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BACMM, and its divisions, has been sold!

10/15/2019

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Dear Loyal Clients,

  1. I am writing to let you know that I have sold my business, and its six divisions, because the timing and the terms of sale were the "perfect storm." Yes, somebody made me an offer I couldn't refuse! But seriously, I always wanted to go out on top and on my own terms, and that, I'm happy to say I did.
  2. The value in the business is created through the support of loyal clients like yourselves, and so I have worked hard to ensure that the on-going business recognizes that client interface support and processes are embedded in the underlying culture.
  3. The new owners, who will be named at a later date, recognizes that the price they are paying includes a premium for the goodwill that has been created through our excellent relationships with our existing clients, and so they are keen to ensure that they protect that value by working hard to keep existing clients happy.
  4. We have sought out a buyer who really appreciates the business, understands how to operate it properly, and is keen and capable of developing its future potential.
  5. I will be staying on through the transition period to ensure a smooth handover of the business.
  6. No major changes are planned for the business in the short term. The new owners, however, will be seeking client feedback to identify how additional clients value can be created.
  7. The employees of the business support the sale and are positive about the future under new management.
  8. I am available to answer any questions you loyal clients may have.

Thank you for 15 wonderful years of loyal business. I am in your debt and it was truly an honor to serve you..

Best wishes,

Bruce A. Cadkin, MBA

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transparency push in pharma: lower Prices?

9/16/2019

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Pharmaceutical industry price transparency has been a hot topic since even before the 2016 presidential election. Now, just over two years into his term in office, President Donald Trump has been making moves when it comes to transparency regulations. We previously wrote about his recent executive order wherein he directed the United States Department of Health and Human Services (HHS) and other federal agencies to begin several rule-making processes, including one focused on requiring hospitals and payers to release information on their privately negotiated rates.

Industry experts, though, are skeptical that his efforts will actually result in lower prices to patients. While this action by President Trump – coupled with other actions taken by Congress – may work to assuage public frustration over high prescription drug prices, it is unlikely to actually work to lower any prices in a meaningful way.

Many policy analysts and economists said that while price transparency is good in theory, current evidence shows patients don’t take advantage of pricing information now available, said Ateev Mehrotra, associate policy of healthcare policy and Harvard Medical School. Mehrotra noted that because the healthcare system has so many moving parts, understanding the medical bill patients receive and how the price was calculated can be very difficult, “[t]hat complexity hinders the ability of people to effectively shop for care. It’s not like going to Amazon and buying a toothbrush or whatever.”

Industry Reaction

While the American Hospital Association understands the details are still being worked out, it did release a statement recognizing that “publicly posting privately negotiated rates could, in fact, undermine the competitive forces of private market dynamics, and result in increased prices.”

The Federation of American Hospitals also released a statement, “FAH believes that American consumers should have actionable out-of-pocket cost information to assist them in making important health care decisions. We appreciate the administration’s executive order where it will meet consumer transparency needs. If implementing regulations take the wrong course, however, it may undercut the way insurers pay for hospital services resulting in higher spending. The Federal Trade Commission has said that spending would likely increase if hospital-insurer payment arrangements were published.”

Mollie Gelburd, the associate director of government affairs at Medical Group Management Association (MGMA), said doctors don’t want to be in the position of explaining complex insurance terms and rules to a patient, noting, “While physicians should be encouraged to talk to patients about costs, to unnecessarily have them be doing all this education when they should be doing clinical care, that sort of gets concerning.”

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senate opioid investigation expands

8/12/2019

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In 2012 Senators Grassley and Baucus sent letters to the American Pain Society and other pain-related organizations including the Joint Commission and the Federation of State Medical Boards asking for information on their relationships with industry.

This past week, Senate Finance Committee Chairman and Ranking Member sent follow-up letters to ten tax-exempt organizations associated with pain, requesting information about their financial relationships with opioid manufacturers and other medical entities.  This time asking for a significantly greater amount of information than in 2012.

