Life Science Compliance Update

December 08, 2016

21st Century Bill Headed to President Obama’s Desk

President-obama-desk

Nearly three years after its initial introduction, the 21st Century Cures Act has finally passed both houses of the Congress, and is expected to be signed by President Obama relatively quickly. This bill represents one of the few truly bipartisan efforts undertaken by this Congress.

We have previously written about some of the items included (and excluded) in the bill. The bill gives the health institutes the authority to finance high-risk, high-reward research using special procurement procedures, as opposed to more conventional grants and contracts. It also requires the agency’s director to establish “Eureka prize” competitions to advance biomedical research and improve treatments for serious illnesses. The bill also creates a new assistant secretary for mental health and substance use, to be appointed by the president, thereby raising the status of mental health issues throughout the country.

Further, the bill directs federal agencies to step up their enforcement of laws that require equal insurance coverage for mental and physical illnesses. Federal laws and rules requiring mental health parity have been adopted with bipartisan support over the last twenty years, but a White House task force recently found that compliance with those laws has been lagging.

Political Reactions

The bill includes $500 million a year to help states prevent opioid misuse and get better treatment for addicts. "These additional resources are particularly critical in rural areas, where rates of opioid misuse and overdose are high, access to treatment is limited, and patients who seek treatment are often met with waitlists that can mean the difference between life and death," said Agriculture Secretary Tom Vilsack.

In a statement made by President Obama shortly after passage of the bill, “We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need.”

Obama also noted, “This is a reminder of what we can do when we look out for one another. Like Joe Biden and so many other Americans, I’ve lost people I love deeply to cancer. I’ve heard often from those whose loved ones are suffering from Alzheimer’s, addiction and other debilitating diseases. Their heartbreak is real, and so we have a responsibility to respond with real solutions. This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk.”

Senator Susan Collins (R-ME) stated, “I doubt that there is a family in America who will not be touched by this important legislation.” Representative Steve Cohen (D-TN) was also pleased with the passage, saying, “I don’t think there is enough money that we can put into the N.I.H., because it is important and affects all Americans independent of political party, race, sexual orientation – you name it.”

Medical and Industry Reactions

"The remarkable bipartisan, bicameral support for the 21st Century Cures Act proves that congressional lawmakers are serious about the need for scientific research, effective care-delivery, and the removal of barriers to scientific progress," said Dr. Daniel Hayes, president of the American Society of Clinical Oncology.

"This legislation will improve the lives and health of countless Americans," said American Psychological Association President Susan McDaniel. "It will increase access to effective, evidence-based care, particularly for those with serious mental illness."

In a Statement from Sharad Lakhanpal, MBBS, MD; President of the American College of Rheumatology, he noted,  "While we are pleased that the 21st Century Cures Act will infuse additional, much-needed funding to the NIH to support medical research across the healthcare spectrum, we also know that more can and should be done to help Americans who are disproportionately impacted by arthritis and other rheumatic diseases. Today, arthritis is the leading cause of disability among U.S. veterans and the second most common reason for medical discharge from the U.S. Army. One in three veterans is diagnosed with arthritis, compared with one in five members of the general U.S. population.

As Congressional leaders turn their attention to budget appropriations for the upcoming fiscal year, we urge them to prioritize the creation of a dedicated $20 million arthritis research program at the Department of Defense so that we can better meet the care needs of the thousands of active duty and veteran members of our Armed Forces who live with arthritis.”

Conclusion

Once the bill is signed by President Obama, it will be up to the Food and Drug Administration (FDA) to implement many portions of the law, which could take years. Funding may be immediate, but the actions the FDA and other federal agencies are responsible for may still be quite a bit away. We will all have to stay tuned as this bill, and its effects, continue to progress.

November 30, 2016

21st Century Cures No Longer Includes Open Payments Exemption for Reprints, Textbooks and Non Promotional Education

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We previously wrote about the updated version of the 21st Century Cures bill – one that we, along with many others, thought would pass both the House and the Senate with minimal edits, if any. However, the new bill no longer includes a provision that would have exempted drug makers from disclosing non promotional continuing medical education (CME) payments to physicians, including text books and reprints.

The version of the bill released late last week would have allowed manufacturers to be exempt from reporting industry payments to physicians for textbooks, journal reprints, and for speaking at continual medical education events.

This change follows a speech by Senator Elizabeth Warren on Monday, where she described the exemption as covering up bribery. She relayed her belief, which is that drug companies have opted to “cozy up to enough people in Congress to pass this Cures bill that would let drug companies keep secret any splashy junkets or gifts associated with ‘medical education’ and make it harder for enforcement agencies to trace those bribes.”

The opposition to the exemption even crossed party lines, with Senator Chuck Grassley planning to “object to unanimous consent to take up the 21st Century Cures Bill in the Senate,” unless the reporting exemption was removed. As a reminder, Grassley was a co-author of the Physicians Payment Sunshine Act, which requires drug makers and medical device makers to disclose payments they make to physicians to a public database.

Grassley believes that the “Sunshine Act brings transparency to a big part of the health care system for public benefit. Transparency brings accountability wherever it’s applied. With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever.”

He further went on to say, “a lot of earlier payments to doctors were under the umbrella of Continuing Medical Education. We shouldn’t create a loophole that would let drug and medical device companies mask their payments to doctors under a payment category that’s too broad and could gut the spirit and the letter of the Sunshine Act."

