This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue describing how FDA’s regulatory scheme has persisted in light of the key First Amendment decisions involving off-label promotion. Even though FDA hesitated in and ultimately rejected promulgating regulations that would make any action “that directly or indirectly suggests to the physician or to the patient that an approved drug may properly be used for unapproved uses for which it is neither labeled nor advertised” (37 Fed. Reg. 16,503, 16,504) into a matter warranting enforcement action, the Agency used this reasoning to shape an off-label communication policy. As I described in Part 2, FDA’s policy enjoyed some support from federal courts; however, this support was only temporary. More recently, federal courts have shown support for the idea that truthful and non-misleading promotions of off-label uses of drugs and devices by manufacturers are protected under the First Amendment. A review of the pivotal cases in this area will help put FDA’s off-label policy in perspective, especially in light of FDA’s reaction to these cases in a memorandum published in January 2017. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3
On May 23, the White House released its 2018 budget proposal, outlining its priorities for the upcoming fiscal year. In health care, the President has proposed cuts to several agencies and programs. The Administration’s annual budget is seen as a statement of policy, not necessarily a legislative proposal certain to become law. That said, ML Strategies has summarized the highlights from the Health and Human Services Budget that are worth monitoring as Congress begins its work on the FY 2018 budget. The summary is available here. ML Strategies will continue its coverage here of ongoing health care issues on Capitol Hill that will need to be addressed later this year, such as the FY18 budget and the Health Care Minibus.
ML Strategies has published the first installment of a new weekly preview, designed to give you quick overview of health happenings in the coming week. The preview highlights upcoming activity in the House and Senate and other hot topics on the Hill.
Spoiler alert: the confirmation processes for Dr. Scott Gottlieb (FDA) and Judge Neil Gorsuch (Supreme Court) will get a lot of attention this week.
See HERE for this week’s preview and be sure to stay tuned in the coming weeks.
This week, in their “Future of the Affordable Care Act” series on our Employment Matters blog, my colleagues Alden Bianchi and Edward Lenz provided an analysis of the major provisions of the American Health Care Act (“AHCA”).
Introduced on March 6, 2017, the AHCA is the first concrete legislative proposal detailing the initial provisions designed to repeal and replace the Affordable Care Act. As Alden and Ed discuss, the bill currently is the subject of widespread media scrutiny and intense criticism. The bill is not final and will likely face numerous changes, including the last minute proposals changes of the past 48 hours. The March 6th version offers an outline of Republican priorities in the regulation of health and health care financing, which include a strong bias in favor of market-based solutions and aversion to most (but not all) government intervention in the health care markets.
Check out their full analysis on The Future of the Affordable Care Act Week 7: The American Health Care Act, here. Continue Reading Future of the Affordable Care Act and the American Health Care Act
The President has released a “budget blueprint” for fiscal year 2018. Although there are many aspects of the budget blueprint to digest, several budget items signal that government health care fraud enforcement remains a priority under the new administration.
- Overall, the President’s 2018 budget requests $69.0 billion for the Department of Health and Human Services (“HHS”). According to the blueprint, this a $15.1 billion or 17.9% decrease from the FY 2017 annualized level.
- However, the budget blueprint increases funding for the Health Care Fraud and Abuse Control (HCFAC) program, which is designed to coordinate federal, state and local health care fraud and abuse enforcement efforts.
- Specifically, the blueprint proposes $751 million of discretionary funding for the HCFAC program, which exceeds FY 2017 funding by $70 million, according to the budget blueprint.
- The budget blueprint explains that additional funding for the HCFAC program “has allowed the Centers for Medicare & Medicaid Services in recent years to shift away from a ‘pay-and-chase’ model toward identifying and preventing fraudulent or improper payments from being paid in the first place.”
In a proposed budget that cuts HHS funding by nearly 18%, the increase in HCFAC funding stands out. The President’s budget affirms a trend that we have observed away from “pay-and-chase” toward proactive data analysis. As discussed in a prior post, recent False Claims Act cases strongly suggest that growing experience with data mining has given enforcers greater confidence in their ability to identify potential fraud and abuse. As a result, proactive data analysis could lead to a greater number of FCA cases originating with government investigators instead of through qui tam FCA actions.