The letter reads, “We write to request information regarding your organization and its financial relationship with opioid manufacturers and other entities that manufacture products to treat pain. As Chairman and Ranking Member of the Senate Finance Committee, we have a responsibility to ensure transparency and accountability in matters that directly affect Federal healthcare programs and tax-exempt organizations. This responsibility includes examining the extent to which pharmaceutical manufacturers fund tax-exempt organizations and how these payments may influence pain treatment practices and policy.”

It continues, stating, “We acknowledge that the answer to the opioid epidemic continues to be anything but simple. However, we believe that it is important to shed light on these financial relationships to ensure transparency and accountability in matters that affect Federal healthcare programs and the patients that participate in them.”

The senators ask for the following information from the organizations:

  • All Form 990s that the organization filed with the IRS from 2012 to present, as well as the organization’s complete Schedule Bs;
  • A detailed accounting of all payments/transfers received from any drug, device, biologic, or medical supply manufacturer, and from individuals that produce, market, or promote products on the manufacturer’s behalf. Specifically, the senators are looking for the following information on each transfer:
    • Date of payment,
    • Source or entity making the payment,
    • Description of the payment (i.e., general support, project specific, etc.),
    • Amount of payment,
    • Year-end or year-to-date payment total and cumulative total payments for each organization or individual, and
    • The percentage of funding from organizations identified above to total revenue for each year a payment was received;
  • A description of any collaborative activity between the organization and the entities identified above from 2012 to the present and the timeframe in which the activity took place;
  • A copy of the conflict of interest policy maintained by the organization, if such exists, as well as a description of any additional mechanisms the organization uses to police conflicts of interest and promote transparency of funding sources;
  • A detailed list of all funding received from the Federal government since 2012, including the year, amount, and purpose of the funding, in hard copy, PDF, and Excel spreadsheet formats;
  • Copies of all comments or other written materials the organization has made to Federal task forces, committees, advisory groups or similar entities from 2012 to present;
  • If any activity identified in the two prior questions pertains to information distributed to physicians and patients concerning prescription pain medication, identify any materials developed by organizations identified above and provide copies of those materials;
  • A complete list of all instances from 2012 to present in which a board member, executive, staff or affiliated volunteer has served on any Federal task force, committee, advisory group or other entity; and
  • Identification of any person employed by the organization who communicated with the entities outlined above regarding the content of materials distributed to patients and physicians pertaining to opioid use and/or prescribing practices from 2012 to present, including their name, position, dates of employment, and job description. This shall also be provided in hard copy, PDF, and Excel spreadsheet formats.

The letters were sent to the: American Chronic Pain Association, American Pain Society, American Society for Pain Management Nursing, American Society of Pain Educators, Center for Practical Bioethics, Federation of State Medical Boards, The Joint Commission, American Academy of Physical Medicine and Rehabilitation, Alliance for Patient Access, and International Association for the Study of Pain.

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new #cabudget deal will  help a lot of people

7/11/2019

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Recently, the California Budget Conference Committee voted on a budget proposal that reflected a deal between the Governor and Legislature, including investments in health services with additional steps to universal coverage.

As a result of this budget, hundreds of thousands of Californians will get more help to access and afford health coverage, preventing premium increases for everyone and benefiting the health system we all rely on.

This budget deal builds on some of the Governor’s first-in-the-nation proposals with important next steps to a more affordable and universal health system. Many Californians will get more help with health care costs and coverage under this budget.

Beyond the Governor’s May Revise budget, health highlights that were sought by health and consumer advocates include:

  • Additional affordability assistance in Covered California beyond the revenue raised by a new state-level individual mandate, for around those under 138% of the poverty level (below around $16,800/year for an individual, benefiting around 35,000 Californians), and especially middle-income Californians between 400-600% of the poverty level ($48,000-$72,000/year for an individual, benefiting around 190,000 Californians).
  • The end of the “senior penalty” in Medi-Cal, raising the eligibility level for seniors and people with disabilities up to 138% of the poverty level, aligning with the rest of the Medi-Cal program.
  • The restoration of several Medi-Cal benefits, including optical, audiology, speech therapy, podiatry, and incontinence creams and washes, which were cut a decade ago during the Great Recession.
  • Funding for outreach and enrollment in Medi-Cal, and
  • An agreement to extend the Managed Care Organization (MCO) tax, although no revenues were allocated until federal approval.

