States Pass Record Number Of Laws To Reel In Drug Prices

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Source: Kaiser Health News

Whether Congress will act this year to address the affordability of prescription drugs — a high priority among voters — remains uncertain. But states aren’t waiting.

So far this year, 33 states have enacted a record 51 laws to address drug prices, affordability and access. That tops the previous record of 45 laws enacted in 28 states set just last year, according to the National Academy for State Health Policy, a nonprofit advocacy group that develops model legislation and promotes such laws.

Among the new measures are those that authorize importing prescription drugs, screen for excessive price increases by drug companies and establish oversight boards to set the prices states will pay for drugs.

“Legislative activity in this area is escalating,” said Trish Riley, NASHP’s executive director. “This year, some states moved to launch programs that directly impact what they and consumers pay for high-cost drugs.”

And more laws could be coming before year’s end. Of the handful of states still in legislative session — including California, Massachusetts, Michigan, New Jersey, Ohio and Pennsylvania — debate continues on dozens of prescription drug bills. In New Jersey alone, some 20 proposed laws are under consideration.

“Both Democrat and Republican leaders have shown a willingness to pursue strong measures that help consumers but also protect state taxpayer dollars,” said Hemi Tewarson, director of the National Governors Association’s health programs.

Riley, Tewarson and others note, however, that states can go only so far in addressing rising drug prices, and that federal legislation would be necessary to have a major impact on the way the marketplace works.

Federal lawmakers are keeping a close eye on the state initiatives, Tewarson said, to gauge where legislative compromise may lie — even as Congress debates more than a dozen bills that target drug costs. Political divisiveness, a packed congressional schedule and a looming election year could stall momentum at the federal level.

The pharmaceutical industry has opposed most — though not all — state bills, said Priscilla VanderVeer, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, the industry’s main trade group.

“We agree that what consumers now pay for drugs out-of-pocket is a serious problem,” said VanderVeer. “Many states have passed bills that look good on paper but that we don’t believe will save consumers money.”

Limiting Gag Rules For Pharmacists

At least 16 states have enacted 20 laws governing the behavior of pharmacy benefit managers. The so-called PBMs serve as middlemen among drugmakers, insurance companies and pharmacies, largely with pharmaceutical industry support.

Those laws add to the 28 passed in 2018. Most of the new laws ban “gag clauses” that some PBMs impose on pharmacists. The clauses, written into pharmacy contracts, stop pharmacists from discussing with customers whether a drug’s cash price would be lower than its out-of-pocket cost under insurance.

With widespread public outrage over gag clauses pushing states to act, federal lawmakers got the message. In October, Congress passed a federal law banning such clauses in PBM-pharmacy contracts nationwide and under the Medicare Part D prescription drug benefit. The Senate passed it 98-2.

Even so, many of this year’s PBM laws contain additional gag clause limitations that go beyond the 2018 federal law.

Importing Cheaper Drugs

Four states — Colorado, Florida, Maine and Vermont — this year have enacted measures to establish programs to import cheaper prescription drugs from Canada and, in Florida’s case, potentially other countries. Six other states are considering such legislation.

Medicines in Canada and other countries are less expensive because those nations negotiate directly with drugmakers to set prices.

“This is an area where states once feared to tread,” said Jane Horvath, a consultant who has advised Maryland and Oregon, among other states, on prescription drug policy. “Now both Republicans and Democrats view it as a way to infuse more price competition into the marketplace.”

Hurdles remain, however. A 2003 law allows states to import cheaper drugs from Canada but only if the federal Health and Human Services Department approves a state’s plan and certifies its safety. Between 2004 and 2009, the federal government halted nascent drug import efforts in five states.

Even so, momentum for importation has built in recent years in states and Congress as drug prices have continued to rise. And the Trump administration this summer threw its support behind the idea.

Florida Gov. Ron DeSantis, a Republican and close ally of President Donald Trump’s, signed his state’s measure into law on June 11, claiming he did so after Trump personally promised him the White House would back the initiative.

On July 31, HHS announced an “action plan” to “lay the foundation for safe importation of certain prescription drugs.” The plan includes a process to authorize state initiatives. It also requires formal regulatory review, including establishing Food and Drug Administration safety criteria. That process could take up to two years.

Two big problems remain: In the weeks since the announcement, the Canadian government has opposed any plan that would rely solely on Canada as a source of imported drugs. The pharmaceutical industry also opposes the plan.

Creating Drug Affordability Boards

Maryland and Maine enacted laws this year that establish state agencies to review the costs of drugs and take action against those whose price increases exceed a certain threshold.

New Jersey and Massachusetts are debating similar legislation this year.

Maryland’s law establishes a five-member board to review the list prices and costs of drugs purchased by the state and Maryland’s county and local governments. The board will probe drugs that increase in price by $3,000 or more per year and new medicines that enter the market costing $30,000 or more per year or over the course of treatment.

If approved by future legislation, upper payment limits on drugs with excessive price increases or annual costs would take effect in January 2022.

“My constituents have signaled loud and clear that bringing drug prices down is one of their top priorities,” said state Sen. Katherine Klausmeier, a Democrat representing Baltimore, who sponsored the legislation.

Maine’s law also establishes a five-member board. Beginning in 2021, the board will set annual spending targets for drugs purchased by the state and local governments.

Increasing Price Transparency

This year, four states — Colorado, Oregon, Texas and Washington — became the latest to enact laws requiring drug companies to provide information to states and consumers on the list prices of drugs and planned price increases.

