Life Science Compliance Update

July 30, 2015

Congressional Briefing on the Importance of Medical Communication

Doctors

This past month, the House of Representatives convincingly passed the 21st Century Cures Act. This bill contains important provisions related to how life science companies can communicate information about their products to patients, doctors, and payers. As the Senate contemplates a similar measure, it is important that legislation includes provisions that are needed to update the current regulatory constraints on communicating the latest medical information to those most in need.

The Coalition for Healthcare Communication provided a great writeup of a recent congressional briefing, sponsored by the Medical Information Working Group, that addressed the limitations and challenges of the current legal and regulatory framework, how this affects patient access to critical therapies, and how Congress can improve regulatory oversight of medical information.  

During the hearing, Sandra Raymond, CEO and president of the Lupus Foundation of America, spoke to the importance of open channels of communication for doctors looking to best treat patients with lupus. She stated that for patients with lupus, current treatments primarily are off-label uses of drugs approved for other purposes, such as immunosuppressants, anti-malarials and steroids. Without a steady flow of information from companies about these uses, physicians are “uninformed about the current treatments for a disease they don’t understand well,” she said. “The result? Patient care is impacted.” Raymond told congressional staffers that regulators need to balance patient benefit and risk to determine appropriate healthcare communications, permit adequate directions for use on approved and alternative uses, and encourage approval for additional instructions.

Alan Bennett, senior counsel at Ropes & Gray. and co-leader of the Medical Information Working Group, also weighed in from the legal perspective. Currently, the regulation of medical information seems trapped in the past, with a promotional system that was “designed in the 1970s for 1970s conditions” that do not account for significant changes in reimbursement, technology, and evolving case law regarding free speech, according to told the Coalition for Healthcare Communication that MIWG wants to work with the FDA on making the regulation of medical information communication more clear and expansive.

“This would be a major change in the way the agency regulates, and major changes tend to take a lot of time, but recent First Amendment developments and marketplace factors, such as reimbursement and technology, are causing the FDA to pay attention,” Bennett said.

At the briefing Bennett highlighted three recent cases — Sorrell v. IMS Health Inc.U.S. v. Caronia, and Amarin Pharma Inc. et al. v. U.S. Food and Drug Administration et al. – that are bolstering the First Amendment right to speech or to hear a message. Although the Amarin case is still pending, Bennett noted that “if it comes out in favor of greater First Amendment rights, the agency will have to address that.”

Bennett also touched on other major issues that affect medical information communication:

  • Payer communication. Congress thought that enacting Section 114 of the Food and Drug Administration Modernization Act of 1997 would allow companies to disseminate healthcare economic information to payers for formulary decision making, but in practice, the provision “remains unclear and FDA has muddied the waters further,” he said. He added that companies need a roadmap so dissemination is not ambiguous and companies can communicate with payers late in the FDA approval process to ensure that their drugs can be covered upon approval.
  • Scientific Exchange. “Everyone relies on this, but no one really knows what it is,” Bennett said. “It is clear at the margins, but there are a lot of activities that go on between the poles,” he remarked.
  • Definition of Labeling (and Advertising). The statute provides some definition, but that definition has been broadened by the FDA, according to Bennett. “We want the FDA to align its definition with the statute and case law,” he said.
  • Substantial Evidence Standard for Claims. For comparative claims, the regulations state that claims based on any study that is not a randomized, controlled clinical trial is automatically false and misleading, even for an on-label claim, Bennett explained. “There are data today that didn’t exist in the 1970s – real-world data – that companies ought to be able to use to support claims,” he said. “The standard needs to be more flexible.”
  • Intended Use. If a company knows its product is being used off-label, communicating that intended use is against the law, according to Bennett. Although the FDA is not enforcing this provision, “it is still on the books for the Justice Department to use and it needs to be clarified, especially when the standard of care for various conditions is an off-label use of an approved drug.”
  • Guidelines. The FDA’s guidelines for unsolicited requests for information and textbook dissemination need to be updated and streamlined so that truthful and non-misleading information about treatments can be communicated in a timely and effective manner, Bennett told briefing attendees.

The bottom line, Bennett added, is that “a patient’s role in his or her own healthcare has become more important, so that patient and his or her physician should have access to the best information, for which companies are the most valuable source.”

Bennett also asserted that addressing this issue legislatively “is appropriate and necessary to provide the FDA with guidance to align with the statute and the Constitution,” he said. Although the House’s 21st Century Cures legislation “is a start, more comprehensive changes are essential and Congress needs to address the specific issues we have raised.”

