Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Saturday, February 28, 2015
House Approves Bill to Limit Commercial Compounding Operations
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https://ww3.workcompcentral.com/.../0c0...
Friday, February 27, 2015
Highly Recommend that all compounding pharmacists and attorneys that represent them get a copy and read the recently unsealed indictment against Med Prep Consulting, Inc. A list of the specific charges are found below, but the indictment should also be obtained and read
press release here
| Med Prep Consulting, Inc. | ||
Pending Counts | ||
| ATTEMPT AND CONSPIRACY TO COMMIT MAIL FRAUD (1) | ||
| FRAUD BY WIRE, RADIO, OR TELEVISION (2-3) | ||
| FRAUD BY WIRE, RADIO, OR TELEVISION (5-11) | ||
| FRAUD BY WIRE, RADIO, OR TELEVISION (13-16) | ||
| CONSPIRACY TO DEFRAUD THE UNITED STATES (17) | ||
| INTRODUCTION INTO INTERSTATE COMMERCE OF DRUGS ADULTERATED BECAUSE CONTAMINATED BY FILTH (18-22) | ||
| INTRODUCTION INTO INTERSTATE COMMERCE OF DRUGS ADULTERATED BECAUSE OF INSANITARY CONDITIONS (23-27) | ||
| INTRODUCTION INTO INTERSTATE COMMERCE OF DRUGS MISBRANDED BECAUSE DANGEROUS TO HEALTH WHEN USED AS LABELED (28-32) | ||
| INTRODUCTION INTO INTERSTATE COMMERCE OF DRUGS MISBRANDED BECAUSE OF FALSE AND MISLEADING LABELING (33-37) |
Updated on Alabama Pain Clinic vs. CENTERS FOR MEDICARE AND MEDICAID SERVICES, et al., 5:14-cv-2476-AKK filed in the Northern District of Alabama
February 27, 2015
by Sue Tuck Richmond
As previously reported here and here (copy of complaint) the Alabama Pain Clinic sued the Center for Medicare and Medicaid Services (CMS) over billing changes for compounded drugs. The clinic claims the CMS cannot retroactively change reimbursement policies. Today, as expected, the CMS filed a motion to dismiss based on a lack of subject matter jurisdiction. The CMS argues that the complaint should be dismissed because, "under the Medicare statute, and pursuant to clear precedent from the Supreme Court and the Court of Appeals for the Eleventh Circuit, a court has jurisdiction over a Medicare dispute only after the plaintiff has presented its grievance to the Secretary, channeled its challenge through the Medicare administrative appeals process, exhausted its administrative remedies, and received a final decision of the Secretary[]" and in this case the plaintiffs have failed to do so. The district court entered an order today giving plaintiff's until March 10, 2015 to respond to the motion to dismiss. CMS will then have until March 13, 2015 to reply once the Clinic files its response.
Stay tuned to see how this case turns out.
by Sue Tuck Richmond
As previously reported here and here (copy of complaint) the Alabama Pain Clinic sued the Center for Medicare and Medicaid Services (CMS) over billing changes for compounded drugs. The clinic claims the CMS cannot retroactively change reimbursement policies. Today, as expected, the CMS filed a motion to dismiss based on a lack of subject matter jurisdiction. The CMS argues that the complaint should be dismissed because, "under the Medicare statute, and pursuant to clear precedent from the Supreme Court and the Court of Appeals for the Eleventh Circuit, a court has jurisdiction over a Medicare dispute only after the plaintiff has presented its grievance to the Secretary, channeled its challenge through the Medicare administrative appeals process, exhausted its administrative remedies, and received a final decision of the Secretary[]" and in this case the plaintiffs have failed to do so. The district court entered an order today giving plaintiff's until March 10, 2015 to respond to the motion to dismiss. CMS will then have until March 13, 2015 to reply once the Clinic files its response.
Stay tuned to see how this case turns out.
Canada Recall of API: Xenex Laboratories Inc. API - Meloxicam, Nystatin, Retinoic Acid, Omeprazole, Liothyronine Sodium, Levothyroxine Sodium, Azelaic Acid, Dichloroacetic acid sodium salt
- API - Azelaic Acid, Dichloroacetic acid sodium salt (2015-02-13) Recalled Products API - Azelaic Acid, Dichloroacetic acid sodium salt Lack of evidence product was fabricated specific to quality standard for drugs. Wholesalers and compounding pharmacies API - Azelaic Acid, Dichloroacetic acid...Posted:2015-02-13Type of communication:Recall
- API - Meloxicam, Nystatin, Retinoic Acid, Omeprazole, Liothyronine Sodium, Levothyroxine Sodium (2015-02-13) Recalled Products API - Meloxicam, Nystatin, Retinoic Acid, Omeprazole, Liothyronine Sodium, Levothyroxine Sodium Lack of evidence of temperature control for cold storage Wholesalers and compounding...Posted:2015-02-13Type of communication:
Recall
Canada Recall: Apothecare (APC) Bisacodyl (2015-02-18)
Apothecare (APC) Bisacodyl (2015-02-18)
Report a Concern
- Starting date:
- February 18, 2015
- Posting date:
- February 25, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43829
- more
Are you in compliance with the HIPAA Privacy and Security Rules? Audits most likely coming soon.
The Department of Health and Human Services Office for Civil Rights (“OCR”) will likely soon begin auditing individual covered entities for compliance with the HIPAA Privacy and Security Rules, according to OCR Director Jocelyn Samuels. The time frame for and the scope of these audits are presently unknown at this time. More details will be announced in the near future.
source ABA Health Law Section
source ABA Health Law Section
Great Read! FDA Proposal to Regulate Laboratory Developed Tests Raises ... The National Law Review
FDA Proposal to Regulate Laboratory Developed Tests Raises ...
Back in August, we wrote about the FDA's controversial plan to release draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) ...
Legislators Want to Exempt Much of FDA's Funding from Future from austerity measures
Legislators Want to Exempt Much of FDA's Funding from Future ...
Regulatory Focus-22 hours agoShare
New legislation introduced in Congress would exempt nearly half of the US Food and Drug Administration's (FDA) budget from austerity measures meant to help ...
Bill Seeks to Protect FDA User Fees Against Sequestration
Medical Device and Diagnostics Industry-Feb 26, 2015
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