Pipeline & Gas Journal - for the original article go HERE.
Democrats in the House are about to pass a new pipeline safety bill which is unlikely to attract any Republican support. The Pipeline Safety Act (H.R. 5120), passed by two House committees in November with no GOP votes in favor, also clashes with the bi-partisan bill passed last summer by the Senate Commerce, Science and Transportation Committee.
The House Democratic bill was praised by the Environmental Defense Fund (EDF), an environmental group, which has typically been at loggerheads with the Interstate Natural Gas Association of America (INGAA) with regard to how safety and environmental factors should affect pipeline permitting. The INGAA supported a rival bill proposed by Republicans in the House Transportation and Infrastructure Committee. That bill attracted support from one Democrat.
A few days before the Transportation and Commerce Committees voted to approve H.R. 5120 on November 19 and 20, a number of natural gas industry trade groups, including the INGAA and American Petroleum Institute, sent a letter to members of those committees expressing concern about the lack of bipartisan support for H.R. 5120. The letter stated: “Pipeline safety legislation historically has been enacted on a bipartisan basis, and bipartisanship will ultimately be essential to achieve the bicameral support needed in this Congress to reauthorize PHMSA.” The PHMSA is the Pipeline and Hazardous Materials Safety Administration. Its legislative authorization ceased at the end of September 2019 but the agency can continue to do its business nonetheless although new legislation is eventually needed, and sooner rather than later.
The INGAA letter ticked off a number of actions the industry would support in a new pipeline safety bill, including: enhancing PHMSA’s workforce, increasing funding for State pipeline safety regulators, reauthorizing emergency responder grant funding, promoting innovative technologies, and updating PHMSA regulations to address the intent of relevant National Transportation Safety Board recommendations.
Prior to the November 19 and 20 votes by both House committees, Democrats in the Energy & Commerce Committee supported a much milder version of H.R. 5120. But they ditched that bill and jumped on the more radical—from industry’s perspective—bill presented by the House Transportation and Infrastructure Committee.
Elizabeth Gore, Senior Vice President, EDF, lauded H.R. 5120 called the Safe, Accountable, Fair and Environmentally Responsible Pipelines Act of 2019. "By putting in place critical new public safety and climate protections, the SAFER Pipelines Act is a win-win for all American families. It's well past time to give PHMSA the tools and direction to contribute to our nation's efforts to prevent the worst impacts of climate change."
One of the provisions of the bill would essentially prohibit the Environmental Protection Agency from completing an ongoing rulemaking announced last September which would change current regulations imposed in 2012 and 2016 obligating pipelines to reduce methane leaks. The creation in those years of Clean Air Act new source performance standards (NSPS) subparts OOOO and OOOOa subjected pipelines to limits on emissions of volatile organic chemicals and methane from controllers and compressor stations. There were subsequent legal challenges in 2016 and 2017 which led to the EPA reconsidering a few provisions of the 2016 final rule, including those having to do with fugitive emissions. Then, last September, in a proposed rule, the Trump EPA essentially proposed cancelling the 2016 final rule which dealt primarily with methane.
At the end of November 2019, a week after the House committees acted, the INGAA submitted comments on the EPA’s September proposed rule. The group said it was particularly concerned about the provisions in the 2016 EPA final rule dealing with “certain repairs” but added: “Although INGAA’s participation in the legal challenge of NSPS OOOOa was limited to this particular technical issue, INGAA does support a broad review of these rules...”
The comments point out that the INGAA board of directors had formally committed to methane reductions in voluntary pledges issued on July 19, 2018. These included core principles such as minimizing emissions from interstate natural gas pipelines, pneumatic controllers and compressor stations. More specifically, members of INGAA said they will install air-driven, low-bleed, or intermittent pneumatic controllers when installing new pneumatic controllers, unless a different device is required for safe operations; minimize emissions during maintenance, repair and replacement of pipelines; replace rod packing on all transmission and storage reciprocating compressors; conduct leak surveys at all member-owned and operated transmission and transmission and storage compressor stations by 2022 and at all natural gas storage wells owned and operated by INGAA member companies by 2025; and transparently report methane emissions.
Those voluntary commitments obviously did not move House Democrats. H.R. 5120 goes beyond the Obama-era 2016 “methane release from pipelines regulation” by imposing a host of new federal requirements in the area of leak detection and elsewhere. Another provision would require comprehensive pipeline mapping for the first time. Automatic shutoff or remote-controlled valves would be required on existing, new and replaced pipelines. The maximum civil penalties that could be imposed by the PHMSA would be increased from $200,000 to $2 million per violation. It would be easier for the PHMSA to assess criminal penalties for operators who act recklessly. Operators would have to immediately repair major gas leaks.
Democrats in the House believe those far-reaching actions are necessary. “There are nearly 3 million miles of pipelines transporting hazardous liquid and natural gas just feet below countless communities across the U.S., yet federal efforts to ensure these pipelines are safe, reliable and environmentally-sound are woefully outdated,” Transportation Chair Peter DeFazio (D-OR) said, “Last year alone, there were 636 pipeline incidents that left eight people dead and injured another 90, including the horrific incident that killed one person, sent 21 others to the hospital, and damaged 131 structures in Merrimack Valley, Massachusetts. Moreover, it’s estimated that this industry is responsible for one-third of our country’s emissions of methane, a greenhouse gas that is 84 times more potent than carbon dioxide in the first few decades of its release and a major contributor to climate change.”
But those provisions go too far for the pipeline industry, and for Republicans in the House, and most likely, for GOPers in the Senate, where Republicans are in control. After the Transportation Committee vote on November 20, ranking member Sam Graves (R-MO), said, “The most disappointing fact about today’s partisan markup is that if Republicans had been offered the chance to work on these bills with our colleagues in the majority, we could have produced legislation that every member of the committee supported.” The GOP bill, which one Democrat supported, is called the Pipeline Safety Improvement Act of 2019. It includes a number of industry “asks” including prohibiting three overt actions that jeopardize safety: unauthorized turning of a valve; puncturing of a pipe, pump, or valve; and causing a defect to a pipe, pump, or valve. It also creates a safety-enhancing testing program for innovative technologies and operational practices.
Don Santa, President and Chief Executive Officer of the INGAA, said, “The Pipeline Safety Improvement Act of 2019 includes a number of provisions that enjoy wide support…and along with elements of the SAFER Pipeline Act of 2019 reflects the bipartisan approach that has characterized each renewal of this important law. We urge the committees to work together to reconcile these proposals into a legislative package that can be signed into law.”
The House Democratic bill is considerably different from the bill passed by the Senate Commerce Committee on July 31. That bill is milder than even the bill the House Energy and Commerce Committee passed, and then jettisoned on November 19 in favor of the tougher H.R. 5120. The Senate bill is the Protecting Our Infrastructure of Pipelines Enhancing Safety (PIPES) Act of 2019 (S. 2299).
Author Bio:
Mr. Barlas is a freelance writer in Washington, D.C. who covers issues inside the Beltway.
House and Senate At Odds On Drug Pricing Legislation
P&T Journal - for the original article go HERE.
Neither bill will pass as is but there’s room for compromise.
Momentum in Congress to pass legislation aimed at slowing down prescription drug price increases seems to have slowed as Democrats and Republicans are at loggerheads over competing solutions. However, given the heated criticism of pricing by drug manufacturer from both parties, Congress is likely to do something, perhaps passing legislation forcing companies to provide transparency on costs of drug development and other pricing factors. Key committees in both houses of Congress have passed separate bills.
The Democratic House bill is called the Lower Drug Costs Now Act (H.R. 3). It passed three separate House committees with nary a Republican “yea.” It was expected to be approved by the House sometime before the end of 2019 and, again, probably along party lines. It won’t pass the Senate as is. The Senate bill, which was approve by the Senate Finance Committee, is called the Prescription Drug Pricing Reduction Act (S. 2543). The legislation represents the bipartisan work of the Republican chairman, Sen. Chuck Grassley of Iowan, and ranking Democrat, Sen. Ron Wyden of Oregon. The bill, which has not come to the Senate floor as P&T went to press, passed the committee by a vote of 19-9. Every Democrat voted for the bill, but most of the Republicans, with the exception of Grassley and a few others, voted against it.
Both the House and Senate bills have many provisions aimed at lowering drug prices for seniors, and, in some cases, all consumers. The bills would also reduce costs for the Medicare and Medicaid programs. But the key provisions in each attempt to limit drug price increases and introductory prices, but they do so in very different ways. That divergence is the main reason neither bill will pass Congress as is.
Republican support of the Senate bill is doubtful because many in the party see the provision in the bill that forces down manufacturers’ prices as federal price controls, a characterization that Grassley and Wyden refute. The provision they are arguing about would require prescription drug and biological manufacturers to pay a rebate to Medicare equal to the difference their price hikes for Medicare Part B or D drugs or biologicals and the inflation rate, as measured by the Consumer Price Index for All Urban Consumers (CPI-U).
Adding to the bill’s political tribulations is a threat by Wyden to withdraw Democratic support unless a vote is held on the Senate floor on cementing insurance protections for people with pre-existing conditions.
In the House, the partisan divide is clear and thorough: Democrats are solidly behind the bill and the Republicans just as solidly against it. The legislation, which was put together with strong input from House Speaker Nancy Pelosi, would allow the Health and Human Services secretary to directly negotiate prices of drugs that are determined to contribute the most to Medicare drug costs and are without generic competitors. As written, the legislation says that a minimum of 25 drugs can be on that list and a maximum of 250 drugs. Drug manufacturers who opt out of accepting the secretary’s negotiated rates would incur steep penalties, beginning at 65% of the drug manufacturer’s gross sales of the drug from the prior year. For every quarter the drug manufacturer elects not to participate, the penalty would increase by 10%, with a maximum penalty of 95% of a drug’s gross sales. Like the Senate bill, the House bill has less controversial other provisions, such as reducing out-of-pocket costs and creating discount programs for eligible Medicare beneficiaries.
