Category: Health Care Law

Connecticut Enacts Law to Increase Access to Epinephrine Auto Injectors

On June 13, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-19 “An Act Concerning Epinephrine Auto Injectors” (PA 19-19). PA 19-19 went into effect on the same date.

This legislation expands access to epinephrine, which can be lifesaving when treating anaphylactic allergic reactions. PA 19-19 permits “authorized entities” to acquire and maintain a supply of epinephrine cartridge injectors, subject to certain conditions. With a few exceptions, authorized entities are for-profit or nonprofit entities or organizations that employ at least one “person with training.” The new legislation defines a person with training as a person who either:

  • Has completed and received a certification in a first aid course that has been approved by a “prescribing practitioner” pursuant to a medical protocol (as described below); or
  • Has received training in the recognition of the signs and symptoms of anaphylaxis, the use of an epinephrine cartridge injector and emergency protocol by a licensed physician, physician assistant, advanced practice registered nurse or emergency medical services personnel.

Prior to PA 19-19, drug wholesalers and manufacturers were permitted to sell epinephrine cartridge injectors to select categories of purchasers, including hospitals, physicians, nursing homes with a full-time pharmacist, pharmacies and certain other institutions with a full-time pharmacist.

PA 19-19 requires authorized entities who desire to acquire or maintain epinephrine cartridge injectors, together with a “prescribing practitioner,” to establish a medical protocol on the administration of epinephrine cartridge injectors by a person with training. Under PA 19-19, a prescribing practitioner is a Connecticut-licensed physician, dentist, podiatrist, optometrist, physician assistant, advanced practice registered nurse, nurse-midwife or veterinarian, authorized to prescribe medication within his or her scope of practice. The medical protocol must address, among other things, proper storage, maintenance and documentation of epinephrine cartridge injectors, and procedures for emergency medical situations involving anaphylactic allergic reactions at the authorized entity’s place of business. The authorized entity must maintain a copy of the medical protocol at the place of business to which it applies, and must annually review the medical protocol with a person with training and a prescribing practitioner.

In the event of an anaphylactic reaction, a person with training may, in accordance with the medical protocol, provide an epinephrine cartridge injector to the individual or to the individual’s parent, guardian or caregiver, or administer the epinephrine cartridge injector, regardless of whether the individual has a prescription or a prior medical diagnosis of an allergic condition. After any such administration of epinephrine, the authorized entity must notify a local emergency medical services organization as well as the prescribing practitioner.

Notably, PA 19-19 holds prescribing practitioners free from civil and criminal liability for establishing the medical protocol or for use of the epinephrine cartridge injector in accordance with PA 19-19. This legislation also holds persons with training and authorized entities free from civil or criminal liability to the individual who experienced anaphylaxis for the provision or administration, in accordance with PA 19-19, of the epinephrine cartridge injector when the person with training has a good faith belief that the individual is experiencing anaphylaxis.  However, the immunity does not apply to willful or wanton misconduct or acts or omissions constituting gross negligence.

 

Copyright © 2019 Robinson & Cole LLP. All rights reserved.
Read more about healthcare legislation on the National Law Review Health Law and Managed Care page.

Incapacitated Woman Gave Birth in Arizona Nursing Home: Attorneys Seeking $45M from the State

Late last December, a nurse at Hacienda HealthCare in Arizona panicked and called 911 as a patient unexpectedly gave birth. The 29-year-old patient, who has been in a vegetative state since age 3, delivered a healthy baby boy. A police investigation concluded that one of her caregivers, a 32-year-old male nurse, raped the patient several times and fathered the child. The victim’s attorneys filed a $45 million notice of claim against the state of Arizona in late May.

After giving birth in the nursing home, the victim and baby were transferred to a nearby hospital. According to the hospital, the baby’s birth was “a repeat parous event,” meaning the victim had likely been pregnant before.

As a result of a near drowning experience in 1992, the victim is described as non-verbal and generally unresponsive. However, she does experience pain and can respond to her surroundings with a groan or a smile.

The staff full of medical professionals said they did not realize the woman was pregnant until a nurse went to change the victim and saw the baby’s head.

