Consumer privacy protection continues to be top of mind for regulators given a climate where technology companies face scrutiny for lax data governance and poor data stewardship.  Less than a year ago, California passed the California Consumer Privacy Act (CCPA) of 2018, to strengthen its privacy laws.  In many regards, the CCPA served as a watershed moment in privacy due to its breadth and similarities to the E.U. sweeping General Data Protection Regulation (GDPR) law.

Yet, California continues to push the envelope further.  Recently, California State Senator Jackson and Attorney General (AG) Becerra introduced a new bill (SB561) that will expand the consumer’s right to bring private lawsuits for violations of the CCPA. If passed, SB561 will: (1) provide for a private right of action for all CCPA violations—not just those stemming from a data breach; (2) eliminate the 30-day period for businesses to cure after receiving notice of an alleged violation; and (3) allow the AG to publish guidance materials for businesses instead of allowing businesses’ the option to seek specific opinions of the AG. Currently, the CCPA allows the AG office to bring action against business, in most instances, only allowing consumers to bring private action in instances of data breach resulting from a business’s failure to implement reasonable security measures. If SB561 is passed, the CCPA will materially expose businesses to private actions for damages applicable to other violations under the CCPA, including failure to provide consumers with proper notifications required under the CCPA.

These developments are just the tip of the iceberg.  Emboldened by California’s example, many other states are following suit. As such, businesses that implement an effective CCPA compliance program will likely position them to satisfy potential compliance obligations in other states moving forward.  For example, Colorado recently passed as sweeping law to protect patient privacy (HB18-1128), which went into effect September 1, 2018.  Colorado now requires covered entities (e.g., business entities that maintain, own, or licenses personal identifying information (PII) in the course of their business) to implement, and ensure that third-party service providers implement, reasonable security procedures and practices.  Additionally, the law requires covered entities to develop written policies and procedures concerning the destruction of paper and electronic documents that contain PII. Further, the law authorizes the AG to bring criminal prosecution against covered entities that violate the new rules.

Other states including Hawaii, Maryland, MassachusettsNew Mexico, New York, North Dakota, Rhode Island, and Washington are also using the CCPA and the GDPR as templates to perform similar overhaul of their privacy laws. As a result of this state law trend, businesses should closely monitor the legislative progress of these state bills.  Further, if businesses have not yet started shoring up their privacy and data security practices and programs, they had better do so in short order. It is likely that many of these state laws, if passed, will carry stiff penalties for noncompliance and may subject businesses to class actions.

In addition to these piecemeal state law efforts to strengthen privacy, the U.S. Chamber of Commerce is currently exploring whether a Federal consumer privacy protection law should be enacted.  It appears that the privacy tidal wave starting on California’s west coast is making its way eastward . . . .

 


Daniel Kim


Alaap B. Shah

On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to spur innovation and efficient access to new regenerative medicine products.

FDA Commissioner Scott Gottlieb remarked that the finalization of regenerative therapy guidance documents “demonstrate[s] [FDA’s] continued commitment” to fulfilling the promise of providing a clear and predictable pathway to approval. Moreover, he noted that these guidance documents help stakeholders to “understand our regulatory framework” and, in turn, “may help to more efficiently advance access to safe and effective regenerative medicine therapies.” These guidance documents, which are discussed in further detail below, provide information to product developers about FDA’s current thinking with respect to evaluating devices used with regenerative medicine advanced therapies and provide information on the expedited development programs that may be available.

Guidance for Industry: Evaluation of Devices Used with Regenerative Medicine

The final guidance entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies” (available here) clarifies how FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative medicine advanced therapies (RMATs). This guidance finalizes FDA’s current thinking on how the agency will streamline and simplify its application of regulatory requirements for combination device and cell or tissue products.

In this guidance document, FDA acknowledges that a wide range of devices may be used in conjunction with an RMAT, ranging from simple, low-risk devices to complex, higher risk devices to devices that are constituent parts of an RMAT that is classified as a combination product. FDA reiterates that the primary factor in determining the availability of premarket pathways for a device is the device’s classification (i.e., Class I, Class II, or Class III), followed by the risks associated with the device type and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.

