CMS, CCIO, and IRS Release Guidance Proposals on Employer Health Insurance Coverage

The National Law Review recently published an article by Gary E. Bacher and Joshua Booth of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. regarding Employer Health Insurance Coverage:

The Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight (CCIIO) and the Internal Revenue Service (IRS) recently released four important documents related to the implementation of the Affordable Care Act (ACA) that address employer-provided health insurance plan reporting requirements and the availability of premium tax credits to individuals and families.  The ACA makes tax credits available to help individuals pay insurance premiums, but these credits do not apply if the individual is eligible for employer-provided coverage that is both affordable (in terms of required employee contribution to premium payments) and provides “minimum value” (in terms of overall cost-sharing).

CCIIO issued a Bulletin that describes the procedures it intends to use to verify whether an employee is eligible for employer-provided coverage, and thus precluded from claiming premium tax credits.  To help determine eligibility and availability of employer-provided coverage to an individual, the IRS issued a Notice and Request for Comment that solicits responses to how the IRS intends to determine whether coverage offered by an employer provides “minimum value,” as well as two Requests for Comment (RFC), Notice 2012-32 and Notice 2012-33, on how insurers, government agencies, and employers should be required to report insurance coverage data to implement sections 6055 and 6056 of the Internal Revenue Code, respectively.  The IRS will accept comments related to the above three issuances until June 11, 2012.

Together, all four issuances provide the government’s initial proposals of how to determine an individual’s eligibility for premium tax credits and when employers will be subject to penalties for failing to offer health care coverage.

The CCIIO Bulletin on Verification of Employer Coverage

The CCIIO Bulletin describes the process by which Health Insurance Exchanges (HIEs) will verify whether an individual is eligible for coverage through an employer. The CCIIO Bulletin recognizes that demonstrating that employer-sponsored coverage is unavailable or unaffordable requires data and documents that may not be easily obtainable by employees.  So, the CCIIO Bulletin suggests that theU.S. Department of Health and Human Services (HHS) will give applicants and employers guidance on what information will be needed, where it can be found, and the types of documentation required.  The CCIIO Bulletin also suggests that, where verification might be difficult, an HIE could initially accept an employee’s attestation that he or she is not eligible for employer-provided coverage and require the employee to provide supporting documentation of his or her ineligibility within 90 days of the attestation.  The CCIIO Bulletin anticipates that these strategies would be interim solutions to be used only until more reliable database systems can be implemented.

The IRS Notice on Calculating Minimum Value

The IRS Notice discusses approaches to determining whether employer-sponsored coverage provides minimum value.  The ACA generally states that a plan provides minimum value if it pays at least 60 percent of the enrollee’s costs for allowed expenses, thus having an actuarial value (AV) of at least 60 percent.  Minimum value is thus closely related to AV.  The Notice builds upon a bulletin regarding AV issued by CCIIO on February 24, 2012, and explicitly adopts many of its core calculation methodologies, such as basing AV on a standard population (adjusted for state or regional differences) and the methodology for evaluating employer’s contributions to an Health Savings Account (HSA).

Because the Notice applies to all employer-sponsored coverage including large group or self-insured health plans, while the February Bulletin applies only to individual and small group market plans, these plans’ distinct features required the IRS to propose an AV calculation methodology in the Notice that differs in certain ways from that proposed in the February Bulletin.  For instance, because self-insured and large group plans are not required to provide the essential health benefits (EHBs) upon which the calculations in the CCIIO Bulletin are based, the IRS has proposed that the AV for such plans would be calculated based on four core categories of benefits: “physician and mid-level practitioner care, hospital and emergency room services, pharmacy benefits, and laboratory and imaging services.” In addition, the population set on which this calculation is based will the population for a “typical self-insured employer-sponsored plan,” rather than the general population that is described in the February Bulletin.

New requirements related to employer-provided health coverage are an integral component of health care reform, so industry responses to the above-described guidance will be important in shaping how the ACA’s changes will be implemented.

©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012

The National Law Review is pleased to bring you information about an upcoming conference:

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012 in Washington, DC

The marcus evans 5th Product and Pipeline Enhancement for Generics Conference will host industry leaders within the Generic Pharmaceutical, Branded Pharmaceutical and API industries operating globally as they share best practices, strategies and tools on portfolio management and business strategy, as well as legal, intellectual property and patent issues.