The majority of states now have such transparency laws, and most post the data on public websites. The details vary, but all states with such laws seek to identify drugs with price increases above 10% or more a year, and drugs with price increases above set dollar values.

Oregon’s new law, for example, requires manufacturers to notify the state 60 days in advance of any planned increase of 10% or more in the price of brand-name drugs, and any 25% or greater increase in the price of generic drugs.

“That 60-days’ notice was very important to us,” said Rep. Andrea Salinas, chair of the Oregon House’s health committee, who represents Lake Oswego. “It gives doctors and patients advance notice and a chance to adjust and consider what to do.”

U.S. Judge Approves CVS Purchase of Insurer Aetna

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Source: The New York Times

A federal judge reviewing a Justice Department decision to allow U.S. pharmacy chain and benefits manager CVS Health Corp to merge with health insurer Aetna said on Wednesday that the agreement was in fact legal under antitrust law.

Judge Richard Leon of U.S. District Court for the District of Columbia had been examining a government plan announced in October to allow the merger on condition that Aetna sell its Medicare prescription drug plan business to WellCare Health Plans Inc. Both deals have already closed.

Leon had initially balked at approving the merger conditions and insisted on hearing from critics of the deal, but finally decided to grant the motion to approve the consent agreement.

But he took aim at the common practice of companies’ closing multibillion-dollar deals while the court review, required by the Tunney Act, was still in process.

“If the Tunney Act is to mean anything,” Leon wrote, “it surely must mean that no court should rubberstamp a consent decree approving the merger of ‘one of the largest companies in the United States’ and ‘the nation’s third largest health-insurance company,’ … simply because the Government requests it!”

In December, Leon said he was “less convinced” than the government that the asset sale to WellCare would resolve antitrust concerns. Since then, Centene Corp agreed to acquire WellCare for $15.27 billion.

Assistant Attorney General Makan Delrahim, head of the Justice Department’s Antitrust Division, said he was pleased with Leon’s decision.

CVS said the judge’s decision reinforced that CVS and Aetna have already merged.

“CVS Health and Aetna have been one company since November 2018, and today’s action by the District Court makes that 100 percent clear. We remain focused on transforming the consumer health care experience in America,” CVS spokesman T.J. Crawford said in an emailed statement.

Critics of the CVS-Aetna deal included the American Medical Association and the AIDS Healthcare Foundation.

Another critic, U.S. PIRG, expressed skepticism that savings from the merger would end up in consumers’ pockets.

“Again and again, CVS Caremark has used its market power to both increase the cost of medications for consumers and rip off the government, instead of passing on savings its promised to consumers,” PIRG said in a statement.

Pending Leon’s approval, CVS agreed to temporarily allow Aetna to independently make critical product, pricing and personnel decisions.

CVS has been in the process of converting itself into a healthcare company and said in June that it would offer expanded health services such as nutrition counseling and blood pressure screenings in 1,500 stores by the end of 2021.

Most consent agreements that the antitrust agencies strike with companies to resolve competitive concerns are approved by federal courts with little fuss under the 1974 Tunney Act, which requires courts to ensure the agreements are in the public interest.

Companies generally do not wait for final court approval before closing their transactions.

Medicare Plan Finder Upgrade: Will Brokers Need to Keep Hard Copy RX Lists?

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Source: Modern Healthcare

The CMS on Tuesday launched a redesigned Medicare Plan Finder to help Medicare beneficiaries and their caregivers shop for and compare Medicare Advantage and Part D plans, the first major update to the most popular tool in a decade.

The changes include an improved mobile-friendly design, as 25% of beneficiaries accessed the plan finder via mobile devices in 2018 and that number is growing quickly.

The new plan finder will also inform users if a generic version of their prescription drug is available, which is likely an effort to address the high out-of-pocket costs for prescription drugs. Beneficiaries and their caregivers can use the new tool to enroll in Medicare Advantage and Part D plans, as well as view and compare the supplemental benefits of Medicare Advantage plans.

The new plan finder is part of the CMS’ eMedicare initiative announced last year, which promises to deliver a streamlined user experience for Medicare beneficiaries.

“President Trump has made it clear that he wants to protect and strengthen Medicare,” CMS Administrator Seema Verma said in a statement. “The redesigned Medicare Plan Finder is another example of how CMS is empowering beneficiaries with price and quality information to take advantage of lower rates and new benefits in MA and Part D.”

The new tool will let users compare prices among original Medicare, Medicare prescription drug plans, Medicare Supplement Insurance (or Medigap) policies and Medicare Advantage plans. Users will have access to plan costs and benefits.

Users can also create a personalized drug list and view drug coverage across Medicare Part D plans. If someone is already a Medicare recipient, their recent claims data will be used to prefill a personalized drug list that they can modify based on recent changes in their medical care.

The old Medicare Plan Finder will be available through the end of September. The CMS will continue to gather feedback about the new tool as the Medicare open-enrollment period approaches. Open enrollment begins October 15.

The CMS also said that it would release by the end of the year real-time Medicare plan data in an application programming interface format. It hopes that the private sector will use this information to create new tools that Medicare recipients can adapt to make informed decisions about their health coverage.

During a Q&A session, Verma said the new tool largely addresses the concerns outlined in a July report from the Government Accountability Office that found the old plan finder was difficult to use for beneficiaries and provided incomplete information. She claimed that ongoing issues regarding incomplete information are due to a lack of data availability and cited the absence of some Medigap pricing information as an example.

