Category: Health

Hungry for Change: ASA and Government Target Junk Food Ads

With childhood obesity rates in the UK among some of the worst in Europe, the Government has set a national target to halve childhood obesity by 2030. Whilst the Government acknowledges that this is a multi-faceted problem, it has reported that evidence suggests that children’s exposure to advertising of products that are high in fat, salt and/or sugar (“HFSS”) contributes to their consumption patterns.

HFSS product advertising is currently subject to content and placement restrictions under the Committees of Advertising Practice (“CAP”) broadcast and non-broadcast codes of advertising (“Codes”); however, campaigners and industry bodies have raised concerns that adverts are not being targeted correctly and that the existing rules do not go far enough. The Advertising Standards Authority (“ASA”) and the Government have taken steps in recent months to address these issues, with the ASA launching a monitoring exercise on targeted ads and the Government consulting on options to reduce children’s exposure to HFSS ads.

The rules

Each of the Codes contains rules dealing with adverts that are directed at or feature children, as well as specific rules in relation to advertising HFSS products, whether directly or indirectly. The restrictions include:

  • a prohibition on the use of licensed characters and celebrities popular with children in ads for HFSS products where the ad is targeted at under 12s;
  • in relation to broadcast TV, a prohibition on HFSS products being advertised “in or adjacent to programmes commissioned for, principally directed at or likely to appeal particularly to audiences below the age of 16”; and
  • in relation to ads placed in children’s media, “HFSS product advertisements must not be directed at people under 16 through the selection of media or the context in which they appear. No medium should be used to advertise HFSS products, if more than 25% of its audience is under 16 years of age”.

ASA monitoring

Although compliance with the Codes by advertisers is generally high, the ASA recently published the results of a ‘compliance sweep’ that used online avatars to monitor ads for HFSS products that were served to children. Similar technology was used earlier this year to track brands that breached CAP’s gambling rules on advertising to under 18s, which we reported on in April.

The avatars replicated the browsing habits of children of various ages and collected information about HFSS adverts appearing on children’s websites and on YouTube. The monitoring exercise found that the vast majority of HFSS ads on children’s websites were being targeted correctly; however, potential issues were identified in relation to HFSS ads being served on YouTube.

Moving away from its typically ‘reactive role’, the ASA took proactive action to notify a number of non-compliant brands which were each required to take steps to prevent further breaches, including making improvements to their targeting approach.

Government consultation

Despite strong compliance by the industry, the Government is still considering further advertising prohibitions and earlier this year launched a consultation in which it sought views on options to further reduce children’s exposure to HFSS in broadcast and online media, including the introduction of a 9pm watershed. Other options included a ‘ladder’ system for advertising restrictions on broadcast TV, the strengthening of current targeting restrictions for online advertising and a mixed option for online advertising consisting of a watershed for video and additional targeting restrictions for other types of marketing.

Whilst the watershed proposals have received extensive support from campaign groups such as The Children’s Food Campaign (Sustain) and the Obesity Health Alliance, the ASA and the Institute of Practitioners in Advertising have both stated that the proposed changes would be ineffective and disproportionate, particularly given the high level of compliance with the HFSS rules in the Codes.

Steps to take

The ASA has stated that it will carry out further compliance sweeps in future, and so advertisers should take care to continue to comply with the Codes.

Anyone advertising in the area should also make use of any available tools which allow the targeting of ads so as to restrict children and young people from seeing adverts for HFSS products. Advertisers must also ensure that terms with their media buyers are sufficient to guarantee that targeting has been put in place correctly. As with labelling or other regulated industries such as financial services, agencies may wish to make clear that responsibility for compliance with these specialist rules lies with their clients (in particular if an assessment as to whether a product is indeed HFSS is required).

 

© Copyright 2019 Squire Patton Boggs (US) LLP

Drone Delivers Human Kidney for Transplant

Last month, a University of Maryland unmanned aerial system (UAS or drone) delivered a donor kidney to surgeons at the University of Maryland Medical Center (UMMC) in Baltimore for an ultimately successful transplant to a patient with kidney failure. The drone flew 2.6 miles in approximately 10 minutes.

This University of Maryland project is important to determine whether this process of delivery works; if it is a proven system of delivery, unmanned organ transport can potentially be done at much greater distances. This would minimize the need for multiple pilots and flight time and address safety issues.

The drone flight was monitored by AiRXOS Air Mobility Platform, which manages the volume, density and variety of UAS traffic data for safe operations while functioning as an apparatus for maintaining and monitoring a viable human organ.

 

Copyright © 2019 Robinson & Cole LLP. All rights reserved.
This post was written by Kathryn M. Rattigan of Robinson & Cole LLP.

