On March 8, the White House encouraged Congress to pass stabilization legislation that would not authorize the reimbursement of cost-sharing reductions (CSRs) made by health plans in 2017, as reported by Modern Healthcare. This move comes almost five months after the Trump Administration’s announcement in October that it would discontinue CSR payments effective immediately. The legislation, if passed, would preclude the government from paying CSRs for the 2017 year and would allow CMS to claw back surplus money that plans have received from the federal government and applied towards CSRs. Continue Reading
On Thursday, March 8, the Trump Administration rejected Idaho’s plan to sell health plans that do not include the consumer protections required by the Affordable Care Act (ACA). The rejection came in the form of a letter touting adherence to current law, though in many ways the letter was written by an apologetic Centers for Medicare and Medicaid Services (CMS) wanting to appease Idaho Republicans.
Earlier this year, Idaho Governor C.L. “Butch” Otter signed an executive order that allowed some Idaho health insurance plans to drop certain ACA requirements. For example, plans would not need to cover maternity care, mental illness, or other essential health benefits; insurers could charge higher premiums to those with preexisting conditions; and insurers could deny people coverage if they had failed to maintain continuous coverage. Insurers who sold such “junk” plans would be required to also sell at least one ACA-compliant option over the exchanges. Gov. Otter’s actions seemed to test just how far Alex Azar, Secretary of the U.S. Department of Health and Human Services, would go to support the “state experimentation” Mr. Azar himself advocated for under the exchanges, as discussed in our earlier post. The answer, for Idaho, is not far enough. Continue Reading
Crowell & Moring has issued its “Regulatory Forecast 2018: What Corporate Counsel Need to Know for the Coming Year.”
The health care section of the Forecast, “Mergers: Keeping Care Competitive,” outlines how regulators have kept a close eye on the impact of industry consolidation and how the government has been aggressively blocking mergers it feels will hurt consumers. There is also an interesting section on the regulation of digital health technology in the cover story, “Digital Transformation: The Sky’s the Limit.”
The theme of the fourth-annual Regulatory Forecast is how digital technology is driving the future of business across a wide range of industries – and how Washington, as well as state and global regulators, is forging the appropriate balance between fostering innovation and protecting consumers. This report is the companion piece to the firm’s 2018 Litigation Forecast, which was published in January and also focused on the opportunities and challenges general counsel face in navigating the Big Data revolution.
Be sure to follow the conversation on Twitter with #RegulatoryForecast.
Alex Azar assumed office as HHS Secretary on January 29, 2018, and has hit the ground running. Among discussions on stabilization bills (see blog post discussion here and how these proposals further the Administration’s efforts on Trump’s Inauguration Day Executive Order here), Secretary Azar has been a vocal advocate for, in his own terms, “state experimentation” under both the Medicaid and health insurance exchanges (“Exchanges”).
Secretary Azar has not provided detail as to what type of experimentation he would like to see from states, but in his remarks at HHS headquarters on Tuesday, February 20, he stated that he was working with the Centers for Medicare and Medicaid Services (CMS) Administrator, Seema Verma, to give states “a menu of options” to decrease the restrictions under the Affordable Care Act (ACA). In particular, Secretary Azar noted that he was exploring ways to allow states greater flexibility through federal waivers.
On Tuesday, February 20, Department of Health and Human Services (HHS) Secretary Alex Azar announced that the agency intends to expand access to short-term, low-cost insurance policies. On Wednesday, HHS published its proposed rule, which promises to reduce restrictions on such limited-duration policies. The short-term insurance plans have fewer benefits and more limited consumer protections as compared to those proscribed by the Patient Protection and Affordable Care Act (ACA). While such short-term plans currently can only be carried for 90 days, the new proposal would extend that maximum coverage period to one year.
