Category: Health

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.

©1994-2018 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

ARTICLE BY

Aaron L. Josephson

Nurse Staffing Ratios May Be Coming to a Hospital Near You

On November 6, 2018, when Massachusetts voters go to the polls to select a new Governor and other key elected officers, they will also consider Ballot Question 1, which will mandate rigid registered nurse staffing ratios for hospitals across the Commonwealth effective as of January 1, 2019. This proposal would make Massachusetts the second state in the United States to have specific staffing ratios mandated in all units. This initiative follows only California, which passed a less comprehensive law through the legislative process in 1999 and provided over five (5) years for hospitals to implement by 2004.[1] The Massachusetts ballot initiative process, like that of some other states, allows the voters to write entirely new law into books. Question 1 appears to be the most heavily-fought ballot initiative in Massachusetts in recent memory. While Massachusetts seems to be the only state this year with a nurse staffing ratio as a referendum ballot initiative,[2] unions nationally will focus on the results of this year’s effort.

What is Question 1?

Question 1, if passed, would mandate highly-prescriptive and specific nurse-to-patient ratios based on the type of patients/units in hospitals, regardless of market, acuity of the patient, physician orders, or nursing judgement. Hospitals are required to implement a written plan detailing the maximum number of patients to be assigned to a registered nurse by unit at all times, while also “concurrently detailing the facility’s plans to ensure that it will implement such limits without diminishing the staffing levels of its health care workforce.”

Hospitals would also be required to develop a “patient acuity tool” for each unit to be used to determine whether the maximum number of patients that may be assigned should be lower than the assignment limits in the law. Notices regarding the patient assignment limits must be posted in conspicuous places, including each unit, patient room, and waiting area.

What are the Ratios?

The specific ratios mandated are summarized as follows (nurse:patient):

  • Step-down/intermediate care 1:3
  • Post anesthesia care (PACU) 1:1; PACU post-anesthesia 1:2
  • All units with operating room (OR) patients 1:1; OR patients post-anesthesia 1:2
  • Emergency Services Department: 1:1, 1:2,1:3, or 1:5 depending on the emergent or urgent nature of a patient which often changes by the minute
  • Maternal child care patients:
    • Active labor, intermittent auscultation for fetal assessment, and patients with medical or obstetrical complications 1:1
    • During birth and for up to two hours immediately postpartum 1:1 for mother and baby; when the condition of the mother and baby are determined to be stable and the critical elements are met, 1 nurse may care for both the mother and the baby(ies)
    • During postpartum for uncomplicated mothers or babies 1:6 (either 6 mothers or babies, 3 couplets of mothers and babies, or, in the case of multiple babies, not more than a total of 6 patients
    • Intermediate care or continuing care babies is 1:2 for babies
    • Well-babies 1:6
  • Pediatric 1:4
  • Psychiatric 1:5
  • Medical, surgical and telemetry patients 1:4
  • Observation/outpatient treatment 1:4
  • Rehabilitation units 1:5
  • All others 1:4

How Would the New Law be Enforced?

Question 1 also requires the state’s Health Policy Commission (HPC) (as opposed to the Department of Public Health, which is the state authority to license and regulate hospitals and other health care providers) to promulgate regulations and conduct inspections governing the implementation of the initiative.  The HPC is a six year old independent state agency charged with monitoring health care spending growth, it does not have the staff or infrastructure to conduct routine hospital surveys to monitor internal facility management and operations. It is also important to note that the proposed ballot would restrict the HPC by preventing it from issuing any delays, temporary or permanent waivers, or modifications of the ratios. Thus, even if the HPC believed that the January 1st  implementation date was unfeasible, it may be prohibited from offering waivers.

The HPC may report violations to the State Attorney General, who could file suit to obtain injunctions as well as civil penalties of up to $25,000 per violation and up to $25,000/day for continued violations.

The Impact if Question 1 Passes

Coalitions have lined up on both sides of Question 1.  Each side has painted dramatically-different pictures of a future for the industry with mandated nurse staffing ratios. The supportive nursing union has cast the initiative as being relatively small dollars for the industry, costing only $47 Million for all hospitals in the state in total according to their study.[3],[4]  The Massachusetts Health and Hospital Association and a broad-based coalition of health care providers and other nursing organizations opposed to the initiative point to studies estimating that the cost will be in excess of $1 Billion to the industry.[5]  Increased costs are based on the need to recruit new nurses, as well as the across-the-board increases in pay. There will be a need to hire 5,911 registered nurses within 37 business days to comply with January 1st  deadline and this is in a state that already has a shortage of approximately 1,200 registered nurses.[6]  Individual community hospitals are reporting projected additional expenditures that amount to more than the $30 Million per year, with teaching hospitals anticipating increased expenditures higher than that.[7]

