In a prior blog post, we discussed CMS’ Hospital Price Transparency Rule at 45 C.F.R. § 180.10 et. seq., effective January 1, 2021 (the “Rule”), which requires hospitals to make public “a machine-readable file containing a list of all standard charges for all items and services.” Specifically, the Rule requires hospitals to post (1) a description of each item or service provided by the hospital; (2) the gross charge that applies to each individual item or service; (3) payer-specific negotiated rates that apply to each item or service for which a payer negotiated rate has been established. Each payer negotiated price must be clearly associated with the name of the applicable third-party payer and plan; (4) de-identified minimum negotiated rates that apply to each item or service; (5) de-identified maximum negotiated rates that apply to each item or service; (6) discounted cash prices that apply to each item or service; and (7) CPT, HCPCS, or other billing codes used by the hospital for purposes of accounting or billing for the item or service.

In a study published on March 16, 2021, Health Affairs found that out of the largest 100 hospitals in the U.S. (by certified bed count), 65 were “unambiguously noncompliant.” 12 of these 65 (18%) did not post any files or provided links to searchable databases that were not downloadable and 53 (82%) either did not include the payer-specific negotiated rates with the name of payer and plan clearly associated with the charges or were in some other way noncompliant. The data informing this study was pulled from late January 2021 to early February 2021. Continue Reading Recent Study Shows Lack of Compliance With CMS’ Hospital Price Transparency Rule

In a report issued by the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) on March 23, 2021 (the “2021 Report”), representatives from 320 hospitals in 45 states, the District of Columbia, and Puerto Rico were interviewed on their experiences responding to the COVID-19 pandemic. Questions were focused on the hospitals’ most difficult challenges in responding to COVID-19, strategies used by the hospitals in addressing or mitigating those challenges, and how the government could best support hospitals responding to COVID-19. This report was a follow-up to a similar OIG pulse survey released about a year ago on April 3, 2020 (the “2020 Report”), which summarized hospitals’ answers to the same questions near the start of the pandemic. The two reports, published one year apart, provide a useful snapshot into how hospital challenges have evolved in responding to the pandemic. Looking at the two reports side-by-side, we compare the challenges hospitals faced in 2020 versus the challenges they are now contending with one year later in 2021. Continue Reading One Year Later: OIG Reports Describe Evolving Challenges Hospitals Have Faced in Pandemic Health Care Delivery

As is the case with most new technologies or significant industry innovations, companies embracing and driving the disruptions often move very fast in a legal and political landscape that is always playing catch-up. This is very true for the fast-growing telemedicine and digital health industries. However, likely motivated by COVID-19, state governments are moving faster than they traditionally do to pass new regulations and to extend certain regulatory waivers.

COVID-19 required a shift in the delivery of medical care with the state and local lockdowns. During the pandemic, the United States Department of Health and Human Services (HHS) has issued guidance on various compliance waivers and enhanced flexibility. Governors across the country issued executive orders to help address the requirements of providing ongoing medical care while maintaining proper social distancing (e.g., New Mexico, Texas, etc.). The result was more people receiving medical care remotely. Similar to the realization by many that working from home was not only feasible but in some cases preferable, many also came to the conclusion that a trip to the doctors’ office was not necessary for the treatment of certain conditions. Continue Reading Propelled by COVID-19, State Governments Attempt to Keep Up With Telemedicine Innovation and Digital Health Platforms

Although vaccine rollout began slowly in the United States, millions of people are now being vaccinated against COVID-19 per day. As individuals receive the vaccine, states have been collecting personal health data in individual immunization registries. Experts say this data collection is essential to effectively monitor vaccination progress, report adverse reactions, compare vaccine efficacy in cross sections of the population, and keep track of who needs second doses and when. Continue Reading Federal Vaccination Tracking Raises Privacy Concerns

A recent Fourth Circuit decision, United States v. Mallory (988 F.3d 730), upheld damages and penalties for more than $100 million for violations of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) (the “AKS”) and the False Claims Act (31 U.S.C. § 3729) by a blood testing laboratory and its contracted sales agents.  The Court held that commission payments made by the laboratory to its sales agents (sales companies that, in turn, hired and contracted salespeople to sell the laboratory blood tests), which were based on the percentage of revenue the sales agents generated for the laboratory through marketing services, constituted improper “remuneration” that intended to induce the sales agents to sell as many laboratory tests as possible. The defendants failed to show that the arrangements fit within an AKS Safe Harbor. Continue Reading Developments Regarding Commission-Based Compensation Arrangements with Independent Contractors

As promised, this is a follow-up to our first blog post on the new federal transparency requirements. In our prior post, we summarized the Hospital Price Transparency rule which went into effect on January 1, 2021, and here we discuss the transparency rules contained in the Consolidated Appropriations Act, 2021 (the “Act”), which apply to both health plans and health care providers.

Beginning January 1, 2022, the Act requires providers (individual practitioners and facilities) to send the health plan a “good faith estimated amount” of scheduled services, including any expected ancillary services and the expected billing and diagnostic codes for all items and services to be provided. This notice then triggers the health plan’s obligation to send enrollees an “Advanced Explanations of Benefits” (“AEOB”) prior to scheduled care (or upon patient request). If the patient is uninsured, the provider must send the notice directly to the patient. Continue Reading New Federal Transparency Requirements Impacting Health Providers and Plans

This post is part one of two in a series on new transparency requirements impacting both health plans and health care providers.

In an effort to assist patients in understanding the cost of hospital services, the Hospital Price Transparency rule at 45 C.F.R. § 180.10 et. seq., effective January 1, 2021, requires all hospitals to make public the following pricing information: Continue Reading The Hospital Price Transparency Rule: Is it Worth the Cost of Compliance?

During the COVID-19 pandemic, health care providers have faced unique challenges in the delivery of health care. As COVID-19 began to spread across the United States, the CDC advised health care providers, especially in areas with widespread COVID-19 transmission, to offer care via telemedicine technologies where appropriate. As a result, although telemedicine has been emerging as an important player in the delivery of health care over the past several years, the pandemic has caused the use of and access to telemedicine to grow to an unprecedented scale. During the pandemic, telemedicine has materialized as an especially useful tool in triaging patients in emergency care settings. This “tele-triage” model provides significant opportunity for the health care industry. Continue Reading “Tele-Triage”: The COVID-19 Crisis’s Transformation of Emergency Care and Potential Post-Pandemic Opportunities

The latest COVID-19 stimulus bill, the American Rescue Plan of 2021 (the “Act”), enacted on March 11, 2021, provides $1.9 trillion in funding for various COVID-19 relief measures. However, while the Act includes many funding provisions, including those funding direct assistance to lower-income individuals and families, expanding “Obamacare” insurance subsidies and availability, increasing federal medical assistance percentage (“FMAP”) rates for Medicaid programs under certain circumstances, supporting public health workforce development, funding technical assistance to skilled nursing facilities (“SNFs”), and bolstering COVID-19 vaccine and testing efforts, it also has a few provisions that create new or directly augment existing financial supports available to providers and hospitals that have sustained losses during the pandemic. Continue Reading The COVID-19 Provider Funding Tap Begins to Run Dry: The American Rescue Plan Offers Minimal Financial Relief to Non-Rural Providers and Hospitals

The COVID-19 pandemic has had well-documented transformative effects on the delivery of health care. Investors, providers, payors and other stakeholders have often been at the forefront of the industry shifts in the trailing twelve-month period. We have set forth below three investment trends that may be particularly compelling. Continue Reading Three Health Care Investment Trends That We Are Currently Following