Featuring case studies from leading generics experts, including:

  • Richard Dicicco, Chairman at Harvest Moon Pharmaceutical
  • Dr. Vijay Soni, Executive Vice President, IP, BD and Product Portfolio at Glenmark Pharmceuticals
  • Candis Edwards, Senior Vice President, Regulatory Affairs & Compliance at Amneal Pharmaceuticals
  • Gregory Fernengel, Senior Intellectual Property Counsel at Ben Venue Laboratories, Inc.
  • Markus H. Meier, Assistant Director, Health Care Division, Bureau of Compensation at Federal Trade Commission
  • Vishal K. Gupta, Chief Scientific Officer, Vice President, Research & Development at CorePharmaLLC
  • Sherri Leonard, VP, Business Development and Portfolio Management at OrchidPharma, Inc.

Attendees will leave this conference with a better understanding of:
1. Current and upcoming FDA proposals and regulations to ensure compliance
2. Innovation in the drug pipeline
3. Portfolio management and business development
4. How to protect the company’s patents’ and intellectual property
5. Expanding the commercial reach through biosimilars
6. Market changes and future industry developments

Testimonials:

“Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis

”Terrific chance to connect with other industry traders to exchange ideas and explore solutions to the challenges we all face.” – OrchidPharma

Upcoming Spring 2012 CLE National Institutes

The National Law Review is pleased to bring you information about the ABA’s Upcoming Spring 2012 CLE National Institutes:

Learn and network at these in-person,full-day or multi-day seminars held live in various locations across the country that draw lawyers from across the nation.

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012

The National Law Review is pleased to bring you information about an upcoming conference:

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012 in Washington, DC

The marcus evans 5th Product and Pipeline Enhancement for Generics Conference will host industry leaders within the Generic Pharmaceutical, Branded Pharmaceutical and API industries operating globally as they share best practices, strategies and tools on portfolio management and business strategy, as well as legal, intellectual property and patent issues.

Featuring case studies from leading generics experts, including:

  • Richard Dicicco, Chairman at Harvest Moon Pharmaceutical
  • Dr. Vijay Soni, Executive Vice President, IP, BD and Product Portfolio at Glenmark Pharmceuticals
  • Candis Edwards, Senior Vice President, Regulatory Affairs & Compliance at Amneal Pharmaceuticals
  • Gregory Fernengel, Senior Intellectual Property Counsel at Ben Venue Laboratories, Inc.
  • Markus H. Meier, Assistant Director, Health Care Division, Bureau of Compensation at Federal Trade Commission
  • Vishal K. Gupta, Chief Scientific Officer, Vice President, Research & Development at CorePharmaLLC
  • Sherri Leonard, VP, Business Development and Portfolio Management at OrchidPharma, Inc.

Attendees will leave this conference with a better understanding of:
1. Current and upcoming FDA proposals and regulations to ensure compliance
2. Innovation in the drug pipeline
3. Portfolio management and business development
4. How to protect the company’s patents’ and intellectual property
5. Expanding the commercial reach through biosimilars
6. Market changes and future industry developments

Testimonials:

“Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis

”Terrific chance to connect with other industry traders to exchange ideas and explore solutions to the challenges we all face.” – OrchidPharma

Upcoming Spring 2012 CLE National Institutes

The National Law Review is pleased to bring you information about the ABA’s Upcoming Spring 2012 CLE National Institutes:

Learn and network at these in-person,full-day or multi-day seminars held live in various locations across the country that draw lawyers from across the nation.