An anonymous former caregiver for the woman told ABC-15 she didn’t believe the pregnancy went undetected. “I can’t believe that somebody would bathe her daily for nine months and never know that she wasn’t having a period, that she [was] growing in her midsection, that nurses weren’t keeping track [of her weight],” the former caregiver said. “Those things are shocking to me.”

According to the notice of claim, the nursing home missed 83 opportunities to diagnose the pregnancy. The staff noted the patient’s abdomen was sticking out during 24 checks, and noted swollen legs and feet 12 times. A doctor saw the patient at least 10 times during her third trimester.

Hacienda HealthCare was entrusted to give the patient around-the-clock care. Not only did they overlook the signs of repeated sexual abuse the hospital reported, which allowed for it to continue, but they also failed to detect her pregnancy. The facility’s negligence caused the patient to go through her pregnancy without any proper care and in a state of malnutrition.

The complaint argues that the state of Arizona “cultivated circumstances” that enabled this misconduct and failed to monitor the long-term care facility.

There are many forms of abuse in nursing homes, to both younger and elderly patients. The long-term care facilities we trust with our loved ones are responsible for their safety and well-being.

 

COPYRIGHT © 2019, STARK & STARK
Article by Sherri Warfel of Stark & Stark.
For more on health care issues see the National Law Review Health Law & Managed Care page.

Arkansas and Kentucky Halt Medicaid Work Requirements

On April 10, 2019, the Department of Justice filed notices[1] appealing two District Court rulings that struck down Medicaid work requirements in both Kentucky[2] and Arkansas[3] to the U.S. Court of Appeals for the District of Columbia Circuit. The rulings, issued on March 27, 2019, by Judge James E. Boasberg of the Federal District Court for the District of Columbia, held that the U.S. Department of Health and Human Services (“HHS”) acted arbitrarily and capriciously in violation of the Administrative Procedure Act (“APA”) when it approved the Arkansas Works Amendments and Kentucky HEALTH programs. Arkansas and Kentucky halted the programs, pending resolution of the appeals.

Background

Arkansas Works Amendments

In 2017, Arkansas Governor Asa Hutchinson proposed substantial amendments to the Arkansas Medicaid program (known as Arkansas Works since 2017) (the “Arkansas Works Amendments”). While States generally must meet specific federal requirements when implementing their Medicaid programs, Federal law allows the Secretary of HHS (the “Secretary”) to waive federal requirements for “experimental, pilot, or demonstration project[s]” proposed by States.[4]   Specifically, if, in the Secretary’s judgment, the proposals would be “likely to assist in promoting [Medicaid’s] objectives,”[5] then the Secretary may waive compliance with certain Federal Medicaid requirements to the extent necessary to enable the State to carry out its proposed project (a “Section 1115 Waiver”).[6]

The Arkansas Works Amendments included a new requirement that adults ages 19 to 49 complete 80 hours of employment, or earn income equivalent to 80 hours of employment, each month as a condition of continued Medicaid coverage.[7] On March 5, 2018, the Secretary approved the work requirements and issued a Section 1115 Waiver allowing Arkansas to implement the new requirements. After the work requirements were implemented, more than 16,900 individuals lost Medicaid coverage for at least some period of time due to not reporting their compliance.[8]

Arkansas Medicaid recipients filed suit against the Secretary in August 2018. They asserted that the Secretary’s approval of the Arkansas Works Amendments was arbitrary and capricious, exceeded the Secretary’s statutory authority, and violated the “Take Care Clause” at Article 2, Section 3 of the Constitution – such clause requiring that the President, “take care that the laws be faithfully executed.”[9]

Kentucky HEALTH

In 2018, Kentucky submitted its own Medicaid proposal – the Kentucky HEALTH program – which CMS approved.[10] Like the Arkansas Works Amendments, Kentucky HEALTH made significant changes to Kentucky Medicaid, including, among other things, the implementation of work requirements. Kentucky HEALTH would require Medicaid beneficiaries to spend at least 80 hours per month on certain qualified activities, including: (i) employment; (ii) job skills training; (iii) education; (iv) community service; and (v) participation in Substance Use Disorder treatment. Failure to meet the 80 hour threshold, or failure to report compliance, would result in loss of Medicaid coverage.[11]