In addition, FDA discusses the factors it will consider when determining whether a device may be labeled for use with a specific RMAT or class of RMATs. When determining which devices may be suitable for use with a specified RMAT or type of RMAT, FDA will consider the distinct biological and physical characteristics of RMATs, intended use, and conditions for use. With respect to cellular products that are RMATs, FDA intends to review the cellular products’ characteristics, their interaction with different devices, as well as any impact on cell viability, differentiation potential, activation state and ability to respond to stimuli after administration and other similar factors.

Substantively, there were no major or unexpected changes between the draft guidance and the final guidance issued by FDA.

Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

The second final guidance, “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions” (available here), provides information regarding the use of accelerated approval pathways for regenerative medicine therapies that have been granted designation as an RMAT, as well as considerations in the clinical development of regenerative medicine therapies and opportunities for sponsors of such products.

This guidance makes clear that the following therapies could qualify for an RMAT designation: cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except those regulated solely under section 361 of the Public Health Service Act (42 U.S.C. 264) and 21 C.F.R. Part 1271. Notably, the final version of this guidance clarifies that “cell therapies” includes both allogeneic and autologous cell therapies, as well as xenogenic cell products. Products that qualify for an RMAT designation receive all of the benefits of the fast track and breakthrough therapy designation programs, including early interactions with FDA. Although sponsors may apply for and receive both breakthrough and RMAT designation for a product, FDA advised that each designation requires a separate application.

Factors that FDA may consider when determining whether the preliminary clinical evidence is sufficient to support RMAT designation include, but are not limited to, the rigor of data collection; the consistency and persuasiveness of outcomes; the number of subjects and sites contributing to the data; and the severity, rarity, or prevalence of the condition. Unlike the breakthrough therapy designation, RMAT designation does not require a sponsor to produce evidence indicating that the drug offers a substantial improvement over available therapies.

To apply for RMAT designation, a sponsor should submit either a new investigational new drug application (“IND”) or an IND amendment, along with a concise summary of information in support of the RMAT designation. The application should include a description of the investigational product; rationale for the investigational new drug meeting the definition of an RMAT; a discussion to support that the disease or condition the product is intended to treat is serious; and preliminary clinical evidence that the product has the potential to address the specified unmet medical need for the serious condition. The requirement to provide a description of the product is new to the final guidance.  No later than 60 calendar days after receipt of the designation request, FDA will notify the sponsor as to whether the regenerative medicine therapy has received the RMAT designation.

Finally, this guidance provides recommendations for clinical trial design. FDA states that it will consider clinical trials in support of a Biologics License Application (“BLA”) that “incorporate adaptive designs, enrichment strategies, or novel endpoints.” This final guidance provides new language indicating that historical controls and natural history data (the course a disease takes from its onset, through presymptomatic and clinical stages, to a final outcome in the absence of treatment) may be considered, if appropriate. Natural history data, however, may only provide the basis of a historical control if the “control and treatment populations are adequately matched, in terms of demographics, concurrent treatment, disease state, and other relevant factors.”

FDA’s continued focus on developing and finalizing guidance in the regenerative medicine space suggests that FDA is serious about helping industry to both navigate the application process in an effort to streamline the premarket approval process and to better understand and address identified regulatory pain points. For these reasons, sponsors of investigational regenerative therapies should pay close attention to and take into consideration the recommendations set forth in these final guidance documents.

For the first time since 2008, the Advanced Medical Technology Association (“AdvaMed”) has updated its “Code of Ethics on Interactions with Health Care Professionals.”  These updates were announced on January 9, 2019 and will become effective on January 1, 2020.

AdvaMed’s goal in updating the Code was to address the evolving nature of interactions between the medical device industry and health care professionals (“HCPs”), bring existing examples up-to-date, and enhance user-friendliness.  Topics that were previously covered in multiple areas of the Code are now consolidated into more comprehensive sections on Company programs, Third-Party Programs, Travel and Meals.  There are also three new sections on: Jointly Conducted Education and Marketing Programs, Communicating for the Safe and Effective Use of Medical Technology, and Company Representatives Providing Technical Support in the Clinical Setting.  Additionally, the updated Code includes language that clarifies when it is acceptable to provide evaluation products, and adds additional detail to the section on Consulting.  These changes are explained in further detail below.

