Lawmakers Blast Pharma For ‘Outrageous’ Prices And ‘Anticompetitive Conduct’ In Culmination Of 3-Year Probe

Lawmakers blast pharma for 'outrageous' prices and 'anticompetitive conduct'  in culmination of 3-year probe | FiercePharmaSource: Fierce Healthcare, by Fraiser Kansteiner

For years, drugmakers have targeted “weaknesses” in the U.S. healthcare system to reap dividends on older meds, The House Oversight Committee said Friday.

The “outrageous prices” and “anticompetitive conduct” that dictate the market make a strong case for the passing of President Joe Biden’s Build Back Better Act, which would allow Medicare to petition for lower prices on certain drugs like insulin, committee chairwoman Rep. Carolyn Maloney (D-NY) argued.

The findings mark the culmination of an almost three-year probe into the industry’s pricing strategies, launched by the late Rep. Elijah Cummings in 2019. The report cites more than 1.5 million pages of internal company documents that shed light on “the decision-making of many of the world’s most profitable drug companies,” the Oversight Committee said. The investigation specifically focused on 12 drugs from companies such as Sanofi, Eli Lilly, Pfizer and Novo Nordisk.

“Drug companies have raised prices relentlessly for decades while manipulating the patent system and other laws to delay competition from lower-priced generics,” Rep. Maloney said in a statement.

Looking at just seven of the dozen drugs in the probe—Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica—the committee’s analysis found that U.S. taxpayers could have saved more than $25 billion over a five-year stretch if private Medicare Part D plans had the same negotiating power as their foreign counterparts.

Meanwhile, pharma companies “abuse” the U.S. patent system and FDA market exclusivity to stifle competition, the Oversight Committee said. Its investigation turned up more than 600 patents on the 12 drugs examined.

The committee also chided the industry on its use of patient-assistance programs. Drugmakers often see these programs as potent public relations tools to boost sales, especially for drugs heading toward a patent cliff, the committee said. Internal documents suggest companies’ spending on these programs is eclipsed by the “enormous” amount of revenue the associated drugs bring in.

“These programs often do not provide sustainable support for patients and do not address the burden that the company’s pricing practices have placed on the U.S. health care system,” the committee said.

The report also homed in on insulin titans Eli Lilly, Novo Nordisk and Sanofi. The triumvirate controls some 90% of the insulin market in the U.S., Reuters points out. Medicare could have saved more than $16.7 billion between 2011 and 2017 on purchases of the insulin products Humalog, Lantus and NovoLog, had it been able to angle for discounts.

Meanwhile, despite the Build Back Better Act’s promise to curb pricey prescription drug costs, Evercore ISI analysts recently branded the Medicare framework “negotiation in name only.” The plan will empower Medicare to hash out costs on just 10 of the country’s most-expensive medicines starting in 2025, with more drugs to be added gradually down the line.

Senate Passes Bill To Delay Nearly 10% In Medicare Cuts Expected To Start In January

House passes bill that delays 6% in Medicare cuts, postpones radiation  oncology model | FierceHealthcareSource: Fierce Healthcare, by Robert King

The Senate passed legislation late Thursday that delays nearly 10% in Medicare cuts set to take effect next year, giving providers a major boost.

The Senate passed the bill by 59 to 35 on Thursday, sending the legislation to President Biden after a successful House vote earlier this week. The bill included a provision to raise the debt ceiling via a simple majority vote.

The legislation would delay a 2% cut to Medicare payments that was created under sequestration but has been put on hold over the past two years due to the pandemic.

Congress decided to delay the 2% cut until April, when it will install a 1% cut to payments until June.

Lawmakers also delayed a 4% cut to Medicare reimbursements triggered by the Pay-As-You-Go law, which installs cuts to government programs if spending reaches a certain threshold. The PAYGO cuts were delayed until 2023.

The bill also trims a 3.75% cut expected to hit physicians as part of the Physician Fee Schedule. But the legislation reduces that percentage to 0.75% instead.

With the vote on the legislation, expected to be signed by President Biden, provider groups are turning towards a more permanent solution to the issue.

The Medical Group Management Association said Thursday that Congress needs to refocus policies that “penalize physician practices and the millions of beneficiaries they treat,” Anders Gilberg, senior vice president of government affairs for MGMA, said in a statement.

