Nita Garg

Nita Garg

BakerHostetler

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21st Century Cures Act Passes House Committee

The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more

6/8/2015 - 21st Century Cures Initiative FDA Healthcare Medical Devices NIH Pending Legislation Pharmaceutical Pharmaceutical Manufacturers Sunshine Act

Otsuka Suit Results in Victory for FDA

According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though...more

6/5/2015 - FDA FDCA Generic Drugs Otsuka Pharmaceutical Pharmaceutical Pharmaceutical Manufacturers Product Exclusivity

Amarin Pharma Sues FDA Over Constitutional Right to Discuss Off-Label Uses

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain...more

5/15/2015 - Corporate Counsel FDA Off-Label Promotion Off-Label Use Pharmaceutical Pharmaceutical Manufacturers

FDA Finalizes Guidance Documents on Biosimilars

Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance...more

5/15/2015 - Biosimilars BPCIA FDA Final Guidance Pharmaceutical Pharmaceutical Manufacturers

New Data on Part D Prescription Drugs Available

On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) made available a dataset that provides detailed information on medications that physicians and other healthcare providers prescribed under the Medicare...more

5/15/2015 - CMS Health Care Providers Healthcare Medicare Advantage Medicare Part D Prescription Drugs Section 340B

OIG Provides Additional Compliance Guidance for Healthcare Governing Boards

On April 20, 2015, the HHS Office of Inspector General (HHS OIG), in collaboration with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA), and the Health Care Compliance...more

4/27/2015 - Board of Directors Chief Compliance Officers Corporate Governance Health Care Providers Hospitals OIG

FDA Establishes Docket for Public Comments on Drug Compounding

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA...more

3/17/2015 - Drug Compounding Drug Manufacturers FDA FDCA Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Section 503

FDA Guidance Documents Change Compounding Landscape

Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance...more

3/9/2015 - DQSA Drug Compounding FDA FFDCA Healthcare New Guidance Outsourcing Outsourcing Facilities Pharmaceutical

Medicare Advantage and Medicare Part D Changes for 2016 Released

On February 6, 2015, the Centers for Medicare & Medicaid Services (CMS) released a final rule regarding changes to Medicare Advantage and Medicare Part D to take effect in 2016. According to CMS, this final rule “implements...more

3/6/2015 - CMS Final Rules Health Care Providers Medicare Medicare Advantage Medicare Part D

Seventh Circuit Upholds Physician’s Conviction for Violation of the Anti-kickback Law Based on Expansive Definition of “Referral”

On February 10, 2015, the U.S. Court of Appeals for the Seventh Circuit upheld the conviction of Dr. Kamal Patel for violation of the anti-kickback law, reinforcing a broad definition of “referring” under the statute (U.S. v....more

3/4/2015 - Anti-Kickback Statute Criminal Prosecution Home Health Care Patient Referrals Physicians

New Limitations on RAC Program

In March 2014, CMS temporarily suspended the Recovery Audit Contractor (RAC) program until it secured new contracts. The contracts for the program expired in June 2014, and in August, CMS said that it would restart the...more

1/22/2015 - CMS Healthcare Hospitals Medicare RAC Audits RACs

Pharmacy Benefit Manager Faces Lawsuit by Compounding Pharmacies

In response to a decision to deny coverage of approximately 1,000 active ingredients that are widely used by compounding pharmacies to create topical treatments, three compounding pharmacies have filed a lawsuit against the...more

12/1/2014 - Drug Compounding Healthcare Pharmacies Prescription Drug Coverage Prescription Drugs

HRSA Withdraws Proposed “Mega Rule” for 340B Drug Pricing Program

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing...more

11/24/2014 - HHS HRSA Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Proposed Regulation Section 340B

Medical Information More Valuable to Hackers Than Credit Card Numbers

In light of the recently reported large healthcare data breaches that have resulted in the potential theft of the personal information of millions of patients, the FBI warned healthcare providers yet again of the dangers of...more

10/20/2014 - Cyber Attacks Electronic Medical Records FBI Hackers Health Care Providers Hospitals Personally Identifiable Information PHI Physicians

CMS Offer Deadline to Settle Hospital Inpatient Claim Appeals Draws Near

In an attempt to clear the backlog of appeals of short inpatient stays, CMS recently announced a settlement offer for hospitals with claims currently pending in the appeals process. In exchange for withdrawal of their...more

10/6/2014 - CMS Deadline Healthcare Hospitals Inpatient Billing

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

9/29/2014 - Draft Guidance Drug Manufacturers FDA Manufacturers Medical Devices Online Platforms Popular Prescription Drugs Public Comment Social Media

Purple Is the New Orange

Last week, the Food and Drug Administration (FDA) announced that it has published a list of licensed biological products and interchangeable biosimilars to be known as the Purple Book. The Purple Book is meant to be the...more

9/24/2014 - Biosimilars FDA Pharmaceutical Prescription Drugs Purple Book

FDA Regulation of Laboratory Developed Tests on the Horizon

At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of...more

9/22/2014 - Congressional Investigations & Hearings Draft Guidance FDA Laboratory Developed Tests

Implications on Pharmacies of Recent OIG Advisory Opinion on Per-Fill Fees

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee...more

9/10/2014 - Anti-Kickback Statute Fees Healthcare HHS OIG Pharmacies

Changing Financial Landscape for Medical Debts of the Uninsured

The implementation of the ACA has afforded many with the opportunity to obtain insurance coverage. Despite the opportunity, a large number of individuals have either chosen not to enroll in a health plan or have been unable...more

6/17/2014 - Affordable Care Act Health Insurance Exchanges Healthcare HFMA Medical Expenses

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