Policy and Medicine

Policy & Medicine delivers daily updates on the legal, regulatory, and compliance matters impacting the pharmaceutical and medical device sectors. Established in 2008, it has grown to be one of the most popular websites in this area. The platform offers in-depth insights into various key compliance topics and stands out as a top source for information regarding the Physician Payments Sunshine Act and transparency-related concerns.

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Final Rule Makes it Easier for Broker ACA Violations to be Punished

1 month ago | policymed.com | Thomas Sullivan

The Biden administration finalized a rule making it easier for regulators to punish insurance agents and brokers for violating rules when selling Affordable Care Act (ACA) plans. The rule expands the CMS' ability to immediately suspend a broker from the marketplace if they pose a risk to eligibility determinations, operations or enrollees. It also updates consent forms to ensure applications for plans are accurate and to prevent unauthorized changes to ACA coverage.
HHS OIG Finds Favorably for Free Access to Pharmaceutical Product

1 month ago | policymed.com | Thomas Sullivan

In its first advisory opinion of the year, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on January 15, 2025 that addressed an arrangement by a pharmaceutical manufacturer to offer certain patients free access to a pharmaceutical product that has limited coverage by Federal health care programs.
MA Reimbursement Program Proposes Average Increase of 4.3%

1 month ago | policymed.com | Thomas Sullivan

The Biden administration's last Advance Notice on the Medicare Advantage program proposed a 4.3% hike on average to MA reimbursement, which would result in $21 billion in additional payments to insurers next year. The rule increases the average benchmark payment to MA plans by 2.2%, with insurers' coding for member sicknesses making up the rest of the projected payment jump. The rule also completes the phase-in of changes to insurers' coding practices that are unpopular with the industry.
HHS Proposes Changes to HIPAA to Bolster Cybersecurity

1 month ago | policymed.com | Thomas Sullivan

The U.S. Department of Health and Human Services (HHS) wants to update the HIPAA security rule for the first time in more than a decade to bolster healthcare cybersecurity. On January 6, the Office for Civil Rights (OCR), which enforces HIPAA, proposed changes to the regulation that aims to clarify and offer more specific instruction on securing electronic health data.
Teva Pharmaceuticals Sues Over Implementation of Inflation Reduction Act

1 month ago | policymed.com | Thomas Sullivan

Teva Pharmaceuticals recently sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) over its implementation of the drug price negotiation program baked into the Inflation Reduction Act (IRA). In the Complaint, Teva refers to its "unique position" as a developer of both innovative medicines and high-quality generic drugs and biosimilars.
The Pioneer Institute Raises Concerns About PBM Transparency

2 months ago | policymed.com | Thomas Sullivan

The Pioneer Institute recently released a study raising concern over the lack of transparency around the role pharmacy benefit managers (PBMs) play in serving patients. According to the study, a lack of competition, transparency, and oversight together make it difficult to understand who actually receives the benefits - are the savings passed on to patients or are they boosting the profits of the PBM "at the expense of patients, employers, and government entities"?
Aetna Alleges Conspiracy Among Generic Pharmaceutical Manufacturers

2 months ago | policymed.com | Thomas Sullivan

Aetna recently filed a lawsuit against pharmaceutical manufacturers for allegedly conspiring to overcharge the insurer for generic drugs. According to the Complaint, the pharmaceutical companies engaged in secret communications and meetings to fix the prices of certain generic medications, which increased costs for insurers, patients, and the government.
HHS OIG Reviews FDA's Accelerated Approval of Aducanumab

2 months ago | policymed.com | Thomas Sullivan

Earlier this year, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) conducted a review of the Food and Drug Administration (FDA) accelerated approval pathway for prescription drugs, to better understand the extent to which the FDA's review varied throughout the accelerated approval pathway.
Judge Rules that California Law May Not Apply Outside the State

2 months ago | policymed.com | Thomas Sullivan

Recently, Chief United States District Judge of the United States District Court for the Eastern District of California, Troy L. Nunley, ruled that the state of California could not enforce a state law - largely focused on the generic and brand-name pharmaceutical industries - outside the borders of the state. The case started in 2019 with California Assembly Bill 824, which stopped drug companies from paying competitors to keep generic drugs off of store shelves.
CMS Notes Progress on Accountable Care Goals

2 months ago | policymed.com | Thomas Sullivan

Earlier this year, the United States Centers for Medicare and Medicaid Services (CMS) acknowledged progress that had been made on its goal for Traditional Medicare beneficiaries to be in a care relationship with accountability for quality and total cost of care by 2030. In fact, as of January 2025, 53.4% of people with Traditional Medicare (fee-for-service) were in an accountable care relationship with a provider, representing more than 14.8 million people and a 4.3% increase from January 2024.