The GAO report also found that the old tool did not include an integrated provider directory that beneficiaries could use to find out if their doctors are in-network. The new tool doesn’t fix that problem because the CMS doesn’t have the data required to build an integrated directory of providers. Verma said that’s one of the reasons the CMS has requested in a pending interoperability rule that health plans provide information about participating providers in an open API format.

Both the old and new tools include external links to health plan provider directories.

Paging More Doctors: California’s Worsening Physician Shortage

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Source: CalMatters

In a northern California valley stretching under miles of bright blue sky between two snowy volcanic peaks, Mt. Lassen and Mt. Shasta, Daniel Dahle is known as a godsend, a friend, a lifesaver, a companion until the end.

For more than three decades, “Doc” Dahle has been the physician in Bieber, serving a region about the size of five smaller U.S. states. When he started, he was one of five doctors in the region.  Today he is joined by only one other full-time physician.

At 71, Dahle has delayed retirement for years — waiting for someone to take his place.

“I was going to retire November 8th of last year; it was going to be a third of a century,” he said. “It’s tough to recruit young new vibrant family practitioners or internists or pediatricians to come up here.”

Unfortunately, Dahle’s situation is not unique.

California is facing a growing shortage of primary care physicians, one that is already afflicting  rural areas and low-income inner city areas, and is forecasted to impact millions of people within ten years. Not enough newly minted doctors are going into primary care, and a third of the doctors in the state are over 55 and looking to retire soon, according to a study by the Healthforce Center at UC-San Francisco.

That means by 2030, the state is going to be in dire need of physicians. Studies show the state could be down by as many as 10,000 primary care clinicians, including nurse practitioners and physician assistants. Some areas — the Central Valley, Central Coast and Southern Border region — will be hit especially hard. So too will be remote rural and inner-city residents, communities of color, the elderly, those with mental illness or addiction, and those without health coverage.

Many people will be forced to wait longer for doctor visits, travel longer distances to see someone, and may become so discouraged they forego preventative care and even care for chronic, serious disease until emergency treatment is necessary.

The federal government’s Council on Graduate Medical Education recommends 60 to 80 primary care doctors per 100,000 people. Statewide in California, the number already is down to just 50 per 100,000 — and in some places it’s even lower:  down to 35 in the Inland Empire and 39 in the San Joaquin Valley, according to a report from The Future Health Workforce Commision.

Among the causes of the physician shortage:

  • High student loan debt induces medical students to go into specialty care, which pays more than primary care — currently only 36 percent of doctors provide primary care.
  • Low Medi-Cal reimbursement rates for primary care drive doctors away from low-income areas and primary care.
  • Even primary care physicians often shy away from rural areas, opting instead to practice in big cities near medical centers and specialists.
  • Medical school students don’t reflect the diversity of the state, which also influences where new doctors practice — and where they don’t.

UC Davis Medical School Dean of Admissions and Outreach Mark Henderson said his medical school is focused on trying to eliminate the shortage between Davis and the Oregon border.

At Davis, where there is a focus on primary and rural care, about half of graduates go into primary care. But at most other medical schools, that percentage is 20 to 30 percent and it’s not enough.

“We still don’t take enough students from (rural and underserved) communities that will have a deep desire to want to go back to the community,” Henderson said. “You have to take a different type of a student, you can’t take the same old usual suspect.”

New doctors “take these specialty areas that pay higher, and that leaves us with a shortage of primary care physicians including pediatricians, internists, family practice physicians and OB/GYNs,” said John Baackes, CEO of LA Care Health Plan, which has the largest number of Medi-Cal members in the state.

He said in rural areas, veteran doctors who are solo practitioners are having a hard time bringing in new doctors to take over.

“Young doctors are increasingly going to salaried positions” at institutions such as Kaiser, said Baackes.

In low-income areas, a different deterrent comes into play. Dismal Medi-Cal reimbursement rates  keep some students out of primary care and repels some primary medical graduates, said Elaine Batchlor, CEO of MLK Jr. Community Hospital in South Los Angeles.

“It’s difficult for physicians to support a practice in that environment and organized medical groups are not attracted to the community because of low (Medi-Cal) reimbursements,” she said.

The California Future Health Workforce Commission — made up of business, elected and health care leaders — released a report earlier this year warning of the looming shortage of health workers to meet the needs of the “growing, aging and increasingly diverse population.”

“If we’re looking to the future in a state where we have everyone covered, we can’t do it with the workforce we have and we are not doing it well now in many places,” said Assemblyman Jim Wood, a Santa Rosa Democrat who was part of the commission.

The commission found that already 7 million Californians live in federally designated Health Professional Shortage Areas because they lack primary care physicians, dentists and mental health professionals. Most are in the Inland Empire, part of Los Angeles, the San Joaquin Valley and in remote parts of the state, like where Dahle practices.

He tries to assist the next generation of providers: He takes physician-assistant trainees nearly year-round from the University of Iowa, where one of his former physician assistants runs a program.

“These guys are smarter than me already,” Dahle said. “Actually, we teach each other. We teach them the art of medicine and they teach me all the new science of medicine. It works out really good.”

The trainees live with Dahle in his log cabin on 160 acres just outside of town, down a 5-mile dirt road. His dog Clint, a Pyrenees he rescued, eagerly awaits him each afternoon.

Over the course of two recent days, Dahle treated patients with hyperthyroidism, migraines, diabetes, swollen lymph nodes, chronic ear infections, knee pain and constant nausea, and performed a skin biopsy to test for cancer.

Inevitably, country doctors have to be able to do more with less — and be willing to live far from urbanity.

