US Senate Passes 21st Century Cures Act

21st Century Cures ActA sprawling health bill that passed the Senate Wednesday and is expected to become law before the end of the year is a grab bag for industries that spent plenty of money lobbying to make sure it happened that way.

Here are some of the winners and losers in the 21st Century Cures Act:

Winners

Pharmaceutical and Medical Device Companies. The bill will likely save drug and device companies billions of dollars bringing products to market by giving the Food and Drug Administration new authority and tools to demand fewer studies from those companies and speed up approvals.

The changes represent a massive lobbying effort by 58 pharmaceutical companies, 24 device companies and 26 “biotech products and research” companies, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics. The groups reported more than $192 million in lobbying expenses on the Cures Act and other legislative priorities, the analysis shows.

Medical schools, hospitals and physicians. The bill provides $4.8 billion over 10 years in additional funding to National Institutes of Health, the federal government’s main biomedical research organization. (The funds are not guaranteed, however, and will be subject to annual appropriations.)

The money could help researchers at universities and medical centers get hundreds of millions more dollars in research grants, most of it toward research on cancer, neurobiology and genetic medicine.

21st Century Cures ActThe bill attracted lobbying activity from more than 60 schools, 36 hospitals and several dozen groups representing physician organizations. They reported spending more than $120 million in disclosures that included Cures Act lobbying.

Mental health and substance abuse advocates. The bill provides $1 billion in state grants over two years to address opioid abuse and addiction. While most of that money goes to treatment facilities, some will fund research.

The bill also boosts funding for mental health research and treatment, with hundreds of millions of dollars authorized for dozens of existing and new programs.

Mental health, psychology and psychiatry groups spent $1.8 million on lobbying disclosures that included the Cures bill as an issue.

Patient groups. Specialty disease and patient advocacy groups supported the legislation and lobbied vigorously. Many of these groups get a portion of their funding from drug and device companies. The bill includes more patient input in the drug development and approval process, and the bill is a boost to the clout of such groups.

More than two dozen patient groups lobbied the bill, and reported spending $6.4 million in disclosures that named the bill as one of their issues.

21st Century Cures ActHealth information technology and software companies. The bill pushes federal agencies and health providers nationwide to use electronic health records systems and to collect data to enhance research and treatment. Although it doesn’t specifically fund the effort, IT and data management companies could gain millions of dollars in new business.

More than a dozen computer, software and telecom companies reported Cures Act lobbying. The groups’ total lobbying spending was $35 million on Cures as well as other legislation.

Losers

Preventive medicine. The bill cuts $3.5 billion — about 30 percent — from the Prevention and Public Health Fund established under Obamacare to promote prevention of Alzheimer’s disease, hospital acquired infections, chronic illnesses and other ailments.

Consumer and patient safety groups. Groups like Public Citizen and the National Center for Health Research either fought the law outright or sought substantial changes. Although they won on some points, these groups still say Cures opens the door for unsafe drug and device approvals and doesn’t address rising drug costs.

Hair growth patients. The bill says federal Medicaid will no longer help pay for drugs that help patients restore hair. The National Alopecia Areata Foundation spent $40,000 on lobbying disclosures this cycle that included Cures.

The FDA. The bill gives the FDA an additional $500 million through 2026 and more hiring power, but critics say it isn’t enough to cover the additional workload under the bill. The agency also got something it opposed: renewal of a controversial voucher program that awards companies that approve drugs for rare pediatric diseases.

(Kaiser Health News, Sydney Lupkin and Steven Findlay, December 7, 2016)

A Pharmacist Looks at the Opioid Epidemic

By Zafeira Sarrimanolis, PharmD, MedCost Clinical Consultant

The statistics prove it — more Americans die from accidental drug overdoses each year than from traffic accidents. Data from 2014 showed more deaths from drug overdoses than any other year on record.[i]  Approximately six out of 10 of those deaths involved opioids.[ii]

opioid epidemicSource: Centers for Disease Control and Prevention[iii]

The week of September 18-24 was designatedPrescription Opioid and Heroin Epidemic Awareness Week.”[iv] As a pharmacist, I know that opioid medications can be beneficial in controlling certain types of pain. However, this benefit must be weighed against the risks associated with these medications.

The Epidemic

The number of opioid prescriptions in the US quadrupled from 1999 to 2014, while the number of American reporting chronic pain remained constant.[v]

Opioid pain medications like Opana, OxyContin and Percocet were originally used to treat short term-pain, such as after a surgery or accident, and for long-term pain associated with cancer. Today, we see these medications prescribed and utilized more commonly for all forms of pain and over longer periods of time.