The American Medical Association also called for the need to avoid such 11th-hour efforts by Congress.

“There is no need to wait for the last minute to start working on the systemic problems,” AMA President Gerald Harmon said in a statement. “These automatic cuts should remind members of the needed reforms. Congress can get a head start on doing the right thing when it reconvenes early next year.”

Medicare Urged To Flex Its Power And Slash Back Premium Hike

How to Choose the Right Medicare Plan for You

Source: Modern Healthcare, by Associated Press

The head of a Senate panel that oversees Medicare says the Biden administration should use its legal authority to cut back a hefty premium increase soon hitting millions of enrollees, as a growing number of Democratic lawmakers call for action amid worries over rising inflation.

Last month, Medicare announced one of the largest increases ever in its “Part B” monthly premium for outpatient care, nearly $22, from $148.50 currently to $170.10 starting in January.

The agency attributed roughly half the hike, about $11 a month, to the need for a contingency fund to cover Aduhelm, a new $56,000 Alzheimer’s drug from Biogen whose benefits have been widely questioned. For most Medicare enrollees, the premium is deducted from their Social Security checks. Without further action, it  would swallow up a significant chunk of seniors’ 5.9% cost of living increase.

“Rather than assessing the current $21.60 per month … premium increase in full, I urge you to reduce the amount,” Senate Finance Chairman Ron Wyden, D-Ore., wrote health secretary Xavier Becerra. “Taking this type of approach would reduce near-term expenses for seniors on fixed incomes.” A copy of the letter was provided to The Associated Press on Monday.

There was no immediate response from the administration.

But Wyden wrote Becerra that as secretary of Health and Human Services, he has “broad authority” to determine the “appropriate contingency margin” to use in setting premiums.

Given that Medicare is still developing its formal policy for covering Aduhelm, Wyden said there is a clear rationale for collecting less up front at this particular time.

“It is possible that any near-term Medicare coverage for Aduhelm … could have a limited and narrow scope,” he wrote. “Uncertainty” over the drug’s financial impact on Medicare appeared to be driving much of the calculation of the new premium, Wyden noted.

Soon after Medicare announced the increase last month, Vermont Independent Sen. Bernie Sanders called on the administration to roll it back. Wyden also said he had concerns and was exploring options. And last week Democratic Senators Maggie Hassan of New Hampshire, Jacky Rosen of Nevada, Chris Van Hollen of Maryland, Mark Kelly of Arizona, and Jack Reed of Rhode Island wrote President Joe Biden that “we must address this issue as quickly as possible.”

Some groups representing older people are anticipating a backlash from Medicare recipients if nothing is done.

“Once the Part B premium for 2022 starts getting deducted from their Social Security benefits, I think Congress is really going to be in for it,” said analyst Mary Johnson of the nonpartisan Senior Citizens League, which advocates to preserve benefits for retirees.

The Labor Department reported Friday that consumer prices jumped 6.8% over the past year, ;the biggest inflation increase in nearly four decades. Prices for basic necessities from food, to energy costs, to housing were at the root. Inflation worries are adding to the political uncertainty for Democrats heading into the 2022 midterm elections.

Biden’s social agenda legislation would take significant action to lower drug costs for Medicare recipients. But even if the bill is approved, Medicare would have to wait years to negotiate over the price of new drugs like Aduhelm. Other provisions that would reduce costs more immediately don’t take effect for a couple of years. The Medicare premium increase would hit first.

Older people “feel that younger working families have received most of the benefits of recent legislation and would continue to do so under the Build Back Better Act,” said Johnson, the advocacy group analyst.

Usually the financial impact of high-cost drugs falls most directly on patients with serious diseases such as cancer, rheumatoid arthritis or multiple sclerosis. But with Aduhelm, the financial pain would be spread among Medicare recipients generally, not just Alzheimer’s patients needing the drug.

The issue has turned into a case study of how one pricey medication can swing the needle on government spending and impact household budgets. People who don’t have Alzheimer’s would not be shielded from the cost of Aduhelm, since it’s big enough to affect their premiums.

Alzheimer’s is a progressive neurological disease with no known cure, affecting about 6 million Americans, the vast majority old enough to qualify for Medicare.

