Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On July 9, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry. This final guidance provides information on how FDA will define and process submissions for modifications and revisions of risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications or revisions of the REMS. The guidance also provides instructions to application holders related to procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA's review of and action on such changes. The definitions of REMS modifications and revisions apply to all types of REMS. This guidance updates the guidance of the same name, issued April 7, 2015, including finalizing the portion that sets forth the submission procedures for REMS revisions.
- On July 10, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program: Specialty Care Models to Improve Quality of Care and Reduce Expenditures. This rule proposes to implement two new mandatory Medicare payment models under section 1115A of the Social Security Act—the Radiation Oncology Model (RO Model) and the End-Stage Renal Disease (ESRD) Treatment Choices Model (ETC Model). The proposed RO Model would promote quality and financial accountability for providers and suppliers of radiotherapy (RT). The RO Model would test whether making prospective episode payments to hospital outpatient departments (HOPD) and freestanding radiation therapy centers for RT episodes of care preserves or enhances the quality of care furnished to Medicare beneficiaries while reducing Medicare program spending through enhanced financial accountability for RO Model participants. The proposed ETC Model would be a mandatory payment model focused on encouraging greater use of home dialysis and kidney transplants, in order to preserve or enhance the quality of care furnished to Medicare beneficiaries while reducing Medicare expenditures.
- On July 11, 2019, CMS issued a proposed rule entitled, Medicaid Program: Methods for Assuring Access to Covered Medicaid Services – Rescission. In response to state concerns over the administrative burden associated with the current regulatory requirements, this proposed rule would remove the regulatory text that sets forth the current required process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist enough providers to assure beneficiary access to covered care and services consistent with the Medicaid statute.
- On July 11, 2019, CMS issued a proposed rule entitled, Medicare and Medicaid Programs: CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements. This proposed rule would update the home health prospective payment system (HH PPS) payment rates and wage index for CY 2020; implement the Patient-Driven Groupings Model (PDGM), a revised case-mix adjustment methodology, for home health services beginning on or after January 1, 2020. This proposed rule also implements a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the Bipartisan Budget Act of 2018, and proposes a 30-day payment amount for CY 2020. Additionally, this rule proposes to: modify the payment regulations pertaining to the content of the home health plan of care; allow physical therapy assistants to furnish maintenance therapy; and change the split percentage payment approach under the HH PPS. This proposed rule would also solicit comments on the wage index used to adjust home health payments and suggestions for possible updates and improvements to the geographic adjustment of home health payments. In addition, it proposes public reporting of certain performance data under the Home Health Value-Based Purchasing (HHVBP) Model. It also proposes changes with respect to the Home Health Quality Reporting Program to remove one measure, to adopt two new measures, modify an existing measure, adopt new standardized patient assessment data beginning with the CY 2022 HH QRP, codify the HH QRP policies in a new section, and to remove question 10 from all the HH Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys. Lastly, it would set forth routine updates to the home infusion therapy payment rates for CY 2020 and propose payment provisions for home infusion therapy services for CY 2021 and subsequent years.
- August 1, 2019: HHS announced a public meeting entitled, Advisory Committee on Heritable Disorders in Newborns and Children. The purpose of this meeting is to solicit public comments on the condition nomination, evidence review, and decision-making processes. The Committee can accommodate oral comments made in person or via the telephone.
- August 6 and August 7, 2019: Department of Health and Human Services (HHS) announced a public meeting entitled, National Committee on Vital and Health Statistics. The goal of this expert roundtable meeting is to identify research questions to inform evaluation of the benefit and cost of transition from International Classification of Diseases-10 (ICD-10) to ICD-11 for mortality and morbidity. Specific meeting objectives include: developing a shared understanding of lessons from the ICD-10 planning process/transition and the differences between ICD-10 and ICD-11; reaching consensus on the research questions to be answered to inform evaluation of cost and benefit of transition from ICD-10 to ICD-11 for mortality and morbidity—and to identify impacts of not moving to ICD-11 for morbidity; and identifying key topics and messages to communicate to the industry to foster early stakeholder engagement and preparation for the transition to ICD-11.
