Category: Health Care Law

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

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.

CMS Proposes to Overhaul the Medicare Shared Savings Program

On August 9, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to overhaul the Medicare Shared Savings Program (MSSP). The proposal, titled “Pathways to Success,” would make significant changes to the accountable care organization (ACO) model at the heart of the program. The proposed changes include a restructuring of the current ACO risk tracks, updating spending benchmarks, increased ACO flexibility to provide care, as well as changes to the electronic health records requirements for ACO practitioners.

Background

There are currently 561 Shared Savings Program ACOs serving over 10.5 million Medicare fee-for-service (FFS) beneficiaries. Under the MSSP, ACOs are assessed based on quality and outcome measures, and by comparing their overall health care spending to a historical benchmark. ACOs receive a share of any savings under the historical benchmark if they meet the quality performance requirements.

Currently, the MSSP allows ACOs to participate in one of three “tracks.” Track 1 is a “one-sided” model, meaning that participating ACOs share in their savings, but are not required to pay back spending over the historical benchmark. Track 2 and Track 3 are “two-sided” models, meaning that participating ACOs share in a larger portion of any savings under their benchmark, but may also be required to share losses if spending exceeds the benchmark. Currently, the vast majority of ACOs participate in Track 1.

Restructuring the Tracks

CMS proposes retiring Track 1 and Track 2, creating a BASIC track, and renaming Track 3 the ENHANCED Track. CMS describes the BASIC track as a “glide path” that will help ACOs transition to higher levels of risk and potential reward.  To that end, the BASIC track contains five levels that ACOs would transition through over the course of a five year contract period, spending a maximum of one year at each level. The first two years would involve upside-only risk, with a transition to increasing levels of financial risk in the remaining three years. Current Track 1 ACOs will be limited to one-year of upside-only participation before taking on downside risk. This is a substantial acceleration from the current Track 1 Model, which permits ACOs to avoid downside risk for up to six years.

Finally, the proposed rule draws a distinction between low revenue ACOs and high revenue ACOs. Low revenue ACOs (typically composed of rural ACOs and physician practices) would be permitted to spend two 5-year contract periods on the BASIC track. High revenue ACOs (typically composed of hospitals) would be permitted only one 5-year contract period on the Basic track.

Source: Proposed Rule: Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations–Pathways to Success

Updating the Historical Spending Benchmarks

Every year, an ACO’s spending is comparing to its historical benchmark to determine the ACO’s participation in any shared savings or losses. Under the proposed rule, the benchmark methodology will incorporate regional FFS expenditures beginning in the first contract period. Also, the historical benchmark will be rebased at the beginning of each 5-year contract period. Adjustments to the benchmark related to regional expenditures will be capped at 5% of the national Medicare FFS per capita expenditure. According to CMS, these changes will improve the predictability of historical benchmark setting and increase the opportunity for ACOs to achieve savings against the historical benchmark.

Expanding ACO Flexibility in Beneficiary Care

The proposed rule contains several changes to the MSSP aimed at increasing the flexibility of ACOs to provide cost-effective care to their assigned beneficiaries. For example, to support the ACO’s coordination of care across health care settings, ACOs will be eligible to receive payment for telehealth services furnished to prospectively assigned beneficiaries even when they would otherwise be prohibited based on geographic prerequisites. The proposed rule also expands the Skilled Nursing Facility (SNF) 3-Day Rule Waiver to all ACOs in two-sided models. This waiver permits Medicare coverage of certain SNF services that are not preceded by a qualifying 3-day inpatient hospital stay.

Finally, the proposed rule permits ACOs in two-sided models to reward beneficiaries with incentive payments of up to $20 for primary care services received from ACO professionals, Federally Qualified Health Centers, or Rural Health Clinics.

Changing Electronic Health Record Requirements

Currently, one of the quality measures for which ACOs are assessed relates to the percentage of participating primary care providers that successfully demonstrate meaningful use of an electronic health records system for each year of participation in the program. The proposed rule eliminates this measure. Instead, CMS proposes to adopt an “interoperability criterion” that assesses the use of certified electronic health record technology for initial program participation and as part of each ACO’s annual certification of compliance with program requirements.

Commentary

CMS’s proposal is not surprising in light of CMS Administrator Seema Verma’s recent comments about upside-only ACOs. At an American Hospital Association annual membership meeting this past spring, Administrator Verma is quoted as saying:

[T]he majority of ACOs, while receiving many waivers of federal rules and requirements, have yet to move to any downside risk.  And even more concerning, these ACOs are increasing Medicare spending, and the presence of these ‘upside-only’ tracks may be encouraging consolidation in the market place, reducing competition and choice for our beneficiaries.  While we understand that systems need time to adjust, our system cannot afford to continue with models that are not producing results.

