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Tag Archives: CMS

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

Parallel Review – Forcing Manufacturers to Go All In

On October 24, 2016 the Food and Drug Administration (“FDA”) in conjunction with the Centers for Medicare & Medicaid Services (“CMS”) announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required for receiving Medicare coverage nationally.  Sounds good.  So, why have so few manufacturers taken advantage of the program to date?

Despite its admirable goals, the current Parallel Review Process is too limited in scope and involves significant risks for manufacturers.

The standard process for obtaining … Continue Reading

HHS Increases Civil Monetary Penalties and 299 Other Fines

Health care providers, life sciences companies and other entities subject to regulation by the Food and Drug Administration (“FDA”) or the Centers for Medicare & Medicaid Services (“CMS”) should be aware that the U.S. Department of Health and Human Services (“HHS”) is increasing the maximum civil monetary penalty amounts that may be assessed by the agency.

The new maximum adjusted penalty amounts may have a significant impact on entities that violate or fail to meet mandatory reporting requirements set by FDA or CMS. Of the 299 enumerated increased fines, 137 fines (45.8%) have increased by over 75%, 100 fines (33.4%) … 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

Disruptor Meets Regulator, and Regulator Wins: Lessons Learned from Theranos

On July 7, 2016, the Centers for Medicare and Medicaid Services (“CMS”) imposed several administrative penalties on Theranos, a clinical laboratory company that proposed to revolutionize the clinical laboratory business by performing multiple blood tests using a few drops of blood drawn from a finger rather than from a traditional blood draw that relies on needles and tubes. However, after inspecting the laboratory, CMS concluded that the company failed to comply with federal law and regulations governing clinical laboratories and it posed an immediate jeopardy to patient health and safety. CMS has revoked the CLIA certification of the company’s California … 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

Bipartisan Budget Act of 2015 – Potential Impact on Hospitals

House Republican leaders introduced legislation on Monday, finalizing a two-year budget agreement between Congressional leaders and the White House. This legislation is currently being considered and may be up for a vote as early as Wednesday on the bipartisan budget deal.

Hospitals should note the language in Section 603 (which is on pages 35-39 of the draft bill) codifies the definition of a “provider-based off-campus hospital outpatient department” (PBD HOPD) as a location that is not on the main campus of a hospital and is located more 250 yards from the main campus.  The section defines a “new” PBD HOPD … 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

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

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

CMS Implements Sunshine Final Rule Changes for Open Payments

On November 13, 2014, CMS published the 2015 Medicare Physician Fee Schedule (“MPFS”) finalizing the following changes to the Sunshine Open Payments regulations.  The MPFS:

  1. Deleted  the provision exempting certain payments to CME providers from the reporting requirements;
  2. Added  three new forms of payment designations;
  3. Made  the reporting of the marketed name of a covered device no longer optional; and
  4. Deleted the definition of covered device.

These changes will be effective January 1, 2016, with reports to CMS in 2017.

(A summary of the final Open Payment regulations can be accessed here)

1. Changes to reporting requirements for certain Continue Reading

Home Care Fraud and Abuse on the Radar Screen of Federal and State Enforcement

Healthcare Fraud and Abuse is an ever growing problem.  The Federal government has taken several steps in its enforcement efforts to cut down on health care fraud.  It is estimated that health care fraud costs the United States about $80 billion per year.  And it continues to rise in an alarming manner, as total U.S. health care spending continues to rise, currently topping $2.7 trillion.

In the last year, spending on home health care has increased over 5 percent from previous years.  Since 2000, the senior population has increased by 15.1% versus 9.7% for the population as a whole.  According … Continue Reading

CMS Gets the Message – Updated Governance Changes to the Medicare Conditions of Participation

By Arthur J. Fried

The Controversy – 2012 Rulemaking Attempts

Roughly two years ago, the Centers for Medicare and Medicaid Services of the Department of Health and Human Services (“CMS”) published final regulations announcing two controversial rule changes addressing hospital governance.  The industry was taken by surprise, to say  the least, as neither of these requirements had been in the proposed rule.  The changes, promulgated as amendments to the Governing Body Condition of Participation (CoP) included (i) the requirement that a hospital’s board include at least one member of its medical staff; and (ii) a statement in the preamble interpreting … Continue Reading

Client Alert: Federally Facilitated Exchanges Are Almost Ready

Health Reform - Epstein Becker Green

Our colleagues at Epstein Becker Green have issued a client alert: "Federally Facilitated Exchanges Are Almost Ready," by Linda V. Tiano.