Consulting Arrangements with HCPs

While the updated section on consulting arrangements retains much of the same content as the previous version, it also provides additional clarity on determining whether there is a legitimate need for consulting services, explaining that a legitimate need arises when a company requires the services of an HCP to achieve a specific objective.  It also specifies that rewarding an HCP for referrals, or designing an arrangement to generate business, are not considered legitimate needs.  Additionally, the updated section includes criteria on how manufacturers can establish fair market value compensation rates for consulting services.  These include the HCP’s specialty, years and type of experience, geographic location, practice setting, and the type of service performed.

Third-Party Programs

The updated Code consolidates existing language on providing support for third-party educational, charitable, and research programs into one section on grants, donations, and commercial sponsorships.  This section includes a checklist that companies can use to review requests for educational grants, and adds language on whether companies can host satellite symposia.  It also expands and clarifies the requirements for supporting independent research grant requests or charitable donations.

Travel and Meals

The updated Code also consolidates its previous guidance on travel and lodging into one section and provides clarity on situations for which a company may pay for travel and lodging expenses (e.g., consulting, training, legitimate need for meeting, HCP presence) and when such payments are prohibited (e.g., general education, attending a third-party program, no legitimate need).  It also includes additional information on evaluating appropriate venues for meetings, taking into consideration whether the venue is in a central location and whether it is conducive to an exchange of information. The added language also places a limit on “top category” or luxury hotels.

Jointly Conducted Education and Marketing Programs

The Code’s new section on Jointly Conducted Education and Marketing Programs explains that these types of programs are typically educational programs that are aimed at highlighting a medical technology as well as an HCP’s ability to treat a condition using that technology (e.g., a manufacturer promotes its surgical implant device while a surgeon discusses his or her ability to perform the implant procedure using the device.)  AdvaMed acknowledges the benefits of such jointly conducted programs; however, it also advises manufacturers to follow certain principles to ensure that the program does not unduly benefit the HCP in a manner that violates the Anti-Kickback Statute.  For example, the manufacturer and the HCP must establish a bona fide partnership, meaning the arrangement should be documented in a written agreement and any contributions and costs should be shared equitably between them.

Communications & Technical Support

The updated Code also features a new section on communicating for the safe and effective use of medical technology, which sets forth principles for communicating information on unapproved or uncleared uses. For example, communications should be truthful and non-misleading, provided by authorized personnel, and appropriately identified as off-label.  AdvaMed advises that companies develop policies on the dissemination of off-label information based on existing guidance.

The final new section added to the Code is on the provision of technical support in the clinical setting. This section provides guidelines for company representatives who provide technical support in this setting to follow.  This includes, but is not limited to, being transparent that they are acting on behalf of the company and not interfering with an HCP’s clinical decision-making.

Although only certain states, such as California, Nevada, and Connecticut, have required device manufacturers to model their compliance programs after principles set forth in AdvaMed’s Code of Ethics, the Code has long been relied upon as the industry standard for maintaining ethical and compliant relationships between device manufacturers and HCPs. As such, manufacturers should carefully review the changes that have been made to the Code and update their internal policies and procedures as necessary.  Manufacturers in states like California, Nevada, and Connecticut should also look out for any updates in their states’ legislation to adopt the changes made to the Code.

The updated Code is available here and a brief overview of the changes can be found here.

Please join Epstein Becker Green attorneys for a fall webinar series—via five 45-minute sessions—that will address how proactive compliance initiatives are critical to a platform’s operations, expansion efforts, and eventual monetization upon exit.