Though the rule is only a proposal at this time, the above comments illustrate that CMS is serious about requiring providers to be more financially accountable for the care of their patients. And the agency is clear-eyed about the short-term impact of the proposal, estimating that more than 100 ACOs will exit the MSSP over the next 10 years if the proposal is finalized.  The agency nevertheless believes that the new program would be attractive to providers due to its simplicity (as compared to the current program) and the new opportunity it offers clinicians to qualify as participating in an Advanced Alternative Payment Model (APM) when they reach year 5 of the BASIC track. APMs are an important concept under the Quality Payment Program (QPP) that was ushered in by the Medicare Access and CHIP Reauthorization Act of 2015. Clinicians participating in an Advanced APM are exempt from reporting under the QPP’s Merit-based Incentive Payment System (MIPS) and are eligible for certain financial incentives. The fates of the MSSP and the QPP are thus intertwined, and the co-evolution of the programs is at a critical stage, especially in light of CMS’s July release of a proposed rule modifying the QPP. We will continue to report on the developments of both of these programs.

 

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

Are you Afraid of What Lurks in the Deep Water of your ERISA Plan?

Fear of creatures that lurk in deep water is pretty universal – for confirmation, look no further than the numerous summer movies featuring unexpected attacks by fierce underwater predators with sharp teeth. Inevitably, none of the victims seem to have any tools that will actually save them.  One after another, their tools break, and their escape attempts fail pitifully.  Unfortunately, such movies give the impression that the only protection from these predators is staying out of the water altogether.

If sponsoring and administering ERISA employee benefit plans seems as dangerous to you as swimming in deep water, be assured that there are tools and approaches that can be vital to risk management. Amending your ERISA plan document and summary plan description to include appropriate plan provisions, for instance, can minimize your exposure as a plan administrator.  For example:

  • Does your plan reserve discretionary authority to the plan administrator? Explicitly reserving discretionary authority to the plan administrator can prevent a court from exercising its own discretion to your detriment. Almost thirty years ago, the Supreme Court of the United States recognized the effectiveness of such language; court opinions continue to highlight the importance of this provision, as was done in a recent opinion issued by the Sixth Circuit in Clemons v. Norton Healthcare Inc. Retirement Plan, 890 F.3d 254 (May 10, 2018). Because it is so important, you should not assume that it is automatically included in every plan document and summary plan description. Work with benefits counsel to have your documents reviewed to make sure this provision is included.
  • Does your plan invalidate assignments of claims? Sometimes, a doctor or hospital asks a participant to sign a document that assigns to the provider the participant’s claim for benefits, meaning that the provider can stand in the shoes of the participant in bringing suit against your plan for coverage of claims. An anti-assignment clause invalidates such an assignment. Your plan’s participants and beneficiaries can still bring claims (and suit, if necessary), but they cannot assign such claims to their providers. Such a clause was upheld recently by the Third Circuit in American Orthopedic & Sports Medicine v. Independence Blue Cross & Blue Shield, 2018 WL 2224394 (May 16, 2018).
  • Does your plan contain a plan-based statute of limitations? In ERISA cases, a question about which statute of limitations applies (which, as a practical matter, means how many years later a plaintiff can sue you) can be a complicated issue, involving both state and federal law. Short-circuit those disagreements by amending your plan and summary plan description to establish a reasonable plan-based statute of limitations. Make sure your claims and appeal provisions, and all claim or appeal denial notices, discuss the statute of limitations. For example, a properly drafted plan-based statute of limitations resulted in a dismissal of a lawsuit because a plaintiff failed to bring suit within 3 years of his claim – without that plan provision, the court would have applied Puerto Rico’s default statute of limitations for contract claims, which would have permitted suit within 15 years of the claim. Santaliz-Rioz v. Met. Life Ins. Co., 693 F.3d 57 (1stCir. 2012), cert. denied., 569 U.S. 904 (2013).

When it comes to health and welfare plans, note that, if you do not yet have a plan document and summary plan description, now is the time to get one. Benefit summaries provided by your insurer are helpful and important documents, but they may not contain all the elements required by ERISA.  Moreover, by adopting a plan document and summary plan description, you will have a document to include provisions like those highlighted above.

Having an ERISA attorney review (or draft) your plan document and summary plan description can save you money and headaches down the line. After all, a lawsuit may not be quite as scary as staring into a 75-foot-long prehistoric shark’s open jaws – but do you really want to find out through personal experience?

 

© Steptoe & Johnson PLLC. All Rights Reserved.