The Pharmaceutical Research Manufacturers Association (PhRMA) opposes both the Senate and House bill. “If H.R. 3 becomes law, it is lights out for a lot of very small biotech companies that are pre-revenue and depend on attracting capital,” Steve Ubl, PhRMA CEO told reporters in October. A PhRMA blog criticizes the Senate bill this way: “Unfortunately, the Senate Finance Committee has pushed for changes that would upend Part D without any immediate and meaningful savings for most patients at the pharmacy counter.”
Some patient advocacy groups are concerned that the Pelosi bill will cause drug manufacturers to tap the brakes on drug development. But other groups, like AARP, support the legislation and the stated intent of reining in drug prices.
The near certainty that neither bill will pass as is doesn’t mean that there isn’t room for compromise. For example, the Senate bill has a provision that requires companies to report “documentation to justify price increases” in 2021 for drugs with price increases of 100% in the preceding 12 months or at least 150% in the preceding two years. The numbers change slightly in successive years. The House requires reporting on drug price increases of 10% in one year or 25% over three years. Compromise legislation might a middle ground between the two bills.
Stephanie Kennan, a senior vice president at McGuireWoods Consulting, a major lobbying firm who was health policy advisor to Sen. Wyden for about 10 years, says, “The House has passed bills that reflect some of the provisions in the Senate Finance Committee’s proposal. It would make sense that some form of the Senate Finance Committee’s bill becomes the base of a compromise.”
Neither bill will pass as is but there’s room for compromise.
Momentum in Congress to pass legislation aimed at slowing down prescription drug price increases seems to have slowed as Democrats and Republicans are at loggerheads over competing solutions. However, given the heated criticism of pricing by drug manufacturer from both parties, Congress is likely to do something, perhaps passing legislation forcing companies to provide transparency on costs of drug development and other pricing factors. Key committees in both houses of Congress have passed separate bills.
The Democratic House bill is called the Lower Drug Costs Now Act (H.R. 3). It passed three separate House committees with nary a Republican “yea.” It was expected to be approved by the House sometime before the end of 2019 and, again, probably along party lines. It won’t pass the Senate as is. The Senate bill, which was approve by the Senate Finance Committee, is called the Prescription Drug Pricing Reduction Act (S. 2543). The legislation represents the bipartisan work of the Republican chairman, Sen. Chuck Grassley of Iowan, and ranking Democrat, Sen. Ron Wyden of Oregon. The bill, which has not come to the Senate floor as P&T went to press, passed the committee by a vote of 19-9. Every Democrat voted for the bill, but most of the Republicans, with the exception of Grassley and a few others, voted against it.
Both the House and Senate bills have many provisions aimed at lowering drug prices for seniors, and, in some cases, all consumers. The bills would also reduce costs for the Medicare and Medicaid programs. But the key provisions in each attempt to limit drug price increases and introductory prices, but they do so in very different ways. That divergence is the main reason neither bill will pass Congress as is.
Republican support of the Senate bill is doubtful because many in the party see the provision in the bill that forces down manufacturers’ prices as federal price controls, a characterization that Grassley and Wyden refute. The provision they are arguing about would require prescription drug and biological manufacturers to pay a rebate to Medicare equal to the difference their price hikes for Medicare Part B or D drugs or biologicals and the inflation rate, as measured by the Consumer Price Index for All Urban Consumers (CPI-U).
Adding to the bill’s political tribulations is a threat by Wyden to withdraw Democratic support unless a vote is held on the Senate floor on cementing insurance protections for people with pre-existing conditions.
In the House, the partisan divide is clear and thorough: Democrats are solidly behind the bill and the Republicans just as solidly against it. The legislation, which was put together with strong input from House Speaker Nancy Pelosi, would allow the Health and Human Services secretary to directly negotiate prices of drugs that are determined to contribute the most to Medicare drug costs and are without generic competitors. As written, the legislation says that a minimum of 25 drugs can be on that list and a maximum of 250 drugs. Drug manufacturers who opt out of accepting the secretary’s negotiated rates would incur steep penalties, beginning at 65% of the drug manufacturer’s gross sales of the drug from the prior year. For every quarter the drug manufacturer elects not to participate, the penalty would increase by 10%, with a maximum penalty of 95% of a drug’s gross sales. Like the Senate bill, the House bill has less controversial other provisions, such as reducing out-of-pocket costs and creating discount programs for eligible Medicare beneficiaries.
The Pharmaceutical Research Manufacturers Association (PhRMA) opposes both the Senate and House bill. “If H.R. 3 becomes law, it is lights out for a lot of very small biotech companies that are pre-revenue and depend on attracting capital,” Steve Ubl, PhRMA CEO told reporters in October. A PhRMA blog criticizes the Senate bill this way: “Unfortunately, the Senate Finance Committee has pushed for changes that would upend Part D without any immediate and meaningful savings for most patients at the pharmacy counter.”
Some patient advocacy groups are concerned that the Pelosi bill will cause drug manufacturers to tap the brakes on drug development. But other groups, like AARP, support the legislation and the stated intent of reining in drug prices.
The near certainty that neither bill will pass as is doesn’t mean that there isn’t room for compromise. For example, the Senate bill has a provision that requires companies to report “documentation to justify price increases” in 2021 for drugs with price increases of 100% in the preceding 12 months or at least 150% in the preceding two years. The numbers change slightly in successive years. The House requires reporting on drug price increases of 10% in one year or 25% over three years. Compromise legislation might a middle ground between the two bills.
Stephanie Kennan, a senior vice president at McGuireWoods Consulting, a major lobbying firm who was health policy advisor to Sen. Wyden for about 10 years, says, “The House has passed bills that reflect some of the provisions in the Senate Finance Committee’s proposal. It would make sense that some form of the Senate Finance Committee’s bill becomes the base of a compromise.”
Author bio:
Mr. Barlas is a freelance writer in Washington, D.C. who covers issues inside the Beltway.
P&T Committees May Want to Alter Some Formulary Policies Because of New Medicare Part D Standards
P&T Journal - for the original article go HERE. For a PDF version go HERE.
Medicare’s proposed use of a new electronic prescribing (eRx) standard for prior authorization requests between physicians and Part D plans has been well received by the various players in the prescription drug delivery chain. That doesn’t mean, however, that it is problem free and without a number of concerns.
The new standard, which won’t be implemented prior to 2021, may force pharmacy and therapeutics committees to reconsider which tiers they put a couple of categories of drugs on. It may also prompt revision of step therapy policies.
The first thing to remember, though, is that there is no requirement that prescribers or plans implement eRx for seniors with Medicare outpatient drug coverage. But if they do, they must use standards sanctioned by the Centers for Medicare and Medicaid Services (CMS).
The current standard with regard to electronic prior authorization—the X12 278 standard designed to conduct batch transactions—was adopted mainly because it is compliant with HIPAA and was established mostly for durable medical equipment. So, understandably, the X12 standard is not really the right tool for the job. Important prescribing information can’t be inputted, and it doesn’t allow for “real-time” responses, or follow-up by physicians, health plans, or pharmacies.
For these and other reasons, CMS has proposed replacing the standards with National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard Version 2017071. CMS had already designated that SCRIPT standard for eRx prescriptions starting January 1, 2020. It would become mandatory for electronic prior authorization transactions one year later, if CMS finalizes its proposed rule.
Today under Medicare Part D, prior authorization requests and responses are transmitted mostly by fax and phone using the X12 standard. Prior authorization, both within and outside Medicare health plans, is a big deal these days as more plans use it for opioid prescriptions in response to overprescribing and the opioid epidemic.
Prior authorization requirements for oncology drugs are also an issue because the drugs are increasingly expensive. Howard Burris III, MD, the president of the American Society of Clinical Oncology, expressed reservations about streamlining prior authorization in his comments on the new standard. He urged the agency to “exercise caution in order to avoid unintended consequences of restricting or delaying care, resulting in harmful outcomes.”
CMS was required to designate a standard for electronic prior authorization by the 2018 SUPPORT for Patients and Communities Act. CMS had endorsed the SCRIPT standard for Medicare eRX standards prior to the SUPPORT Act, but it was constrained from extending the SCRIPT standard to electronic prior authorization transactions by the HIPAA issue. The SUPPORT Act eliminated that barrier by saying a new standard could be adopted “notwithstanding” any other provision of law, if such proposals were made in consultation with stakeholders and the NCPDP or other standard-setting organizations. As a result, HIPAA noncompliance is not a barrier to adoption of the SCRIPT standard by Medicare.
Health plans and pharmacists appear to be generally happy with the application of the SCRIPT standard to prior authorization requests and decisions, even though some health plans with both Medicare and commercial plans currently use non-SCRIPT standards.
Joel White, the executive director of the Opioid Safety Alliance pointed out in his comments to CMS that in considering only two sets of electronic prior authorization transaction standards (X12 and SCRIPT) CMS “seemingly ignores current industry use of HL7 FHIR standards or APIs [application programming interfaces].” Leaving these additional standards out of consideration “unnecessarily and prematurely” limits the scope of public consideration and comments, wrote White. The agency’s proposed solution also runs “contrary to other agency efforts, such as increased interoperability and prohibiting information blocking,” he stated.