Following is an excerpt:

On March 1, 2013, the Center for Consumer Information and Insurance Oversight ("CCIIO") and the Centers for Medicare & Medicaid Services ("CMS") released lengthy and detailed draft guidance regarding the federally facilitated exchanges ("FFEs") that will operate in the 26 states that have chosen not to establish their own exchange or partner with CMS. Although the guidance was issued in draft form, CCIIO and CMS allowed only two weeks for the public to

Continue Reading

The Sunshine Act Also Rises: One More Chance for Medical Device Manufacturers to Prepare

The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.

First, although Centers for Medicare & Medicaid Services (CMS) was required to publish standards for reporting information and making that information available online to the public, it has yet to … Continue Reading

CMS Issues Final Rule Modifying Restrictions on “Direct Solicitation” of Beneficiaries by DMEPOS Suppliers; Changes to Other DMEPOS Supplier Safeguards

On March 9, 2012, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule that modifies several of the durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”) supplier standards. Most notably, the final rule modifies restrictions on the “direct solicitation” of Medicare beneficiaries by DMEPOS suppliers. CMS stated in the final rule that its reason for making this modification is that the definition of “direct solicitation” was not feasible and has been criticized for being overly broad. DMEPOS suppliers and other providers need to be aware of this modification to the supplier standards set forth in the final … Continue Reading

Status Report on the Federal Health Insurance Rate Review Program

by Jesse M. Caplan and Serra J. Schlanger

Since November 2011 the Center for Consumer Information & Insurance Oversight (“CCIIO”) in the Centers for Medicare & Medicaid Services has completed 22 reviews of health insurance premium rate increase filings in the individual and small group markets. Under the new federal rate review regulations, CCIIO has determined that six of the reviewed premium rate increases represented “unreasonable” increases while 16 of the rate increases were deemed “not unreasonable.”

This Implementing Health and Insurance Reform alert provides a summary and analysis of the completed federal rate review determinations to date. It also … Continue Reading

The Clock Is Ticking: CMS Issues a Proposed Rule on Reporting and Returning Overpayments

by Jason B. Caron, O. Benton Curtis III, Anjali N.C. Downs, and Jennifer K. Goodwin

Almost two years after the passage of the Patient Protection and Affordable Care Act (“ACA”), the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule regarding overpayments to providers and suppliers, as provided for under Section 6402(a) of the ACA. To date, regulators, courts, clients, and members of the bar have interpreted the requirements of Section 6402(a) in various ways. The proposed rule provides CMS’s view on this matter, and, given that CMS is proposing a number of potentially onerous … Continue Reading

CMS Issues Proposed Rule Relating to Manufacturer Rebates and Reimbursement Amounts for Outpatient Prescription Drugs Dispensed to Medicaid Beneficiaries

by Kathleen A. Peterson, Benjamin S. Martin, Wendy C. Goldstein, and Constance A. Wilkinson

This issue of Implementing Health & Insurance Reform summarizes and discusses some issues raised by the proposed rule ("Proposed Rule") that the Centers for Medicare & Medicaid Services ("CMS") published on February 2, 2012, to implement changes to the Medicaid Drug Rebate Program ("MDRP") and to reimbursement limits for outpatient drugs covered by Medicaid.

In Part 1, we discuss proposals relating to the MDRP that would change the manner in which pharmaceutical manufacturers calculate Average Manufacturer Price ("AMP") and Best Price for Medicaid-covered … Continue Reading

New Rules Issued on Medical Loss Ratio Requirements

by Gretchen Harders, Daly D.E. Temchine, and Joseph J. Kempf, Jr.

On December 7, 2011, final rules on the medical loss ratio (“MLR”) requirements for insured health plans (and an interim final rule for non-federal governmental plans) were issued by the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act. The MLR requirements are effective January 1, 2012, and any issuer who does not meet the MLR requirements for the 2011 MLR reporting year must pay rebates by August 1, 2012. This alert will … Continue Reading