Health Care Counsel Blog
400 total results. Page 1 of 16.
As EMS Assumes a More Diversified Role in Health Care Delivery, Ambulance Service Compliance Takes Center Stage
In recent years, the emergency medical services (EMS) sector has assumed a more central role in health care delivery, including care in the home and, in some cases, emergency department visit prevention.
Texas Health and Human Services announced that beginning April 1, 2021, drug manufacturers who wish for their products to be added to the Texas Drug Code Index (the Texas Medicaid formulary) must create an electronic account.
Applicable drug manufacturers and group purchasing organizations that are subject to the reporting rules under the Open Payments System are reminded that March 31, 2021, is the final day to submit and attest to data for the June 2021 publication of Program Year 2020 data.
Health Resources and Services Administration Enjoined from Implementing the 340B Dispute Resolution Rule
Immediately at issue was Lilly and Company and Lilly USA’ refusal to sell covered outpatient drugs at the 340B Ceiling Price to contract pharmacies acting as agents for 340B Covered Entities. Several 340B Covered Entities had petition for a hearing by the ADR panel.
Passage of American Rescue Plan Act of 2021 Could Mean Larger Medicaid Drug Rebate Program Rebates for Pharmaceutical Manufacturers
The American Rescue Plan Act of 2021, signed into law by President Biden on March 11, 2021, is a $1.9 trillion aid package that provides assistance to businesses and individuals experiencing financial hardship due to COVID-19.
Douglas A. Grimm, FACHE, Anne M. Murphy, Diane Roldán, Jill A. Steinberg, Rachel Hold-Weiss, Stephanie Trunk, Thomas E. Jeffry, Jr., Candace C. Sandoval, Michele L. Gipp, Erin E. Atkins, Hillary M. Stemple
Our Health Care team has a complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.
Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements necessary to protect those arrangements.
February 2021 Update: California Department of Consumer Affairs Extends and Issues Additional Healthcare Professional Licensing Waivers
This is the latest in a series of articles discussing selected updates to the Department of Consumer Affairs’ (DCA) waivers issued in response to Governor Newsom’s March 30, 2020 Executive Order N-39-20.
Changes to Stark and Anti-Kickback Regulations Address Technology Advances, Tighten Rules for EHR Contributions, and Promote Cybersecurity
Fraud and abuse regulations have been adapted to meet today’s technology for electronic data, promoting cooperation among health care providers for the exchange of health information and the protection of such information from cyberattacks.
The Department of Health and Human Services (HHS) is working to dramatically increase the number of available vaccinators who may administer COVID-19 shots.
New Stark Exception Provides Additional Flexibility for Limited Financial Arrangements With Physicians
As part of its recent rulemaking process, the Centers for Medicare and Medicaid Services (CMS) finalized a new exception to the Physician Self-Referral Law (the Stark Law) to protect arrangements where limited remuneration is provided to a physician in exchange for items or services provided by the
Stark Law Fair Market Value Compensation Exception Expanded to Cover Office Space and Equipment Leases and Clarifies Writing Requirements
In its first significant Stark Law rulemaking since 2015, the Centers for Medicare and Medicaid Services (CMS) recently issued a new final rule (Final Rule) intending to provide physicians and designated health services (DHS) entities with additional flexibility in complying with the law’s stringent
Changes to the Stark Law’s Special Rules on Compensation Create Flexibility and Reduce Confusion for Physicians and Other Health Care Providers
In its recent Final Rule significantly revising the federal Physician Self-Referral Law (Stark Law), the Centers for Medicare and Medicaid Services (CMS) implements several important changes to the special rules on compensation set forth in 42 C.F.R. § 411.354(d).
Searching for Safe Harbors? CMS-Sponsored Model Participants Receive Anti-Kickback Statute Protection
Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor.
The Centers for Medicare & Medicaid Services (CMS) published a Final Rule in the Federal Register on December 2, 2020, overhauling the regulations governing the federal Physician Self-Referral Law (Stark Law).
Changes to Stark Law Definitions Impact Innovative Relationships and “Commercially Reasonable” Considerations
The Final Rule of the Stark Law revises the definitions of Fair Market Value and includes a definition of General Market Value to better align with actual practices without unduly restricting innovative relationships between physicians and entities providing designated health services.
On December 28, 2020, Judge Vince Chhabria of the US District Court for the Northern District of California joined Judge Catherine Blake of the US District Court of the District of Maryland in enjoining the application of the Medicare Part B Most Favored Nations Reimbursement Rule.
Early Christmas Presents for Pharmaceutical Manufacturers: Court Grants Temporary Ban on Medicare Part B Most Favored Nations Reimbursement Rule
On December 23, 2020, Judge Catherine Blake of the US District Court for the District of Maryland put in place a 14-day restraining order while she considers whether to issue a preliminary injunction. She plans to consider whether the Centers for Medicare & Medicaid Services rulemaking was adequate
States seeking to regulate pharmacy benefit managers (PBMs) and prescription drug pricing received a win from the Supreme Court, which reversed an Eighth Circuit decision that had invalidated an Arkansas law governing pharmacy and PBM conduct on ERISA preemption grounds.
Nearly two years after soliciting public suggestions to modify HIPAA rules to improve the coordination of care, the Department of Health and Human Services (DHHS) issued a Proposed Rule.
OIG and CMS, through a coordinated effort, have issued sweeping and much-anticipated final changes to the Anti-kickback and Stark rules. These changes are generally industry-friendly.
The Nevada Division of Public and Behavioral Health will hold an open public meeting to discuss proposed amendments to current regulations impacting the State’s drug transparency program. The meeting will take place on December 9, 2020, at 1 pm PST.
Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute.
CMS Releases Interim Final Rule Establishing Reimbursement for Part B Drugs Based on International Pricing
Most Favored Nations Model will alter how certain Medicare Part B drugs are reimbursed.