Foley Hoag LLP

SUMMARY

Section 2715 of the Public Health Service Act (PHS Act), which was enacted as part of the Patient Protection and Affordable Care Act (also referred to as PPACA, the Affordable Care Act, or the ACA), requires health insurers and group health plans offering health care coverage to enrollees and beneficiaries in the plan to provide a “Summary of Benefits and Coverage” (SBC) and Uniform Glossary to insured individuals and plan enrollees.  The purpose of the SBC is to ensure that individuals enrolled in these plans are able to receive a simple, easy-to-understand summary of the benefits and coverage available under their plan.

SUMMARY

After nearly a year and half of negotiations with Bank of America, Wells Fargo, JPMorgan Chase, Citi, and GMAC, 49 state attorneys general yesterday announced a settlement regarding mortgage servicing and foreclosure issues.  Joining the settlement was Massachusetts, which had filed a lawsuit against the five banks on December 1, 2011. There are at least two significant aspects to the settlement for Massachusetts.

SUMMARY

Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), signed into law in March 2010 as part of the Patient Protection and Affordable Care Act.

SUMMARY

Today, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars.  Biosimilar products are biological products shown to be highly similar to, or interchangeable with, biological products previously approved by FDA (known as reference products).  Section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), signed into law in March 2010 as part of the Patient Protection and Affordable Care Act, established an abbreviated approval pathway for biosimilar products.  Applications to FDA seeking approval of biosimilar products are known as 351(k) applications.

SUMMARY

On December 14, 2011, the Centers for Medicare & Medicaid Services (“CMS”) released the long-awaited Proposed Rule for implementing the so-called “Sunshine Act” physician payment reporting requirements. These proposed regulations provide some additional clarity regarding the reporting obligations for most drug and device manufacturers, contained in Section 6002 of the Affordable Care Act (“the Act”). The Act will require most drug and device manufacturers to file annual disclosure reports detailing their financial relationships with physicians and teaching hospitals.  [more... ]

SUMMARY

The last decade has seen the creation of complex genomic tests, sometimes as the outcome of tens of millions of dollars of research, designed from ground up to solve a recognized clinical problem. These tests, which range in price from $500 to $3000, are the “poster child” for the potential as well as the challenges when genomics and advanced bioinformatics are brought together and enter the clinic. According to a number of published studies, at least some tests in these categories can be net cost-saving in real-world scenarios, in addition to improving medical decision-making.

In March 2012, the local Medicare contractor for all California-based laboratories plans to launch an elaborate program for genomic test evaluation, coding, and pricing. This essay discusses major features of the program, as they have been released up to November 2011. The program is likely one of the most distinctive strategic policy efforts proposed by a Medicare contractor in the forty-five year history of the Medicare program. 

SUMMARY

Overview

Yesterday, the United States Supreme Court granted certiorari (meaning it has agreed to hear an appeal) on three petitions concerning the constitutionality of the Affordable Care Act (“ACA”). Given the Supreme Court’s timeline for the filing of briefs, oral argument will likely be scheduled for the end of March or beginning of April 2012. The Supreme Court has set aside five and a half hours for oral arguments on four different issues. Under this timeline, the Court’s final ruling will likely be handed down at the end of June 2012, just before the Court recesses for the summer.

Key Points About The Decision

The Supreme Court has complete discretion to decide which cases (and which issues raised by those cases) it will hear. Each year the Court receives approximately 10,000 certiorari petitions, of which it hears between 80 and 100. A petition must receive the vote of four Justices to be granted certiorari. [continues...]

SUMMARY

On Thursday, June 23, the United States Supreme Court voted 6-3 to strike down a Vermont statute that sought to impose significant restrictions on pharmaceutical detailing and “data mining” activities. Justice Kennedy’s opinion in the closely-watched case of Sorrell v. IMS Health Inc. held that the Vermont statute was an unconstitutional regulation of commercial speech. In so doing, the Court found that the sale, disclosure, and use of redacted pharmacy records containing physician prescribing information constituted “speech in aid of pharmaceutical marketing” and therefore enjoyed First Amendment protection. This case is an important victory for the pharmaceutical, medical device, biotechnology, and related sectors, The following summarizes this ruling and its potential consequences to those involved in these industries. 

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SUMMARY

CDRH Hopes to Increase “Predictability, Reliability, and Efficiency”

In response to protracted public and political criticism of the Food and Drug Administration’s (FDA or Agency) regulation and review of medical devices under the premarket notification, or 510(k), process, the FDA’s Center for Devices and Radiological Health (CDRH or Center) today released a set of proposed reforms to better “foster medical device innovation and assure the safety and effectiveness of medical technology.” [more...]