The American Association of Family Physicians has a different concern: the “significant administrative burden and/or access issues” that general practitioners face in introducing relevant software into their practices. The AAFP wants a “safe harbor” for primary care physicians and, like the Opioid Safety Alliance, the freedom to use standards other than SCRIPT if both a prescriber and a health plan agree to that. One of the concerns about imposing SCRIPT is that physicians might be faced with having to use different standards for e-prescribing within the state Prescription Drug Monitoring Programs and the Part D programs.
When all is said and done, CMS is likely to give physicians, pharmacies, and Part D plans some leeway in a final rule for eletronic prior authorization. Even so, P&T commmitees in and out of Medicare will have to consider new factors when putting together their prior authorization policies and programs.
Medicare’s proposed use of a new electronic prescribing (eRx) standard for prior authorization requests between physicians and Part D plans has been well received by the various players in the prescription drug delivery chain. That doesn’t mean, however, that it is problem free and without a number of concerns.
The new standard, which won’t be implemented prior to 2021, may force pharmacy and therapeutics committees to reconsider which tiers they put a couple of categories of drugs on. It may also prompt revision of step therapy policies.
The first thing to remember, though, is that there is no requirement that prescribers or plans implement eRx for seniors with Medicare outpatient drug coverage. But if they do, they must use standards sanctioned by the Centers for Medicare and Medicaid Services (CMS).
The current standard with regard to electronic prior authorization—the X12 278 standard designed to conduct batch transactions—was adopted mainly because it is compliant with HIPAA and was established mostly for durable medical equipment. So, understandably, the X12 standard is not really the right tool for the job. Important prescribing information can’t be inputted, and it doesn’t allow for “real-time” responses, or follow-up by physicians, health plans, or pharmacies.
For these and other reasons, CMS has proposed replacing the standards with National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard Version 2017071. CMS had already designated that SCRIPT standard for eRx prescriptions starting January 1, 2020. It would become mandatory for electronic prior authorization transactions one year later, if CMS finalizes its proposed rule.
Today under Medicare Part D, prior authorization requests and responses are transmitted mostly by fax and phone using the X12 standard. Prior authorization, both within and outside Medicare health plans, is a big deal these days as more plans use it for opioid prescriptions in response to overprescribing and the opioid epidemic.
Prior authorization requirements for oncology drugs are also an issue because the drugs are increasingly expensive. Howard Burris III, MD, the president of the American Society of Clinical Oncology, expressed reservations about streamlining prior authorization in his comments on the new standard. He urged the agency to “exercise caution in order to avoid unintended consequences of restricting or delaying care, resulting in harmful outcomes.”
CMS was required to designate a standard for electronic prior authorization by the 2018 SUPPORT for Patients and Communities Act. CMS had endorsed the SCRIPT standard for Medicare eRX standards prior to the SUPPORT Act, but it was constrained from extending the SCRIPT standard to electronic prior authorization transactions by the HIPAA issue. The SUPPORT Act eliminated that barrier by saying a new standard could be adopted “notwithstanding” any other provision of law, if such proposals were made in consultation with stakeholders and the NCPDP or other standard-setting organizations. As a result, HIPAA noncompliance is not a barrier to adoption of the SCRIPT standard by Medicare.
Health plans and pharmacists appear to be generally happy with the application of the SCRIPT standard to prior authorization requests and decisions, even though some health plans with both Medicare and commercial plans currently use non-SCRIPT standards.
Joel White, the executive director of the Opioid Safety Alliance pointed out in his comments to CMS that in considering only two sets of electronic prior authorization transaction standards (X12 and SCRIPT) CMS “seemingly ignores current industry use of HL7 FHIR standards or APIs [application programming interfaces].” Leaving these additional standards out of consideration “unnecessarily and prematurely” limits the scope of public consideration and comments, wrote White. The agency’s proposed solution also runs “contrary to other agency efforts, such as increased interoperability and prohibiting information blocking,” he stated.
The American Association of Family Physicians has a different concern: the “significant administrative burden and/or access issues” that general practitioners face in introducing relevant software into their practices. The AAFP wants a “safe harbor” for primary care physicians and, like the Opioid Safety Alliance, the freedom to use standards other than SCRIPT if both a prescriber and a health plan agree to that. One of the concerns about imposing SCRIPT is that physicians might be faced with having to use different standards for e-prescribing within the state Prescription Drug Monitoring Programs and the Part D programs.
When all is said and done, CMS is likely to give physicians, pharmacies, and Part D plans some leeway in a final rule for eletronic prior authorization. Even so, P&T commmitees in and out of Medicare will have to consider new factors when putting together their prior authorization policies and programs.
Author bio:
Mr. Barlas is a freelance writer in Washington, D.C. who covers issues inside the Beltway.
NIH Establishes Early Version of Personalized Medicine Platform
P&T Journal - for the original article go HERE. For a PDF version go HERE.
Congress has been pumping money into the precision-medicine
initiative at the National Institutes of Health (NIH). The first, early
results of that spending were announced on May 7, when the All of Us
research project went live with three types of aggregate health data on
142,000 individuals. It was the first wave of what is expected to amount
to, or hoped to amount to, one million participants. All of Us grew out
of the 21st Century Cures Act and is a favored target for
federal funding. President Trump has proposed a 12% cut in NIH funding
for fiscal 2020 (starting on October 1, 2019), which Congress is likely
to reverse, as it has done in the last few years when similar cuts were
asked for by the White House. However, the President’s 2020 budget does
contain $313 million for All of Us.
The program was kicked off one year ago in seven cities around the country, with a particular emphasis on convincing members of underrepresented and minority communities to come forward with their health data. The idea is eventually to be able to check genomic data against environmental experience with a view to finding clues on the origin of various health conditions, so as to better target prevention and treatment measures. So far, more than 206,000 people have begun the enrollment process, and more than 142,000 have completed all the steps in the protocol. Most participants (> 75%) are from communities that have been underrepresented in biomedical research. “Those people are often left behind,” said Francis Collins, Director of NIH. “We’re hoping to chip away at vexing health disparities.”
A number of universities around the country have received grants to pay for participant enlistment efforts, including the University of Alabama at Birmingham (UAB). Bruce Korf, MD, Chief Genomics Officer, UAB Medicine, says, “The All of Us research program is creating an unprecedented rich set of medical and biological data on one million participants who reflect the diversity of the United States. It will provide the foundation for the broadapplication
of precision medicine for years to come, including the development of
approaches to predict individuals at risk of disease and more precise
and effective treatments.”
The NIH program is headed by Eric Dishman, former vice president of the Health and Life Sciences Group at Intel Corporation, where he was responsible for driving global strategy, research and development, product and platform development, and policy initiatives for health and life science solutions. Dishman––and Collins, among others––spoke at the one-year anniversary conference held at NIH on May 6. He explained that All of Us works with a consortium of 2,000 organizations and people from local communities to convince individuals to provide three types of data:electronic health records , responses to survey questions, and physical measurements. The data are available on the All of Us website (https://databrowser.researchallofus.org/.),
where one can view, for example, the top 10 health conditions and then
drill down in each category to get breakdowns, such as the age of those
people affected and other measures.
Dishman was honest in his appraisal of the initial product. “Our tools are pretty crude,” he said. “Over time, the viewer experience will get better.” He noted that the early data can’t be sorted by ethnicity or race, which would seem like a pretty important goal considering that the project’s overarching objective is mining health statistics from the African American and Hispanic populations.
Gary Gibbons, MD, Director of the Heart, Lung and Blood Institute at NIH, posited the potential by explaining that further study of genomic variations among African Americans could help explain the root causes of sickle cell disease. He noted that individuals’ African roots may have caused variations in their hemoglobin genes via interaction with malaria vectors, and ultimately resulted in the sickle cell trait. An individual could have one genetic copy of that trait, or two, and that difference would have health implications. On one hand, the variations could have been protective, against malaria. On the other hand, that same sickle cell trait may predispose African Americans to chronic kidney disease, for which they are at higher risk.
Beyond sickle cell disease, Gibbons noted that genomic/environmental interaction could identify people who are at increased risk for heart disease, hypertension, coronary disease, and asthma. “We’re working toward a day when we can predict that you’ll have atrial fibrillation, which today may only become manifest when you come to an emergency room feeling dizzy and short of breath with a rapid heartbeat. But if we already know from your polygenic risk score that you are [susceptible to] atrial fibrillation, you may be wearing a watch that detects your heart rhythm, allowing us to detect the arrhythmia and provide an electric jolt to short-circuit it.”
Much of the promise of the All of Us initiative appears to rest on genomic exploration, and there are no genomic data available at present. Collins said that the data would be included in 2020 and that the program has a “bold timetable” for enrolling the 800,000 individuals who wouldcomplete the cohort of one million.
The program was kicked off one year ago in seven cities around the country, with a particular emphasis on convincing members of underrepresented and minority communities to come forward with their health data. The idea is eventually to be able to check genomic data against environmental experience with a view to finding clues on the origin of various health conditions, so as to better target prevention and treatment measures. So far, more than 206,000 people have begun the enrollment process, and more than 142,000 have completed all the steps in the protocol. Most participants (> 75%) are from communities that have been underrepresented in biomedical research. “Those people are often left behind,” said Francis Collins, Director of NIH. “We’re hoping to chip away at vexing health disparities.”
