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Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more

FCA Enforcement Risk Remains for Rare Disease Stakeholders

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Medicare Part B Enrollees Will Save on 64 Newly Selected Drugs Under Inflation Rebate Program

Medicare Part B enrollees as of July 1, 2024 will experience savings on coinsurance for 64 drugs selected by the Biden administration. Pursuant to the Inflation Reduction Act and its Medicare Prescription Drug Inflation...more

Florida Healthcare Director Charged in Fraud Case Against CMS

Continuing its recent slate of high-profile indictments, convictions, and plea agreements involving healthcare executives who have violated federal healthcare laws, the US Department of Justice (DOJ) recently announced...more

Connecticut Rolls Out Legislation on Pharmaceutical Sales Reps, Costly Outpatient Drugs

Connecticut will bolster its existing prescription drug reporting and transparency regime with new requirements on pharmaceutical sales representative registration and updates to existing manufacturer transparency reporting,...more

How the End of the PHE Will Impact the Healthcare Industry

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

CMS Issues Sweeping Telehealth Interim Final Rule in Response to COVID-19 Crisis

The Center for Medicare and Medicaid Services (CMS) released a far-reaching interim final rule (IFR) to address the coronavirus (COVID-19) pandemic on March 30. The IFR represents a comprehensive set of policy changes...more

CMS Implements Massive Rule Change To Bolster Telehealth Amid COVID-19: What Providers Need To Know To Serve Their Patients

On March 30, 2020, the Centers for Medicare & Medicaid Services released a stunning and far-reaching interim final rule to address the coronavirus (COVID-19) crisis. The rule is a comprehensive set of policy changes designed...more

CARES Act Offers Short-term Financial Relief for Medicare Providers/Suppliers

The Centers for Medicare & Medicaid Services has expanded its payment program to provide emergency funding and increased cash flow to providers and suppliers that participate in Medicare based on historical Medicare payments...more

HHS to Exercise Enforcement Discretion in Response to CMS Telehealth Waiver

As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the...more

CMS Issues Program Instructions for Medicare Telehealth Waiver

CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the...more

Proposed Physician Fee Schedule Rule Tweaks, Expands Open Payments Program

The Open Payments program established by the Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of covered drugs, medical devices, biologicals, and medical supplies (applicable manufacturers) to report...more

CMS Administrator Touts Changes to RAC Program

In CMS’s continuing effort to take “a strategic approach to protecting taxpayer dollars and reducing regulation to put patients over paperwork,” Administrator Seema Verma recently highlighted changes to the Recovery Audit...more

The SUPPORT Act and Healthcare Providers—A First Look

The newly enacted SUPPORT Act’s wide-ranging provisions take aim at the entire healthcare continuum, including providers, who will be on the front lines of change as the new law takes effect. The law includes amendments to...more

Something Old, Something New: The Proposed Medicare Physician Fee Schedule Rule

Mixing innovative change with standing policy, the proposed physician fee schedule rule for CY 2019 highlights a Medicare payment system in transition. Clinicians and groups focused solely on driving volume without devoting...more

Medicare’s Proposal to Streamline Evaluation and Management Documentation and Payment—What Practitioners Need to Know

Responding to input from stakeholders who have long maintained that evaluation and management documentation guidelines are too complex and fail to meaningfully distinguish differences among code levels, a proposal by the...more

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