Breaking new ground nationally, low- and middle-income Californians will get more help affording insurance through Covered California. A state-level individual mandate, paired with additional affordability assistance, will keep people covered and help lower premiums. This vital help for families to afford coverage will go beyond the revenue raised by re-instituting this key part of the ACA here in California. These new state subsidies make a real, tangible difference for those around or below poverty, and especially for those middle-income Californians who now don’t get any help under the federal law, despite the urgent need in our high-cost state. The ACA provides affordability assistance for folks up to four times the poverty level, but with this deal Covered California will now be the first to provide some subsidy to those up to six times the poverty level. This is a big deal to not just defray the high cost of health premiums, but to bring more Californians into coverage.

This budget improves Medi-Cal in multiple ways, including improving access and benefits for the 13 million Californians who depend on the crucial program, while also removing unfair exclusions from full Medi-Cal coverage for seniors and people with disabilities, undocumented young adults, and others. And, after a decade since they were cut in a recession, this budget finally restores key benefits like podiatry, audiology, and speech therapy.

Health and immigrant advocates are pleased that a key provision that we have sought for years will become a reality in California – expanding Medi-Cal coverage to not just all income-eligible children but young adults up to age 26 as well. While a handful of states cover all income-eligible children and pregnant women, California will become the first state to remove the exclusion for other adults, recognizing our health system is stronger when more people can get primary and preventive care. As we cheer this first-in-the-nation step, we were nonetheless disappointed as we were unable to make that same commitment to all California’s undocumented seniors this year.

Health Access’ push to include undocumented seniors, and ultimately to the goal of #Health4All, will continue in the months ahead. Additionally, we will continue to pursue steps in the near-term to achieve the Governor’s and Legislature’s shared goal of getting to universal coverage in the next few years, with greater affordability assistance in Covered California and further expansions of Medi-Cal.

Since 2017, the over 70 consumer and community groups of the #Care4AllCA campaign have advocated to take additional steps to move California towards universal coverage, including the investments needed to close the remaining gaps in our system. The campaign is proud to have successfully argued for more help in affordability assistance up and down the income spectrum, and those impacted by the “senior penalty” in Medi-Cal.

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prescription drug "star" act passes committee

6/5/2019

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Recently, the House Ways & Means Committee unanimously passed the Prescription Drug Sunshine, Transparency, Accountability, and Reporting (“STAR”) Act, a bipartisan effort to increase transparency and public reporting of information in the “opaque” prescription drug market. The STAR Act is intended to address the high cost of prescription drugs, and to provide insight across the health care supply chain to ultimately reduce costs for families.
If passed into law, the STAR Act would:

Require manufacturers to justify large price increases and high launch prices, referred to as “triggered spike increases:" If an existing drug price increases by more than 10% or $10,000 over one year, or 25% or $25,000 over three years, or if the manufacturer launches a new drug at or above $26,000, a triggered spike increase has occurred. The manufacturer must then submit a “justification” to the Department of Health and Human Services (“HHS”), which will be posted to the HHS website. The justification must describe the individual factors that have contributed to the cost increase, and an explanation of the role each factor played in contributing to that increase. The justification must also include the manufacturer’s total expenditures for the drug on materials, manufacturing, acquiring patents or licenses, and the cost to purchase the drug from another company (if applicable), as well as research and development expenditures, revenue and net profit, and marketing and advertising costs. The STAR Act provides civil monetary penalties for failing to submit a timely justification of $10,000 per day, and for providing false information in the justification of up to $100,000 per false item.

Require manufacturers to report the monetary value and quantity of samples: Manufacturers must annually report to the Center for Medicare and Medicaid Services (“CMS”) the monetary value of samples, and the quantity of samples provided to covered recipients each year. This data will be posted in the Open Payments Database.

