Payer snubs PTC’s Emflaza, signaling pricing trouble ahead of launch – FiercePharma

Washington State continues to battle for lower cost prescriptions. This is your government in action. It’s a good thing.

As Washington State’s HCA noted, PTC Therapeutics has not announced its new price. But the group published a report (PDF) stating that prednisone—at a cost of 5 cents per tablet and $55 per year—will be its preferred corticosteroid for DMD patients. It’s the “lower cost, equally effective” option, according to HCA.

Read the whole story here:

http://www.fiercepharma.com/pharma/policy-report-washington-s-largest-healthcare-purchaser-snubs-ptc-s-emflaza

Trump Makes His First Big Changes To Obamacare – Huffington Post

This is a very important read for any of us tracking the Administration’s attack on healthcare.

The overall consequence of the new rules is that health insurance will be harder to buy in 2018, especially for people whose circumstances change during the year, enabling them to buy policies outside the annual sign-up period. The length of that sign-up period is also cut in half.

Thank you to the Huffington Post for making this news digestible to almost anyone that knows how to read. Read the whole article here:

Trump Makes His First Big Changes To Obamacare

Washington State Passes Pregnant Workers Fairness Act

From NARAL: The Washington State Legislature has unanimously passed the Pregnant Workers Fairness Act and the bill is now on its way to the Governor’s desk.

The Pregnant Workers Fairness Act will protect pregnant workers by requiring employers to provide reasonable work accommodations during pregnancy, such as temporary reassignment to light duty, additional bathroom breaks, and flexible scheduling for prenatal appointments. It would also prohibit employers from requiring pregnant workers to take paid or unpaid leave instead of providing reasonable job modifications, as well as protect pregnant workers from unequal treatment or retaliation for asking for an accommodation.

Washington State joins fifteen states, D.C., and four cities that have passed laws requiring employers to provide reasonable accommodations to pregnant workers and protecting pregnant workers from retaliation when they request accommodations.

Congratulations to all the groups that spent huge amounts of time phone calling the legislators and going to meet them in Olympia.

 

State passes law giving credence to reflexology and somatic education

The Washington State legislature has updated it’s RCW 18.108 to reflect state credence of the massage techniques of reflexology and somatic education. Both these methods have no basis in proven scientific methods of treatment, and are considered by some in the medical profession to be nothing more than fake medicine. It is disheartening to see the State legislature taking steps to legitimize these massage techniques that come with little or no proof of their ability to treat patients other than that the industry has come up with educational programs to train people in these techniques. While there seems to be nothing more than hearsay to validate their techniques, the legislature abrogates it’s duty to protect the public from non-scientifically valid procedures, and work towards giving these techniques and their practitioners a cloak of medical respectability.

According to information on Quackwatch.com, the leading source for tracking non-scientific health claims in the US:

Many proponents claim that foot reflexology can cleanse the body of toxins, increase circulation, assist in weight loss, and improve the health of organs throughout the body. Others have reported success in treating earaches, anemia, bedwetting, bronchitis, convulsions in an infant, hemorrhoids, hiccups, deafness, hair loss, emphysema, prostate trouble, heart disease, overactive thyroid gland, kidney stones, liver trouble, rectal prolapse, undescended testicles, intestinal paralysis, cataracts, and hydrocephalus (a condition in which an excess of fluid surrounding the brain can cause pressure that damages the brain). Some claim to “balance energy and enhance healing elsewhere in the body.” [2] One practitioner has even claimed to have lengthened a leg that was an inch shorter than the other. There is no scientific support for these assertions.

Reflexology was introduced into the United States in 1913 by William H. Fitzgerald, M.D. (1872-1942), an ear, nose, and throat specialist who called it “zone therapy.” Eunice D. Ingham (1899-1974) further developed reflexology in the 1930s and 1940s, concentrating on the feet [3] Mildred Carter, a former student of Ingham, subsequently promoted foot reflexology as a miraculous health method [4-6]. A 1993 mailing from her publisher stated:

Not only does new Body Reflexology let you cure the worst illnesses safely and permanently, it can even work to reverse the aging process, Carter says. Say goodbye to age lines, dry skin, brown spots, blemishes—with Body Reflexology you can actually give yourself an at-home facelift with no discomfort or disfiguring surgery [7].

