Electric shock device to treat mental illness reduced to medium risk

The FDA has proposed reclassification of the electroconvulsive therapy (ECT) device for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients 18 years of age and older. The proposed use would be limited to patients who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

The ECT device is used to induce a major motor seizure in the patient by applying a brief intense electrical current to the patient’s head. Under the proposed order, the device would be reclassified based on the availability of new clinical literature from Class III (highest risk–premarket approval) to Class II (medium risk) with certain special control requirements. The reclassification, however, would not exempt the device from the necessity of filing a premarket notification (510(k)) submission prior to marketing.

Regulatory background

In 1979, the FDA decided to classify the ECT device into Class III, rather than Class II, after several Neurological Device Classification Panel members expressed doubt that the characteristics of the device had been identified precisely enough such that special controls could be established providing reasonable assurance of safety and effectiveness (44 FR 51776, September 4, 1979).

Clinical evidence

In 2009, the FDA opened a public docket to receive information regarding classification of the device (74 FR 46607, September 10, 2009) and received over 3,000 submissions, with the majority of respondents (80 percent) opposing reclassification. The majority of those opposing reclassification cited adverse events from ECT treatment, such as memory loss, brain damage, and death.

The FDA’s review of new clinical literature submitted was summarized in the Executive Summary to the January 27-28, 2011, Neurological Device Panel meeting to discuss ECT classification. The Panel transcript and other meeting materials are available on FDA’s website. Based on this review, FDA concluded that the ECT device demonstrated effectiveness in the acute phase (less than 3 months after treatment).

Panel members, however, indicated that controlled clinical trials are lacking regarding the effectiveness of ECT beyond the acute phase (e.g. long-term effectiveness), in part, due to the fact that many patients have an initial improvement in the depressive symptoms following an acute course of ECT and are able to return to other treatments for managing depression, such as medications and psychotherapy. The FDA examined the results of over 60 randomized controlled clinical trials comparing ECT with either placebo (sham) or antidepressant therapy. The FDA also examined other conditions, including bipolar mania, schizophrenia, schizoaffective disorder, schizophreniform disorder, and catatonia, but there were insufficient clinical data to support effectiveness for these conditions. The ECT device will remain in Class III to be approved for these uses.

The recommended reclassification is limited to patients 18 years of age and older because data on the use of ECT in children and adolescents is limited. Most of the published literature FDA is aware of and reviewed focused on subject populations that did not receive benefit from prior treatments; therefore, the recommended reclassification is limited to treatment resistant populations as well as those patients who require a rapid response due to the severity of their psychiatric or medical condition. Further, practice guidelines published by the American Psychological Association task force on ECT and the National Institute for Health and Clinical Excellence in the United Kingdom recommend that ECT be considered for primary use (i.e., prior to medications) when there is a need for rapid, definitive response due to the severity of a psychiatric or medical condition.


According to the clinical evidence, while medical and physical risks may occur with ECT, they vary in frequency, with the most severe risks being quite rare. Death associated with ECT appears to occur at a very low rate comparable to that of minor surgical procedures. In fact, recent estimates of the mortality rate associated with ECT treatment are one per 10,000 patients or one per 80,000 treatments.

The risks of greatest concern to clinicians and patients remain cognitive and memory impairment. Both the FDA review of literature and the meta-analyses of the randomized controlled studies indicate that while post-procedure disorientation occurs frequently, it is transient, typically resolving within minutes after the procedure is complete.

Several of the risks associated with ECT, including adverse reaction to anesthetic agents/neuromuscular blocking agents, cardiovascular complications, death, and pulmonary complications, are medical/physical risks related to the use of the device. For these risks, safe use of the device is based on appropriate directions for use. FDA believes that labeling provisions are adequate to mitigate these risks.

Finally, the risks of skin burns can be mitigated by performance testing of the device to demonstrate safe electrical performance, adhesive integrity, and physical and chemical stability of the stimulation electrodes.

