The recent influx of state legislation on biologics and biosimilars may actually hinder rather than advance the use of biosimilars. Our colleagues Theresa Carnegie, Joanne Hawana, and Ellyn Sternfield discuss this issue in a recent article published in BNA’s Medicare Report. The article examines recent state and federal action affecting substitution and reimbursement of biosimilars. In a previous blog post, we looked at the guidance released by the Centers for Medicare and Medicaid Services on reimbursement of biosimilars under Medicare Parts B and D and Medicaid.
Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would have prevented prescribing via telemedicine. The regulation’s suspension stems from an antitrust claim brought by a national telehealth provider, Teladoc, Inc. (“Teladoc”), and other plaintiffs against the Board alleging that the Board’s new regulation violates Section 1 of the Sherman Act and the Commerce Clause.
The injunction is the latest blow in a lengthy battle in Texas regarding the standards for appropriate telemedicine practice and is one of the first major cases challenging the actions of a state medical board in the wake of the Supreme Court’s decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission, No. 13-354, slip op. (U.S. Feb. 25, 2015). In that case, the Supreme Court held that the antitrust laws would apply to – and the state action exemption would not protect – activities of state agencies or boards made up of market participants, absent active state supervision of the Board’s challenged conduct. (Further discussion of the case is available in the Mintz Levin Antitrust Alert, Feb. 26, 2015, “No Active State Supervision, No Antitrust Immunity for North Carolina State Dental Board”.)
Although the Board is a state agency “statutorily empowered to regulate the practice of medicine in Texas,” notably, it did not assert a state action immunity defense. The court found the absence of a state action defense significant and somewhat unusual, stating:
Significantly, in this case, the TMB declined to assert any immunity defenses, including Parker immunity, solely as to Plaintiffs’ application for a preliminary injunction. The normal deference afforded to a state under antitrust law is, therefore, not an issue in reviewing Plaintiff’s application for a preliminary injunction. The Court’s opinion is properly read through that narrow, and unusual, lens.
Teladoc Inc. v. Texas Medical Board, No. 1-15-CV-343-RP (W.D. Tex. May 29, 2015) (order granting preliminary injunction).
In the wake of the Supreme Court’s North Carolina Board of Dental Examiners decision, whether the Board asserts a state action immunity defense in future proceedings will undoubtedly be closely followed and analyzed, as will any basis asserted for the defense.
On June 1st, the Centers for Medicare and Medicaid Services (CMS) released a State Medicaid Director Letter (SMD Letter) providing guidance to states on the criminal background check and fingerprinting requirements for Medicaid provider enrollment. This sub-regulatory guidance starts a 60 day clock for state Medicaid programs to implement these enhanced provider screening requirements. Meaning, on August 1st providers determined to be at a high risk of defrauding the Medicaid program should expect fingerprint-based background checks.
The regulations requiring states to perform criminal background checks and fingerprinting on certain providers as part of the Medicaid enrollment, re-enrollment, and verification processes are not new. CMS issued these regulations in 2011 to implement Section 6401 of the Affordable Care Act, which requires the Secretary of the Department of Health and Human Services to develop procedures for screening providers and suppliers under Medicare and Medicaid. Following the release of these rules, CMS released an Informational Bulletin stating “additional sub-regulatory guidance will be issued on criminal background checks and fingerprinting requirements, following which States will have 60 days to implement these enhanced provider screening requirements.” This SMD Letter represents that additional sub-regulatory guidance. Continue Reading
Yesterday, ML Strategies posted its Health Care Update and Telehealth Policy Alert. This publication provides timely information for those who are already in, or contemplating entering, the telehealth space.
Key legislative initiatives so far this year include the Sustainable Growth Rate (SGR) repeal, which addressed several aspects of telehealth policy, the 21st Century Cures Initiative, the Telehealth Enhancement Act, and the Senate chronic care working group. Although many of these initiatives do not go as far as some stakeholders would like to address the barriers to widespread implementation of telehealth, the Alert notes that larger legislative efforts appear to be underway that would expand Medicare reimbursement for telehealth.
In addition to legislative initiatives, the Obama Administration has been active in the area of telehealth. In March, CMS unveiled its “Next Generation ACO” program that promises flexibility around Medicare telehealth rules. And the FDA and FTC have provided guidance on the regulation of medical device data systems.
These congressional and administrative initiatives (as well as several others) are discussed in detail in the Alert and highlight current opportunities for stakeholders to consider for shaping the future of telehealth.
The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31, 2015.