A number of universities around the country have received grants to pay for participant enlistment efforts, including the University of Alabama at Birmingham (UAB). Bruce Korf, MD, Chief Genomics Officer, UAB Medicine, says, “The All of Us research program is creating an unprecedented rich set of medical and biological data on one million participants who reflect the diversity of the United States. It will provide the foundation for the broad
The NIH program is headed by Eric Dishman, former vice president of the Health and Life Sciences Group at Intel Corporation, where he was responsible for driving global strategy, research and development, product and platform development, and policy initiatives for health and life science solutions. Dishman––and Collins, among others––spoke at the one-year anniversary conference held at NIH on May 6. He explained that All of Us works with a consortium of 2,000 organizations and people from local communities to convince individuals to provide three types of data:
Dishman was honest in his appraisal of the initial product. “Our tools are pretty crude,” he said. “Over time, the viewer experience will get better.” He noted that the early data can’t be sorted by ethnicity or race, which would seem like a pretty important goal considering that the project’s overarching objective is mining health statistics from the African American and Hispanic populations.
Gary Gibbons, MD, Director of the Heart, Lung and Blood Institute at NIH, posited the potential by explaining that further study of genomic variations among African Americans could help explain the root causes of sickle cell disease. He noted that individuals’ African roots may have caused variations in their hemoglobin genes via interaction with malaria vectors, and ultimately resulted in the sickle cell trait. An individual could have one genetic copy of that trait, or two, and that difference would have health implications. On one hand, the variations could have been protective, against malaria. On the other hand, that same sickle cell trait may predispose African Americans to chronic kidney disease, for which they are at higher risk.
Beyond sickle cell disease, Gibbons noted that genomic/environmental interaction could identify people who are at increased risk for heart disease, hypertension, coronary disease, and asthma. “We’re working toward a day when we can predict that you’ll have atrial fibrillation, which today may only become manifest when you come to an emergency room feeling dizzy and short of breath with a rapid heartbeat. But if we already know from your polygenic risk score that you are [susceptible to] atrial fibrillation, you may be wearing a watch that detects your heart rhythm, allowing us to detect the arrhythmia and provide an electric jolt to short-circuit it.”
Much of the promise of the All of Us initiative appears to rest on genomic exploration, and there are no genomic data available at present. Collins said that the data would be included in 2020 and that the program has a “bold timetable” for enrolling the 800,000 individuals who would
House Democrats Push Competing Drug Price Transparency Bills
P&T Journal - for the original article go HERE. For a PDF version go HERE.
May Provide Useful Data, But Not Downward Pressure on Prices
EPA Ditches Spray Requirement for Two Key Metal Fabrication Sectors
The Fabricator - for the original article go HERE.
Agency won’t mandate the use of high-efficiency spray equipment for coatings application. The Environmental Protection Agency’s (EPA) final rule on air contaminant limits for two metal manufacturing sectors involved in surface coating applications was notable for provisions the agency did not include.
The good news for those in the metal furniture and large-appliance manufacturing segments is that the agency, in the end, stepped back from some mandates it had been thinking of requiring. One mandated the use of high-efficiency application equipment for spray coatings. In its proposed rule, the EPA made a critical assumption that the four high-efficiency spray equipment technologies rulemaking (which covered high-volume, low-pressure; electrostaticapplication ;
airless; and air-assisted, airless spray equipment) would achieve at
least 65 percent transfer efficiency when used in painting metal
furniture and large appliances .
Those two fabricating sectors are under separate National Emission Standards for Hazardous Air Pollutants (NESHAP). The EPA is supposed to conduct a residual risk and technology review (RTR) every eight years after a NESHAP goes into effect. The idea is to see whether air contaminant limits in the NESHAP are still appropriate. But the agency said in the final RTR rule that new information led it to conclude that the transfer efficiency of the proposed high-efficiency spray application technologies may be less than 65 percent, as it is dependent on parameters such as part size, part shape, distance of the spray gun from the parts, atomizing air pressure, fluid pressure, painting technique, type of coating, viscosity of the coating, and other factors.
The EPA, after getting pushback from the American Coatings Association, admitted it did not have enough good data to make a new requirement stick. Besides that, the agency said a number of states already require high-efficiency spraying, and that companies already lean toward using it, required or not, because it reduces coatings consumption and lowers waste disposal costs.
As a result of this joint RTR, the EPA did not tighten air emission limits for either metal furniture or large-appliance manufacturers. However, the EPA did finalize a new requirement that companies in the two categories must submit electronic copies of certain required performance test reports through the agency’s Central Data Exchange website.
EPA also is requiring manufacturers to conduct control device performance testing in certain situations.
The good news for those in the metal furniture and large-appliance manufacturing segments is that the agency, in the end, stepped back from some mandates it had been thinking of requiring. One mandated the use of high-efficiency application equipment for spray coatings. In its proposed rule, the EPA made a critical assumption that the four high-efficiency spray equipment technologies rulemaking (which covered high-volume, low-pressure; electrostaticapplication ;
airless; and air-assisted, airless spray equipment) would achieve at
least 65 percent transfer efficiency when used in painting metal
furniture and large appliances .
Those two fabricating sectors are under separate National Emission Standards for Hazardous Air Pollutants (NESHAP). The EPA is supposed to conduct a residual risk and technology review (RTR) every eight years after a NESHAP goes into effect. The idea is to see whether air contaminant limits in the NESHAP are still appropriate. But the agency said in the final RTR rule that new information led it to conclude that the transfer efficiency of the proposed high-efficiency spray application technologies may be less than 65 percent, as it is dependent on parameters such as part size, part shape, distance of the spray gun from the parts, atomizing air pressure, fluid pressure, painting technique, type of coating, viscosity of the coating, and other factors.
The EPA, after getting pushback from the American Coatings Association, admitted it did not have enough good data to make a new requirement stick. Besides that, the agency said a number of states already require high-efficiency spraying, and that companies already lean toward using it, required or not, because it reduces coatings consumption and lowers waste disposal costs.
As a result of this joint RTR, the EPA did not tighten air emission limits for either metal furniture or large-appliance manufacturers. However, the EPA did finalize a new requirement that companies in the two categories must submit electronic copies of certain required performance test reports through the agency’s Central Data Exchange website.
EPA also is requiring manufacturers to conduct control device performance testing in certain situations.
Author bio:
Mr. Barlas, a freelance writer based in Washington, D.C., covers topics inside the Beltway.
Agency won’t mandate the use of high-efficiency spray equipment for coatings application. The Environmental Protection Agency’s (EPA) final rule on air contaminant limits for two metal manufacturing sectors involved in surface coating applications was notable for provisions the agency did not include.
The good news for those in the metal furniture and large-appliance manufacturing segments is that the agency, in the end, stepped back from some mandates it had been thinking of requiring. One mandated the use of high-efficiency application equipment for spray coatings. In its proposed rule, the EPA made a critical assumption that the four high-efficiency spray equipment technologies rulemaking (which covered high-volume, low-pressure; electrostatic
Those two fabricating sectors are under separate National Emission Standards for Hazardous Air Pollutants (NESHAP). The EPA is supposed to conduct a residual risk and technology review (RTR) every eight years after a NESHAP goes into effect. The idea is to see whether air contaminant limits in the NESHAP are still appropriate. But the agency said in the final RTR rule that new information led it to conclude that the transfer efficiency of the proposed high-efficiency spray application technologies may be less than 65 percent, as it is dependent on parameters such as part size, part shape, distance of the spray gun from the parts, atomizing air pressure, fluid pressure, painting technique, type of coating, viscosity of the coating, and other factors.
The EPA, after getting pushback from the American Coatings Association, admitted it did not have enough good data to make a new requirement stick. Besides that, the agency said a number of states already require high-efficiency spraying, and that companies already lean toward using it, required or not, because it reduces coatings consumption and lowers waste disposal costs.
As a result of this joint RTR, the EPA did not tighten air emission limits for either metal furniture or large-appliance manufacturers. However, the EPA did finalize a new requirement that companies in the two categories must submit electronic copies of certain required performance test reports through the agency’s Central Data Exchange website.
EPA also is requiring manufacturers to conduct control device performance testing in certain situations.
The good news for those in the metal furniture and large-appliance manufacturing segments is that the agency, in the end, stepped back from some mandates it had been thinking of requiring. One mandated the use of high-efficiency application equipment for spray coatings. In its proposed rule, the EPA made a critical assumption that the four high-efficiency spray equipment technologies rulemaking (which covered high-volume, low-pressure; electrostatic
Those two fabricating sectors are under separate National Emission Standards for Hazardous Air Pollutants (NESHAP). The EPA is supposed to conduct a residual risk and technology review (RTR) every eight years after a NESHAP goes into effect. The idea is to see whether air contaminant limits in the NESHAP are still appropriate. But the agency said in the final RTR rule that new information led it to conclude that the transfer efficiency of the proposed high-efficiency spray application technologies may be less than 65 percent, as it is dependent on parameters such as part size, part shape, distance of the spray gun from the parts, atomizing air pressure, fluid pressure, painting technique, type of coating, viscosity of the coating, and other factors.
The EPA, after getting pushback from the American Coatings Association, admitted it did not have enough good data to make a new requirement stick. Besides that, the agency said a number of states already require high-efficiency spraying, and that companies already lean toward using it, required or not, because it reduces coatings consumption and lowers waste disposal costs.
As a result of this joint RTR, the EPA did not tighten air emission limits for either metal furniture or large-appliance manufacturers. However, the EPA did finalize a new requirement that companies in the two categories must submit electronic copies of certain required performance test reports through the agency’s Central Data Exchange website.
EPA also is requiring manufacturers to conduct control device performance testing in certain situations.
Author bio:
Mr. Barlas, a freelance writer based in Washington, D.C., covers topics inside the Beltway.
Democratic Takeover of House Sparks Drug-Price Legislation Talks
P&T Journal - for the original article go HERE. For a PDF version go HERE.
