Nita Garg

Nita Garg

BakerHostetler

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Vermont to Require Drug Transparency

Vermont recently became the first state to require drug manufacturers to provide justification for price increases. Under the new law, data on the cost of the drug will come from the state Medicaid program. The Department of...more

6/20/2016 - Attorney Generals Drug Pricing Manufacturers Medicaid Pharmaceutical Industry

HHS Reopens Comment Period for Proposed Rule on 340B Drug Program

The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released...more

4/26/2016 - Civil Monetary Penalty Drug Pricing HHS Medicaid Pharmaceutical Industry Prescription Drugs Public Comment Section 340B

New Medicare Part B Payment Model is Most Recent Payor Response to Increasing Drug Prices

Recent activity by the federal government along with commercial payors may be indicative of further changes to how payors, providers, and pharmaceutical manufacturers engage in prescription drug arrangements. A recently...more

4/11/2016 - CMS HHS Medicare Medicare Part B Medicare Part D Pharmaceutical Industry Prescription Drug Coverage Prescription Drugs

CMS Pitches Controversial Payment Model for Medicare Part B Drugs

CMS recently announced a proposed rule that would potentially create a new Medicare Part B prescription drug payment model. The proposed model is intended to improve quality of care and deliver better value for Medicare Part...more

3/28/2016 - CMS Health Care Providers Medicare Part B Pharmacies Prescription Drugs

Increased Scrutiny of Drug Pricing What Should Pharmaceutical Companies Know

As U.S. spending on pharmaceuticals continues to rise, reaching $373.9 billion in 2014, government scrutiny of drug pricing practices has increased in response. Early last year, the U.S. Department of Health and Human...more

2/3/2016 - Audits Drug Pricing HHS OIG Pharmaceutical Industry Prescription Drugs

House Passes Bill to Help Prevent Prescription Drug Abuse

On September 8, 2015, the House of Representatives passed a bill intended to combat prescription drug abuse through the reauthorization of a program that provides federal grants to states for prescription drug monitoring...more

10/15/2015 - Data Collection Drug & Alcohol Abuse Federal Grants Healthcare Pending Legislation Pharmaceutical Industry Prescription Drugs U.S. House

340B Guidance: Eight Key Points Covered Entities Should Consider

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

9/11/2015 - AIDS Audits Compliance Covered Entities Drug Pricing Fee-for-Service FQHC GPOs Healthcare HHS HRSA Managed Care Contracts MCOs Medicaid Pharmaceutical Industry Pharmacies Prescription Drugs Section 340B

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more

8/20/2015 - Amarin DOJ FDA Healthcare Off-Label Promotion Pharmaceutical Industry Preliminary Injunctions Prescription Drugs Product Labels Warning Labels

House Passes 21st Century Cures Act

On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...more

7/21/2015 - 21st Century Cures Initiative FDA Healthcare Medicaid Medicaid Reimbursements Medical Devices Medical Research Medicare NIH Physician Medicare Reimbursements Prescription Drugs

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 Industry 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 Industry 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 Industry

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 Industry

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 FDA FDCA Pharmaceutical Industry 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 Industry

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 Recovery Audit Contractors (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 Industry 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 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 FDA Manufacturers Medical Devices Online Platforms Pharmaceutical Industry Popular Prescription Drugs Public Comment Social Media

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