I. REGULATIONS, NOTICES, & GUIDANCE
- On November 21, 2014, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016”. This proposed rule would set forth payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It would also provide additional standards for the annual open enrollment period for the individual market for benefit years beginning on or after January 1, 2016, essential health benefits, qualified health plans, network adequacy, quality improvement strategies, the Small Business Health Options Program, guaranteed availability, guaranteed renewability, minimum essential coverage, the rate review program, the medical loss ratio program, and other related topics. Comments are due December 26, 2014.
- On November 21, 2014, the Internal Revenue Service (IRS) released final regulations entitled “Minimum Essential Coverage and Other Rules Regarding the Shared Responsibility Payment for Individuals”. This document contains final regulations relating to the requirement to maintain minimum essential coverage enacted by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, as amended by the TRICARE Affirmation Act and Public Law 111-173 (collectively, the Affordable Care Act, or ACA). These final regulations provide individual taxpayers with guidance under section 5000A of the Internal Revenue Code on the requirement to maintain minimum essential coverage and rules governing certain types of exemptions from that requirement. These regulations are effective immediately.
- On November 21, 2014, the Office of Personnel Management (OPM) released a proposed rule, entitled “Establishment of the Multi-State Plan Program for the Affordable Insurance Exchanges”, to implement modifications to the Multi-State Plan (MSP) Program based on the experience of the Program to date. This proposed rule clarifies the approach used to enforce the applicable requirements of the ACA with respect to health insurance issuers that contract with OPM to offer MSP options. The proposed rule amends MSP standards related to coverage area, benefits, and certain contracting provisions under section 1334 of the ACA. Comments are due December 26, 2014.
- On November 17, 2014, the Food and Drug Administration (FDA) released draft guidance for industry entitled “Rare Pediatric Disease Priority Review Vouchers”. Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section. These vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. These vouchers can be sold or transferred for use to another sponsor any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. Comments on the draft guidance are due January 16, 2014.
- On November 17, 2014, the Census Bureau released a proposed study entitled “Comparing Health Insurance Measurement Error (CHIME)”. This study is designed to assess reporting accuracy in surveys that measure health insurance. Several federal, state and private surveys measure health insurance coverage, but have different origins and methodological approaches, and serve different purposes. They also produce different estimates of coverage, and few studies have assessed reporting accuracy across surveys. Previous research indicates that much of the variation in the estimates is rooted in subtle differences in the questionnaires. A common strategy for assessing the validity of a self-reported measure from a survey is a reverse ‘‘record check’’ study in which administrative records are assumed to contain the correct status on a given measure (e.g., health insurance coverage). Contact information from the records is used as sample to conduct a survey in which the same information, in this case health insurance, is asked about. Data from the records is then compared to the answers from the survey to assess reporting accuracy. The proposed study will survey a sample of people enrolled in Medica Health Plans (a Minnesota based health insurance plan) whose coverage type is known from the records to be Medicaid, MinnesotaCare, employer-sponsored insurance, non-group coverage within the marketplace (called MNSure) or non-group coverage outside the marketplace. Comments are due January 16, 2015.
- On November 17, 2014, CMS announced that the following information collection activity had been submitted to the Office of Management and Budget (OMB) for review: “Payments for Services Furnished by Certain Primary Care Providers and Supporting Regulations in 42 CFR 438.804, 447.400, and 447.410”. The information will be used to document expenditures for the specified primary care services in the baseline period for the purpose of then calculating the expenditure eligible for 100 federal matching funds in calendar years 2015 and 2016, should Congress extend the availability of such funding and make no additional changes in statutory language necessitating programmatic alterations. Comments are due December 17, 2014.
- On November 17, 2014, CMS released the following information collection activities for public review and comment: 1) Ambulatory Surgical Center Quality Reporting Program; and 2) Certification as a Supplier of Portable X-Ray and Portable X-Ray Survey Report Form and Supporting Regulations. Comments are due January 16, 2015. More information may be found here.
