At the end of each year, we attempt to give you an overview of what happened in previous year and give some spin on predictions for the coming year, much like an end-of-the-year family newsletter. For those who are a bit more nostalgic, here is a link to our 2014 story.
Perhaps the End of Off Label Lawsuits?
With the Amarin Injunction, Caronia standing for two years without any pushback from the government, and the recent settlement with Pacira, there seems to be a trend of the FDA pulling away from off-label citations. Perhaps this trend is a signal of the end of cases against manufacturers for off label promotion. At least one Assistant United States Attorney this year stated that off-label cases were "dead." This end of off-label suits can be a good thing, but now we should be on the lookout for more enforcement around the areas of kickbacks, pricing, and manufacturing.
Open Payments Year 2– Where Did All the Research Money Go
In late June, we saw the release of the first full year of data for the Open Payments program. What we saw – unsurprisingly – was that a vast majority of the funds companies spend go to research. What did surprise us, however, was that when we looked at the year over year data (last five months of 2013 compared to the last five months of 2014), research spending dropped 30% from 2014-2015, yet the number of payments remained virtually the same.
Many Settlements, but Not Many Big Ones
2015 seems to have been the year of settlements with the DOJ; however, while settlements were numerous, there were few "big" settlements. Sanofi, Novartis, Millennium Health, Amgen, Daiichi Sankyo and Pacira were some of the bigger ones. Other important cases included Warner Chilcott, PharMerica, and Purdue Pharma.
While we cannot be positive where the DOJ and other federal agencies will focus their energy on in the coming year, many of 2015's settlements focused on off-label promotions and False Claims Act allegations. As previously mentioned, off-label promotion cases are not likely to play as prominent a role going forward, but kickbacks and pricing are likely to be next year's "star" cases.
ICD 10 Lite
October 1 saw the implementation of ICD 10, a change in the coding practices for all providers. However, for the first year, CMS is allowing for some leniency by permitting physicians to still obtain payment if they bill with the incorrect ICD-10 code, as long as they used a valid code from the right family. Even still, there is a fair amount of angst from practitioners once CMS goes to enforcing the full coding rules.
If you have the time, it is still worth a read through the ICD-10 codes, as you never know when you are going to run into a lamppost and will have to bill under W22.02XD. My favorite ICD-10 Code is z56.3, "Stressful work schedule." We recommend everyone reading this give this code to your physician next time you need to use some of your sick days for a quick vacation...
In March, the FDA approved the first biosimilar under the BCPIA. Before reality set in, this approval in March was treated with full pomp and circumstance. First, Novartis (Sandoz) had to overcome the Patent Dance, an arcane process set up in the law where companies have to give away their IP to the reference product company in this case Amgen. Novartis (Sandoz) opted not to go through this and received relief from a judge to proceed in marketing their version of Filgrastim, Zarxio, which was launched in September.
The FDA has still not approved a second biosimilar and several of the current submitted applications for biosimilar approval have been either withdrawn or delayed. The FDA has also issued a draft guidance on biosimilar products. Look for more action around biosimilars in 2016, but this has been a slow start to say the least.
Maintenance of Certification Lite
After just about every living internal medicine physician protested in one way or another, the American Board of Internal Medicine (ABIM) backed off of their Maintenance of Certification (MOC) program. In a letter written by the ABIM CEO, he acknowledged, "we got it wrong." ABIM is now coordinating with the Accreditation Council for Continuing Medical Education (ACCME) on a system to have MOC approved content without the laborious approval process.
Doc Fix Really Happened
After fifteen or more years of constant struggle, the United States House and Senate worked together to pass a permanent fix to the SGR formula, which reduced payments to physicians by Medicare up to 25%. Starting in 2015 physicians received a .05% increase in their billings per year for several years. While Congress was working together, they combined three largely hated programs: Meaningful Use, Value Based Modifier, and Physician Quality Reimbursement System (PQRS), into one Merit-Based Incentive Payment System (MIPS), which will also penalize physicians by up to 10% of their Medicare reimbursement. In other bipartisanship actions, in late December congress passed a two year moratorium on the Affordable Care Act's onerous device tax.