340B Drug Ceiling Prices Now Available

On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site).  Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa.gov/

Since the creation of the 340B program in 1992, participating covered entities could not verify whether they received the correct price for medication purchased through the program. In 2010, as part of the Patient Protection and Affordable Care Act, Congress directed HRSA to create a secure database that lists the 340B ceiling price.   Nearly nine years later, HRSA launched the 340B Ceiling Price Site which allows covered entities to now access verifiable 340B drug pricing information.

The 340B ceiling price is statutorily defined as a drug’s average manufacturer price (AMP) of a drug reduced by the unit rebate amount (URA).  The URA is calculated by dividing the drug’s Medicaid drug rebate amount (DRA) by the AMP.  The 340B ceiling price can be calculated as AMP – (DRA/AMP).

To populate the 340B Ceiling Price Site, HRSA obtains AMP and URA information from the Centers for Medicare and Medicaid Services (CMS), as well as a third-party drug pricing publisher, First Databank.   Manufacturers are also tasked with providing pricing information to HRSA during quarterly price reporting windows, which will last for two weeks each calendar quarter. If there is a discrepancy between HRSA’s data and manufacturer reported data, the manufacturer may either: (1) accept HRSA’s data as its own, (2) refuse to edit the manufacturer data and provide explanations for each discrepancy, or (3) edit the manufacturer data and provide reasoning for any remaining discrepancies.  After resolving pricing discrepancies, HRSA will publish the calculated 340B ceiling price to the 340B Ceiling Price Site.

Covered entities’ access to the 340B Ceiling Price Site is limited to the covered entity’s authorizing official (AO) and primary contact (PC).  AOs and PCs are strictly prohibited from sharing 340B pricing information outside of their organization and from exporting pricing information from the 340B Ceiling Price Site. They must attest to their compliance with these obligations each time they log into the 340B Ceiling Price Site.

Although the 340B Ceiling Price Site provides covered entities with valuable pricing information, covered entities are reminded that the price they pay for 340B-eligible drugs could differ from the 340B ceiling price depending upon the covered entity’s wholesale pricing contract terms. The price paid for 340B eligible medications may vary for a number of reasons, including wholesale cost-minus/plus calculations and the availability of sub-340B ceiling pricing for drugs through the 340B Prime Vendor Program.

 

© 2019 Dinsmore & Shohl LLP. All rights reserved.
Read more drug pricing news on the Health Care type of law page.

Maryland Proposes New Telehealth Psychology and Therapy Rules

Two Maryland licensing boards – the Board of Examiners of Psychologist and the Board of Professional Counselors and Therapists – issued a pair of proposed rules setting forth practice standards for mental health services delivered via telehealth technologies. The Boards previously did not have specific practice standards or rules unique to telehealth. Once finalized, psychologists, counselors, and therapists using telehealth in their services should read and apply these new requirements to their operations and service models.

The proposed rules closely mirror each other. Both apply to professionals delivering care to patients located in Maryland. Both allow a wide range of modalities, defining telehealth as the “use of interactive audio, video or other telecommunications or electronic media,” but excluding an audio only telephone conversations, email, fax or text.  Both rules prohibit treatment based solely upon an online questionnaire.

The Board of Professional Counselors and Therapists rule allows therapists to conduct the initial patient evaluation via telehealth. The Board of Psychology rule requires an in-person initial evaluation unless the psychologist or psychologist associate documents in the record the reason for not meeting in person. (The rule doesn’t enumerate a list of acceptable or unacceptable reasons; it simply requires the reason to be documented.)

Professionals must confirm the identity of the client/patient, as well as the client’s location and contact information. The professional must also identify contact information for emergency services at the client’s location. Curiously, the rule issued by the Board of Professional Counselors and Therapists refers to the client’s location as the “practice setting.” While this could raise a suggestion that the client must be physically located in a clinical practice setting, it is more likely a drafting error because there is no mention of any originating site requirements in the rule.

Professionals must also identify everyone at the client’s location and confirm those individuals are permitted to hear the client’s health information. The use of the term “permitted” as opposed to “authorized or “legally authorized” and the absence of reference to any state or federal privacy law, suggests another person’s presence is subject to the client’s permission and not legal authority.

With regard to client consent to telehealth services, the Board of Psychology rule requires “written informed consent,” whereas the Board of Professional Counselors and Therapists rule requires the client’s “written and oral acknowledgement.” Both rules state that the standard for services delivered via telehealth is the same as services delivered in-person.

The Boards are considering comments and Maryland providers are awaiting the final regulations.  We will continue to monitor further developments including the passage of these final rules and any changes.

 

© 2019 Foley & Lardner LLP
This post was written by Emily H. Wein and Nathaniel M. Lacktman of Foley & Lardner LLP.

Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers

U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning Letters”). In just the last week, the USAO for the Eastern District of Wisconsin sent warning letters to over 180 prescribers identified by Drug Enforcement Administration (“DEA”) data as prescribing opioids at relatively high levels. The Food and Drug Administration and the Federal Trade Commission have also been issuing their own warning letters to opioid marketers and distributors over the past several months, evidencing a concerted effort to combat the opioid epidemic on a number of fronts through various federal enforcement and regulatory efforts.

The Warning Letters appear to be based entirely on review and analysis of DEA’s data with no other investigation into the patients who received opioid prescriptions or their medical conditions. Importantly, each of these USAOs has recognized explicitly that the prescribers have not necessarily broken any laws and that the prescriptions may all be medically appropriate. Nevertheless, any warning from an office wielding criminal enforcement authority should never be taken lightly, particularly when related to an issue – opioid overprescribing – that remains a top Department of Justice and U.S. government enforcement priority. While the Warning Letters themselves are issued without meaningful investigation, they may often signal that additional investigatory or enforcement action is forthcoming. In some cases, for instance, prescribers may be visited unannounced and in-person by DEA diversion investigators, special agents, or other law enforcement officers.

Prescribers who have already received a Warning Letter should contact legal counsel to assist in taking measures to assess their degree of risk and preparing for potential further government inquiry. Contacting legal counsel early and preserving privilege could be key to prevent an informal inquiry from becoming a protracted criminal investigation. Experienced counsel can help focus the government’s inquiry, provide the information in a manner that is responsive to the government’s request while also providing relevant context, and limit disruption to the provider’s practice. In collaboration with their counsel, contacted Prescribers should consider:

  • An audit of medical records related to patients who have received opioid prescriptions to confirm their propriety in light of medical documentation;
  • Correction and supplementation of any deficient records, consistent with government requirements for medical documentation to support such prescriptions; and
  • Implementing any required process improvements to mitigate future risk.

Prescribers who prescribe opioids as part of their practices but who have not received a Warning Letter should consider taking prophylactic measures in response to this increased government scrutiny, as should their employers and partners. For instance, Prescribers – and those who employ or contract with prescribers – should consider:

  • Reviewing prescribing patterns against local and national benchmarks;
  • Reviewing a sample of documentation related to opioid prescription decisions to ensure that it sufficiently supports medical necessity and provides additional training on documentation practices as needed;
  • Reviewing and implementing the most current standards of care related to opioid prescribing and patient monitoring, including recommendations issued by the Centers for Disease Control and Prevention’s Guideline for Prescribing Opioids for Chronic Pain; and
  • In larger practices, implementing or updating, as necessary, policies and procedures related to opioid prescribing.
Copyright © 2019, Sheppard Mullin Richter & Hampton LLP.
This post was written by Erica J. Kraus, Michael W. Paddock, David L. Douglass, Danielle Vrabie and A. Joseph Jay, III of Sheppard Mullin Richter & Hampton LLP.
Read more health care compliance news on the National Law Review’s Health Care Type of Law page.

Health Care Enforcement 2019: How 2018’s Enforcement Actions Can Shape Your Compliance Plan

While it’s impossible to predict what government enforcement officials are currently working on, the trends from 2018 provide strong guidance for planning compliance efforts in 2019. In fact, 2018 was another busy year for the Department of Justice (the DOJ) and the Office of the Inspector General for Health and Human Services (the OIG). The following are some notable enforcement trends that may be helpful in planning your 2019 compliance initiatives.

Anti-Kickback and Physician Self-Referral Law Enforcement

One of the most notable trends in the last several years is the prevalence of False Claims Act cases premised on physician compensation relationships that are alleged to violate the Physician Self-Referral Law (Stark) and/or the Anti-Kickback Statute (the AKS). Here is a summary of a few exemplary cases that were resolved in 2018:

  • The University of Pittsburgh Medical Center Hamot was alleged to have entered into medical director or administrative services contracts with twelve physicians that violated both Stark and the AKS. The government contended that there was no legitimate need for the agreements because the services were either not performed or were duplicative in that they were already being provided by other physicians who were not being paid. The case was resolved for $20.75 million.

  • Montana-based Kalispell Regional Healthcare System (KRH) was alleged to have paid excessive full-time compensation to 60 specialists, many of whom worked less than full-time, to induce referrals. In addition, a subsidiary of KRH allegedly provided administrative services at below fair market value to a hospital joint venture owned by both the KRH subsidiary and an affiliated physician group in order to reduce expenses and increase the profits for the physician investors as a means of inducing referrals. The whistleblower was the CFO of the physicians’ network for the health system. The allegations were resolved for $24 million.