You can read the whole overview by Dr. Barrett along with research studies that have been done that conclude that reflexology has no legitimate scientific standing.

http://quackwatch.com/01QuackeryRelatedTopics/reflex.html

Dr. Barrett’s conclusion: “Reflexology is based on an absurd theory and has not been demonstrated to influence the course of any illness. Done gently, reflexology is a form of foot massage that may help people relax temporarily. Whether that is worth $35 to $100 per session or is more effective than ordinary (noncommercial) foot massage is a matter of individual choice. Claims that reflexology is effective for diagnosing or treating disease should be ignored. Such claims could lead to delay of necessary medical care or to unnecessary medical testing of people who are worried about reflexology findings.”

Also from Dr. Barrett’s web site, the definition of “Somatic Therapy” that the state is tacitly supporting:

somatic therapy (somatic disciplines, somatic methods, somatics, somatic techniques, somatic therapies): Field that encompasses aikido, the Alexander Technique, applied kinesiology, Arica, Aston-Patterning, Awareness Through Movement, bioenergetics, Body-Mind Centering®, “Capoeria,” “Continuum,” CranioSacral Therapy, Eutony, Focusing, Functional Integration, Hakomi, Hellerwork, judo, karate, kundalini yoga, kung fu, “Lomi” (see “lomi-lomi” and “Lomi work”), “Oki yoga” (see “Oki-Do”), Process-Oriented Psychotherapy (process psychology), rebirthing, reflexology, Resonant Kinesiology, Rolfing, “Rosen work” (see “Rosen Method”), “sensory awareness,” SHEN, somasynthesis, tai chi, Touch for Health, Trager, “Trans Fiber,” yoga therapy, and Zero Balancing. “Subtle-energy elements” are a commonality of somatic therapies. Thomas Hanna, founder of the journal Somatics, coined the word “somatics.”

While I have no doubt that some of these techniques, such as Capoeria, Akidido, etc. are good exercise and lead to relaxation, by turning these into some kind of pseudo medical technique leads to people thinking it’s a treatment for a disease or condition that should be treated with proven medical techniques. It’s disappointing to see the Washington State Legislature give validity to these marketing tactics for these  techniques.

We can hope the Governor chooses to not sign this update to the RCW.

Thoughts on Trump’s approach to Healthcare

From Diane Jones:Here is what I hear from the healthcare advocates group I connect with:
1. What changes will the Trump Administration attempt to make through rulemaking?

 

Republicans have talked about a three-pronged strategy for ACA repeal and replace: (1) enact the American Health Care Act (AHCA) through the budget reconciliation process; (2) make changes through the regulatory process; and (3) enact follow-up legislation through normal order (i.e., not through the budget reconciliation process). They have emphasized within their own caucus that they can do a lot through the second prong. According to Politico, President Trump’s budget director, Mick Mulvaney, even went so far as to present the Freedom Caucus “a letter from Trump outlining all the Obamacare regulations his administration would repeal on its own” as part of the last-ditch effort to win over its members last Thursday night.

 

Presumably, the administration will still move forward with a major portion of these planned rule changes. HHS had already begun using the rulemaking process to make change before the AHCA was even unveiled. On February 17, HHS issued a proposed rule billed by the Department as aimed at improving market stabilization, though its primary elements were in fact directed at making it more difficult for individuals to purchase coverage, opening the door to lower-value plans, and lowering the amount of federal premium tax credits. (The AFL-CIO comments on the proposed rule are attached.) The IRS also reportedly is softening enforcement of the individual shared responsibility penalty. There are many other areas the administration could pursue. Back in January, Nicholas Bagley and Adrianna McIntyre at the Incidental Economist had a good run down of potential changes: Executive Actions Trump Could Take to Change the ACA. We discuss a few potential avenues for change in the questions below.

 

2. Does the Trump Administration go along with Congress in stopping cost sharing subsidy reimbursements to insurers participating in the marketplaces?

 

It is widely recognized that a surefire way to tank the ACA individual marketplaces quickly would be to halt reimbursement of insurers for cost-sharing subsidies they are required to provide enrollees with household incomes below 250 percent of the federal poverty level. That’s why resolution of an ongoing lawsuit between congressional Republicans and the federal government over whether the government has the authority to reimburse insurers absent a congressional appropriation is so important. The Trump Administration and congressional Republicans need to decide whether to pay up or create havoc.