As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration (see here and here). However, since taking office, President Trump has followed through on his campaign promise to significantly roll back Federal regulations and has taken several actions aimed at slowing and reversing agency regulatory processes, including processes at the DHHS sub-agencies CMS and FDA. These executive actions are creating a climate of uncertainty for regulated industries and their stakeholders. Continue Reading Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries
The pharmacy industry continues to be under scrutiny from all angles. As legislative, agency, and enforcement priorities take shape under the new administration, the industry is faced with what seems like daily developments in terms of policy updates, legislation, and potential regulation. Our 2017 Pharmacy Industry Summit will bring together stakeholders and thought leaders from across the industry to discuss legal and policy challenges facing manufacturers, PBMs, payors, pharmacies, and providers and to assess the various swirling initiatives and their potential impact on the industry.
The Summit will be held on April 5-6 at the Mintz Levin Washington, DC office. Event details can be found here.
Session topics will include:
- A Keynote Address from Mark Merritt, President and CEO of The Pharmaceutical Care Management Association (PCMA)
- An update on the current state of Affordable Care Act Reform
- Drug Pricing Debate and the Evolving Role of Pharmacy Industry Players
- State Issues Affecting the Pharmaceutical Industry
- Congressional Staffer Panel
- Value-Based and Innovative Contracting and Reimbursement
- FDA’s Impact on the Supply Chain – Evolving Policies and Changing Priorities
- Government Enforcement and the Pharmaceutical Industry
We hope you can join us! Please register by March 29, 2017.
The Massachusetts health care industry is facing policy changes from state and federal decision makers. In a recent Alert, my ML Strategies colleagues Julie Cox, Steven Baddour, Dan Connelly, Caitlin Beresin and Max Fathy consider how state and federal government action will affect a wide variety of health care stakeholders.
In addition to certain health care aspects of Governor Baker’s proposed FY2018 budget, the Massachusetts legislature is expected to debate a number of health care issues during the 2017-2018 legislative session. And while Massachusetts is a national leader in health care, federal health care law and policy will always impact the Commonwealth, so ML Strategies is watching how the new presidential administration and Congress move forward with their plans to reshape the nation’s health care policy.
Two key Massachusetts budget items relating to health care are controversial amongst industry:
- A $2,000 per employee “fair share” assessment for certain Massachusetts employers that fail to meet certain enrollment or contribution thresholds for their employee health insurance plans.
- Permanent tiered caps on the rate of growth for all acute hospitals and most professional service providers.
My colleagues also highlight several bills that Massachusetts legislators have introduced relating to drug pricing transparency, recognizing that pharmaceutical spending is a key driver of total health care expenses. We can also expect recommendations from both the Health Policy Commission and the legislature’s Special Commission on Provider Price Variation this spring.
Read the full Alert, and stay tuned as ML Strategies continues to monitor health care in the Commonwealth.
From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible. However, given the political climate in the federal government and the lack of an appointed FDA commissioner, it is unclear whether FDA will hold its ground or be forced to retreat.
For Health Care stakeholders, ML Strategies considers priorities that have been identified by the Trump Administration and the Republican-controlled Congress, and forecasts possible legislative and administrative actions to move their agendas along. We all know that the ACA is a target, and whether the chosen path forward is repeal and replace, or repair and rebuild, there are some key components of the law that are vital to a healthy marketplace. ML Strategies outlines some strategies and tactics we might see in the coming weeks.
In addition to ACA repeal, the Health Care Outlook also discusses key Administration appointees for HHS, CMS and FDA, as well as potential policy advisors. There are also a number of Congressional acts up for reauthorization – the “UFAs” for FDA, CHIP and Medicare outpatient therapy caps – each important in its own right, but which also creates opportunities for ‘ride-along’ policy initiatives.
Finally, ML Strategies looks to what may happen to the ACA cost-sharing reductions with the House v. Burwell litigation, and considers whether Telemedicine might provide an opportunity for this new Congress to work together, across party lines.