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Health plan costs - prescription drugs

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HHS Proposes Changes to Rebates for Part D Plans Under the Anti-Kickback Statute
"HHS has requested feedback on many aspects of the proposals such as ... the impact upon beneficiary access to prescription pharmaceutical products either due to cost or formulary placement.... If enacted, the proposals will likely lead to an increase in the Part D premiums as it will substantially alter the relationship between pharmaceutical manufacturers, Medicare Part D plans, PBMs, and participants. The new relationship could also extend to or impact those in the non-Medicare, i.e., commercial, marketplace." (Cheiron)
17 Ways Employers Are Fighting Prescription Drug Costs
"Nearly all (97.6%) organizations responding to the survey offer prescription drug benefits, either as part of their health plan (83.1%) or through a separate plan (14.5%).... Responding organizations use a number of cost-sharing initiatives to ease the burden of rapidly escalating costs... Survey respondents also employ a diverse range of strategies to limit the use of certain drug types.... Responding organizations employ a range of drug access controls to control plan costs.... Finally, organizations have various prescription drug purchasing and administrative initiatives." (International Foundation of Employee Benefit Plans [IFEBP])
Prices for and Spending on Specialty Drugs in Medicare Part D and Medicaid: An In-Depth Analysis (PDF)
62 pages. "In 2015, the weighted average net price for 50 top-selling brand-name specialty drugs in Medicare Part D was $3,600 per 'standardized' prescription -- a measure that roughly corresponds to a 30-day supply of medication -- whereas the weighted average net price for the same set of drugs in Medicaid was $1,920. In Medicare Part D, net spending on specialty drugs rose from $8.7 billion in 2010 to $32.8 billion in 2015. In Medicaid, net spending on specialty drugs roughly doubled over the same period, reaching $ 9.9 billion in 2015. For beneficiaries in the Medicare Part D program who took brand-name specialty drugs, average annual net spending on such drugs per beneficiary (in 2015 dollars) increased from $11,330 in 2010 to $33,460 in 2015." [Also available: 10-page Summary Report] (Congressional Budget Office [CBO])
CMS Updates Drug Dashboards with Prescription Drug Pricing and Spending Data
"This Administration's version of the drug dashboards ... adds information on the manufacturers that are responsible for price increases and includes pricing and spending data for thousands more drugs across Medicare Parts B and D and Medicaid.The dashboards focus on average spending per dosage unit for prescription drugs paid under Medicare Parts B and D and Medicaid, and track the change in average spending per dosage unit over time." (Centers for Medicare & Medicaid Services [CMS], U.S. Department of Health and Human Services [HHS])
House Committee Hearing on Lowering the Cost of Prescription Drugs: Reducing Barriers to Market Competition
March 13 hearing. Page includes description and links to text of seven bills directed at controlling prescription drug prices, along with video of hearing, Chairman's briefing memo, and written testimony of invited witnesses. (Energy & Commerce Committee, U.S. House of Representatives)
[Guidance Overview] HHS Proposed Rule Could Significantly Impact Drug Manufacturers, PBMs, and Other Stakeholders
"The proposed rule ... adds a new safe harbor for point-of-sale price reductions ... [which] requires that the following criteria be met: [1] The reduced price must be set in advance with a plan sponsor under Medicare Part D, a Medicaid MCO, or the PBM acting under contract with either; [2] the sale does not involve a rebate unless the full value of the reduction in price is provided to the dispensing pharmacy through a chargeback or series of chargebacks, or is required by law; and [3] the reduction in price must be completely applied to the price of the prescription drug charged to the beneficiary at the point of sale." (Wilson Sonsini Goodrich & Rosati)
UnitedHealthcare Will Expand a Drug Discount Program Aimed at Lowering Consumer Costs
"UnitedHealthcare said Tuesday that it will expand a program that passes drug discounts directly to consumers ... United said the plan would take effect next year and would be required for all new employer clients, although existing clients would be permitted to continue under the older system." (The New York Times; subscription may be required)
Lawmakers United Against High Drug Prices Bare Partisan Teeth
