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 July 10, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, Reassignment of Medicaid Provider Claims. This proposed rule would remove the regulatory text that allows a state to make payments to third parties on behalf of an individual provider for benefits such as health insurance, skills training, and other benefits customary for employees. CMS has concerns that the provisions are insufficiently linked to the exceptions permitted by statute and invites the public to comment on the proposed rule.
- On July 12, 2018, CMS issued a proposed rule entitled, Medicare Program: Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; etc. This major proposed rule addresses changes to the Medicare physician fee schedule and other Medicare Part B payment policies and is intended to reflect changes in medical practice as well as changes in statute.
- On July 12, 2018, CMS issued a proposed rule entitled, Medicare Program: 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 Competitive Bidding Program and Fee Schedule Amounts, etc. This proposed rule would update and make revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2019. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, it proposes a rebasing of the ESRD market basket for CY 2019. This proposed rule also proposes to update requirements for the ESRD Quality Incentive Program (QIP), and to make technical amendments to correct existing regulations related to the CBP for certain DMEPOS. Finally, this proposed rule proposes changes to bidding and pricing methodologies under the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) competitive bidding program (CBP); 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 payment methodology revisions for mail order items furnished in the Northern Mariana Islands. This rule also includes a request for information related to establishing fee schedule amounts for new DMEPOS items and services. It also includes Requests for Information on promoting interoperability and electronic healthcare information exchange, and improving beneficiary access to dialysis facility and DMEPOS charge information.
- On July 13, 2018, the Drug Enforcement Administration (DEA) issued a final rule entitled, Controlled Substances Quotas. The DEA is publishing this final rule in efforts to strengthen the process for setting controls over diversion of controlled substances and make other improvements in the quota management regulatory system for the production, manufacturing, and procurement of controlled substances.
- July 25, 2018: The CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The meeting will focus on obtaining the MEDCAC’s appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements, trans-catheter aortic valve replacements and percutaneous coronary interventions for hospitals.
- July 30, 2018: The Department of Health and Human Services (HHS) announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer’s Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. The Advisory Council will spend the majority of the July meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations in the afternoon will include a presentation on a recent study by RAND on the health care infrastructure, the CDC/Alzheimer’s Association’s joint Healthy Brain Initiative Roadmap, federal workgroup updates, and updates on work by the non-federal members.
- August 1, 2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The CSAT NAC will discuss substance use disorder spending estimates and the opioid epidemic.
- August 3, 2018: The FDA announced a meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The committees will discuss results from assessments of the trans-mucosal immediate-release fentanyl medicines’ risk evaluation and mitigation strategy.
- August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.
- August 21, 2018: The FDA announced a public work shop entitled, Development of Non-Traditional Therapies for Bacterial Infections. The purpose of the workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
- September 12, 2018: The FDA announced a public hearing to solicit comments on FDA’s Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review.
- September 28, 2018: the FDA announced a conference entitled, Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery – Influences of Sex and Gender. The purpose of the conference is to discuss the biological and sociological influences on misuse, abuse, and cessation of opioids and tobacco.
II. Congressional Legislation & Committee Action
- No health-related hearings this week.
House of Representatives
- On July 11, 2018, the House Appropriations Committee held a markup entitled, Full Committee Markup – FY19 Labor, Health and Human Services, Education, and Related Agencies. The Committee advanced the FY 2019 Labor, Health and Human Services, Education, and Related Agencies funding bill by a 30-22 vote.
- On July 11, 2018, the House Energy and Commerce Committee held a hearing entitled, Opportunities to Improve the 340B Drug Pricing Program. Witnesses present included: Debra Draper, Director, Health Care Team, Government Accountability Office; Frederick Cerise, MD, President and Chief Executive Officer, Parkland Hospital; Debra Patt, MD, MPH, MBA, Texas Oncology; and Charles Daniels, PhD, Pharmacist-In-Chief and Associate Dean, University of California, San Diego.
- On July 11-12, 2018, the House Ways and Means Committee held a markup on a number of health-related bills. The Committee advanced all bills to the House floor.
- On July 12, 2018, the House Energy and Commerce Committee held a markup on a number of bills including four health-related bills. All health-related bills were advanced to the House floor.
III. Reports, Studies, & Analyses
- On July 13, 2018, the Robert Wood Johnson Foundation and the Urban Institute issued a report entitled, Characteristics of the Remaining Uninsured: An Update. The report found that the number of uninsured nonelderly people fell from 32.9 million in 2015 to 30.1 million in 2017 with many being young adults ages 18-34.
IV. Other Health Policy News
- On July 9, 2018, CMS released a report entitled, Summary Report on Permanent Risk Adjustment Transfers for the 2017 Benefit Year. The report highlights the risk adjustment transfers for the 2017 benefit years and found that the program functioned smoothly for the 2017 benefit year.