compound drug must not be commercially available, and the active
ingredient of the compound drug must follow coverage policy of drugs
(FDA approved, non-DESI, not obsolete, etc).
When a provider administers a drug that must be purchased from a
compounding pharmacy because it is no longer commercially available
(e.g. due to the manufacturer no longer marketing the product), the
applicable claim form may be submitted for consideration of payment.  The
billed amount should represent the lesser of the actual acquisition cost for
the drug or Medicaid rate on file (ASP CMS pricing) at the time of service.
When billing the HCPCS code for a purchased compounded drug, only
one NDC can be used per procedure code.  Providers must use the
HCPCS procedure code, billing units and corresponding covered NDC
number on the claim form; for example, J1094 Injection, dexamethasone
acetate, 1 mg.  The NDC billed should be the one that represents the drug
as described in the HCPCS code definition, in this case dexamethasone
acetate.  See the section entitled “Calculation of Billing Units and
Wastage” for information on calculating billing units.
The Agency does not reimburse non-pharmacy providers for prescription
compounding time or non-covered ingredients used in the compounding
process.  The Alabama Medicaid Agency only reimburses for the
compounding time by the billing of NDC numbers through the Pharmacy
Program.

Taken from January 2012 manual found here

Blue Cross Blue Shield of Texas: Information on Compounding

Introduction

Pharmacy Compounding is an ancient practice in which pharmacists combine, mix or alter ingredients to create unique medications that meet specific needs of individual patients. Compounding is a practice that continues to attract the scrutiny of the U.S Food and Drug Administration (FDA) – mainly because of instances where compounded drugs have endangered public health.

The FDA considers virtually all compounded drugs as unapproved new drugs for which safety and efficacy have not been demonstrated with the type of data the FDA requires to approve a new drug. However, the FDA also considers "traditional compounding" to be a valuable service and does not take enforcement action against these practices. The FDA defines traditional compounding as customizing a drug for someone who is allergic to a dye or preservative in an FDA approved medicine, or compounding a liquid dosage form specifically for a younger patient, etc. Compounding does not generally include mixing or reconstituting commercial products in accordance with the manufacturer’s instructions or the product’s approved labeling.

Red Flags and Enforcement Activities by the FDA

The emergence over the past 10-15 years of firms with pharmacy licenses making and distributing unapproved new drugs in a way that is clearly outside the bounds of traditional pharmacy practice is of great concern to the FDA. FDA enforcement has been directed to those pharmacies whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of the new drug, adulteration, or misbranding provisions of the federal Food, Drug, and Cosmetic Act (FDCA). In addition, unlike commercial drug manufacturers, pharmacies are not required to report adverse events associated with compounded drugs. In a May 2007 consumer newsletter, the FDA reported knowing of more than 200 adverse events involving 71 compounded products since 1990. Examples of some of these adverse events included: three deaths due to contaminated compounded intravenous solutions, and blinding of two patients as well as damaged eyesight to others from a bacterially contaminated compounded product used in cataract surgery. In a 2001 FDA survey of compounded drug products, the agency found 34% of the products tested failed standard quality tests (usually failing potency analyses) as opposed to a less than 2% failure rate for commercially produced drug samples. Examples of medications included in the testing sample included sterile injectables (e.g. dipyridamole, papaverine, phentolamine, etc.), pellet inplants (e.g. estradiol), ophthalmic solutions/ointments (e.g. ciprofloxacin, dexamethasone, timolol, etc.), inhalation (e.g. tobramycin), and oral products (e.g. progesterone, estradiol, etc.). As a consequence, the FDA has issued a number of warning letters to pharmacies that specialize in female hormone products (e.g. ‘Bioidentical hormone replacement therapies’), anti-infective inhalation products, sustained-release/delayed-release/extended-release products, and local anesthetic pain products. FDA Warning Letters have also been sent in cases where the FDA believes pharmacy communications (e.g. advertisements, website information, etc.) contain false and misleading claims about product safety, effectiveness, and superiority to FDA approved and commercially available products. When contemplating further action against compounding pharmacies the FDA considers whether the pharmacy engages in the following acts:

• Compounding drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions.
• Compounding drugs that were withdrawn or removed from the market for safety reasons.
• Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs (e.g. estriol) without an FDA sanctioned investigational new drug application (IND).
• Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA registered facility.
• Receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements.
• Using commercial scale manufacturing or testing equipment for compounded drug products.
• Compounding drugs for third parties who resell to individual patients or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale.
• Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products. In certain circumstances, it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available. In these circumstances, FDA will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient.
• Failing to operate in compliance with applicable state law regulating the practice of pharmacy.

The New Texas Health Care Privacy Law (HB 300) and HIPAA/HITECH Compliance: What You Need To Know Now

Registration

Schedule:
Wednesday, September 26, 2012

12PM CENTRAL
(1:00 ET / 10:00 PT / 11:00 MT )
Duration: 60 minutes



$45 for Members
$70 for Non-members

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Questions?

For immediate assistance please consult our FAQ page. 

If you're unable to find the answer you need, please call 800-701-5161 (M-F, 8am-6pm CT) or e-mail customer service

Summary

This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians. This program has been approved for 1.0 contact hours of continuing education credit (0.1 CEUs). 

Texas Pharmacy Association (154) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program has been assigned ACPE number 0154-0000-12-012-L03 and is accredited for 1.0 Contact Hours (0.1 CEUs). 

Description: This program will cover existing Texas privacy laws and information on the new legislation. 