  • Detroit’s William Beaumont Hospital paid $85.5 million to resolve the allegations made by four whistleblowers that Beaumont paid compensation substantially in excess of fair market value to physicians and provided office space and employees at below fair market value to physician groups. Specifically, the allegations made by the whistleblowers included:

    • Full-time salaried cardiologists were paid in excess of fair market value as evidenced by the fact that they also continued to maintain separate private practices from which they retained the compensation;

    • The hospital provided office space and leased employees to the physicians’ practices at less than fair market value; and

    • 56 salaried medical directorships and other leadership positions had no job descriptions, no performance standards, no metrics, and no recorded evidence of any activities in exchange for the payment and were above fair market value. Some physicians in these positions also maintained full-time private practices.

The settlement also resolved claims that Beaumont allegedly misrepresented that a CT radiology center qualified as an outpatient department of Beaumont.

False Claims Enforcement Related to Medical Necessity

Cases involving medically unnecessary services continue to be a significant focus for the DOJ. Importantly, the legal community awaits a long-pending decision by the 11th Circuit Court of Appeals that may impact the government’s ability to bring FCA cases based on a lack of medical necessity. In U.S. ex rel. Paradise vs. AseraCare (Docket No. 16-13004), the trial judge found that the government could not bring FCA claims against a hospice provider for medically unnecessary services. The judge reasoned that, because determinations of medical necessity are subjective medical determinations, the government’s expert testimony that patients were not terminally ill (and, therefore, the services were not medically necessary) was insufficient to establish that the claims were false. The government argued that determining the falsity of hospice claims does not rest simply on two conflicting expert opinions on subjective medical determinations. Rather, the government contended that the expert testimony goes to the more objective determination of whether the medical records contained clinical information and documentation to support the patient’s terminal prognosis.

Despite the pending 11th Circuit decision, several significant FCA cases based on medically unnecessary services were resolved in 2018. A key theme in several of these cases was that, when there was a vendor or supplier providing the services in a hospital or skilled nursing facility, the government pursued both entities for submitting false claims or causing false claims to be submitted. Therefore, effective compliance programs must monitor the medical necessity of services provided by any vendor or supplier. The following are several representative examples of resolutions involving medically unnecessary services:

  • Two cases were resolved in which the government contended that the hospitals billed Medicare for medically unnecessary inpatient stays, when less expensive outpatient or observation care could have been provided. Banner Health settled for $18 million and Prime Healthcare Services settled for $65 million.

  • Healogics settled allegations that it caused the submission of claims for medically unnecessary hyperbaric oxygen (HBO) therapy. Healogics managed hospital-based wound clinics and was alleged to have caused those clinics to submit claims for medically unnecessary HBO therapy. The case settled for $22.5 million. In addition, the OIG issued an audit report (A-01-15-00515) in 2018 concerning medically unnecessary HBO therapy. Medicare only pays for HBO therapy for diabetic patients that meet certain coverage criteria. The OIG audit found that a significant portion of HBO claims it analyzed were not supported by sufficient documentation that the beneficiary met the coverage criteria for diabetic patients.

  • The government continues to aggressively pursue medically unnecessary rehabilitation services provided by long term care facilities. Signature HealthCARE paid $30 million to resolve allegations of medically unnecessary rehabilitation claims caused by presumptively placing patients in the highest therapy reimbursement category rather than individually evaluating patients to determine the level of need and by pressuring therapists to complete planned therapy minutes even when the patients were ill or declined treatment. Similarly, Southern SNF Management, Rehab Services in Motion, and several skilled nursing facilities where they provided therapy services, paid $10 million to resolve allegations related to medically unnecessary therapy.

  • A post-acute medical management company and four hospitals paid $1.7 million to resolve allegations that they provided medically unnecessary intensive outpatient psychotherapy to patients.

Opioid-Related Enforcement

Opioid-related enforcement continues to be a major focus of DOJ. Most states now have an opioid task force that includes the DOJ and federal and local law enforcement. The DOJ’s 2018 national “health care fraud takedown” announced a significant number of opioid enforcement matters. Most of these were criminal “pill mill” type cases focused on providers unlawfully distributing of controlled substances, including opioids. As part of the takedown, the U.S. Attorney’s Office for the Eastern District of Wisconsin announced the indictment of an advanced nurse practitioner and several other individuals related to a cash-only pain clinic for conspiring to distribute oxycodone and methadone outside of professional medical practice and not for legitimate medical purposes.