Aduhelm is the first Alzheimer’s medication in nearly 20 years. It doesn’t cure the life-sapping condition, but the Food and Drug Administration determined that its ability to reduce clumps of plaque in the brain is likely to slow dementia. However, many experts say that benefit has not been clearly demonstrated.

Medicare is currently covering Aduhelm on a case-by-case basis, pending a formal evaluation that could take months.

Pharmaceutical company Biogen says it priced Aduhelm fairly after taking into account payments for other innovative drugs aimed at hard-to-treat diseases.

Looming Medicare Cuts are Unsustainable and Threaten Access to Care

Providers slam House for not delaying nearly 10% Medicare payment cuts in  must-pass spending deal | FierceHealthcare

Source: California Medical Association

The California Medical Association (CMA) and the California Hospital Association (CHA) today sent a joint letter to the California Congressional Delegation, urging immediate action to eliminate or delay the Medicare payment cuts that are scheduled to go into effect on January 1, 2022.

“California’s hospitals and physicians continue to provide critical health services to their patients and communities during this pandemic, all while facing their greatest financial crisis,” the letter said.

To ensure they can continue to provide essential care and emerge from the pandemic equipped to tackle tomorrow’s challenges, CMA and CHA are urging California’s members of  Congress to support legislation that would both extend the moratorium on the 2% Medicare sequestration cuts and prevent the Pay-As-You-Go (PAYGO) sequestration — which would further reduce Medicare payments by 4% — from taking effect at the end of the year. We also urge your support for stopping the additional 3.75% Medicare physician cut.

These three cuts would result in as much as a 10% payment cut to our nation’s hospitals and physicians — specifically, $1.1 billion in cuts to California’s hospitals and roughly $85 million in cuts to California’s physicians. This represents a significant and devastating financial burden during an extraordinary public health crisis and threatens access to care for all Californians.

California’s doctors and hospitals continue to incur significant COVID-19-related expenses that have not been adequately covered by the Provider Relief Funds distributed to date.

While we are grateful for the federal relief funds that have been made available to hospitals and physicians so far, our greatest public health and financial challenges lie ahead. These three Medicare cuts are simply unsustainable.

Medicare Telehealth Visits Increased 63-Fold From 2019 To 2020, New Government Data Shows

HHS: Telehealth use in Medicare increased 63-fold last year with behavioral  health increasing the most | FierceHealthcareSource: Healthcare Dive, by Rebecca Pifer

Dive Brief:

  • * New government data puts in stark relief how dramatically telehealth use exploded last year, with the share of Medicare visits conducted virtually skyrocketing from just 840,000 in 2019 to 52.7 million in 2020.
  • * That’s a nearly 63-fold increase. Specialists like behavioral health providers saw the highest telehealth use relative to their peers, according to the report from HHS’ Office of the Assistant Secretary for Planning and Evaluation.
  • * Other interesting findings include that telehealth services were accessed more in urban areas than rural ones, and Black Medicare beneficiaries were less likely than White beneficiaries to use virtual care.

Dive Insight:

Telehealth was a valuable tool in ensuring access to care last year as COVID-19 swamped the U.S. medical system. As a result of consumer demand and laxer restrictions on virtual care from Washington, telehealth visits for Medicare beneficiaries went from hundreds of thousands pre-pandemic to tens of millions in 2020, with many beneficiaries using virtual care for the first time.

But it’s still unclear how many COVID-era flexibilities Washington will continue after the national health emergency expires, how much payers will decide to reimburse for the service and how much patient demand will remain once fears of in-office virus transmission are less acute.

CMS Administrator Chiquita Brooks-LaSure said her agency planned to use the insights from the ASPE report to inform future Medicare telehealth policies.

During the pandemic, CMS has temporarily waived a slew of previous limitations on telehealth, including geographic restrictions and letting Medicare beneficiaries receive telehealth in their home. Outside of the COVID-19 public health emergency declared early last year, Medicare only paid for virtual services in select (mostly rural) areas and mostly required beneficiaries to receive telehealth in medical facilities.

Regulators have already enshrined some of the flexibilities. CMS recently announced that Medicare will permanently pay for mental health visits furnished by rural health clinics and other health centers via telehealth. The agency is also eliminating geographic barriers and allowing patients to receive care in their homes for the diagnosis, evaluation and treatment of mental health disorders.