The Health Effects of Divorce can be both Detrimental and Beneficial

Recently an article by Rebecca L. Palmer and Crystal Espinosa Buit of Lowndes, Drosdick, Doster, Kantor & Reed, P.A. regarding The Health Effects of Divorce was published in The National Law Review:

Divorces affect every aspect of an individual’s life – their financial situation, their children, their home, their friendships, everything. Divorces are notoriously stressful events and, while a stressful marriage can absolutely consume a person to their detriment, many people would also agree that their lives are negatively impacted in some way by the process. What most people may not recognize, however, is how significant a role divorce plays in their overall mental and physical health. While short term effects are generally associated with divorce, recent studies have focused on the long-term impacts to health. The findings are troubling. In a 2009 study conducted by sociologists Linda Waite and Mary Elizabeth Hughes of the University of Chicago, research showed that divorced or widowed individuals are 20 percent more likely than married people to have chronic health conditions, such as heart disease, diabetes, or cancer. In addition, they also showed 23 percent more mobility limitations, such as trouble climbing stairs or walking. The study, which examined the marital history and health indicators for 8,652 people between the ages of 51 and 61, focused on four categories: chronic health conditions, mobility, depressive symptoms and self-assessment. The results of the study support the contention that those who experience a divorce or the death of a spouse have long-term negative consequences related to their health.

University of Texas at Austin researcher Mark Hayward tells WebMD “that long-term stress before, during, and after a divorce may accelerate the biologic processes that lead to cardiovascular disease and possibly other chronic diseases.” In his study on the impact of divorce on heart disease, he showed that divorced, middle-aged women were more likely to develop heart disease than other non-divorced, married women. Although Hayward’s study focused on women, the health consequences of divorce are not specific to gender. In a 2010 article on marriage and men’s health, the Harvard Medical School cited a MFRIT study of 10,904 American married men which revealed that men who divorced were 37 percent more likely to die during the nine-year study than men who remained married. This may be due to the biological effects stress is having on men and women alike. The Harvard Medical School notes that stress triggers inflammation, which is a newly recognized cardiac risk factor. Thus, it may come as no surprise that divorced men have higher levels of inflammatory markers than married men.

Divorce also alters lifestyle habits and behaviors that may adversely affect health. Researchers from Ohio State University found that, two years after a divorce, separated partners tended to be heavier as compared to couples who remained married, although men showed larger weight gains than women. Harvard Medical School similarly points out that divorced men don’t eat as well as married men. Furthermore, divorced men are less likely to exercise and are more likely to smoke, drink excessively, and engage in other risky behaviors. It is clear that divorce may cause some people to engage in destructive conduct that inevitably affects their physical and mental well being.

There is no doubt that electing to end your marriage is a decision that should be weighed heavily. The unsettling studies on the health effects of divorce can only lead one to question why divorce has such a powerful impact on a person’s health. When discussing her research on the subject, sociologist Linda Waite noted that “previous research suggests that marriage has protective health benefits by providing financial, social, and emotional stability.” Specifically, women often have more financial security, thus allowing them access to health care and reduced stress, while married men have better health habits in comparison to single males. It also goes without saying that the stress of determining the division of marital assets and child custody directly contributes to this impact.

On the other hand, while a healthy marriage has been shown to provide protective health benefits, several studies also “show that the marriage advantage doesn’t extend to those in troubled relationships, which can leave a person far less healthy than if he or she had never married at all.” One study, for instance, showed that a stressful marriage can be as bad for the heart as a regular smoking habit. Further, just as divorce has been found to negatively impact women’s health specifically, researchers have also found that “bad relationships [are] bad for health” as women in troubled relationships (who likely face anger, stress and hostility) are more likely than other women to be depressed, have metabolic syndrome, low levels of HDL (good) cholesterol, abdominal obesity, and elevated blood sugar – “all basically steps on the road to heart attack or diabetes.”

Accordingly, it is important to remember that, while divorce has been shown to have negative impacts on health, this is not true for everyone as an unhealthy relationship can also lead to certain health problems, including physical ailments and mental depression. As researcher Mark Hayward noted, “For people in highly stressful marriages, divorce may be beneficial for their health.”

Ultimately, those seeking to prevent their current circumstances, whether a troubled marriage or divorce, from impacting their physical and mental health should seek measures to reduce stress and remember that a divorce should serve as a gateway to a healthier and happier life. When going through a divorce it is vital to remember the basics – eat well, exercise and, quite simply, remember to do the things that make you happy. Further, surrounding oneself with a supportive environment and attending counseling, if needed, will lessen health risks by helping one to cope with the stress.

© Lowndes, Drosdick, Doster, Kantor & Reed, PA

Upcoming Spring 2012 CLE National Institutes

The National Law Review is pleased to bring you information about the ABA’s Upcoming Spring 2012 CLE National Institutes:

Learn and network at these in-person,full-day or multi-day seminars held live in various locations across the country that draw lawyers from across the nation.