SUMMARY

The I.R.S. has recently issued its annual cost-of-living adjustments applicable in 2011 to qualified retirement (pension, profit-sharing, § 401(k), money purchase and stock bonus) plans. Generally, there has been such a low rate of inflation in the nation’s economy that many of these cost-of-living adjustments will remain unchanged.

SUMMARY

As the end of 2010 approaches and we receive numerous inquiries concerning developing hiring plans, I thought you might be especially interested to note some particulars about the Hiring Incentives to Restore Employment Act (the “HIRE Act”) which was enacted earlier this year to stimulate prompt hiring of workers by businesses.

SUMMARY

The Affordable Care Act (§ 9008, as amended by § 1404 of the Reconciliation Act), established an annual fee that will be imposed on covered entities that manufacturer or import branded prescription drugs.

The Department of Treasury recently issued guidance on this new annual fee, available at http://www.irs.gov/pub/irs-drop/n-10-71.pdf . The guidance describes a proposed methodology for calculating the fee, how the IRS will use the methodology to provide covered entities with a preliminary 2011 fee calculation, and solicits public comments. Comments must be submitted by June 2, 2011.

IRS Form 8947, which is referenced in the guidance, is available at http://www.irs.gov/pub/irs-pdf/f8947.pdf

SUMMARY

In this Issue: 

• The Sarbanes-Oxley Act provides whistleblower protection to certain employees who report wrongdoing by a publicly-traded company.

• A federal district court in Massachusetts has held that Sarbanes-Oxley whistleblower protection covers not only employees of the publicly-traded company, but also employees of that companys contractors, subcontractors, and agents.

• The district court is the only one in the United States that has interpreted Sarbanes-Oxley whistleblower protection to be so broad.

• The First Circuit has accepted the case for interlocutory appeal, and will likely be the first appellate court to determine the proper coverage of Sarbanes-Oxley whistleblower protection.
  

SUMMARY

The Affordable Care Act (also known as the ACA) was enacted earlier this year culminating over a year of intense political negotiations, legislative drafting and numerous Congressional hearings over whether, and how, to comprehensively reform the nation's health care system.

SUMMARY

On Wednesday, August 4, 2010, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released for public comment two preliminary reports recommending steps to: (1) foster medical device innovation; (2) enhance regulatory predictability; and (3) improve patient safety. According to CDRH Director Jeffrey Shuren, MD, JD, the actions proposed in the reports represent “a blueprint for smarter medical device oversight” and are intended to advance CDRH’s responsibility to both protect and promote public health. The reports were prepared by two separate internal groups within CDRH, both convened in September 2009.  [continues... ]

SUMMARY

Transparency Initiative

In June 2009, Dr. Margaret Hamburg, the newly appointed Commissioner of Food and Drugs, announced the Food and Drug Administration (“FDA” or “Agency”) Transparency Initiative and created the FDA Transparency Task Force to carry out the Initiative. The goals of the initiative were in keeping with President Obama’s January 2009 memorandum calling for “creating an unprecedented level of openness in Government” to “promote accountability and provide information for citizens about what their Government is doing.”    [continues...]

SUMMARY

As provisions of the Patient Protection and Affordable Care Act (PPACA), Pub. L. No. 111-148 are implemented to expand coverage and improve the quality of health care, it is important for the health care industry to be aware of another provision in PPACA – the Cures Acceleration Network, which will be a valuable tool to fund the development of cutting edge drugs, diagnostics, biologics, and medical devices.  [continues... ]

SUMMARY

The Qualifying Therapeutic Discovery Project Tax Credit program was created by the Patient Protection and Affordable Care Act (PPACA), Pub. L. No. 111-148. This new, and temporary, program will be a valuable tool to incentivize industry to develop cutting edge drugs, diagnostics, biologics, and medical devices.  [continues... ]

SUMMARY

Last week, President Obama signed into law the Continuing Extension Act of 2010, which among other provisions, provides for another extension of the federal COBRA subsidy created by the American Recovery and Reinvestment Act of 2009 (“ARRA”). Under ARRA, employees who were involuntarily terminated between September 1, 2008 and December 31, 2009 are entitled to a government subsidy of 65% of the premium cost for health care continuation coverage under COBRA.

SUMMARY

President Obama has signed the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) and an associated reconciliation bill that "fixes" certain fiscal elements in the Act. The Act is intended over ten years to expand health coverage to 32 million uninsured Americans and reduce the Federal budget deficit by $143 billion, while banning discrimination on the basis of pre-existing conditions, gender or health status, and ending lifetime and annual limits on health benefits. [continues... ]