Draft guidance

The FDA has also announced the availability of a draft guidance document entitled “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses,” that, when finalized, would provide recommendations for 510(k) submissions on how to comply with the special controls. Comments on the proposed order and the draft guidance must be submitted by March 28, 2016.

AFIRM Act introduced to streamline and improve Medicare audits and appeals

A bill has been introduced in the U.S. Senate to increase the coordination and oversight of Medicare audit contractors and implement new strategies to address the growing number of audit determination appeals that delay payment of providers. The Audit & Appeal Fairness, Integrity, and Reforms in Medicare (AFIRM) Act of 2015 (S. 2368), introduced by Senator Orrin Hatch (R-Utah) on December 8, 2015, is designed to ease the burden of the Medicare audit and appeals process on providers by creating a more level playing field, while still giving auditors the necessary tools to protect the Medicare Trust Fund.

The Improper Payments Information Act of 2002 (P.L. 107-300) requires HHS to identify programs within HHS that may be susceptible to significant improper payments. As a result, CMS utilizes a variety of audit contractors to discover improper payments, fraud, waste, and abuse. According to a Senate Finance Committee report, more and more providers are concerned with the accuracy of these audits and have been appealing their denied claims, leading to a backlog in the appeals process. Of additional concern is that even as these audit contractor programs have expanded, HHS and CMS oversight of these auditor programs have not kept pace.

The AFIRM Act would strengthen the current audit and appeals process by:

  • Improving the oversight capabilities of HHS and CMS;
  • Coordinating efforts between auditors and CMS to ensure that all parties receive transparent data regarding audit practices, improved methodologies, and new incentives and disincentives to improve auditor accuracy;
  • Creating an independent Ombudsman for Medicare Reviews and Appeals to assist in resolving complaints by appellants and those considering appeal;
  • Requiring the new independent Ombudsman to publish data regarding the number of determinations appealed, each appeal’s outcome, and aggregate appeal statistics for each contractor and provider type;
  • Establishing a voluntary alternate dispute resolution process to allow for multiple pending claims with similar issues of law or fact to be settled as a unit, rather than as individual appeals;
  • Ensuring timely and high quality reviews by raising the amount in controversy for review by an administrative law judge (ALJ) to match the amount for review by the federal district court;
  • Creating a new Medicare Magistrate program for claims below the new amount in controversy, and allowing senior attorneys with expertise in Medicare law and policies to hear and decide the cases in the same manner as ALJs;
  • Allowing for the use of sampling and extrapolation, with the provider’s consent, to expedite the appeals process; and
  • Requiring HHS to study the possibility of shortening the look-back period for audits and giving HHS the authority to shorten the period to less than three years.

AFIRM would also require the Secretary of HHS to submit a report to Congress with recommendations to change audit payment structure from an incentive-based program to a non-incentive based program, in a budget neutral manner.

To fund these changes, AFIRM requires that $127 million would be appropriated from the Medicare Hospital Insurance and Supplemental Medical Insurance trust funds to the Office of Medicare Hearings and Appeals and the Departmental Appeals Board at HHS. These funds will be used to finance reviews, hearings, and appeals.

CBO predicts 2M fewer full-time workers in 2025 due to ACA

The Affordable Care Act (ACA) (P.L. 111-148) will make the labor supply, measured as the total compensation paid to workers, 0.86 percent smaller in 2025 than it would have been without that law, according to a Congressional Budget Office (CBO) report. This will result in about a two million reduction in full-time equivalent (FTE) workers from current levels.

During the 2016–2018 period, the CBO believes that the effects of the ACA on the supply of labor will be smaller, mostly because of delays in responses to changes in law. By 2019, however, the CBO predicts that the ACA will reduce the labor supply by 0.80 percent, increasing to 0.86 percent by 2025.

