HIT Consultant

MAY 31, 2023

The pharmaceutical industry has experienced a wave of accelerated consolidation since 2010. Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. million Americans.

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals Telemedicine FDA 96

Innovaare Compliance

JANUARY 15, 2024

2] The current Coverage Gap Discount Program (CGDP), pursuant to the Affordable Care Act 2010 , [3] will be sunset on December 31, 2024. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D.

Medicare 52

Medicare Medicare Compliance FDA 52

Sharps Compliance

MAY 11, 2022

Between 2010 and 2018, there were 48,000 accidental prescription opioid exposures among young children.3. Continue reading FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics at Sharps Compliance Blog.

FDA 82

FDA Compliance 82

Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

C&M Health Law

JANUARY 25, 2023

Section 1001 of the Act delays the 4% Statutory Pay-As-You-Go Act of 2010 (PAYGO) sequester for two years, through the end of calendar year 2024. In addition, Section 1331 of the Act authorizes grants to states to enforce and ensure compliance with mental health and substance use disorder parity requirements.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. See Prasol v.

FDA 52

FDA Fraud Compliance Hospitals 52

Drug & Device Law

MARCH 13, 2023

Unlike almost every state in the country, since 1987, Pennsylvania law has prohibited defendants from introducing evidence of their compliance with government and/or industry standards in strict liability design defect cases – generally. 393, 400 (2010). Coloplast Corp. , 3d 448 (W.D. E.g. , Lewis v. Coffing Hoist Division , 528 A.2d

FDA 59

FDA Compliance Governance Doctors 59