- On November 18, 2014, OMB released a notice entitled “Calendar Year 2014 Cost of Outpatient Medical, Dental, and Cosmetic Surgery Services Furnished by Department of Defense Medical Treatment Facilities; Certain Rates Regarding Recovery From Tortiously Liable Third Persons”. These rates are for use in connection with the recovery from tortiously liable third persons for the cost of outpatient medical, dental, and cosmetic surgery services furnished by military treatment facilities through the Department of Defense (DoD). The rates were established in accordance with the requirements of OMB Circular A-25, requiring reimbursement of the full cost of all services provided. The CY14 Outpatient Medical, Dental, and Cosmetic Surgery rates referenced are effective upon publication of this notice in the Federal Register and will remain in effect until further notice. Previously published inpatient rates remain in effect until further notice. Pharmacy rates are updated periodically. A full disclosure of the rates is posted at the DoD's Uniform Business Office Web site, which may be accessed here.
- On November 20, 2014, FDA announced that a proposed information collection entitled “Risk and Benefit Perception Scale Development” had been submitted to OMB for review and clearance. FDA’s Office of Prescription Drug Promotion (OPDP) has an active research program that investigates how direct-to-consumer (DTC) advertising influences consumer knowledge, perceptions, and behavior. As OPDP’s research program has matured, the way in which they measure risk and benefit perception has evolved over time. This has resulted in perception measures that, while internally valid, tend to vary by study. Consequently, FDA needs a pool of reliable and valid measurement items for assessing consumers’ drug risk and benefit perceptions—as well as other elements of prescription drug decision making—consistently across studies. The purpose of this project is to create that measurement pool, thus increasing the rigor and efficiency of FDA’s research. Comments on the proposal are due December 22, 2014.
- On November 20, 2014, the Health Resources and Services Administration (HRSA) published an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP). The Secretary announces that the revised average cost of a health insurance policy under the VICP is $473.54 per month. More information may be found here.
- On November 20, 2014, FDA announced the availability of guidance for industry entitled “Vaginal Microbicides: Development for the Prevention of Human Immunodeficiency Virus Infection”. The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides, defined as vaginal drug products that prevent human immunodeficiency virus (HIV) acquisition. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of vaginal microbicides. This guidance finalizes the draft guidance issued on November 23, 2012.
- On November 19, 2014, FDA’s Center for Drug Evaluation and Research (CDER) is announced the availability of a document entitled ‘‘Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.’’ CDER is making this document available to improve the standardization and quality of clinical data submitted to CDER, as well as to improve the predictability of data quality and usefulness. More information may be found here.
- On November 19, 2014, FDA announced the opening of a public docket and requesting comments on proposed criteria for ‘‘first generic’’ abbreviated new drug application (ANDA) submissions. The purpose is to facilitate FDA’s establishment of review prioritization under the Generic Drug User Fee Amendments of 2012 (GDUFA). Establishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made under GDUFA. Clear criteria for this category will also lead to less industry confusion and more consistent identification of ‘‘first generic’’ submissions. Comments must be submitted by December 19, 2014. More information may be found here.
- On November 21, 2014, CMS announced a 3- year Medicare Prior Authorization model for non-emergent hyperbaric oxygen therapy services in the states of Illinois, Michigan, and New Jersey where there have been high incidences of improper payments for these services. The model will begin on March 1, 2015. More information may be found here.
- On November 21, 2014, CMS announced a Town Hall meeting to discuss fiscal year (FY) 2016 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment systems (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2016 new medical services and technologies applications meet the substantial clinical improvement criterion. The Town Hall Meeting announced in this notice will be held on Tuesday, February 3, 2015. 9:00 a.m. Eastern Standard Time. The meeting will take place in Baltimore, Maryland, and will be available via teleconference. More information may be found here.
