The enactment, on October 24, 2018, of a federal law with a far too complicated name, i.e. the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act”, created an all-payor anti-kickback statute aimed at prohibiting certain marketing practices of the substance abuse treatment community. Specifically, within the … Continue Reading
Category Archives: Healthcare Law
Subscribe to Healthcare Law RSS FeedNew Year, New Wellness Program Rules
Employers with established wellness programs that collect health information and/or require a medical exam can no longer rely on the EEOC regulations to justify that incentives provided under their wellness programs are voluntary. On December 20, the EEOC published a final rule (83 Fed. Reg. 65296) vacating the rules that allowed employers to offer those financial incentives to … Continue Reading
Privacy Policy: The Midterm Effect
Congress has long attempted to grapple with issues of cyber-security, both within the healthcare field, and generally in the United States. The Health Insurance Portability and Accountability Act (HIPAA), as well as the Health Information Technology for Economic and Clinical Health Act (HITECH) have provided significant compliance requirements for healthcare entities in the area of data security. For the last … Continue Reading
Drug Pricing Legislation Sent to the President for Enactment into Law
Two pieces of related legislation that would prohibit so called “gag clauses” in contracts between pharmacists and health plans and pharmacy benefit managers (PBM’s) have been passed by both the Senate and the House. The legislation prohibits any restrictions on the ability of pharmacists to alert consumers to situations where it may be less expensive for them to pay for … Continue Reading
CMS Announces Loosening of Rules Regarding Part D Formularies
In a memorandum issued by the Centers for Medicare and Medicaid Management (“CMS”) on August 29, 2018, the federal government outlined new ‘flexibility’ and tools for Part D plans to “expand choices and lower drug prices for patients.” Beginning in 2020, Part D plans will be able to utilize what is called ‘indication-based formulary design’ to change their drug formularies … Continue Reading
States Begin to Hold Hearings on the Proposed CVS/Aetna Merger
In December of 2017, CVS Health and Aetna announced their intention to merge. The transaction, if approved by regulators, would combine the country’s second largest pharmacy benefit manager (PBM), Caremark – a CVS subsidiary – and the nation’s third largest commercial health insurer, Aetna, and has been valued at $69 billion. Since the announcement, federal and state regulators have been … Continue Reading
Florida Imposes new ID Requirements for Pharmacist Dispensing of Controlled Substances
The Florida legislature passed HB 21, which imposes a number of new requirements on prescribers and pharmacists regarding controlled substance prescribing and dispensing. Part of the law requires pharmacists to verify the identity of the person named on the prescription. These requirements do not apply in an institutional setting or to a long-term care facility, including assisted living facilities or … Continue Reading
U.S. Supreme Court Rules That Class Action Waivers Are Enforceable
Employers may require employees to enter into arbitration agreements that waive such employees’ ability to participate in a class or collective action lawsuit, the U.S. Supreme Court ruled this week. In a long-awaited decision that represents a significant victory for employers, the Court in Epic Systems Corp. v. Lewis held that such agreements do not violate the National Labor Relations … Continue Reading
Derailing the Gravy Train – Trump Unveils Plan to Reduce Drug Prices
Throughout his presidential campaign, President Trump championed the need to allow the government to negotiate drug prices on behalf of the Medicare program. However, that third rail for pharmaceutical companies was not included as part of the President’s recently released blueprint for lowering drug prices. Instead, the plan takes aim at the entire supply chain that lies between drug manufacturers … Continue Reading
GDPR: What You Need to Know Now
It is safe to say that there has been much fear and confusion over the European Union (EU) General Data Protection Rule, or GDPR. With an effective date of May 25, 2018, and little guidance as to how the GDPR applies to organizations that do not have a physical presence in the EU or do not target their goods and … Continue Reading
Reversal of Fortune: Rhode Island Court Withdraws “Tentative” Decision to Grant Summary Judgment to Health Insurer in Health System Antitrust Case and Sets Matter for Trial
In what was a surprise result, on April 23, Judge William Smith (Chief Judge of the District of Rhode Island) reversed the “tentative” decision he had announced last November, in Steward Health v. Blue Cross & Blue Shield of Rhode Island, which would have granted defendant Blue Cross & Blue Shield of Rhode Island (BCBS-RI) summary judgment on all claims … Continue Reading
Courts May Now Stop Medicare from Recouping Payments
In recent years, many Medicare providers who have received significant overpayment determinations from Medicare contractors have gone out of business while waiting to be heard before an Administrative Law Judge (ALJ) for a hearing. That is the result of 2 factors. The first is that there is currently a 3-5 year backlog of appeals waiting for an ALJ hearing. The … Continue Reading
Partial Summary Judgment Granted to Plaintiffs in the In re Blue Cross Blue Shield Antitrust Litigation MDL Proceeding