"The Doggett-Brown proposal is based on a concept known as compulsory licensing, which would allow the government to use its power to issue patents as a lever if manufacturers are seen as not operating in good faith.... Republicans at the hearing maintained that this government market muscle would discourage research and development of new medicines and treatments, echoing industry representatives who say the strategy is not only costly but also doesn't always lead to a breakthrough." (Kaiser Health News)
Senate Finance Committee Hearing: Drug Pricing in America: A Prescription for Change, Part 2
Feb. 26 hearing; page includes video and statements by Committee members Ron Wyden (D-OR) and Chuck Grassley (R-IA), along with written testimony by witnesses: [1] Richard A. Gonzalez, AbbVie Inc.; [2] Pascal Soriot, AstraZeneca; [3] Giovanni Caforio, M.D., Bristol-Myers Squibb Co.; [4] Jennifer Taubert, Johnson & Johnson; [5] Kenneth C. Frazier, Merck & Co., Inc.; [6] Albert Bourla, D.V.M. Ph.D., Pfizer; [7] Olivier Brandicourt, M.D., Sanofi. (Committee on Finance, U.S. Senate)
Key Takeaways from Pharma Testimony at Senate Drug Pricing Hearing
"Pharmaceutical executives were questioned by lawmakers about why they have not effectively reduced list prices for prescription drugs. While acknowledging room for improvement, the executives also blamed PBMs and insurers for the high prices consumers face. Industry watchers said that while substantive change is unlikely in the short-term, the public impression of Tuesday's hearing will linger negatively on drugmakers." (HealthLeaders Media)
In Florida, Drug Re-Importation from Canada Finds New Champions, Old Snags
"Florida is joining the growing ranks of states that, squeezed by climbing drug prices, are eyeing the Canadian fix.... Legislation has been advanced this year in about a dozen states that would advance wholesale drug importation programs ... While statehouses may be abuzz, in Washington, national politics impedes feasibility. And skeptics question how much relief these initiatives could actually provide." (Kaiser Health News)
Congress Mulls Cap on What Medicare Enrollees Pay for Drugs
"The effort to cap out-of-pocket costs in Medicare's prescription plan is being considered as part of broader legislation to restrain drug prices. Limits on high medical and drug bills are already part of most employer-based and private insurance. They're called 'out-of-pocket maximums' and are required under the Obama-era health law for in-network services. But Medicare has remained an outlier even as prices have soared for potent new brand-name drugs, as well as older mainstays such as insulin." (Associated Press)
[Opinion] American Benefits Council Comment Letter to HHS on Notice of Benefit and Payment Parameters for 2020
"The Council supports the proposal to allow plans to treat a brand prescription drug as not an EHB where there is a medically appropriate generic equivalent available on the plan's formulary. This proposal, in particular, would provide group health plans the necessary flexibility to design pharmacy benefits to encourage enrollees to use a lower-cost generic equivalent drug, when medically appropriate, and positively impact a plan's prescription drug costs and premiums." (American Benefits Council)
Supreme Court Deals a Fatal Blow to Maryland Drug 'Price Gouging' Law
"The law, which the Maryland General Assembly passed in 2017, would have prohibited generic drug manufacturers from raising prices in a manner the state deemed 'unconscionable.' It was nullified in April 2018, when an appeals court held it was unconstitutional because it regulated commerce beyond Maryland's borders. The Supreme Court on Tuesday formally declined to hear the appeal from the state's Democratic attorney general[.]" (STAT)
Lowering Drug Costs: New Proposed Rule Targets Drug Rebates
"Employers with self-funded plans, or who sponsor retiree plans, especially those providing plans in place of Medicare Part D for whom they receive a subsidy, should begin discussions with their PBMs to understand the potential implications to their plan and contracts. Others should monitor communications from their carriers and brokers to determine any cost shifting that may transfer over to the private market." (OneDigital Health and Benefits)
Express Scripts Reports Record Low Drug Trend Across Commercial Plans in 2018
"The PBM cited 'an unprecedented 0.3% decline' in per-beneficiary drug spending across Medicare plans. Overall, there was a 1.4% decrease in unit cost trend, which allowed clients to absorb a 1.1% increase in utilization, the PBM said. Oncology replaced diabetes as Medicare's top therapy class by per member per year spend. Express Scripts also reported falling unit drug costs for employer, Medicare and [ACA] exchange plans." (AISHealth)
Remote Prescribing Trends in Telehealth
