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Congress Wants to Reform Agency Rulemaking: Refinements or Tectonic Shifts?

Congress is currently considering two bills that would dramatically alter the ways in which all federal agencies develop and publish rules. If enacted, both would create significant new obligations for agencies such as CMS and the FDA, expand the scope of judicial review of rules, and would increase the potential for political influence over the rulemaking process. Both bills passed the House on party-line votes, and are under consideration by the Senate.

The first bill, H.R. 5, would overhaul multiple phases of the federal rulemaking process. These proposed changes would make the rulemaking process significantly longer and more complex for … Continue Reading

FDA Announces November Public Hearing on Off-Label Communications: An Important Step Forward or a Signal that FDA is Headed Back to the Drawing Board?

On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.

In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics on which FDA is … Continue Reading

CMS Issues Proposed Rule Advancing Care Coordination through Three New Mandatory Episode Payment Models and Introducing a Cardiac Rehabilitation Incentive Payment Model

If your organization has missed an opportunity to participate in the voluntary Medicare Bundled Payments for Care Initiatives and/or the mandatory CJR program, CMS’ Centers for Medicare and Medicaid Innovation has issued a proposed rule introducing three new mandatory Episode Payment Models (EPMs) and a Cardiac Rehabilitation incentive payment model intended to be tested with a broad scope of hospitals which may not have otherwise participated in innovative payment model testing.

In the proposed rule issued August 2, 2016, CMS introduced EPMs for Acute Myocardial infarction (AMI), Coronary Surgery Bypass Graft (CABG) and Surgical Hip/Femur Fracture Treatment- Excluding Lower Joint … Continue Reading

DOL’s New “White Collar” Exemption Rule To Impact Health Care Industry

Act-Now-Advisory-BadgeOur colleagues, Michael S. Kun, Member of the Firm, and Jeffrey H. Ruzal, Senior Counsel, at Epstein Becker Green, have written an Act Now Advisory that will be of interest to many of our readers: DOL’s New “White Collar” Exemption Rule Goes Into Effect on December 1, 2016.

On May 18, 2016, the U.S. Department of Labor (“DOL”) announced the publication of a final rule that amends the “white collar” overtime exemptions to significantly increase the number of employees eligible for overtime pay. The final rule will go into effect on December 1, 2016.

What Is NewContinue Reading

Antitrust Enforcement Agencies Issue Joint Statement Encouraging Repeal of Virginia’s CON Program

M. Brian Hall, IV

Daniel C. Fundakowski

On October 26, 2015, the Federal Trade Commission (“FTC”) and the Antitrust Division of the U.S. Department of Justice (“DOJ”) (collectively the “Agencies”) issued a joint statement to the Virginia Certificate of Public Need (“COPN”) Work Group encouraging the Work Group and the Virginia General Assembly to repeal or restrict the state’s certificate of need process.  The Virginia COPN Work Group was tasked by the Virginia General Assembly to review the current COPN process and recommend any changes that should be made to it.

Thirty-six states currently maintain some form of certificate of need (“CON”) program.  Although there are variations … Continue Reading

CMS Issues Long-Awaited Rule Regarding Reporting and Returning Overpayments

Epstein-Becker-Green-ClientAlertHCLS_gif_pagespeed_ce_KdBznDCAW4In February 2012, two years after the passage of the Affordable Care Act (“ACA”), the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule, which was subject to significant public comment, concerning reporting and returning certain Medicare overpayments (“Proposed Rule”). On February 12, 2016, four years from the issuance of the Proposed Rule (and six years after passage of the ACA), CMS issued the final rule, which becomes effective on March 14, 2016 (“A and B Final Rule”).

The A and B Final Rule applies only to providers and suppliers under Medicare Parts A and B. The return … Continue Reading

More Time Given To Stakeholders to Respond to CMS’ Request for Information on Physician Payment Reforms

On September 28, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued a request for information (“RFI”) seeking comments on two key components of the physician payment reform provisions included in the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), the law enacted on April 16, 2015, repealing the sustainable growth rate formula used to update payment rates under the Medicare Physician Fee Schedule.  The RFI was originally open for a 30-comment period.  However, CMS has announced that it is extending the comment period for an additional 15 days.  Comments to the RFI are now due to CMS Continue Reading

CMS Progress Note Template for Home Health Patients: Comments due by October 13

In January 2015, CMS announced that it was considering developing voluntary clinical templates to help physicians adequately document their encounters with Medicare patients who receive home health services.[1] CMS initially proposed a sample paper template progress note and suggested clinical template elements for an electronic progress note. CMS hosted three Special Open Door Forums to solicit feedback on the proposed templates from physicians, home health agencies, and other interested stakeholders to provide feedback on the proposed templates.

