News and information useful to Cleveland-Marshall College of Law students, faculty and staff.


CDC Clarifies Guidelines for Prescribing Opioids for Chronic Pain

Photo of 2 opioid prescription bottlesThe U.S. Centers for Disease Control and Preventions recently released a letter clarifying its 2016 Guideline for Prescribing Opioids for Chronic Pain.  The letter is actually dated 2/28/19, and was written by Deborah Dowell, MD, Chief Medical Officer, CDC National Center for Injury Prevention and Control, and a co-author of the 2016 Guideline.  The clarification letter addresses concerns of physicians caring for patients with cancer, sickle cell disease, and other serious illnesses.  Treatment options for pain are often being limited by laws or denied by insurers who say they are following the 2016 Guideline.  In her letter, Dr. Dowell restates that the 2016 Guideline “provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.” [My underline.]  She then notes “Because of the unique therapeutic goals, and balance of risks and benefits with opioid therapy in such care, clinical practice guidelines specific to cancer treatment, palliative care, and end of life care should be used to guide treatment and reimbursement decisions regarding use of opioids as part of pain control in these circumstances.”  Dr. Dowell also cites “useful guidance” documents, including the American Society of Clinical Oncology Management of Chronic Pain in Survivors of Adult Cancers, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Adult Cancer Pain, and the National Heart, Lung, and Blood Institute’s Evidence Based Management of Sickle Cell Disease Expert Panel Report.

Hemp, Cannabidiols and the FDA

image of cannabis leaf & cbd oilThe Agriculture Improvement Act of 2018 became Public Law 115-334 on 12/20/18.  Title XII Section 12619 of this act removed hemp and “tetrahydrocannabinols in hemp” from the Controlled Substances Act (CSA).  [Tetrahydrocannabinols (THC) are a cannabinoid subclass, as are Cannabidiols (CBD).]  Also on 12/20/18, Scott Gottlieb, the Food and Drug Administration (FDA) Commissioner, issued a Statement on the agency’s regulation of products containing cannabis and cannabis-derived compounds.  The 12/20/18 Statement acknowledges hemp’s removal from the CSA, but goes on to state “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds….  We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products….  The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.”  State lawmaker and public confusion on the legal status of CBD ensued.  On 1/15/19, Oregon Senators Ron Wyden and Jeffrey A. Merkley wrote Gottlieb asking the FDA “to immediately update federal regulations governing the use of certain hemp-derived ingredients in food, beverages or dietary supplements.”  On 2/19/19, Maine Congresswoman Chellie Pingree and 11 other Representatives wrote Gottlieb “to swiftly provide guidance on lawful pathways for food products containing hemp-derived CBD in interstate commerce.”  The FDA has not yet issued additional guidance, and Gottlieb recently announced his resignation effective 4/5/19.

New HHS Title X Rule Challenged

DHHS logoThe U.S. Department of Health and Human Services (HHS) Office of Population Affairs recently issued a final rule governing the Title X Family Planning program.  The new rule will become effective 60 days after it is published in the Federal Register (which has not yet happened).  The Title X program was established in 1970 (see Pub. L. No. 91-572, § 6(c), 84 Stat. 1506), and authorized the HHS Secretary “to make grants to and enter into contracts with public or nonprofit entities to assist in the establishment and operation of voluntary family planning projects.”  From its beginning, “none of the funds appropriated under this title shall be used in programs where abortion is a method of family planning.”  The new rule “provides for clear financial and physical separation between Title X and non-Title X activities…,” “removes the requirement for abortion referral…,” and “no longer requires nondirective pregnancy counseling” including such counseling on abortion.  [See 2/22/19 Fact Sheet: Final Title X Rule Detailing Family Planning Grant Program.]  Critics of the new rule say it amounts to a “gag rule,” preventing physicians from informing patients that a prenatal care facility also provides abortion services.  Yesterday, the Washington state Attorney General announced a lawsuit challenging the new rule, stating it “permits Title X providers to withhold information from patients about their healthcare options, bars them from referring patients for abortion care, and requires Title X clinics to physically separate abortion care and referrals from their services funded by Title X.”  The Washington branch of the ACLU also plans to file a lawsuit, and the two cases will likely be consolidated in the Eastern District of Washington.

GAO Recommends CMS Action to Ensure Medicaid Abortion Coverage

GAO LogoThe U.S. General Accounting Office (GAO) recently released the CMS Action Needed to Ensure Compliance with Abortion Coverage Requirements report.  Federal law prohibits federal funding for abortions in most circumstances, but state Medicaid programs are required to cover abortions if the pregnancy is the result of rape or incest, or the life of the pregnant woman is physically endangered by the pregnancy.  [See Pub. L. No. 115-245, §§ 506-7, 132 Stat. 2981, 9/28/18.]  The GAO report documents “state variation in Medicaid abortion coverage and payment requirements,” including South Dakota’s Medicaid state plan not covering abortions in cases of rape or incest, and 14 states not covering Mifeprex, a drug used in non-surgical abortions.  The GAO report also identifies “seven key factors that could pose challenges to women accessing abortions…:  gestational limits, mandatory counseling, out-of-pocket costs, parental involvement requirements, provider availability, stigma and harassment, and waiting period requirements.”  As the federal agency that oversees Medicaid, the Centers for Medicare & Medicaid Services (CMS) monitors state compliance with federal requirements.  The GAO report recommends CMS action to ensure South Dakota’s compliance with federal law, as well as to determine state Medicaid program coverage of Mifeprex and accurate reporting of fee-for-service abortions.

Revised OPTN Liver Transplantation Policy

anatomical images of human digestive systemOn December 3, 2018, the U.S. D.H.H.S. Organ Procurement & Transplantation Network (OPTN) Board of Directors approved a revision to the liver allocation policy.  [Allocation of organs is addressed in 42 C.F.R. 121.8.]  The revised policy is raising concerns in rural areas, and its implementation has been postponed.  Livers have been allocated using a medical urgency formula through a local/regional/national sequence.  The revised policy “eliminates the use of DSA [donation service area] or [OPTN] region in liver allocation or in scoring liver candidate exceptions,” and “would allocate livers to candidates within 150, 250, or 500 nautical miles (nm) of donor hospitals before offering them nationally.”  Under the revised policy’s expansion of geographic availability, rural transplant centers will likely have access to fewer livers.