Carol Loepere

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Five Key Takeaways from OCR’s Proposed Rule to Scale Back the Non-Discrimination Requirements Applicable to Health Care Entities

The Department of Health & Human Services (HHS) Office for Civil Rights (OCR) recently issued a proposed rule (Proposed Rule) that would significantly scale back the non-discrimination regulations applicable to health care entities under the authority of Section 1557 of the Affordable Care Act (ACA). This Proposed Rule, issued on May 24, 2019 and scheduled … Continue Reading

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

A Complete Victory for Multi-Office Team as the U.S. Department of Justice Dismisses Billion-Dollar False Claims Act Case

On November 8, 2017, following many years of investigation, the U.S. Department of Justice dismissed a billion-dollar False Claims Act (FCA) case against our long-standing client HCR ManorCare, the industry leader in post-acute rehabilitation care. The DOJ alleged that HCR ManorCare delivered unnecessary therapy to patients covered under Medicare Part A in its skilled nursing … Continue Reading

Significant Changes for Long-Term Care Facilities Participating in Medicare and Medicaid Programs Issued by CMS

The Centers for Medicare & Medicaid Services (CMS) issued a final rule on September 28, 2016, comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities participating in the Medicare and Medicaid programs (the Final Rule). As the first major update to the requirements for LTC facilities in 25 years, the … Continue Reading

Major Changes To Nondiscrimination Requirements Under ACA Effective Soon: Are Covered Entities Ready?

The HHS Office of Civil Rights (“OCR”) published a final rule May 18, 2016, broadening the nondiscrimination requirements applicable to all health programs and activities receiving federal financial assistance from HHS, those administered by HHS, and Health Insurance Marketplaces. The final rule implements section 1557 of the ACA and adds two important categories of protections: … 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

Caution Lights Ahead for Pharmaceutical Settlements? Impact of Medicaid Exclusion Provisions of PPACA

We want to alert our manufacturer clients to the potential importance of a specific provision included in our analysis of the recent health care reform legislation. As we note at page 108 of our memorandum: Medicaid Exclusion from Participation Relating to Certain Ownership, Control, and Management Affiliations (Sec. 6502) [T]his provision requires Medicaid agencies to exclude individuals or entities from participating in Medicaid for a specified period of time if the entity or individual owns, controls, or manages an entity that: (1) has failed to repay overpayments during the period as determined by the Secretary; (2) is suspended, excluded, or terminated from participation in any Medicaid program; or (3) is affiliated with an individual or entity that has been suspended, excluded, or terminated from Medicaid participation.… 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

Medicare Secondary Payer Law: New Registration And Reporting Requirements Strengthen Existing Duties And Obligations

The Medicare secondary payer ("MSP") law requires Medicare to be the "secondary" payer of health benefits for Medicare beneficiaries where another entity is the "primary" payer of health benefits. Determining whether another entity is "primary" and when Medicare is "secondary" has often been difficult due to the wide range of circumstances in which another party may be responsible for a Medicare beneficiary's health expenses, the number of potential parties involved, and the somewhat confusing terminology in the law itself. As a result, Congress enacted new rules to enhance the enforcement of the MSP law. Any entity that might pay settlements to Medicare-eligible plaintiffs that would cover any health expenses, or might otherwise compensate Medicare beneficiaries for health expenses as part of group health insurance, workers' compensation, or any other arrangement or plan, needs to become familiar with these new rules. Specifically, Congress now requires such entities to (1) register as a responsible reporting entity ("RRE"), and (2) electronically report information to the Centers for Medicare & Medicaid Services ("CMS").CMS will use this information to track and recover health expenses it incurred on behalf of Medicare beneficiaries but that another entity, as a primary payer under the existing MSP requirements, may be responsible for paying.… Continue Reading

Health Information Privacy and Incentives, Medicaid Funding, and Other Health Care Provisions in the American Recovery and Reinvestment Act

On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the "ARRA"). The sweeping $790 billion economic stimulus package includes a number of health care policy provisions. Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.… Continue Reading

FTC Grants Six-Month Delay on Enforcement of the “Red Flag Rules”

Today, the Federal Trade Commission (FTC) issued a press release to announce that it will suspend enforcement of the new “Red Flag Rules” until May 1, 2009, to give “creditors” and financial institutions additional time in which to develop and implement written identity-theft prevention programs. Reed Smith has worked on behalf of the American Health Care … Continue Reading

FTC’s Identity Theft Red Flag Regulations: Implications for Health Care Providers

In November 2007, the Federal Trade Commission ("FTC") issued sweeping regulations aimed at deterring, detecting and preventing identity theft. Under these rules, known as the Red Flag Regulations, 16 C.F.R. § 681.1 et seq. and Final Rule ("Red Flag Regulations"), financial institutions and creditors of covered accounts must establish a program to detect, prevent and mitigate identity theft.… Continue Reading

The “Medicare Improvements for Patients and Providers Act of 2008”: Delay and Reform of the Medicare DMEPOS Competitive Bidding Program

This post was also written by Robert J. Hill and Kathleen McGuan. I.  INTRODUCTION On July 15, 2008, the House and Senate overrode President Bush’s veto of H.R. 6331, the “Medicare Improvements for Patients and Providers Act of 2008” (“MIPPA”).1  Among many other things, MIPPA delays and reforms the Centers for Medicare & Medicaid Services’ (“CMS”) … Continue Reading

Expansion of Medicare DMEPOS Competitive Bidding Announced

I. INTRODUCTION On January 8, 2008, CMS announced the second phase of Medicare competitive bidding for durable medical equipment (“DME”), prosthetics, orthotics, and supplies (“DMEPOS”). In this second round, competitive bidding will be implemented in 70 areas, including the nation’s largest cities. The complete list of areas can be found at Appendix 1. With very … Continue Reading
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