"On the federal level, we should expect to see promulgation of regulations by the U.S. Drug Enforcement Administration outlining the special registration exception as mandated by the SUPPORT Act passed in 2018, allowing a pathway for health care providers to prescribe controlled substances through telemedicine ... On the state level, as telehealth becomes a mainstream mode of health care delivery, we are seeing states attempt to legislate telehealth services in more targeted, and potentially contentious, areas of health care." (Epstein Becker Green)
House Ways & Means Committee Hearing: The Cost of Rising Prescription Drug Prices
Feb. 12, 2019, hearing; includes link to video along with statement by Chairman Richard Neal, (D-MA) and witness testimony from: [1] Mark E. Miller, Ph.D., Arnold Ventures; [2] Rachel Sachs, Washington University in St. Louis, MO; [3] Alan Reuther, UAW Retiree Medical Benefits Trust; [4] Ola Ojewumi, Patient; [5] Joseph R. Antos, Ph.D., American Enterprise Institute. (Committee on Ways and Means, U.S. House of Representatives)
[Guidance Overview] HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates
"If the Proposed Rule goes into effect, PBMs may be more vulnerable to [Anti-Kickback Statute (AKS)] enforcement actions for discounts that they negotiate with drug manufacturers.... [T]he Pharmaceutical Care Management Association has expressed concern that eliminating rebates could increase drug prices and force Medicare beneficiaries to pay higher premiums and out-of-pocket costs in order to access the prescription drugs they need.... Comments are due by April 8, 2019." (Sheppard Mullin)
Administration Salutes Parade of Generic Drug Approvals, But Hundreds Aren't Yet on the Market
"The administration's aggressive push to approve more generics is designed to spur more competition with expensive brand-name drugs, and drive prices lower... The [FDA] has approved more than 1,600 generic drug applications since January 2017 -- about a third more than it did in the last two years of the Obama administration. But more than 700, or about 43 percent, of those generics still weren't on the market as of early January[.]" (Kaiser Health News)
[Guidance Overview] HHS Aims to Reduce Prescription Drug Prices Through Proposed Changes to the Anti-Kickback Statute's Safe Harbors
"HHS proposes to create a new safe harbor ... [which] would require that any reduction in price: [1] Be set in advance... [2] Not involve a rebate, unless the full value of the reduction in price is provided to the dispensing pharmacy through a 'chargeback'; and [3] Be completely reflected in the price the pharmacy charges to the beneficiary at the point of sale.... [T]his new safe harbor would exclude from protection price reductions offered to one payor but not to Medicare or Medicaid." (Vorys)
[Guidance Overview] HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan Sponsors and PBMs
"As rebates paid by pharmaceutical manufacturers to health plan sponsors and PBMs are a central feature of the U.S. drug distribution and reimbursement system, the Proposed Rule represents a groundbreaking reform measure that could dramatically impact consumers and supply chain stakeholders. If finalized, the Proposed Rule would go into effect on January 1, 2020." (Epstein Becker Green)
[Guidance Overview] HHS Proposes New Rules to Eliminate Drug Rebates and Encourage Direct Discounts
"The proposed rule has the potential to cause significant disruption to the status quo of the drug supply chain. PBMs interact and affect all stakeholders throughout the prescription drug supply chain and markets, including prescription drug benefit plans ... pharmaceutical manufacturers and pharmacies." (Foley & Lardner LLP)
[Guidance Overview] Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans
"Because the proposed exclusion is limited to Part D plans and Medicaid MCOs, it would not alter current safe harbor protection for price reductions offered to other entities such as wholesalers, pharmacies, physicians and other third-party payers. In lieu of the exclusion it proposes to eliminate, HHS proposes to create new discount safe harbor protections for (1) discounts offered to plans and organizations that are provided to beneficiaries at the point of sale, and (2) fixed-amount service fees to PBMs that do not take into account the volume or value of the business between the manufacturer and the PBM." (Skadden)
[Guidance Overview] HHS Proposes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors
"The Proposed Rule would make explicit that the AKS discount safe harbor does not protect manufacturer rebates on prescription drugs paid to Medicare Part D plan sponsors, Medicaid managed care organizations (MCOs), or pharmacy benefit managers (PBMs) in the context of these government programs. The Proposed Rule would create new safe harbors for certain point-of-sale price reductions on prescription drugs and for certain PBM service fees paid by manufacturers." (King & Spalding)
