Showing posts with label Medicaid. Show all posts
Showing posts with label Medicaid. Show all posts

Friday, March 1, 2013

Florida’s Medicaid Program Receives Settlement Payment from Pharmaceutical Company: Healthpoint Ltd for ointment Xenaderm


By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Florida Attorney General’s (AG) Medicaid Fraud Control Unit (MFCU), 46 other states and the federal government reached a $48 million agreement with pharmaceutical company Healthpoint Ltd., on February 25, 2013. According to the Florida AG, the settlement is in response to allegations of misrepresenting the regulatory status of an ointment used to treat skin conditions and submitting false Medicaid claims. Florida’s Medicaid program will receive almost $900,000 of the settlement.
Pharmaceutical Company Allegedly Submitted False Claims to Medicaid.
According to the Department of Justice (DOJ), Healthpoint launched the ointment for the treatment of nursing home patients with bed sores. The settlement resolves allegations that Healthpoint marketed the ointment, Xenaderm, without the approval of the Food and Drug Administration (FDA) by modeling it on a pre-1962 drug that the FDA never reviewed. The DOJ states that the main ingredient in Xenaderm was determined by the FDA to be less-than-effective for its intended use. The government contends those determinations render the ointment ineligible for Medicaid reimbursements. Healthpoint is accused of knowingly submitting false claims to Medicaid programs.
The settlement is th result of litigation by the United States Attorney’s Office for the District of Massachusetts, the DOJ and fifteen (15) states, including Florida.
Responding to a Medicaid Audit.
Continue reading here

Sunday, September 2, 2012

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

Monday, July 30, 2012

Alabama Rules Regarding Medicaid Reimbursement

Alabama Rules Regarding Medicaid Reimbursement provide:


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.
This guideance can be found here.
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Tuesday, July 17, 2012

48 Charged in Massive Medicaid Fraud Case

A nationwide prescription drug ring bought mountains of HIV medications and other drugs from down-and-out Medicaid recipients in New York City, then marketed the pills to pharmacies that dispensed them to unsuspecting consumers, authorities said Tuesday. To read rest of article, click here.

Friday, June 22, 2012

Medicaid claims for Compound Drugs


The Office of  Inspector General of the United States Department of Health and Human Services issued the following statement regarding Medicaid claims for compound drugs:

Compound Drug Claims
We will review a State agency’s Medicaid claims for compound drugs to determine whether the drugs’ components complied with Federal requirements for reimbursement and collection of rebates. We will identify claimed drug components that are not eligible for Medicaid coverage and determine whether accountability and controls were established for collecting eligible drug component rebates. Compound drugs are custom blended by pharmacists from bulk ingredients based on doctors’ prescriptions. For payments to be available under Medicaid or Part B of Medicare, Federal law requires manufacturers to enter into and have in effect rebate agreements with the Secretary of Health & Human Services (HHS) (except that the Secretary may authorize a State to enter directly into agreements with a manufacturer) and meet certain other requirements. (Social Security Act, § 1927.) States may then claim Federal financial participation (FFP) and report drug utilization to the manufacturers for rebates. CMS requires States to use a drug tape that lists all drugs covered by rebate agreements to determine whether the drugs they purchase are eligible for Medicaid coverage. (CMS’s Medicaid Drug Rebate Program State Release No. 130.) CMS outlined States’ responsibility for preventing claims for terminated drugs in its Medicaid Drug Rebate Program State Release No. 19. (OAS; W-00-12-31317; various reviews; expected issue FY 2012; work in progress.

Report is found here.