Ms Meenakshi Datta

Meenakshi Datta

Updates

Healthcare & Life Sciences

Government will allow broader use of co-pay accumulator programmes for 2020
USA | 18 September 2019

The Department of Health and Human Services (HHS), the Department of Labour and the Treasury have jointly announced that they will not enforce the HHS's recently finalised policy that limits private health plans' use of accumulator programmes to prescription brand drugs for which a medically appropriate generic equivalent is available. Stakeholders should remain alert to any changes in state enforcement policies and consider opportunities to engage with the administration on future revisions.

California passes sweeping prescription drug price transparency law and co-pay coupon ban
USA | 06 December 2017

California recently passed two bills with significant implications for pharmaceutical manufacturers: one imposing prescription drug price transparency requirements and another prohibiting certain types of co-pay coupon and other prescription drug discounting programmes that lower patient cost-sharing amounts for prescription drugs.

HHS significantly expands permissive exclusion authority
USA | 08 February 2017

The US Department of Health and Human Services Office of Inspector General (OIG) recently published a final rule that provides guidance on its new and expanded bases for permissive exclusion from federal healthcare programmes. The preamble to the final rule addressing the OIG's enlarged exclusion authority suggests that the agency views its enforcement oversight as mirroring the reach of the False Claims Act.

OIG finalises long-awaited rules on civil monetary penalties and new Anti-kickback Statute safe harbours
USA | 18 January 2017

The US Office of Inspector General recently finalised two key proposed rules. The first relates to the civil monetary penalties and exclusion statutes, and the second amends the safe harbours to the Anti-kickback Statute and the definition of 'remuneration' under the beneficiary inducements civil monetary penalty.

Advocate Health to pay largest-ever HIPAA settlement
USA | 31 August 2016

Advocate Health Care Center has agreed to pay $5.55 million to settle multiple violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This is the largest HIPAA settlement to date against a single entity and is reportedly due to the severity of the HIPAA violations and the length of time that they were allowed to persist.

CMS issues FAQs on Medicaid Drug Rebate Programme final rule
USA | 27 July 2016

The Centres for Medicare and Medicaid Services (CMS) recently issued frequently asked questions (FAQs) regarding the Covered Outpatient Drug Final Rule and a state Medicaid director letter. The FAQs address topics such as calculating the average manufacturer price, determining the best price, the treatment of line extensions and the setting of state reimbursement rates.

FTC issues guidance for mHealth app developers
USA | 27 April 2016

The Federal Trade Commission – in coordination with the Food and Drug Administration, the Department of Health and Human Services' Office for Civil Rights and the Office of the National Coordinator for Health Information Technology – has developed an interactive web-based tool to help mobile health app developers to understand what federal laws and regulations might apply to their apps.

Medicaid drug reimbursement and rebates: final rule with comment period
USA | 10 February 2016

The Centres for Medicare and Medicaid Services recently released an advance-print copy of the long-awaited final rule on the Medicaid Drug Rebate Programme. The final rule implements various statutory amendments, revises the calculation of average manufacturer price, changes the determination of best price and addresses other issues relating to Medicaid price reporting and reimbursement.

OIG issues advisory opinion addressing clinical study patient subsidies
USA | 01 July 2015

The Office of Inspector General has issued an advisory opinion offering several new points of guidance for medical device manufacturers in the process of designing patient subsidies for clinical research studies. Clinical studies involving subsidies paid to patient participants are less likely to violate the federal Anti-kickback Statute or the federal prohibition on beneficiary inducements if certain criteria are fulfilled.

OIG issues report and advisory bulletin on manufacturer-sponsored coupons
USA | 22 October 2014

The US Department of Health and Human Services' Office of Inspector General (OIG) recently issued a controversial report entitled "Manufacturer Safeguards May Not Prevent Copayment Coupon Use for Part D Drugs", along with a companion special advisory bulletin. The report and the advisory bulletin reflect the OIG's efforts to use transparency as a way to reduce what it considers to be a source of fraud and abuse.

OIG issues alert regarding laboratory relationships with physicians
USA | 10 September 2014

The Department of Health and Human Services' Office of Inspector General has released a special fraud alert addressing two increasingly common relationships between clinical laboratories and physicians that may raise fraud and abuse concerns – payments to referring physicians for specimen collection and data submission/review for laboratory registries.

OCR levies nearly $2 million in fines for stolen unencrypted laptops
USA | 07 May 2014

The Department of Health and Human Services Office for Civil Rights recently announced that Concentra Health Services Inc and QCA Health Plan Inc have agreed to pay a total of $1,975,220, collectively, to resolve potential violations of the Health Insurance Portability and Accountability Act Privacy and Security Rules stemming from the theft of unencrypted laptops.

Sunshine Act data submission delayed
USA | 12 March 2014

The Centres for Medicare and Medicaid Services announced that Physician Payments Sunshine Act registration and data submission for applicable manufacturers and group purchasing organisations will be executed in two phases. Detailed payment information covering August to December 2013 will be due no earlier than May 2014.

Health Insurance Portability and Accountability Act enforcement continues
USA | 24 July 2013

The Department of Health and Human Services recently announced that Shasta Regional Medical Centre (SRMC) had agreed to pay $275,000 and enter into a one-year corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act Privacy Rule. The settlement relates to allegations that SRMC disclosed a patient's protected health information to media sources and its entire workforce.

OCR issues new guidance on methods to de-identify protected health information
USA | 16 January 2013

The Office for Civil Rights (OCR) has issued important new guidance regarding the two existing methods by which covered entities may de-identify protected health information in accordance with the privacy rule promulgated under the Health Insurance Portability and Accountability Act. The guidance may signal that the OCR will make proper de-identification of protected health information an enforcement priority.