- On November 21, 2014, FDA announced the availability of a guidance document entitled “Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture”. The guidance document provides manufacturers of licensed whole blood and blood components intended for transfusion or for further manufacture, including source plasma, with recommendations concerning submission of changes to an approved biologics license application (BLA). The guidance document also provides manufacturers of licensed whole blood and blood components recommendations in connection with the applicability and content of comparability protocols and labeling changes. The guidance applies to the manufacture and distribution of licensed products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2013 and supersedes the document of the same title dated July 2001 (July 2001 guidance).
- On November 21, 2014, FDA announced a public workshop entitled ‘‘Developing and Using Precision Therapies in the ‘Omics’ Era: Generating and Interpreting Evidence for Rare Subsets.’’ This public workshop is being cosponsored with the Center for Translational and Regulatory Sciences at the University of Virginia (UVA). The goals of this public workshop are to facilitate discussion on current scientific approaches using rare subsets during drug development programs and to further seek input from multiple stakeholders on approaches to obtain evidence that inform the regulatory evaluation of therapeutic products in rare subsets of patients identified through in-vitro diagnostic testing when specific, controlled trials are not feasible. The workshop will be held on December 12, 2014, beginning at 9:00 AM at FDA’s White Oak Campus in Silver Spring, Maryland. More information may be found here.
II. LEGISLATION & COMMITTEE ACTION
- On November 20, 2014, the Senate Health, Education, Labor and Pensions (HELP) Primary Health and Aging Subcommittee held a hearing entitled “Why Are Some Generic Drugs Skyrocketing In Price?” The sole witness for Panel I was Representative Elijah E. Cummings (D-MD), Ranking Member of the House Committee on Oversight and Government Reform. Panel II witnesses included Stephen W. Schondelmeyer, PharmD, PhD , Professor and Director, PRIME Institute at the University of Minnesota College of Pharmacy; Robert Frankil, RPh , President, Sellersville Pharmacy, Inc.; Carol Ann Riha; Scott Gottlieb, MD, Resident Fellow, American Enterprise Institute; and Aaron S. Kesselheim, MD, JD, MPH , Associate Professor of Medicine, Brigham and Women’s Hospital and Harvard Medical School. The hearing follows an investigation launched on October 2, 2014, when Senator Bernie Sanders (I-VT), Chairman of the Subcommittee, along with Representative Cummings, issued letters to 14 pharmaceutical companies asking the firms to respond to reports of recent steep price spikes for generic drugs. The lawmakers cited data from the Healthcare Supply Chain Association on recent purchases by group purchasing organizations (GPOs) of ten generic drugs, which suggests that pharmacists “have seen huge upswings in generic drug prices that are hurting patients” and are having a “very significant” impact on pharmacists’ ability to continue serving patients. During the hearing lawmakers discussed companion bills introduced by Sanders and Cummings, the Medicaid Generic Drug Price Fairness Act, which would require generic drug manufacturers to pay a rebate to Medicaid when drugmakers raise prices at a rate greater than inflation. More information on the hearing may be found here.
House of Representatives
- On November 19, 2014, the House Ways and Means Subcommittee on Health Chairman Kevin Brady (R-TX) unveiled the Hospitals Improvements for Payment (HIP) Act of 2014 discussion draft as part of the Committee’s broader effort on Medicare reform, addressing the problems associated with Medicare’s two-midnights policy, short inpatient stays, outpatient observation stays, auditing and appeals. Title I of the HIP discussion draft includes detailed solutions to these problems; Title II includes 19 different policies introduced by various members of the Ways and Means Committee that pertain to hospital reform. In response to the release of the discussion draft, Brady stated, “The complex challenges facing hospitals require a comprehensive solution. This draft legislation retains the needed oversight of auditors while offering reforms to the RAC process and appeals, and an additional option to the CMS settlement proposal. It also includes a number of proposed health care policies developed by both Republican and Democrat members of Congress. To determine the best solutions going forward we need all stakeholders to review this discussion draft carefully and provide timely, real-world feedback.” A Committee press release on the discussion draft may be found here.
- On Wednesday November 19, 2014, the House Science, Space and Technology Subcommittee on Oversight held a hearing entitled "The Role of the White House Chief Technology Officer in the HealthCare.gov Website Debacle." The sole witness for the hearing was Todd Park, former Chief Technology Officer of the United States, Office of Science and Technology Policy. More information may be found here.
