Tag Archives: Regulatory review

340B Ceiling Price/CMP Rule Effective Date Pushed Back to May 22, 2017 — “At the Earliest”

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 rule … Continue Reading

Regulatory “Freeze” Thaws for HHS: Medicare FY 2018 IPPS/LTCH Rulemaking Process Gets Underway

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 … Continue Reading

The Fine Print of the Trump Administration “2-for-1” Regulatory Reduction Executive Order

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 … Continue Reading

Trump Executive Order Directs Executive Agencies to Minimize “Unwarranted” ACA Economic and Regulatory Burdens

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 … Continue Reading

President Trump’s Regulatory Review to Impact Recent Health Rules

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 … Continue Reading

Obama Administration Releases Regulatory Agenda – But Changes Expected Under Trump Administration

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 a … Continue Reading

HHS Posts Fall 2015 Regulatory Agenda Listing Rules in Pipeline

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, and … Continue Reading

Final FY 2016 Medicare Payment Rules on the Horizon

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 … Continue Reading

HHS Issues Spring 2015 Regulatory Agenda

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 others.… Continue Reading

HHS Posts Fall 2014 Regulatory Agenda

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 others. … Continue Reading

HHS Issues Spring 2014 Semiannual Regulatory Agenda

The Department of Health and Human Services (HHS) has released its Spring 2014 Semiannual Regulatory Agenda, which outlines planned regulatory initiatives across the Department and in a wide range of policy areas. Major prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities are compiled in a separate Federal … Continue Reading

CMS Adopts Final Rule to Reduce Provider Regulatory Burdens

On May 12, 2014, the Centers for Medicare & Medicaid Services (CMS) published a final rule that reforms federal health policy regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. The rule also is intended to eliminate or reduce requirements that impede quality patient care or that … Continue Reading

CMS Streamlines Medicare Requirements for Imaging Services Performed in ASCs and Hospital Radiopharmaceutical Preparation

This post was written by Paul Pitts and Thomas Greeson. CMS has put on display a final rule that reforms Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. Two provisions address imaging services offered in ambulatory surgical centers (ASCs) and hospitals. Supervision of Radiology Services in ASCs … Continue Reading

HHS Invites Suggestions for Streamlining Regulations

On September 13, 2013, HHS published a notice requesting comments on existing regulations HHS should consider reviewing in order to reduce unnecessary or burdensome regulations, or to increase their effectiveness and flexibility. For instance, HHS welcomes suggestions for rules it should review to: promote economic growth, innovation, competitiveness, and job creation; address rules where costs … Continue Reading

CMS Issues Final Rules to Ease Regulatory Burdens on Hospitals, Other Providers

On May 10, 2012, CMS released two final rules designed to reduce regulatory burdens on health care providers as part of the Administration’s ongoing regulatory review initiative. According to CMS, the regulations, will save approximately $1.1 billion across the health system in the first year and more than $5 billion over five years.  The rules … Continue Reading

HHS Issues Final Plan to Reduce Regulatory Burdens

On August 22, 2011, HHS released its “Plan for Retrospective Review of Existing Rules.”  The plan was developed in compliance with Executive Order 13563, which directed agencies to design cost effective, evidence-based regulations that are compatible with economic growth, job creation, and competitiveness, and which rely on the best, most innovative, and least burdensome tools to … Continue Reading

HHS Seeks Comments on Reducing Regulatory Burdens

HHS is seeking comments on its preliminary plans for retrospective reviews of existing HHS regulations, in compliance with President Obama’s Executive Order 13563, which directed agencies to design cost effective, evidence-based regulations that are compatible with economic growth, job creation, and competitiveness, and which rely on the best, most innovative, and least burdensome tools to … Continue Reading

June Congressional Hearings on Health Policy Issues

Earlier this month, the House Oversight and Government Reform Health Care Subcommittee held a hearing on “Pathway to FDA Medical Device Approval: Is There a Better Way?”; the House Small Business Healthcare Subcommittee reviewed “Health IT Barriers for Small Medical Practices“; and the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing on HHS regulatory reform. The Energy … Continue Reading

Federal Agencies Outline Regulatory Review Plans

On May 26, 2011, the White House posted the preliminary regulatory reform plans submitted by individual federal departments and agencies under President Obama’s Executive Order 13563. The agency plans include both discussions of general approaches to regulatory review and listings of specific regulations that may be revised.  HHS lists numerous current regulations it identifies as candidates … Continue Reading

FDA Solicits Comments on Effectiveness of Regulations

This post was written by Paul Sheives. Under Executive Order 13563, ‘‘Improving Regulation and Regulatory Review,’’ FDA is reviewing the effectiveness of the Agency’s regulations in light of public health needs and advances in innovation. To this end, FDA requests public comment and supporting data on which of its existing rules are outmoded, ineffective, insufficient, or … Continue Reading

HHS Invites Suggestions for Regulatory Reviews

In accordance with President Obama’s January 18, 2011 Executive Order on “Improving Regulation and Regulatory Review,” the Department of Health and Human Services (HHS) is inviting public comment as it develops its plan to review existing regulations. The goal of the review is to determine whether any HHS regulations should be modified, streamlined, expanded, or … Continue Reading

Congressional Hearings

The new 112th Congress has already held a number of hearings on health policy issues and other policy areas that also can impact the health industry. For instance, with regard to health reform, the House Ways and Means Committee held a hearing on the “Health Care Law’s Impact on Jobs, Employers, and the Economy.” In addition, the … Continue Reading
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