The Department of Health and Human Services (HHS) recently published its Spring 2015 regulatory agenda which sets forth HHS’ upcoming rulemaking initiatives. The agenda includes numerous items affecting healthcare stakeholders, including biopharmaceutical and medical device manufacturers, patients, providers and suppliers, health IT companies and researchers, among others. Below, we highlight several key agenda items, organized by agency within HHS. Stakeholders may wish to comment on the proposals as they are issued.
Centers for Medicare and Medicaid Services (CMS)
- CMS expects to issue its annual rulemakings for 2016 related to the Physician Fee Schedule (proposed rule expected in June), Hospital Inpatient Prospective Payment System (proposed rule was issued in April, with comments due in late June; final rule expected in August), Hospital Outpatient Prospective Payment System (proposed rule expected in June), Home Health Prospective Payment System (proposed rule expected in June) and End-Stage Renal Disease (ESRD) Prospective Payment System (proposed rule expected in June), among others. The ESRD rulemaking will also address the methodology for adjusting the Durable Medical Equipment, Prosthetics, Orthotics and Supplies fee schedule payment amounts.
- In February 2016, CMS expects to finalize a rule to implement the ACA provisions that require the Secretary to establish a process for a provider or supplier to return an overpayment to Medicare, and to establish a process for CMS and its contractors to receive and apply the overpayment.
- This November, CMS plans to finalize its proposal to establish waivers of the application of the Physician Self-Referral Law, the federal Anti-Kickback Statute (AKS) and certain Civil Monetary Penalty (CMP) law provisions to specified Accountable Care Organization arrangements under the Medicare Shared Savings Program.
- CMS also plans to issue an interim final rule revising certain requirements for beneficiary access to covered Part D drugs. CMS plans to accept comments on the interim final rule by July 2015 and to issue final action on the interim final rule by May 2018.
- The long-awaited Medicaid Drug Rebate Program (MDRP) “Covered Outpatient Drugs” final rule is slated for release in August 2015, according to the regulatory agenda. This rule revises requirements pertaining to Medicaid rebates and reimbursement for covered outpatient drugs, including changes to implement the ACA’s amendments to the MDRP.
- As required by the ACA, CMS also plans to issue a final rule in August that will revise the Medicaid “home health services” definition to add a requirement that physicians document the existence of a face-to-face encounter with the Medicaid eligible individual within reasonable timeframes.
- This May, CMS plans to finalize changes to the definition of an “eligible organization” that can avail itself of an accommodation in connection with coverage of certain preventive services (including contraception) without cost-sharing under the Public Health Service Act, as amended by the ACA.
- In November, CMS expects to issue a proposed rule that would set forth benefit and payment parameters for the Federally-facilitated Exchanges created pursuant to the ACA. This proposed rule will include provisions related to the risk adjustment programs; cost-sharing parameters and cost-sharing reductions; user fees for Federally-facilitated Exchanges and possibly Essential Health Benefits requirements.
- The agenda includes two items related to the Electronic Health Records (EHR) Incentive Program, expected to be proposed in late May/June of this year and then finalized in March/April of 2018. These rules will implement a number of updates to the program.
Health Resources and Services Administration (HRSA)
The agenda includes three HRSA regulatory actions related to the 340B drug pricing program.
- One proposal, expected in July, is required under the ACA and would impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers who intentionally charge a covered entity a price above the 340B ceiling price, and would define standards and methodology for calculating the 340B ceiling pricing.
- Another proposal, expected in December and also required by the ACA, would establish a required and binding administrative dispute resolution process to resolve claims raised by covered entities asserting they have been overcharged for drugs purchased under the 340B program. This process would also be available to manufacturers.
- In response to a court ruling striking down previous regulations, HRSA plans to propose “omnibus guidance” in September to “address key policy issues raised by stakeholders for which HHS does not have statutory rulemaking authority.”
Office of Inspector General
The agenda includes three significant OIG final rules.
- In October, OIG plans to finalize its proposal to revise the CMP rules to implement authorities under the ACA and other statutes, including provisions to provide CMS with assessments and exclusions for a number of activities, including making false statements or omissions in an enrollment application and failure to return an overpayment. The rule would also finalize an alternate methodology for calculating penalties and assessments for employing excluded individuals under several authorities.
- This November, OIG plans to finalize its proposal to codify changes made by the ACA regarding OIG’s authority to protect the federal healthcare programs from fraud and abuse. OIG also plans to update and clarify its regulations pursuant to other statutory authorities.
- OIG plans to finalize its proposed amendments to the AKS safe harbors and CMP rules to add new safe harbors, to codify the ACA’s revised definition of “remuneration” and to add a gainsharing CMP provision to existing regulations. This final rule is expected to be released in December.
Office for Civil Rights (OCR)
The following are among the anticipated rulemaking activities for OCR this year:
- OCR plans to issue a proposed rule, expected in June, to implement provisions against discrimination in federal health programs and activities as called for under the ACA.
- OCR also plans to release an advanced notice of proposed rulemaking, expected in December, that would solicit comments on establishing a methodology under which an individual who is harmed by a Health Insurance Portability and Accountability Act (HIPAA) offense may receive a percentage of any CMP or settlement collected by the government.
The full agenda can be accessed at http://www.reginfo.gov/public/do/eAgendaMain.
For more on other breaking drug pricing related news, visit Sidley’s Global Drug Pricing page.
If you have any questions regarding this Sidley Update, please contact the Sidley lawyer with whom you usually work, or
Paul E. Kalb, M.D.
Stephanie P. Hales
Sidley Global Life Sciences Practice
Sidley Healthcare Practice
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