The CBO’s estimate of the ACA’s effect on the labor supply by 2025 is based on following factors:

  • Health insurance coverage expansions are together expected to reduce the labor supply by 0.65 percentage points. To reach the 0.65 percent reduction, the CBO estimate included the following valuations: (1) exchange subsidies, such as premium assistance credits and cost-sharing subsidies (-0.43 percent reduction); (2) rules governing health insurance, such as provisions prohibiting preexisting health conditions and restricting premiums on the basis of age (-0.17 percent reduction); and (3) an expansion of the Medicaid program (-0.05 percent reduction).
  • The Medicare Hospital Insurance (HI) surtax on high income workers is expected to reduce the labor supply by 0.12 percentage points. The HI surtax raises the Medicare payroll tax by 0.9 percentage points for workers who earn more than $200,000 per year (or $250,000 for those filing a joint return).
  • Other factors expected to collectively reduce the labor market by 0.10 percent include: (1) the penalty on larger employers (50 or more FTE employees) that do not offer insurance coverage (-0.06 percent); (2) the 40 percent excise tax on certain employment-based high-premium insurance plans (-0.03 percent); and (3) the penalty on certain individuals who do not obtain coverage (-0.01 percent). In 2016, for example, the individual penalty is $695 per person in a household or 2.5 percent of household income in excess of the general tax-filing threshold.

To determine the ACA’s effect on FTE employment, the CBO took its  0.86 percent reduction estimate, valued at $120 billion, and divided that number by $61,000, the estimated amount that workers affected by the ACA would earn if they worked full time for all of 2025. The result was an estimated reduction in FTE workers of about 2 million.

The CBO concedes that its estimates of the ACA’s effects on the labor supply are uncertain. This is because they are based in large part on projections of the ACA’s effects on health insurance coverage and on the federal budget, which are highly uncertain and could deviate from the agency’s estimates.


FDA quietly lifts knowledge-based labeling requirement from the ‘intended use’ definition for drugs and devices

On September 25, 2015, the FDA issued a proposed rule ostensibly designed to merely clarify the circumstances in which a tobacco product “intended” for human consumption will be deemed subject to regulation as a drug, device, or a combination product.  On its face, the proposed rule only affects tobacco products. However, if one reads the preamble and the proposed regulations carefully, they will see that the FDA  is also quietly proposing the amendment of the drug and device “intended use” definitions at 21 C.F.R. §§201.128 (drugs) and 801.4 (devices) to: (1) eliminate the need for a manufacturer or distributor to label a drug or device for an off-label, or unapproved, use solely because it has knowledge that the product is being prescribed or used by a physician(s) for that off-label use; and (2) to ameliorate industry fears that the FDA may deem the off-label use by a physician(s) to be an unapproved use, potentially resulting in FDA action against the manufacturer or distributor.

The original “intended use” definitions for drugs and devices were issued in on February 13, 1976 (41 FR 6911). They state that to establish a product’s intended use, and thereby determine the FDA’s regulatory authority and appropriate labeling, the FDA is not limited by the manufacturer or distributor’s subjective claims of intent, but can also consider objective evidence, such as direct and circumstantial evidence. This objective intent may be shown by labeling claims, advertising matter, or oral and written statements by the manufacturer or distributors or their representatives. It may also be shown by circumstances in which the product is, with the knowledge of the manufacturer, distributor, or their representatives, offered and used for a purpose for which it is neither labeled or advertised. This objective intent definition will not be altered if the proposed rule is finalized.

The proposed rule, however, removes the following language from both 21 C.F.R. §§201.128 and 801.4, which has been present since 1976:

“But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.”

While the FDA has never enforced this so-called ‘knowledge’ provision, this long-overdue removal of the language should eliminate any lingering doubt in the minds of industry that providing FDA-approved on-label product use information to physicians that may be prescribing the product off-label will not subject the manufacturer or distributor to criminal or civil liability, or accusations that their labeling is inadequate.  As the FDA explicitly states on page 57757 of the proposed rule: “The Agency would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by doctors for such use [emphasis added].”

Firms, however, are not totally off the hook.  They should take note of the fact that the FDA deliberately used the word “solely.” Therefore, if something more than mere knowledge of off-label use by the physician is present, the FDA may still take action.