Require the HHS Secretary to conduct a study on inpatient drug costs: HHS will conduct a study and provide an analysis to Congress on the spending and volume of drugs that are administered in inpatient settings. The analysis will include data on inpatient hospital drug costs, Medicare spending, and volume and spending per admission. The analysis will also consider trends in inpatient hospital drug costs, such as trends by hospital size, as well as categorizations, such as whether the hospital is urban or rural, or is a teaching hospital. The analysis will also examine the impact of drug shortages on services that are provided in an inpatient hospital setting.

Require the HHS Secretary to disclose rebates, discounts and prices concessions achieved by pharmaceutical benefit managers: This will be disclosed on a public website.

Require all manufacturers to submit information on the average sales price (“ASP”) for physician-administered drugs under Medicare Part B:  Current law requires that most manufacturers report this information, but the STAR Act requires all manufacturers to submit. The STAR Act provides civil monetary penalties for failing to submit this information of $10,000 per day, for providing false information in the submission of up to $100,000 per false item, and for refusing the request for information of up to $100,000.
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new canadian drug agency established

5/1/2019

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Here in the USA, there has been a tremendous amount of discussion in recent years about the soaring cost of prescription drugs, and about potential strategies to increase patient access and affordability. However, some may be surprised to learn that there is a similar discussion going on north of the border in Canada. While the Canadian federal government provides universal healthcare to Canadians, that benefit does not include prescription drug coverage. Rather, Canadians have a complex patchwork system of public and private insurance plans that provide coverage for prescription drugs. However, many are critical of this public-private system as it has led to coverage gaps and failed to prevent soaring drug prices, resulting in 4.1 million Canadians being uninsured or underinsured.

On March 19, 2019, the Canadian federal government announced the formation of a new “Canadian Drug Agency” which will “take a coordinated approach to assessing effectiveness and negotiating prescription drug prices.” This new federal agency will work in concert with existing provincial and territorial governments, which are currently responsible for administering their own publicly-funded plans, typically directed to those patients most in need. The Canadian Drug Agency will also develop a “comprehensive, evidence-based” list of prescription drugs, in an effort to provide a uniform and consistent formulary for patients across the country. Finally, the Agency will develop a “national strategy for high-cost drugs for rare diseases.”

In announcing the new Agency, the Canadian federal government noted that prescription drug spending by Canadians has soared over the past three decades, increasing from C$2.6 billion in 1985 to C$33.7 billion in 2018. The government also noted that, while the public-private drug coverage system includes over 100 public programs and 100,000 private plans across Canada, it is not adequate “to handle the increasingly expensive drugs coming to market.” The Canadian Drug Agency is expected to respond to this ever-increasing and unsustainable need, and, according to the Canadian federal government, is expected to “help lower the cost of prescription drug prices for Canadians by up to C$3 billion per year over the long term.”

Reactions to the creation of the Canadian Drug Agency has been mixed. Innovative Medicines Canada (“IMC”), a policy and advocacy association for the “innovative pharmaceutical industry,” said that it welcomed the measure as it “has the potential to streamline … complex drug regulatory processes,” but also cautioned that the Agency’s success would depend on collaboration by all stakeholders, including federal and provincial governments. The IMC also stressed that drivers of life sciences investment and innovation must be protected in the process. Meanwhile, the Canadian Life and Health Insurance Association, an association representing Canada’s health insurance companies, applauded the Canadian federal government’s plan, but said that it “was looking forward to further details” on how the coordination of efforts would lower drug prices while ensuring a “common level of coverage regardless of where Canadians live or work.”

The new Agency would be phased in over the next several years. The Canadian federal government has proposed providing Health Canada with C$35 million over a four-year period, beginning in 2019-2020, to establish a transition office to support the formation of the new Agency. There is to be an additional investment of C$1 billion over a two-year period, beginning in 2022-2023, to implement the rare diseases component of the initiative, with up to C$500 million per year going forward.

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    Bruce A. Cadkin, MBA President                          BAC Medical Marketing

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