But Strong Legislation Unlikely Given Patient and Industry Opposition
FERC Begins a Likely Skein of Mandatory Rate Cases
Pipeline & Gas Journal - for the original article go HERE.
FERC’s initiation of what amounts to a wholesale review of interstate pipeline rates threatens to shake up the industry and maybe its customers. The commission is in the early stages of reviewing the rates of about 130 pipeline and storage companies to see if they shouldlower their rates because of the 2017 tax cut enacted by Congress and a couple of other subsequent agency actions.
On Jan. 16, FERC announced the results of the first tranche of 12 reviews and initiated three Section 5 rate cases against two interstate pipelines and one storage company contending their current rates are “unjust and unreasonable.”
Extrapolating those early results means perhaps 30 companies could be subject to Section 5 rate cases, an unprecedented step. One industry observer who works with pipeline companies on rates, and asks not to be identified, says, “This has never happened before.”
He points out that it is possible that while FERC can force companies to lower rates, some companies, rather than subject themselves to a FERC-ordered Section 5 process, might instead voluntarily and peremptorily decide to file a Section 4 rate case.
That is exactly what Northern Natural Gas has done. It was one of the two big pipelines slapped with Section 5 cases in January. Northern disputed the FERC’s calculation of its return on equity (DOE) as affected by the 2018 tax cut and filed a motion Jan. 28 asking FERC to terminate the order subjecting Northern to a rate review or, in the alternative, to hold the proceeding in abeyance pending Northern’s filing of its FERC Form No. 2 in April 2019.
This is not the first time that the commission has pursued a Section 5 action against Northern based on erroneous support. “In 2009, FERC initiated a Section 5 against Northern that concluded with a request from customers to terminate the proceeding with no rate change,” said Mark Hewett, president and CEO of BHE Pipeline Group, which includes Northern. The company said from a purely financial perspective, the issuance of a Section 5 action is expected to produce positive results for Northern because the action will accelerate Northern’s filing of a Section 4 rate increase to allow Northern to recover the significant investment required to modernize its pipeline system. BHE is Berkshire Hathaway’s pipeline subsidiary, which also includes Kern River, which agreed to a settlement, based on the tax cut, of a customer-approved plan for an 11% rate credit, according to BHE.
Besides Northern Natural, FERC announced Section 5 cases against Bear Creek Storage Company and Panhandle Eastern Pipe Line Company, LP. FERC is basing its rates review on an analysis of the Form 501-Gs all companies have filed. Carl Fink, an outside attorney for Panhandle, declines to comment on FERC’s action against his client. Panhandle is a 6,009-mile natural gas pipeline that extends from sources of supply in the states of Texas, Kansas and Oklahoma, running through Missouri, Illinois, Indiana and Ohio to its northern termini in Michigan and at the International Boundary between the United States and Canada. Bear Creek is 50-50 jointly owned by Southern Natural Gas Company and Tennessee Gas Pipeline Company, both subsidiaries of Kinder Morgan. Kinder Morgan did not respond to requests for comment.
In each of these initial Section 5 cases, pipeline customers, whether local distribution companies or industrials such as U.S. Steel, are clamoring for FERC to reduce the company’s rates.
Northern is an about 14,700-mile natural gas pipeline that provides natural gas services to markets from Texas to Michigan’s Upper Peninsula. Northern reports that it has over 200 shippers.
In moving forward with a Section 5 rate case, FERC said based on its 501-G, Northern has a 17.3% return on equity (ROE). The commission added that based on that number it is “concerned that Northern’s current rates may be unjust and unreasonable.” If it moves forward, the investigation will look at Northern’s costs and revenues for most of 2018 and for part of 2019.
Northern argues no investigation is necessary, because FERC made mistakes in its ROE calculation. In its Jan. 28 motion, Northern stated its ROE is really 13.7%. “This result is very consistent with Northern’s calculated ROE for 2018 of 13.5%, and considerably below the erroneously calculated ROE of 17.3%,” Northern wrote.
The 12 companies identified on Jan 19 by FERC – the three Section 5 cases plus nine given a pass –account
for 12 of the pipelines in Group 1, which has 29 companies. Group 1
companies had the earliest deadline for filing 501-Gs. Group 2 has 30
companies and Group 3 has 66 companies. If three of the first 12
companies examined by FERC were found to have unreasonable rates, that
means 30 or more companies out of the 130 total could find themselves in
Section 5 territory before all is said and done.
Order No. 849 required all interstate natural gas companies, with cost-based stated rates, that filed a 2017 FERC Form No. 2, or 2-A, to file a FERC Form No. 501-G informational filing. Using the data in the pipelines’ 2017 FERC Form Nos. 2 and 2-A, the form estimates: (1) the percentage reduction in the pipeline’s cost of service resulting from the Tax Cuts and Jobs Act and the Revised Policy Statement, and (2) the pipeline’s current return on equity (ROE) before and after the reduction in corporateincome taxes and the elimination of income tax allowances for MLP pipelines.
Author bio:
Mr. Barlas, a freelance writer based in Washington, D.C., covers topics inside the Beltway.
FERC’s initiation of what amounts to a wholesale review of interstate pipeline rates threatens to shake up the industry and maybe its customers. The commission is in the early stages of reviewing the rates of about 130 pipeline and storage companies to see if they should
On Jan. 16, FERC announced the results of the first tranche of 12 reviews and initiated three Section 5 rate cases against two interstate pipelines and one storage company contending their current rates are “unjust and unreasonable.”
Extrapolating those early results means perhaps 30 companies could be subject to Section 5 rate cases, an unprecedented step. One industry observer who works with pipeline companies on rates, and asks not to be identified, says, “This has never happened before.”
He points out that it is possible that while FERC can force companies to lower rates, some companies, rather than subject themselves to a FERC-ordered Section 5 process, might instead voluntarily and peremptorily decide to file a Section 4 rate case.
That is exactly what Northern Natural Gas has done. It was one of the two big pipelines slapped with Section 5 cases in January. Northern disputed the FERC’s calculation of its return on equity (DOE) as affected by the 2018 tax cut and filed a motion Jan. 28 asking FERC to terminate the order subjecting Northern to a rate review or, in the alternative, to hold the proceeding in abeyance pending Northern’s filing of its FERC Form No. 2 in April 2019.
This is not the first time that the commission has pursued a Section 5 action against Northern based on erroneous support. “In 2009, FERC initiated a Section 5 against Northern that concluded with a request from customers to terminate the proceeding with no rate change,” said Mark Hewett, president and CEO of BHE Pipeline Group, which includes Northern. The company said from a purely financial perspective, the issuance of a Section 5 action is expected to produce positive results for Northern because the action will accelerate Northern’s filing of a Section 4 rate increase to allow Northern to recover the significant investment required to modernize its pipeline system. BHE is Berkshire Hathaway’s pipeline subsidiary, which also includes Kern River, which agreed to a settlement, based on the tax cut, of a customer-approved plan for an 11% rate credit, according to BHE.
Besides Northern Natural, FERC announced Section 5 cases against Bear Creek Storage Company and Panhandle Eastern Pipe Line Company, LP. FERC is basing its rates review on an analysis of the Form 501-Gs all companies have filed. Carl Fink, an outside attorney for Panhandle, declines to comment on FERC’s action against his client. Panhandle is a 6,009-mile natural gas pipeline that extends from sources of supply in the states of Texas, Kansas and Oklahoma, running through Missouri, Illinois, Indiana and Ohio to its northern termini in Michigan and at the International Boundary between the United States and Canada. Bear Creek is 50-50 jointly owned by Southern Natural Gas Company and Tennessee Gas Pipeline Company, both subsidiaries of Kinder Morgan. Kinder Morgan did not respond to requests for comment.
In each of these initial Section 5 cases, pipeline customers, whether local distribution companies or industrials such as U.S. Steel, are clamoring for FERC to reduce the company’s rates.
Northern is an about 14,700-mile natural gas pipeline that provides natural gas services to markets from Texas to Michigan’s Upper Peninsula. Northern reports that it has over 200 shippers.
In moving forward with a Section 5 rate case, FERC said based on its 501-G, Northern has a 17.3% return on equity (ROE). The commission added that based on that number it is “concerned that Northern’s current rates may be unjust and unreasonable.” If it moves forward, the investigation will look at Northern’s costs and revenues for most of 2018 and for part of 2019.
Northern argues no investigation is necessary, because FERC made mistakes in its ROE calculation. In its Jan. 28 motion, Northern stated its ROE is really 13.7%. “This result is very consistent with Northern’s calculated ROE for 2018 of 13.5%, and considerably below the erroneously calculated ROE of 17.3%,” Northern wrote.
The 12 companies identified on Jan 19 by FERC – the three Section 5 cases plus nine given a pass –
Order No. 849 required all interstate natural gas companies, with cost-based stated rates, that filed a 2017 FERC Form No. 2, or 2-A, to file a FERC Form No. 501-G informational filing. Using the data in the pipelines’ 2017 FERC Form Nos. 2 and 2-A, the form estimates: (1) the percentage reduction in the pipeline’s cost of service resulting from the Tax Cuts and Jobs Act and the Revised Policy Statement, and (2) the pipeline’s current return on equity (ROE) before and after the reduction in corporate
Author bio:
Mr. Barlas, a freelance writer based in Washington, D.C., covers topics inside the Beltway.
Views Conflict on Trump’s Drug-Pricing Blueprint
P&T Journal - for the original article go HERE. For a PDF version go HERE.