The DEA continues to be a significant player in opioid enforcement related to institutional providers. In August, the DEA announced a $4.3 million civil settlement with the University of Michigan Health System primarily related to violations of the Controlled Substances Act’s (CSA) record-keeping requirement. After the opioid overdoses of two UMHS providers (one of which was fatal), the DEA conducted an investigation and concluded that a number of the hospital’s practices concerning controlled substances were in violation of the CSA. For example, UMHS failed to secure DEA registrations for 15 off-site ambulatory care locations, each of which received narcotics from the main hospital’s pharmacy and dispensed them to patients. The DEA also determined that UMHS failed to maintain complete and accurate records of certain controlled substances that it received, sold, delivered or otherwise disposed of, and failed to notify the DEA in a timely manner regarding certain instances of thefts or significant losses of controlled substances. It is note-worthy that the DEA has had a number of significant settlements in recent years related to providers failing to timely notify it of thefts or losses of controlled substances.

The Department of Health and Human Services (HHS) is also adding to the conversation of opioid related enforcement. In June, HHS’s Office of Evaluations and Inspections (OEI) issued a data brief concerning opioid use in Medicare Part D that ultimately focused on prescribers who issued an aberrant number of opioid prescriptions. OEI identified Medicare Part D beneficiaries receiving large numbers of opioid prescriptions and then drilled down to the prescribers issuing those prescriptions. The report concluded that, based on the data analyzed, there were 282 prescribers that stood out for questionable prescribing. The report specifically identified providers who ordered opioids for a high number of beneficiaries with non-cancer diagnoses who were receiving “extreme” amounts of opioids and those providers who wrote prescriptions for beneficiaries that the data showed the patient was likely doctor-shopping. It is likely that the OIG is looking further into the providers identified by OEI’s data analysis.

Yates Memo Revisions

After the change in administrations, there was a lot of buzz about comments from DOJ officials that the Yates Memo (officially, the “Memorandum on Individual Accountability for Wrongdoing”) was being “reviewed.” Recently, Deputy Attorney General Rod Rosenstein announced the results of that review but the changes are likely to be considered only minor adjustments or clarifications, rather than the hoped-for large-scale revisions. For criminal liability, the revisions clarify that companies seeking cooperation credit must identify every individual who was substantially involved in or responsible for any criminal conduct, rather than every employee involved regardless of relative culpability. Further, the revisions to the policy for civil cases recognizes that civil cases primarily target the recovery of funds and that pursuing all employees involved in wrong-doing may not be an efficient use of resources. As a result, the new policy makes clear that cooperation in a civil case is not an “all or nothing” proposition and that a company that identifies senior management but not lower level employees involved in wrongful conduct may qualify for at least partial cooperation credit.

HIPAA Enforcement

The penalties for violations of the Health Insurance Portability and Accountability Act (HIPAA) continue to stiffen. While providers for many years were focused on implementing HIPAA policies and procedures, the enforcement trends suggest the growing importance of rigorous audits and enforcement of those policies. The following are representative examples:

  • University of Texas MD Anderson Cancer Center (MD Anderson) was found to have violated HIPAA’s Privacy and Security Rules by an administrative law judge and ordered to pay $4,348,000 in civil money penalties. OCR investigated MD Anderson following three separate data breach reports in 2012 and 2013 involving the theft of an unencrypted laptop of an MD Anderson employee and the loss of two unencrypted USB drives containing the electronic protected health information (ePHI) of over 33,500 individuals. OCR’s investigation found that MD Anderson had written encryption policies as far back as 2006 and that MD Anderson’s own risk analyses had found that the lack of device-level encryption posed a high risk to the security of ePHI. Despite the policies and risk analysis findings, MD Anderson did not begin to adopt an enterprise-wide solution to implement encryption of ePHI until 2011 and failed to encrypt its inventory of electronic devices containing ePHI until 2013.

  • In February, a physician in Massachusetts pleaded guilty to a misdemeanor count of wrongful disclosure of individually identifiable health information in violation of HIPAA. The physician allowed a pharmaceutical sales representative to access the confidential medical information of patients to identify potential candidates for one of the pharmaceutical company’s drugs.

Conclusion

One of the hallmarks of an effective compliance program is to regularly engage in an assessment of the risks faced by the organization. One method of assessing those risks is to be familiar with the recent enforcement trends and evaluate whether those trends apply to the organization. Based on the past year, financial relationships with physicians and the medical necessity of services billed to Medicare and Medicaid are enforcement risk areas and should be considered for incorporation into compliance planning. As noted above, the evaluation of the medical necessity of services should not be limited to those provided internally as the government has sought to impose liability for services provided by external business partners. Moreover, with the ongoing and significant impact of the opioid epidemic on the country, law enforcement will undoubtedly continue to be focused on enforcing the Controlled Substances Act. Finally, while for many years providers have been focused on implementing HIPAA policies and procedures, the enforcement trends suggest that the focus needs to shift to ensuring that those policies and procedures are monitored and enforced to avoid exposure to increasing penalties.