 

3. What will happen to Medicaid?

 

Medicaid still has a huge target on its back. The House Republican plan would have cut $839 billion Medicaid spending over 10 years, not only rolling back the ACA Medicaid expansion but also ending the half-century-old federal Medicaid funding guarantee through per capita caps (or optional block grants for some beneficiaries) among other changes. Republicans will be tempted to make another run at Medicaid in subsequent budget reconciliation legislation, since cuts to it could be used to pay for tax cuts.

 

Also, as we noted last week, HHS secretary Tom Price and CMS administrator Seema Verma recently sent a letter to governors signaling that HHS and CMS are now open for business when it comes to waivers (known as Section 1115 waivers). They would like to allow states to make significant changes to their Medicaid programs, like imposing work requirements for certain enrollees (which the failed House Republican plan would have permitted by statute).

 

4. How will HHS try to use state innovation waivers to reshape the ACA?

 

The ACA comes with a built-in tool for trying alternative approaches to achieving the ACA’s coverage and affordability goals, through state innovation waivers under Section 1332 of the Act. The Trump Administration has expressed some initial interest in using these waivers.On March 13, HHS secretary Tom Price sent a letter to governors soliciting state innovation waiver applications, with an emphasis on applications that include high-risk pools or state-operated reinsurance programs. More broadly, conservatives have expressed interest in using these waivers in combination with Medicaid Section 1115 waivers, as a way to devolve control to states. See, for example, the Manhattan Institute’s State Waivers: A Federalist Rx for Obamacare Ills. HHS likely will issue new agency guidance and possibly use the rulemaking process to give states more leeway under Section 1332.

 

5. What will happen to Value-Based Payment Models with Tom Price in charge of HHS?

 

On March 21, HHS and CMS issued an interim final rule (IFR) announcing a further delay of two mandatory bundled payment programs under Medicare for heart attack treatment and bypass surgery, a delay of the Cardiac Rehab Incentive Payment Model and a delay in the expansion of the mandatory Comprehensive Care for Joint Replacement Model. The IFR solicits comments on the delay as well as a further delay. This raises questions about the future of many of the on-going efforts to improve care and reduce costs through alternative payment models. HHS Secretary Tom Price does not support much of this work and considers the Center for Medicare and Medicaid Innovation (CMMI)—the ACA-created entity that develops new models for delivering and paying for care under certain government programs—to be an incursion into Congressional authority and oversight. This is despite CBO’s view that CMMI reduces federal spending. Questioning value-based payment models may also lead to changes under MACRA and impact physician payments under Medicare.

 

6. How will health care come up in tax reform?

 

President Trump and congressional Republicans say they soon will turn to tax reform. Health care is likely to come up in several ways. The biggest question is whether Republican tax reform plans will go after the tax exclusion for workplace health plans. Leaders like House Ways & Means Committee chairman Kevin Brady (R-TX) made it clear early in the ACA repeal and replace debate that they really would like to cap the tax exclusion. The leaked version of the House health bill capped it at the premium for the 90th percentile plan, before the drafters removed it in favor of a straight-up delay in “Cadillac tax.” Other things to keep an eye on include HSA changes (especially big increases in the contribution limits) and restoring the medical expense deductibility threshold at its pre-ACA level (7.5% of income).

 

7. What’s next for the “Cadillac tax”?

 

The excise tax on high-cost health plans is scheduled to go into effect beginning in 2020. Failure of the Republican health plan may lead Treasury and IRS to restart the regulatory process and move toward issuing a proposed rule. On the other hand, Treasury and IRS may slow walk things if they believe Congress is likely at least to delay the effective date again before it goes into effect. The last version of the House bill would have delayed the tax until 2026. As noted above, Congress may also try to replace the tax with a cap on the tax exclusion as part of comprehensive tax reform.

 

8. Will Congress try to move smaller pieces of legislation?

 

House Republicans have teed up several health care bills separate from their ACA repeal and replace plan. For example, the House passed theSmall Business Health Fairness Act (H.R. 1101) on Wednesday. (See the AFL-CIO letter opposing this bill attached to this e-mail.) At the moment, it seems unlikely this bill, which authorizes so-called association health plans, will move in the Senate, but Republicans could try to show some progress on health care with smaller pieces of legislation like this bill.

