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

Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the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Today, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars.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 January 21, 2012, the Internal Revenue Service (IRS) released a revised version of Form 990 and accompanying instructions and schedules for tax year 2011. Notable changes to Form 990 and its associated schedules relate to joint ventures, investment partnerships, compensation disclosure and hospitals. In addition, the instructions to the revised form include many clarifications that were lacking in previous guidance.

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

Effective January 1, 2012, employers with 50 or more employees in Connecticut are required to pay sick leave to qualified “service workers.” Connecticut becomes the first state in the country to mandate paid sick leave. [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

Introduction

The core set of genetic test codes used by U.S. insurers and Medicare date to 1993. Only general information is conveyed by these codes to insurers – “DNA probe x 2.” They lead to payment for genetic tests based on a fixed price per genetic test step (such as “DNA probe x 2” or “DNA amplification x 3”). The payment was set using rules for the Medicare clinical laboratory fee schedule, rules which date to 1984. [more... ]

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. 

[more... ]

SUMMARY

On April 14, 2011, the Massachusetts Attorney General issued a report outlining two steps that the Attorney General will take to limit – but not explicitly ban – independent director compensation at public charities. [more...]

SUMMARY

The Federal Circuit yesterday issued a ruling in In re BP Lubricants USA, Inc., available here, that is likely to have a significant impact on the recent spate of lawsuits claiming “false marking.” In these lawsuits, a plaintiff alleges that the defendant is marking a product with a patent that does not, in fact, cover the product, and that the defendant is doing so “for the purpose of deceiving the public.”

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

On Dec. 29, 2010, CMS issued the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) Final Rule, which applies to Medicare outpatient ESRD dialysis providers and facilities (published on Jan. 5, 2011).

SUMMARY

CMS recently announced updates to the Medicare Physician Fee Schedule (MPFS), which affect Medicare payments to physicians for calendar year 2011.

SUMMARY

Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 08-1403, (December 17, 2010), available here.

In the first case to consider the patentability of a life sciences invention since the U.S. Supreme Court decided Bilski v. Kappos, the Federal Circuit held that medical treatment claims asserted by Prometheus Laboratories were eligible for patent protection.

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

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.

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.