 

©2019 von Briesen & Roper, s.c.
Read more health legal news on the National Law Review’s Health Page.

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify a regulatory provision that had previously protected certain pharmaceutical manufacturer rebates from criminal prosecution and financial penalties under the federal Anti-Kickback Statute.

Specifically, the Proposed Rule would exclude from “safe harbor” protection rebates and other discounts on prescription pharmaceutical products offered by pharmaceutical manufacturers to Medicare Part D plan sponsors or Medicaid Managed Care Organizations (MCOs), unless the price reduction is required by law (such as rebates required under the Medicaid Drug Rebate Program). The proposed exclusion would apply to rebates offered directly to Part D plan sponsors and Medicaid MCOs, as well as those negotiated by or paid through a pharmacy benefit manager (PBM). HHS stated that it does not intend for the revisions in this Proposed Rule to negatively impact protection of prescription pharmaceutical product discounts offered to other entities such as wholesalers, hospitals, physicians, pharmacies and third-party payors in other federal health care programs. The proposed effective date of this regulatory modification is January 1, 2020, although HHS has sought comments regarding whether this allows sufficient time for parties to restructure existing arrangements.

In addition, the Proposed Rule would add two new regulatory safe harbors for:

  • Certain price reductions that are fully passed through to the dispensing pharmacy and applied to the price charged to the member at the point-of-sale; and

  • Fixed fee payments from manufacturers to PBMs for the services that PBMs provide those manufacturers. In order to be protected, the fees would have to be for services that relate to the PBM’s arrangements with health plans (e.g., services that rely on data collected from health plan customers).

These new safe harbors would become effective 60 days after HHS publishes a final rule.

The potential implications of the Proposed Rule extend beyond the context of federal Anti-Kickback Statute compliance to drug reimbursement in the United States more broadly. The proposals will likely be subject to significant public debate and legal scrutiny.

The Proposed Rule is scheduled to be published in the Federal Register on February 6, 2019, and public comments on the proposals would be due 60 days later. The Proposed Rule can be found here and the HHS Factsheet is available here.

 

© 2019 McDermott Will & Emery

Nursing Shortage Expected to Continue Through 2024: How CMS Is Easing the Burden on Hospice Agencies

The U.S. Department of Labor’s Bureau of Labor Statistics has forecast a nursing shortage through 2024, with the United States projected to need more than half a million new nurses to replace those who leave the profession. This nursing shortage stems from a convergence of factors. First, the healthcare arena has experienced an influx of new patients due to the Affordable Care Act and an aging population, increasing the demand for healthcare services. Second, many baby boomers have already reached or will soon reach retirement age. Finally, there are barriers to education for new nurses, including a lack of programs, faculty, and clinical sites to support training needs.

Extraordinary Circumstance Designation

On December 21, 2018, the director of the Quality, Safety & Oversight Group of the Centers for Medicare & Medicaid Services (CMS) issued a memorandum that officially extends CMS’s designation of the national nursing shortage as an “extraordinary circumstance.” This extension will permit hospice agencies to use contract workers to provide core nursing services through September 30, 2020.

Under 42 C.F.R. 418.64, hospice agencies “must routinely provide substantially all core services” through their own employees. Hospice agencies may use contract staff in their facilities only if there are “extraordinary or other non-routine circumstances.” These circumstances are generally unforeseen temporary events, such as “[u]nanticipated periods of high patient loads, staffing shortages due to illness or other short-term temporary situations that interrupt patient care; and temporary travel of a patient outside of the hospice’s service area.”

CMS’s designation of the nursing shortage as an “extraordinary circumstance” means that hospice agencies are exempt from the general rule requiring them to employ their own nurses to provide core nursing services. While this exemption will allow hospice agencies to hire contractors to supplement their own employee workforces, these agencies still will be responsible for all professional, financial, and administrative functions, as well as counseling, medical social services, and other core hospice services.

The memorandum also eases the paperwork burden on hospice agencies. CMS previously required that hospice agencies provide notification and a stated justification to CMS and the agency’s state survey agency whenever they used contract staff during extraordinary circumstances. Under this memorandum, the notification and justification are no longer required. Documentation, however, is still required if a hospice agency uses contract staff for other reasons and will be reviewed as part of the routine survey process.

Key Takeaways

This may be welcome news for hospice agencies struggling to care for patients, but there are some limitations these agencies may want to keep in mind. Notably, the “extraordinary circumstances” designation permits agencies to use contract staff only to supplement—not replace—their core nursing staff. Additionally, although hospice agencies may hire contract staff for core nursing functions, the exemption does not apply to other professional, financial, and administrative functions. Finally, hospice agencies should remember that they must still document their use of contract staff when it is due to a reason other than the nursing shortage.