[Guidance Overview] Administration Releases Long-Awaited Drug Rebate Proposal
"[T]he proposed rule envisions two new safe harbors: one for rebates which are passed on to the patient at the point of sale, and another for flat service fee payments made to PBMs, which could not be tied to the list prices of drugs." (Rachel Sachs, in Health Affairs)
Winners and Losers Under HHS Plan to Slash Drug Rebate Deals
"Consumers are unlikely to collect the full benefit of eliminated rebates. At the same time, the change would produce uncertain ricochets, including higher drug-plan premiums for consumers, that would produce new winners and losers across the economy.... Possible Winners: Chronically ill patients who take lots of expensive medicine ... Drug companies ... Possible Losers: Pharmacy benefit managers ... Insurance companies ... Patients without chronic conditions and high drug costs." (Kaiser Health News)
Impact of Potential Changes to the Treatment of Drug Manufacturer Rebates (PDF)
41 pages. "Members have overall cost savings on average, driven by lower cost sharing, partially offset by higher premiums.... The government could have cost increases ... Manufacturer claim liabilities through the coverage gap discount program (CGDP) would be lower.... [I]ncreased formulary controls, higher price concessions, and lower price trends would all reduce overall program costs, including greater average member savings." (Milliman, for Assistant Secretary for Planning and Evaluation [ASPE], U.S. Department of Health and Human Services [HHS])
HHS Proposal Could Kill PBM Rebates
"The idea is to pass savings along to patients by increasing transparency, encouraging discounts given directly to consumers rather than middlemen, and prohibiting a compensation system that incentivizes annual price hikes, according to [HHS]." (HealthLeaders Media)
[Official Guidance] Text of HHS Proposed Regs: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain PBM Fees
123 pages. "The amendment would revise the discount safe harbor to explicitly exclude from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D, Medicaid managed care organizations ... or pharmacy benefit managers (PBMs) under contract with them. In addition, the Department is proposing two new safe harbors. The first would protect certain point-of-sale reductions in price on prescription pharmaceutical products, and the second would protect certain PBM service fees." (Office of Inspector General, U.S. Department of Health and Human Services [HHS])
[Guidance Overview] Administration Proposes to Lower Drug Costs by Targeting Backdoor Rebates and Encouraging Direct Discounts to Patients
"The HHS proposal would expressly exclude from safe harbor protection under the Anti-Kickback Statute rebates on prescription drugs paid by manufacturers to pharmacy benefit managers (PBMs), Part D plans and Medicaid managed care organizations. It would create a new safe harbor for prescription drug discounts offered directly to patients, as well as fixed fee service arrangements between drug manufacturers and PBMs. The proposal would also provide a historic new level of transparency to a system that has been shrouded in secrecy for decades." (U.S. Department of Health and Human Services [HHS])
Provider Payments Criticized as Congress Targets High Drug Costs
"On Jan. 29, both the Senate Finance Committee and the House Oversight and Reform Committee held hearings to identify actions Congress could take to lower drug costs for the public. The 340B discount drug program and the Medicare Part B policy that pays average sales price (ASP) plus 6 percent to providers that order the drugs both drew criticism for contributing to rising drug costs." (Healthcare Financial Management Association [HFMA])
[Opinion] Comprehensive Reform to Lower Prescription Drug Prices
"Even when manufacturers do account for the value of their drugs, it is largely based on their own studies and data -- which are often not made public. There are two main problems that comprehensive legislation should address. [1] Steep launch prices of new drugs ... [2] Price hikes on existing drugs." (Center for American Progress)
Essential Facts About Medicare and Prescription Drug Spending
"[1] Medicare's share of the nation's retail prescription drug spending has increased from 18% in 2006 to 30% in 2017.... [2] Prescription drugs covered under both Part B and Part D accounted for 19% of all Medicare spending in 2016.... [3] Ten drugs accounted for 17% of all Part D spending in 2016 ... [4] Prescription drugs accounted for $1 in every $5 that Medicare beneficiaries spent out-of-pocket on health care services in 2016, not including premiums." (Henry J. Kaiser Family Foundation)