On October 4, 2018, the HPC issued its independent report on the estimated costs of Question 1, essentially validating the opposition’s concerns, and projecting annual increased costs of $676 Million to $949 Million, and noted that the projections were “conservative.” The HPC study undercounted costs as it only looked at increased costs in certain units, and excluded costs associated with increased staffing in emergency departments, observation units, outpatient departments, or any costs for implementation or to non-acute hospitals.[8]  Wage increases of 4 – 6% are predicted in the HPC study, based on the California experience with across-the-board staffing requirements in place, and estimated increases of total health expenditures in Massachusetts of 1.1 – 1.6%, with increases of 2.4 – 3.5% for hospital spending alone, again, based on a conservative and partial analysis. Thus, it appears that the industry fears of greater than $1Billion in annual increased expenses are valid.

Ancillary adverse impacts anticipated by the HPC included reduced access to emergency care, increased wait times, decreased patient flow, increased “boarding,” and more ambulance diversions.

The HPC also compared Massachusetts to California hospitals and concluded that there was “no systematic improvement in patient outcomes post-implementation of ratios.”

What Should Hospitals be Doing Now?

Question 1, if passed, would only apply to Massachusetts licensed hospitals.  But hospitals and health systems in other jurisdictions should be prepared for similar efforts in their states. The following are some initial steps hospitals should be considering

Access Management.  Access problems will be common starting in January if Question 1 passes. Elective procedures, non-emergent appointments and other services may need to be curtailed effective January 1, 2019.  Hospitals will need to meet staffing levels on that day with respect to then-current inpatients and outpatients.  Avoiding new admissions in December may be necessary to assure the hospital is not in instant violation on New Year’s Day. Early patient contact to warn about the possibility of rescheduling procedures will prudent.

Payer Contract “Reopeners.”  Payer contracting “reopeners” should be added to managed care contracts now. The hospital community has been watching the interest of the unions in pushing nurse staffing ratios in Massachusetts and other states for a number of years. Health systems and hospitals negotiating long-term contracts with payers have often included “reopeners” to permit the hospital to revisit contract rates even during the term of an agreement if certain extreme events come to pass.  Hospitals in all jurisdictions are encouraged to consider adding such reopeners to their agreements today.

Massachusetts hospitals should review their payer contracts now to confirm if they have the right to a mid-term reopening and, if so, provide notice immediately upon passage to their payers that the hospital will need to renegotiate rates to address the increased costs. Charge masters will also need to be reviewed immediately.

Union status? Based on their efforts to rally public support around Question 1, the Massachusetts Nurses Association is trying to do an end-run around the collective bargaining table where their past efforts on the issue of staffing ratios have failed.  Health systems and hospitals should review their collective bargaining agreements to determine whether they are in a position to trigger a reopener during the term of the contract to address the numerous monetary and non-monetary consequences of rigid staffing ratios contemplated by Question 1.

Unit Closure Plans.  If passed, hospitals in Massachusetts will likely need to immediately assess whether and how they could comply with these new ratios. Units that already operate at a loss, or for which meeting the staffing requirements is impossible, should be closed or reduced to the smallest possible patient compliment.  Closure plans and negotiations will need to commence immediately.

Massive Recruitment Efforts.  While there are believed to be a few hospitals that may already meet these staffing levels (at some times), most hospitals will need to recruit many more registered nurses, as well as have additional nurses standing by for fluctuations in patient loads on various units on a daily basis.  As noted above, the law will require hiring nearly 6,000 RNs in the fourth quarter of this year.[9]

Conclusion

If Question 1 passes, conservative projections estimate extreme new costs will be incurred by Massachusetts hospitals, which will result in both reductions in levels of service, and increased costs to payers and patients.  It is important to note that the dire circumstances of the ballot has led to an increasing large number of nursing organizations and physician groups in Massachusetts to all oppose Question 1. While Massachusetts hospitals are making plans akin to natural disaster preparedness, hospitals in other states should watch carefully these events to be ready should similar initiatives arise locally.

———————————

[1] A few other states have limited ratios in certain special types units (like intensive care units), but Question 1 applies to all hospital units.

[2] See http://www.ncsl.org/research/elections-and-campaigns/ballot-measures-database.aspx(June 6, 2018); downloaded on October 8, 2018.

