I. REGULATIONS, NOTICES, & GUIDANCE
- On July 14, 2014, the Health Resources and Services Administration (HRSA) issued a request for comment regarding reconciliation of advanced premium tax credits under the Affordable Care Act (ACA) and the Ryan White HIV/AIDS Program (RWHAP). HRSA's HIV/AIDS Bureau (HAB) recently released HAB Policy Clarification Notice 14-01, which requires RWHAP grantees and sub-grantees that use program funds to purchase health insurance in the ACA Marketplace to establish appropriate mechanisms to vigorously pursue any excess premium tax credit a client receives from the Internal Revenue Service (IRS) upon submission of the client's tax return. HRSA now seeks public comment on the operational feasibility for RWHAP grantees and sub-grantees to implement a complementary policy that would allow RWHAP grantees and sub-grantees to use RWHAP funds to pay the IRS any additional income tax liability a client may owe to the IRS solely based on reconciliation of the premium tax credit. In addition to general comments about the feasibility of implementing such a policy, HRSA would like feedback on the following issues related to this policy: 1) Could this proposed policy be easily implemented by a grantee? 2) What challenges would grantees and sub-grantees face in implementing this proposed policy? 3) Will grantees be able to conduct fiscal monitoring of this proposed policy? If so, what level of effort would be required? Responses are due August 13, 2014. More information may be found here.
- On July 14, 2014, the Food and Drug Administration announced the availability of a draft guidance entitled “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.” The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The draft guidance provides the Agency's recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations. Comments must be received by the Agency before September 15, 2014 before it begins work on the final version of the guidance. More information may be found here.
- On July 14, 2014, FDA announced a request for Office of Management and Budget (OMB) approval to revise the Health and Diet Survey, a voluntary consumer survey intended to gauge and to track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling. Currently this collection is approved as a traditional collection, however, the Agency wishes to employ future collections under the generic collection process. This survey has been repeated approximately every 3 to 5 years over the course of the past 3 decades for the purpose of tracking changes and trends in public opinions and consumer behavior, with some new questions added or omitted or partially modified in each iteration in response to emerging and current events or issues. Comments are due September 12, 2014. More information may be found here.
- On July 15, 2014, FDA announced the availability of a draft guidance document entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.” This guidance is intended to provide greater clarity regarding the principal benefit-risk factors that FDA considers during the review process for a premarket notification (510(k)) submission when there are different technological characteristics between the new device and the legally marketed (predicate)device. Comments must be received by the Agency before October 14, 2014 before it begins work on the final version of the guidance. More information may be found here.
- On July 15, 2014, FDA announced the availability of a draft guidance entitled “Substantial Equivalence Reports: Manufacturer Requests for Extensions or To Change the Predicate Tobacco Product.” This draft guidance provides information to tobacco product manufacturers about FDA's policies on manufacturer requests for extensions of time to respond to deficiencies that FDA has identified, and manufacturer requests to change the predicate tobacco product, in substantial equivalence (SE) reports. Comments must be received by the Agency before September 15, 2014 before it begins work on the final version of the guidance. More information may be found here.
- On July 16, 2014, FDA announced that a proposed information collection entitled “Exception From General Requirements for Informed Consent” had been submitted to OMB for review and clearance. In the Federal Register of June 7, 2006 (71 FR 32827), FDA issued an interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The Agency took this action because it was concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. Comments on the proposed collection are due August 15, 2014.