Congress Wades Into Debate Over High-Cost Prescription Drugs; Pharma Execs Refuse to Testify
"Senators railed against pharmaceutical executives [at a Jan. 29 hearing] for declining to testify before Congress about out-of-control drug prices, as lawmakers on both sides of the U.S. Capitol kicked off investigations sure to rattle one of the nation's most powerful industries." (Kaiser Health News)
Senate Finance Committee Hearing: Drug Pricing in America -- A Prescription for Change, Part I
Testimony from: [1] Kathy Sego, Mother of a child with insulin-dependent diabetes; [2] Douglas Holtz-Eakin, Ph.D., American Action Forum; [3] Mark E. Miller, Ph.D., Laura and John Arnold Foundation; [4] Peter B. Bach, MD, MAPP, Memorial Sloan Kettering Center for Health Policy and Outcomes. (Committee on Finance, U.S. Senate)
California Makes Waves with Pharma Benefits, Purchasing Plan
"California is planning to take control of the pharmacy benefit for all of the state's Medi-Cal beneficiaries -- the vast majority of which currently have that part of their care administered by private insurers and their PBMs. What's more, the order directs state agencies to create bulk-purchasing arrangements for high-priority drugs and establish a framework for letting private businesses and insurers join the state's buying pool." (AISHealth)
CMS Addresses Drug Manufacturer Coupons in Proposed 2020 Payment Notice
"Currently, the amount that patients save using drug manufacturer coupons goes toward their annual cost-sharing maximum. However, in the Proposed 2020 Payment Notice, CMS states that drug manufacturer coupons can cause prescribing physicians and beneficiaries to choose expensive brand-name drugs over less expensive generics. In addition, CMS expresses concern that, by reducing patients' copayment obligations, drug manufacturer coupons relieve manufacturers of market constraints on drug prices, distorting the market." (Mintz)
TRICARE Issues Request for Information on Formulary Management
"The Defense Health Agency (DHA), which manages the TRICARE health care benefits, has issued a Request for Information (RFI) regarding inpatient-clinic administered pharmaceuticals formulary management.... [R]esponding vendors have the opportunity to shape the standard list of drugs prescribed across all military medical treatment facilities, as well as the broader program administering the list. Responses are due February 5, 2019." (Sheppard Mullin)
Including Drug Prices in TV Ads May Deter Consumers from High-Priced Drugs
"According to a new study, these drug price disclosures could significantly influence consumer thinking and behavior, especially for expensive drugs. However, the study also found that this effect was mitigated when the ad mentioned that patient out-of-pocket costs for the drug would be zero because of insurance and other discounts." (American Journal of Managed Care)
HHS Proposals Could Increase Health Costs for Consumers
"Health plans have annual limits on consumers' out-of-pocket costs. Under the proposal, insurers would not have to count the full amount of a consumer's co-payment for a brand-name drug toward the annual limit on cost-sharing. Insurers would have to count only the smaller amount that would be charged for a generic version of the drug." (The New York Times; subscription may be required)
California Prescription Drug Purchasing Initiative Raises Numerous Questions
"Would [the California Department of Health Care Services (DHCS)] really be able to negotiate better rebates for Medi-Cal than managed care organizations? ... Is the program permissible under federal law, and if so, does it require Trump Administration approval? ... Are changes in California law required? ... Is the initiative permissible under the antitrust laws? ... How would 'the self-insured' receive the benefit of the negotiated discounts?" (Reed Smith LLP)
[Guidance Overview] CMS Announces New Model to Lower Drug Prices in Medicare Part D and Transformative Updates to Existing Model for Medicare Advantage
"Under the new model, which takes effect for the 2020 plan year, participating plans will take on greater risk for spending in the catastrophic phase of Part D, creating new incentives for plans, patients, and providers to choose drugs with lower list prices. Based on plan year performance, CMS will calculate a spending target for what governmental spending would have been without plans taking on this additional risk. Participating Part D plans will share in savings if they stay below the target but will be accountable for losses if they exceed the target. For the first time, the model also introduces a Part D rewards and incentives program to align this model with the changes to VBID, and to provide Part D plans with additional tools to control drug costs and help enrollees in choosing drugs with lower list prices." (Centers for Medicare & Medicaid Services [CMS], U.S. Department of Health and Human Services [HHS])