- On Wednesday November 19, 2014, the House Veterans Affairs Health Subcommittee held a hearing on a series of veterans’ healthcare bills, including: HR 4720 — Medal of Honor Priority Care Act; HR 4887 — Expanding Care for Veterans Act; HR 4997 — United States Leadership to Eradicate Obstetric Fistula Act; HR 5059 — Clay Hunt Suicide Prevention for American Veterans Act; HR 5475 — A bill to amend title 38, US Code, to improve the care provided by the secretary of Veterans Affairs to newborn children; and the HR 5484 — Toxic Exposure Research Act. More information may be found here.
- On Wednesday November 19, 2014, the House Energy and Commerce Subcommittee on Health held a hearing entitled “Examining Medical Product Development in the Wake of the Ebola Epidemic”. Witnesses for the hearing included Robin Robinson, Director, Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response; Luciana Borio, assistant commissioner, Counterterrorism Policy, Food and Drug Administration; Rear Adm. Steve Redd, senior adviser for Ebola response, Centers for Disease Control and Prevention; and Anthony Fauci, director, National Institute for Allergy and Infectious Diseases, National Institutes of Health. More information may be found here.
- On November 14, 2014, a bipartisan group of 32 lawmakers, led by Representatives Diane Black (R-TN) and Earl Blumenauer (D-OR) sent a letter to CMS Administrator Marilyn Tavenner calling for adjustments to the Medicare Advantage (MA) risk adjustment and star ratings system. Specifically, the letter calls on CMS to risk-adjust MA plans to account for low-income beneficiaries. They wrote, “The current MA payment system—specifically the risk adjustment payment model and the star ratings and quality bonus program—does not adequately recognize the types of high-cost interventions and care management required to provide high-quality care to the unique and specific needs of dually-eligible beneficiaries.” The lawmakers suggest that improvement to the risk adjustment model should consider the Medicare Payment Advisory Commission’s recommendations to use two years of condition data in the risk adjustment formula, include the number of conditions as an adjustment factor, and include variables for partial and full dual status.
III. REPORTS, STUDIES, & ANALYSES
- On November 14, 2014, the Congressional Budget Office (CBO) released a revised cost estimate for legislation (H.R. 4015, S. 2000) that would replace the flawed Medicare physician reimbursement scheme known as the Sustainable Growth Rate (SGR). According to CBO, replacing SGR would cost $144 billion from 2015 to 2024. This is an increase from CBO’s $138 billion ten-year estimate in February, when the bills were introduced. In the document, CBO also estimates that freezing physician payment at the current rate through 2024 would cost $118.9 billion, while giving doctors a 0.5% increase in each of those years would increase the cost to $140.2 billion.
- On November 14, 2014, Avalere published an initial analysis of the 2015 Exchange premium files released last week by the Department of Health and Human Services (HHS). The study examines: average lowest-cost Bronze premium by state: 2014 vs. 2015 and percent change; average lowest-cost Silver premium by state: 2014 vs. 2015 and percent change; average second-lowest Silver (SLS) premium by state: 2014 vs. 2015 and percent change; and percent of regions by state where the SLS benchmark plan has changed for 2015. The analysis may be accessed here.
- On November 14, 2014, analysts at HealthPocket used newly released 2015 Medicare drug plan data to examine how differences in plans’ premiums corresponded to differences in plans’ deductibles and enhanced drug coverage during the “donut hole” period of coverage. HealthPocket collected the premiums and drug deductibles for every stand-alone Medicare Part D plan offered across the United States and assigned each plan into one of three groups: plans whose premiums were in the lowest third of the premium range, plans whose premiums were in the middle third of the premium range, and plans whose premiums were in the highest third of the premium range. When examining differences among the groups of Part D plans, HealthPocket observed a trend where the average deductible amount decreased as the average premium increased. The trend of lower deductibles for higher premiums, however, was not proportional, which is to say that the average deductible did not decrease at the same rate that the average premium increased. The authors concluded that, “When shopping for a Medicare Part D plan, consumers should be careful not to overemphasize the significance of the deductible amount. Selecting a Part D plan based on a lower deductible could result in a higher premium, the added annual expense of which could be far in excess of the value of the deductible savings”. More information may be found here.