- On July 16, 2014, FDA announced that a proposed information collection entitled “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile” had been submitted to OMB for review and clearance. Under the Public Health Service Act (PHS Act), the Department of Health and Human Services (HHS) stockpiles medical products that are essential to the health security of the nation (see PHS Act, 42 U.S.C. 247d-6b). This collection of medical products for use during national health emergencies, known as the SNS, is to “provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency.” It may be appropriate for certain medical products that are or will be held in the SNS to be labeled in a manner that would not comply with certain FDA labeling regulations given their anticipated circumstances of use in an emergency. However, noncompliance with these labeling requirements could render such products misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act. Under §§ 201.26, 610.68, 801.128, and 809.11 (21 CFR 201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center Director may grant a request for an exception or alternative to certain regulatory provisions pertaining to the labeling of human drugs, biological products, medical devices, and in vitro diagnostics that currently are or will be included in the SNS if certain criteria are met.
- On July 17, 2014, FDA issued a proposed information collection for public comment entitled “Quantitative Testing as Used by the Food and Drug Administration Center for Tobacco Products”. To ensure that such health communication messages have the highest potential to be received, understood, and are accepted by those for whom they are intended, FDA's Center for Tobacco Products will conduct research and studies relating to the control and prevention of disease. This type of research involves (1) assessing audience knowledge, attitudes, behaviors, and other characteristics for the purpose of determining the need for and developing health messages, communication strategies, and public information programs; and (2) pretesting these health messages, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. Quantitative testing messages and other materials with a sample of the target audience will allow FDA to refine messages, advertisements, and materials, including questionnaires or images, directed at consumers while they are still in the developmental stage. Comments are due September 15, 2014.
- On July 18, 2014, the Centers for Medicare and Medicaid Services (CMS) released the following information collections for public comment: 1) Medicaid Incentives for Prevention of Chronic Disease (MIPCD) Demonstration; 2) Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regulations; and 3) State Plan Preprint for Medicaid Recovery Audit Contractors (RACs). Comments are due September 16, 2014. More information may be found here.
- On July 18, 2014, FDA announced the availability of a draft document entitled “Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines”. The draft guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). FDA recently published in the Federal Register a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The draft guidance, when finalized, is intended to help applicants required to submit postmarketing safety reports comply with the final rule. The draft guidance, when finalized, also will supersede the document entitled “Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS-1)” dated September 1998. More information may be found here.
- August 11, 2014: The Centers for Disease Control and Prevention (CDC) will hold a meeting of the federal Advisory Committee on Breast Cancer in Young Women (ACBCYW) on August 11th from 1:00 PM to 5:00 PM EST. The committee provides advice and guidance to the Secretary, HHS; the Assistant Secretary for Health; and the Director, CDC, regarding the formative research, development, implementation and evaluation of evidence-based activities designed to prevent breast cancer (particularly among those at heightened risk) and promote the early detection and support of young women who develop the disease. The advice provided by the Committee will assist in ensuring scientific quality, timeliness, utility, and dissemination of credible appropriate messages and resource materials. The agenda will include discussions on the current and emerging topics related to breast cancer in young women. These include current survivorship activities and public health campaign activities. Other areas of discussion may include risk communication and health education, as well as approaches to increase awareness of clinicians/practitioners regarding topics such as breast cancer risk, breast health, symptoms, diagnosis, and treatment of breast cancer in young women. The meeting will take place at the CDC National Center for Chronic Disease Prevention and Health Promotion in Atlanta, Georgia. This meeting is also accessible by teleconference and web access; more information may be found here.
- August 11, 2014: FDA will hold a public hearing that will provide a forum to discuss confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs) submitted to the Agency while the trials are still ongoing. The purpose of the public hearing is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public, about appropriate handling of interim analysis results of these ongoing CVOTs. FDA is also opening a public docket to receive comments on this topic. The hearing will be held August 11th from 8:00 AM to 5:00 PM at FDA’s White Oak Campus in Silver Spring, Maryland. Individuals who wish to present at the public hearing must register by July 28, 2014. Comments must be submitted by July 28, 2014. More information may be found here.