The proposed rule is in response to President Trump’s Executive Order from October 12, 2017, which called for HHS to expand access to low-cost insurance plans. The Executive Order asked the agency to explore the possibility of extending the maximum duration of such short-term, limited-duration plans in order to increase options for consumers. The short-term insurance plans are contemplated for individuals who are unemployed, between jobs, or otherwise looking to reduce premium costs for up to one year. The plans do not have to meet ACA requirements. Notably, they do not have to cover individuals with pre-existing conditions and they do not have to cover prescription drug plans. The plans offer more limited coverage for consumers, but impose less immediate financial burden through reduced premium cost. Insurers who sell the short-term plans would need to include clear statements on applications and plan documents that the coverage does not meet ACA requirements.
The proposed rule continues the Trump administration’s efforts to roll back the ACA and minimize its economic burden and comes just over a year after the president issued an Executive Order laying out that goal. It comes on the heels of earlier rules from the administration geared at stabilizing the individual and small group insurance markets. It also follows the signing of the new tax reform bill, which repeals the individual mandate of Section 5000A of the Tax Code and eliminates the shared responsibility payment for failure to obtain health insurance starting in 2019.
Crowell & Moring has issued its “Litigation Forecast 2018: What Corporate Counsel Need to Know for the Coming Year.”
The health care section of the Forecast, “FCA Enforcement: Different, But Still Here,” outlines how health care companies should expect continued enforcement of the False Claims Act, but with perhaps different emphasis on key areas such as drug pricing.
The Forecast explores the important litigation trends and challenges that businesses may face in 2018, and it features an in-depth look at how data-driven innovation is driving new opportunities and risks for clients across industries.
Be sure to follow the conversation on Twitter with #LitigationForecast.
This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users—both healthcare professionals, and patients and caregivers. It also provides guidance on FDA’s interpretation of new software provisions in Section 3060 of the 21st Century Cures Act.
Given the explosion of these innovative digital health tools and their strong potential to transform healthcare, this guidance is a significant development for tech companies and investors focusing on this space. Comments will be accepted for 60 days. Continue Reading
CMS announced important changes to Medicare reimbursement for remote patient monitoring and telemedicine that can help accelerate adoption and use of these digital health tools. These changes are implemented through two rules released this week that will take effect January 1, 2018. Understanding these rules can help you incorporate these tools into clinical practice and can positively affect the business model for technology developers and innovators.
What are these new rules and do they affect me?
The 2018 Quality Payment Program Final Rule provides policy updates to the Quality Payment Program (QPP), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and will be entering its second year. MACRA offers two “tracks” for eligible clinicians to take as they move toward value-based care:
- Participation in QPP and its scoring, or
- Participation in an Advanced Alternative Payment Model (APM).
The majority of Medicare payments are still tied to fee-for-service, but HHS has set a goal of moving to 50 percent of Medicare payments for alternative payment models by 2018. For previous coverage of QPP proposals, visit our summary here.
The 2018 Physician Fee Schedule Final Rule addresses revised payment policies for the Medicare physician fee schedule. Any provisions in the PFS rule typically apply to fee-for-service type providers. Continue Reading
The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information safely and effectively.
For device manufacturers, this guidance provides clarity on how the FDA is thinking about interoperability and patient safety in the premarket submission process and provides considerations for manufacturers in the development and design of interoperability medical devices. It demonstrates the FDA’s focus on the safety and effectiveness of devices as implemented in an interconnected environment and the expectations of FDA on manufactures to anticipate and design for anticipated uses and reasonably foreseeable misuses. Manufactures should consider this guidance in the design, development, and on-going monitoring of connected medical devices.
This guidance may be helpful for other audiences as well:
- Care providers that frequently interact with medical devices in the course of patient care
- Hospital IT teams who make device purchasing decisions
- Vendors of health technologies that frequently exchange data with medical devices
Internet defamation (and intellectual property infringement) cases are on the rise. And cases involving anonymous defendants are becoming more common. They of course present tricky First Amendment issues. Indeed, most such cases result in the anonymous defendants remaining masked and escaping liability. But in four example health care cases – a scare tactic, accidental disclosure, hacking, and impersonation set of cases – the plaintiffs successfully took on the First Amendment challenge. Knowing how these plaintiffs prevailed may help with your own response plan to a surprise cyber-attack by persons you don’t know.
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