Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On April 17, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2020 and Updates to the Inpatient Rehabilitation Facility Quality Reporting Program. This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2020. As required by the Social Security Act (the Act), this proposed rule includes the classification and weighting factors for the IRF prospective payment system’s (PPS) case-mix groups (CMGs) and a description of the methodologies and data used in computing the prospective payment rates for FY 2020. CMS is proposing to rebase and revise the IRF market basket to reflect a 2016 base year rather than the current 2012 base year. Additionally, CMS is proposing to replace the previously finalized unweighted motor score with a weighted motor score to assign patients to CMGs and remove one item from the score beginning with FY 2020 and to revise the CMGs and update the CMG relative weights and average length of stay values beginning with FY 2020, based on analysis of 2 years of data (FY 2017 and FY 2018). CMS is proposing to update the IRF wage index to use the concurrent FY inpatient prospective payment system (IPPS) wage index beginning with FY 2020. CMS is soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust IRF payments. CMS is proposing to amend the regulations to clarify that the determination as to whether a physician qualifies as a rehabilitation physician (that is, a licensed physician with specialized training and experience in inpatient rehabilitation) is made by the IRF. For the IRF Quality Reporting Program (QRP), CMS is proposing to adopt two new measures, modify an existing measure, and adopt new standardized patient assessment data elements. CMS also proposes to expand data collection to all patients, regardless of payer, as well as proposing updates related to the system used for the submission of data and related regulation text.
- On April 18, 2019, CMS issued a final rule entitled, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020. This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal Platform (SBE-FPs). It finalizes changes that will allow greater flexibility related to the duties and training requirements for the Navigator program and changes that will provide greater flexibility for direct enrollment entities, while strengthening program integrity oversight over those entities. It finalizes a change intended to reduce the costs of prescription drugs. This final rule also includes changes to Exchange standards related to eligibility and enrollment; exemptions; and other related topics.
- On April 18, 2019, CMS issued a proposed rule entitled, Medicare Program; FY 2020 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2019 (FY 2020). This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an inpatient prospective payment system hospital or critical access hospital. Additionally, this proposed rule would revise and rebase the IPF market basket to reflect a 2016 base year and remove the IPF Prospective Payment System (PPS) 1-year lag of the wage index data. This proposed rule also solicits comments on the IPF wage index. Finally, this rule proposes updates to the Inpatient Psychiatric Facilities Quality Reporting Program. These changes would be effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2019 through September 30, 2020.
- On April 19, 2019, the Department of Health and Human Services (HHS) issued an extension of comment period entitled, 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. On March 4, 2019, HHS published a proposed rule that would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking. The comment period for the rule was scheduled to close on May 3, 2019. This document extends the comment period for the proposed rule by 30 days to June 3, 2019.
- On April 19, 2019, CMS issued a proposed rule entitled, FY 2020 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements. This proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year 2020. This rule proposes to rebase the continuous home care, general inpatient care, and the inpatient respite care per diem payment rates in a budget-neutral manner to more accurately align Medicare payments with the costs of providing care. In addition, this rule proposes to modify the election statement by requiring an addendum that includes information aimed at increasing coverage transparency for patient under a hospice election. Finally, this rule proposes changes to the Hospice Quality Reporting Program.
- On April 19, 2019, CMS issued a proposed rule entitled, Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2020. This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2020. CMS proposes minor revisions to the regulation text to reflect the revised assessment schedule under Patient Driven Payment Model (PDPM). Additionally, CMS proposes to revise the definition of group therapy under the SNF PPS, and to implement a subregulatory process for updating the code lists (International Classification of Diseases, Tenth Version (ICD-10) codes) used under PDPM. CMS is also soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust SNF payments. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs.
Event Notices
- April 29, 2019: The Food and Drug Administration (FDA) announced a public meeting entitled, Perspectives on the Impact of Rare Diseases: Bridging the Commonalities. The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to asses commonalities that may help the FDA and medical product developers further understand and advance the development of treatments for rare diseases.
- May 9 – 10, 2019: The FDA announced a meeting of the Pain Management Best Practices Inter-Agency Task Force. The Task Force will review clinical guidelines and identify gaps and/or inconsistencies for best practices for pain management.
- May 13, 2019: The FDA announced a public meeting entitled, The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products. The hearing is set to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.
II. Congressional Legislation & Committee Action
U.S. Senate
- There were no health-related hearings this week.
House of Representatives
- There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On April 16, 2019, the Journal of the American Medical Association published a study entitled, Effect of a Workplace Wellness Program on Employee Health and Economic Outcomes: A randomized Clinical Trial. The report found that employees exposed to a workplace wellness program reported significantly greater rates of some positive health behaviors, but there were no significant effects on clinical measures of health, health care spending and utilization, or employment outcomes after 18 months.
IV. Other Health Policy News
- On April 18, 2019, the Congressional Budget Office (CBO) issued a new health insurance model entitled, The Health Insurance Simulation Model (HISIM2). The HISIM2 is a new version of the model CBO uses to generate estimates of health insurance coverage and premiums for the population under age 65. It is also used to estimate the effects of proposed changes in policies that affect health insurance coverage, among other things.