II. LEGISLATION & COMMITTEE ACTION
- On Tuesday July 15th, the Senate Finance Committee held a hearing entitled “Chronic Illness: Addressing Patients' Unmet Needs”. Witnesses for the hearing included: Stephanie Dempsey, patient, Varnville, S.C.; Mary Margaret Lehmann, caregiver, Minneapolis, Minn.; William A. Bornstein, chief quality and medical officer, Emory Healthcare, Atlanta, Ga.; Cheryl DeMars, president and CEO, The Alliance, Fitchburg, Wis.; and Chester Burrell, president and CEO, CareFirst BlueCross BlueShield, Baltimore, Md .More information on the hearing may be found here. Of note, in January Finance Committee Chairman Ron Wyden (D-OR) and Senator Johnny Isakson (R-GA) introduced the Better Care, Lower Cost Act (S. 1932) to provide a framework for encouraging innovative chronic care delivery across the country. The Act directs the HHS Secretary to establish an integrated chronic care delivery program (Better Care Program or BCP) that promotes accountability and better care management for chronically ill patient populations and coordinates items and services under Medicare parts A, B, and D. A summary of the bill may be found here. The companion House bill may be accessed here.
- On Wednesday July 16th, the Senate Veterans’ Affairs Committee held a hearing to examine steps taken by the Department of Veterans Affairs to provide health care to those on long waiting lists. The sole witness for the hearing will be Sloan Gibson, Acting Secretary, Department of Veterans Affairs. More information may be found here.
- On Wednesday July 16th, Senate Republicans blocked a motion to proceed to vote on legislation that would mitigate the Supreme Court’s controversial ruling in Burwell v. Hobby Lobby Inc. The ruling held that HHS’ preventive care mandates regarding contraceptive coverage issued under the ACA violate the Religious Freedom Restoration Act (RFRA) when applied to closely held, for-profit corporations that hold sincere religious beliefs against such coverage. The Senate measure, known as the “Not My Boss’s Business Act”, would have banned employers from refusing to cover any health coverage, including contraceptive coverage, guaranteed to their employees and dependents under federal law. The bill was defeated 56-43 on a procedural vote, with three Republicans—Mark Kirk (R-IL), Lisa Murkoswki (R-AK), and Susan Collins (R-ME)—joining nearly the entire Democratic caucus in support of the measure. Senate Majority Leader Harry Reid (D-NV) said the Senate would vote again on the issue before year’s end. On July 17th, the Departments of Labor, HHS, and Treasury issued an FAQ document related to the ruling. The document states that if a closely held for-profit corporation’s health plan ceases providing coverage for some or all contraceptive services mid-plan year, the plan must notify plan participants and beneficiaries.
- On Wednesday July 16th, the House Rules Committee held a hearing on a draft resolution that would provide authority to initiate a lawsuit on behalf of the House of Representatives against the President. The resolution argues that by suspending the start date of the ACA employer mandate, President Obama operated outside of his constitutional power. During the hearing, Jonathan Turley, JB, of the George Washington University Law School said: “Today’s hearing is a historic step to address the growing crisis in our constitutional system. After years of eroding legislative authority, the decision of this body to take a stand and seek judicial review is a welcome change … [W]e remain a nation of laws and we have a court system designed to resolve such controversies. That is precisely where this authorization would take us and it is where these questions should be answered."
- On Thursday July 17th, the Senate Health, Education, Labor and Pensions (HELP) Primary Health and Aging Subcommittee held a hearing entitled "More Than 1,000 Preventable Deaths a Day Is Too Many: The Need to Improve Patient Safety." More information may be found here.
- On July 17, 2014, the Senate Commerce, Science and Technology Committee held a hearing entitled “The Federal Research Portfolio: Capitalizing on Investments in R&D”. Witnesses for the hearing included Dr. Vinton G. Cerf, Vice President at Google and Member of the National Science Board (NSF); Ms. Mariette DiChristina, Editor in Chief and Senior Vice President at Scientific American; Dr. Neal F. Lane, University Professor and Professor of Physics and Astronomy, Rice University and Co-Chair, Committee on New Models for U.S. Science and Technology Policy, American Academy of Arts & Sciences; and Dr. Stephen E. Fienberg, Maurice Falk University. The hearing considered the federal government’s role in research and development (R&D), and the nation’s science, technology, engineering, and mathematics (STEM) education and outreach initiatives. More information may be found here.