Saliva Test Predicts Prolonged Concussion Symptoms in Children

According to the American Academy of Pediatrics, although the majority of concussions that are diagnosed annually occur in children, clinical guidelines are usually based on adult concussion sufferers. The lack of guidelines may limit the ability of pediatricians to accurately predict the duration of a child’s symptoms, including headaches, fatigue, and concentration problems — which can interfere with school and other activities.

In many concussion cases, concussion symptoms last only a few days. However, up to 25 percent of children have prolonged concussion symptoms which can last for months.

Concussion Symptom Saliva Test Study Presented at Annual Meeting

New research presented at the 2017 Pediatric Academic Societies (PAS) Meeting suggests that a saliva test for children may offer answers as to how long concussion symptoms will last. Researchers presented an abstract of the study, “Peripheral microRNA patterns predict prolonged concussion symptoms in pediatric patients.” The PAS Meeting is produced through a partnership of four organizations: Academic Pediatric Association, American Academy of Pediatrics, American Pediatric Society, and Society for Pediatric Research.

Results of Concussion Symptom Saliva Test Study

Following a concussion, injured brain cells release fragments of genetic material (microRNAs) which show up in blood and saliva. Studies have found altered micro ribonucleic acids (miRNA) levels in the saliva of children with mild concussions. Similar miRNA changes have been found in cerebrospinal fluid of patients with severe brain injury.

Researchers at Penn State College of Medicine studied 50 children, ages 7 to 18 years old who experienced mild traumatic brain injury. Spit samples from each child were tested for miRNA levels. Concussion symptoms were evaluated through the parent and child Sports Concussion Assessment Tool (SCAT-3) surveys.

Researchers found that salivary miRNA levels were more effective than SCAT-3 surveys in predicting which children would continue to experience concussion symptoms that lasted longer than four weeks. The SCAT-3 surveys were less than 70 percent accurate in identifying children who would have prolonged concussion symptoms. The miRNA saliva test correctly predicted whether concussion symptoms would last for at least a month nearly 90 percent of the time.

The saliva-based RNA testing indicates the potential for an accurate and non-invasive method to evaluate pediatric concussions and provide a more accurate prognosis.

This post was written by Bruce H. Stern of STARK & STARK., COPYRIGHT © 2017
For more Health Care Law legal analysis go to The National Law Review

Mild Traumatic Brain Injury and the Pupillary Light Reflex

According to a recent review study of Pubmed Central/National Library of Medicine databases, the pupillary light reflex provides an optimal opportunity to investigate mild traumatic brain injury (mTBI).

Based on the findings of the review, the pupillary system may provide a noninvasive “window” to mTBI, in terms of documenting its existence and the often-accompanying symptom of photosensitivity. When an individual experiences mTBI, visual dysfunction may occur, and the pupillary light reflex may be affected. Pupils are routinely assessed for abnormal size and responsivity to determine the neural integrity of the visual system. Investigating pupillary light reflex in the mTBI population, researchers found that pupillary response was significantly delayed, slowed, and reduced, symmetrically, with a smaller baseline diameter. These findings may indicate dysfunction of the pupillary pathway.

Several objective biomarkers for the presence of mTBI and photosensitivity provide further insight into neurological dysfunction. In mTBI, photosensitivity may be due to dysfunction in the baseline neural sensor. Photosensitivity as a perceptual phenomenon can be confirmed through objective, noninvasive, rapid, vision-based, pupillary biomarkers.

Pupillary light reflex in mTBI may be investigated with pupillometers to assess subtle abnormalities in pupil size as well as pupillary responses. The resulting information can provide diagnostic or prognostic indicators relating to the extent of the injury, and neurophysiological linkages. Pupillometers offer precise and extensive pupillary testing for the mTBI population, especially those individuals who experience photosensitivity. The major drawback is cost. Development of a more inexpensive hand-held pupillometer would help with diagnosis of mTBI and improve patient care.

With such instrumentation, pupillary light reflex could be used to investigate the possibility of a very early, acute-stage mTBI/concussion in emergency rooms, in the workplace, and even on the sideline of sports games. Such information can be relevant to a worker’s compensation determinations, social security disability determinations, and return-to-play/work/learn standards for both adults and children.

This post was written by Bruce H. Stern of STARK & STARK., COPYRIGHT © 2017
For more Biotech legal analysis, go to The National Law Review 

Elder Abuse: Are Granny Cams a Solution, a Compliance Burden, or Both?