[3] See https://www.massnurses.org/news-and-events/p/openItem/11083

[4] See https://safepatientlimits.org/wp-content/uploads/Shindul-Rothschild-Esti…

[5] See https://www.protectpatientsafety.com/get-the-facts/

[6]  See Mass Insight Global Partnership, Protecting the Best Patient Care in the Country, Local Choices v Statewide Mandates in Massachusetts (April, 2018)  http://www.bwresearch.com/reports/bwresearch_mha-nlr-report_2018Apr.pdf (“Mass Insight Study”)

[7] See Financial impact of nurses ballot question? Depends who’s counting, Priyanka Dayal McCluskey, Boston Globe (Sept. 17, 2018).  https://www.bostonglobe.com/metro/2018/09/17/financial-impact-nurses-ballot-question-depends-who-counting/mlS4yZa5IB8hcDaFZ7ojXM/story.html

[8] See Analysis of Potential Cost Impact of Mandated Nurse-to-Patient Staffing Ratios, October 3, 2018, https://www.mass.gov/doc/presentation-analysis-of-potential-cost-impact-…

[9] Mass Insight Study.

 

© 2018 Foley & Lardner LLP
This post was written by Lawrence W. Vernaglia and Donald W. Schroeder of  Foley & Lardner LLP.

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”).  Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that would require pharmaceutical manufacturers to disclose the list price of their pharmaceutical products in direct-to-consumer (“DTC”) television ads (the “Proposed Rule”).  This comes only a week after the President signed legislation prohibiting “gag clauses” in pharmacy agreements and allowing pharmacists to tell patients that they can obtain a product for less by paying the cash price instead of their insurance company’s negotiated rates.

This recent Proposed Rule is relatively straightforward: any prescription drug or biologic with a list price of more than $35 that may be directly or indirectly covered by Medicare or Medicaid must include the following statement in DTC television ads:

  • “The list price for a [30-day supply of] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.”

CMS proposes that the “list price” in the above statement should be the product’s Wholesale Acquisition Cost (“WAC”); however, CMS is seeking comment on whether WAC best reflects the “list price.”  WAC is the published price that pharmaceutical manufacturers charge wholesalers for their products.  WAC does not include any prompt pay or other discounts, rebates or reductions in price. It is also different from the usual and customary price that a cash paying patient pays at the pharmacy.

CMS further proposes that the only “enforcement mechanism” under the Proposed Rule would be the annual publication of a list of manufacturers that have not complied with the disclosure requirements.  CMS believes violations of the regulation would be enforced as unfair and deceptive marketing through the Lanham Act, which allows competitors to bring causes of action against each other.  In other words, CMS is anticipating that the industry will self-police compliance with the regulation.  However, CMS is also seeking comment on other approaches to enforce compliance with the Proposed Rule.

Notwithstanding the straightforward nature of the Proposed Rule, it is clear that CMS is bracing itself for legal challenges.  CMS spends a significant portion of the preamble defending its rationale for requiring list price to be disclosed and its authority to issue this Proposed Rule, as well as attempting to preempt potential First Amendment challenges.

The stated purpose of the Proposed Rule is to reduce the price “that consumers pay for prescription drugs and biological products.”  CMS’ rationale is that by providing beneficiaries with “relevant information about the costs of prescription drugs and biological products,” beneficiaries can make informed decisions that minimize their out-of-pocket costs and reduce costs to Medicare and Medicaid.  CMS believes that requiring pricing information in ads allows beneficiaries to “price shop,” so that the prescription drug market can be similar to other commodities.  CMS points to market research among other commodities finding that when pricing information is available, competition increases resulting in price reductions.  One interesting note is that out-of-pocket costs only impact non-dual-eligible Medicare beneficiaries.  States can only charge Medicaid beneficiaries a nominal prescription drug copay that is identified in the Medicaid State Plan or in regulation.  Dual-eligible beneficiaries have a copayment that ranges from $0 to $8.35, regardless of the drug’s WAC.

CMS states that it has legal authority to promulgate this Proposed Rule because the Social Security Act requires that the Secretary administer the Medicare and Medicaid programs in a manner that minimizes unreasonable expenditures.  Further, it explains that Congress explicitly directs HHS to operate the Medicare and Medicaid programs efficiently.  CMS argues that promoting pricing transparency promotes efficient markets and can reduce unnecessary expenditures.  It is interesting to note the Administration determined that this rule should be issued by CMS, rather than FDA or Federal Trade Commission, which otherwise regulate the advertisement of prescription drugs and market competition, respectively.  Statements from Secretary Azar and HHS officials indicate that HHS did not use FDA’s authority because such authority is limited to drug claims and side effects.

