Since the start of 2021, cyber-attacks have dominated headlines across every industry. From governments and government organizations, healthcare companies, and banks, to gaming companies and oil pipelines, ransomware has impacted organizations of all types and sizes. The scale and scope of these attacks have continued to grow and have far reaching consequences. Despite current agency attempts to strengthen cybersecurity through regulation, individual users continue to pose a serious threat due to insufficient security education.
In the United States, Assisted Reproductive Technology (ART) is predominantly self-regulated by a network of medical agencies that publish guidelines. ART refers generally to any fertility procedure where eggs or embryos are handled. ART clinics are not federally funded, and there is no specific national legislation that establishes a clear regulatory framework about the standard of operations, the quality-of-care patients should be provided with, the permissible uses of ART, or recourse for patients who have not benefited from their financial investments in ART. There are minimum standards set forth by the Food and Drug Administration (FDA) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which require strict compliance before patients can consult and use clinics’ ART services including the use of pharmaceutical products. The Federal Trade Commission (FTC) also oversees truthful advertising and marketing practices within ART to ensure that clinics’ reports of success are consistent with their patient data. All states require that physicians obtain a license before providing care, and physicians are subject to investigation by state boards. Aside from this general regulation for safety and transparency, the only explicit regulation targeting the ART industry is the United States Fertility Clinic Success Rate and Certification Act, mandating all US fertility clinics to report their ART cycles performed to the Center for Disease Control (CDC). The data collected through this reporting act is governed by the NASS 2.0 (National Assisted Reproductive Technology Surveillance System), which is a collaborative surveillance system between the CDC, and private stakeholders. Self-reported data to NASS 2.0 is verified by comparing information from a patient’s medical record with data submitted for the report.
For the first time in about twenty years, the U.S. Food and Drug Administration (FDA) approved a drug to combat the progression of Alzheimer’s. The newly approved drug is manufactured by Biogen and will be called Aduhelm. The FDA granted fast track designation of the drug to speed up access to patients. While Aduhelm will not reverse already developed Alzheimer’s symptoms, it will slow down the advancement of the disease by removing deposits of beta-amyloid, a protein found in early-stage Alzheimer’s patient’s brains.
The COVID-19 pandemic has impacted residents and staff of nursing homes and long-term care facilities more than any other demographic, accounting for nearly 40 percent of the total mortality rate from the virus in the United States. According to Centers for Medicare & Medicaid Services (“CMS”), at least 132,000 residents and employees have died from complications of the COVID-19 across 31,000 facilities, although some estimates place the death count closer to 200,000. One factor aggravating the number of deaths in nursing homes is the extraordinarily high rate of staff turnover each year.
The Department of Health and Human Services (“HHS”) finalized revised regulations that implemented Section 1557 of the Affordable Care Act (“ACA”) in June of 2020. This section prohibits discrimination within health programs and activities receiving federal financial assistance based on race, color, sex, age, disability, and national origin. In comparison to the Obama-era regulations issued in 2016, the new final rule does away with gender identity and sexual orientation nondiscrimination protections not only under Section 1557, but under ten other federal regulations as well. This also includes a roll back of certain health insurance coverage protections for transgender individuals.
As the United States continues to grapple with the effects of the coronavirus epidemic, the U.S. Department of Health and Human Services (“HHS”) announced new rules extending compliance dates and timeframes under the Cures Act. The agency’s new rules—most of which take effect on Dec. 4, 2020—are aimed at giving IT developers and health care providers flexibility in responding to the coronavirus pandemic.
The Federal Bureau of Investigation (“FBI”), the Department of Health and Human Services (“HHS”), and the Department of Homeland Security Cybersecurity and Infrastructure Security Agency (“CISA”) recently announced that hackers have been and will continue to target the United States hospitals and health-care providers. These attacks are cyber in nature and often lead to ransomware attacks, data left, and inevitable disruption of health care services when patient information is locked until the ransom can be paid.
The Centers for Medicare & Medicaid Services (“CMS”) Innovation Center (“CMMI”) recently announced a new model for health care providers in rural areas to receive payment from the federal government. The Community Health Access and Rural Transformation (“CHART”) initiative aims to improve rural health care while promoting the Trump Administration’s push to shift health care providers into a more expansive value-based payment model.
Signed by President Obama on March 23, 2010, The Affordable Care Act (“ACA”) provided a monumental change to healthcare. The ACA created access, added provisions to improve quality, and created cost containment measures. However, the ACA created a quintessential question of Federalism. As it exists today, the Supreme Court will listen to oral arguments in November on the constitutionality of the ACA, in California v. Texas. If the Court decides that the ACA is unconstitutional, millions of Americans who are insured under the Act will lose coverage. Additionally, aside from access, the ACA includes regulatory laws such as Section 1557’s nondiscriminatory provisions, and amendments to the False Claims Act & HIPAA.
The Centers for Medicare & Medicaid Services (“CMS”) released new guidance for skilled nursing facilities (“SNFs”) as part of a larger rulemaking agenda for healthcare institutions in the throes of the current public health emergency with COVID-19. CMS has also detailed the fines for non-compliance with the new COVID-19 requirements for SNFs and other healthcare institutions such as hospitals and laboratories.