Open Payments and CME – CMS Comes Around
21st Century Cures Not Yet
In a rare moment of bipartisanship in the United States House of Representatives, the 21st Century Cures bill overwhelmingly passed the House including the Burgess/Defazio bill "Encouraging Continuing Medical Education" to exempt educational materials and CME from Open Payments Reporting. This section of 21st Century Cures was supported by over one hundred associations and CME providers. Today, it lingers in the United States Senate but there is still hope that the bill is taken up before the end of summer.
ACCME Changes the Guard
This year the ACCME saw after twenty years of Murray Kopelow, MD at the helm as CEO. In his footsteps, ACCME appointed a new CEO, Graham McMahon, MD, MMSc. Dr. Kopelow saw the organization through significant changes including the Bridge to Quality, FDA Mandated REMS, International coordination and revisions of the Standards for Commercial Support. During the end of Dr. Kopelow's tenure, the CME economy finally stabilized. Dr. McMahon has already proven to be a strong advocate for Continuing Medical Education; we look forward to his further actions in helping to facilitate both content changes and technological changes in the way CME is accredited and delivered.
FDA and CMS also Change Guard
This year also saw new Commissioners at the Food and Drug Administration and the Centers for Medicare and Medicaid Services. Dr. Robert Califf originally joined the FDA in early 2015 from a thirty year career with Duke Medical and was nominated by President Obama as FDA Commissioner in late 2015.
CMS Administrator Marilyn Tavenner left the agency in early 2015, and was succeeded by Andy Slavitt, the current CMS Acting Administrator. Prior to this post, Mr. Slavitt was the Principal Deputy Administrator of CMS since joining CMS on July 8, 2014.
State Disclosure: Some Wins and Some Losses
States once again are garnering attention in the area of payment transparency. Connecticut is to begin collecting payment information for advanced practice Nurse Practitioners on July 1, 2017. The reporting of Nurse Practitioners payments from manufacturers in Connecticut came about because of one NP who was indicted for receiving kickbacks; this action has led to the introduction of a bill by United States Senators Blumenthal of Connecticut and Grassley of Iowa to expand the Physician Payment Sunshine act to NP's and PA's .
West Virginia repealed their reporting pharmaceutical advertising spending in that state.
Medical Journals Acknowledge Conflicts of Interest
In a stunning reversal, the New England Journal of Medicine ran a series of articles on the benefits of working with industry. This was a very well thought out series that should not be forgotten. Not to be outdone, the Journal of the American Medical Association (JAMA) published an article on the confluence of interest. This much-welcomed change is a huge reversal from several years ago when all of us who were working with industry were treated as criminals by medical journals.
Drug Prices, Drug Prices
All eyes in the 2016 elections will be focused on prescription drug prices. The political firestorm started when it was announced that Gilead was charging $80,000 for a treatment regiment to cure Hepatitis C. This spring, we saw state legislators from around the country attempting to pass "Price Transparency Laws." While those efforts failed, this summer's introduction to Martin Shkreli, a hedge fund manager masquerading as a pharmaceutical executive buying up old generic drugs and raising prices, reignited the flame. Look for all the candidates in 2016 to include prescription drug prices as part of their lexicon, beating up on "those evil pharma companies." Expect articles and reports coming out - both in favor and against - controlling pricing and direct negotiations. With at least two ballot initiatives in 2016 on drug price negotiation (Ohio and California), these issues are sure to become front and center.
2016 and Beyond
Look for 2016 to be dominated by the election of our next president. With that in mind, the continued demonization and the sanctification of the Affordable Care Act is expected to be front and center. The Administration may do some last minute unilateral moves, but for the most part, the healthcare economy will be in a "watch and see" mode. It is expected that there will be less expansion and fewer tough decisions made until the markets are sure of the direction we are heading.