“The younger generation of providers, they don’t have the clinical skills or know-how. They’re not trained the same as Dr. Dahle,” said Shannon Gerig, CEO of Mountain Valleys Health Centers, which operates seven centers across 6,000 square miles in the northern part of California including in Bieber, where Dahle is the lone doctor at that center. “It’s a scary thing for them to come out and be so remote, and know that they are going to be solo a lot, and they are going to be depended on by the mid-level staff…and they don’t have specialty (doctors) around them.”

Dahle has birthed thousands of babies, diagnosed cancers, done skin biopsies, assisted in minor surgeries, attended to patients on their deathbeds and occasionally rushed out into the forest or to a ranch to treat those whacked by a falling hay bale, a downed tree or a stubborn horse. He once finished a pelvic exam by flashflight because the power went out, did minor toe surgery in his office while taking direction from a surgeon on the phone, and jumped in a helicopter transport to accompany a patient with a broken neck enroute to a far-away trauma center.

He also works in the Fall River Mills’ emergency room one 24-hour shift a week, and makes hospital rounds first thing most days.

One recent morning, he greeted and joked with Wilma Chesbro, 88, who used to be an operating room scrub nurse with Dahle, and now is a patient in long-term care.

She grasped his hand, reminding him that when they first met decades ago she thought he was a “yokel” because he’s from a local town. But Chesbroe cried and lost her breath every time she tried to express just how much Dahle meant to her.

“He’s brilliant,” she said through her tears. “But he doesn’t show it. I have so much respect for him.”

Earlier this year he was named Country Doctor of the Year by AMN Healthcare, the largest health staffing agency in the country. The welcome sign to Bieber announces it has 510 residents; the health centers there cater to about 17,000 residents across several towns.

Much of the area is designated “frontier” by the federal government because so few people live there. Beiber has one motel, and passersby who blink might miss the Big Valley Market, where Dahle gets a maple bar for breakfast most days. Fields and ranches dot the wide-open valley, giving way to forests and rising peaks. The nearest Safeway grocery store is in Burney, 40 miles away. The isolation has made some prospective physicians make a U-turn and drive away, without ever stepping foot in the clinic for their scheduled interview. Many have told Dahle their spouse or partner saw the town and said “no way.”

Doc Dahle grew up in nearby Tulelake, the son of a potato farmer. He was drafted from college to Vietnam. Later he finished college at Oregon State, then was turned down for medical school there four times before he was accepted at the University of Rochester. When he graduated he returned to northern California to practice. His cousin is Brian Dahle, a GOP state senator who represents the area.

But Doc Dahle may just be the better known of the two. Thousands of  residents in these parts go out of their way to see him.

“Patients are fine waiting, because they know when they see Dr. Dahle he will take whatever amount of time he needs to talk with them, to get the care they need. I guess you’d call it old school,” said Gerig, who was Dahle’s patient before becoming his boss.

She began working as a registered nurse with Dahle 25 years ago, and he delivered her three babies via C-section. It seems everyone has a connection like that. At a local bar, a group of guys ticked off what Dahle has done for them — one called him a “lifesaver” for diagnosing a 99 percent carotid artery blockage.

This is why Dahle is fired up about finding his replacement. This is his “family,” he said.

He’s got his eye on a young doctor couple out of Davis. But there is one hitch. The local hospital in Fall River Mills, just about 25 miles up the road, closed its obstetrics unit, forcing pregnant women go at least a hundred miles to Redding or Shasta to deliver.

Unless the hospital reopens that wing, Dahle may not be able to land the couple despite their interest. The husband is in primary care and has already filled in at Dahle’s clinic, but the wife, who is from Fall River Mills, is training to be an OB-GYN.

“We’re not going to be able to recruit these homegrown kids to come back here without something changing,” said Dahle. “We have got to do this for our community.”

That’s the reason he’s sticking around, for the community and to work on bringing the couple back home.

“I love my job,” said Dahle, who is twice divorced, acknowledging it was always hard to stay married because he is wedded to medicine. “I have never regretted ever being a doctor.  Everyday I go to work and say that I help somebody.”

If he ever does retire, he plans to scuba dive, hunt rocks and travel.

But he’ll still probably have lunch on Tuesdays at the Roundup Bar, just like he does now for the hot dog special. Sometimes, if someone sees Dahle heading over, they’ll call the bar and buy Dahle’s beer.

“He’s a staple in our community. He holds us all together,” said bar owner Scott Johnson. “This is like his second office. He comes here and everyone gathers round and asks him questions to avoid a doctor visit.”

Will Gavin Newsom’s Plan Lower Prescription Drug Costs in California?

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Source: San Francisco Chronicle

Eight months ago, Gov. Gavin Newsom released a plan to lower the state’s prescription drug costs. The central idea: By consolidating the market power of state agencies into one statewide pool, California could gain greater leverage to negotiate with drugmakers.

In late August, the administration took a first step toward making the proposal a reality.

Under the plan, which was outlined in an executive order announced shortly after Newsom took office, the state — rather than individual managed care insurance plans — will take on the role of negotiating drug costs on behalf of all 13 million Californians on Medi-Cal, the state’s Medicaid insurance plan for low-income residents.

The Department of Health Care Services, which administers Medi-Cal, began soliciting proposals Aug. 22 from companies to help the state manage pharmacy benefits. This transition is to be completed by January 2021.

“It’s a step in the right direction,” said Ramon Castellblanch, a professor emeritus at San Francisco State University who has studied drug pricing.