On April 5, United States District Judge David Proctor (N.D. Alabama) granted partial summary judgment to the plaintiffs in the In re Blue Cross Blue Shield Antitrust Litigation, ruling that a network of trademark licensing agreements between the Blue Cross Blue Shield Association and its member insurance companies (referred to as the ‘Blues’), which plaintiffs characterized as “horizontal market allocation … Continue Reading
Outpatient Surgery Center Avoids Dismissal of Antitrust Action Through an Assist from the DOJ
In 2012, Marion Healthcare, an outpatient surgery center in southern Illinois, commenced an antitrust action against Southern Illinois Healthcare (“SIH”), a multi-hospital system operating in the same market. Marion alleged that SIH had negotiated exclusive dealing relationships with several area health insurers, and that these agreements made it difficult, if not impossible, for Marion to compete for surgical patients in … Continue Reading
Class III Hospital Permits – Efficient Drug Management May Become a Reality
At the close of the 2018 session, the Florida Legislature passed Senate Bill (SB) 675, which if allowed to become law by the Governor, will help hospitals and their facilities that are under common control manage their patients’ drugs much more efficiently. Under prior law, the hospitals had to obtain a restricted drug distributor-health care entity permit to allow the … Continue Reading
New Jersey Congressman Calls for a Hearing on the Proposed Cigna/Express Scripts Merger
Recently, Cigna announced its plan to purchase pharmacy benefit manager (“PBM”) Express Scripts. In a March 14, 2018 letter to the chair of the House Committee on Energy and Commerce, Gregory Walden (R-Oregon), Congressman Frank Pallone (D-New Jersey) called for a hearing on the proposed merger. In the letter, Congressman Pallone notes that the combination would combine the nation’s largest … Continue Reading
Cigna Announces Proposed Acquisition of Express Scripts, Quickening the Pace of Vertical Mergers in the Healthcare Industry
Late last year, CVS and Aetna announced a merger, combining one of the nation’s largest health insurance companies and a large pharmacy benefits management company (a “PBM”), that being CVS’ Caremark division. The trend continues, as on March 8, Cigna announced its intention to acquire Express Scripts, another PBM, in a deal reportedly valued at $67 billion. Both transactions, if … Continue Reading
CMS Expands Reimbursement for Telehealth Services
Despite telehealth’s significant expansion over the past ten years, it has been plagued by a historically unstable regulatory and reimbursement landscape. While the reimbursement environment may still have room for improvement, the Centers for Medicare & Medicaid Services (CMS) Medicare physician fee schedule (PFS) Final Rule for CY 2018 (Final Rule) marked some significant victories for those advocating for a … Continue Reading
New Consequences for Unpaid Medicare Overpayments
For years, CMS has had the authority to refuse to enroll new Medicare providers if they or their owners have an unpaid Medicare overpayment, but CMS was not exercising this authority. Now, it appears that CMS is going to start. In January, CMS published Transmittal 1998 announcing that it intends to begin denying provider enrollment applications, or change-of-ownership applications, where … Continue Reading
Has the DOJ Signaled a More Critical Approach to FCA Cases?
Defendants have faced an ever increasing number of qui tam actions, yet the government has historically declined to seek dismissal of those actions where it declined to intervene. On January 10, 2018, the Director of the DOJ Civil Division Commercial Litigation Branch’s Fraud Section issued a memorandum to all DOJ attorneys, including AUSAs, advising them that when declining to intervene … Continue Reading
DEA Implements CARA, Enlisting Mid-Level Practitioners in the War on Opioid Addiction
Prior to the Comprehensive Addiction and Recovery Act of 2016 (CARA) only “physicians” could dispense and prescribe narcotic drugs for maintenance and detoxification treatment. CARA expanded who may prescribe for maintenance and detoxification treatment to “qualifying practitioners” (temporarily through October 1, 2021), a broader term than “physicians” that allows for a wider array of practitioners to prescribe. This change opened … Continue Reading
2018 Legislative Session –A Sampling of Health Related Bills Filed
The 2018 Florida Legislative Session began its 60 day trek to completion on Tuesday, January 9, 2018. Both House and Senate will be debating various health related bills which may be of interest to healthcare providers in the State. The following is a sample of those bills which we feel are pertinent to our clients’ practices and the patients/customers that … Continue Reading
AHCA Sees the Light on Nursing Home Generator Rule, Unplugging Challenge
After Hurricane Irma made landfall in Florida, a nursing home in South Florida lost power, and several residents of that nursing home died allegedly as the result of increased temperatures caused by the loss of air conditioning. In the immediate aftermath of this tragic accident, the Agency for Health Care Administration (AHCA) (for nursing homes) and the Department of Elder … Continue Reading
Get your Single IRB lined up for Multi-Site Research
Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted, supported, or regulated by the federal government. While many of the Common Rule changes go into effect in 2018, the single IRB requirement has a compliance date … Continue Reading