Immediate Post-Closing Operational Fixes
When:  October 2, 2018 at 12:00pm – 12:45pm
People:  John Eriksen, Josh Freemire, Gary Herschman, and Marc Mandelman
Location:  Webinar (ET)

Add-On Diligence Strategy
When:  October 9, 2018 at 12:00pm – 12:45pm
People:  Josh Freemire, Anjana Patel, David Weiss
Location:  Webinar (ET)

Proactive Employment Compliance
When:  October 16, 2018 at 12:00pm – 12:45pm
People:  Denise Dadika, Paul DeCamp, Peter Steinmeyer
Location:  Webinar (ET)

Proactive Health Care Regulatory Compliance
When:  October 23, 2018 at 12:00pm – 12:45pm
People:  John Eriksen, Josh Freemire, Kevin Ryan
Location:  Webinar (ET)

Employee Benefits and Executive Compensation Compliance and Planning
When:  October 30, 2018 at 12:00pm – 12:45pm
People:  Christopher McMican, Kevin Ryan, Peter Steinmeyer
Location:  Webinar (ET)

Registration is complimentary click here.

If you have questions regarding this event, please contact David Stone.

On June 20, 2018, the Centers for Medicare and Medicaid Services (“CMS”) published an advance copy of a request for information seeking public input on reforms to the Physician Self-Referral Law (or “Stark Law”).

The request for information stems from on-going efforts by the Department of Health and Human Services (“HHS”) to accelerate the government’s transformation from a fee-for-service to a value-based system focused on care coordination.  Dubbed the “Regulatory Sprint to Coordinated Care” (#RS2CC), HHS expressed an intent to first identify regulatory requirements that act as obstacles to coordinated care, and then issue guidance or revise regulations to address these obstacles and/or incentivize coordinated care.

In connection with this HHS initiative, CMS acknowledged and identified that certain aspects of the Stark Law may pose potential obstacles to coordinated care.  Through their request for information, CMS seeks additional information and input from the public to help achieve their goal of “reducing regulatory burden and dismantling barriers to value-based care transformation.”  In particular, CMS has asked the public to share their thoughts and experiences related to:

  • the structure of arrangements between DHS entities that are used to effectuate alternative payment models and novel financial arrangements;
  • potential revisions to current Stark Law exceptions and key defined terms that would serve to permit or encourage the implementation of alternative payment models; and
  • the creation of new Stark Law exceptions to permit or encourage the implementation of alternative payment models.

The request for information follows a number of other administrative actions and announcements focused on reforming the current regulatory environment, particularly with respect to physician arrangements and, more specifically, the Stark Law. In January, CMS Administrator Seema Verna announced a plan to form an interagency group focused on reviewing the regulatory barriers to alternative payment models created by the Stark Law.  In addition, the Fiscal Year 2019 budget proposal, issued by the Office of Management and Budget in February, includes a proposal to reform the Stark Law to “better support and align with alternative payment models and to address overutilization.”  These more recent actions continue to build on concerns and suggestions identified in a white paper released by the Senate Finance Committee in 2016 titled “Why Stark? Why Now? Suggestions to Improve the Stark Law to Encourage Innovative Payment Models.”

This request is only the first formal step in the combined efforts of HHS and CMS to adopt what may be significant changes to the Stark Law.  However, the government appears to be poised to move quickly on regulatory reforms now that the ball is rolling, as evidenced by their branding of these efforts as a “sprint.”

Epstein Becker Green is in the process of coordinating with clients that are interested in submitting responses to the request for information.  If your organization is interested in developing comments to this request and would like assistance in these efforts, please contact Victoria Sheridan by e-mail at vsheridan@ebglaw.com or by phone at (973) 639-8296.

The final copy of the request for information is scheduled to be published in the Federal Register on June 25, 2018.

Our colleague  at Epstein Becker Green has a post on the Technology Employment Law blog that will be of interest to our readers: “The GDPR Soon Will Go Into Effect, and U.S. Companies Have to Prepare.”