The administration estimates the transition will save the state $393 million by 2023. The nonpartisan Legislative Analyst’s Office in April said the move could potentially save the state hundreds of millions of dollars each year, but that it lacks details about how it will be implemented and how it will affect Medi-Cal enrollees, pharmacies, health care providers and managed care plans. Community hospitals that benefit from a federal drug discount program might also take a financial hit under the proposal because they would receive less money from the state than they would under the current system for drugs.

Experts say the downside of such a proposal is that it could limit the types of drugs available for patients, or make some drugs more expensive. This is because purchasing pools can get a discount on a drug only if they guarantee the drugmaker that a lot of people will use it — essentially leveraging market power to obtain a discount. If a certain drug is less commonly used, the drugmaker is less likely to offer a discount on it, potentially making the medicine more expensive.

The counties of San Francisco, Los Angeles, Alameda and Santa Clara, which buy drugs for county hospitals and inmates, recently said they will join the statewide pool.

The executive order does not directly address, at least not right away, the problem of high out-of-pocket prescription drug costs for the millions of Californians on private health insurance plans — such as consumers stuck paying several hundred dollars for a single dose of lifesaving medication like insulin or EpiPens. That’s because the order seeks to first change the way state agencies work together to purchase drugs. Private insurance companies are encouraged but not required to join the pool.

California is not the first state to attempt a state-managed bulk purchasing pool. Since 1999, when Massachusetts authorized a statewide bulk prescription plan, a growing number of state agencies have implemented or explored bulk purchasing, according to the National Conference of State Legislatures.

Perhaps of greatest interest to California is Washington state, which in 2005 created a pool to determine how much it will pay pharmacies for prescription drugs for state employees. Called the Northwest Prescription Drug Consortium, it has been joined by some Oregon Medicaid beneficiaries, public employees and residents on workers’ compensation, and Washington’s Department of Corrections (which buys drugs for offenders in state prisons) — for a pool of more than 500,000 people.

Some date indicate states and consumers save money on prescription drugs when the state takes on the role of negotiating costs. For the roughly 284,000 Washington residents on the Uniform Medical Plan — the health plan for Washington public employees and retirees, which is part of the Northwest Prescription Drug Consortium — many drugs are available with no co-pay or a co-pay of $10.

One 2018 study found that the Uniform Medical Plan spent 35% less than the California Public Employees’ Retirement System plan on prescription drugs for state employees and retirees ($58 per month compared with $89 per month) in 2016, according to a report co-written by Castellblanch. But those differences also could be attributed to different co-pays and whether employees were sicker or older in one pool than the other.

California has tried to create a statewide drug purchasing pool in the past. The California Pharmaceutical Collaborative was created by legislation nearly 20 years ago with similar goals. The collaborative, housed within the Department of General Services — which purchases drugs for state hospitals and prisons — was supposed to bring together other state agencies for drug purchasing. But because of fragmented bureaucracy and a lack of political appetite in previous administrations, it hasn’t done so, said Assemblyman David Chiu, D-San Francisco.

Chiu wrote a 2017 bill that would have created a statewide drug purchasing pool by getting state departments under one system; parts of the governor’s executive order are similar to that bill, which passed the Assembly but not the Senate.

New York recently explored the idea of getting the state, rather than pharmacy benefit managers, to determine which drugs will be covered for Medicaid beneficiaries and how much they will cost. West Virginia, which did so in 2017, recently said it saved $55 million in its first year.

“This is a hot topic in the U.S.,” Castellblanch said. “California is part of a national movement.”

And 28 states are part of various multistate drug purchasing pools — where states’ Medicaid programs or agencies within states partner with agencies in other states for, in theory, more market power.

It is a model that Chiu wants California to explore with Oregon and Washington. The idea is in its infancy. Chiu has introduced a nonbinding resolution in the Legislature, encouraging the three states to work together. The resolution faces a mid-September deadline to pass the Legislature. A similar resolution was passed by Washington lawmakers and was attempted but not approved in Oregon. If the three states pool their Medicaid beneficiaries alone, it would represent more than 14 million people.

“As six-figure drug prices have permeated the market, we need to do more to control skyrocketing drug prices,” Chiu said. “The failure of Washington, D.C., to tackle this issue is compelling states to be innovative in their approaches.”

Combining Washington state’s existing operations with California’s large population and market power could create a powerful body.

“With our muscle and their brain, we’d have the Terminator,” said Castellblanch, who advised Chiu on the 2017 bill and testified in favor of it. “We’d have the the drug price killing machine.”

Here’s What Can Go Wrong When You Shop in Mexico and Canada for Cheap Drugs

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Source: Los Angeles Times

In its effort to temper the sky-high prices Americans pay for many vital medications, the Trump administration last month unveiled a plan that would legalize the importation of selected prescription drugs from countries where they sell for far less. But the plan addresses imports only at the wholesale level; it is silent about the transactions by millions of Americans who already buy their medications outside the United States.

Americans routinely skirt federal law by crossing into Canada and Mexico or tapping online pharmacies abroad to buy prescription medications at a fraction of the price they would pay at home.

In some cases, they do it out of desperation. It’s the only way they can afford the drugs they need to stay healthy — or alive. And they do it despite warnings from the Food and Drug Administration, echoed by the pharmaceutical industry, about the risk of contaminated or counterfeit products.

“The reality is that literally millions of people get their medications this way each year, and they are either saving a lot of money or they are getting a drug they wouldn’t have been able to get because prices are too high here,” says Gabriel Levitt, president of PharmacyChecker.com, an online company that allows people to compare prescription drug prices among international and U.S. pharmacies.

For people with diabetes, the inability to pay U.S. prices for insulin can be a matter of life and death, which is why so many families look to Canada or Mexico to meet their needs.