Additionally, CMS tries to preempt any First Amendment challenges against its proposal, stating that this price disclosure “consists of purely factual and uncontroversial information about a firm’s own product.”  CMS argues that prescription drug price disclosure is no different from requiring the disclosure of calories on menus or an insurer’s financial interest in PBMs, which have been upheld by either the United States Supreme Court or circuit courts.

CMS will accept comments on this rule for 60 days following its publication to the Federal Register.  Given the speed in which the Administration is tackling the proposals in its Blueprint, we will continue to track developments.

 

©1994-2018 Mintz All Rights Reserved.
This post was written by Lauren M. Moldawer of Mintz.

Celebrating the Promise of Mental Health Parity and the Path Forward

This October 3rd marked the 10-year anniversary of the passage of the Mental Health Parity and Addiction Equity Act (MHPAEA). Thinking back to 2008, there had already been several failed attempts to pass a more substantive parity bill. New rounds of negotiations began and were difficult. Substance use disorders (SUD) were still considered a step-child to mental health and labeled a human failing rather than a treatable disease with disabling consequences. If these conditions were not recognized and addressed, it would become a national crisis. However, value change is hard to legislate.

MHPAEA was intended to be more than insurance reform, it was intended to be civil rights legislation that brought mental health (and, for the first time SUD) to a level playing field with physical health. It was a long road to passage because it required a change in health care philosophy and value related to mental health and SUD— not just a change in coverage and payment protocols.

Now, 10 years later, the question is whether the law has changed the playing field to ensure greater access to care and more equitable financial parameters. Close to 100 million people now have parity protections and lives have been saved. Through enforcement of the law more restrictive financial requirements have been removed for patients, additional coverage has been added to insurance plans for mental health/SUD, and overly stringent precertification requirements have been eliminated.

Although the passage of this legislation created a pathway for change, there are still challenges to address.  Discrimination related to SUD remains a challenge, as evidenced by the exclusion of ADA protections for those with SUD.  Advocates continue to call for more transparency, established certifications, expanded provider network capacity, and more guidance on non-quantitative treatment limitations.  The ongoing silos in which mental health/SUD and physical health conditions are treated as separate benefits with their own eligibility, fee schedules for services, credentialing, and poor provider network adequacy continue as areas to be addressed.

A couple of examples in which mental health/SUD services are treated differently: Providers have not been eligible for incentive payments to move to electronic medical records; payers have struggled in designing alternative payment models and value-based payments for providers that move beyond simple process measures;  payment restriction on same-day care are problematic in integrated settings where a person may be seen by both a mental health professional and a non-psychiatric physician; and physicians (non-psychiatrists) providing services in a specialty clinic creates credentialing and payment challenges.

New bipartisan legislation enacted to address the opioid crisis will be an important step to improving access to and the quality of substance use treatment, particularly in the Medicaid and Medicare programs — but doesn’t address the health system transformation that is needed to promote sustainable recovery. That is the challenge we face.

Hopefully our path forward will continue address these issues of implementation, so we approach the day when those living with mental health and substance use disorders will be seen as having a condition or disease that deserves prevention strategies, supports and treatment services, and civil rights protections similar to all other medical conditions.

 

©1994-2018 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.
ARTICLE BY: Health Law Practice

The Blame Game: Senators Clash with the Trump Administration

Why are prescription drug prices so high in the U.S.? While this question can hardly be considered a new topic in American healthcare, the recent clash of words between the Trump Administration and Democratic Senators has once again brought focus to the issue of prescription drug prices. According to the Administration, pharmacy benefit managers (“PBMs”) and drug distributors – who President Trump has dubbed as “middlemen” – are largely to blame for higher drug prices. However, Democratic Senators, PBMs, and drug distributors have recently pushed back against the Administration’s claims, arguing that the Administration’s claims are not supported by any evidence, and, in some cases, are contrary to the core functions of PBMs and drug distributors.

Background

PBMs and drug distributors have been in the crosshairs of the Administration for several months. In a speech on May 11, 2018, President Trump outlined the American Patients First blueprint (the “Blueprint”), which outlined the approach that the Administration would pursue to lower drug prices. Among several targets for change were PBMs and drug distributors, noting that among the Administration’s top goals was “eliminating the middlemen.”[1]

The Blueprint specifically sets forth the Administration’s belief that “[b]ecause health plans, pharmacy benefit managers [], and wholesalers receive higher rebates and fees when list prices increase, there is little incentive to control list prices.”[2] The Blueprint did not, however, provide any evidence or rationale for these claims. Nevertheless, the Blueprint proposes several changes to the way that PBMs operate, including creating a fiduciary duty for PBMs, and restricting the ability of PBMs to retain a percentage of the rebate collected on behalf of health plans. The Blueprint does not, however, elaborate on the Administration’s plans for drug distributors.