Following is an excerpt:

The European Union’s (“EU’s”) General Data Protection Regulations (“GDPR”) go into effect on May 25, 2018, and they clearly apply to U.S. companies doing business in Europe or offering goods and services online that EU residents can purchase. Given that many U.S. companies, particularly in the health care space, increasingly are establishing operations and commercial relationships outside the United States generally, and in Europe particularly, many may be asking questions akin to the following recent inquiries that I have fielded concerning the reach of the GDPR:

What does the GDPR do? The GDPR unifies European data and privacy protection laws as to companies that collect or process the personally identifiable information (“PII” or, as the GDPR calls it, “personal data”) of European residents (not just citizens). …

Read the full post here.

The Centers for Medicare and Medicaid Services’ (“CMS”) recently announced its intent to expand what may be considered “supplemental benefits,” broadening the scope of items and services that could be offered to Medicare Advantage (“MA”) plan enrollees over and above the benefits covered under original Medicare. However, in articulating the standards for covering this broadened group of items and services, CMS proposed a new requirement that could greatly limit enrollees’ ability to access all types of supplemental benefits and increase the already substantial burden on MA participating providers; CMS now proposes to require that the supplemental benefits be ordered by a licensed provider.

Under current CMS guidance, supplemental benefits may not be a Part A or Part B covered service, must be primarily health related in that “the primary purpose of the item or service is to prevent, cure or diminish an illness or injury,” and the plan sponsor must incur a non-zero cost for the benefit. Medicare Managed Care Manual, Ch. 4, Sec. 30.1. Within the draft 2019 Call Letter, released on February 1, 2018, CMS proposes to expand the scope of items and services considered “primarily health related” to now include items and services to help maintain health status and not only those that “prevent, cure or diminish illness or injury.” According to CMS, under its new interpretation, in order for a service or item to be primarily health related “it must diagnose, prevent, or treat an illness or injury, compensate for physical impairments, act to ameliorate the functional psychological impact of injuries or health conditions, or reduce avoidable emergency and healthcare utilization.” Current CMS guidance explicitly excludes from being a supplemental benefit those items or services which are solely for daily maintenance purposes.  CMS’s broadened definition follows medical and health care research studies which have shown the value of certain ‘maintenance’ items and services in diminishing the effects of injuries or health conditions and decreasing avoidable emergency and health care services.

While broadening the scope of items and services eligible to be considered supplemental benefits, CMS concurrently proposes to add a more stringent standard to an enrollee’s receipt of such benefits. “Supplemental benefits under this broader interpretation must be medically appropriate and ordered by a licensed provider as part of a care plan if not directly provided by one.” Although current guidance specifies medical necessity as a standard for supplemental benefits that extend the coverage of original Medicare, there is no requirement that supplemental benefits be ordered by a licensed provider. Depending upon the nature of the supplemental benefit, such a rule could prevent an enrollee from accessing certain benefits. For example, plan sponsors may provide acupuncture or other alternative therapies as supplemental benefits, but enrollees would only be able to access such services if their provider accepts the value of such services and agrees that they are medically necessary. Given that many in traditional medicine do not support the use of alternative therapies, it is likely that at least some enrollees will be unable to access these benefits under this newly proposed standard.  Also, requiring a provider to review and order other types of supplemental benefits would likely create a paperwork burden with no benefit, including, for example, with respect to a supplemental transportation benefit, fitness benefit or over-the-counter drug benefit.

Although CMS should be applauded for seeking to expand the definition of “health related” in identifying eligible supplemental benefits, its proposal to require that such benefits be ordered by a provider as part of a treatment plan will decrease plan flexibility and increase burden for providers and enrollees alike, with minimal benefit.

CMS is accepting comments on the draft Call Letter through 6pm EST, Monday March 5, 2018.

On January 5, 2018, consistent with the 21st Century Cures Act’s focus on creating interoperability and correspondingly a Trusted Exchange, the Office of the National Coordinator for Health Information Technology (“ONC”) released its “Draft Trusted Exchange Framework” (“Draft Framework”).  The Draft Framework is intended to streamline the exchange of Electronic Health Information (“EHI”) so that both health care providers and patients have better access to health information, thus improving communication and quality health care.  EHI includes information beyond protected health information, such as health information from other consumer driven devices.  ONC has asked for public comments; the comment period is open until February 18, 2018.

