Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Sheppard Mullin Richter & Hampton ordered by Published Date Descending.
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New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement...
United States
8 Oct 2019
MSPV 2.0 Is Alive
The Department of Veterans Affairs (VA) has resurrected its search for prime vendors under the Medical Surgical Prime Vendor (MSPV) 2.0 Program
United States
7 Oct 2019
Bipartisan Push To Repeal ACA's Cadillac Tax
One of the most controversial taxes of the Affordable Care Act (ACA) is in danger of repeal. The tax colloquially known as the "Cadillac Tax"
United States
2 Oct 2019
Tips For When To Consider Legal Review Of Quality System Investigations
As a lawyer with extensive experience in good manufacturing practice (GMP) issues, clients will ask me to review complex Quality System investigations.
United States
27 Sep 2019
Annual DDE Recertification Due 9/30 (And Other DDE Pitfalls)
Direct Data Entry (DDE) access is a company's revenue lifeline: without it, hospices cannot comply with NOE filing requirements or submit claims for payment.
United States
27 Sep 2019
FDA's New Safety And Performance Based Pathway For Medical Devices Reflects A More Modern Approach To Finding Substantial Equivalence
On September 19, 2019, FDA issued a guidance document, "Safety and Performance Based Pathway," describing an optional pathway for medical devices ...
United States
26 Sep 2019
D.C. District Court Vacates CMS Final Rule, Finds That CMS' Lesser Reimbursement Of Services Provided At Grandfathered Off-Campus Provider-Based Departments Was Improper
On September 17, 2019, the U.S. District Court for the District of Columbia ruled against the Centers for Medicare and Medicaid Services ("CMS"),
United States
25 Sep 2019
California Department Of Managed Health Care Opposes AB 1249
On Monday, August 8th, the Deputy Director of Legislative Affairs of the Department of Managed Health Care (the "Department")
United States
24 Sep 2019
Hospice False Claims: AseraCare Lost A Battle But Has Helped Win The War
Last week, the 11th Circuit Federal Court of Appeals reversed summary judgment given to AseraCare in its hospice false claims case
United States
24 Sep 2019
The Eleventh Circuit Remands AseraCare, But Affirms High Hurdle For Proving Falsity
In a highly anticipated opinion in the AseraCare case, issued on September 9, 2019, the Eleventh Circuit Court of Appeals affirmed the district court's holding
United States
16 Sep 2019
CMS Finalizes Rule Expanding Its Authority To Deny And Revoke Medicare Program Enrollment, Among Other Changes
On September 5, 2019, the Centers for Medicare and Medicaid Services ("CMS") released a final rule with comment period entitled, "Program Integrity Enhancements to the Provider Enrollment Process"
United States
13 Sep 2019
Long-Term Care Providers And Corporate Compliance Programs: The Impending November 28, 2019 Deadline Is Fast Approaching
A 2016 Final Rule from CMS created a new regulatory requirement for long-term care facilities, 42 C.F.R. § 483.85, that mandates such facilities have in operation, by November 28, 2019,
United States
10 Sep 2019
CMS Plans Updates To Star Ratings
On August 19, 2019, the Centers for Medicare and Medicaid Services ("CMS") announced plans for two updates to its Overall Hospital Quality Star Ratings ("Star Ratings").
United States
2 Sep 2019
What's The VA Got To Do With It? Military Medical Procurement Changes Reach The VA
There are big changes happening in military healthcare procurement. Some are unsurprising given the October 1, 2019 deadline for the reorganization of all military hospitals and clinics
United States
30 Aug 2019
Eleventh Circuit Affirms Key Kickback Statute, Stark Law, And False Claims Act Principles In Dismissing Allegations Against HCA
On July 31, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a lower court's decision to grant summary judgment to hospital operator HCA and dismiss relator Thomas
United States
20 Aug 2019
How FDA Considerations Impact Food And Beverage Acquisitions
When considering an acquisition of a food and beverage company, potential buyers of a company or its assets should pay particular attention to U.S. Food and Drug Administration requirements
United States
19 Aug 2019
CMS Finalizes 2020 Hospice Rule: Big Changes Coming
On August 6, 2019, CMS finalized its 2020 hospice rule, including adopting, without substantial modification, two controversial and material changes to the hospice benefit:
United States
14 Aug 2019
Unintended Consequences: Dynamex And California Health Care Employers
The California Supreme Court's 2018 landmark decision, Dynamex Operations West, Inc. v. Superior Court (Dynamex),
United States
12 Aug 2019
Proposed And Expanded Disclosure Obligations For Hospitals Regarding Not Only Gross Charges, But Third Party Payor Pricing As Well
On July 29, 2019, CMS released its proposed outpatient prospective payment system ("OPPS") rule outlining a variety of changes it may implement for calendar year 2020.
United States
8 Aug 2019
Is Prescription Drug Pricing The Cure For Partisanship?
The bill passed out of committee by a 19-9 vote on July 25th.
United States
2 Aug 2019
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