Two weeks after the Kentucky HEALTH program was approved, Kentucky Medicaid recipients sued the Secretary. The plaintiffs argued that the Secretary failed to consider Medicaid’s objectives and exceeded his statutory authority when he approved Kentucky HEALTH. The Federal District Court for the District of Columbia agreed with the plaintiffs, and vacated the Secretary’s approval on June 29, 2018, and remanded to HHS for reconsideration.[12]

Following remand, HHS re-opened public comments for Kentucky HEALTH, and approved a slightly modified proposal on November 20, 2018. Again, Kentucky Medicaid recipients sued the Secretary, arguing that the Secretary still had not considered Medicaid’s core objectives in violation of the APA.[13]

The Administrative Procedure Act

The APA establishes two important frameworks: (1) procedures which executive agencies must follow when developing, reviewing, and promulgating rules and regulations; and (ii) a judicial framework for courts to review executive agency actions.[14] Under the APA, courts must “hold unlawful and set aside agency action, findings, and conclusions” that are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”[15] An agency must “examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made,” or the agency’s action may be stuck down by the courts.[16]

The District Court Held That HHS Failed to Consider Medicaid’s Core Objective

Using the APA framework, the court analyzed whether HHS identified the objectives of Medicaid and explained why the Arkansas Works Amendments and Kentucky HEALTH programs would promote such objectives.[17] The court found that, while HHS had considered several Medicaid objectives, HHS failed to consider one critically important objective – providing medical assistance to needy populations.[18]

While HHS itself admitted that providing health coverage to vulnerable populations is “Medicaid’s core objective,”[19] the court found that HHS failed to consider the impact that the Kentucky and Arkansas projects would have on current and future Medicaid coverage.[20] The court determined this failure alone made the Secretary’s approval of the states’ work requirements arbitrary and capricious.[21] The court vacated HHS’s approval of both the Kentucky and Arkansas programs, and remanded both programs to HHS for reconsideration.[22]

Arkansas and Kentucky Halt Implementation of Work Requirements Pending Appeal

Following the District Court decision, Arkansas suspended the changes made by the Arkansas Works Amendments, which have been in effect since June 2018, and Kentucky halted implementation of its Kentucky HEALTH program, which was scheduled to take effect on April 1, 2019. Governor Hutchinson praised the Justice Department’s decision to appeal the cases, and indicated that the Government will likely seek an expedited appeal.

[1] Notice of Appeal, Stewart v. Azar, Case No. 1:18-cv-152-JEB (D.D.C. Apr. 10, 2019); Notice of Appeal, Gresham v. Azar, Case No. 1:18-cv-1900-JEB (D.D.C. Apr. 10, 2019)

[2] Memorandum Opinion, Stewart v. Azar, Case No. 18-152-JEB (D.D.C. Mar. 27, 2019)

[3] Memorandum Opinion, Gresham v. Azar, Case No. 18-1900-JEB (D.D.C. Mar. 27, 2019)

[4] 42 U.S.C. § 1315(a)

[5] Id.

[6] 42 U.S.C. § 1315(a)(i).

[7] Gresham at 7-9.

[8] Id. at 8-9.

[9] Gresham at 10.

[10] Stewart at 4.

[11] Stewart at 5.

[12] Stewart at 6-7.

[13] Stewart at 5-8.

[14] See generally 5 U.S.C. § 551 et seq.

[15] 5 U.S.C. § 706(2).

[16] Stewart at 10 (quoting Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983))

[17] Gresham at 16; Stewart at 14-15.

[18] Gresham at 17-18; Stewart at 14.

[19] Gresham at 17.

[20] Stewart at 16-17

[21] Stewart at 15

[22] Gresham at 33; Stewart at 48.

Copyright © 2019, Sheppard Mullin Richter & Hampton LLP.

Federal Government Slaps $600K Fine on Wanaque Center After 11 Children Die

The federal government imposed a $600,331 fine on the New Jersey nursing center where a viral outbreak left 11 children dead and 36 sick last year. Investigators reported Wanaque nursing home’s poor infection controls, lack of administrative oversight, and slow response from medical staff “directly contributed” to the rapid spread of the virus and its related death toll.