Grassley, Warren, and other critics of the exemption have long complained that CME and textbooks have the ability to influence physicians to prescribe expensive brand-name drugs, and that transparency is undermined if drug and device companies are permitted to avoid reporting the value of such sessions and handouts.”

John Kamp, executive director of the Coalition for Healthcare Communication, however, expressed his disappointment at the removal of such a “reasonable provision that enables doctors to be fully informed about medicines.”

This is a disappointment but the vast majority of accredited CME still falls under an exemption for Open Payments reporting as long as the applicable manufacturer does not select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program.   

Interestingly enough, the 21st Century Cures Act is one of the most lobbied healthcare bills in recent history, with almost 1500 lobbyists representing 420 companies, universities, and other organizations looking to influence the bill’s contents..

It was just last summer when more than 100 national and state medical societies backed a Senate bill to create the exemption, complaining of “onerous and burdensome reporting obligations…that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals,” seeking to avoid “a similar negative impact” on CME.

The House is still expected to pass the bill on Wednesday, November 30, but only time will tell if it will pass with this most recent edit, and what other edits may be waiting in the wings.

November 29, 2016

21st Century Cures Update - Includes Exemption for Education in Open Payments

CuresActCongress

When lawmakers head back to Washington, D.C. this week, one of the votes they have ahead of themselves is the 21st Century Cures bill, legislation that is intended to spur the development of new medical treatments. The bill was updated the Friday after Thanksgiving, leaving many of the provisions of previous versions intact, but also adding language intended to improve America’s mental health system and dedicates $1 billion over the course of two years to help combat the opioid epidemic.  

The updated package directs $4.8 billion in funding over a decade to the National Institutes of Health and includes $1.4 billion for President Obama’s Precision Medicine Initiative, $1.8 billion for Vice President Joe Biden’s cancer “moonshot” program, and $1.6 billion for a program focused on enhanced understanding of brain-related diseases like Alzheimer’s. The bill would be paid for mostly through sales of the U.S. strategic petroleum reserve and a fund created in the 2010 health care overhaul intended to promote disease prevention and public health.

The vehicle for the new bill will be existing legislation (HR 34) related to tsunami warning systems. Since the Senate has already passed an amended version of that bill, the package could be sent from the House back to the upper chamber and acted on relatively quickly. The vote is expected to take place on Wednesday, under suspension of the rules, preventing any amendments.

House Energy and Commerce Chairman Fred Upton of Michigan and Senate Health, Education, Labor and Pensions Chairman Lamar Alexander of Tennessee, the two main sponsors of the package, touted the bill as beneficial to virtually every American family. “What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day,” the lawmakers said in a joint statement. “We look forward to swift and favorable consideration of the 21st Century Cures Act in both the House and Senate.”

Sen. Christopher S. Murphy, D-Conn., a vocal supporter of mental health changes, on Sunday released a statement praising the package. “I'm excited Republicans and Democrats have put politics aside and reached a compromise that will allow a mental health reform bill to pass side by side with major new funding to confront the nation's opioid crisis. Both parties needed to make concessions to get this deal done, but the deal that has been struck is good for patients and families. I hope we get it done,” Murphy said.

Key Provisions of the Bill

Measures related to the FDA largely remain intact from the previous House-passed bill. The biggest change is the addition of language to help speed the development of regenerative medicine, or treatments that are designed to help regrow damaged cells or tissues. Such a provision would give the FDA the ability to put some of these treatments through what’s known as “accelerated approval,” a pathway that allows companies to conduct clinical trials on smaller populations and requires follow-up studies once the drug is on the market.

The $1 billion to curb painkiller abuse would effectively grant President Obama’s budget request from February. Included in the funding is a bid to gather support from Democrats, as well as an acknowledgement that this year’s stalled appropriations process would not be adequate for funding the opioid response envisioned by the backers of an opioid abuse package signed into law this summer.

The bill’s section on mental health would make changes to the leadership structure at the Substance Abuse and Mental Health Services Administration and establish/reauthorize grants for state and community mental health services. It would give HHS tools to enhance compliance with parity laws, which require insurers that cover mental health to offer mental health benefits that are as valuable as other medical coverage.

The most notable additions are aspects of a bill from Sen. John Cornyn (S. 2002). Those provisions would offer grants to law enforcement and the judicial system to improve their capacities to deal with mental health problems. Lawmakers wound up dropping controversial language from Cornyn’s bill that would have restored gun rights to certain individuals who had been committed for mental health treatment.

The legislation also changes policies governing electronic medical records by directing the federal government to issue a voluntary model framework on the sharing of patients' health information, and creates a grant program to help develop a reporting system that would provide the government with more information about the use and security of electronic health records.

Open Payments

Inserted into the legislation is a provision from Congressman Defazio, Burgess, and Senator Barrasso to exempt applicable manufacturers from reporting payments made for continuing medical education sessions, medical journals, or textbooks. We tend to believe that the reporting requirements stifle access to important information and have a detrimental effect on continuing medical education (CME) programming.

This represents a smart tweak to the current regulation.  Unlike the other categories under Open Payments, education represents the free exchange of ideas.

“This is about patient care — doctors need good information fast and this facilitates the process,” said John Kamp, who heads the Coalition for Healthcare Communication, a group of ad agencies and medical publishers. “I want my doctors to have information about whatever the latest science is saying.” He noted that the Food and Drug Administration is currently weighing rules for allowing companies to distribute information to physicians about unapproved uses of medicines.

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