Drug-Pricing Transparency, Vertical PBM Deals Are Top of Mind for Employers in 2019
"As they look to win over employer clients this year, PBMs should be prepared to face stiff competition and embrace emerging trends such as value-based formularies and rebate-free models ... Companies are also considering how the vertical integration in the PBM space is 'reshaping the landscape' ... [M]any of the same themes that employers are focused on will apply, including greater transparency around drug pricing and rebates, and even rebate-free models[.]" (AISHealth)
Bringing 'Transparent Thinking' to PBM Management (PDF)
50 presentation slides. Topics: [1] What is a PBM? [2] Who are the parties to a PBM contract? [3] Why do PBMs have so much power? [4] How do PBMs make money? [5] Contract terms -- the need for solid terms in a contract. [6] A push for transparency. [7] Policy news. [8] A real life example: PBGH's Waste-free formulary study. (Trucker Huss)
HHS Secretary Raises Possibility of Allowing Drug Importation to Help Rein in Drug Prices
"[HHS] Secretary Alex Azar ... expressed support for the safe importation of drugs from other countries as a means to spur competition in the prescription drug market and prevent manufacturers from imposing price hikes -- a significant turning point in the administration's approach to drug costs ... Unlike other proposals to reduce drug costs, such as Medicare negotiation or allowing the government to manufacture drugs, importation has bipartisan support." (Morning Consult)
HHS Medicare Drug Shift Plan Could Reduce Costs Overall But Raise Them for Some
"At 2018 prices, Part B spending for the 75 brand-name drugs with the highest Part B expenditures was estimated to be $21.6 billion annually. Under the proposed policy, total Part D drug spending for these drugs would fall to an estimate in the range of $17.6 billion and $20.1 billion after rebates, corresponding to a 6.9% to 18.3% decrease in drug spending in Part D compared with Part B costs." (American Journal of Managed Care)
Sen. Sanders, Rep. Cummings to Introduce Bill to Lower U.S. Drug Prices
"The Sanders and Cummings bill would peg U.S. prescription drug prices to the median price from five countries -- Canada, Britain, France, Germany and Japan -- where drug costs are typically far lower because of government price controls.... The bill would also allow the U.S. Secretary for Health and Human Services (HHS) to negotiate prices in Medicare Part D ... The proposal would also end a ban that keeps Americans from buying medicines at lower prices from Canada and other countries." (Reuters)
Health Care Industry Spends $30 Billion Each Year Pushing Its Wares, From Drugs to Stem Cell Treatment
"Spending on health care marketing doubled from 1997 to 2016.... The biggest increase in medical marketing over the past 20 years was in 'direct-to-consumer' advertising, including the TV commercials that exhort viewers to 'ask your doctor' about a particular drug. Spending on such ads jumped from $2.1 billion in 1997 to nearly $10 billion in 2016[.]" (Kaiser Health News)
Drug Costs Driven Largely By Price Increases, Not Innovation
"[T]he cost of brand-name oral prescription drugs rose more than 9 percent a year from 2008 and 2016, while the annual cost of injectable drugs rose more than 15 percent.... [I]ncreases in prices of brand-name drugs were largely driven by year-over-year price increases of drugs that were already in the market[.]" (National Public Radio [NPR])
Policy Options for Increasing Generic Drug Competition Through Importation
"Although overall generic drug prices have slowly decreased since 2010, off-patent drugs with few or no competitors, such as pyrimethamine (Daraprim) and lomustine (Gleostine), have been subject to sudden, large price increases. Bolstering competition by importing versions of these off-patent drugs from abroad may help prevent the dramatic price increases that have grabbed recent headlines, particularly if the working group establishes permanent importation channels with comparable foreign regulatory agencies and targets a wider selection of off-patent drugs with insufficient competition." (Health Affairs)
Prescription Drug Policy: The Year in Review, and the Year Ahead
"Democratic members of Congress, many of whom will now serve in leadership positions in the new Congress, have introduced a flood of bills on the topic of drug pricing.... All of these bills go beyond the comprehensive legislation already introduced by Democrats into both houses in 2017[.]" (Health Affairs)
Dozens of Pharmaceutical Makers Raise Prices on Hundreds of Drugs to Ring in the New Year