The 114-page federal inspection report, published in December, claimed the staff at Wanaque failed to correct issues that could have controlled the outbreak, allowing residents and one staff member to contract the virus and placing others in “immediate jeopardy.”

The report alleges the center had a faulty infection-control plan, did not respond appropriately when the outbreak emerged, and failed to properly monitor the infection rate.

Multiple children at Wanaque retained high fevers for days before staff sent them to the emergency room, two of which died within hours of arriving at the hospital. At least two other children, who had been symptom-free, contracted the virus and died after staff failed to separate them from their sick roommates.

Wanaque’s pediatric medical director appeared to be absent during the crisis and claimed he did not fully understand the responsibilities of his position. The director also failed to attend quality assurance and performance meetings and had not filed monthly reports for the last four years.

The Wanaque facility is strongly disputing the findings in the federal investigation report, arguing the staff followed proper protocols and the outbreak was “unavoidable.”

New Jersey ceased all admission to the nursing home following the outbreak, but is now allowing the facility to admit new patients. A restriction does still remain in place barring Wanaque from admitting pediatric ventilator patients until federal and state officials approve the facility’s written infection-control plan.

In addition to the $600,331 federal fine, the New Jersey Department of Health is imposing a $21,000 penalty on the nursing home for each infection-control-related failure.

 

COPYRIGHT © 2019, STARK & STARK
This post was written by Jonathan F. Lauri of Stark & Stark.
Read more Malpractice Enforcement on our Professional Malpractice Page.

Five Unanswered Questions on the Medicare for All Act

On February 27, 2019, Representative Pramila Jayapal (D-WA) and more than 100 co-sponsors in the House of Representatives introduced the Medicare for All Act (HR 1384). The bill, like its predecessors, creates a single payer, government-funded health care program. The new program would cover enumerated medical benefits, prescription drugs, vision, dental, mental health and substance abuse services.

As expected, progressive House Democrats are using Medicare for All to message their position on coverage expansion heading into the 2020 election. The legislation threatens to expose divides in the Democratic Party, with some Democratic leaders publicly silent on the bill as the left flank of the party tries to advance the proposal. In previous years, other Democrats introduced competing proposals aimed at tackling coverage, including Medicaid and Medicare Buy-In approaches. Messaging the future of the Affordable Care Act (ACA), covering the un- and underinsured, and reducing costs promise to dominate the airwaves in the lead-up to the 2020 presidential election.

It is unclear whether Medicare for All will see a vote on the House floor, either as a whole or in its component parts. Even if the bill were to pass in the House, it is almost certainly doomed in the Republican-controlled Senate. Regardless of the bill’s fate, stakeholders should take this opportunity to prepare for forthcoming conversations about how to address the uninsured population and the rising cost of health care.

Many components of the bill are consistent with versions introduced in previous congressional sessions. There are many questions raised by the legislation: This +Insight focuses on five big ones for stakeholders to consider as they evaluate Medicare for All:

1. Is Medicare for All the Democrats’ “Repeal and Replace”?

Since the enactment of the ACA, congressional Republicans have run on “Repeal and Replace” as a counter message to the Democrats’ signature legislative achievement. When the balance of power shifted in Washington after the 2016 election, pressure intensified on Republican lawmakers to come up with an alternative to the ACA. Ultimately, efforts to repeal and replace the ACA failed legislatively, and efforts to modify the law have been piecemeal and primarily regulatory.

Similarly, Medicare for All and other single payer proposals have largely been Democratic messaging tools, with many of the details unspecified or unaddressed, and many aspects of the proposals ambiguous. If Democrats were to see a presidential victory in 2020, will they be in the same “dog that caught the car” position?

2. How much time is necessary to revamp the US health care system?

Medicare for All is a fundamental, sweeping policy change to the way the United States pays for health care. The legislation reorganizes nearly one-fifth of the nation’s economy. Rep. Jayapal’s proposal envisions a very quick transition to the new system—a two-year period, with certain individuals eligible to enroll in Medicare for All beginning one year after the date of enactment. Other proposals, including Senator Bernie Sanders’ (I-VT) Medicare for All plan, have contemplated longer transition periods (four years in the case of the Sanders plan). In interviews following the bill’s release, Rep. Jayapal stated that the swift transition was necessary because a longer transition period would provide perverse incentives in the marketplace.

