September 10, 2018

More Changes Expected on Drug Prices; New Report Shows Prices are Still Rising

HHS Secretary Alex Azar met with House Ways and Means Committee Republicans last week to discuss the President’s plan to lower drug prices. Azar is said to have given lawmakers an update on steps the administration has taken on drug prices. Following the meeting, Committee Chairman Kevin Brady (R-TX) indicated the Administration plans to announce more actions in the near future and that there are certain policies that will require Congressional action. To read the full article, click here.

  • A new Wells Fargo report shows that drug manufacturers raised the prices of 60 products in August and 110 products in July, click here.
  • The House Energy and Commerce Health Subcommittee approved a bill last week that prohibits health plans from restricting a pharmacy’s ability to inform a customer about the lower cost, out-of-pocket price for their prescription. Click here for all the bills voted on.
  • Hospitals looking to deal with drug prices and shortages have created their own pharmaceutical company, click here.
  • PhRMA releases new report that says hospitals mark up prescription drugs by an average of almost 500 percent and one in six hospitals set prices that are at least seven times more than what the hospital paid, click here.

Senate Opioid Package is Released; Vote Scheduled for this Week

Senate Leadership announced a bipartisan deal on its Opioid Package last week stating that they hope for a vote as early as this week. The package includes more than 70 proposals from five separate Committees that will be amended into the House-passed opioid bill, H.R. 6. The proposals include provisions regarding stopping illegal drugs at the border, plus FDA requirements on packaging and aiding development of new non-addictive painkillers. The Senate package authorizes additional privacy training for health care providers, which is different from the House version. Also, the Senate bill does not include the House policy that would allow for Medicaid reimbursement for residential substance abuse facilities for up to 30 days per year for individuals with opioid or cocaine use disorders. For the section-by-section of the Senate bill, click here.

  • New data released by NIH shows the proportion of young adults not in college who report using marijuana on a daily basis hit a record high in 2017, click here.

Hospitals Re-File 340B Lawsuit

On Sept. 5th, the American Hospital Association, Association of American Medical Colleges and America’s Essential Hospitals refiled their lawsuit to reverse CMS’ cut to Part B reimbursement for drugs paid for under the 340B program.  This follows the dismissal of the original lawsuit by the federal district court in D.C.,  that said the suit was premature  and then a dismissal in July by the federal D.C. appeals court that said the hospitals hadn’t yet been harmed by the rule when they filed the earlier suit. The new complaint details hospitals’ appeals, and says they have exhausted the administrative review process because “(a) no adjudicator within CMS has authority to invalidate a CMS regulation, and (b) CMS has taken the position that there is no administrative review of 340B Program reimbursement disputes.” Click here for more.

HHS Secretary Says There Will Be More Cost Saving Payment Models

HHS Secretary Alex Azar said last week that while there are more alternative payment models available for physicians than ever, a number of them do not provide significant savings.  He said that CMS is considering looking at mandatory models for physicians again to see if they work, as it would help with “what we see as an urgent need for reform.” He also stated that the Administration intends to have more two-sided risk models where participants have accountability for outcomes and can either gain or lose Medicare payments based on whether they meet benchmarks. For his full remarks, click here.

  • The American Medical Association last week released the 2019 CPT code set and it includes new telehealth codes to allow doctors to bill for remote patient monitoring and internet consulting, click here.
  • Nurse Practitioners could fill the gap in primary care if they would be willing to work in under-served areas, according to a new study in Health Affairs, click here.

Ways & Means Leaders Respond to Recent CMS Payment Rules

In three separate letters last week, House Ways and Means Committee leaders laid out their perspectives on CMS’ efforts to reduce regulatory burdens and the proposed payment rules.  On the Physician Fee Schedule, they urged CMS to consider a less drastic collapse of payment codes.  Regarding the site neutral payment reductions for hospital outpatient departments, they urged CMS not to impose regulations that could have the unintended effect of forcing patients into higher cost setting.  These letters are worth reviewing to get a better understanding of committee priorities.

  • Click here for the hospital issues letter.
  • Click here for the post-acute policies letter.
  • Click here for the letter regarding physicians.

MedPAC Focuses on a New Post-Acute Unified Payment System

The Medicare Payment Advisory Commission last week continued looking at moving the four post-acute care payment systems into one. The staff presentation detailed how the unified payment system would be based on patient characteristics rather than by site of care, as it is now. This research is due to a congressionally mandated report from the IMPACT Act of 2014 that tasked MedPAC, as well as CMS, to review the current way PAC providers are paid and make a recommendation for a unified PAC payment system. The presentation proposes a payment system with a two-tiered approach – a “general” tier for typical patients, and a second tier for patients with highly specialized needs. Click here for the MedPAC presentation slides, and here for more on the IMPACT Act.

OIG Details Unsafe Conditions for Nursing Home Patients

The House Energy and Commerce Oversight and Investigations Subcommittee heard from the HHS Inspector General during a hearing last week that an alarming number of nursing home patients face unsafe conditions, harmful medical care, abuse and neglect while federal health officials are not doing enough.

  • Click here for the OIG report.
  • Click here for the GAO report on its review of safety efforts.
  • Click here for CMS’ report on its own safety efforts.