Robin Cressman, who was diagnosed with Type 1 diabetes in 2012 and has become a vocal advocate for lower drug prices, says that even with insurance she was paying $7,000 a year out-of-pocket for the two insulin drugs she needs: Lantus and Humalog. At one point, her credit card debt hit $30,000, says Cressman, 34, of Thousand Oaks.

While on an outing in Tijuana last year, she popped into a few pharmacies to see if they stocked her medications. With little fanfare, she says, she was able to buy both drugs over the counter for less than 10% of what they cost her north of the border.

“I left Tijuana that day absolutely trembling because I could not believe how easy it was for me to get my insulin,” she says, “but also how little money it cost and how badly I was being extorted in the U.S.”

If you are planning to cross the border for your medications, or get them through an online pharmacy abroad, here are two things you should know. First: It is technically illegal. Second: It is unlikely you will be prosecuted.

Despite the official prohibition, FDA guidelines allow federal agents to refrain from enforcement “when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user.”

Personal use generally means no more than a 90-day supply. You should think twice before bringing in quantities larger than that because if authorities suspect you have commercial intentions, you could land in legal jeopardy — and lose the drugs.

People familiar with the practice say you generally can pass through customs without much hassle if you have no more than three months’ worth of a medication, you declare it to customs agents and you show them a doctor’s prescription or a personal note attesting it is for personal use, along with contact information for your physician.

Even in the worst-case scenario, an unsympathetic agent might confiscate the drugs — but not arrest you.

Ordering drugs online from foreign pharmacies also tends to go largely unchallenged. Legally, the FDA can refuse entry of the package at an international mail facility. “That does happen from time to time,” but not often, says Levitt.

It is more common for shipments that do get through to be detained for several days pending FDA inspection. So, if you need to take your medication every day, be sure to build in a sufficient margin for potential delays.

A far bigger risk if you’re shopping abroad for medications is that you might not get what you paid for — and it might not be safe. “There’s a lot of junk in the pharmaceutical world,” says Dr. Ken Croen, a primary care physician at the Scarsdale Medical Group in Westchester County in New York, who advises many of his patients on how to buy drugs safely in Canada.

And there are plenty of rogue operators, especially in the world of online pharmacies. You will need to do a little vetting.

Before doing business with an online pharmacy, confirm it is licensed in its country of origin and that the country has strong pharmacy regulations, says Dr. Aaron S. Kesselheim, a professor of medicine at Brigham & Women’s Hospital and Harvard Medical School. (Read below for websites that can help with that.)

Countries with well-regulated pharmacies include Canada, New Zealand, Australia, much of Western Europe and Turkey.

Also, check to make sure the pharmacy posts an address and phone number on its website. Experts advise against using online pharmacies that don’t require a doctor’s prescription: They are more likely to cut other corners, as well.

A couple of websites do the vetting for you, using these and other criteria.

The Canadian International Pharmacy Assn. runs a site (cipa.com) that allows you to compare drug prices among dozens of pharmacies whose legitimacy it has certified. Its customers “tend to be people who live in the U.S., are on fixed income or low income and can’t afford the medications where they live,” says Tim Smith, the association’s general manager.

To buy through one of CIPA’s certified pharmacies, you must have a valid prescription and submit a medical profile to help guard against adverse drug interactions. The site also maintains a list of “rogue” online pharmacies.

PharmacyChecker.com offers a similar service, linking customers to a broader range of online pharmacies abroad and in the U.S.

Levitt, its president, notes that while importing drugs from overseas is a “critical lifeline” for many people, it is still possible to buy many medications affordably in the U.S. He and others suggest you take the time to comparison shop in the U.S. because prices can vary significantly from pharmacy to pharmacy.

Santa Monica-based GoodRx tracks prescription drug prices at more than 70,000 pharmacies across the U.S. and offers coupons.

Levitt also recommends asking your doctor if there is a viable therapeutic alternative or a lower-cost generic drug. Recent research from PharmacyChecker shows that 88% of the most commonly prescribed generic drugs can be purchased more cheaply in the U.S. than from Canadian pharmacies.

“Many times there is no reason to go international,” Levitt says. “The drug will actually be cheaper here.”

Medicare Could Have Saved Nearly $1 Billion by Using Generics, Study Finds

Image result for Medicare Could Have Saved Nearly $1 Billion by Using Generics, Study Finds imagesSource: Washington Examiner

Medicare could have saved nearly $1 billion in 2016 if it used generic versions of pricey combination drug-device products instead of the brand name versions, according to a new study.

The study, published Tuesday in the Journal of the American Medical Association, indicates that Medicare is doing an inadequate job of getting doctors to prescribe more generic drugs. The Trump administration released a blueprint in May to tackle drug prices, but it does not include anything to get doctors to prescribe more generics.

The report looked at Medicare spending in 2016 for brand-name combination products, which are combinations of drugs and devices. An example of a combination product is a stent that is coated with a drug and implanted in the body.

The study looked at the cost of 29 brand-name combination products and the estimated spending for the generic equivalent at the same dose under Medicare Part D, the program’s prescription drug plan. It found that Medicare in 2016 could have saved $925 million if it substituted the brand-name product with the cheaper generic.

Sometimes a doctor does not prescribe a generic for their patient if the patient asks for the brand name version or they do not know a generic is available. Medicare needs to change those practices in order to save on drugs, the study concluded.

“Promoting generic substitution and therapeutic interchange through prescriber education and more rational substitution policies may offer important opportunities to achieve substantial savings,” wrote the authors, researchers affiliated with Brigham and Women’s Hospital and Harvard Medical School.