House of Representatives
- On Tuesday July 15th, the House Energy and Commerce Committee held a markup to consider the following bills: HR 594 — Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments; HR 669 — Sudden Unexpected Death Data Enhancement and Awareness Act; HR 4290 — Wakefield Act; HR 4771 — Designer Anabolic Steroid Control Act; HR 4250 — Sunscreen Innovation Act; HR 4450 — Travel Promotion, Enhancement, and Modernization Act; and HR 5057 — Official title to be confirmed. The Committee advanced all seven measures. More information on the markup may be found here. A press release from the Committee released after the markup may be found here.
- On Wednesday July 16th, the House Veterans’ Affairs Committee held a hearing on private sector best practices and the VA health care system. Witnesses for the hearing included Steve Stang, National Partner-In-Charge, Health Care Assurance Services, Clifton Larson Allen, LLP; Walter Gorski, Principal, Gorski Healthcare Group, LLC; Jessica Meeske, DDS, Board Certified Pediatric Dentist, Pediatric Dental Specialists of Greater Nebraska and American Dental Association; Diana Haramboure, Senior Vice President And Chief Administrative Officer, First Coast Service Options; Margaret Hambleton, Vice President And Corporate Compliance Officer, Dignity Health; Kathleen King, Director, Healthcare, Government Accountability Office; Chad Janak, Vice President, Audit Operations, Connolly Healthcare; and Mindy Hatton, Senior Vice President And General Counsel; American Hospital Association More information may be found here.
- On Wednesday July 16th, the House Committee on Oversight and Government Reform issued a letter to FDA Commissioner Margaret Hamburg requesting that FDA provide additional information on the Agency’s proposed rule “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. “FDA developed the proposed rule to ensure manufacturers of generic drugs would face liability, and resulting litigation, by establishing a process for generic drug manufacturers to change their label without prior FDA approval,” the lawmakers wrote in the letter. “It seems to us that the proposed rule is not designed to address a health or safety related concern, instead it is designed to placate special interests groups and increase lawsuits.” In a press release, Committee Chairman Darrell Issa (R-.CA), Subcommittee on Economic Growth, Job Creation, and Regulatory Affairs Chairman Jim Jordan (R-OH), and Rep. Rob Woodall (R-GA) characterized the proposal as a “giveaway to trial lawyers”. “Given the intent of the rule is to create an environment for increased litigation, the Committee finds it troubling that the FDA consulted only with trial lawyers, but no other major stakeholder likely to be affected,” the lawmakers write.
- On Wednesday July 16th, the House Energy and Commerce Subcommittee on Health held a hearing entitled "Failure to Verify: Concerns Regarding PPACA's Eligibility System." Witnesses for the hearing included: Kay Daly Assistant Inspector General Office of Audit Services, Office of Inspector General, HHS; and Joyce Greenleaf Regional Inspector General Office of Evaluation and Inspections, Office of Inspector General, HHS. More information may be found here.
- On Thursday July 17th, the House Science, Space and Technology — Subcommittee on Research and Technology will hold a hearing entitled "Policies to Spur Innovative Medical Breakthroughs from Laboratories to Patients." Witnesses for the hearing will include: Craig Venter, founder, chairman, and CEO, J. Craig Venter Institute, Synthetic Genomics, Inc., and Human Longevity, Inc.; Marc Tessier-Lavigne, president and professor, Laboratory of Brain Development and Repair, The Rockefeller University; Jay Keasling, professor of biochemical engineering, University of California, Berkeley; and Harold Varmus, director, National Cancer Institute. More information may be found here.