As a messaging tool, the short transition period serves its purpose: to illustrate that the bill’s supporters are serious and are taking quick action to reform the health care marketplace. Practically speaking, however, if this or a similar bill were to make it across the finish line, the aggressive timeline could create additional challenges. To ensure success while preventing delay requires a delicate balance.

For example, when the ACA passed in 2010, states were mandated to expand Medicaid coverage and given a four-year transition period to make the necessary changes.[1] That was a far smaller expansion than the one envisioned by Medicare for All, and lawmakers provided twice the time to implement it. Nine years later, legal complications and administration changes mean the outlook is still murky. At the same time, if the transition is too long, advocates risk giving opponents time to pressure Congress for delays, as evidenced by the repeated delays and suspension of some of the taxes imposed by the ACA.

3. What might supplemental coverage look like?

Like previous single payer bills, this bill outlaws the sale of private health coverage that duplicates the benefits provided under Medicare for All. It similarly prohibits an employer from providing benefits to employees, retirees and their dependents. The bill also covers many services currently served by a supplemental market—vision, dental, hearing, long-term care and prescription medication, for example.

The bill contains two provisions, however, that leave open the potential for a private market to exist. First, the bill allows the sale of insurance for additional benefits not covered by the Act.[2] Second, like others before it, this bill leaves significant discretion to the Secretary of Health and Human Services regarding coverage for certain categories of services. If the Secretary promulgates rules and regulations that provide minimal coverage, could a private supplemental market thrive? If the Secretary goes the other direction, what would be left for the private market to profitably cover?

4. What is the role of the states?

Under this legislation, states may provide additional benefits for their residents, and may provide benefits to individuals not eligible under the Act at the state’s expense, provided that the state’s rules provide equal or greater eligibility and access than the single payer plan.

States thus could potentially treat Medicare for All as a floor and build policies to expand services and coverage within state lines. However, this would all be on the state’s dime. The bill effectively ends the Medicaid program, which is where many states have the opportunity to innovate with service and coverage expansion. What would states be able to accomplish without a federal matching rate?

5. What becomes of value-based purchasing?

The legislation would require the Secretary to establish a national fee schedule for items and services provided under the Act. The Secretary is required to take into account the value of items and services provided and amounts currently paid. The Secretary will negotiate annually the prices to be paid for pharmaceuticals, medical supplies, medical technology and equipment.[3]

The legislation sunsets all federal pay-for-performance programs and terminates value-based purchasing, including the merit-based incentive payment system, incentives for meaningful use of electronic health records technology, alternative payment models, hospital value-based purchasing, payment adjustments for health-care-acquired infections, the Medicare Shared Savings Program, independence at home and the hospital readmissions reduction program.[4]

The bill’s approach of shifting back to fee-for-service payments (as evidenced by the programs the bill would eliminate) is interesting, coming as it does after years of congressional, administration and private market efforts to move toward a value-based payment system. Do the bill’s authors envision reinstituting these types of programs once the new system settles? Do the authors believe these programs are no longer necessary given the global payments approach included in the bill?

Conclusion

There will be ample opportunities to draw out the consequences (intended and unintended) of implementing this sweeping change in how health care is provided in the United States. The House Rules and Budget Committees have already confirmed intentions to hold hearings on this bill. The House Energy and Commerce and Ways and Means Committees, which notably are the committees of jurisdiction, do not have immediate plans to hold hearings on the bill as a whole, but they are already discussing specific policy provisions. The Democratic presidential primary will certainly keep this issue at the forefront of health care policy in 2019 and 2020.

[1] In National Federation of Independent Business v. Sebelius, the Supreme Court of the United States ruled that Congress could not require states to expand the Medicaid program. Medicaid expansion then became an option for states.

[2] Section 107.

[3] Section 616.

[4] Section 903.

 

© 2019 McDermott Will & Emery
This post was written by Mara McDermott and Rachel Stauffer from McDermott Will & Emery.

