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 October 31, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies; Extension of Timeline for Publication of Final Rule. This document announces the extension of the timeline for publication of the “Medicare and Medicaid Program; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies” final rule. CMS is issuing this document in accordance with section 1871(a)(3)(B) of the Social Security Act, which requires notice to be provided in the Federal Register if there are exceptional circumstances that cause CMS to publish a final rule more than 3 years after the publication date of the proposed rule. In this case, the complexity of the rule and scope of public comments warrants the extension of the timeline for publication.
- On October 31, 2018, the Health Resources and Services Administration (HRSA) issued a proposed rule entitled, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. HRSA administers section 340B of the Public Health Service Act, which is referred to as the “340B Drug Pricing Program” or the “340B Program.” HRSA published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HRSA published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After further consideration of the issue, the Department of Health and Human Services (HHS) proposes to cease any further delay of the rule and change the effective date from July 1, 2019 to January 1, 2019.
- On October 31, 2018, CMS issued a final rule entitled, Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements ; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations. This final rule with comment period updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2019. This rule also: updates the HH PPS case-mix weights for calendar year (CY) 2019 using the most current, complete data available at the time of rulemaking; discusses CMS’ efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CYs 2014 through 2017; finalizes a rebasing of the HH market basket (which includes a decrease in the labor-related share); finalizes the methodology used to determine rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123) hereinafter referred to as the “BBA of 2018”; finalizes regulations text changes regarding certifying and recertifying patient eligibility for Medicare home health services; and finalizes the definition of “remote patient monitoring” and the recognition of the costs associated with it as allowable administrative costs. This rule also summarizes the case-mix methodology refinements for home health services beginning on or after January 1, 2020, which includes the elimination of therapy thresholds for payment and a change in the unit of payment from a 60-day episode to a 30-day period, as mandated by section 51001 of the Bipartisan Budget Act of 2018. This rule also finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model. In addition, with respect to the Home Health Quality Reporting Program, this rule discusses the Meaningful Measures Initiative; finalizes the removal of seven measures to further the priorities of this initiative; discusses social risk factors and provides an update on implementation efforts for certain provisions of the IMPACT Act; and finalizes a regulatory text change regarding OASIS data. For the home infusion therapy benefit, this rule finalizes health and safety standards that home infusion therapy suppliers must meet; finalizes an approval and oversight process for accrediting organizations (AOs) that accredit home infusion therapy suppliers; finalizes the implementation of temporary transitional payments for home infusion therapy services for CYs 2019 and 2020; and responds to the comments received regarding payment for home infusion therapy services for CY 2021 and subsequent years. Lastly, in this rule, CMS is finalizing only one of the two new requirements proposed to implement in the regulations for the oversight of AOs that accredit Medicare-certified providers and suppliers. More specifically, for reasons set out more fully in section X. of this final rule with comment period, CMS has decided not to finalize the proposal to require that all surveyors for AOs that accredit Medicare-certified providers and suppliers take the same relevant and program-specific CMS online surveyor training that the State Agency surveyors are required to take. However, CMS is finalizing the proposal to require that each AO must provide a written statement with their application to CMS, stating that if one of its fully accredited providers or suppliers, in good-standing, provides written notification that they wish to voluntarily withdraw from the AO’s CMS-approved accreditation program, the AO must continue the provider or supplier’s current accreditation until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first.
- On November 1, 2018, CMS issued a final rule entitled, End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments to Correct Existing Regulations Related to the CBP for Certain DMEPOS. This final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2019. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, it updates and rebases the ESRD market basket for CY 2019. This rule also updates requirements for the ESRD Quality Incentive Program (QIP), and makes technical amendments to correct existing regulations related to the CBP for DMEPOS. Finally, this rule finalizes changes to bidding and pricing methodologies under the DMEPOS competitive bidding program; adjustments to DMEPOS fee schedule amounts using information from competitive bidding for items furnished from January 1, 2019 through December 31, 2020; new payment classes for oxygen and oxygen equipment and a new methodology for ensuring that new payment classes for oxygen and oxygen equipment are budget neutral; payment rules for multi-function ventilators or ventilators that perform functions of other durable medical equipment (DME); and revises the payment methodology for mail order items furnished in the Northern Mariana Islands. This rule also includes a summary of the feedback received for the request for information related to establishing fee schedule amounts for new DMEPOS items and services.
- On November 1, 2018, CMS issued a final rule entitled, Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; etc. This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also finalizes policies included in the interim final rule with comment period in “Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year” that address the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria. In addition, this final rule addresses a subset of the changes to the Medicare Shared Savings Program for Accountable Care Organizations (ACOs) proposed in the August 2018 proposed rule “Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations--Pathways to Success.” This final rule also addresses certain other revisions designed to update program policies under the Shared Savings Program. The interim final rule implements amendments made by the SUPPORT for Patients and Communities Act to the Medicare telehealth provisions in the Social Security Act and regarding permissible telehealth originating sites for purposes of treatment of a substance use disorder or a co-occurring mental health disorder for telehealth services furnished on or after July 1, 2019 to an individual with a substance use disorder diagnosis.
- On November 2, 2018, CMS issued a final rule entitled, Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2019 to implement changes arising from CMS’s continuing experience with these systems. In this final rule with comment period, CMS describes the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, CMS is updating the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey measure under the Hospital Inpatient Quality Reporting (IQR) Program by removing the Communication about Pain questions; and retaining two measures that were proposed for removal, the Catheter-Associated Urinary Tract Infection (CAUTI) Outcome Measure and Central Line-Associated Bloodstream Infection (CLABSI) Outcome Measure, in the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program beginning with the FY 2021 program year.
- November 5, 2018: The Food and Drug Administration (FDA) announced a public hearing and an opportunity for public comment on the future format of the National Drug Code (NDC). FDA is seeking input from a variety of stakeholders through comments and responses to FDA questions included in the above notice and associated web content that will be published before the hearing.
- November 7, 2018: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The CLIAC will hear updates from other agencies on a range of laboratory-related issues, including laboratory interoperability.
- November 8, 2018: The FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will hear an overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review.
- November 27, 2018: The FDA announced a public meeting entitled, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. The purpose of the hearing is to give stakeholders the opportunity to provide input on the underlying systemic causes of drug shortages and make recommendations for actions to prevent or mitigate drug shortages.
- December 5, 2018: The FDA announced a public hearing to discuss its efforts to eliminate youth electronic cigarette use as well as other tobacco use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies.
- There were no health-related hearings this week.
House of Representatives
- There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On October 29, 2018, the Office of Inspector General at the Department of Health and Human Services issued a report entitled, Food and Drug Administration’s Policies and Procedures Should Better Address Post-market Cybersecurity Risk to Medical Devices. The report recommended FDA do the following: continually assess the cybersecurity risks to medical devices and update its plans and strategies; establish written procedures and practices for securely sharing sensitive information about cybersecurity events with key stakeholders who have a “need to know”; enter into formal written agreements with Federal agency partners to establish roles and responsibilities to further FDA’s cybersecurity mission; and ensure the establishment and maintenance of procedures for handling recalls of medical devices vulnerable to cybersecurity threats.
IV. Other Health Policy News
- On November 1-2, 2018, the Medicare Payment Access Commission (MedPAC) held their November meeting. MedPAC’s meeting agenda is available here.