Most Actions Face Political, Legal, and Technical Roadblocks
Battle
lines have been drawn and heavy political armaments have been moved to
the front line as drug-industry partisans fight to protect the parts of
their turf endangered by the policy advances proposed in President
Donald Trump’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.1
Its aggressive concepts, such as forcing the posting of drug list
prices, ending rebate payments to pharmacy benefit managers (PBMs),
introducing formulary management to Part B of Medicare, and changing
formulary requirements for Part D, have been the equivalent of a trumpet
rallying call to manufacturers, PBMs, health insurers, pharmacy
professionals, and patient groups, who are often on the opposite sides
of any anticipated initiative.
The wide-ranging Blueprint includes 136 questions or possibilities of changes that cover Medicare most heavily, but also affect Medicaid and private plans. The spotlight on the president’s suggestions burns a bit more brightly after Pfizer, Novartis, and Merck claimed national headlines this summer for postponing plans to raise drug prices in the third quarter of 2017 with the intention of giving the Trump administration time to finalize details and actions stemming from the Blueprint.
Some in the pharmaceutical distribution chain have even proposed doing Trump one better. Fanning the flames of the controversy surrounding high list prices, Express Scripts, the giant PBM, thinks drug companies should “reintroduce their products as competing brand drugs, with new/different NDCs [national drug codes], that would allow the market to move to lower list price products.” A spokeswoman for Pharmaceutical Research and Manufacturers of America (PhRMA), the drug manufacturers trade group, declined to comment on that proposal, which goes beyond anything in the Blueprint.
P&T committees could take on both added responsibilities and added burdens as a result of any Trump administration initiatives, particularly with regard to Medicare. The Trump administration wants to allow PBMs to negotiate prices for some or all Part B drugs. Those are pharmaceuticals infused or injected in either a physician’s office or an outpatient clinic. Currently, Medicare pays the list price for those drugs and patients pay for them subject to a Part B deductible of $250. These are often expensive oncology drugs, which, if they were paid for under Part D, as the administration wants, would be subject to formulary management by P&T committees at Part D plans or their PBMs. There is no guarantee, however, that patients would pay less for oncology, hepatitis C, and other expensive drugs under Part D. They could conceivably (in some instances) pay more.
Part D is also under the microscope as far as its formulary and P&T committee policies are concerned. The American Medical Association (AMA) thinks that disclosure of P&T committee information for Part D Medicare plans would constitute “a critical step forward.” There are a few rules today governing P&T committee membership, but very few if any requiring significant “transparency.” An AMA spokesman did not respond to a query asking what kinds of disclosures the group has in mind.
The fact that drug companies are sitting on the edge of their seats waiting for the administration to put a plan in place doesn’t mean a plan will evolve quickly. It clearly won’t. Health and Human Services (HHS) Secretary Alex Azur told the Senate Health, Education, Labor, and Pensions (HELP) Committee on June 26, six weeks after the Blueprint was released, that, for example, he believes his department, through the Food and Drug Administration, has the authority to force drug companies to disclose list prices in television advertisements. But he added that he would welcome legislation to “shore up” that authority because manufacturers will “certainly challenge” any new requirement in court. He went on to say that he would also welcome legislation eliminating the 100% cap on drug rebates imposed under the Patient Protection and Affordable Care Act, “which would create a significant disincentive for drug companies to raise list prices.”
Congress is unlikely to jump at those requests. Senator Dick Durbin (D–Illinois), the second-ranking Democrat in the Senate, introduced the Drug-Price Transparency in Communications Act (S. 2157) in November of 2017.2 No Republican has cosponsored it and no hearings have been held. In March of 2017, Senator Ron Wyden (D–Oregon) introduced the Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 (S. 637), which would require the HHS to publish rebates PBMs obtained from drug manufacturers under Part D and the Marketplace Exchange insurance program.3 Again, no action taken, no Republican co-sponsors obtained. Neither the House Energy and Commerce Committee nor the Ways and Means Committee, the two committees with jurisdiction over health care, have held hearings on drug prices, much less the Blueprint.
Taylor Haulsee, spokesman for the Senate HELP Committee, did not respond to an inquiry asking whether the committee had plans to take up the Durbin and Wyden bills or to develop its own drug-pricing legislation. If the Republican president expects help from the Republican Congress to smooth the way for some of his more controversial policy proposals, he may be waiting a long time. That said, there is no question that the Trump administration has already moved perceptibly in some minor areas on drug pricing. But the Blueprint raises the stakes for drug companies, pharmacy benefit managers, insurance companies, health professionals, and consumers. Here are some of the more flammable, high-profile possibilities:
The premise of the Trump administration’s attempt to rein in drug prices is that those prices are out of control. As a general premise, that probably is inaccurate. The American Hospital Association (AHA) cites figures from National Health Expenditures data showing that retail drug spending increased by 1.3% in 2016. But the AHA argues that while that level of growth may appear low, it follows two consecutive years of expansive growth in retail drug spending: 12.4% in 2014 and 8.9% in 2015.4
What are particularly worrisome are launch prices for new brand-name drugs. The AHA cited:4
High drug prices can also be untenable in some instances for hospitals, where drug prices are bundled into diagnosis-related group (DRG) reimbursement. In 2016, the AHA and the Federation of American Hospitals worked with NORC at the University of Chicago (a nonprofit research institute) to document hospital and health system experience with inpatient drug spending. Specifically, NORC found that, while retail spending on prescription drugs increased by 10.6% between 2013 and 2015, hospital spending on drugs in the inpatient space rose 38.7% per admission during the same period.5 In its comments to the HHS, the AHA stated: “These price increases, from the hospitals’ perspective, appeared to be random, inconsistent and unpredictable: large unit price increases occurred for both low- and high-volume drugs and for both branded and generic drugs.”
There are some who argue that seemingly unreasonably high drug prices themselves are not the problem. Jonah Houts, Vice President for Corporate Government Affairs at Express Scripts and the author of the company’s comments, suggested that lowering drug prices as an absolute goal might not even be the smartest thing to do. “The central flaw with focusing on incentivizing lower drug prices is that this concept necessarily assumes clinical efficacy of all drugs are equal across all classes and disease indications,” he wrote. “Incentivizing payments for lower-priced drugs comes at the expense of discouraging considerations of clinical effectiveness or other factors such as likelihood for adherence, then even the ‘cheapest’ drug ends up costing Medicare significantly by failing to potentially treat the patient’s condition according [to] their needs. Of course, such failures may eventually lead to more costly medical interventions in the future, or worse—patient harm.”
Certainly there is a good argument to be made for value-based drug pricing, which is in its infancy and has had trouble getting out of the crib because of, if one listens to the manufacturers, impediments ensconced in federal law such as the Anti-Kickback statute and the rules for reporting the Medicaid Best Price. That said, value-based drug pricing doesn’t help some patients, especially less well-heeled ones, who may have high deductibles and out-of-pocket costs. The fact that, in the long run, they may avoid the costs and terrible effects of a chronic disease such as hepatitis C may be hard to appreciate if they go bankrupt in the short term.
The HHS raises the possibility of “indication-based” pricing, in which consumer and payer costs are linked to the effectiveness of a drug’s indication. Joint comments submitted by a large number of patient advocacy organizations across many disease states said, “This is highly concerning for patients for a number of reasons. Patients using the medications in higher-priced indications would be discriminated against through higher cost-sharing and could have impeded access as a result.”
Those higher out-of-pocket costs are often linked to the “list prices” posted by the drug companies. The health insurers use those prices to determine coinsurance and deductible amounts. But the insurer doesn’t pay the list price because it, or its PBM, negotiates discounts and rebates, which don’t find their way to the pharmacy counter when the consumer reaches for his or her wallet. Patient out-of-pocket costs under Medicare Part D are distributed unevenly each year, such that patients face 100% coinsurance until they reach their deductible ($405 in 2018), up to 25% coinsurance until the patient reaches the initial coverage limit ($3,750 in 2018), 35% coinsurance in the coverage gap until the patient reaches the out-of-pocket threshold ($5,000 in 2018), and finally up to 5% coinsurance above that threshold. “For example, in 2015, beneficiaries without low-income subsidies who had spending above the catastrophic threshold (over 1,000,000 individuals) spent on average $5,200.92,” Bristol-Myers Squibb said in its comments. “These high out-of-pocket costs present affordability challenges that jeopardize patient adherence to needed medicines, which could in turn increase costs to the broader health care system.”
According to PhRMA, more than half of all new brand-name osteoporosis prescriptions, more than 40% of all new brand-name autoimmune and oral antidiabetic prescriptions, and more than 30% of all new brand-name antipsychotic prescriptions brought to a pharmacy in 2016 had cost sharing greater than $250. “Not surprisingly, many of these prescriptions went unfilled,” the group stated.
Two Part D reforms included in the president’s fiscal year 2019 budget proposal would provide much-needed financial relief for beneficiaries facing high cost-sharing and high annual out-of-pocket costs:
Although the list price/rebate relationship is frequently cited as the main cause of high consumer drug prices, AHIP argues that rebates are not prevalent, including for the most expensive drugs. A report by the consultant Milliman found that nearly 90% of Part D drug claims were for drugs with no rebates. The Milliman report also found that, when measured on an individual drug basis (i.e., not a script count basis), approximately 70% of brand-name drugs did not have significant rebates. Further, physician-administered drugs paid for under Part B, which account for 30% of prescription drug spending, typically do not receive rebates.6
Insurance companies and their PBMs argue that with regard to the Part D program, the best way to cut costs would be to allow P&T committees more leeway in formulary development. That could entail decreasing from two to one the number of drugs that formularies have to offer in each class and category and doing away with the “all or almost all” language that forces Part D plans to offer all drugs in six categories, the so-called “protected” classes: immunosuppressants, antidepressants, anti-psychotics, anticonvulsants, antiretrovirals, and antineoplastics.