Other virtual services added to the Medicare reimbursement list temporarily during the public health emergency will remain in place through the end of 2023, giving CMS more time to evaluate whether they should be permanently allowed.

Mental healthcare has emerged as a key clinical area for telehealth services. Experts expect that demand to continue, even after the pandemic wanes, due to a lack of mental and behavioral healthcare providers across the U.S., especially in rural areas, and the high cost of such treatment.

While overall healthcare visits for Medicare beneficiaries declined in 2020 as compared to 2019, telehealth was particularly helpful in ensuring access to behavioral healthcare during the pandemic, the ASPE report found.

In 2020, telehealth visits made up a third of total Medicare visits to behavioral health specialists, compared to 8% of visits to primary care providers and 3% of visits to other specialists, researchers said.

Hospitals Eye Spending Bill to Stop Cuts

Medicare Expansion Clashes With Health Care for the Poor as Budget Bill  Shrinks - The New York TimesSource: Bloomberg Government, by Brandon Lee

Hospital groups are asking lawmakers to prevent billions of dollars in Medicare pay reductions next year as part of a government funding bill that’s on Congress’s agenda for this week.

The Coalition to Protect America’s Health Care, which represents hospital groups, announced yesterday it will launch a television ad campaign in Washington, D.C., urging Congress to stop the cuts.

Some of those same hospital lobbies, such as the American Hospital Association and the Federation of American Hospitals, sent a letter to congressional leaders asking for action before the end of the year and warning that hospitals already face increasing supply costs due to the Covid-19 pandemic.

“Additional Medicare reductions to providers are not sustainable and put our members’ ability to care for their patients at risk,” the groups warned in their letter.

One hospital lobbyist said the groups are pushing for action this week to stop cuts set to take effect at the end of the year. Congress must pass legislation to fund the government by Dec. 3 or the government will partially shut down. Leaders are considering a measure that would run to mid-to-late January.

Medicare fee-for-service payments could be reduced by $14.1 billion in 2022 unless there’s action by the end of the year, according to the AHA, because of mandatory spending sequestration under the Budget Control Act and statutory pay-as-you-go (PAYGO) requirements — two mechanisms meant to limit federal spending.

Hospitals are asking Democratic and Republican leaders to agree to waive PAYGO, something Congress has done to prevent across-the-board cuts to federal programs triggered when lawmakers pass bills that add to government spending without some kind of offset.

They’re also asking lawmakers to postpone sequestration — automatic cuts to federal spending meant to help with the deficit — to the end of the federal public health emergency around Covid-19, which is set to expire in mid-January but is likely to be extended further into 2022. Read more from Alex Ruoff.

Premiums, Deductibles And Copays Will Be Higher—Medicare Changes For 2022

Source: MarketWatch, by Kate Ashford

Open enrollment for Medicare goes from Oct. 15 to Dec. 7 each year, when Medicare beneficiaries choose their coverage for the next plan year. As Medicare enrollees contemplate their choices for 2022, here are overall Medicare changes to keep in mind.

Original Medicare costs are going up

Original Medicare includes Part A and Part B. A separate Medicare drug plan, called Part D, is also available. Here’s how deductibles, premiums and coinsurances are changing in 2022:

Medicare Part A (hospital insurance)

Although most Medicare beneficiaries don’t pay a premium for Medicare Part A, those who do will see higher costs, paying $499 a month in 2022, up from $471 a month in 2021. This premium applies to you if you worked and paid Medicare taxes for less than 30 quarters. If you worked and paid Medicare taxes for 30 to 39 quarters, you’ll pay $274 a month for Part A in 2022, up from $259 in 2021. If you paid Medicare taxes for 40 quarters or more, you won’t owe a premium.

The Part A inpatient hospital deductible is increasing to $1,556 in 2022 for each benefit period, up from $1,484 in 2021. Coinsurance is also rising as follows:

  • * Hospitalization days 1 to 60: Members pay $0 coinsurance for each benefit period.
  • * Hospitalization days 61 to 90: Members pay $389 coinsurance per day for each benefit period, up from $371 in 2021.
  • * Hospitalization days 91 and up: Members pay $778 coinsurance per every “lifetime reserve day” after day 90 for each benefit period, up from $742 in 2021. Members get up to 60 lifetime reserve days over the span of their life.