- On November 18, 2014, the HHS Office of Inspector General (OIG) released a document outlining its “2014 Top Management & Performance Challenges”. Annually, OIG prepares a summary of the most significant management and performance challenges facing HHS, which reflect continuing vulnerabilities that OIG has identified for HHS over recent years as well as new and emerging issues that HHS will face in the coming year. OIG says that state and federal marketplaces will need to focus on four key areas: ensuring accurate tax credit payment, ensuring eligibility is properly determined, improving management and administration of the law, and ensuring the site is secure and any personally identifiable information is protected.
- On November 18, 2014, the Government Accountability Office (GAO)_ released a report entitled “Health Care Transparency: Actions Needed to Improve Cost and Quality Information for Consumers”. Results obtained from two selected private consumer transparency tools GAO reviewed—websites with health cost or quality information comparing different health care providers—show that some providers are paid thousands of dollars more than others for the same service in the same geographic area, regardless of the quality of such services. GAO identified key characteristics of effective transparency tools through a literature review and interviews with experts. GAO found that CMS’ five transparency tools—Nursing Home Compare, Dialysis Facility Compare, Home Health Compare, Hospital Compare and Physician Compare—are limited in their provision of relevant and understandable cost and quality information for consumers. Because none of the tools contain information on patients’ out-of-pocket costs, GAO reports, they do not allow consumers to combine cost and quality information to assess the value of health care services or anticipate the cost of such services in advance. GAO found substantial limitations in how the CMS tools present information, such as, in general, not using clear language and symbols, not summarizing and organizing information to highlight patterns, and not enabling consumers to customize how information is presented. Finally, GAO reports that CMS’ process for developing and selecting cost and quality measures for its tools has been heavily influenced by the concerns of providers rather than consumers. Without procedures or metrics focusing on consumer needs, the report concludes, CMS cannot ensure that these efforts will produce cost and quality information that is relevant and understandable to consumers seeking to make meaningful distinctions.
- On November 13, 2014, GAO released a study entitled “Small Business Health Insurance Exchanges: Low Initial Enrollment Likely due to Multiple, Evolving Factors”. The ACA required Small Business Health Options Programs (SHOPs)—exchanges, or marketplaces, where small employers can shop for health coverage for their employees—to be established in all states; enrollment in SHOPs was to begin in October 2013, with coverage effective as early as January 2014. GAO was asked to examine the early implementation experiences of the SHOPs. In this report GAO describes 1) SHOP functionality, enrollment, plan availability, and premiums and 2) stakeholders’ views on key factors that have affected current SHOP enrollment or may affect future enrollment growth. GAO found that several factors may have led to current low SHOP enrollment and that may affect future enrollment growth. For example, many stakeholders reported that the primary incentive for employers to use the SHOPs has been the small business tax credit available to eligible employers who offer coverage through a SHOP, although some noted that the credit may be too small and administratively complex to motivate many employers to enroll. Other factors identified that may have hindered current enrollment include the ability of employers to renew plans that existed before the SHOPs—which, depending on state requirements, is permitted until October 1, 2016—and employer misconceptions about SHOP availability. Stakeholders also described factors that may help stimulate or detract from future SHOP enrollment growth. For instance, the phase-out of existing pre-SHOP plans, the implementation of employee choice by an increasing number of SHOPs, improved coordination with agents and brokers, and increased marketing to small employers may help stimulate enrollment growth. Conversely, other factors, such as the 2-year limit on the availability of the small business tax credit and the likelihood, according to stakeholders, that SHOP premiums will not be lower than non-SHOP premiums, may hinder future enrollment growth. GAO concludes that the evolving and localized nature of these factors suggests that that a determination of the SHOPs’ long-term impact remains premature at this time.