The diagram below highlights opioid prescribing patterns in the US. In some states, including NC, the number of painkiller prescriptions per 100 people is equal to or exceeds 100.[vi]

opioid epidemicThere are many sources of misused opioid prescriptions. The majority, approximately 60%, of misusers obtain opioid medications from a friend or relative, either for free, by stealing or by buying them.[vii] 

 

The Dangers

Imagine you are in a car accident and have persistent back pain that makes it difficult for you to sit and stand

comfortably. The doctor prescribes an opioid medication used regularly to control your pain.  Soon you find that you have become dependent on this medication—even after your back feels better.

This scenario happens more often than we think. The danger of opioids is that they can become addictive to any user. For this reason, they should only be prescribed in appropriate cases.

In addition to risk for addiction, these medications are dangerous because of side effects like sedation and respiratory depression. These effects can be compounded when combined with other medications. For example, a common drug interaction with Xanax (a medication used for anxiety) can lead to slowed breathing, oversedation and possible death.

Action Steps

The fight against the opioid epidemic requires action from everyone. Prescribers and pharmacies are more regularly monitoring those taking opioid medications. In North Carolina, the Board of Medicine and Board of Pharmacy have strategies to control these medications to decrease utilization and death from opioid abuse and overdose.

The opioid reversal agent, naloxone, is more readily available from retail pharmacies. Efforts are being made to increase access to treatment for addiction. Communities are educating the public on the dangers of opioids and offeopioid epidemring “take-back” programs for disposal of unused opioid medications.

In July, the US Senate passed the Comprehensive Addiction and Recovery Act, the first major federal legislation on addiction in 40 years. The purpose of this law is to expand education, strengthen state monitoring programs and create new treatment programs.

Real progress can only result when doctors, nurses, pharmacists, patients, government officials, community leaders and the family and friends of those affected work together to put an end to the opioid epidemic.

Pharmacist on Staff for Clients

As the new MedCost Pharmacist, I discuss pharmacy management strategies with clients and brokers to control the explosion of drug costs. Prior authorizations, step therapy programs and quantity limits can be frustrating and disruptive. But we know that these utilization management strategies are key in controlling costs. 

Our partnership with OptumRx, ensures that members take safe, effective medications appropriate for their conditions, while implementing cost-saving strategies.

Opioid epidemic

 

 

 

 

 

 

 

 


Source: 
Mercer National Survey of Employer-Sponsored Health Plan -2015l[i]

Our goal at MedCost is to help ensure that our clients’ covered members are being treated appropriately and safely, without the risk of exorbitantly high costs. This will not only be the most cost-effective strategy, but it can result in members with healthier, happier lives.MedCost

 

[i] “The Opioid Epidemic: By the Numbers,” US Health & Human Services, June 15, 2016, http://www.hhs.gov/sites/default/files/Factsheet-opioids-061516.pdf (accessed September 26, 2016)

[ii] “Injury Prevention & Control: Opioid Overdose,” Centers for Medicaid and Medicare Services, https://www.cdc.gov/drugoverdose/data/index.html (accessed September 22, 2016).

[iii] Ibid.

[iv]Office of the White House Press Secretary, September 16, 2016, https://www.whitehouse.gov/the-press-office/2016/09/16/presidential-proclamation-prescription-opioid-and-heroin-epidemic (accessed September 22, 2016).

[v] Guideline for Prescribing Opioids for Chronic Pain, Centers for Medicaid and Medicare Services, March 16, 2016, http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm (accessed September 22, 2016).

[vi]  “Injury Prevention & Control: Opioid Overdose,” Centers for Medicaid and Medicare Services, http://www.cdc.gov/drugoverdose/data/prescribing.html (accessed September 22, 2016).

[vii] Ibid.

[viii] Bruce Lee, “With the Excise Tax in Their Sights, Employers Hold Health Benefits Cost Growth to 3.8% in 2015,” Mercer, November 19, 2015, http://www.mercer.com/newsroom/national-survey-of-employer-sponsored-health-plans-2015.html (accessed September 22, 2016).

US Drug Spending Up 8.5% in 2015

Increases Due to Rising Prices and Prescriptions Filledpills, drugs, medicine, opioids, health costs

U.S. spending on prescription drugs rose 8.5 percent last year, slightly less than in 2014, driven mainly by growing use of ultra-expensive new drugs and price hikes on other medicines.

A report from data firm IMS Health estimates patients, insurers, government programs and other payers spent a combined $309.5 billion last year on prescription medicines.

The IMS Institute for Healthcare Informatics is forecasting that annual increases in U.S. prescription drug spending will slow to 4 to 7 percent through 2020, after rising around 10 percent in each of the past three years. It predicts spending will reach $370 billion to $400 billion in 2020.

(Associated Press, April 14, 2016)