CVS believes Part D plans’ P&T committees are well qualified and structured to ensure that beneficiaries have an appropriate choice of drugs in these six classes on the plan’s formulary. Another reason CVS feels the six protected classes ought to be eliminated is that plans cannot impose any type of utilization management edits on the use of the drugs, even if these are based on clinical criteria. This is because Part D plans may only apply prior authorizations and transition fill limitations to beneficiaries who are considered new starters to these drugs. When beneficiaries are new to the plan, however, the plan frequently does not have enough claims history (at least 108 days) to determine whether the drug is considered new as opposed to ongoing therapy. In this case, the plan is required to assume that the drug is ongoing therapy and to provide it without the opportunity to recommend more cost-effective or clinically superior therapies.
While P&T committees are limited in certain respects, in terms of what they can do in Part D, they do not even have a role in Part B, which pays for physician-administered drugs, often expensive oncology medications. Part B drugs are provided “incident to” physician services and include some antigens, injectable osteoporosis drugs, erythropoiesis-stimulating drugs, blood-clotting factors, oral end-stage renal disease drugs, cancer medications, parenteral and enteral nutrition, nebulizers, immunosuppressive agents, intravenous immune globulin, and vaccines. Part D drugs are infused either in a physician’s office or a hospital outpatient clinic.
HHS Secretary Azar noted at a June 12, 2018, Senate HELP hearing that cost-savings are the key rationale for moving drugs from Part B to Part D, saying that “right now, we’re paying sticker price for these drugs, no discounting. We ought to be able to get 20 to 40% discounting, as we do in Part D, on those drugs. That’s $30 billion of spend.” The Blueprint, however, doesn’t specify which drugs might be switched to Part D, and what would happen if a Medicare recipient did not have a Part D plan.
For a variety of reasons, however, there are some categories of drugs now paid for under Part B that might have a smoother path than others into Part D, including insulin, antiemetics, inhalants, immunosuppressants, and oral anticancer medications, according to the Pharmaceutical Care Management Association, which represents PBMs and like seemingly every interest group—including PhRMA, which is totally opposed to the switch—has concerns about a Part B-to-D move.
A potential Part B-to-D shift for drugs brings up another potential Trump administration move likely to affect hospital outpatient clinics, where many Part B drugs are infused. The HHS is considering a site-neutral payment policy to account for differences in reimbursement between the outpatient prospective payment system and the physician fee schedule for drug administration services. In short, hospital outpatient reimbursement for Part B would be reduced.
The AHA opposes a site-neutral payment policy for drug administration services under Medicare Part B. Hospitals with newer off-campus hospital outpatient departments are already subject to significant payment reductions for the “nonexcepted” services they furnish in these settings.
The Blueprint has a host of other suggestions related to the uptake of biosimilars, risk evaluation and mitigation strategies (which have been cited as reasons to deny generic-drug companies samples of brand-name drugs), 340B, Medicaid, and so-called “gag clauses” imposed on pharmacists and other programs. For Medicaid, the Blueprint suggests a new demonstration authority for up to five states to test drug coverage and financing reforms that build on private-sector best practices. This would open the door to “closed formularies” developed by P&T committees, now absent from state Medicaid drug programs. But there is opposition to that limited initiative, as there is to everything the Blueprint considers, from one corner of the industry or another. As to formularies in Medicaid, GlaxoSmithKline says, “We strongly oppose any proposals that ration access to prescription drugs in Medicaid through a closed formulary.”
One thing stands out from reading through some of the 3,000 comments on the Blueprint. They all start out pledging fealty to the Trump administration’s efforts to lower drug prices. Then they all degenerate into opposition to most of the Blueprint’s suggestions. Normally that reaction—and it is broad and deep—would be enough to sink any significant reforms. Of course, President Trump has been known to remain impervious to any cloud of negativity surrounding him—witness trade tariffs or immigration, for instance. Will drug pricing be the next arena in which he upends conventional thinking?
Author bio:
Mr. Barlas, a freelance writer based in Washington, D.C., covers topics inside the Beltway.
Most Actions Face Political, Legal, and Technical Roadblocks
The wide-ranging Blueprint includes 136 questions or possibilities of changes that cover Medicare most heavily, but also affect Medicaid and private plans. The spotlight on the president’s suggestions burns a bit more brightly after Pfizer, Novartis, and Merck claimed national headlines this summer for postponing plans to raise drug prices in the third quarter of 2017 with the intention of giving the Trump administration time to finalize details and actions stemming from the Blueprint.
Some in the pharmaceutical distribution chain have even proposed doing Trump one better. Fanning the flames of the controversy surrounding high list prices, Express Scripts, the giant PBM, thinks drug companies should “reintroduce their products as competing brand drugs, with new/different NDCs [national drug codes], that would allow the market to move to lower list price products.” A spokeswoman for Pharmaceutical Research and Manufacturers of America (PhRMA), the drug manufacturers trade group, declined to comment on that proposal, which goes beyond anything in the Blueprint.
P&T committees could take on both added responsibilities and added burdens as a result of any Trump administration initiatives, particularly with regard to Medicare. The Trump administration wants to allow PBMs to negotiate prices for some or all Part B drugs. Those are pharmaceuticals infused or injected in either a physician’s office or an outpatient clinic. Currently, Medicare pays the list price for those drugs and patients pay for them subject to a Part B deductible of $250. These are often expensive oncology drugs, which, if they were paid for under Part D, as the administration wants, would be subject to formulary management by P&T committees at Part D plans or their PBMs. There is no guarantee, however, that patients would pay less for oncology, hepatitis C, and other expensive drugs under Part D. They could conceivably (in some instances) pay more.
Part D is also under the microscope as far as its formulary and P&T committee policies are concerned. The American Medical Association (AMA) thinks that disclosure of P&T committee information for Part D Medicare plans would constitute “a critical step forward.” There are a few rules today governing P&T committee membership, but very few if any requiring significant “transparency.” An AMA spokesman did not respond to a query asking what kinds of disclosures the group has in mind.
Backing From Congress Unlikely
The fact that drug companies are sitting on the edge of their seats waiting for the administration to put a plan in place doesn’t mean a plan will evolve quickly. It clearly won’t. Health and Human Services (HHS) Secretary Alex Azur told the Senate Health, Education, Labor, and Pensions (HELP) Committee on June 26, six weeks after the Blueprint was released, that, for example, he believes his department, through the Food and Drug Administration, has the authority to force drug companies to disclose list prices in television advertisements. But he added that he would welcome legislation to “shore up” that authority because manufacturers will “certainly challenge” any new requirement in court. He went on to say that he would also welcome legislation eliminating the 100% cap on drug rebates imposed under the Patient Protection and Affordable Care Act, “which would create a significant disincentive for drug companies to raise list prices.”
Congress is unlikely to jump at those requests. Senator Dick Durbin (D–Illinois), the second-ranking Democrat in the Senate, introduced the Drug-Price Transparency in Communications Act (S. 2157) in November of 2017.2 No Republican has cosponsored it and no hearings have been held. In March of 2017, Senator Ron Wyden (D–Oregon) introduced the Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 (S. 637), which would require the HHS to publish rebates PBMs obtained from drug manufacturers under Part D and the Marketplace Exchange insurance program.3 Again, no action taken, no Republican co-sponsors obtained. Neither the House Energy and Commerce Committee nor the Ways and Means Committee, the two committees with jurisdiction over health care, have held hearings on drug prices, much less the Blueprint.
Taylor Haulsee, spokesman for the Senate HELP Committee, did not respond to an inquiry asking whether the committee had plans to take up the Durbin and Wyden bills or to develop its own drug-pricing legislation. If the Republican president expects help from the Republican Congress to smooth the way for some of his more controversial policy proposals, he may be waiting a long time. That said, there is no question that the Trump administration has already moved perceptibly in some minor areas on drug pricing. But the Blueprint raises the stakes for drug companies, pharmacy benefit managers, insurance companies, health professionals, and consumers. Here are some of the more flammable, high-profile possibilities:
- requiring drug manufacturers to include list prices in drug ads
- putting a ceiling on out-of-pocket payments by Part D participants
- reducing from two to one the number of drugs offered in the six Part D protected classes
- allowing state Medicaid programs to use formularies and P&T committees
- moving drugs now paid under Part B to Part D and subjecting them to utilization review
- reimbursing for drugs based on their indication
- charging higher prices for a drug when it is used off-label
How Out of Whack Are Drug Prices?
The premise of the Trump administration’s attempt to rein in drug prices is that those prices are out of control. As a general premise, that probably is inaccurate. The American Hospital Association (AHA) cites figures from National Health Expenditures data showing that retail drug spending increased by 1.3% in 2016. But the AHA argues that while that level of growth may appear low, it follows two consecutive years of expansive growth in retail drug spending: 12.4% in 2014 and 8.9% in 2015.4
What are particularly worrisome are launch prices for new brand-name drugs. The AHA cited:4
- Taltz (Eli Lilly), used for treating psoriasis, costs $50,000 a year.
- Keytruda (Merck), used for treating melanoma, costs $152,400 a year.
- Kymriah (Novartis), used for treating leukemia, costs $475,000 for a course of treatment.
- Spinraza (Biogen), used to treat spinal muscular atrophy, costs $750,000 for the first year of treatment and $375,000 per year thereafter.
