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Medicare Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) Final Rules Released; What Pharma...

The Centers for Medicare & Medicaid Services (CMS) has issued its annual final rules related to both the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for calendar year 2023 (the HOPPS...more

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

Contract Year 2023 Part D Proposed Rule Released: Changes To 'Negotiated Price' Would Require Potential DIR Fees at the Point of...

The Centers for Medicare & Medicaid Services (CMS) published the proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the Proposed Rule) on...more

Supreme Court To Hear Case Impacting Medicare Reimbursement for 340B Drugs

The United States Supreme Court has agreed to hear a case that has a direct impact on the 340B Drug Discount Program (the 340B Program) and how Medicare will reimburse hospitals for dispensing of 340B covered drugs, as well...more

What Should Pharma Companies Expect From the Biden Administration?

With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more

OIG Issues Fraud Alert: Should Pharma and Device Companies Cease Speaker Programs?

The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more

CMS Launches Part D Senior Savings Model for Insulin Products

On March 11, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a voluntary model within the Medicare Part D program that would allow certain Part D plans to cap Medicare beneficiaries’ out-of-pocket costs for...more

CMS Issues COVID-19 Guidance to Medicare Advantage Organizations and Part D Sponsors

On March 10, 2020 the Centers for Medicare & Medicaid Services released a memo to Medicare Advantage Organizations and Part D Sponsors to inform them of their obligations and permissible flexibilities related to disasters and...more

CMS Releases Proposed Changes for Medicare Advantage and Medicare Part D

The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more

Investigations Newsletter: Whistleblower Collects on Cybersecurity FCA Case

Whistleblower Collects on Cybersecurity FCA Case - On July 31, 2019, Cisco Systems agreed to pay $8.6 million in civil damages to settle claims that it sold video surveillance technology with known security flaws to several...more

Investigations Newsletter: Telemarketing Business Agrees to Pay $2.5 Million to Settle FCA Allegations of Telemedicine Scheme

Telemarketing Business Agrees to Pay $2.5 Million to Settle FCA Allegations of Telemedicine Scheme - The US Attorney’s Office for the Middle District of Florida, in collaboration with the US Attorney’s Office for the...more

Investigations Newsletter: Patient Recruiter Convicted in $1.3 Million Kickback Conspiracy Scheme

Patient Recruiter Convicted in $1.3 Million Kickback Conspiracy Scheme - After a six-day trial, a federal jury in Detroit found a patient recruiter guilty of one count of conspiracy to pay and receive health care...more

2020 Proposal for Medicare Part B Drug Reimbursement: Business as Usual

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed update to the hospital outpatient prospective payment system (Proposed Rule)....more

Investigations Newsletter: Podiatrist Sentenced to Prison for Fraudulent Billing Scheme

Podiatrist Sentenced to Prison for Fraudulent Billing Scheme - On July 19, 2019, a New York podiatrist was sentenced to 366 days in prison, assessed a $50,000 fine, ordered to pay $869,651 in restitution and forfeit...more

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