- On November 18, 2014, the Tufts Center for the Study of Drug Development released a press release, backgrounder, and slides detailing the results of a forthcoming study on the cost of drug development. According to the Center, the process of a new prescription medicine that gains marketing approval is estimated to cost $2,558 million, taking into account average out-of-pocket costs ($1,395 million) and “time costs”, i.e. expected returns that investors forego while a drug is in development ($1,163 million). The new analysis, which updates similar Tufts CSDD analyses, was developed from information provided by 10 pharmaceutical companies on 106 randomly selected drugs that were first tested in human subjects anywhere in the world from 1995 to 2007. In a study published in 2003, Tufts CSDD estimated the cost per approved new drug to be $802 million (in 2000 dollars) for drugs first tested in human subjects from 1983 to 1994, based on average out-of-pocket costs of $403 million and capital costs of $401 million. The $802 million, equal to $1,044 million in 2013 dollars, indicates that the cost to develop and win marketing approval for a new drug has increased by 145% between the two study periods, or at a compound annual growth rate of 8.5%. Factors that likely have boosted out-of-pocket clinical costs include increased clinical trial complexity, larger clinical trial sizes, higher cost of inputs from the medical sector used for development, greater focus on targeting chronic and degenerative diseases, changes in protocol design to include efforts to gather health technology assessment information, and testing on comparator drugs to accommodate payer demands for comparative effectiveness data.
IV. OTHER HEALTH POLICY NEWS
- On November 14, 2014, one day before the launch of the 2015 open enrollment period for Health Insurance Exchanges established under the ACA, CMS released a slew of data on the 2015 Health Insurance Marketplace. The data include:
- Health Insurance Marketplace Landscape Files. While health plan information including benefits, copayments, premiums, and geographic coverage is publically available on HealthCare.gov through the new window shopping tool, CMS has also released downloadable public use files (PUFs) so that researchers and other public stakeholders can access Marketplace data. The Landscape files include data on certified qualified health plans (QHPs) and Stand-alone Dental Plans (SADPs) for all states that use the HealthCare.gov eligibility and enrollment system, and for the Federally Facilitated Small Business Health Options Program (SHOP).
- Health Insurance Marketplace Public Use Files. These files for the 2015 plan year include detailed information for researchers. They include data on certified QHP and SADPs for all states that use the HealthCare.gov eligibility and enrollment system.
- Rate Review Public Use File. CMS released information on final 2015 rates in the individual and small group markets for plans inside and outside of the Marketplace for all states and the District of Columbia. The information released today does not take into account premium tax credits.
- On November 17, 2014, the State of Indiana announced that CMS has approved its Healthy Indiana Plan (HIP) waiver program. The current program was first approved in 2007 to serve adults with income under the federal poverty level who do not otherwise qualify for Medicaid. Under Republican Governor Mike Pence’s new proposal, the state would require people to contribute to their savings accounts. “This decision by the federal government to renew our current Healthy Indiana Plan is welcome news and will bring certainty to the more than 60,000 Hoosiers who currently enjoy the benefits of this proven health care program,” said Governor Pence. “Since this marks the third time the Obama Administration has approved the Healthy Indiana Plan in its current form, we hope that this decision signals an openness by this Administration to move forward with approval of HIP 2.0, which is built on the same principles of personal responsibility and consumer choice.” The State continues to await a decision by the federal government on covering 350,000 more uninsured Indiana residents through HIP 2.0, which was submitted for approval in July of 2014 and has been the subject of ongoing discussions between state and federal officials. The approval letter from CMS may be found here.
- On November 19, 2014, CMS announced that it has created the Office of Enterprise Data and Analytics (OEDA) which will be led by Niall Brennan, the agency’s first Chief Data Officer (CDO), and tasked with overseeing improvements in data collection and dissemination. More information may be found here.
This advisory is published by Alston & Bird LLP’s Health Care practice area to provide a summary of significant developments to our clients and friends. It is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.