On August 12, 2015, CMS announced that a suggested clinical template had been submitted to the Office of Management and Budget (OMB) … Continue Reading

2012 Breach and Lacking Compliance Program Results in $750,000 Settlement for Radiation Oncology Group

By Arthur J. Fried, Patricia M. Wagner, Adam C. Solander, Evan Nagler, and Jonathan Hoerner

On September 2, 2015, the U. S. Department of Health and Human Services (“HHS”) announced a $750,000 settlement with Cancer Care Group, P.C. (“CCG”), a radiation oncology practice in Indiana, for Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules violations. The alleged violations occurred in 2012, but a subsequent HHS Office for Civil Rights (OCR) investigation led to allegations from OCR that there was a lack of compliance with HIPAA Privacy and Security Rules requirements … Continue Reading

HRSA Issues Proposed “Omnibus Guidance”

The Health Resources and Services Administration (“HRSA”) issued a notice proposing guidance under the 340B Drug Pricing Program.  The proposed Omnibus Guidance was issued in pre-publication format and is available online at https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-21246.pdf.  The notice is scheduled to be published in the Federal Register on August 28, 2015 and will be available at https://www.federalregister.gov/articles/2015/08/28/2015-21246/guidance-340b-drug-pricing-program-omnibus.

HRSA intends to finalize the proposed guidance after consideration of public comments.  The notice is open for a 60-day public comment period, with comments due on or before October 27, 2015.

The proposed Omnibus Guidance notice attempts to clarify current 340B Program … Continue Reading

BNA Webinar: Opportunities and Obstacles: Preparing for the Transition to the ICD-10 Code Set

On Tuesday, September 1, 2015, from 1:00 PM to 2:00 PM ET, George BreenChair of Epstein Becker Green’s National Health Care and Life Sciences Practice Steering Committee, will co-present “Opportunities and Obstacles: Preparing for the Transition to the ICD-10 Code Set,” a webinar hosted by Bloomberg BNA.

With the transition to the ICD-10 code set coming in October, the health-care industry is grappling with adopting new technology and making last-minute preparations. The switch to ICD-10 also presents new opportunities to increase productivity and improve patient health.

The International Classification of Diseases is a standardized coding system used by … Continue Reading

Health Care Industry: OSHA Is Quietly Gunning for You – Is Your Workplace Ready?

On April 2, 2015, Thomas Galassi, Director of the Directorate of Enforcement for OSHA, sent a memorandum to all Regional Directors announcing that the agency’s National Emphasis Program on Nursing and Residential Care Facilities would be extended until replaced by updated guidance or removed by the agency.  Mr. Galassi went on to state that, because the health care industry reports more work-related injuries and illnesses than any other general industry,
the Agency will continue to use both enforcement and collaborative efforts to address hazards such as musculoskeletal disorders from lifting patients or residents, exposures to tuberculosis, bloodborne pathogens, workplace violence, Continue Reading

House Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation

By Alan J. Arville, Constance A. Wilkinson and Selena M. Brady

The House of Representatives Energy and Commerce Committee (“the Committee”) circulated draft language to include in its 21st Century Cures legislation earlier this week to reform the 340B drug discount program (the “340B Program”). Although the draft 340B language was pulled from the legislation yesterday, the language proposed provides insight into what future legislative reform may include. The draft language, if adopted, would have a substantial impact on all 340B Program stakeholders, including, covered entities, contract pharmacies, 340B technology vendors, and drug manufacturers.

The draft language addressed … Continue Reading

Members of House Subcommittee Express Support for the 340B Program, but Need for Clarity, Oversight and Transparency

On March 24, 2015, the House of Representatives Energy and Commerce Health Subcommittee[1] (the “Subcommittee”) held a 340B Program hearing with testimony from the Deputy Administrator of Health Resources and Services Administration (“HRSA”), the Director of the Office of Pharmacy Affairs (“OPA”) of HRSA,[2] the Director of Health Care of the Government Accountability Office (“GAO”), and Assistant Inspector General of the Office of Evaluation and Inspection of the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”).

The purpose of the hearing was to assess the functionality of the 340B Program, and, in particular, HRSA’s … Continue Reading

Higher Bar for “Good Faith Compliance” in Second Year of Exchange Operations

The Centers for Medicare & Medicaid Services (“CMS”) expects Qualified Health Plan (“QHP”) Issuers to be more familiar with Marketplace requirements and better reflect those standards in Issuers’ written policies and procedures, officials stated at the recent 2015 QHP Certification Conference held at CMS Headquarters in Baltimore, Maryland.

Twenty-three Issuers across fifteen Federally-facilitated Marketplace (“FFM”) States were audited for compliance with Federal QHP requirements during 2014.  The audits focused largely on QHP’s policies and procedures relating to FFM operations, including oversight of first tier, downstream and related entities (“FDRs).  While CMS held to its previously announced policy to not pursue … Continue Reading

Extension of Timeline for Publication of the Final Rule – Medicare Programs; Reporting and Returning of Overpayments

CMS announced on February 13  (and to be published in a Federal Register notice this week) that despite the general guideline that final rules be issued within 3 years of a proposed or interim final rule, CMS will be taking an additional year to finalize the “Medicare Program; Reporting and Returning of Overpayments” final rule.   In February 2012 (see EBG’s February 22, 2012 Client Alert), CMS issued a proposed rule on the requirements under the ACA to report and return overpayments within 60 days to the Medicare program for providers and suppliers of services under Parts A and B.  … Continue Reading

CMS Proposes Home Health Physician Documentation Templates

In the most recent updates to the Medicare Home Health Prospective Payment System,[1] CMS made significant changes to the face-to-face encounter documentation requirements by eliminating the physician narrative requirement for most home health services for care episodes beginning on or after January 1, 2015.[2] In making this change, CMS stated that the medical records of the certifying physician or the acute/post-acute care facility (if a patient in that setting was directly admitted to home health) must contain sufficient documentation to support the physician’s certification of patient eligibility for home health services.