In Minnesota, 97% of the 25,226 allegations of elder abuse (neglect, physical abuse, unexplained serious injuries and thefts) in state-licensed senior facilities in 2016 were never investigated. This prompted Minnesota Governor, Mark Dayton, to announce plans last week to form a task force to find out why. As one might expect, Minnesota is not alone. A studypublished in 2011 found that an estimated 260,000 (1 in 13) older adults in New York had been victims of one form of abuse or another during a 12-month period between 2008 and 2009, with “a dramatic gap” between elder abuse events reported and the number of cases referred to formal elder abuse services. Clearly, states are struggling to protect a vulnerable and growing group of residents from abuse. Technologies such as hidden cameras may help to address the problem, but their use raises privacy, security, compliance, and other concerns.

With governmental agencies apparently lacking the resources to identify, investigate, and respond to mounting cases of elder abuse in the long-term care services industry, and the number of persons in need of long-term care services on the rise, this problem is likely to get worse before it gets better. According to a 2016 CDC report concerning users of long-term care services, more than 9 million people in the United States receive regulated long-term care services. These numbers are only expected to increase. The Family Caregiver Alliance reports that

by 2050, the number of individuals using paid long-term care services in any setting (e.g., at home, residential care such as assisted living, or skilled nursing facilities) will likely double from the 13 million using services in 2000, to 27 million people.

However, technologies such as hidden cameras are making it easier for families and others to step in and help protect their loved ones. In fact, some states are implementing measures to leverage these technologies to help address the problem of elder abuse. For example, New Jersey’s Attorney General recently expanded the “Safe Care Cam” program which lends cameras and memory cards to Garden State residents who suspect their loved ones may be victims of abuse by an in-home caregiver.

Common known as “granny cams,” these easy-to-hide devices which can record video and sometimes audio are being strategically placed in nursing homes, long-term care, and residential care facilities. For example, the “Charge Cam” (pictured above) is designed to look like and actually function as a plug used to charge smartphone devices. Once plugged in, it is able to record eight hours of video and sound. For a nursing home resident’s family concerned about the treatment of the resident, use of a “Charge Cam” or similar device could be a very helpful way of getting answers to their suspicions of abuse. However, for the unsuspecting nursing home or other residential or long-term care facility, as well as for the well-meaning family members, the use of these devices can pose a number of issues and potential risks. Here are just some questions that should be considered:

  • Is there a state law that specifically addresses “granny cams”? Note that at least five states (Illinois, New Mexico, Oklahoma, Texas, and Washington) have laws specifically addressing the use of cameras in this context. In Illinois, for example, the resident and the resident’s roommate must consent to the camera, and notice must be posted outside the resident’s room to alert those entering the room about the recording.
  • Is consent required from all of the parties to conversations that are recorded by the device?
  • Do the HIPAA privacy and security regulations apply to the video and audio recordings that contain individually identifiable health information of the resident or other residents whose information is captured in the video or audio recorded?
  • How do the features of the device, such as camera placement and zoom capabilities, affect the analysis of the issues raised above?
  • How can the validity of a recording be confirmed?
  • What effects will there be on employee recruiting and employee retention?
  • If the organization permits the device to be installed, what rights and obligations does it have with respect to the scope, content, security, preservation, and other aspects of the recording?

Just as body cameras for police are viewed by some as a way to help address concerns over police brutality allegations, some believe granny cams can serve as a deterrent to abuse of residents at long-term care and similar facilities. However, families and facilities have to consider these technologies carefully.

This post was written by Joseph J. Lazzarotti  of Jackson Lewis P.C. © 2017
For more legal analysis, go to The National Law Review 

FDA Issues Final Regulations Easing the Path for Direct-to-Consumer Genetic Testing

New regulations issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers, without a health-care provider intermediary.

The first regulation finalizes a new medical device classification for “autosomal recessive carrier screening gene mutation detection systems.”  This regulation essentially codifies classification already established by FDA in response to a request by 23andMe, and  enables other laboratories to offer their DTC tests according to the criteria specified in the classification regulation.  These tests may be offered without the need for FDA premarket review.

Similarly, the second regulation finalizes a new medical device classification for  DTC “genetic health risk assessment” (GHR)  (i.e., predictive) tests.  The classification specifies the conditions under which these tests may be marketed, and includes the requirement for a 510(k) premarket notification to FDA. However, in a Federal Register Notice, also issued yesterday, FDA proposes to exempt GHR tests from the 510(k) premarket submission requirement after a lab has successfully obtained FDA clearance of its first GHR assay.  Comments to this proposed exemption are being accepted by FDA until January 8. 

This post was written by Gail H. Javitt of Epstein Becker & Green, P.C. All rights reserved., ©2017
For more Health Care legal analysis, go to The National Law Review