ONC’s Draft Framework develops a mechanism to connect Health Integrated Networks (“Qualified HINs”) across the country. The ONC intends to select a single Recognized Coordinating Entity (“RCE”) through a competitive bidding process, which will be open in the spring of 2018.  The RCE’s responsibilities will be to develop the Common Agreement and operationalize the Trusted Exchange.  The Draft Framework includes the Principles of a Trusted Exchange (Part A) and the minimum terms and conditions that will be required for a Trusted Exchange (Part B) (the contractual terms that operationalize the principles of Part A).

The Draft Framework sets a number of conditions on Qualified HINs, some of which may require more direct interaction with patients than currently exists, or may require the Qualified HIN to disclose information that might otherwise be considered proprietary to the Qualified HIN. The biggest takeaways from the Principles (Part A) are:

  • Qualified HINs will be expected to use standards adopted or recognized by ONC’s Health IT Certification Program and Interoperability Standards Advisory (“ISA”) or industry standards readily available to all stakeholders;
    • Participants of Qualified HINs that provide services and functionality to providers are expected to follow the 2015 Edition Health IT Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modification final rule (“2015 Edition final rule”), and associated guidance for the certification of health IT; and
    • Qualified HINs and participants will be expected to implement processes that encourage more “person-centered” care;
  • Qualified HINs will be required to operate openly and transparently by:
    • Making terms and conditions for participation publicly available;
    • Supporting permitted uses and disclosures of EHI. Qualified HINs that only support HIPAA Treatment purpose exchanges, may want to support additional permitted purposes;
    • Making their privacy practices publicly available;
  • Qualified HINs must cooperate with and not discriminate among the various stakeholders across the continuum of care by not implementing policies, procedures, technology or fees that will obstruct access and exchange of EHI between other Qualified HINs, participants, and end users;
  • Qualified HINs must exchange EHI securely and in a manner that preserves data integrity by:
    • Including appropriate information to ensure the correct matching of individuals to their EHI; and
    • Ensuring providers and other organizations are confident that appropriate consents and authorizations have been captured;
  • Qualified HINs must ensure that individuals have easy access to their information by:
    • Ensuring full and consistent access to information; and
    • Having policies in place to allow an individual to withdraw or revoke his or her participation in the Qualified HIN; and
  • Qualified HINs will be expected to support the ability for participants to pull and push population level records—bulk transfer—in a single transaction rather than transmit one record at a time.

The Draft Framework is ONC’s most significant push toward interoperability among electronic health care systems and most likely will affect all stakeholders in the health IT industry and their participants at some point.

At this point, it’s not really ground-breaking news that America has a problem with opioid drugs. By way of anecdote, when I became a federal prosecutor in 2011, the last heroin case that had been prosecuted in the Nashville U.S. Attorney’s office was in the early-1990s; although, to be fair, there were then lots of what we called “pill” cases involving opioids. When I left the office in 2017, at least half of the office’s major investigations were directly related to opioids–some pills, but mostly outright heroin or fentanyl/carfentanyl . In Nashville, Tennessee, OxyContin (which is an opioid-based painkiller) can be worth up to $1.25/milligram (mg). That means that just one 80mg OxyContin has a street value of $100. Price, is of course, a reflection of demand and demand, in this case, is driven by addiction.

That addiction is costing Americans a lot of money. The White House estimates that in 2015, over 33,000 Americans died from opioid related overdoses and that the economic cost of the opioid crisis was $504.0 billion, or 2.8% of GDP. To put that in some perspective, 2015 U.S. healthcare spending accounted for 17.7% of GDP, which means that Americans spent ~1/6 as much on opioids as they did on healthcare. State governments, often stuck footing the bill for indigent addicts because of increased law-enforcement activity and drug/medical treatment, are looking at the opioid manufacturers and distributors to help pay some of this cost.

