Debra A. McCurdy

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OIG Issues RFI Regarding Federal Anti-kickback Statute and Beneficiary Inducement CMP

The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) is seeking input on Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP. The OIG describes this request for information (RFI) as part of HHS’s endeavor “to transform the health … Continue Reading

Analysis of Medicare, Medicaid, and Other Health Policy Provisions in Bipartisan Budget Act

The newly-enacted Bipartisan Budget Act of 2018 includes numerous Medicare, Medicaid, and other policy and payment provisions impacting health providers and manufacturers. Of particular note, the new law:  increases Medicaid rebate obligations with respect to line extension drugs; changes manufacturer discount obligations in the Medicare Part D “donut hole”; repeals the Independent Payment Advisory Board … Continue Reading

CMS Finalizes Two-Track System to Implement Significant Changes in Medicare Physician Payment Policies Under MACRA

The Centers for Medicare & Medicaid Services (CMS) has finalized sweeping reforms of the Medicare physician fee schedule (MPFS) update framework, as mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Beginning in 2017, physicians can choose one of two tracks within its “Quality Payment Program” to determine their MPFS update: reporting … Continue Reading

FDA Gauges Coverage Organizations’ Interest in Connecting with Device Sponsors to Discuss Evidence Needs During Clearance Process

The FDA published a notice on February 24, 2016 requesting whether organizations (e.g. insurers, health technology assessment organizations) that evaluate clinical evidence used to support private payer medical device coverage decisions are interested in providing input to medical device developers on clinical trial design or other evidence-gathering needed to support positive coverage decisions.  If coverage … Continue Reading

Extensive Medicare & Medicaid Funding and Program Integrity Provisions in Obama’s Released FY 2017 Budget Proposal

On February 9, 2016, the Obama Administration released its proposed fiscal year (FY) 2017 budget, which contains significant Medicare and Medicaid reimbursement and program integrity legislative proposals – including $419 billion in Medicare savings over 10 years. These proposed policy changes would require action by Congress, and Republican Congressional leaders have already voiced general opposition … Continue Reading

21st Century Cures Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, … Continue Reading

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

On May 5, the Office of Inspector General (OIG) issued a report entitled "FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs" in response to a Congressional request expressing concerns about the safety and quality of generic drugs produced by manufacturers outside the United States. The OIG report contains an analysis of FDA's inspections of generic drug manufacturers over the past several years, and provides several recommendations for the FDA going forward.… Continue Reading

Bipartisan Energy & Commerce Committee Leaders Release Updated 21st Century Cures Draft

The bipartisan leadership of the House Energy and Commerce Committee has released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment development and delivery of treatment to patients. The nearly 200-page legislation is the product of a year-long collaboration between lawmakers and stakeholders.… Continue Reading

FDA, CMS Form Interagency Task Force on LDT Quality Requirements

FDA and CMS have announced that they are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs) - tests intended for clinical use and designed, manufactured, and used within a single lab. According to an FDA blog post, the goals of the FDA/CMS task force include identifying areas of similarity between the FDA quality system regulation and requirements under the Clinical Laboratory Improvement Amendments (CLIA); working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and leveraging joint resources to avoid duplication and maximize efficiencies.… Continue Reading

CMS Discusses Medicare Implications of FDA Approval of First Biosimilar Product

CMS has issued an educational article on the FDA's approval of the first biosimilar product, and what implications this approval will have for Medicare coverage. CMS plans to ensure that Medicare beneficiaries will have access to this new product, as it does for other drugs that receive FDA approval. The CMS article addresses several questions that have arisen regarding biosimilars.… Continue Reading

FDA Draft Guidance Addresses Electronic Informed Consent in Clinical Investigations

FDA has issued a draft guidance providing recommendations for clinical investigators, sponsors and institutional review boards on the use of electronic informed consent for FDA-regulated clinical investigations of medical products, including drugs, medical devices and biological products. FDA is accepting comments on the draft guidance until May 8, 2015. In addition, the HHS Office for Human Research Protections (OHRP) is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations and to issue a joint OHRP/FDA guidance document on this topic once the FDA's final guidance document has been developed.… Continue Reading

House Approves ACA Device Tax Repeal Bill in Face of Veto Threat

This post was also written by Ruth N. Holzman and Angelo Ciavarella. Yesterday the House approved by a vote of 270-146 legislation to repeal the ACA’s controversial 2.3% excise tax on the sale price of certain medical devices, which is scheduled to apply to sales after December 31, 2012. The repeal provision is included in H.R. 436, the … Continue Reading

CMS and FDA Announce Parallel Review Pilot Program

On Friday, October 7, 2011, the Centers for Medicare & Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") (collectively, the "Agencies") announced they were soliciting nominations from sponsors of medical devices to participate in the Agencies' parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the "Notice"), with an effective date of November 10, 2011, although the Agencies began accepting nomination submissions October 7.… Continue Reading

FDA to Hold Public Meeting on ACA Biosimilars Pathway – November 2-3, 2010

Today the FDA published a notice announcing public hearings on November 2 and 3, 2010 on implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was enacted as part of the Affordable Care Act (ACA). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be … Continue Reading

Reed Smith Health Care Reform Review: The Affordable Care Act – Analysis and Implications for DMEPOS Suppliers

In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act).  In this analysis, we concentrate on those provisions in the new law that will … Continue Reading

Reed Smith Health Care Reform Review: The Affordable Care Act – Analysis and Implications for Drug, Device and Biotech Manufacturers