United States Department of Health and Human Services (“HHS”) Secretary Alex Azar elaborated on the Blueprint’s claims during a June 12, 2018 hearing before the Senate Committee on Health, Education, Labor and Pensions, where he claimed that PBMs threatened to remove drugs from their formularies if the drug manufacturers decreased list prices.[3] Secretary Azar repeated these claims on June 26, 2018, before the Senate Committee on Finance, where he claimed that drug manufacturers who voluntarily reduced list prices would be harmed by PBMs that would prioritize competing drugs with higher prices when setting their drug formularies.[4]

Senators and Stakeholders Push Back

In a letter to Secretary Azar , Senators Elizabeth Warren (D-MA) and Tina Smith (D-MN) criticize Secretary Azar’s allegations regarding the role of PBMs in drug pricing, calling them “disturbing and serious.” [5] The Senators argue that PBMs and drug distributors hold themselves out as “key players in negotiating lower drug prices and making the market for drugs more efficient” – directly contrary to Secretary Azar’s claims.[6]

The Senators investigated Secretary Azar’s claims by reaching out to the six largest PBMs and three largest drug distributors in the United States. The PBMs unanimously indicated that they never pushed back or otherwise disadvantaged any drug manufacturer for lowering list prices. Express Scripts noted that lower list prices receive favorable formulary consideration, exactly the opposite of Secretary Azar’s claims.[7] The drug distributors gave similar answers, indicating that they did not influence or have any ability to influence the list prices for drugs. Instead, one drug distributor indicated that it negotiated fees for distribution services “agnostic of [the manufacturer’s] product pricing.”[8]

Moving Forward

The Administration appears unfazed by the questions and concerns of PBMs, drug distributors, and Democratic Senators, and has focused its attention on changes to the way PBMs operate. One manner in which PBMs aim to reduce drug prices is by negotiating rebates with drug manufacturers who want to list their products on PBM formularies. On August 17, 2018, Secretary Azar claimed that HHS has the power to eliminate rebates on prescription drug purchases. While the PBM industry contends that only Congress has the ability to change the rebate system, Secretary Azar stated that rebates were created by HHS regulations, and “[w]hat one has created by regulation, one could address by regulation.” [9]

The Secretary’s claims are likely related to a proposed rule that HHS submitted to the Office of Management and Budget (“OMB”) titled “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection” on July 18, 2018.[10] The OMB is still reviewing the proposed rule, and nothing is currently known about the rule beyond its title; however, Secretary Azar’s comments indicate that the rule may be aiming to adjust or eliminate the ability of PBMs to negotiate with drug manufacturers for rebates. While it is unclear exactly what will be presented in such proposed rule, it appears likely that the Administration will continue pursuing aggressive changes to the way that PBMs operate.

[1] Kerry Dooley Young, Trump Lays Out Drug Plan, Calling for More Competition, Less ‘Global Freeloading’, Medscape (May 11, 2018)

[2] United States Department of Health & Human Services, American Patients First, The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, (May 2018)

[3] Prescription Drug Pricing, C-SPAN, (June 12, 2018)

[4] Prescription Drug Supply and Cost, C-SPAN, (June 26, 2018)

[5] Senator Elizabeth Warren & Senator Tina Smith, Letter to U.S. Department of Health and Human Services Secretary Alex Azar, August 17, 2018, at 3, Senator Elizabeth Warren & Senator Tina Smith, Letter to U.S. Department of Health and Human Services Secretary Alex Azar, August 17, 2018, at 3

[6] Id. The Pharmaceutical Care Management Association, which promotes PBMs nationwide, claims PBMs will save employers, unions, government programs, and consumers $654 on drug costs over the next decade. Pharmaceutical Care Management Association, Our Industry

[7] Senators Warren and Smith, at 4

[8] Id. at 6.

[9] Yasmeen Abutaleb, U.S. Health Secretary Says Agency Can Eliminate Drug Rebates, U.S. News, (Aug. 20, 2018)

[10] Office of Management and Budget, RIN 0936-AA08, (July 18, 2018)

 

Copyright © 2018, Sheppard Mullin Richter & Hampton LLP.