Searching Content by Ropes & Gray LLP's Health Care Practice from Ropes & Gray LLP ordered by Published Date Descending.
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CMS Releases Proposed Rules On PFS, QPP And Price Transparency
On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) issued two significant proposed rules: (a) a Proposed Rule that addresses changes to the Physician Fee Schedule
United States
9 Aug 2019
Senator Chuck Grassley Presses Comptroller General To Investigate Foreign Threats To Taxpayer-Funded Research
On Tuesday, Senate Finance Committee Chairman Chuck Grassley of Iowa sent a letter to the General Accountability Office asking it to examine "how federal agencies implement and oversee conflict-of-interest policies and...
United States
9 Aug 2019
New International Pharmaceutical Practice Code Tightens Restrictions On Gifts
On January 1, 2019, the revised Code of Practice issued by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) went into effect.
United States
7 Mar 2019
HHS Proposed Rule On Prescription Drug Safe Harbors
On January 31, 2019, the Office of Inspector General ("OIG") of the U.S. Department of Health & Human Services ("HHS" or the "Department") released a proposed rule that would narrow the existing regulatory discount safe harbor under the Anti-Kickback Statute ("AKS") and create two new safe harbors.
United States
15 Feb 2019
AdvaMed Releases Updated Code Of Ethics
The Advanced Medical Technology Association ("AdvaMed") has updated its Code of Ethics on Interactions with U.S. Health Care Professionals (the "Code").
United States
4 Feb 2019
Changes In Federal Regulation Of CBD And Other Hemp Products Will Create New Opportunities For Investment, But Regulatory Challenges Remain
On December 20, 2018, President Trump signed the Agriculture Improvement Act of 2018 (P.L. 115-332), commonly referred to as the "2018 Farm Bill," into law
United States
16 Jan 2019
CMS Finalizes Overhaul Of Medicare Shared Savings Program
The Final Rule also includes modifications to the repayment mechanism requirements, to reduce the burden on ACOs in performance-based risk tracks.
United States
11 Jan 2019
Another Step Toward Harmonization: FDA Issues Proposed Rule To Waive Informed Consent Requirements In Minimal-Risk Studies
On November 15, 2018, the U.S. FDA published a proposed rule1 that would allow IRBs to waive or alter informed consent when a clinical investigation poses no more than minimal risk to, and includes appropriate safeguards...
United States
30 Nov 2018
CMS Releases Final Medicare Rules On OPPS And ASC Payment Systems, And Expanded Telehealth Opportunities
On November 21 and 23, 2018, the Centers for Medicare & Medicaid Services ("CMS") finalized rules reinforcing a developing trend away from delivery of care in traditional inpatient care settings.
United States
29 Nov 2018
CMS Proposes Significant Changes For Medicare Advantage And Part D Plans, Including Telehealth Expansion And New Integrity Initiatives
On November 1, 2018, the CMS released a proposed rule, available here, that updates requirements of the MA program, also known as Medicare Part C, and the Medicare Prescription drug benefit program.
United States
29 Nov 2018
HHS Proposes January 1, 2019 Rollout Of The 340B Drug Pricing Program's Civil Monetary Penalties And Clarified Drug Ceiling Price Calculation
On November 2, 2018, the Health Resources and Services Administration of the United States Department of Health and Human Services
United States
29 Nov 2018
CMS Outpatient Payment, MA Plan Design, And 340B Rules: Cost-Cutting Trends
These final rules, released for prepublication display on November 1 and 2, reinforce a developing trend away from delivery of care in traditional inpatient care settings.
United States
29 Nov 2018
The SUPPORT Act Of 2018: New All-Payor Anti-Kickback Provisions; Broader Telehealth And Other Coverage
On October 24, 2018, the President signed a far-reaching bill addressing issues related to opioid use and abuse—the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018.
United States
31 Oct 2018
Bid Rigging: For Multinationals, More Than Just A Local Law Violation
In many countries, purchases of products or services1 by government or public entities take place primarily through public tenders.
United States
6 Sep 2018
CMS Proposes Overhaul Of The Medicare Shared Savings Program
The table at the end of this Alert summarizes the key characteristics of proposed paths.
United States
24 Aug 2018
Implications Of Distributor Misconduct For Global Health Care And Life Sciences Companies
Health care and life sciences companies with operations in the United States and abroad face increased liability arising from their common reliance on third-party distributors in international markets.
United States
2 Aug 2018
Revisions To Common Rule Delayed Until January 21, 2019
In January 2017, the federal departments and agencies that follow the Federal Policy for the Protection of Human Subjects, typically referred to as the Common Rule ...
United States
20 Jun 2018
Spotlight On Korea
Although historically U.S. regulators have not focused FCPA enforcement efforts in Korea to the same extent as other Asian jurisdictions such as China and India, multinational companies doing business in Korea, particularly in the life sciences space, should remain vigilant.
United States
29 Mar 2018
Health Care Provisions In Bipartisan Budget Act Of 2018
On Friday, February 9, President Trump signed The Bipartisan Budget Act of 2018 (the "2018 Act") into law. Among other things, the 2018 Act makes changes to the Medicare Access and CHIP Reauthorization Act of 2015 ...
United States
26 Feb 2018
CMS's New Advanced APM: Bundled Payments For Care Improvement Advanced
On January 9, 2018, the CMS CMMI announced a new voluntary bundled payment model called "Bundled Payments for Care Improvement Advanced".
United States
7 Feb 2018
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