Life Science Compliance Update

« November 2017 | Main

8 posts from December 2017

December 11, 2017

CMS Institutes New Medicaid Policy Regarding Opioids

Pills-drugs

Recently, the Centers for Medicare & Medicaid Services (CMS) announced a new policy to allow states to design demonstration projects that increase access to treatment for opioid use disorder (OUD) and other substance use disorders (SUD). This new demonstration policy responds to President Trump's directive and provides states with greater flexibility to design programs that improve access to high quality, clinically appropriate treatment. In addition to the new policy, CMS announced an immediate approval of both New Jersey and Utah’s demonstration waivers under the new policy.

Through this updated policy, states will be able to pay for a fuller continuum of care to treat SUD, including critical treatment in residential treatment facilities that Medicaid is unable to pay for without a waiver.

“This new demonstration policy comes as a direct result of the President’s commitment to address the opioid crisis and ensure states have immediate relief and flexibility,” said CMS Administrator Seema Verma. “Previous policies ignored the growing urgency of the national opioid epidemic and instead put onerous requirements on states that ultimately prevented individuals from accessing these needed services. The Trump Administration’s approach reflects the pressing nature of the issues states are facing on the ground.”

Previously, states were required to build out their entire delivery system for SUD treatment while also meeting rigid CMS standards before Medicaid demonstration approvals could be granted. The new policy will allow states to provide greater treatment options while improving their continuum of care over time.

New Jersey and Utah Waivers

Under the new CMS demonstration policy, New Jersey will provide a comprehensive and coordinated SUD benefit to adults and children while also allowing for the continuum of SUD services provided to Medicaid beneficiaries who reside in residential treatment facilities. The services covered as part of the SUD benefit will include residential treatment, withdrawal management, medication-assisted treatment, peer supports and targeted case management.

“CMS’ approval of New Jersey’s Medicaid Demonstration will remove a decades-old federal barrier so that thousands more New Jerseyans with the disease of addiction will have access to treatment and recovery,” said New Jersey Gov. Chris Christie. “President Trump acknowledged the need for this policy change when he addressed the nation last week and declared a national public health emergency. This is a tremendous step forward in our efforts to aggressively combat the opioid epidemic and save lives.”

Utah’s program is part of a broader delivery system reform effort to address the needs of individuals with SUD, individuals who are chronically homeless, and individuals within the justice system. The demonstration will also expand access to SUD treatment to a more complete continuum of services, including previously excluded residential treatment sites.

"I've always maintained the role of the federal government should be to provide states with the flexibility to be innovative in how they operate their Medicaid programs. Nobody knows how to address the unique challenges we face as a state better than we do,” said Utah Gov. Gary R. Herbert. “Today's announcement from the Centers for Medicare and Medicaid Services will allow us to address a specific challenge - extending health care coverage, including substance abuse and mental health services, to the homeless population. I applaud CMS for approving our waiver request, and look forward to getting to work on providing these critical services."

This policy will also help CMS evaluate how effectively the demonstration programs are working, through the collection of information and data that can be used to inform CMS on best practices and methods to specifically combat the opioid epidemic, increasing the agency’s capacity to learn what treatment delivery methods are the most effective.

December 08, 2017

Drug Pricing Report Released by NASEM

Download

The most recent example of drug marketing being caught in the crossfire of the drug pricing debate can be found in a report by the National Academies of Sciences, Engineering and Medicine, which included suppression of consumer marketing in a set of recommendations on how to lower the cost of prescription drugs for patients. One recommendation was that advertising costs should no longer be considered tax deductible as a business expense.

The report offers eight recommendations with twenty-seven different actions for their implementation (a sample of actions in each area appears below) to improve the affordability of prescription drugs without discouraging the development of new and more effective drugs for the future.

“Over the past several decades, the biopharmaceutical sector in the United States has been successful in developing and delivering effective drugs for improving health and fighting disease, and many medical conditions that were long deemed untreatable can now be cured or managed effectively,” said Norman Augustine, former chairman and CEO of Lockheed Martin Corp., former chairman of the National Academy of Engineering, and chair of the committee that conducted the study and wrote the report. “However, high and increasing costs of prescription drugs coupled with the broader trends in overall medical expenditures, which now equals 18 percent of the nation’s gross domestic product, are unsustainable to society as  whole. Our report seeks to address the market failures that currently permeate the biopharmaceutical sector, such as lack of competition due to distortions in the application of the patent protection process, the imbalance between the negotiating power of suppliers and purchasers, and the convoluted structure of the supply chain. Although changes within the current system will be demanding, they are likely to better serve the nation.”

