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Policy & Medicine 08/20/2019 04:24
In early August 2019, the Canadian government announced regulations to reduce patented drug prices, with the intent to save Canadians over $10 billion (USD) over the course of a decade. The new regulations are the final amendments to the Patented Medicines Regulations and come after months of delay, which had prompted speculation that the government […]
Policy & Medicine 08/19/2019 05:05
This summer has been the summer of reimportation with the Trump administration proposing pathways for national reimportation. The states have been active as well with Florida adding to Vermont and Colorado with state reimportation laws. In an effort to lower the price of prescription drugs for residents of Florida, Governor Ron DeSantis recently signed into […]
Policy & Medicine 08/15/2019 05:01
The Trump administration is continuing the push for hospitals to disclose to patients how much they charge for all supplies, tests and procedures. In the proposed 2020 Medicare hospital outpatient prospective payment system (OPPS) rule, Medicare stated its intent to make it easier for patients to shop around for the best price by forcing hospitals […]
Policy & Medicine 08/14/2019 05:07
On July 1, 2019, Connecticut Governor Ned Lamont signed into law a bill relating to continuing medical education (“CME”) requirements for Alzheimer’s disease. The Act, which is entitled “An Act Concerning Alzheimer’s Disease and Dementia Training and Best Practices,” will be effective on January 1, 2020. The current CME provisions for Connecticut-licensed physicians include a […]
Policy & Medicine 08/12/2019 05:03
The Centers for Medicare and Medicaid Services (CMS) requires each State Medicaid Program to submit to CMS an annual report on the operation of its Medicaid Drug Utilization Review (DUR) fee-for-service (FFS) program, including information on prescribing patterns, cost savings generated by the state’s DUR program, and the state’s DUR program’s overall operations, including any [...]
Policy & Medicine 08/09/2019 04:52
Health Canada recently published a draft guidance document, “The Distinction Between Promotion and Non-Promotional Messages and Activities for Health Products.” The draft guidance represents the first substantive update to Health Canada’s policy on health product communications since it was originally published in 1996 and relates to promotion of all health products including prescription drugs (including […]
Policy & Medicine 08/08/2019 05:05
The US Food and Drug Administration (“FDA”) recently published its quarterly Real Time Report on new drug application (“NDA”) and biologics license application (“BLA”) filings for FY 2019. The report shows that numerous NDAs and BLAs were filed in the first quarter (“Q1”) of FY 2019, with 53 and 4 filings, respectively. These numbers were […]
Policy & Medicine 08/07/2019 05:01
The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published its Spring 2019 Semiannual Report to Congress. The Report covers the period of October 1, 2018 through March 31, 2019, and identifies “significant problems, abuses, deficiencies, remedies, and investigative outcomes relating to the administration of HHS programs and operations” for that […]
Policy & Medicine 08/06/2019 05:04
Last month, a federal judge in Boston overturned the convictions of two former employees of New England Compounding Center ("NECC") who had been accused of conspiring to help NECC interfere with and obstruct "the lawful government functions" of the US Food and Drug Administration ("FDA") in conjunction with the 2012 fungal meningitis outbreak associated with [...]
Policy & Medicine 08/02/2019 05:05
The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently issued an enforcement letter to Aclaris Therapeutics, Inc., regarding direct-to-consumer (“DTC”) advertising for its Eskata product. Eskata is a hydrogen peroxide topical solution used to treat seborrheic keratoses (“SK”). The FDA asserted that the DTC advertising makes false or misleading claims […]
Policy & Medicine 07/29/2019 05:04
The US Department of Justice ("DOJ") recently charged Wheeling Hospital, Inc., located in Wheeling, West Virginia, with violations of the Stark Law, and the Anti-Kickback statute for alleged "improper financial arrangements and remunerations" in conjunction with Wheeling Hospital’s recruitment of physicians with high patient volumes in an effort to increase patient referrals to other Wheeling [...]

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