News & Analysis as of

Department of Health and Human Services (HHS) Covered Entities Medicare

Proskauer - Health Care Law Brief

New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive...

On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more

Dorsey & Whitney LLP

Significant New Healthcare Privacy and Cybersecurity Developments

Dorsey & Whitney LLP on

As the federal government continues to take action in response to events impacting the healthcare landscape, stakeholders must ensure that they are staying up-to-date with health information privacy and security developments...more

McDermott Will & Emery

This Week in 340B: October 2023

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on

The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

McDermott Will & Emery

This Week in 340B: August 2023 #2

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Emery

This Week in 340B: May 2023 #4

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

McDermott Will & Emery

This Week in 340B: April 2023 #5

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

BakerHostetler

Discounted Drugs under the 340B Program

BakerHostetler on

The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B...more

BakerHostetler

HHS Proposes Rule Strengthening Section 1557 Protections Against Nondiscrimination in Health Activities

BakerHostetler on

​​​​​​​On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 30, Number 2. News Briefs: January 2021 #2

Report on Medicare Compliance 30, no. 2 (January 18, 2021) - Recovery audit contractors (RACs) may soon be auditing positron emission tomography (PET) for initial treatment strategy in oncologic conditions for compliance...more

K&L Gates LLP

K&L Gates Triage: 340B Update - Hospitals Request Eligibility Flexibilities Amid COVID-19 Pandemic

K&L Gates LLP on

In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests...more

Foley & Lardner LLP

Compliance: Top Takeaways from Foley and PYA’s Annual “Let’s Talk Compliance” Event

Foley & Lardner LLP on

For the second year in a row, Foley & Lardner LLP and PYA hosted a compliance master class on various health-related compliance issues. “Let’s Talk Compliance” is an annual one-day event featuring a panel of presenters that...more

Proskauer - Employee Benefits & Executive...

HHS Proposes to Narrow Scope of Nondiscrimination Regulations under Affordable Care Act

The U.S. Department of Health and Human Services (HHS) recently proposed regulations that scale back nondiscrimination protections under Section 1557 of the Affordable Care Act (ACA). The new regulations, proposed on May 24,...more

Baker Donelson

OIG's List of Excluded Individuals/Entities – What Employers Need to Know

Baker Donelson on

OIG maintains a list of all currently excluded individuals and entities called the "List of Excluded Individuals/Entities," or LEIE. Covered entities that hire – or continue to employ or work with – an individual or entity on...more

K&L Gates LLP

340B Update: HRSA Accelerates Implementation of Long-Delayed 340B Pricing and Manufacturer Penalties Rule

K&L Gates LLP on

On October 31, 2018, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (“NPRM”) which proposes to move up the...more

Foley & Lardner LLP

Court Rules Against 340B Hospitals, Allows Medicare Reimbursement Cuts to Go Forward

Foley & Lardner LLP on

On Friday, December 29, 2017, the U.S. District Court for the District of Columbia dealt a blow to hospitals participating in the 340B Drug Pricing Program. By participating in the 340B program, eligible public and...more

Mintz - Health Care Viewpoints

Six Key Follow-Up Questions Asked by Congress in 340B Hearing

Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more

Mintz - Health Care Viewpoints

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more

Bond Schoeneck & King PLLC

Health-Related Facilities That Receive Federal Financial Assistance Now Required to Post Non-Discrimination Notices

Health-related facilities that receive Federal financial assistance (e.g., Medicare or Medicaid reimbursement) have been required to comply with Federal, as well as State, non-discrimination laws in the provision of services....more

Poyner Spruill LLP

Nondiscrimination Final Rule under the ACA Imposes New Requirements on Hospice Agencies

Poyner Spruill LLP on

On May 26, 2016, the United States Department of Health and Human Services (HHS), Office of Civil Rights (OCR), issued the “Nondiscrimination in Health Programs and Activities” final rule, implementing Section 1557 of the...more

Sheppard Mullin Richter & Hampton LLP

HHS Final Rule Extends Anti-Discrimination Protection to Transgender Patients

This past May, the Department of Health and Human Services (HHS) issued a final rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin,...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

King & Spalding on

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

McDermott Will & Emery

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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