Coinsurance for skilled nursing facility care will remain at $0 for days 1 to 20 for each benefit period, and will be $194.50 per day for days 21 to 100 of each benefit period in 2022, up from $185.50 per day in 2021.

Medicare Part B (medical insurance)

All Medicare members pay a Part B premium, and that is increasing to $170.10 per month in 2022, up from $148.50 in 2021. You may pay a higher premium, depending on your income. For example, those who file taxes individually with a modified adjusted gross income of more than $91,000 (or those who file joint tax returns with a modified adjusted gross income of more than $182,000) will pay an additional $68 to $408.20 per month on top of the Medicare Part B premium.

The Part B deductible is increasing to $233 in 2022, up from $203 in 2021. Once you meet your deductible, you generally will pay 20% of Medicare-approved costs for Part B services.

Medicare Part D (prescription drug coverage)

The average Medicare Part D premium in 2022 will be $33 per month, versus $31.47 in 2021. Those with higher incomes will pay more: Those who file taxes individually with a modified adjusted gross income of more than $91,000 (or those who file joint tax returns with a modified adjusted gross income of more than $182,000) will pay an additional $12.40 to $77.90 per month on top of their Part D premium.

Medicare Advantage plan ratings are higher

Medicare Advantage is a bundled alternative to Original Medicare that includes all the coverages of Medicare Part A, Part B and usually Part D. Medicare Advantage plans, also called Medicare Part C, often include additional benefits, such as some cost help with dental, vision and hearing care, fitness memberships, over-the-counter allowances and meal delivery.

Each year, the Centers for Medicare & Medicaid Services assigns every Medicare Advantage plan a star rating, ranking each plan from best (5 stars) to worst (1 star). These ratings are based on plans’ quality of care and measurements of customer satisfaction, and those ratings can change each year.

In 2022, the average star rating for Medicare Advantage Prescription Drug plans is 4.37, compared to 4.06 in 2021. In fact, 68% of Medicare Advantage plans that include prescription drug coverage have received an overall rating of 4 stars or higher for 2022, compared to 49% in 2021, according to the CMS.

Medicare Advantage premiums are lower

The average premium in 2022 for Medicare Advantage plans will be $19 per month, versus $21.22 in 2021. (Note: Medicare Advantage members are still responsible for the Medicare Part B monthly premium, which is $170.10 in 2022.)

More people are projected to enroll in Medicare Advantage in 2022 as well: The CMS estimates 29.5 million people will sign up, compared to 26.9 million in 2021.

There are 3,834 Medicare Advantage plans available in 2022, up 8% from 2021. Of the 2022 plans, 59% are health maintenance organization, or HMO, plans, and 37% are preferred provider organization, or PPO, plans.

Making plan changes

Changes you make during Medicare open enrollment will take effect on Jan. 1. During this open enrollment period from Oct. 15 to Dec. 7, you can switch from Original Medicare to Medicare Advantage, or vice versa, or switch from one Medicare Advantage plan to another one.

If you discover that you’ve erred in your plan choice after the enrollment period ends, there’s a Medicare Advantage open enrollment period from Jan. 1 to March 31. During this time, you can do the following:

  • * Switch Medicare Advantage plans.
  • * Return to an Original Medicare plan, with the option to join a Part D prescription drug plan.

During Medicare Advantage open enrollment, you can’t switch to a Medicare Advantage plan if you’re enrolled in Original Medicare. Additionally, if you return to Original Medicare, you might not be able to buy a Medigap policy. Your coverage will begin on the first day of the month after you request a plan change.

CDC Expands Eligibility For Covid-19 Booster Shots To All Adults

Moderna and Pfizer boosters approved by FDASource: STAT, by Helen Branswell

An expert committee that advises the Centers for Disease Control and Prevention on vaccines voted 11-to-0 on Friday to recommend Covid-19 booster shot eligibility be thrown open to all adults 18 and older.