- On Thursday July 17th, the House Energy and Commerce Subcommittees on Communications and Technology & Health held a hearing on advancements in technology and health care. The hearing was part of the Committee’s “21st Century Cures” initiative launched earlier this year. Witnesses for the hearing included Robert Jarrin, Senior Director, Government Affairs, Qualcomm Incorporated; Paul Misener, Vice President, Global Public Policy, Amazon; Dr. Jonathan Niloff, Chief Medical Officer and Vice President, McKesson Connected Care and Analytics, McKesson Corporation; Dan Riskin, Founder, Health Fidelity; and Dave Vockell Chief Executive Officer, LyfeChannel. More information may be found here.
III. REPORTS, STUDIES, & ANALYSES
- On July 14, 2014, the Office of Inspector General (OIG) issued a report entitled “Public Assistance Reporting Information System: State Participation in the Medicaid Interstate Match is Limited”. The Public Assistance Information Reporting System (PARIS) Medicaid Interstate Match is a tool that has the potential to reduce improper Medicaid payments by identifying beneficiaries who are enrolled in multiple State Medicaid programs; the Social Security Act (SSA) mandates that States participate in the match, but neither the SSA nor guidance from CMS defines the meaning of such participation. OIG found that state participation in the Medicaid Interstate Match is limited, as is CMS guidance to states participating in the match. OIG recommended that CMS issue guidance to States on the requirement for participating in the Medicaid Interstate Match. CMS concurred with our recommendation.
- The Robert Wood Johnson Foundation released a report this week detailing what is at stake—in terms of health coverage and dollars—in the Halbig v Burwell decision expected soon out of the U.S. Court of Appeals for the D.C. Circuit. The case challenges the Obama Administration’s interpretation of the ACA, relying upon a single phrase in the law’s text. The plaintiff claims the phrase prohibits residents of moderate income from receiving financial assistance (i.e., federal subsidies) for the purchase of private insurance coverage if their state does not run its own Health Insurance Marketplace, and has instead left this responsibility to the federal government. If the court rules against the Obama Administration, researchers estimated that 7.3 million people, or about 62 percent of the 11.8 million people expected to enroll in federally facilitated marketplaces by 2016, could lose out on $36.1 billion in subsidies. Residents in Texas and Florida would lose the most, $5.6 billion and $4.8 billion respectively in subsidies at risk in this court decision.
- On July 15, 2014, the Kaiser Family Foundation released a report entitled “Survey of Health Insurance Marketplace Assister Programs: A First Look at Consumer Assistance under the Affordable Care Act”. The ACA provides for a substantial new infrastructure of consumer assistance in health insurance: all state Marketplaces are required to have Navigators and other similar Assister Programs to help consumers understand their coverage options, apply for assistance, and enroll. This report uses results from an internet survey conducted among Marketplace Assister Programs from April 24th through May 12th, shortly after the first ACA open enrollment period concluded. The report finds that more than 4,400 Assister Programs, employing more than 28,000 full-time-equivalent staff and volunteers, helped an estimated 10.6 million people during the first Open Enrollment period. Results show that during the first year, more than 70% of Assister Programs were supported privately or by a federal safety net clinic program. In addition, Assister Programs overwhelmingly reported that people sought help because they simply do not understand the ACA or health insurance and lacked confidence to apply on their own.
