Today, Connecticut Governor Ned Lamont signed into law HB6669, “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (“the Act”), which seeks to reduce the costs of health care services for Connecticut residents. The Act is extensive and is aimed at increasing competition in the health care market, heightening price transparency, and reducing prescription drug costs. We have summarized key provisions of the Act below.
On June 16, 2023, nearly half of the State Attorneys General[1] penned a letter (the “Letter”) to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) advocating for broader privacy protections surrounding reproductive health care information. Specifically, the Letter targeted the Notice of Proposed Rulemaking (the “Proposed Rule”) published by OCR in April of 2023, which proposed a number of revisions to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).[2]
This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced by the Inflation Reduction Act of 2022 stands in violation of multiple constitutional provisions.
All types of healthcare providers depend on medical directors to oversee clinical operations and consult with administrative leadership on facility, unit, or clinical service line plans and performance. Medical directors function at the intersection of administration and clinical care, weighing in on matters as varied and important as accreditation, capital expenditures for equipment, staffing, standard operating procedures, and peer review. In addition to clinical skills, they ideally need excellent people skills to balance competing priorities and communicate effectively with different stakeholders. They are a valuable resource and partner for compliance professionals. With proper support, medical directors can support an organization’s compliance efforts and help mitigate risk for both employee issues and healthcare regulatory matters. This article outlines five key best practices in contracting for medical director services:
Continue Reading Do Your Medical Director Arrangements Meet the Top Five Best Practices?
For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. On review, the Fifth Circuit held that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail, temporarily suspending more recent modifications to the FDA’s approval.
What is New:
Department of Health Care Access and Information (“HCAI”) posted a draft methodology for evaluating applications for the Distressed Hospital Loan Program (“Loan Program”) and is surveying California hospitals to assess interest in the Loan Program.
Yesterday, the Supreme Court issued a unanimous decision holding that the aggravated identity theft statute –and its mandatory minimum of two years – is not triggered merely because someone else’s identification facilitates or furthers the offense in some way. See Dubin v. United States. We have seen a growing trend of the government adding aggravated identity theft in healthcare fraud cases. As a result of this decision, we may see that statute far less.
Continue Reading Is this “Good-Bye” to the Two Year Mandatory Minimum in Healthcare Fraud Cases?
On April 26, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a fact sheet on Hospital Price Transparency Enforcement Updates[1] (the “Fact Sheet”) under the Hospital Price Transparency Rule (the “Rule”).[2] CMS’ updates were targeted at increasing compliance by hospitals with the Rule and providing a more streamlined enforcement process for violations of the Rule.
Continue Reading CMS Releases Updates to Hospital Pricing Transparency Rule
Yesterday, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway. See United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway. The Court’s ruling was narrow and avoided the more challenging—and common—issues raised during oral argument (which we previously discussed here).
The Florida Legislature recently amended the Florida Electronic Health Records Exchange Act (the “Act”) to prohibit certain health care providers utilizing certified electronic health record technologies from storing qualified electronic health records[1] outside of the United States, its territories, or Canada.[2] Significantly, the prohibition also extends to qualified electronic health records that are stored through a third-party or subcontracted computing facility or cloud service provider.[3]
Continue Reading Florida Bans Offshoring of Certain Patient Information