Numerous State Laws and Pending Bills Intended to Address Rising Drug…
While the federal government continues to debate various policies for lowering prescription drug prices, many states have already…
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November 2019
FDA Issues Four Final Guidances on 510(k) Medical Device Programs
The US Food and Drug Administration (“FDA”) recently issued four final guidance documents related to 510(k) medical device…
Step Therapy: Is it Really More Cost Effective?
Step therapy, the requirement that more cost effective/inexpensive drugs and therapies must be prescribed for a patient before a…
HHS Secretary Alex Azar Addresses Changes to Kidney Care Reimbursement
On Thursday, November 7, 2019, Health and Human Services (HHS) Secretary Alex Azar spoke at the American Society of Nephrology…
Physicians Disagree with Judge Who Struck Down Site-Neutral Payments
In September 2019, District of Columbia Federal Judge Rosemary Collyer issued a court ruling that struck down the Trump…
CMS Moves Forward with OPPS, Resulting in 340B Payment Changes
Despite a ruling from a federal judge earlier this year, the United States Centers for Medicare and Medicaid Services (CMS) has…
2020 Physician Fee Schedule Includes Changes to Open Payments and CME…
As we reported in July, the Centers for Medicare and Medicaid Services (CMS) was proposing changes to the CME industry and Open…
Allergan Subsidiary Forest Settles for $750 Million in Namenda Class Action…
On October 28, 2019, Allergan announced that its subsidiaries, several units of Forest Laboratories, have reached an agreement to…
US House HELP Committee Debates Pelosi’s Drug Pricing Bill
Recently, the House Health, Employment, Labor and Pensions (“HELP”) Subcommittee held a hearing to consider testimony and discuss…