The Advisory Committee on Immunization Practices also recommended, by the same vote, that the CDC lower the age for adults who should be urged to get a booster, changing it from age 65 and older to age 50. These changes pertain to the messenger RNA vaccines made by Pfizer and Moderna; people who received these vaccines can get a booster shot six months or more after receiving their second dose of vaccine. People who received the one-dose Johnson & Johnson vaccine have already been cleared to receive a booster shot two months after their original jab.

CDC Director Rochelle Walensky quickly signed-off on the changes, which will vastly simplify delivery of Covid boosters.

“Booster shots have demonstrated the ability to safely increase people’s protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays,” Walensky said in a statement. “Based on the compelling evidence, all adults over 18 should now have equitable access to a Covid-19 booster dose.”

Until now, eligibility for the Moderna and Pfizer booster shots has been determined by a complex formula involving a variety of age cutoffs as well as health conditions and exposure risks. For some of the people who are eligible, the recommendations have been more strenuous, suggesting they “should” be boosted. For others, the recommendation has been what’s termed as permissive — that designated people “may” get boosted if they wish.

The new recommendations state that people between the ages of 18 and 49 who have no risk factors may get a booster if they wish. All other people should get a booster. From now on health personnel administering booster doses will need to ask two simple questions of people who received one of the mRNA vaccines as their primary Covid series: Are you 18 or older? and Has it been six months or longer since you received your second shot?

The ACIP meeting started just hours after the FDA broadened the eligibility criteria spelled out in the emergency use authorizations for the Pfizer and Moderna boosters. The meeting was called on such short notice — it was announced Tuesday — that only 13 of the committee’s members were able to attend. When the meeting went longer than scheduled, two members had to leave without voting.

Friday’s proceeding brings to full fruition the Biden administration’s goal of offering all vaccinated adults booster shots. The policy, announced in mid-August, initially drew ire from some in the scientific community. Not everyone believed the evidence supported a need to boost all people who had been vaccinated, especially at a time when many low-income countries have yet to secure first doses for most of their citizens. Also, the decisions on boosters before the FDA, the CDC, and their respective advisory committees raised questions about the administration’s commitment to “follow the science.”

At a September meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the expert panel indicated it felt Pfizer boosters should be offered to a narrower band of people. The FDA defined that as those 65 and older, people 18 to 64 with health conditions that raise their risk of severe Covid infection, and people 18 to 64 whose jobs or living conditions put them at increased risk of contracting Covid. Later the same criteria were applied to the Moderna booster shot.

Initially that latter group — those at risk because of where they lived or worked — was described as people such as health care workers, teachers, prison guards and prisoners, as well as people who work and stay in homeless shelters. More recently, though, more than a dozen states, including Massachusetts, California, and Colorado, decided not to wait for the FDA and CDC to broaden eligibility criteria. They declared that because of high local transmission rates, everyone 18 and older meets the threshold for a booster.

The recommendations have been difficult to operationalize, ACIP members were told on Friday. The CDC presented polling data that showed that significant portions of the population didn’t know if they were eligible for a booster or not. Some ACIP members noted that the long list of health conditions that made people under the age of 65 eligible for a booster was not something doctors would know off the top of their heads. The guidelines, “though well intentioned and thoughtful, generate an obstacle to uptake of boosters,” Nirav Shah, president of the Association of State and Territorial Health Officials, told the committee as he made a plea for simpler booster guidance.

States “are strongly in support of expanding, clarifying and simplifying the eligibility guidance in the manner that’s been discussed and proposed,” said Shah, who is director of Maine’s Center for Disease Control and Prevention and a non-voting representative to the ACIP. “There was not a single state that voiced opposition to this move.”

Biden Admin Finalizes Rule That Requires Insurers To Submit Data On Drug Costs, Rebates

Explaining the Prescription Drug Provisions in the Build Back Better Act |  KFF

Source: Fierce Healthcare, by Paige Minemyer

The Biden administration has issued an interim final rule that requires private insurers to report prescription drug costs to the federal government.

The interim rule, which also includes a request for comment, is the latest in a series of regulations implementing provisions of the No Surprises Act and the Consolidated Appropriations Act of 2021. Insurers providing employer-sponsored coverage, other group plans or individual plans must submit key data on drug costs to the departments of Health and Human Services (HHS), Labor and Treasury.