Obamacare Insurance Cost Increases Moderating Despite Dire Predictions

According to newly released analysis, the predictions that changes made to the Affordable Care Act by the Trump Administration and Congressional Republicans would lead to dramatic increases in premiums and cause insurance companies to leave the exchanges were incorrect. The study shows that premiums for ACA customers are expected to have a minimal rise of 3.6 percent on average, as opposed to an average increase of 30 percent in 2018 and 27 percent in 2017. Looking at 47 states, the study found that 41 will have a rise in premiums of no more than 10 percent, or will actually fall. Click here for the analysis.


$60 Million Awarded To Community Health Centers in Hurricane-Ravaged Areas

HHS is awarding nearly $60 million to community health centers in six hurricane-ravaged states and two U.S. territories. The new dollars  come from a disaster relief package included in the Bipartisan Budget Act, H.R. 1892 (115), which was signed into law in February. The money was directed to a total of 161 community health centers in Alabama, Florida, Georgia, Louisiana, South Carolina, Texas, Puerto Rico and the U.S. Virgin Islands. The full list, including a Mississippi-based center with a location in Alabama, is here.


FDA Boosting Transparency for Medical Device Approval

The FDA has issued draft guidance that Commissioner Scott Gottlieb said will boost the transparency of the agency’s decisions on medical devices.  Gottlieb also announced initiatives to speed decisions on low-risk devices and recommend cybersecurity efforts for device makers as he spoke at the Medical Device Innovation Consortium’s public forum. The agency has launched a “QUik Review” pilot that could slash review time up to 30 percent for certain well-understood and lower-risk devices submitted through the 510(k) pathway, Gottlieb told the Medical Device Innovation Consortium’s public forum. Click here to read the guidance.


DoJ Could Soon Approve Mega-Mergers

The Justice Department could soon approve Cigna’s acquisition of Express Scripts as well as CVS’s acquisition of Aetna, although CVS-Aetna will likely need to shed some overlapping Medicare Part D businesses, The Wall Street Journal reported.  Click here.


CMS Health Disparities Mapping Tool Now Includes Hospital View and Cancer Rates

CMS has added a new hospital view to its Mapping Medicare Disparities Tool that allows users to compare health outcomes and quality measures between hospitals. This new view within the tool will allow users to compare quality at the hospital level in their communities by specific measures, such as avoidable hospitalizations and 30-day readmission rates. Additionally, CMS has added cancer metrics to the original “population view” to show health outcome, spending, and utilization rates across cancer types by region. Click here to view the MMD Tool.


New Findings Show that Synthetic Antibiotics Could Help Defeat ‘Super Bacteria’
Recently published research from the Journal of ACS Synthetic Biology suggests that peptides and amino acids can be used to fight harmful bacteria that have become resistant to current antibiotics being prescribed. In 2013 the Centers for Disease Control released its findings on the impact of antibiotic resistance. It was estimated that at least 2 million people are diagnosed with antibiotic- resistant bacteria annually in the U.S, and of those infected, 23-thousand die. However, according to the study, the secret to stopping the increase of antibiotic resistance is in antimicrobial peptides. Researchers from the study say that these peptides represent a promising new class of antibiotics that can be used to target and kill specific antibiotic-resistant bacteria. To view the entire study, click here.


New Study Shows Smoking Linked to Dementia 

The study, published in the Annals of Clinical and Translational Neurology, followed 46,140 men over the age of 60 who took part in a Korean health screening, found that smoking increases the risk of dementia. Those who never smoked, or had quit smoking, had less chance of developing the degenerative brain condition than those who still smoke cigarettes. The researchers found that long-term smokers who had recently quit had a 14 percent less chance of developing Alzheimer’s later in life and they also had a 32 percent reduced chance of developing vascular dementia, one of the most common forms of the disease. People who have never taken a puff on a cigarette were 19 percent less likely to develop Alzheimer’s and 29 percent less likely to develop vascular dementia. To read the study, click here.

  • A federal judge has ordered the FDA to issue a final rule on graphic health warnings for cigarettes and gave the agency three weeks to provide the court with a plan for setting it in motion. Click here.

Central Louisiana Hospitals Cut Infant Mortality Rate in Half
Louisiana’s Office of Public Health utilized a federal grant for an initiative that cut their high infant mortality rate in half. The region used these funds to offer more care to young women and mothers in their impoverished region; every parish in the region received a public health nurse to counsel women on reproductive health needs, contraceptives, and STD testing. Medicaid-eligible mothers in the region also receive access to a nurse to help them through pregnancy and the baby’s first year. Click here to read the full story.

  • The Critical Access Hospital Coalition advocates for the health of rural communities. Click here to learn more.

Doubles Tennis Might Increase Your Longevity

A recent study by the Mayo Clinic compared exercises that were done alone versus with a partner (or partners) to what is the most beneficial. It found that exercises done with another person increased health and had more physical benefits, even if it was not as strenuous or less time was spent doing the exercise. The social aspect is good for a person’s mental health and can leave a person more relaxed and happy. Tennis is expected to add about 9.7 years to one’s life. To read the study, click here.

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