The Report highlights OIG’s accomplishments over the first half of FY 2015, including OIG’s expected recoveries of over $1.8 billion, comprised of approximately $544.7 million in audit receivables and $1.26 billion in investigative receivables. Over the same period, OIG reported 486 criminal actions against individuals and entities that engaged in crimes against HHS programs and 326 civil actions, including false claims cases, unjust-enrichment lawsuits, civil monetary penalties settlements, and administrative recoveries related to provider self-disclosure matters. OIG also reported exclusions of 1,735 individuals and entities from participation in Federal health care programs.
Whether you are on the defense side or the relator side of the qui tam world, you can count the Supreme Court’s opinion in Kellogg, Brown & Root Services, Inc. v. United States ex. Rel. Carter as a win and a loss. Since January’s oral arguments, the False Claims Act bar has eagerly awaited the Supreme Court’s ruling on the Wartime Suspension of Limitations Act (WSLA) and the qui tam “first to file” provision in the False Claims Act (FCA).
The defense bar can celebrate because the Supreme Court reversed the Fourth Circuit and found that the WSLA applies only to criminal offenses, not civil FCA claims. Relators can applaud the Supreme Court’s ruling that the FCA’s first-to-file bar only blocks a claim while a related action is actively pending, but not after it is dismissed. Continue Reading
Earlier this month, HHS Secretary Silvia Burwell made a game-changing announcement about the Obama Administration’s most significant alternative payment model (APM). The Pioneer Accountable Care Organization (Pioneer ACO) model is the first pilot to receive formal certification of its cost-saving potential from the Office of the Actuary at CMS. This key milestone means that the Pioneer ACO model has met the requirement to show reduced Medicare spending and can now be expanded by CMS, as authorized by the Affordable Care Act (ACA).
The ACA requires APMs to “improve the quality of patient care without increasing spending” as determined by the HHS Secretary before being expanded. It was no accident that, coinciding with the CMS Actuary’s certification on spending, the GAO found that Pioneer ACOs that participated in both 2012 and 2013 had significantly higher quality scores in the second year over the first year for 67 percent of the quality measures. The GAO concluded that this demonstrates the sustainability of the Pioneers’ quality improvement potential.
Finally, to further mark this achievement, CMS officials penned a New England Journal of Medicine perspective piece assessing the CMS Innovation Center’s progress in developing APMs over the past five years. In the article, the authors highlighted the 26 models that have been launched since 2010 and emphasized that they reach across all 50 states and through the entire care spectrum. The article also highlights the Obama Administration’s efforts to accelerate payment reform through multi-payer engagement/alignments and the need for further change in Medicare payment systems, especially as more APMs become eligible for expansion.
UPDATE: On May 27, 2015, FDA announced that it was granting additional time for companies to begin submitting electronic postmarketing safety reports for drugs and biologics. Although the effective date for the requirement is June 10, 2015, the Agency is delaying the compliance date until September 8, 2015 (an additional 90 days). FDA states that it took this action in order to ensure that regulated entities have sufficient opportunity to register with and test the functionality of the Safety Reporting Portal (SRP), which has just become available.
In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and expeditious flow of information about drugs and medical devices from industry to the Agency. The rapid movement by the Agency in this space is being driven by a congressional mandate included in the Food and Drug Administration Safety and Innovation Act (FDASIA).
It is important to note that the shift to electronic submissions does not change the underlying requirements for when the various filings must be made or the content of those filings; it only affects the method of submission and the technical specifications for the e-filings.
This blog post outlines some of FDA’s recent actions to expand the requirements for electronic submissions. If you are a regulated entity that regularly submits adverse event reports, product applications, or promotional materials to FDA (and who doesn’t?), you should ensure that you are aware of the relevant compliance dates and that you are implementing appropriate internal systems to produce and submit electronic data to the Agency.
Earlier this week, ML Strategies posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
The top health policy story continues to be the bi-partisan 21st Century Cures legislation, discussed in this post, by my colleague Carrie Roll. The full House Energy and Commerce Committee will begin consideration of the legislation this week, with markup to begin today. A key question that remains for lawmakers is how to pay for the legislation. Stakeholders have been aggressively pushing for additions to the bill since it was introduced, and negotiations reportedly continue over pay-fors.
Other miscellaneous health care legislation moves forward as the Senate Finance Committee closed a request last week for non-controversial health care bills for possible markup during the June work period.
Past Health Care Updates are available here.
On May 13, 2015, the House Energy and Commerce Committee released the latest draft of its 21st Century Cures Legislation. The proposed legislation includes certain telehealth-related provisions that, among other things, request cooperation between state medical boards to coordinate practitioner licensing, and requires CMS and the Medicare Payment Advisory Commission to conduct various studies and reports on barriers to wider telemedicine use. Continue Reading