I. Regulations, Notices, & Guidance
- On July 6, 2017, the Health Resources and Services Administration (HRSA) issued a notice entitled, Notice of Single Source Award to the Genesee County Health Department for Addressing and Preventing Lead Exposure through Healthy Start in Genesee County, Michigan. The notice announces HRSA’s intent to award up to $14,975,000 for a cooperative agreement to the Genesee County Health Department, which operates the Genesee County Healthy Start program. According to HRSA, the purpose of the cooperative agreement is to expedite and strengthen the ongoing response to address the health effects of lead exposure resulting from the Flint, MI, public water supply contamination.
- On July 6, 2017, HRSA issued a notice entitled, Senior Executive Service Performance Review Board. The notice announces the publication of a list of staff who may be named to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA for the Fiscal Year 2017 and 2018 review period.
- On July 7, 2017, the National Institutes of Health (NIH) issued a notice entitled, Prospective Grant of Exclusive Patent License: Composition and Methods for Delivering Inhibitory Oligonucleotides for the Treatment of Pancreatic Cancer. The notice announces that the National Institute on Aging, within the NIH, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to VeriLuce Therapeutics (“VLT”) located in Toronto, ON, Canada. Comments are due by July 25, 2017.
- On July 7, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a final rule; delay of effective date entitled, Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies. The final rule delays the effective date for the final rule entitled, Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies published in the Federal Register on January 13, 2017 (82 FR 4504). The published effective date for the final rule was July 13, 2017, and this final rule delays the effective date for an additional 6 months until January 13, 2018. This final rule also includes two conforming changes to dates that are included in the regulations text.
- July 28, 2017: The Department of Health and Human Service (HHS) announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council will spend the morning discussing information gaps across the three areas of research, clinical care, and long term services and supports. There will also be a presentation on the recently released National Academy of Sciences, Engineering, and Medicine (NASEM) report on preventing cognitive decline. Additional presentations in the afternoon will include a presentation on planning and progress towards the October Care and Services Summit and federal workgroup updates.
- August 3, 2017: The Food and Drug Administration (FDA) announced public advisory committee meeting of the Arthritis Advisory Committee. The committee will discuss supplemental new drug applications (sNDAs) 203214 supplement 17, for XELJANZ (tofacitinib) tablets and 208246 supplement 3, for XELJANZ XR (tofacitinib) extended release tablets submitted by Pfizer Inc., for the treatment of adult patients with active psoriatic arthritis. The committee will discuss the efficacy and safety data and benefit-risk considerations.
- August 23 – 24, 2017: The Centers for Disease Control and Prevention (CDC) announced a Sunshine Act meeting: Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH). The agenda for the Advisory Board meeting includes: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; Securities and Exchange Commission (SEC) Petitions Update; Site Profile reviews for Pantex Plant (Amarillo, Texas), Pacific Proving Grounds (Marshall Islands), Feed Materials Production Center (Fernald, Ohio), and possibly Nevada Test Site (Mercury, Nevada); SEC petitions for: Metals and Control Corp. (1968- 1997; Attleboro, Massachusetts), Los Alamos National Laboratory (1996-2005; Los Alamos, New Mexico), Idaho National Laboratory (1970-1980; Scoville, Idaho), Area IV of Santa Susanna Field Laboratory (1991-1993; Ventura County, California), Savannah River Site (1973-2007; Aiken, South Carolina), and possibly either Ames Laboratory (1971 – undetermined ending date; Ames, Iowa) or Grand Junction Facilities (1986-2010; Grand Junction, CO); and Board Work Sessions.
- The Senate has adjourned and will reconvene on Monday, July 10, 2017.
- The House has adjourned and will reconvene on Tuesday, July 11, 2017.
- On July 5, 2017, the Office of Inspector General (OIG) released a report entitled, Louisiana Complied With the Requirements of the Social Security Act in Its Review of Cases of Credible Allegations of Medicaid Fraud. The report found that the State agency complied with the requirements of the Social Security Act when it received a credible allegation of fraud by its Medicaid providers.
- On July 5, 2017, the OIG released a public summary report entitled, Readiness of CDC's Strategic National Stockpile Could Be at Risk in Case of a Public Health Emergency. The report found that two primary systemic issues may prevent CDC from ensuring that Stockpile sites are adequately protected and that inventory is readily deployable in a public health emergency: although no longer responsible for providing Stockpile security, the Division of Strategic National Stockpile still controls security funding, and the Stockpile automated inventory system did not always accurately track the movement of all inventory or accurately record inventory locations.
- On July 6, 2017, the OIG released a report entitled, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017. The report found that the rate of Part D plan formularies' inclusion of the 197 drugs commonly used by dual eligibles is high, with some variation. On average, Part D plan formularies include 97 percent of the 197 commonly used drugs. In addition, 70 percent of the commonly used drugs are included by all Part D plan formularies. These results are largely unchanged from the OIG's findings for formularies reported in the mandated annual report from 2016, as well as the OIG’s findings from 2011 through 2015. The report also found that the percentage of drugs to which plan formularies applied utilization management tools remained the same from 2016 to 2017. On average, formularies applied utilization management tools to 28 percent of the unique drugs the OIG reviewed in 2017, the same percentage as in 2016.
IV. Other Health Policy News
- On July 7, 2017, the OIG released Advisory Opinion No. 17-02 regarding a hospital outpatient facility's proposal to reduce or waive, on a non-routine, unadvertised basis, cost-sharing amounts owed by financially needy Medicare beneficiaries for items and services furnished in connection with a clinical research study. The OIG found that the proposed arrangement would not constitute grounds for the imposition of sanctions under the civil monetary penalty provision prohibiting inducements to beneficiaries, section 1128A(a)(5) of the Social Security Act (the “Act”), or under the exclusion authority at section 1128(b)(7) of the Act, or the civil monetary penalty provision at section 1128A(a)(7) of the Act, as those sections relate to the commission of acts described in section 1128B(b) of the Act, the Federal anti-kickback statute.
- On July 7, 2017, Representatives Pat Tiberi (R-OH) and Bill Pascrell (D-NJ) introduced H.R. 3163, the Medicare Part B Home Infusion Services Temporary Transitional Payment Act. According to Rep. Tiberi, H.R. 3163 would create a new transitional payment structure for providers of home infusion services before policies signed into law in 21st Century Cures takes effect in 2021. The full legislative text can be accessed here.
V. ACA Repeal News
- During a Rotary Club lunch in his home district, Senator Majority Leader, Mitch McConnell (R-KY) discussed a possible option of a bipartisan fix for the individual insurance market. According to the Associated Press, Sen. McConnell said, "If my side is unable to agree on an adequate replacement, then some kind of action with regard to the private health insurance market must occur.”