"Many companies' increases are relatively modest this year, amid growing public and political pressure on the industry over prices. Yet a few are particularly high, including on some generics, the cheaper alternative to branded accounting for nine out of 10 prescriptions filled in the U.S. Overall, price increases, including recently restored price increases from Pfizer Inc. continue to exceed inflation." (MarketWatch)
Judge OKs CVS Plan to Keep Aetna Separate Pending Review
"CVS said it is currently operating Aetna's health insurance business separately from CVS's retail pharmacy and PBM business units, with Aetna maintaining control over pricing and product offerings. Aetna personnel will also retain their current compensation and benefits, and CVS will maintain a firewall to prevent the exchange of competitively sensitive information between the two companies." (AISHealth)
Onsite Dispensaries Help Employees Use Medications Properly
"A healthcare delivery model that fosters an open dialogue between patients and their healthcare providers can improve medication adherence.... Having easy access to a trusted provider in a workplace clinic can also help patients access the right team of clinicians to meet their needs in the community, across the care continuum.... Providers in traditional healthcare settings are often constrained by lack of time to communicate effectively with patients -- and their families." (Healthstat)
New PBM Models Respond to Public Pressure, Market Demand
"Express Scripts Holding Co. and CVS Health Corp. have in recent months unveiled new programs that appear designed to transition away from the PBM status quo.... Express Scripts' new National Preferred Flex Formulary allows it to add to its formulary a newly launched lower-cost alternative to a brand medication -- giving members immediate access to that drug -- and lets the PBM exclude the innovator brand product from coverage.... Under CVS's new Guaranteed Net Cost model, the company will pass 100% of rebates to plan sponsors[.]" (AISHealth)
Possible Steep Consequences for U.S. Pharmaceutical and Biologics Industries from ACA Decision
"[T]he ruling could undo the entire U.S. biosimilars industry, because without the ACA, there is no statutory framework for biosimilar drug approval. Second, Judge O'Connor's opinion could potentially leave millions of patients without prescription drug insurance coverage, hurting both the patients themselves as well as the pharmaceutical industry's bottom line. The good news is that while the ACA has been declared unconstitutional, Judge O'Connor did not issue an injunction, so the act remains in force -- at least for now." [Texas v. U.S., No. 18-167 (N.D. Tex. Dec. 14, 2018)] (Schiff Hardin)
For the Asking, a Check Is in the Mail to Help Pay for Costly Drugs
"Drugmakers began using now-popular copay coupons and other forms of assistance more than a decade ago to help patients pay out-of-pocket costs for medicines, particularly high-cost specialty drugs such as those that treat autoimmune disorders. The coupons have a dual purpose: They mask the true costs of a drug for patients and give patients a financial incentive to stay on an expensive drug until their insurance deductible is met." (Kaiser Health News)
[Opinion] Prescription Drugs and Price Controls: What the Debate Gets Wrong
Podcast with transcript. "America has been called the 'Pharmacy to the World' because it's where more than half of new drugs get developed and tested in clinical trials. Patients in Europe and elsewhere enjoy the benefits of these breakthrough drugs. Price controls in the U.S. would significantly curtail new research and development project s-- resulting in a net loss for everyone." (City Journal, published by the Manhattan Institute for Policy Research)
[Official Guidance] Text of Department of Defense Interim Final Rule: TRICARE Pharmacy Benefits Program Reforms
17 pages. "This interim final rule implements Section 702 of the National Defense Authorization Act for Fiscal Year 2018 [which] makes significant changes to the TRICARE Pharmacy Benefits Program, specifically it: [1] updates co-payment requirements; [2] authorizes a new process for encouraging use of pharmaceutical agents that provide the best clinical effectiveness by excluding coverage for particular pharmaceutical agents that provide very little or no clinical effectiveness relative to similar agents and for giving preferential status to agents that provide enhanced clinical effectiveness; and [3] authorizes special reimbursement methods, amounts, and procedures to encourage use or high-value products and discourage use of low-value products with respect to pharmaceutical agents provided as part of medical services from authorized providers." (U.S. Department of Defense)
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