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HHS

The Future of Telemedicine: Controlled Substance Proposed Rule

On January 31, 2020, the Secretary of the Department of Health and Human Services issued a public health emergency as a result of COVID-19. The emergency declaration requires public health professionals, first responders, and public officials to work together to minimize death while preventing illnesses. The declarations provided the government with the flexibility to waive or modify standard requirements as it relates to both public and private insurance, service providers, and authorizations including telehealth. Telehealth provided access to healthcare to those who face barriers as well as flexibility in being able to manage care while reducing the spread of COVID-19 along with other infectious diseases. There remained uncertainty regarding the freedom to prescribe controlled substances via telemedicine with the Biden administration set to end the public health emergency on May 11, 2023. However, on February 24, 2023, the Drug Enforcement Administration (DEA) released a proposed rule that aims to permanently extend controlled substance prescribing flexibilities.

COVID-19 Vaccine Passports and Privacy Concerns

As businesses begin to reopen and resume operations after the pandemic, there are discussions surrounding possible vaccine passports and the concerns protecting individuals’ personal health information. COVID-19 vaccines are becoming more available within the country and more Americans feel safe to resume their normal lives. Many states and businesses are contemplating the idea of making vaccine passports a requirement for travel and large events. The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) was created to protect personal health information. As other countries are beginning to require proof of vaccination, many are contemplating whether vaccine passports are permitted by HIPAA or if the requirement will actually violate the federal health privacy law.

Illinois House Bill 3498: Telehealth Expansion and Payment Equality

The Coalition to Protect Telehealth and State Representative Deb Conroy of the Illinois 46th House District have introduced legislation that would permanently expand access to telehealth services for Illinoisans.  The legislation also details provisions that promote telehealth payment rate partity between telehealth services and in-person care.  In a direct response to the COVID-19 pandemic, telehealth providers have been granted temporary waivers to align their payment rates with those prescribed for traditional care in health care facilities.  These waivers have served as stabilizing financial mechanisms for many practitioners experiencing revenue loss due to the restrictions on elective procedures and non-emergency care.  The proposed legislation would give patients more freedom to utilize telehealth services by removing the patient responsibilities to demonstrate hardship or access issues.

Nursing Home Staff Turnover Rates Partially Explains Disproportionate Number of Deaths during COVID-19 Public Health Emergency

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. 

Final Rule and Updates to Non-discrimination Regulations of the ACA

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.

President Biden’s COVID-19 Data-Driven Executive Order to Promote Health Equity

President Joe Biden has issued a number of Executive Orders, many of which address the ongoing COVID-19 public health emergency. On January 21, 2021, President Biden released another pillar of his Administration’s long-term plan to direct the United States out of the throes of the pandemic. The twelfth Executive Order titled, “Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats” orders the Department of Health and Human Services (“HHS”) Secretary Alex Azar to conduct a nationwide review of the interoperability of public health data systems in an effort to enhance the collection, sharing, analysis, and collaboration of de-identified patient data.

HHS Extends Deadlines to Give Health Care Providers and IT Developers More Flexibility in Responding to COVID-19

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.

Hospitals Across the Country at Serious Risk for Coordinated Ransomware Attacks

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.

Changes in Healthcare Information Regulation: Information Blocking

On November 3, 2020 new rules from the Health and Human Services Department concerning information blocking in healthcare will come into effect. The rules are an implementation of the 21st Century Cures Act (“Act”) which is the latest in the government’s effort to lower costs and allow for greater patient access to electronic health information (“EHI”). The Act aims to prevent covered healthcare providers from restricting the flow of EHI in inappropriate ways. Violations of the new Act may result in considerable civil fines.

Rural Hospitals in Crisis Receive a Boost to Value-Based Care Model from New CMS CHART Model

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.