The United States recently passed the “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act), sweeping legislation that could impact pharmaceutical and medical device companies with U.S. operations or significant U.S. sales. A team of Reed Smith life sciences and health care lawyers, including Scot T. Hasselman, Robert J. Hill, Carol Colborn Loepere, Kevin M. Madagan, Paul W. Pitts, James … Continue Reading
On October 13, 2019, California Governor Gavin Newsom signed into law Assembly Bill 744 (AB 744), marking the latest of many state legislative efforts to modernize health care by ensuring that telehealth services are paid and covered, similar to their face-to-face counterparts. Effective January 1, 2021, the statutory language added by AB 744 requires newly … Continue Reading
Last week marked the end of legislative activity in the state of California for 2019, and with the impending California Consumer Privacy Act (CCPA or the Act) going into effect on January 1, 2020, many businesses were waiting optimistically for some clarification on lingering questions. The California legislature did pass five bills amending the Act, … Continue Reading
The newly-enacted Bipartisan Budget Act of 2018 includes numerous Medicare, Medicaid, and other policy and payment provisions impacting health providers and manufacturers. Of particular note, the new law: increases Medicaid rebate obligations with respect to line extension drugs; changes manufacturer discount obligations in the Medicare Part D “donut hole”; repeals the Independent Payment Advisory Board … Continue Reading
As covered in “Court Overturns $350 Million Judgment in FCA Case: Materiality, Scienter, and Causation Standards Preclude Liability by “’Zaps, Traps, and Zingers’”, Andy Bernasconi discusses a recent case, in which the Middle District of Florida issued a blistering opinion vacating a $350 million judgment in a False Claims Act (FCA) case and granting the … Continue Reading
In France, transparency requirements are regulated by two main sets of laws: “The French Anti-Gift Law” regulates the provision of gifts, discounts and other incentives to health care providers by life sciences companies, while “the French Sunshine Act” imposes disclosure obligations on companies relating to benefits granted to, and agreements concluded with, health care providers. … Continue Reading
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). It is hoped that provisions in the new bill, and the $6.3 billion it provides for medical research over the next decade, will spur innovation and new progress in medical treatments for the patients who need them. This Client … Continue Reading
The HHS Office of Civil Rights (“OCR”) published a final rule May 18, 2016, broadening the nondiscrimination requirements applicable to all health programs and activities receiving federal financial assistance from HHS, those administered by HHS, and Health Insurance Marketplaces. The final rule implements section 1557 of the ACA and adds two important categories of protections: … Continue Reading
For some time, we have been reporting on issues involving federal government scrutiny of physician-owned distributors (“PODs”). From our blog post here on the Department of Health and Human Services Office of Inspector General’s (“OIG”) issuance of the March 2013 OIG Special Fraud Alert (“Special Fraud Alert”), to our post here on the Reliance Medical … Continue Reading
On February 9, 2016, the Obama Administration released its proposed fiscal year (FY) 2017 budget, which contains significant Medicare and Medicaid reimbursement and program integrity legislative proposals – including $419 billion in Medicare savings over 10 years. These proposed policy changes would require action by Congress, and Republican Congressional leaders have already voiced general opposition … Continue Reading
As previously discussed here and over on Health Industry Washington Watch here, this past Thursday, CMS and OMB issued the final, 600+ page Medicaid Rebate Program Final Rule. The pre-Federal Register version of the final rule may be accessed here. While we are still processing what this will mean for drug manufacturers and other health … Continue Reading
As noted in our recent Health Industry Washington Watch blog post, outgoing House Speaker John Boehner and the Obama Administration have reached agreement on a two-year, $80 billion budget/debt-ceiling deal that includes Medicare and Medicaid “offsets” to finance other spending. For manufacturers of generic pharmaceuticals marketed under abbreviated new drug applications, Section 602 of the proposed … Continue Reading
The Department of Health and Human Services (HHS) and Office of Inspector General (OIG) issued Advisory Opinion 15-11 stating that the OIG will not impose sanctions on individuals for a program that provides free drugs to patients experiencing late insurance approvals. The OIG concluded that, although the arrangement has the potential to generate improper payment under … Continue Reading
On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for approving innovative drugs and medical devices, and to address other issues, including those regarding clinical trial design, research funding, and … Continue Reading
The United States Supreme Court has declined to hear a challenge to the Alameda County Drug Disposal Ordinance (“Ordinance”) brought by three pharmaceutical trade organizations. The Court’s decision leaves in force the Ninth Circuit decision, which found that the Ordinance, requiring pharmaceutical manufacturers to fund drug take-back programs in the county, did not interfere with … Continue Reading
Over on the Health Industry Washington Watch blog, Reed Smith attorneys Katie Pawlitz and Jeremy Alexander highlight the proposed changes to the Sunshine Act contained within H.R. 6, the “21st Century Cures Act,” which (as previously reported on Life Sciences Legal Update) was approved by the House Energy and Commerce Committee last Thursday, May 21, … Continue Reading
Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals, pharmaceutical and medical device manufacturers, and government officials, among others. As Reed Smith partner Daniel Kadar points out in “The French Sunshine … Continue Reading
Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, … Continue Reading
The bipartisan leadership of the House Energy and Commerce Committee has released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment development and delivery of treatment to patients. The nearly 200-page legislation is the product of a year-long collaboration between lawmakers and stakeholders.… Continue Reading
Last week, President Obama signed into law a bill that will eradicate Social Security Numbers (SSNs) from all Medicare beneficiary cards over the next eight years. Medicare has four years to begin issuing cards with new identifiers, and four years after that to reissue cards to current beneficiaries. The removal of SSNs from the cards is not only expected to decrease the risks associated with identity theft for Medicare beneficiaries, but also Medicare's risk of exposure associated with breaches of protected health and personal information under HIPAA and state privacy laws.… Continue Reading
On April 16, 2015, President Barack Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The bill permanently transforms the structure of Medicare physician reimbursement and enacts several changes to Medicare payment, program integrity and policy provisions that will affect both health care providers and pharmaceutical/medical device manufacturers. The most … Continue Reading
The French government issued a bill on March 17 for the extension of class actions to health-related claims in France. Starting today, March 31, the text will be discussed at the French National Assembly, particularly to address the issue of compensation for personal injury within the framework of the proposed class action.… Continue Reading
French Minister for Economic Affairs Emmanuel Macron recently introduced a bill proposing the recognition of legal privilege for in-house lawyers in France, which does not currently exist. However, this recognition was rejected by the Special Commission of the French National Assembly before the bill was passed by the lower chamber - a decision consistent with the Grand Chamber of the European Court of Justice's 2010 ruling in Akzo.… Continue Reading
As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and available for patient use. The House Energy and Commerce Committee’s “21st Century Cures Act” discussion draft, released on January 27, 2015, is a wide-reaching bill … Continue Reading