- On July 15, 2014, the Congressional Budget Office (CBO) released “The 2014 Long-Term Budget Outlook”. CBO projects that if current laws remained generally unchanged in the future, federal debt held by the public would decline slightly relative to GDP over the next few years. After that, however, growing budget deficits would push debt back to and above its current high level. Twenty-five years from now, in 2039, federal debt held by the public would exceed 100 percent of GDP, CBO projects. Moreover, debt would be on an upward path relative to the size of the economy, a trend that could not be sustained indefinitely. According to CBO’s projections, federal spending would increase to 26 percent of GDP by 2039 compared with 21 percent in 2013 and an average of 20½ percent over the past 40 years. CBO projects that federal spending for Social Security and the government’s major health care programs—Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and subsidies for health insurance purchased through the ACA exchanges— would rise sharply, to a total of 14 percent of GDP by 2039, twice the 7 percent average seen over the past 40 years. That boost in spending is expected to occur because of the aging of the population, growth in per capita spending on health care, and an expansion of federal health care programs. The House Budget Committee held a hearing this week featuring witness Douglas Elmendorf, CBO Director, during which the CBO report was discussed in detail. More information on the hearing may be found here.
- On July 16, 2014, the Government Accountability Office (GAO) issued a report entitled “Medicaid: Assessment of Variation among States in Per-Enrollee Spending”. GAO was asked to examine variation among states in Medicaid spending and factors that influence such spending, and state approaches to setting rates per enrollee for Medicaid managed care plans. GAO found that certain factors that influence overall per-enrollee Medicaid spending, such as distribution of enrollees among eligibility groups, enrollee health service needs, and scope of benefits offered, varied widely by state. The report also found that states consider a range of demographic and health factors to predict expected spending per enrollee when setting Medicaid managed care rates, including detailed information on enrollee heath status, particularly for aged and disabled enrollees.
- The Milken Institute released a report this week entitled “Healthy Savings: Medical Technology and the Economic Burden of Disease”. The study documents the full costs and broader economic benefits of health-care investments by examining innovations pertaining to four common causes of disability and death: heart disease, diabetes, colorectal cancer, and musculoskeletal disease. The report considers therapeutics and diagnostic devices that are widely used and have substantially affected the lives of patients as well as the overall U.S. economy. The data demonstrate that the use of medical technology brings considerable economic benefits. Some are seen in both aggregate savings in treatment expenditures and prevention as well as the reduction of "indirect impact" through larger contributions to the economy -- for instance, the additional benefits to worker productivity that come with a healthier employee.
IV. OTHER HEALTH POLICY NEWS
- On July 18, 2014, CMS issued a guidance document entitled, “Part D Payment for Drugs for Beneficiaries Enrolled in Medicare Hospice”, a memorandum to Part D sponsors and Medicare Hospices to modify the March 10, 2014 guidance to Part D sponsors to place a prior authorization for all drugs for hospice beneficiaries. The revised guidance expects Part D sponsors to use hospice prior authorization on the four categories of drugs that the Office of Inspector General, in consultation with hospice providers, identified as nearly always covered under the hospice benefit. These categories of drugs will require hospice prior authorization are: analgesics, antinauseants, laxatives, and antianxiety drugs.
- On July 14, 2014, the National League of Cities announced that it has selected eight cities to receive grants and technical assistance to implement outreach campaigns directed at enrolling eligible families and children in Medicaid and the Children’s Health Insurance Program (CHIP). Selected cities include Dallas, Tex., Jacksonville, Fla., Garden City, Mich., Hattiesburg, Miss., New Bedford, Mass., Pittsburgh, Pa., Providence, R.I., and Savannah, Ga. Selected cities will receive up to $260,000 per city in funding and intensive technical assistance over the next 18 months.
- On July 14, 2014, CMS announced new resources to help states improve their Medicaid programs. The Medicaid Innovation Accelerator Program (IAP) is a new technical assistance program intended to improve health and health care for Medicaid beneficiaries by supporting states’ efforts to accelerate new payment and service delivery reforms. The Innovation Accelerator Program and its focus areas were developed with input from states, including the National Governor’s Health Care Sustainability Task Force, and surveys of states participating in the State Innovation Models initiative. The IAP will develop resources to support innovation through 4 key functions: 1) identify and advance new models of care delivery and payment; 2) data analytics; 3) improved quality measurement; and 4) state-to-state learning, rapid-cycle improvement, and federal evaluation.
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.