The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year.

In order for a new drug to

An article in Bloomberg Law’s Health Law & Business, “Allergy Practice Discloses Patient Info to Reporter, Pays $125,000,” discussed a recent HIPAA settlement arising out of a physician’s disclosure of a patient’s protected health information (PHI) to a television reporter. Rivkin Radler’s Eric Fader was quoted in the article.

The settlement was announced on November 26

The final 2019 Medicare Physician Fee Schedule released on November 1, 2018 by the Centers for Medicare & Medicaid Services (CMS) includes a section entitled “Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services.” Effective January 1, 2019, physicians may be reimbursed for certain virtual interactions with patients using several new billing codes.

One new

The December 31 deadline for certain Medicaid providers and third-party billers to certify as to the effectiveness of their compliance program is fast approaching.

New York State Medicaid providers and third-party billing companies who claim, bill, order or receive at least $500,000 in any consecutive 12-month period from the Medicaid Program or Managed Medicaid payors

Two dental care companies are the first entities to be placed on the new High Risk – Heightened Scrutiny list created by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) for providers that pose a significant risk to federal healthcare programs and beneficiaries.  Each of the companies settled with the

On October 29, 2018, the Commissioner of the New Jersey Department of Banking and Insurance issued two bulletins confirming that recent federal changes affecting the Affordable Care Act (ACA) don’t supersede New Jersey state law.

Bulletin No. 18-12, captioned “Short-Term, Limited Duration Insurance,” confirms that short-term, limited-duration health insurance plans, which never comply with New

On Oct. 31, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update the payment system for home health agencies and improve access to remote patient monitoring technology. The rule will allow home health providers to build the costs of remote monitoring technology into their Medicare reimbursement beginning Jan. 1, 2020.

On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that certain policy changes in the Medicare Physician Fee Schedule relating to the documentation, coding and payment structure of Evaluation and Management office/outpatient visits will now be delayed until 2021. The changes were originally set to go into effect on January 1,

Healthcare facilities waiting to hear back on Medicare appeals received good news on November 1, when the U.S. District Court for the District of Columbia ordered the U.S. Department of Health and Human Services (HHS) to eliminate its backlog of 426,594 Medicare appeals by 2022. The order, in American Hospital Association, et al., v. Azar,

The U.S. Department of Health and Human Services (HHS) has issued a proposed rule that would speed up implementation of its previously issued 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Final Rule”). The proposed rule would move up the effective date of the Final Rule by six months, from