Thanks to the Coalition for Healthcare Communication for their coverage of this important event. 

July 23, 2015

Congress Holds CMS’s “Feet to the Fire” on Medicare Part D Fraud

Feet to Fire

Last week, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on Medicare Part D program integrity, an increasingly hot topic. Members of Congress are especially concerned about, as Energy and Commerce Chairman Fred Upton phrased it, the “startling increase in Medicare Part D spending on commonly abused opioids.” Shantanu Agrawal of the Centers for Medicare and Medicaid Services and Ann Maxwell, Assistant Inspector General, Office of Evaluation and Inspections, Office of Inspector General, U.S. Department of Health and Human Service provided testimony.

Ann Maxwell, speaking on behalf of OIG, stated that her agency has made “stopping Part D fraud a top priority.” In June, the Department of Justice announced an unprecedented nationwide sweep led by the Medicare Fraud Strike Force resulting in charges against 243 individuals for their participation in fraud schemes involving $712 million in false billings. Almost 50 of the defendants were charged with fraud related to Part D. While Maxwell was pleased with the enforcement efforts, she noted that they do not solve the problem of prescription drug fraud.

To this point, she outlined her agency’s recommendations to CMS and Part D plan sponsors that would more proactively identify questionable billings and prevent fraud. While CMS has “made some progress,” Maxwell stated, it must do more to protect the Medicare Part D program. (View Maxwell’s testimony, pages 5-7 for specific recommendations).

Subcommittee Chairman Tim Murphy (R-PA) agreed, noting that CMS has not implemented nine HHS-OIG recommendations to stem Part D fraud. HHS-OIG recently issued two reports, “Ensuring the Integrity of Medicare Part D,” and “Questionable Billing and Geographic Hotspots Point to Potential Fraud and Abuse in Medicare Part D,” that summarize their recommendations over the past several years. “[T]hese are commonsense recommendations,” Murphy said. “For example, requiring plan sponsors to report all potential fraud abuse to CMS or the Medicare Drug Integrity Contractor. This recommendation was issued in five different OIG reports. Another important recommendation: implement an edit to reject prescriptions written by providers who have been excluded from the Medicare program.” Members of the committee also honed in on OIG’s recommendation for a beneficiary “lock-in.” OIG found in one investigation, for example, that a “complicit beneficiary” received unnecessary prescriptions, filled them at various pharmacies, and sold the pills to drug-trafficking groups. “This could be addressed by restricting beneficiaries to a limited number of pharmacists or prescribers when warranted.” CMS has stated that it would require legislative authority to implement lock-in restrictions.

“CMS hasn’t taken action to implement these recommendations,” Murphy stated. “Just six weeks ago, one of today’s witnesses, Dr. Agrawal testified before this Subcommittee and said, “holding our feet to the fire is appropriate,” when asked about fraud occurring under CMS’s watch, and that’s precisely what we are here to do today.”

Indeed, during his testimony, Dr. Agrawal agreed that work needed to be done, and that CMS is “committed to working with OIG to address its recommendations.” But he also outlined some of the strides CMS has made, citing his agency’s increased sharing of data with Part D plan sponsors to enhance the detections and prevention of fraud and overutilization of Part D drugs, including opioids.  

Agrawal explained CMS’s plans to use the authority granted in the Affordable Care Act to require most prescribers of drugs paid for by Part D to enroll in Medicare. “CMS is actively working to enroll over 400,000 prescribers of Part D drugs by January 2016 and to enforce the requirement that plans deny Part D claims that are written by prescribers who do not meet the necessary requirements by June 2016,” he said. “These prescribers will be subject to the same risk-based screening requirements that have already contributed to the removal of nearly 575,000 provider and supplier enrollments from the Medicare program [and will] “make sure that Part D drugs are prescribed by qualified individuals, and will prevent prescriptions from excluded or already revoked prescribers from being filled.”

Agrawal also noted that efforts to combat should balance the need to ensure that all Medicare beneficiaries are receiving the medications they need.

On the same day as the hearing, CMS announced that its Fraud Prevention System had identified or prevented $820 million in inappropriate payments over the past three years through, including more than $454 million identified in 2014 alone. The “FPS” uses predictive analytics to identify questionable billing patterns in real time. It can also review past patterns that may indicate fraud.

 

 

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