In September, 41 state attorneys general announced serving subpoenas on 6 opioid manufacturers as part of a multi-state investigation into whether the companies engaged in any unlawful practices in the marketing and distribution of prescription opioids. The attorneys general are also looking into the distribution practices of 3 pharmaceutical distributors that account for the distribution of roughly 90% of the U.S. opioid supply. According the N.Y. State AG, opioid distributors alone make nearly $500 billion a year in revenue, but those numbers (perhaps as a result of the market response to the negative publicity generated by all of this) might not be as robust as they once were. Stock prices (many of these companies are privately held) for two of the manufacturers subject to the AG subpoenas have seen stocks nose dive by ~90% and ~75% respectively after both achieving all-time highs in 2015. Of course, the reason for those drops is likely non-singular, but the timing does perhaps signal the market’s appetite for risk.

So, obviously, if you are an AG looking to combat a public health disaster, going after the manufacturers of opioids (who, at least in 2015, had lots of money), much like the manufacturers of tobacco is pretty appealing. That said, there are some considerations that are likely to be major impediments in the effort to make this into a big tobacco settlement:

  1. Prescription pills are prescribed by a medical doctor. Unlike the pack of cigarettes bought at the gas station from a clerk whose only responsibility is to verify age, opioids are, ostensibly, ordered by someone with years of advanced medical training. Pinning all the responsibility (or even just “most of it”) on manufacturers and distributors alone will be a challenge.
  2. The success of the tobacco litigation was driven in no small part by the efforts of Richard “Dickie” Scruggs, the exceptionally well-connected Mississippi lawyer who spearheaded the class-action effort and coalesced all the states into letting him be the point-man for all negotiations. Much of what made Scruggs successful in that effort–1) the self-proclaimed advantage of home cookin‘; 2) the ability to wheel and deal in the Capital thanks to his access to then Senate Majority Leader, and brother-in-law, Trent Lott; 3) the close relationship with then Mississippi Attorney General Mike Moore (who, coincidentally, is advocating for the opioid suit, this time as a plaintiff’s attorney)–is unlikely to fly in today’s world given the guttural uneasiness associated with any of the tactics utilized by Scruggs, now a convicted felon for attempting to bribe a judge in a post-Katrina litigation, and overall discomfort with anything that smacks of nepotism.
  3. The stated goal of many of the proponents of the tobacco litigation was to put cigarette manufacturers out of business–this, of course, is a sentiment still voiced by some. But, no one is realistically seeking to litigate these pharmaceutical companies into the ground. While these companies manufacture opioids, they also research and manufacture drugs that help treat pediatric Crohn’s disease, multiple sclerosis and Parkinson’s disease, among others. Simply, even if there is a settlement in all of this, the reality is that the settlement is likely to contemplate the ability of these companies to continue to research and manufacture the next wave of pharmaceutical improvements.

On December 14, the Federal Communications Commission (FCC) voted to remove regulations that prohibit providers from blocking websites or charging for high quality service to access specific content. Many worry that allowing telecommunications companies to favor certain businesses will cause problems within the health care industry. Specifically, concerns have risen about the effect of the ruling on the progress of telemedicine and the role it plays in access to care. Experts worry that a tiered system in which service providers can charge more for speed connectivity can be detrimental to vulnerable populations.  Although the ramifications of the ruling are not entirely known, an exception for health care services would ensure that vulnerable populations can continue to gain access to care.

Telemedicine is often used as a tool to improve care by providing access to those who wouldn’t ordinarily have access to care. Through video consultation, patients have the ability to check-in with health care providers and access health specialists. Robust connectivity is vital for these services and community providers, and rural areas may lack the financial means to pay for optimal connectivity in a tiered framework.

In the past, the FCC recognized the importance of broadband connectivity to the health care industry. In 2015, the FCC‘s Open Internet Order acknowledged that health care is a specialized service that would be exempt from conduct based rules.  However, the new rule may undermine the 2015 Order and thus leave vulnerable populations at risk.

Moreover, the technology industry would likewise benefit from a health services exception. Innovation in health care delivery could be stifled by the FCC ruling and hurt the population as a whole. From tech start-ups to access-to-care advocates, various members of the health care ecosystem may need to anticipate building coalitions and urge the FCC to create an exception for health care services.