Expanding generic drug availability is a key pillar of Trump’s drug pricing plan. It aims to boost competition by hastening approval of more generic drugs by the Food and Drug Administration.

The agency has already improved its approvals of generic drugs due in part to a 2012 user fee program through which generic drug makers pay the agency money for new applications. The FDA in turn uses that money to speed up the approval process.

Judge Cites Opioid ‘Menace,’ Awards Oklahoma $572M In Landmark Case

Image result for Judge Cites Opioid ‘Menace,’ Awards Oklahoma $572M In Landmark Case images

Source: Kaiser Health News

An Oklahoma judge has ruled that drugmaker Johnson & Johnson helped ignite the state’s opioid crisis by deceptively marketing painkillers and must pay $572 million to the state.

Oklahoma sought $17 billion, blaming Johnson & Johnson’s marketing practices for fueling the crisis that has claimed the lives of 6,000 people in the state.

It’s the first ruling to hold a pharmaceutical company responsible for one of the worst drug epidemics in American history.

Judge Thad Balkman delivered his decision from the bench after presiding over an eight-week civil trial in the college town of Norman, Okla.

“Defendants caused an opioid crisis that is evidenced by increased rates of addiction, overdose deaths and neonatal abstinence syndrome in Oklahoma,” Balkman said in the ruling.

Johnson & Johnson immediately released a statement saying that the company “plans to appeal the opioid judgment in Oklahoma.”

Oklahoma Attorney General Mike Hunter’s suit alleged that Johnson & Johnson, through its pharmaceutical subsidiary Janssen, helped ignite a public health crisis that has killed thousands of state residents.

Balkman, in the ruling, said the state made its case that Johnson & Johnson contributed to the state’s opioid crisis.

“The opioid crisis is an imminent danger and menace to Oklahomans,” Balkman said. “The state met its burden,” proving the company acted improperly with its “misleading marketing and promotion of opioids.”

The case is being closely watched by plaintiffs in other opioid lawsuits, particularly the roughly 2,000 cases pending before a federal judge in Ohio.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million, about $200 million of which will fund an addiction research and treatment center at Oklahoma State University in Tulsa. Soon afterward, Hunter dropped all but one of the civil claims, including fraud, against the two remaining defendants.

Just two days before the trial began, one of those two defendants, Teva Pharmaceuticals, based in Israel, announced an $85 million settlement with the state.

Both companies deny any wrongdoing.

Johnson & Johnson marketed the opioid painkillers Duragesic and Nucynta. Lawyers for the company say that its products were highly regulated by the Food and Drug Administration, among other agencies, and that the state did not provide any evidence showing that the company’s sales practices helped fuel the crisis.

Will Canada Fight Back?

Image result for Will Canada Fight Back on exporting drugs? images

Source: Reuters

Canada’s main pharmaceutical lobby group has urged the government not to wait for drug shortages before responding to U.S. plans to import Canadian drugs, according to documents seen by Reuters.

The talking points were prepared last month by Innovative Medicines Canada (IMC) for its staff and member companies, before the Trump administration announced on Wednesday that it would allow U.S. states and other groups to start pilot programs importing cheap drugs from Canada in an effort to lower drug costs.

In one early version of its talking points, the IMC proposed the Canadian government ban all drug exports “unless otherwise permitted by regulation.”

“Wholesalers should not be permitted to export drugs in bulk from Canada, and there should be strict and significant penalties for exporting drugs where their export is prohibited by law,” a document prepared in May said.

It warned that “reliance on reactive measures after shortages occur may pose a risk to Canadian patients.”

Asked about the possibility of an export ban, IMC said in a statement: “This is not part of our current positioning shared with our members. That said, we believe the government has tools that could be used to prevent shortages.”

The lobby group’s efforts so far suggest industry is eager to derail the Trump administration’s plan. IMC’s members include major drug companies based in the United States and abroad, and large-scale shipments of cheap drugs from Canada could lower their profits.

The group works closely with PhRMA, the Pharmaceutical Research and Manufacturers of America, the industry’s U.S lobbying group.

“Our government’s priority is ensuring that all Canadians can get and afford the medications they need,” Alexander Cohen, a spokesman for Canada’s health minister, said in a statement.

“All statements and decisions surrounding Canada’s drug supply are made based in the best interest of Canadians, and we are examining all options to ensure it remains secure.”

In the position papers reviewed by Reuters, the IMC warned it may not be possible for drug manufacturers to enforce contract terms with Canadian buyers that forbid the re-export of drugs.

“Although purchasing agreements with suppliers may contain clauses that would prevent bulk export to the US, many Canadian pharmaceutical companies are subsidiaries of US corporations and may become obliged to do so through US legislation,” the group warned in July.

Even if the U.S. plan proceeds as the administration has promised, shipments could be a year or more away, because of consultations required to pass new regulations.

The IMC documents suggest that a “first step” for the Canadian government would be to state publicly that it will act to protect drugs intended for Canadian patients in the event of any shortages.

Prime Minister Justin Trudeau delivered something like that message personally on Thursday, at an event in the Arctic city of Iqaluit.

“We recognize the new situation brought on by American announcements, and Health Canada will continue to ensure that our priority is always ensuring that Canadians have access to the medication they need at affordable prices,” he said.

Reuters reported last month that Canadian officials had privately warned the United States they oppose any import programs that might threaten Canada’s supply or raise costs for Canadians.