- On July 10, 2019, the Senate Special Committee on Aging held a hearing entitled, Redefining Reality: How the Special Diabetes Program is Changing the Lives of Americans with Type 1 Diabetes. Witnesses present included: Griffin P. Rodgers, MD, MACP, Director, National Institute of Diabetes and Digestive and Kidney Diseases, NIH; Aaron Kowalski, PhD, President and CEO of Juvenile Diabetes Research Foundation (JDRF); Victor Garber, Actor; Ruby Anderson, Children’s Congress Delegate; and Adriana Richard, Children’s Congress Delegate.
House of Representatives
- On July 10, 2019, the House Committee on Oversight and Reform held a hearing entitled, The Trump Administration's Attack on the ACA: Reversal in Court Case Threatens Health Care for Millions of Americans. Witnesses present included: David Balat, Director, Right on Healthcare Initiative, Texas Public Policy Foundation; Stephanie Burton, Patient/Consumer, Kansas City, MO; Casey Dye, Patient/Consumer, Monroeville, PA; Paul Gibbs, Patient/Consumer, West Valley, UT; Abbe Gluck, Director, Solomon Center for Health Law and Policy, Yale University Law School; Frederick Isasi, Executive Director, Families, U.S.A; and Peter Morley, Patient/Consumer, New York, NY.
- On July 11, 2019, the House Energy and Commerce Committee Subcommittee on Health held a markup of ten health bills. Legislation included: H.R. 2781, H.R. 728, H.R. 1058, H.R. 2507, H.R. 776, H.R. 2035, H.R. 2296, H.R. 2328, H.R. 3631, and H.R. 3630.
- On July 11, 2011, the House Committee on Oversight and Reform held a hearing entitled, Identifying, Preventing, and Treating Childhood Trauma: A Pervasive Public Health Issue that Needs Greater Federal Attention. Witnesses present included: William Kellibrew, Founder, The William Kellibrew Foundation; Heather Martin, Executive Director and Co-Founder, The Rebels Project; Justin Miller, Deputy Executive Director, Objective Zero Foundation; Creeana Rygg, Survivor and Activist; Dr. Christina Bethell, Director, Child and Adolescent Health Measurement Initiative; James Henry, Former Deputy Governor & Chief of Staff, State of Tennessee; Dr. Debra Houry, Director, National Center for Injury Prevention & Control, on behalf of Centers for Disease Control and Prevention; Charles Patterson, Health Commissioner, Clark County, Ohio; and Dr. Denese Shervington, Clinical Professor of Psychiatry, Tulane University School of Medicine.
III. Reports, Studies, & Analyses
- On July 12, 2019, the Kaiser Family Foundation issued a report entitled, How Many Employers Could Be Affected by the High-Cost Plan Tax. Looking at the share of current plans that might meet the definition of “high cost” over time, this study estimates that if the ACA High-Cost Plan Tax (HCPT) takes effect in 2022, 31 percent of plans will be subject to the tax, increasing to 46 percent by 2030 unless firms reduce costs. Excluding worker FSA contributions, 21 percent of firms will be subject to the tax in 2022, increasing to 37 percent in 2030.
IV. Other Health Policy News
- On July 8, 2019, a federal court blocked the Trump administration's rule requiring drug makers to disclose list prices in television advertisements because Judge Amit Mehta found regulating television ads for prescription drugs is outside CMS' authority. Read more about the decision here.
- On July 9, 2019, The Fifth Circuit Court of Appeals heard oral arguments in the appeal of a district court decision that struck down the entire Affordable Care Act. A summary of the arguments can be found here.
- On July 10, 2019, HHS-OIG recalled its drug rebate rule entitled, Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection. An analysis of this decision can be found here.
- On July 10, 2019, President Trump signed an Executive Order entitled Advancing American Kidney Health. The Order is intended to raise awareness of and expand access to care for patients with chronic kidney disease and end-stage renal disease. In addition to calling for the mandatory ETC Model, the Order provides for the development of four new voluntary models, the Kidney Care First (KCF) and Comprehensive Kidney Care Contracting (CKCC) Graduated, Professional, and Global Models. These models build upon the existing Comprehensive ESRD Care (CEC) Model structure. These models are expected to begin in 2020 and run through 2023 and will focus on care for Medicare beneficiaries with stage 4 and 5 CKD, beneficiaries with ESRD receiving maintenance dialysis, and beneficiaries aligned to a KCF practice. The text of the Executive Order is available here.