This post was also written by Robert J. Hill and Jennifer A. Goldstein. In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). In this analysis, … Continue Reading

Reed Smith Issues Major Analysis of the Patient Protection and Affordable Care Act, Focusing on Health Care Provider and Medical Product Manufacturer Impact

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA), a sweeping measure designed to expand access to health insurance, reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms. The President also signed a second bill into law on March 30, 2010, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), which includes a series of "fixes" to the PPACA, including substantive changes to the PPACA's provisions regarding Medicare prescription drug coverage, Medicare Advantage and fee-for-service payments, Stark law self-referral policy, and Medicaid matching payments, among many others. Within the thousands of pages of the new laws are numerous provisions that will have a direct and material impact on nearly every component of the health care delivery and financing systems in the United States, including health insurers, health care providers, and manufacturers of pharmaceuticals and medical devices, as well as employers, taxpayers, and patients. Moreover, the impact of some of these provisions will be felt immediately, as certain provisions are effective upon enactment, and some have January 1, 2010 effective dates. Reed Smith has prepared a major Alert concentrating on those PPACA provisions we believe are of most interest to health care providers and medical device and pharmaceutical manufacturers.… Continue Reading

CMS Clarifies Telemarketing Rules for DME Suppliers

The Centers for Medicare & Medicaid Services (CMS) has issued new "Telemarketing FAQs" to supplement the Office of Inspector General's (OIG) recent revisions to its Special Fraud Alert on Telemarketing by Durable Medical Equipment Suppliers. As you may recall, in January 2010, the OIG amended the Special Fraud Alert to add a warning about suppliers contacting a beneficiary before the supplier receives written beneficiary consent, as it may violate the statutory provision that prohibits Durable Medical Equipment (DME) suppliers from making unsolicited telephone calls to Medicare beneficiaries regarding the furnishing of a Medicare-covered item. Specifically, the OIG stated that it "has also been made aware of instances when DME suppliers, notwithstanding the clear statutory prohibition, contact Medicare beneficiaries by telephone based solely on treating physicians' preliminary written or verbal orders prescribing DME for the beneficiaries." According to the OIG, the "physician's preliminary written or verbal order is not a substitute for the requisite written consent of a Medicare beneficiary." In response to this new language, Reed Smith contacted the OIG to discuss the adverse impact this policy would have on timely beneficiary access to medically necessary equipment ordered by a physician, since some suppliers call a beneficiary to arrange for equipment deliveries upon receiving an initial physician verbal order. The OIG has just sent us a copy of new CMS Telemarketing FAQs that seek to clarify certain aspects of the revised Special Fraud Alert...… Continue Reading

FDA Guidance on FDA-Industry Meetings

The FDA has issued final guidance regarding formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research (note that the guidance does not apply to abbreviated new drug applications). … Continue Reading

New Proposed DTC Advertising Guidelines

On May 27, 2009, the Food and Drug Administration (FDA) published a notice soliciting comments on a draft guidance document entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.” The draft guidance proposes to use a “reasonable consumer” standard, similar to the Federal Trade Commission’s standard, for assessing whether advertisements are misleading, a … Continue Reading

CMS Prepares to Re-Launch Medicare DMEPOS Competitive Bidding — Tips for Potential Bidders

CMS is preparing to re-launch its controversial competitive bidding program for Medicare suppliers of certain types of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Under competitive bidding, only suppliers who are successful bidders will be eligible to furnish certain categories of DMEPOS to Medicare beneficiaries in certain geographic areas (with very limited exception). Under competitive bidding, successful bidders will be paid based on the median of the winning suppliers' bids for each of the selected items in the region, rather than the Medicare fee schedule or supplier bid amount. This will be CMS's second attempt to institute DMEPOS competitive bidding, after the first round of bidding was blocked by Congress last year because of widespread concerns about how the program was implemented. Reed Smith's Life Sciences and Health Industry Alert, "CMS Prepares to Re-Launch Medicare DMEPOS Competitive Bidding--Tips for Potential Bidders," highlights seven steps suppliers can take now to prepare for the coming bidding period based on the lessons learned during the first round of bidding.… Continue Reading

Objectivity in Research PHS-Funded Research

On May 8, 2009, HHS published an advance notice of proposed rulemaking seeking comments on whether the HHS should amend its regulations on the responsibility of applicants for promoting objectivity in research for which Public Health Service (PHS) funding is sought. Specifically, HHS is considering whether to revise current regulations to provide a more rigorous approach … Continue Reading

Health Care Reform Proposal

On Tuesday, Senate Finance Committee Chairman Max Baucus and Ranking Member Chuck Grassley released a lengthy policy paper discussing for options for reducing health care costs and improving quality in the health care delivery system. The proposals are far-reaching, ranging from bundling of hospital and post-acute care, establishing appropriateness criteria for imaging services, and requiring drug/device manufacturers to report payments to physicians/physician investments. With regard to specialty hospitals, the "whole hospital" and rural exceptions to the general ban on self-referral would be eliminated, but a new exception would be created for hospitals that have physician ownership and a Medicare provider agreement in effect on July 1, 2009 and which meet certain criteria. The release is available at http://finance.senate.gov/press/Bpress/2009press/prb042809.pdf.… Continue Reading

HHS Report on First 100 Days of Obama Administration

On April 29, 2009, the Obama Administration released a report on HHS progress over the first 100 days of the Obama Administration. The report addresses implementation of the American Recovery and Reinvestment Act of 2009, efforts to promote health reform, regulatory review initiatives, and release of the President’s proposed budget, among other things.… Continue Reading
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