At the completion of this program, pharmacists and technicians will be able to:

• Identify the key components and requirements of HIPAA and the new Texas health care privacy law for Texas pharmacists, pharmacy technicians, pharmacies and other Texas entities.
• Appraise the significance of pharmacy accountability and potential enforcement, audit, and civil penalty consequences for privacy breaches.
• Comply with federal and state privacy and security laws, regulations and rules for the protection of identifiable protected health information.

For more information on this seiminar click here.

Texas Pharmacy Association Pharmacy Law Symposium

Texas Pharmacy Association 
presents: 

Texas Pharmacy Law Symposium

This program is for pharmacists.

This program is aimed at giving pharmacy professionals a better understanding of Texas and Federal drug laws. Students & reciprocating pharmacists should take this program to prepare for the state law exam.

When:Saturday - February 16, 2013
Where: Texas Association of School Boards (TASB) Building, 12007 Research Blvd., Austin, TX 78759
CLICK HERE to view a list of area hotels. 

If you need to take the course prior to this date, click here to view TPA's online Texas Pharmacy Law Symposium.

Learning Objectives: 
Upon completion of this program, participant will be able to:

1. Identify the major provisions of the federal Food, Drug and Cosmetic Act that relate to the practice of pharmacy.
2. Compare and contrast the requirements of the federal Controlled Substances Act and the Texas Controlled Substances Act.  
3. Distinguish between dispensing and distribution of controlled substances and the record-keeping requirements for each.
4. Describe the legal requirements for dispensing prescriptions for controlled substances, dangerous drugs and non-prescription medicines. 
5.  Explain the Texas Drug Product Substitution Act.
6. Explain the requirements for pharmacist and pharmacy licenses in Texas. 

Agenda:

  8:00 a.m. – 12:00 p.m.:    Law Review program
12:00 p.m. –   1:00 p.m.:    Lunch break
  1:00 p.m. –   5:30 p.m.:    Law Review program / Q&A
 

For more information, click here.

Oklahoma Pharmacy Association 2012 Law Seminar

2012 OPhA Law Seminar

Please join us for our annual 2012 Law Seminar to be held on Sunday, December the 2nd from 8:00 am - 5:00pm at the OU College of Pharmacy in Oklahoma City. This program is intended for pharmacists, regardless of their practice setting who wish to increase and enhance their knowledge and skills as they relate to their knowledge of Oklahoma law. Our guest speakers include professionals from an array of law related backgrounds. I believe you'll find this eight hour program greatly informative. 

 

For more information cleck here.

Blue Cross position in Michigan regarding compounded drugs

August 2012

Compounded prescriptions covered only if all ingredients covered

Beginning Aug. 1, 2012, for Blue Cross Blue Shield of Michigan commercial (non-Medicare) customers and Sept 1, 2012, for Blue Care Network commercial (non-Medicare) customers, when a customer fills a prescription for a compounded drug, each ingredient in the compound must be covered under the member’s plan in order for the prescription to be payable. If a compound contains a product that is not covered under the member’s plan, even if it has been covered for a member in the past, the claim will now be rejected.

All other pharmacy benefit exclusions and limitations will also apply to compounds, including off-label exclusions, quantity limits for drugs used for erectile dysfunction and exclusions for both cosmetic use and bulk chemicals. Some exceptions exist for select over-the-counter products used as compound vehicles. Please discuss alternatives with your patients.

If you have questions about these changes, please call the Pharmacy Services Clinical Help Desk at
1-800-437-3803 and follow the prompts to reach the BCBSM or BCN prior authorization line.

Members who would like more information about any of their prescription drug benefits can be directed to call the customer service number on the back of their Blues ID cards.

NY judge tosses convictions in Fla. steroids case

The Associated Press

Published: Saturday, September 1, 2012 at 12:54 p.m.

Last Modified: Saturday, September 1, 2012 at 12:54 p.m.

ALBANY, N.Y. - A judge has delivered another blow to a New York prosecutor's attempt to prosecute Floridians for selling steroids, including people connected to an Orlando pharmacy that played a role in baseball's juicing scandals.

Albany Judge Stephen Herrick this week threw out the convictions of two men who had pleaded guilty in 2007 to funneling fraudulent prescriptions from their clinic in Davie, Fla., to Signature Compounding Pharmacy.

The judge ruled that prosecutors had waited too long to get Greg Trotta and Brian Schafler sentenced.

The Times Union reported ( http://bit.ly/S8Cxvn) that the men had been cooperating with the Albany District Attorney and had been expected to get probation, but their case kept getting delayed as prosecutors battled with the judge over their ability to press charges against Signature's owners.

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Information from: Times Union, http://www.timesunion.com

Horse racing: Doping detection stays a neck ahead

Whilst the eyes of the world may currently be focused on the Olympics, human sport is not the only area where drug testing is routinely carried out.

Horse racing is a massive world-wide industry, and regular testing is essential to maintain its integrity.

As with human sport, the authorities constantly need to develop methodologies to detect new compounds that drug cheats are using or may start to use.

Read more ...

Powerpoint Presentation Regarding Use of Non-Pharmaceutical-Grade

Authored and Presented by Patricia Brown, VMD, MS, DACLAM Director, OLAW, NIH
Carol Clarke, DVM, DACLAM Staff Officer, AC, APHIS, USDA, Christian Newcomer, VMD, DACLAM Executive Director, AAALAC International presented at the OLAW Online Seminar
March 1, 2012

To view the Powerpoint click here.