The seismic, virtually overnight transformation of healthcare delivery as a result of the pandemic has flung open doors to innovation, as a diverse cross-section of digital health and life sciences stakeholders mobilize crisis resources; adjust operations for enhanced screening, sanitization and social distancing measures; harness telehealth capabilities to deliver healthcare remotely; and identify opportunities for smarter, better healthcare going forward. Writing for The US-Israel Legal Review, partners from McDermott's Health practice highlight the challenges and opportunities that digital health and life sciences operators and investors should consider as the industry charts a course through the post-pandemic changed healthcare landscape. Access the article.
A new president always brings new policy priorities and objectives, particularly when that president is from a different political party than their predecessor. As we begin 2021, and usher in the Biden era, we should likewise expect a significant shift in the health policy agenda. Writing for the American Health Law Association's Top 10 Issues in Health Law 2021, McDermott partner Eric Zimmerman discusses the top health policy priorities to watch for from the new administration. Access the article.
The Democrats have control of all three levers of power—the Senate, the House and the presidency—for the first time since the early years of the Obama administration. How will President Biden use this new concentration of power to shape healthcare policy? A recent article in Medscape outlined seven key healthcare actions that Biden could pursue, with McDermottPlus consultant Rodney Whitlock weighing in. Access the article.
The US District Court for the District of Columbia recently held that the Centers for Medicare and Medicaid Services (CMS) exceeded its authority by reducing Medicare payment rates for 340B drugs, but, because of the budget-neutral nature of the cuts, the court left implementation details of its order temporarily unresolved to avoid disrupting administration of the Medicare Hospital Outpatient Prospective Payment System. It remains to be seen what remedies the court will ultimately order and whether CMS will appeal the decision. Access the full article.
Late in the afternoon on Friday, December 14, Federal US District Judge Reed O’Connor struck down the Affordable Care Act (ACA) in its entirety, a feat that was, for the past few years, unsuccessfully attempted by the Republican-led Congress. O’Connor reasoned that if the individual mandate is no longer valid, the entire ACA must also be scrapped, because the rest of the ACA is “inseverable” from the individual mandate. The opinion is likely to be appealed, and the final decision may ultimately lay with the US Supreme Court. Despite the ruling, Centers for Medicare & Medicaid (CMS) has stated that the exchanges remain open and 2018 and 2019 coverage will not be impacted.
On October 10, 2018 President Trump signed two bills that ban “gag clauses” in pharmacy contracts. Congress passed the two bills—one for Medicare prescription drug plans (“Know the Lowest Price Act”) that will go into effect in January 2020, and another for commercial employer-based and individual policies (“Patient Right to Know Drug Prices Act”) effective immediately—by almost unanimous vote in September 2018. While many states have already prohibited the use of these clauses, this is the first such action on a federal level. Gag clauses are sometimes found in contracts between pharmacies and insurance companies, pharmacy benefit managers or group health plans and bar pharmacists from telling customers that they could save money by paying cash for their prescriptions rather than using their health insurance. If pharmacists violate the gag rule, they risk penalties and/or contract termination. Under the new legislation, pharmacists are not required to tell...
The Medicare Modernization Act of 2003 requires employers who offer prescription drug coverage to provide an annual notice to all Medicare Part D eligible individuals who are participants in, or eligible for, the employer’s prescription drug coverage indicating whether such coverage is creditable before October 15th of each year. “Creditable coverage” means that the prescription drug coverage offered by an employer plan is expected to pay, on average for all plan participants, as much as the standard Medicare prescription drug coverage pays. Prescription drug coverage is “non-creditable” when it is not expected to pay, on average for all plan participants, as much as the standard Medicare prescription drug coverage pays. The notice must be furnished regardless of whether the employer plan pays primary or secondary to Medicare, and must be sent to all Part D eligible individuals including retirees, actives, COBRA beneficiaries and dependents of such...
When passed in 2010, the Affordable Care Act (ACA), often called “Obamacare,” had three basic goals: increase access to health insurance, reduce costs and spending, and offer patients stability with respect to their insurance coverage. By offering a subsidy for low- and middle-income Americans to purchase private insurance plans, the ACA was successful in expanding coverage for about 14 million previously uninsured individuals, including those with pre-existing medical conditions. Gary Scott Davis authored this bylined article about the future of the ACA. “We need to learn from both the strengths and weaknesses of the ACA to build a long-term sustainable approach that promotes access to care, brings insurance coverage within the reach of the many, contains costs, and aligns economic incentives among payors, providers and patients, while improving the nation’s overall level of health,” he wrote. Access the full article.
Shelby Buettner, Marshall Jackson, Jr., Lisa Schmitz Mazur and Dale Van Demark wrote this bylined article on a proposed US Senate bill to expand Medicare’s coverage of telehealth services. The bill would require the Center for Medicare and Medicaid Innovation to test the effectiveness of telehealth models, and cover through the Medicare program those models that meet criteria for effectiveness, cost and quality improvement. Read the full article.
CMS recently released a final rule with the goal of stabilizing Exchange markets for 2018. The agency also issued several significant guidance documents where CMS extended the deadlines for 2018 rate and Exchange qualified health plan application submissions, adopted a good faith compliance standard for 2018 and delegated additional plan certification responsibilities to states. While these steps may provide some comfort for issuers, the agency did not address the most significant areas of issuer concern when it comes to 2018 Exchange participation. Namely, the Final Rule and guidance documents do not resolve ongoing uncertainty regarding cost-sharing reduction funding, the enforcement of the individual mandate or ongoing efforts to repeal the Affordable Care Act. Read the full article.