 

© 2019, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.

As 2019 Approaches, Private Equity Investment in Health Care Shows No Signs of Slowing Down

As the year draws to a close, it’s clear that 2018 was another record year for private equity investment in health care. In its report on the top health industry issues of 2019, PWC’s Healthcare Research Institute recently highlighted the continued prevalence of private equity in health care transactions, and predicted even more private equity investment in the coming year. Below is an overview of the current and expected trends, as well as a few key considerations for private equity deals in the health care space.

Corporate health care buyers are likely to continue seeing steep competition from private equity firms… 

According to the PWC report, since 2009 the number of health care deals involving private equity buyers or sellers has tripled, and the number of deals is projected to increase further in 2019. Private equity investment in health care remains diversified and frequent, with deals ranging from health care technology to the management of physician practices. Because the health care industry is expected to continue to grow — with CMS projecting national health spending to rise to 20 percent of GDP by 2026 — investment in health care is a relatively safe bet for private equity when compared to more volatile fields like technology. Further, private equity firms tend to be more aggressive in the bid process and more willing to move deals ahead quickly.  As such, traditional health care companies seeking to acquire new lines of business face increased competition from private equity.

…but 2019 may bring additional opportunities for traditional health care companies to partner with private equity in acquisitions.

By partnering with private equity firms, health care companies can diversify their businesses while also mitigating some of the financial and operational risks that come with any deal. Partnerships between private equity and health care companies benefit from the strengths of both parties, enabling further growth while capitalizing on the health care companies’ existing expertise. Private equity firms’ willingness to invest in health care could also mean opportunities for health care companies to divest their non-core assets and refocus on their core business.

Regulatory Considerations for PE Health Care Deals

As with any highly-regulated industry, health care deals present regulatory hurdles for any prospective buyer, some of which may provide additional challenges in the private equity context.

Private equity deals often need to be structured to accommodate corporate practice of medicine (CPOM) issues. In states with CPOM prohibitions, private equity buyers cannot directly acquire medical practices. Instead, the prospective buyer would need to invest in or create a management company through which they manage the practice for a fee, which in many states is capped at a certain percentage of the practice’s revenue.

Regulatory filing requirements and the need for review and approval of deals by regulatory bodies often drive transaction timelines much longer than those to which private equity firms are accustomed. Some states can require up to 120 days’ notice prior to a change in ownership in certain health care companies. Involving regulatory counsel at the beginning of deal negotiations can help set reasonable expectations for timing while also letting the parties get a head start on the sometimes cumbersome filing requirements.

State licensing boards also often require disclosure of detailed information about the prospective ownership and management of licensed health care entities. This information can range from basic background checks to detailed financial information. While many states only require information about individuals who will be actively involved in the day-to-day operations of the health care business, some states require information about anyone with a five percent or greater ownership in the business, which sometimes requires an examination of ownership held by controlling entities, including parent, grandparent and great grandparent companies. Private equity firms should take this into consideration and consult with regulatory counsel about potential disclosure requirements and the feasibility of providing the required information when structuring deals.

Private equity activity in the health care industry presents many evolving opportunities and challenges, but one thing remains clear as 2018 winds down: growth in health care investment is full speed ahead.

©1994-2018 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.
This post was written by Cassandra L. Paolillo of Mintz.

Medical Products & FDA: What to Watch for in 2019

Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar spent on products ranging from heart valves to insulin to breakfast cereal, so there’s always something Congress can do in the realm of FDA’s statutory authorities. Many FDA-related bills are often bipartisan, too, which suggests action despite different parties in power in the House and Senate. Here are a few key medical product issues we’ll be tracking in 2019.

Laboratory Developed Tests (LDTs)

An LDT is a type of in vitro diagnostic test that is designed, manufactured, and used within a single laboratory. In recent years, FDA has attempted to more actively regulate LDTs, claiming they are more complex now than when the agency was granted authority to regulate devices in the 1970s (FDA had, until recently, generally ignored LDTs using a policy known as enforcement discretion). A few years ago, the agency published a proposed approach that caused a stir in Congress and the lab industry and after years of debate Congress seems ready to act on LDTs, which some are now calling In Vitro Clinical Tests (IVCTs). However, New Jersey Democrat Frank Pallone, the likely incoming chairman of the House Energy & Commerce Committee has expressed concern with FDA’s proposed approach to IVCT regulation, especially its heavy reliance on review by accredited persons (i.e., third party review) and pre-certification. FDA’s position was outlined by Commissioner Scott Gottlieb, who in a September 2018 speech stated that FDA envisions reviewing only 10% of IVCTs, 40% would use the pre-certification model, and the remainder would not be subject to FDA premarket review.