One recommendation was that governmental purchasing power should be consolidated and applied to strengthen formulary design and improve drug valuation methods. The report recommends that to achieve that end, Congress modify current legislation to allow the United States Department of Health and Human Services (HHS) to directly negotiate prices with producers and suppliers of medicines, including acting on behalf of any relevant state agency that chooses to participate in the process. The report also recommends that Congress authorize HHS, related federal agencies, and associated private payers to expand flexibility in formulary design, including very selective exclusion of drugs, such as when less costly drugs provide similar clinical benefit.

As alluded to above, the report recommends that actions be taken with respect to marketing, including promoting the adoption of industry codes of conduct and discouraging direct-to-consumer advertising of prescription drugs as well as direct financial incentives for patients.

The report recommends,

Congress should disallow direct-to-consumer advertising of prescription drugs as a tax-deductible business expense. In addition, manufacturers and suppliers should adopt industry codes of conduct that reduce or eliminate direct-to-consumer advertising of prescription drugs and should increasingly support efforts to enhance public awareness of disease prevention and management. Clinicians, medical practices, and hospitals also should substantially tighten restrictions on pharmaceutical companies’ direct visits to clinicians, the acceptance and use of free drug samples, special payments, and other inducements paid by biopharmaceutical companies.

According to the New York Times, the “report is significant for several reasons,” including that a “respected national organization” has given a “searing critique of the way drugs are bought and sold.”

Two members of the panel that created the report filed dissents, including Dr. Michael Rosenblatt, who opined, “Allowing all government health plans to negotiate as a single block would establish a near monopoly” and could have a “devastating effect on long-term, high-risk investment” in drug research and development.”

December 07, 2017

Congress Taking New Approach to Opioid Epidemic

Download

Recently, Representative Bob Latta introduced a bill into the United States House of Representatives. The bill, known as the Indexing Narcotics, Fentanyl and Opioids (INFO) Act, is intended to help create a public electronic database of information and strategies to combat the opioid crisis. The information in the database would be used to help federal, state, and local officials develop the most effective strategies to prevent addiction, treat those that are addicted, and keep prescription drugs from falling into the wrong hands. The INFO Act would also track federal funding being used to combat the epidemic.

The bill requires the Secretary of Health and Human Services (HHS) to appoint a Federal Coordinator to oversee the creation of the database, as well as coordinate related programs within HHS and serve as a liaison to state and local governments. The Federal Coordinator would work in consultation with the Department of Justice, Department of Veteran Affairs, the Office of National Drug Control Policy, and other relevant agencies.

The database would act as a central location for the public to find information on the following:

  • Federal funding allocations made available for research and treatment of opioid abuse;
  • Research relating to opioid abuse from all federal agencies, state and local governments, non-profits, law enforcement, medical experts, public health educators, and even research institutes.

The bill would also require HHS to evaluate other issues relating to pain management, addiction, prescription guidelines, treatments, trends and patterns, and effective solutions and programs used across the country.  HHS would be required to:

  • Examine causes and patterns in pain management and addiction;
  • Evaluate opioid abuse treatment programs, including medicated-assisted treatments, and determine their effectiveness;
  • Analyze opioid prescription guidelines, including types of opioids prescribed and trends, and recommend alternatives for pain treatment; and
  • Examine abuse rates among veterans versus the general population.

The Federal Coordinator would be responsible to submit a report to Congress one year after the date of enactment, and an additional report after five years, of results of any analysis, evaluation, or comparison conducted under their direction.

“Communities in Ohio and around the nation continue to suffer from the rise of opioid abuse and addiction,” said Latta. “While the magnitude of this crisis is evident in the number of opioid-related deaths, we’re still lacking basic information on the effectiveness of federal programs and other efforts. In order to develop the best plans to attack this problem, we need the best information. The INFO Act would improve data collection relating to addiction, prescription guidelines, treatment, pain management, patterns of abuse, and other areas in order to find help find solutions. When it comes to this crisis, failure is not an option.”

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
December 2017
Sun Mon Tue Wed Thu Fri Sat
1 2
3 4 5 6 7 8 9
10 11 12 13 14 15 16
17 18 19 20 21 22 23
24 25 26 27 28 29 30
31