Medical device manufacturers, who may already be seeing the effects of lessened demand stemming from a slow-down of elective procedures outside of the United States, should be aware of recent guidance the U.S. Centers for Medicare and Medicaid Services (CMS) issued to health care providers urging limitations on elective surgeries and nonessential procedures. As an … Continue Reading
Please join us for our 6th Annual Washington Health Care Conference, a program discussing the latest hot topics and anticipated trends impacting health care and life sciences organizations. This year’s program will be held on December 4, 2019 at The Almas Center in Washington, D.C. Sessions include: A thought-provoking keynote. We are pleased to welcome … Continue Reading
On December 7, 2016, the Office of Inspector General of the Department of Health and Human Services published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules prohibiting beneficiary inducements. These changes protect certain practices and arrangements from criminal prosecution or civil sanctions under the … Continue Reading
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
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “12 Months in Health Care Law: A Roller Coaster Journey” on October 25, 2016 at 12:00 p.m. ET. Please join Reed Smith Partner Elizabeth Carder-Thompson as she presents her annual informative and entertaining review of many of the key regulatory … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting a free CLE webinar, “Medicare Secondary Payer: Issues and Best Practices for the Defense,” on July 13, 2016 at 12 p.m. ET. Reed Smith presenters Eric Gladbach and Mildred Segura will be providing an overview and timeline of Medicare Secondary Payer reporting responsibilities; discussing … Continue Reading
As previously discussed here and over on Health Industry Washington Watch here, this past Thursday, CMS and OMB issued the final, 600+ page Medicaid Rebate Program Final Rule. The pre-Federal Register version of the final rule may be accessed here. While we are still processing what this will mean for drug manufacturers and other health … Continue Reading
Recently, the Centers for Medicare & Medicaid Services (CMS) released final regulations under the physician self-referral law known as the Stark Law. We previously discussed the topic here, on our Health Industry Washington Watch blog here and in a American Health Lawyers Association Weekly article “CMS Publishes Final Stark Law Regulations” written by Karl Thallner and Nicole … Continue Reading
As previously discussed here and on our Health Industry Washington Watch blog here the Centers for Medicare & Medicaid Services (CMS) has released final regulations under the physician self-referral law known as the Stark Law. The provisions of the final rule are effective on January 1, 2016, except for certain changes on calculating ownership percentages for … Continue Reading
In a case dating back several years, the first judicial opinion interpreting the Affordable Care Act’s “60-Day Overpayment Rule” in a False Claims Act case was recently issued by the Southern District of New York. In Kane v. Healthfirst, Inc., et al., the court found in favor of the DOJ, denying the defendant hospitals’ motion … Continue Reading
As previously discussed on our Health Industry Washington Watch blog, the Centers for Medicare & Medicaid Services (CMS) has proposed regulations “to reduce burden and to facilitate compliance” under the physician self-referral law known as the Stark Law. However, even with changes, the regulations will remain highly complex, with major implications for health care providers … Continue Reading
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 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
Earlier this week, the Court of Appeals for the Federal Circuit reversed and remanded the Court of Federal Claims’ August 2014 decision in CGI Federal Inc. v. The United States, in which the Court of Federal Claims ruled that the Centers for Medicare and Medicaid Services (CMS) could include contract clauses that deviated from federal … Continue Reading
As highlighted on our Health Industry Washington Watch blog, Reed Smith hosted a dynamic conference on post-acute care in Washington, D.C. in early April. Entitled “Reed Smith 2014 Washington Health Care Conference: Focus on Post-Acute Care,” the conference brought together a panel of experts discussing episodic care, proposed bundling models, and alternative payment and delivery systems; … Continue Reading
As mentioned on our Health Industry Washington Watch blog, pharmaceutical and medical device manufacturers and group purchasing organizations (GPO) are currently in the process of submitting detailed 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services. The submission of this data, as dictated by the Physician Payment Sunshine Act, is intended to highlight certain financial relationships between the manufacturers and GPOs and physicians. With some exceptions, this data will become public by September 1, 2014, at which time the Department of Health and Human Services' Office of the Inspector General, Department of Justice, and relators' attorneys will likely analyze the data to initiate investigations and support complaints under the federal False Claims Act.… Continue Reading
On February 6, 2014, the U.S. Department of Health & Human Services' (HHS) Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, and Office for Civil Rights jointly published a final rule amending the HIPAA Privacy Rule and the Clinical Laboratory Improvement Amendments of 1988 regulations to provide patients with direct access to laboratory test reports. HHS believes that patients should have the right to access these test reports in order to gain vital information, allowing them to better manage their health and take action to prevent and control disease. The amendments to both regulations become effective April 7, 2014, and HIPAA-covered laboratories must comply by October 6, 2014.… Continue Reading