Although the changes to the face-to-face encounter … Continue Reading

HHS Announces Goals for Moving Medicare from Volume to Value Payments.

By Arthur J. Fried.

In what is being called an historic announcement, Department of Health and Human Services Secretary Sylvia Mathews Burwell announced on Monday the setting of clear goals and timeframes for moving Medicare from volume to value payments.  The stated goals are to tie 30% of all Medicare provider payments to quality and cost of care by 2016, moving to 50% by 2018.   Nearly all fee-for-service payments will be aligned with quality and value – 85% by 2016 and 90% in 2018.  This transformation will be achieved by the expansion of mechanisms already in use – Accountable … Continue Reading

Comment Period on Proposed QHP Certification Guidance and Proposed Rule That May Impact Health Insurance Issuers’ Offering of Private Health Insurance Products

Stakeholders received insight on the Obama administration’s expected approach to the certification and oversight of qualified health plans (“QHPs”) late Friday, December 19, 2014, with the release by the Centers for Medicare & Medicaid Services (“CMS”) of its Draft 2016 Letter to Issuers in the Federally-facilitated Marketplaces (“Draft Letter”). This annual release comes more than a month earlier than the release of the 2015 version of this document.

While the Draft Letter largely mirrors the provisions of its 2015 predecessor, or restates earlier proposals, CMS does include several significant changes in approach for the 2016 application cycle. These changes include … Continue Reading

Deadline Extended for Comments on Proposed Changes to Home Health Conditions of Participation

In response to multiple requests, the Centers for Medicare and Medicaid Services (“CMS”) have extended the deadline for comments on the proposed changes to the home health conditions of participation (“CoPs”).  Home health providers and other interested stakeholders now have until 5:00 p.m. EST on January 7, 2015 to submit comments to CMS.

The proposed changes to the CoPs were published on October 9, 2014[1] and represent the most significant changes to the home health CoPs in seventeen years.  According to CMS, the new CoPs are intended to better reflect modern home health practice by acknowledging … Continue Reading

Recent Legislative and Regulatory Efforts Continue to Change the Regulatory Landscape for Hospice and Home Health Providers

Our colleaguesEmily E. Bajcsi, Clifford E. Barnes, Marshall E. Jackson Jr., and Serra J. Schlanger recently published a client alert on legislative and regulatory efforts impacting the hospice and home health industries:

  • President Obama signed the Improving Medicare Post-Acute Care Transformation Act of 2014 (“the IMPACT Act”) into law;
  • The Centers for Medicare and Medicaid (“CMS”) published the Medicare Home Health Prospective Payment System final rule for calendar year 2015 (“Final Rule”); and
  • CMS published proposed changes to the home health conditions of participation and are accepting comments through December 8, 2014.

Each of these … Continue Reading

Eye on Ebola: Latest Updates from the CDC

The 2014 outbreak of the Ebola Virus Disease (“Ebola”) is the largest in history and continues to affect multiple countries in West Africa. Although reports of new Ebola cases in the U.S. – potential or confirmed – have slowed down in recent weeks, the Centers for Disease Control and Prevention (“CDC”) and its various domestic and international partners continue their efforts to prevent further transmission of Ebola in the U.S. as well as abroad. Earlier this week, in fact, the CDC released two new pieces of guidance regarding treatment of Ebola that will be of particular … Continue Reading

OMHA’s Second Appellant Forum Prompts Opportunity for Stakeholder Comments on Reducing Appeals Backlog

Amy F. LermanOn October 29, 2014, the Office of Medicare Hearings and Appeals (“OMHA”) hosted its second Medicare Appellant Forum (“Forum”) to address the status of the Medicare appeals backlog and related processing delays of Administrative Law Judge (“ALJ”) appeals, which are the third level of the Medicare appeals process that is available to suppliers, providers, and Medicare beneficiaries to challenge denied claims. Last week’s Forum was a follow-up to OMHA’s February 2014 Appellant Forum, which offered few assurances to stakeholders at the time that any effective remedies to the delays in the appeals process … Continue Reading

Ebola Preparedness Portal Launched by The Joint Commission

In response to the ongoing threat of the Ebola Virus Disease (“EVD” or “Ebola”) and the increased risk of individuals traveling from the affected countries to the United States, The Joint Commission recently launched an Ebola Preparedness Resources portal on its website.  The portal contains information addressing various safety actions for health care providers to consider, such as ensuring that all staff and clinicians who may come in contact with Ebola patients are educated and trained on Ebola guidance, re-evaluating infection control plans to ensure proper guidelines and requirements, and reviewing emergency operations plans.  While stressing that The Centers for … Continue Reading