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Earlier this month and with little fanfare, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would invoke CMS’s rarely used retroactive-rulemaking authority to essentially ensure that, despite the Supreme Court’s adverse rulemaking decision in Azar v. Allina Health Services, 139 S. Ct. 1804 (2019), CMS will apply the same Medicare payment methodology found procedurally improper in Allina. CMS’s invocation of its retroactive-rulemaking authority to effectively circumvent Allina sets a potentially dangerous precedent that should not go unnoticed by all Medicare stakeholders.
Continue Reading “Contrary to the Public Interest”: CMS invokes retroactive-rulemaking authority to escape consequences of Allina

President Donald Trump has signed an executive order that commits the Department of Health and Human Services (HHS) to taking a series of regulatory and subregulatory actions intended to enhance the fiscal sustainability of the Medicare program, reduce regulatory burdens on providers, and increase beneficiary choice.  The planned initiatives, which would require further policy development…

Seeking to “eliminate any confusion,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has formally withdrawn proposed civil money penalty (CMP) and anti-kickback (AKS) safe harbor regulations that it no longer intends to finalize.  Specifically, the OIG is withdrawing:

  • A 1994 proposed rule that would have codified the

…

As part of its continuing “Patients over Paperwork” initiative, the Centers for Medicare & Medicaid Services (CMS) has released another request for information (RFI) on regulatory or subregulatory changes the agency could make to “reduce unnecessary administrative burdens for clinicians, providers, patients and their families.”  In particular, CMS seeks new ideas for:

  • Streamlining reporting requirements, documentation requirements, or processes to monitor compliance with CMS rules and regulations;
  • Aligning Medicare, Medicaid and other payer coding, payment, and documentation requirements and processes;
  • Enabling operational flexibility, feedback mechanisms, and data sharing that would enhance patient care, support the clinician-patient relationship, and facilitate individual preferences; and
  • Determining how and when CMS issues regulations and policies, and how CMS can simplify rules and policies for beneficiaries, clinicians, and providers.

Additionally, CMS solicits recommendations regarding ways the agency could:
Continue Reading CMS Looking for More Ways to Cut Medicare & Medicaid Red Tape

As part of the Trump Administration’s fall regulatory agenda, the Department of Health and Human Services (HHS) emphasizes its commitment to “reducing and streamlining its regulations and improving the transparency, flexibility, and accountability of its regulatory processes.”  One of the specific deregulatory initiatives noted is a future proposed rule to remove outdated Medicare and…

CMS has issued a proposed rule intended streamline the Medicare and Medicaid regulatory burden on numerous types of providers and suppliers.  CMS generally classifies the proposals as falling into the following categories:  (1) those that simplify and streamline processes, (2) those that reduce the frequency of activities and revise timelines, and (3) those that address…

The Congressional Review Act (CRA) was long viewed as something of a paper tiger, and for good reason. The CRA requires agencies to submit certain rules to Congress before they go into effect. The CRA also creates a streamlined process for Congress to rescind such rules through the passage of a “joint resolution of disapproval”…

The Trump Administration has updated its “Unified Agenda of Regulatory and Deregulatory Actions,” which lists the scope and anticipated timing of pending and future regulations. In releasing the agenda, the Administration highlights its “ongoing progress toward the goals of more effective and less burdensome regulation,” including its plans to finalize three deregulatory actions…

The Health Resources and Services Administration (HRSA) is delaying the effective date of its January 5, 2017 final rule on the calculation of the ceiling price and application of civil monetary penalties (CMPs) under the 340B drug pricing program until May 22, 2017 – with a longer delay being contemplated.  The January 5, 2017 final…

The Centers for Medicare & Medicaid Services (CMS) is moving ahead on its annual Medicare hospital payment update rule – and it actually is ahead of last year’s pace.  Specifically, on March 8, 2017 CMS sent to Office of Management and Budget (OMB) for regulatory clearance its proposed rule updating the Medicare hospital inpatient prospective…

President Trump has signed an executive order entitled “Reducing Regulation and Controlling Regulatory Costs,” also known informally as the “2-for-1 Order,” that directs agencies to take a number of actions aimed at deregulating a variety of industries.  The Order is considerably vague, relying instead on the Office of Management and Budget (OMB) to issue additional implementation guidance.  As a result, it remains unclear how this new regulatory approach will operate in practice.

2-for-1 Regulatory Identification Process

The Executive Order, signed January 30, 2017, directs each department or agency to identify two regulations to be repealed any time it proposes or finalizes a new regulation. It is worth noting that the Executive Order never expressly requires these regulations to actually be repealed; rather, merely identified.  Importantly, the Order provides that this 2-for-1 regulatory identification process need only be followed if it is permitted by law.  That is, Congress often passes laws that require certain administrative agencies to promulgate implementing regulations.  To this end, the Order cannot and does not block regulations required by statute.  Instead, only discretionary regulations would be eligible for elimination.

Critics of the Executive Order view this 2-for-1 regulatory identification process as an illogical approach to industry deregulation, arguing that this approach demonstrates a dearth of understanding about how and why regulations are actually issued. For example, in its examination of costs, the Executive Order ignores expected long-term cost savings, and only focuses on annualized regulatory costs.  Accordingly, agencies might be required to eliminate regulations whose benefits greatly outweigh their regulatory costs, simply to meet this arbitrary regulatory standard.  Supporters contend, however, that a requirement to eliminate regulations in order to promulgate new ones forces agencies to review and update existing regulations.  This perceived lack of periodic of review and update is something that has long troubled many in regulated industries.
Continue Reading The Fine Print of the Trump Administration “2-for-1” Regulatory Reduction Executive Order

President Donald Trump’s first official act in office was to sign an executive order declaring it the policy of his Administration to seek prompt repeal of the Affordable Care Act (ACA) – but in the meantime, he calls for executive branch action “to minimize the unwarranted economic and regulatory burdens of the Act.”  Specifically, Trump’s…

As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect.  In a January 20, 2017 memo to the heads of executive departments and agencies, Assistant to the President and Chief of Staff…

The Obama Administration has updated its regulatory agenda, listing the anticipated timing of pending and future regulatory actions, including a number of Department of Health and Human Services regulations. Note, however, that with the transition to the new Trump Administration, federal regulatory priorities can be expected to change.  Indeed, a new Administration often triggers…

The Obama Administration has released its latest regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity. The agenda includes numerous pending HHS proposed and final rules affecting a wide range of policy areas, including Medicare payment rules, fraud and abuse authorities, the 340B drug pricing program,…

Despite the recent flurry of activity on Medicare payment rules, more are in the pipeline. CMS has sent the final fiscal year (FY) 2016 Medicare skilled nursing facility, hospice, inpatient rehabilitation facility, and inpatient psychiatric facility payment rules to the White House Office of Management and Budget for final regulatory clearance. The FY 2016 final…

The Administration has updated its regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity. The agenda lists numerous pending HHS proposed and final rules in a range of policy areas, including Medicare payment updates, 340B drug pricing policies, and changes to fraud and abuse authorities, among many

The Administration has posted its fall regulatory agenda listing major pending or planned regulatory actions and anticipated timing of rulemaking. The agenda lists numerous pending HHS proposed and final rules in a range of policy areas, including Medicare payment updates, revisions to provider conditions of participation, and changes to fraud and abuse authorities, among many…