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Searching Content indexed under Healthcare by Ropes & Gray LLP ordered by Published Date Descending.
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1
China's Central Government Introduces Major Policy Incentives And Restraints To The MedTech Industry
After continuously reshaping the competitive landscape in the pharmaceutical industry for several years, the Chinese government finally shifted its attention to the medtech industry.
China
21 Aug 2019
2
Non-Binding Guidance: Real-World Evidence In Drug Development And FDA Submissions
The fourth installment of Ropes & Gray's podcast series, Non-binding Guidance, dives into the use of real-world evidence in drug development
United States
15 Aug 2019
3
What OIG Self-Disclosure Guidance Means For HHS Grantees
This article by counsel Valerie Bonham and partners Kirsten Mayer and Mark Barnes was published by Law360 on August 8, 2019.
United States
14 Aug 2019
4
FDA CBD Roundup: Agency Continues Existing Enforcement Approach While Reviewing Public Comments And Considering Future Policy Approaches
On May 31, 2019, the U.S. Food and Drug Administration ("FDA") held a much-anticipated public hearing regarding "Scientific Data and Information
United States
12 Aug 2019
5
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
6
HHS OIG Issues Self-Disclosure Program Guidance For Research Grants And Contracts
Universities, academic medical centers, companies and other recipients and sub-recipients of federal biomedical and basic research funds are under increased scrutiny and facing stiffer
United States
30 Jul 2019
7
CMS Proposes New Payment Models For Radiation Oncology And End Stage Renal Disease (ESRD)
On July 10, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would implement and test two new mandatory payment models under its Center for Medicare & Medicaid Innovation
United States
29 Jul 2019
8
NIH Issues New Guidance On "Other Support" And "Foreign Components" In Funded Research
In the wake of ongoing concerns expressed about "foreign influence" in U.S.-funded research activities, the National Institutes of Health (NIH) last week released
United States
24 Jul 2019
9
New York's Highest Court Holds That Medical Practices That Cede Too Much Control To MSOs Are "Fraudulently Incorporated" And Ineligible To Be Reimbursed By No-Fault Automobile Insurers
On June 11, 2019, the New York Court of Appeals (the "Court")—the highest court in New York State—issued a rare opinion on the State's broad corporate practice of medicine prohibition
United States
5 Jul 2019
10
What's New For CMS Bundled Payments Program
On April 24, 2019, the Centers for Medicare & Medicaid Services released a request for applications for the Bundled Payments for Care Improvement Advanced model for its second cohort
United States
19 Jun 2019
11
CMS Announces Request For Applications: BPCI Advanced Model Year 3
On April 24, 2019, the Centers for Medicare and Medicaid ("CMS") released a Request for Applications ("RFA") for the Bundled Payments for Care Improvement Advanced Model ("BPCI Advanced") for its second cohort of applicants since the program's inception.
United States
6 Jun 2019
12
What To Know About The CMS Primary Cares Initiative
On April 22, 2019, the U.S. Department of Health and Human Services and its Centers for Medicare & Medicaid Services (CMS) announced the "CMS Primary Cares Initiative,"
United States
27 May 2019
13
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb's Unfinished Business
Tune in to this discussion to learn more about the unfinished business of the Gottlieb administration, the impact of his resignation, and how the agency will move forward under Acting Commissioner Ned Sharpless.
United States
8 May 2019
14
India Finalizes Rules Regarding Compensation For Subjects Injured In Clinical Trials And Post-Trial Access To Study Drugs
Since 2013, India's clinical trials regulatory framework has undergone continuous, significant changes to bolster protections for clinical trial participants.
United States
7 May 2019
15
Senators Ask HHS To Step Up Scrutiny Of Pods Under Sunshine Act
On March 19, 2019, Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR) of the Senate Finance Committee ("SFC") wrote a letter (the "POD Letter") to the HHS Office of Inspector General ("OIG")
United States
3 May 2019
16
Podcast: Non-Binding Guidance: FDA's Regulation Of Products Containing CBD
Ropes & Gray's new podcast series, Non-binding Guidance, highlights FDA regulatory developments and trends affecting the life sciences industry.
United States
2 Apr 2019
17
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
18
HHS Sets Out To Tackle Health Information Access And Exchanges
On Feb. 11, 2019, two agencies of the U.S. Department of Health and Human Services coordinated the release of complementary proposed rules designed to support and advance seamless and secure access...
United States
5 Mar 2019
19
In Coordinated Proposed Rules, ONC And CMS Seek To Tackle Interoperability, Information Blocking, And Patient Access To Health Information
On February 11, 2019, two agencies of the U.S. Department of HHS coordinated the release of complementary proposed rules designed to support and advance seamless and secure access, exchange, and use of EHI.
United States
28 Feb 2019
20
Transcending Traditional Health Care: A Growing Trend At HHS Embracing A Broader Vision Of Health Care
In the past few weeks, divisions of the U.S. Department of Health and Human Services ("HHS") have taken three separate actions that, while individually distinct, collectively reflect
United States
19 Feb 2019
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