On December 11, 2013, CMS released an advance notice of proposed rulemaking soliciting comments on specific practices for which civil monetary penalties may or may not be imposed for failure to comply with Medicare Secondary Payer reporting requirements. Among other issues, CMS is seeking comments and proposals on mechanisms and criteria that it would use to evaluate whether and when it would impose penalties for noncompliance with Medicare Secondary Payer reporting requirements.… Continue Reading
On December 19, 2011, the Centers for Medicare & Medicaid Services ("CMS") published a proposed rule (the "Proposed Rule") related to section 6002 of the Affordable Care Act, commonly referred to as the "Physician Payment Sunshine Act." The Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the Secretary of the Department of Health and Human Services ("Secretary") certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations ("GPOs") must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.… Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has recently updated the information on its website with respect to the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), Section 111 "Mandatory Insurer Reporting" requirements. The recent updates cover (1) a revised implementation timeline for certain liability insurance (including self-insurance) total payment obligation to claimant settlements, (2) revised guidance on claims involving exposure, ingestion, and implantation issues, (3) upcoming improvements to the Medicare Secondary Payer (MSP) program, (4) a new exception for certain settlements paid into a qualified settlement fund and (5) a new way for certain injured Medicare beneficiaries to satisfy their past and future MSP obligations.… Continue Reading
On June 9, 2011, Senator Orrin Hatch released a report by the Senate Finance Committee Minority Staff that outlines key concerns about Physician-Owned Distributors ("PODs"), specifically regarding the lack of regulatory oversight and clear guidance from the Department of Health and Human Services Office of Inspector General ("OIG"). The Committee Minority's report, Physician Owned Distributors (PODs): An Overview of Key Issues and Potential Areas for Congressional Oversight, set forth findings of committee staff who spoke to over fifty people and reviewed thousands of pages of documents. In addition to the report, the Chairman and Ranking Members of the Senate Financial Committee, Special Committee on Aging, and Judiciary Committee sent letters on the same day to the Administrator for Centers for Medicare & Medicaid Services ("CMS") and the Inspector General of Health and Human Services ("HHS") requesting further inquiry into the concerns set out in the Senator Hatch's report.… Continue Reading
On May 26, 2011, Vermont Governor Peter Shumlin signed into law Senate Bill 104 ("S.104"), significantly modifying Vermont law banning the provision by manufacturers of gifts to health care providers and requiring disclosure of certain allowable expenditures and gifts to health care providers (18 V.S.A. § 4631a and 18 V.S.A. § 4632). S.104 follows amendments made to the Vermont gift ban and disclosure law enacted just last year. This Client Alert includes a summary of the modifications pursuant to S.104. Except as otherwise noted, the changes are effective July 1, 2011.… Continue Reading
States are increasingly imposing marketing restrictions on device manufacturers through laws that previously focused more specifically on pharmaceutical manufacturers. These laws affect compliance activities and relationships with providers, and create new reporting obligations. The impact is significant in that these state laws directly influence how companies conduct business and interact with customers, but implementation is complicated by the variations that exist between states.
Most significantly, under the federal Patient Protection and Affordable Care Act ("ACA"), beginning March 31, 2013, and annually thereafter, device manufacturers must report payments to physicians and teaching hospitals during the preceding calendar year. This means manufacturers must be prepared to track payments in a comprehensive manner as of January 1, 2012. The Centers for Medicare & Medicaid Services ("CMS") is now in the early stages of developing specific provisions to implement the new ACA provisions, with publication of proposed regulations to occur not later than October 1, 2011.
This Client Alert provides a brief overview of the existing state marketing laws that apply to device manufacturers, including recent changes to those laws, as well as federal reporting requirements under the ACA. Although the laws discussed may apply broadly to other entities, we refer in our Client Alert specifically to medical device manufacturers.… Continue Reading
On May 16, 2011, the Office of Inspector General ("OIG") published a report with the results from its nationwide review of the Centers for Medicare and Medicaid Services ("CMS'") oversight of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). In its review, the OIG sought to determine the sufficiency of CMS' oversight and enforcement actions pertaining to hospitals' implementation of the HIPAA Security Rule. Pursuant to the Security Rule, covered entities, such as hospitals, must implement technical, physical, and administrative safeguards for the protection of electronic protected health information ("ePHI"). According to the OIG, CMS' oversight and enforcement actions were "not sufficient," leaving limited assurance of the security of hospitals' ePHI.
The report details the results from the OIG's audits of seven hospitals. The audits disclosed "numerous internal control weaknesses." Specifically, the OIG identified 151 vulnerabilities in the systems and controls intended to protect ePHI. Of these vulnerabilities, 124 were categorized as "high impact." These vulnerabilities placed the confidentiality, integrity, and availability of ePHI at risk. The consequences of the high impact vulnerabilities is that it (1) may result in the highly costly loss of major tangible assets or resources; (2) may significantly violate, harm, or impede an organization's mission, reputation, or interest; or (3) may result in human death or serious injury.… Continue Reading