Trump Administration ‘Open For Business’ On Drug Imports From Canada

Image result for Trump Administration ‘Open For Business’ On Drug Imports From Canada images

Source: Kaiser Health News

A year after calling proposals allowing Americans to import cheaper drugs from Canada a “gimmick,” Health and Human Services Secretary Alex Azar said the federal government is “open for business” on such a strategy.

Azar announced a preliminary plan Wednesday to allow Americans to import certain lower-cost drugs from Canada. Insulin, biological drugs, controlled substances and intravenous drugs would not be included.

The plan relies on states to come up with proposals for safe importation and submit them for federal approval.

Under a second option, manufacturers could import versions of any FDA-approved drugs from foreign countries — including insulin — and sell them at a lower cost than the same U.S. versions. This appears to be a way drugmakers could avoid some of the contracts they have with drug middlemen, known as pharmacy benefit managers.

“The administration has reason to believe that manufacturers might use this pathway as an opportunity to offer Americans lower cost versions of their own drugs,” according to the plan announced Wednesday. “In recent years, multiple manufacturers have stated (either publicly or in statements to the administration) that they wanted to offer lower cost versions but could not readily do so because they were locked into contracts with other parties in the supply chain.”

The announcement marked the latest shift by the Trump administration on the decades-old debate about formally allowing Americans to buy drugs from Canada, where prices are significantly lower.

Drugmakers were quick to criticize the plan. Stephen J. Ubl, president and CEO of the brand-name drug trade group, the Pharmaceutical Research and Manufacturers of America, called the plan “far too dangerous for American patients.”

“There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain,” he said in a statement. “Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA.”

But Sen. Lamar Alexander (R-Tenn.), chairman of the Health, Education, Labor and Pensions Committee, said he welcomed the administration’s move to reduce costs. “The key for me is whether this plan preserves the Food and Drug Administration’s gold standard for safety and effectiveness,” he said in a statement.

The same medicines are often cheaper in other countries than in the U.S. since most developed countries negotiate with drugmakers to set prices. But opponents of importation say sending drugs over the border will increase the chances Americans get counterfeit medications, a claim often boosted by the drug industry.

As drug prices have soared here, Americans are more open to buying drugs from Canada. Some have for decades been driving over the border; others use online pharmacies or place orders at storefronts that connect buyers to pharmacies in Canada and other countries.

Although these strategies are technically illegal, the government does not prosecute individual offenders. Nor has it moved to stop the dozens of cities, counties and school districts across the United States that have programs for employees to buy drugs from Canada and elsewhere.

The administration is offering “a real plan for America to benefit from prescription drug importation, but the proof is in the follow-through,” said Gabriel Levitt, the co-founder of PharmacyChecker.com, a private company that verifies international online pharmacies and compares prescription drug prices for consumers. He said, given Azar’s support, he thinks the plan “has a good chance.”

While Families USA Executive Director Frederick Isasi praised the announcement, he cautioned it’s not a major fix for high U.S. drug prices.

“This is a tactic not a policy solution,” he said. “We should not fool ourselves into thinking that relying on Canada’s ability to regulate drug prices is a comprehensive or long-term solution for the United States. Most importantly, it also does not solve the egregious problem of pharmaceutical price abuses in America.”

In May 2018, Azar said the prospect of importing drugs from Canada was just a “gimmick” because that country is not large enough to meet all the drug needs of the United States.

But lowering drug prices has been a key promise of President Donald Trump, and a few months later, Azar said he was forming a work group that would explore allowing certain drugs that had seen major price hikes to be imported.

The idea got a boost this spring when Trump offered his support, marking the first time drug importation has won a presidential endorsement.

The 2003 Medicare Modernization Act allows states to import cheaper drugs from Canada, but only if the HHS secretary verifies their safety. Previous attempts by states to allow importation failed because the secretary opposed them.

Azar, a former top executive at the drugmaker Eli Lilly, said Wednesday that the federal government has changed its “mindset” on the issue. In the past few years, “the landscape and opportunities for safe linkages of the drug supply chain have changed, and that is why we are open to importation,” he added.

He acknowledged that HHS and the Food and Drug Administration have consistently said there was no way importing drugs from Canada could be done without putting patients at risk for counterfeit drugs.

“Today we are saying we are open and there is a pathway and we are laying out criteria for states, wholesale drug distributors and pharmacies to convince us they have a plan that protects the integrity of the drug supply chain.”

Canadian health officials have expressed concerns about U.S. importation, Azar said, but he added that it is up to states that want to start a program to work to overcome the obstacles, such as a lack of supply, Canadians foresee.

“That is for them to work out, and there are hurdles, but we think those hurdles are surmountable and this can be done,” Azar said. “We are open-minded. We are open for business.”

Three states — Colorado, Florida and Vermont — have approved legislation to import drugs and are working on proposals.

Vermont, which passed legislation to start planning the program a year ago, is still trying to find a way to ensure the safety of imported drugs and so far has identified only 17 medicines that would save enough money to be worth bringing over the border. Those drugs include treatments for conditions including diabetes, hepatitis C, cancer and HIV/AIDS.

Florida Gov. Ron DeSantis tweeted his thanks to the president “for supporting my efforts to lower prescription drug costs for Floridians. You are helping Florida lead the way to make safe and affordable prescription drugs a reality.”

Trish Riley, executive director of the National Academy for State Health Policy, which is working with states on their importation plans, said the plan to have states set up programs could take years to set up because of the slow federal rule-making process.

Azar did not offer any timeframe on when a system to import drugs from Canada could be in place in any states.

Last Updated 09/12/2019

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