Nita Garg

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Vermont to Require Drug Transparency

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 Vermont Health Access (DVHA) and the Green Mountain Care Board (GMCB) will work together to create a yearly … Continue Reading

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

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 the proposed rule on June 17, 2015, and the original comment period ended August 17, 2015. The 340B Drug Pricing Program requires drug manufacturers … Continue Reading

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

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 announced proposed rule by CMS would create a new Medicare Part B prescription drug payment model intended to improve quality of care and deliver better value for … Continue Reading

CMS Pitches Controversial Payment Model for Medicare Part B Drugs

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 B beneficiaries. However, many providers and drug manufacturers have expressed concern that the new payment model will emphasize cost-cutting measures at … Continue Reading

Increased Scrutiny of Drug Pricing – What Should Pharmaceutical Companies Know

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Nita Garg and Lindsay Holmes on Posted in Uncategorized
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 Services Office of Inspector General (OIG) received a request from Rep. Elijah Cummings (D-Md.) and Sen. Bernie Sanders (I-Vt.) that the government … Continue Reading

House Passes Bill to Help Prevent Prescription Drug Abuse

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 programs (PDMP). The National All Schedule Prescription Electronic Reporting (NASPER) Reauthorization Act, (H.R. 1725), authored by Rep. Edward Whitfield (R-Ky.) and Rep. … Continue Reading

340B Guidance: Eight Key Points Covered Entities Should Consider

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Dena Kessler, Nita Garg and Lindsay Holmes on Posted in Uncategorized
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 as “proposed” guidance by HRSA, the Guidance is intended to clarify a multitude of issues for the thousands of registered covered … Continue Reading

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

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 Amarin has a constitutional right to make certain “truthful and non-misleading” statements regarding unapproved uses of its drug, Vascepa. … Continue Reading

House Passes 21st Century Cures Act

Photo of Lance L. SheaBy Lance L. Shea and Nita Garg on Posted in Uncategorized
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 Century Cures Act” (Cures bill), is to accelerate the drug development process by reducing or removing regulatory obstacles. Specifically, … Continue Reading

21st Century Cures Act Passes House Committee

Photo of Lance L. SheaBy Lance L. Shea and Nita Garg on Posted in Uncategorized
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 medical innovation” bill, key provisions of the Cures bill are intended to speed marketing approval of drugs and medical devices. … Continue Reading

Otsuka Suit Results in Victory for FDA

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 Otsuka retained marketing exclusivity for the drug. This ruling was the most recent in a series of decisions regarding the FDA’s decision … Continue Reading

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

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 situations, the federal government (including the FDA, HHS-OIG, and DOJ) still holds policies and positions that disapprove of the practice. In … Continue Reading

FDA Finalizes Guidance Documents on Biosimilars

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Nita Garg, Dena Kessler and Lindsay Holmes on Posted in Uncategorized
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 to clarify its interpretation of the law. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure … Continue Reading

New Data on Part D Prescription Drugs Available

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 Part D Prescription Drug Program in 2013. CMS intends for this dataset to provide “key information to consumers, providers, researchers, and other stakeholders … Continue Reading

OIG Provides Additional Compliance Guidance for Healthcare Governing Boards

By B. Scott McBride and Nita Garg on Posted in Uncategorized
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 Association (HCCA), released a guidance document on compliance for healthcare governing boards, attorneys, compliance officers, and internal auditors. The insight provided by the … Continue Reading

FDA Establishes Docket for Public Comments on Drug Compounding

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 hopes that these public comments will provide insight on stakeholders’ experience and views regarding drug compounding as the … Continue Reading

FDA Guidance Documents Change Compounding Landscape

Photo of Lee H. RosebushBy Lee H. Rosebush, Cory J. Fox, Nita Garg and Dena Kessler on Posted in Uncategorized
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 documents detailing its view on assorted issues concerning implementation of the statute. The FDA’s most recent offering is … Continue Reading

Medicare Advantage and Medicare Part D Changes for 2016 Released

Photo of Lee H. RosebushBy Nita Garg and Lee H. Rosebush on Posted in Uncategorized
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 statutory requirements, improves program efficiencies, strengthens beneficiary protections, clarifies program requirements, improves payment accuracy, and makes technical changes … Continue Reading

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

By Nita Garg on Posted in Uncategorized
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. Patel, Seventh Circuit Court of Appeals, No. 14-2607, Feb. 10, 2015). Dr. Patel, a physician who often prescribed … Continue Reading

New Limitations on RAC Program

By B. Scott McBride and Nita Garg on Posted in Uncategorized
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 program on a restricted basis under a new contract that allows recovery auditors to review a limited number of … Continue Reading

Pharmacy Benefit Manager Faces Lawsuit by Compounding Pharmacies

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 pharmacy benefit manager (PBM) at the center of the dispute. The lawsuit alleges that Express Scripts is illegally denying prescriptions and causing … Continue Reading

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

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
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 Program. The mega rule was expected to cover contract pharmacy compliance and eligibility criteria for patients, hospitals and off-campus … Continue Reading

Medical Information More Valuable to Hackers Than Credit Card Numbers

Photo of Lynn SessionsBy Lynn Sessions and Nita Garg on Posted in Uncategorized
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 cyber attacks. Healthcare providers, already sensitive to the need for increased patient data protection in response to the 2013 … Continue Reading

CMS Offer Deadline to Settle Hospital Inpatient Claim Appeals Draws Near

By Nita Garg and B. Scott McBride on Posted in Uncategorized
In an attempt to clear the backlog of appeals of short inpatient stays, the Centers for Medicare and Medicaid Services (CMS) recently announced a settlement offer for hospitals with claims currently pending in the appeals process. In exchange for withdrawal of their appeals, CMS is offering these hospitals 68 percent of the net payable sum to resolve … Continue Reading
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