Sex and the (Nursing) Facility

Intervening When Nursing Home Residents with Dementia Engage in Sexual Activity

If Carrie Bradshaw finds herself in a nursing home one day, what obligations will the nursing home have to oversee her sex life? The federal court of appeals in Chicago addressed that question recently, holding that skilled nursing facilities have an obligation to intervene when residents with dementia or Alzheimer’s disease engage in sexual activity.

In Neighbors Rehabilitation Center, LLC v. United States Department of Health and Human Services, three residents who suffered from dementia and/or Alzheimer’s disease engaged in what the facility viewed as consensual sexual activities. One 80-year-old resident suffered from dementia but functioned at a relatively high level. His care plan required staff to assess whether his behavior endangered other residents and to intervene as necessary. Another 65-year-old male resident with Alzheimer’s and dementia had significant cognitive impairments and had exhibited socially inappropriate behaviors, including asking staff to perform sex acts and inappropriately touching staff. The third resident, a 77-year-old female who suffered from Alzheimer’s, had low cognitive functioning and severe hearing impairment.

At various times, the nursing facility staff found two of these residents engaged in sexual activities but failed to intervene because staff viewed the acts as consensual. A survey by the Illinois Department of Public Health, acting for itself and for the Centers for Medicare & Medicaid Services (CMS), cited the nursing facility with an immediate jeopardy violation for failing to adequately supervise the residents and a level J violation of the federal nursing home standards. The surveyors alleged that the nursing facility allowed residents to have consensual sexual interactions and that supervisors told staff they should not intervene or report sexual interactions unless a participant showed outward signs of non-consent.

The nursing facility argued that even residents with cognitive impairments have the right to engage in consensual intimate relationships and that staff monitored the relationships in question as necessary.
The CMS administrative law judge upheld the survey findings after a hearing. In response, the CMS Appeals Board and the nursing facility appealed those decisions to the federal court.

The federal appeals court began its analysis by noting that the facility did not dispute that the sexual interactions had occurred. Rather, the facility only disputed whether its handling of the interactions was inadequate or hazardous under the applicable regulations.

The facility alleged that it had sufficiently monitored the residents’ interactions in a way that properly balanced the residents’ need for privacy against their right to safety and that the staff knew to look for signs that any interaction was not consensual. The court noted, however, that when nursing home residents have cognitive or physical impairments, a facility must ensure that such intimate relationships are, in fact, consensual and that the nursing facility had failed to exercise that level of care.

The court also noted that the facility records showed no evidence that it had undertaken any investigation into whether the interactions at issue were consensual or whether the residents had the capacity to consent.

The federal appeals court, therefore, upheld the finding by the CMS Appeals Board.  Because the facility failed to 1) talk to the residents about their feelings regarding these relationships, 2) document the residents’ capacity for consent and 3) obtain medical assessments of how the residents’ cognitive deficits affected their capacity to consent, the level J violation and the immediate jeopardy findings were correct.

Skilled nursing homes often have to balance residents’ right to privacy against their ability to consent to sexual activity. As with many other concerns faced by nursing facilities, the failure to document residents’ capacity to consent, consult with residents’ physicians and discuss the issue with the residents themselves is a recipe for disaster.

Carrie’s sex life will continue to be overanalyzed, even in her old age.

© 2019 Much Shelist, P.C.
This post was written by Robert K. Neiman of Much Shelist, P.C.

The Rise of the Chief Data Officer

There is a new kid on the block . . . the Chief Data Officer (CDO).  There is no surprise in our data-driven world that such a role would exist. Yet, many organizations struggle with defining the role and value of the CDO. Effective implementation of a CDO may be informed by other historical evolutions in the C-Suite.

Examining the rise of the Chief Compliance Officer (CCO) in the 2000’s mirrors some of the same frustrations that organizations faced when implementing the CCO role. While organizations were accustomed to having legal, HR, and internal audit departments working together to ensure compliance, suddenly CCOs stepped in to pull certain functions from those departments into the folds of the newly-minted Compliance department.  Integrating CDOs appears to follow a similar approach. Particularly in health care, the CDO role is still afloat, absorbing functionality from other departments as demand inside of organizations evolves and intensifies to focus on the financial benefits of their data pools.

Corporate evolution is challenging and often uncomfortable, but the writing is on the wall . . . there are two types of companies:  ones that are data-driven and ones that should be.  Which will you be?