Who blinks first? Based on my experience at FDA, the agency is likely to wait for Congress to make the first move largely because FDA went all in by submitting 59 pages of “technical assistance”—essentially a draft bill—to Congress in August 2018. A Democrat-controlled E&C may push for more oversight or a phased-in approach, which is something FDA has resisted. Sure to further complicate discussions is the role of user fees in funding an IVCT regulatory program. Among the questions that need to be answered: how much IVCT oversight will FDA have relative to third parties, how much will that cost, and who’s paying the bill? As a former user fee negotiator for FDA, I can tell you those conversations are not going to be easy.

Digital Health

FDA’s exploration of a new regulatory paradigm for digital health products hit a bump in the road on October 10 when Senators Warren, Murray, and Smith (all Democrats) sent a letter to FDA asking, among other things, what the legal basis is for the digital health pre-cert program. Because FDA does not have the staff capacity or expertise to review all digital health products (including software), part of its solution is to rely on certifications that a product developer has a culture of quality and organizational excellence. FDA also says the current review paradigm is not well-suited to software and similar products that have fast, iterative development cycles. This idea has merit but the details need to be hammered out—likely in statute. And while 2019 is too early to expect legislation, the October 10 letter foreshadows intense scrutiny from HELP Committee Democrats. The agency is still collecting comments on its proposed framework.

Medical Device Cybersecurity

FDA recently made a splash with its cybersecurity playbook and a recently updated premarket cybersecurity guidance. However, while I was at FDA we responded to a lot of requests for technical assistance from both sides of the aisle on legislative language that would: mandate convening stakeholders to recommend guidelines for improving cybersecurity of devices, mandate software bills of materials, or provide basic cybersecurity operational standards for Internet-connected devices, among other ideas. The jury is out on how much any of these ideas would meaningfully improve the nation’s cybersecurity infrastructure at least as it pertains to medical devices. Considering cybersecurity is a hot topic in other contexts (e.g., election security, personal computing), the 116th Congress will likely continue to look for legislative wins in this space and we’ll be watching closely to see what the impacts could be on medical products.

Device Servicing

FDA continues to look for a solution to problematic device servicing and will be holding another public meeting in December 2018. While we’re optimistic FDA will come out of that meeting with a draft policy (the agency said it plans to issue a draft guidance document before October 2019), we see challenges with some of the ideas mentioned in a discussion paper the agency released in October 2018. Even as FDA reviews public comments and publishes guidance, there could be a role for Congress, such as to ensure appropriate oversight of servicing through mandated inspections. We’re looking forward to seeing how interaction between OEMs, servicers, and FDA at the December workshop could influence the draft guidance.

OTC Monograph Reform

As noted in our Lame Duck Preview for health issues, OTC monograph reform legislation passed the House but awaits action in the Senate, where it’s stuck in committee. An OTC monograph is like a recipe for an over-the-counter drug that, once approved by FDA, can be used by any drug manufacturer without FDA pre-approval of the manufacturer’s specific drug. The bill would speed up the regulatory process for OTC monographs by allowing use of administrative orders rather than rulemaking. Both bills authorize FDA to grant exclusivity for the monograph developer, which would protect market access, though the amount of exclusivity differs (18 months in the House bill; 24 months in the Senate bill). Likely incoming House E&C Chairman Pallone is—again—who we’re looking to regarding action on this. Despite voting for the House version, it is well-known that Rep. Pallone has concerns about the exclusivity provision. The OTC monograph process has not changed since 1972 and reform efforts have been brewing for a while; if this does not move in the lame duck, this could be in play in 2019.

Opioids

Congress passed major opioids legislation in September 2018 so while Congress may shift its focus to other issues, we’ll be keeping an eye on how the administration is implementing its mandates. FDA in particular has as full plate with:

  • Holding a public meeting to address challenges of developing non-addictive medical products for acute or chronic pain;
  • Issuing new or updating existing guidance documents addressing, among other topics, how FDA considers pain, pain control, or pain management in assessing whether a disease or condition is serious or life-threatening and how FDA may require postmarket studies to assess reductions in effectiveness of a drug that change the drug’s benefit-risk profile;
  • Issuing prescribing guidelines for the indication-specific treatment of acute pain;
  • Developing a list of controlled substances to refer to Customs and Border Protection and other import controls; and
  • Implementing new authority to require unit dose packaging (aka blister packs).

This list is not exhaustive, yet it’s clear FDA will be busy. We’ll be keeping a close eye on administration and congressional actions related to these and other important public health issues in 2019.

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Aaron L. Josephson