High drug prices can also be untenable in some instances for hospitals, where drug prices are bundled into diagnosis-related group (DRG) reimbursement. In 2016, the AHA and the Federation of American Hospitals worked with NORC at the University of Chicago (a nonprofit research institute) to document hospital and health system experience with inpatient drug spending. Specifically, NORC found that, while retail spending on prescription drugs increased by 10.6% between 2013 and 2015, hospital spending on drugs in the inpatient space rose 38.7% per admission during the same period.5 In its comments to the HHS, the AHA stated: “These price increases, from the hospitals’ perspective, appeared to be random, inconsistent and unpredictable: large unit price increases occurred for both low- and high-volume drugs and for both branded and generic drugs.”
Is Value Pricing the Answer?
There are some who argue that seemingly unreasonably high drug prices themselves are not the problem. Jonah Houts, Vice President for Corporate Government Affairs at Express Scripts and the author of the company’s comments, suggested that lowering drug prices as an absolute goal might not even be the smartest thing to do. “The central flaw with focusing on incentivizing lower drug prices is that this concept necessarily assumes clinical efficacy of all drugs are equal across all classes and disease indications,” he wrote. “Incentivizing payments for lower-priced drugs comes at the expense of discouraging considerations of clinical effectiveness or other factors such as likelihood for adherence, then even the ‘cheapest’ drug ends up costing Medicare significantly by failing to potentially treat the patient’s condition according [to] their needs. Of course, such failures may eventually lead to more costly medical interventions in the future, or worse—patient harm.”
Certainly there is a good argument to be made for value-based drug pricing, which is in its infancy and has had trouble getting out of the crib because of, if one listens to the manufacturers, impediments ensconced in federal law such as the Anti-Kickback statute and the rules for reporting the Medicaid Best Price. That said, value-based drug pricing doesn’t help some patients, especially less well-heeled ones, who may have high deductibles and out-of-pocket costs. The fact that, in the long run, they may avoid the costs and terrible effects of a chronic disease such as hepatitis C may be hard to appreciate if they go bankrupt in the short term.
The HHS raises the possibility of “indication-based” pricing, in which consumer and payer costs are linked to the effectiveness of a drug’s indication. Joint comments submitted by a large number of patient advocacy organizations across many disease states said, “This is highly concerning for patients for a number of reasons. Patients using the medications in higher-priced indications would be discriminated against through higher cost-sharing and could have impeded access as a result.”
High List Prices and Their Link to Cost-Sharing
Those higher out-of-pocket costs are often linked to the “list prices” posted by the drug companies. The health insurers use those prices to determine coinsurance and deductible amounts. But the insurer doesn’t pay the list price because it, or its PBM, negotiates discounts and rebates, which don’t find their way to the pharmacy counter when the consumer reaches for his or her wallet. Patient out-of-pocket costs under Medicare Part D are distributed unevenly each year, such that patients face 100% coinsurance until they reach their deductible ($405 in 2018), up to 25% coinsurance until the patient reaches the initial coverage limit ($3,750 in 2018), 35% coinsurance in the coverage gap until the patient reaches the out-of-pocket threshold ($5,000 in 2018), and finally up to 5% coinsurance above that threshold. “For example, in 2015, beneficiaries without low-income subsidies who had spending above the catastrophic threshold (over 1,000,000 individuals) spent on average $5,200.92,” Bristol-Myers Squibb said in its comments. “These high out-of-pocket costs present affordability challenges that jeopardize patient adherence to needed medicines, which could in turn increase costs to the broader health care system.”
According to PhRMA, more than half of all new brand-name osteoporosis prescriptions, more than 40% of all new brand-name autoimmune and oral antidiabetic prescriptions, and more than 30% of all new brand-name antipsychotic prescriptions brought to a pharmacy in 2016 had cost sharing greater than $250. “Not surprisingly, many of these prescriptions went unfilled,” the group stated.
Two Part D reforms included in the president’s fiscal year 2019 budget proposal would provide much-needed financial relief for beneficiaries facing high cost-sharing and high annual out-of-pocket costs:
- Requiring plan sponsors to pass through a substantial share of negotiated rebates at the point of sale would immediately lower out-of-pocket costs for millions of beneficiaries.
- Establishing a maximum annual limit on beneficiary out-of-pocket spending would provide a true catastrophic benefit to protect the sickest patients.
The drug manufacturers have been pushing hard behind the proposal to
force PBMs to fork over rebates at the pharmacy counter, a proposal the
Trump administration appears to favor indirectly in the form of
replacing rebates with a fixed price discounting model for PBMs. Big
pharma believes rebates are bad, high list prices are not so bad. What
they object to is the health insurers basing coinsurance and deductibles
on those list prices. Manufacturers believe the health plans should pay
all or a portion of all rebates off those list prices to the consumers
who pick up that drug at the pharmacy counter instead of using the
rebates to lower premiums for all members of a plan. Their argument
appears to be that all plan members ought to suffer a little for high list prices rather than just those with expensive chronic conditions, who are suffering a lot.
Although the list price/rebate relationship is frequently cited as the main cause of high consumer drug prices, AHIP argues that rebates are not prevalent, including for the most expensive drugs. A report by the consultant Milliman found that nearly 90% of Part D drug claims were for drugs with no rebates. The Milliman report also found that, when measured on an individual drug basis (i.e., not a script count basis), approximately 70% of brand-name drugs did not have significant rebates. Further, physician-administered drugs paid for under Part B, which account for 30% of prescription drug spending, typically do not receive rebates.6
Power to the P&T Committee?
Insurance companies and their PBMs argue that with regard to the Part D program, the best way to cut costs would be to allow P&T committees more leeway in formulary development. That could entail decreasing from two to one the number of drugs that formularies have to offer in each class and category and doing away with the “all or almost all” language that forces Part D plans to offer all drugs in six categories, the so-called “protected” classes: immunosuppressants, antidepressants, anti-psychotics, anticonvulsants, antiretrovirals, and antineoplastics.
CVS believes Part D plans’ P&T committees are well qualified and structured to ensure that beneficiaries have an appropriate choice of drugs in these six classes on the plan’s formulary. Another reason CVS feels the six protected classes ought to be eliminated is that plans cannot impose any type of utilization management edits on the use of the drugs, even if these are based on clinical criteria. This is because Part D plans may only apply prior authorizations and transition fill limitations to beneficiaries who are considered new starters to these drugs. When beneficiaries are new to the plan, however, the plan frequently does not have enough claims history (at least 108 days) to determine whether the drug is considered new as opposed to ongoing therapy. In this case, the plan is required to assume that the drug is ongoing therapy and to provide it without the opportunity to recommend more cost-effective or clinically superior therapies.
Part B
While P&T committees are limited in certain respects, in terms of what they can do in Part D, they do not even have a role in Part B, which pays for physician-administered drugs, often expensive oncology medications. Part B drugs are provided “incident to” physician services and include some antigens, injectable osteoporosis drugs, erythropoiesis-stimulating drugs, blood-clotting factors, oral end-stage renal disease drugs, cancer medications, parenteral and enteral nutrition, nebulizers, immunosuppressive agents, intravenous immune globulin, and vaccines. Part D drugs are infused either in a physician’s office or a hospital outpatient clinic.
HHS Secretary Azar noted at a June 12, 2018, Senate HELP hearing that cost-savings are the key rationale for moving drugs from Part B to Part D, saying that “right now, we’re paying sticker price for these drugs, no discounting. We ought to be able to get 20 to 40% discounting, as we do in Part D, on those drugs. That’s $30 billion of spend.” The Blueprint, however, doesn’t specify which drugs might be switched to Part D, and what would happen if a Medicare recipient did not have a Part D plan.
For a variety of reasons, however, there are some categories of drugs now paid for under Part B that might have a smoother path than others into Part D, including insulin, antiemetics, inhalants, immunosuppressants, and oral anticancer medications, according to the Pharmaceutical Care Management Association, which represents PBMs and like seemingly every interest group—including PhRMA, which is totally opposed to the switch—has concerns about a Part B-to-D move.
Site Neutrality
A potential Part B-to-D shift for drugs brings up another potential Trump administration move likely to affect hospital outpatient clinics, where many Part B drugs are infused. The HHS is considering a site-neutral payment policy to account for differences in reimbursement between the outpatient prospective payment system and the physician fee schedule for drug administration services. In short, hospital outpatient reimbursement for Part B would be reduced.
The AHA opposes a site-neutral payment policy for drug administration services under Medicare Part B. Hospitals with newer off-campus hospital outpatient departments are already subject to significant payment reductions for the “nonexcepted” services they furnish in these settings.
The Blueprint has a host of other suggestions related to the uptake of biosimilars, risk evaluation and mitigation strategies (which have been cited as reasons to deny generic-drug companies samples of brand-name drugs), 340B, Medicaid, and so-called “gag clauses” imposed on pharmacists and other programs. For Medicaid, the Blueprint suggests a new demonstration authority for up to five states to test drug coverage and financing reforms that build on private-sector best practices. This would open the door to “closed formularies” developed by P&T committees, now absent from state Medicaid drug programs. But there is opposition to that limited initiative, as there is to everything the Blueprint considers, from one corner of the industry or another. As to formularies in Medicaid, GlaxoSmithKline says, “We strongly oppose any proposals that ration access to prescription drugs in Medicaid through a closed formulary.”
One thing stands out from reading through some of the 3,000 comments on the Blueprint. They all start out pledging fealty to the Trump administration’s efforts to lower drug prices. Then they all degenerate into opposition to most of the Blueprint’s suggestions. Normally that reaction—and it is broad and deep—would be enough to sink any significant reforms. Of course, President Trump has been known to remain impervious to any cloud of negativity surrounding him—witness trade tariffs or immigration, for instance. Will drug pricing be the next arena in which he upends conventional thinking?
Author bio:
Mr. Barlas, a freelance writer based in Washington, D.C., covers topics inside the Beltway.
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