What is a Chief Data Officer?

CDO responsibilities will vary depending on the organization. Some organizations position the CDO to oversee data monetization strategies, which requires melding business development acumen with attributes of a Chief Information Officer. In some organizations, the CDO may oversee the collection of all of the company’s data in order to transform it into a more meaningful resource to power analytical tools.

A survey of CDO positions identified three common aspirations that organizations have for the role: Data Integrator, Business Optimizer, and Market Innovator. Data Integrators primarily focus on infrastructure to give rise to innovation. Business Optimizers and Market Innovators focus on optimizing current lines of business or creating new ones. These aspirations will likely vary depending on the nature and maturity of organizations. Regardless of the specific role, CDOs can help organizations bridge the widening gap between business development, data management, and data analytics.

Further, a key component of a CDO’s activity will relate to responsible data stewardship.  CDO activities will heavily depend on developing a data strategy that complies with legal, regulatory, contractual and data governance boundaries around data collection, use and disclosure.  CDOs should work closely with legal counsel and compliance personnel to effectively navigate these challenges.  Further discussion of the legal and regulatory landscape around data use is available here.

The Importance of CDOs in Transforming Healthcare Companies

It is clear that leveraging data will be key to innovating, gaining efficiencies, and driving down costs over time.  Yet, many organizations continue to struggle with making sense of the data they possess.   For some, the CDO may be a critical driving force to advance a business into a new landscape.  Just as the CCO helped address decades of frustration with corporate ethics and practices (and was soon demanded by lawmakers and regulators), the role of the CDO has emerged in response to demand for efficiencies in business practices and the recognition that data has become the world’s most valuable commodity.

In light of the explosion of data in the healthcare industry, organizations should consider whether and how a CDO will fit into the corporate structure. Furthermore, organizations should work to understand how having a person at the table with a keen eye towards giving life to an organization’s data resources can benefit the business long term from internal and external perspectives.  The ultimate question a CDO can help solve is:  What don’t we know that, if we knew, would allow our organization to innovate or operate more efficiently or effectively?

 

©2019 Epstein Becker & Green, P.C. All rights reserved.
This post was written by Alaap B. Shah and Andrew Kuder of Epstein Becker & Green P.C.

A Momentary Victory for the ACA: Federal Judge Issues a Nationwide Injunction against Trump Administration’s Contraceptive Coverage Carve Outs

On January 14, 2019, US District Judge Wendy Beetlestone in the US District Court for the Eastern District of Pennsylvania issued a nationwide preliminary injunction blocking the Trump administration’s carveouts to the Affordable Care Act’s (ACA) contraceptive coverage mandate. One day prior, US District Judge Haywood Gilliam in the US District Court for the Northern District of California issued a more limited injunction blocking the same carve outs from taking effect in 13 states plus the District of Columbia.

On October 6, 2017, the Trump administration issued rules that are the subject of these two decisions. The rules would have allowed employers to raise religious and moral objections to avoid the ACA’s requirement that contraceptive coverage be provided without cost sharing under their group health plans. Under the ACA, certain contraceptive products and services are included in the list of preventive services that must be covered by most group health plans without cost sharing. The available exemptions to this rule were limited.

Judge Beetlestone reasoned that the loss of contraceptive coverage would have resulted in “significant” and “proprietary harm” to the states by causing increased use of state-funded contraceptive services, along with increased costs associated with unintended pregnancies. Without the preliminary injunction, the Trump administration’s rules would have gone into effect on January 14, 2019. The preliminary injunction does not permanently block the rules, but rather it stops the rules from going into effect while legal challenges are being pursued. Judge Beetlestone indicated that she is likely to invalidate the rules, stating that the US Departments of Health and Human Services, Labor and Treasury exceeded the scope of their authority under the ACA by issuing the carve outs.

Charnae Supplee, a law clerk in the Firm’s Washington, DC office, also contributed to this post. 

 

© 2019 McDermott Will & Emery
This post was written by Jacob Mattinson Judith Wethall and Charnae Supplee of McDermott Will & Emery.