Upcoming Spring 2012 CLE National Institutes

The National Law Review is pleased to bring you information about the ABA’s Upcoming Spring 2012 CLE National Institutes:

Learn and network at these in-person,full-day or multi-day seminars held live in various locations across the country that draw lawyers from across the nation.

Upcoming Spring 2012 CLE National Institutes

The National Law Review is pleased to bring you information about the ABA’s Upcoming Spring 2012 CLE National Institutes:

 

Learn and network at these in-person,full-day or multi-day seminars held live in various locations across the country that draw lawyers from across the nation.

Supreme Court Invalidates Biotech Method Patent in Mayo v. Prometheus

Recently an article by Richard G. Gervase, Jr. and Daniel W. Clarke, Ph.D. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. regarding Biotech Patents recently appeared in The National Law Review:

On March 20, 2012, the United States Supreme Court handed down a groundbreaking decision in the field of biotechnology; however, the repercussions of this decision will be felt throughout the patent community. In a highly anticipated decision, the Court reversed the United States Court of Appeals for the Federal Circuit in Mayo Collaborative Services and Mayo Clinic Rochester v. Prometheus Laboratories, Inc., unanimously finding that process claims directed to optimizing the dosage of a drug for treatment of an immune-mediated gastrointestinal disorder are invalid because they effectively claim no more than an underlying law of nature.

The two patents at issue are exclusively licensed to Prometheus, who sells diagnostic tests that employ the patented processes. At first, Mayo bought and used these diagnostic tests; however, in 2004, Mayo decided to use and sell a slightly different diagnostic test. Prometheus responded by bringing an infringement action in the United States District Court for the Southern District of California, which found that although Mayo infringed a claim of a Prometheus-licensed patent, the asserted claims were invalid for being drawn to non-statutory subject matter. The District Court reasoned that the patents claimed “natural laws or natural phenomena,” which are not entitled to patent protection. Specifically, the District Court opined that the correlations between metabolite levels and the toxicity and efficacy of drug dosages are patent-ineligible laws of nature. The Federal Circuit reversed, and held that the claims were directed to patent-eligible subject matter because they “transform an article into a different state or thing,” and the transformation was “central to the purpose of the claimed process.” The Federal Circuit subsequently reaffirmed this decision on remand from the Supreme Court for reconsideration in view ofBilski v. Kappos.

The question presented to the Supreme Court in Mayo v. Prometheus was “whether the claimed processes have transformed unpatentable natural laws into patent-eligible applications of those laws.” The Court recognized that the threshold inquiry to determine whether a claim is directed to patent-eligible subject matter is governed by 35 U.S.C. § 101, which provides “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

The representative claim analyzed by the Court was directed to methods of calibrating the optimal dosage of a thiopurine drug by administering the drug, and determining the level of subsequent metabolites, where certain metabolite levels correlate with certain results. The Court relied on case precedent, including Diamond v. Diehr and Gottschalk v. Benson, for the proposition that the meaning of “process” in § 101 has been limited to exclude fundamental principles, such as “laws of nature, natural phenomena, and abstract ideas,” but noted that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” The Court concluded that the claims were not patent eligible, reasoning that the claims were merely instructions to apply a natural law, i.e., a natural correlation.

Specifically, the Court stated that the additional steps of “administering” and “determining,” along with the “wherein” clauses, “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.”

Although the Court recognized that in determining whether additional claim steps are routine or conventional, a § 102 novelty inquiry and a § 101 statutory subject matter inquiry “might sometimes overlap,” Justice Breyer repeatedly emphasized that from a policy perspective, a patent should not preempt natural correlations, thereby improperly inhibiting future innovation. The Court also warned that a non-statutory law of nature cannot be transformed into subject matter that is eligible for patent protection by mere clever claim drafting that amounts to no more than “insignificant post-solution activity.”

How the Supreme Court’s decision will impact medical diagnostic patents and patent applications in the future remains to be seen. We note that the Court declined to opine on the desirability of increased protection for diagnostic correlations, inviting Congress to develop “more finely tailored rules” for patent eligibility should the legislature disagree with the Court’s conclusion.

©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.