 

9. What will President Trump do, if anything, about prescription drug prices?

 

President Trump has repeatedly gone after prescription drug manufacturers because of high drug prices and has said he supports government drug price negotiating authority. However, he has sent very mixed signals about his intentions. The day before he met with Rep. Elijah Cummings (D-MD) and Rep. Peter Welch (D-VT) to discuss their draft legislation to give HHS price negotiating authority for Medicare, President Trump tweeted:

 
 

President Trump previously met with PhRMA’s leaders and struck a conciliatory tone toward drug manufacturers, indicating that he saw regulatory barriers and the slow drug approval process as the major problems. So, any action on drug prices is TBD.

 

10. Will single payer proposals or legislation building on the ACA’s basic structure, such as a public option, gain momentum now?

 

Sen. Bernie Sanders (D-VT) has announced that he soon will introduce a “Medicare for All” bill, which Rep. Peter Welch (D-VT) also will introduce in the House of Representatives. This is in addition to the Expanded and Improved Medicare for All Act (H.R. 676) that Rep. John Conyers (D-MI) has introduced in successive congresses. A Sunday Washington Postarticle quotes Sen. Jack Reed (D-RI) and Rep. Jim Langevin (D-RI) also calling for single payer, and their colleague Sen. Sheldon Whitehouse (D-RI) endorsing the public option.

 

11. Will Republicans try to engage Democrats around alternative ACA replacement ideas?

 

Legislation introduced by Sen. Bill Cassidy (R-LA) and Sen. Susan Collins (R-ME) in January, the Patient Freedom Act of 2017 (S. 191), garnered a lot of attention as something that might build a bridge for some Democratic support. That’s partly because this bill would give individual states the option of keeping some elements of the basic ACA structure (individual and employer shared responsibility requirements, marketplaces, and ACA premium tax credits and cost-sharing subsidies at somewhat lower levels), though the emphasis would be on alternatives that are heavy on block grants and state control. There are lots ofproblems with the bill, but it’s worth paying attention to whether Republicans try to engage centrist Democrats around this kind of approach

Health leaders in Washington state seek improvements in existing health care law – Yakima Herald

Good original article by the Yakima Herald’s Molly Rosbach. Especially useful is it’s point on the use of Electronic Health Records, the bain of many physicians.

“Physicians don’t want to get rid of their EHRs; they understand the value, they just want to make sure it works in a way that’s natural to their work flow,” rather than a series of mindless boxes to check off, said Jennifer Hanscom, executive director of the state Medical Association. “It would be great if we could sit down with the folks at (Health and Human Services) in particular to kind of walk through that, and keeping the lens of a physician on all those regulations.”

A big area where documentation regulations appear at odds with the broader transition from fee-for-service to value-based purchasing is in prior authorization, Hanscom said: Why do insurers still require prior authorization, a extra step for patients and doctors, if doctors are already using the best evidence-based guidelines to make decisions about what services the patient needs?”

Read the whole story here:

http://www.yakimaherald.com/news/local/health-leaders-in-washington-state-seek-improvements-in-existing-health/article_70c50382-1767-11e7-ba24-87db1f07d72b.html

Washington State Providers and Delivery System Speak out Against Republican Plan


SEATTLE, March 22, 2017 /PRNewswire/ — Five organizations that represent Washington State’s largest health care delivery systems, physicians and providers are stating their opposition to the American Health Care Act. The Washington State Hospital Association (WSHA), Washington State Medical Association (WSMA), Washington Association of Community and Migrant Health Centers (WACMHC), and the Community Health Network of Washington (CHNW), along with its subsidiary non-profit managed care company, Community Health Plan of Washington (CHPW), are calling on Congress to reject the House proposal that puts their patients at risk. Collectively, these groups represent 107 hospitals, 267 clinics, 10,000 physicians and other providers, 315,000 members, and more than 17 million patient visits a year statewide.

 

Read the whole story here: http://www.prnewswire.com/news-releases/washington-state-providers-and-delivery-system-speak-out-against-the-american-health-care-act-300428243.html