New Medicare Advantage and Part D Drug Pricing Proposed Rule

On November 26, 2018 the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.This proposed rule is the Trump Administration’s latest action to curb prescription drug prices. The proposed rule outlines a number of provisions to for lowering drug prices and reducing out-of-pocket costs in the Part D program that build off the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Below details the major provisions within the proposed rule.

Six Protected Classes

One of the most significant changes the proposed rule details involves increasing flexibility for Part D sponsors in their coverage of drugs in the six protected classes. As background, current Part D policy requires Part D plans to include on their formularies all drugs in the following six classes: (1) antidepressants; (2) antipsychotics; (3) anticonvulsants; (4) immunosuppressants for treatment of transplant rejection; (5) antiretrovirals; and (6) antineoplastics. Together these drugs are commonly referred as the six protected classes.

This rule does not change or remove any of the six protected classes. Instead, it proposes three exceptions that would allow Part D sponsors to not cover a protected class drug. Specifically, it would allow Part D sponsors to: (1) implement broader use of prior authorization and step therapy for protected class drugs; (2) exclude a protected class drug from a formulary if the drug represents only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market; and (3) exclude a protected class drug from a formulary if the price of the drug increased beyond a certain threshold over a specified look-back period.

In 2014, the Obama Administration proposed removing three of the protected classes (antidepressants, antipsychotics, and immunosuppressants). This rule was never finalized due to criticism by Congress as well as drugmakers and beneficiary advocates. We can expect similar criticism of this new proposal. CMS is seeking comment on considerations that would be necessary to minimize (1) interruptions in exiting therapy, and (2) increases in overall Medicare spending from increased utilization of service due to interruptions in therapy.

Gag Clauses

In October, the President signed the Know the Lowest Price Act of 2018 (P.L. 115-262) into law. This law prohibits Part D sponsors from including in their contracts with their network pharmacies “gag clauses.” Gag clauses restrict the ability of pharmacies to discuss the availability of prescriptions at a cash price when it is less than the amount that would be charged when receiving the prescription through insurance. This measure will go into effect January 1, 2020. The proposed rule amends Part D regulations to be consistent with this statutory change.

Real-Time Benefit Tool

The proposed rule is also requiring that Part D sponsors implement an electronic Real Time Benefit Tools (RTBT) for providers beginning on or before January 1, 2020. The tool should have capability to inform prescribers when lower-cost alternative therapies are available under the beneficiary’s prescription drug benefit.

Part D Explanation of Benefits

The proposed rule also requires Part D plans to include the following information in each members’ Explanation of Benefits: (1) the inclusion of drug pricing information and (2) lower cost therapeutic alternatives.

Step Therapy

In August, CMS published a memo announcing that MA plans could use step therapy as a utilization management tool for Part B drugs. This proposed rule formally codifies that change. Step therapy can only be applied to new prescriptions or for enrollees who are not actively receiving the affected medication. MA plans would also be required to use a Pharmacy and Therapeutics committee to review and approve step therapy programs. Additionally, determination and appeals processes for Part B drugs will be subject to shorter adjudication times that mirror Part D timeframes.

Pharmacy Price Concession in the Negotiated Price

The final provision in the proposed rule would re-define “negotiated price.” Negotiated price is the price reported to CMS at point of sale. Under current law, Part D sponsors can generally choose whether to reflect in the negotiated price the various price concessions they or their intermediaries receive. Beneficiary cost-sharing is generally calculated as a percentage of the negotiated price. When pharmacy price concessions and other price concessions are not reflected in the negotiated price at the point of sale, beneficiary cost-sharing increases. The proposed rule is considering to revise the definition of the negotiated price to include all pharmacy price concessions and any dispensing fees, and exclude additional contingent amounts in the negotiated price. This would re-define negotiated price as the baseline, or lowest possible, payment to a pharmacy. Implementation of this change is not certain. However, CMS noted the policy could be implemented as early as 2020.

Next Steps

Comments to the proposed rule can be submitted until January 25, 2019. We can expect significant industry and stakeholder feedback on the proposed rule. Policy changes related to drug pricing are sure to be controversial.  What remains to be seen is which changes are so controversial as to lead to sufficient public outcry that it brings down parts of the proposed regulation or all of it.

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

ARTICLE BY

Katie Weider
Rodney L. Whitlock
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