The data will then be used by HHS’ Assistant Secretary for Planning and Evaluation to publish a report on drug pricing trends and rebates along with their impact on insurance premiums and consumers’ out-of-pocket costs, according to an announcement from the Centers for Medicare & Medicaid Services (CMS).

Data submission must start with information from the 2020 calendar year, but the agencies will defer enforcement until Dec. 27, 2022, to allow insurers to come into compliance.

Data from 2020 and 2021 will be due on that date, CMS said, though insurers can submit them sooner. The agency said it expects to release its first report in June 2023 and then biennially.

“Life-saving prescription drugs should not cost anyone their life savings,” said HHS Secretary Xavier Becerra in a statement. “Today the Biden-Harris Administration is taking additional steps to make health care more accessible and affordable for patients.”

“By collecting key data on the costs of prescription drugs, we are promoting competition and transparency in the health care industry as we continue to curb the rising costs of drugs and surprise medical bills,” Becerra said.

fact sheet on the rule lays out more specifics on the required data. Each year, insurers will be asked to provide information such as the 50 most frequently dispensed brand drugs, the 50 costliest drugs based on total spending and the 50 drugs with the largest increase in plan or coverage expenditures year over year.

Insurers will also be required to submit data on rebates, fees and other remuneration paid by drug companies to the plan in each therapeutic class, as well as the 25 products that yielded the highest amount of rebates. They must also include information on the impact rebates have on premiums and out-of-pocket costs, according to the fact sheet.

“With today’s rule, we’re taking more steps to make sure that the care people receive is affordable,” said CMS Administrator Chiquita Brooks-LaSure in a statement. “Expanding on our earlier efforts to implement the No Surprises Act, we will monitor pricing and premium trends to better identify barriers to the low-cost, comprehensive, and person-centered care we all deserve.”

Comments on the interim final rule are due Jan. 24, 2022.

Here Are The Policies And Reforms That Could Reshape Healthcare In The $2T Bill Just Passed By The House

Biden Details $2 Trillion Plan to Rebuild Infrastructure and Reshape the  Economy - The New York Times

Source: Fierce Healthcare, by Robert King

The House passed a massive, roughly $2 trillion infrastructure package that will give Medicare the power to narrowly negotiate prices on certain prescription drugs and close the Medicaid coverage gap.

The package, called the Build Back Better Act, advanced out of the House late Thursday by a vote of 220 to 213. It now heads to the Senate, where it could face further changes.

Here are the biggest healthcare items included in the package:

  • * Closing the Medicaid coverage gap. The legislation would give enhanced subsidies so eligible residents in states that did not expand Medicaid under the Affordable Care Act can buy coverage on the exchanges. The enhanced subsidies, which would apply to residents in the 12 nonexpansion states, only run through 2025 but would apply coverage to more than 2 million people, according to data from the Kaiser Family Foundation.
  • * Offering several reforms to drug prices. A contentious part of negotiations around the Build Back Better Act was how to lower drug prices. After objections from centrists in the House and Senate, the final package would select a small amount of drugs in Medicare Part B and D that enable Medicare to negotiate lower prices. The legislation would also create a $2,000 annual cap on out-of-pocket costs for seniors in Part D and prevent drugmakers from rising prices above the cost of inflation. It would also cap costs for insulin at $25.
  • * Expanding Medicare benefits to cover hearing aids. Democrats initially hoped to expand traditional Medicare benefits to cover dental, vision and hearing benefits. However, the cost of the package was originally proposed at $3.5 trillion and pared down to $1.75 trillion after concerns from centrists. Now, the package would cover hearing benefits.
  • * Expanding Medicare-supported physician graduate medical education (GME) slots. The legislation gives a major boost toward Medicare-supported GME, expanding the number of slots for physician training by 4,000. The boost adds on to a 1,000-slot increase in a spending bill passed late last year. Advocates say the boost can help avoid a looming shortage of physicians. The legislation would also require some of the slots to go to physicians that can care for rural or underserved areas.

Passage of the legislation earned plaudits from some provider groups, but others were worried about the inclusion of cuts to disproportionate share hospital (DSH) payments that help facilities cover uncompensated care.

The cuts only apply to hospitals in states that have not expanded Medicaid. The thinking behind the cuts is that higher DSH payments won’t be needed because of the expansion of coverage.

Hospital groups, however, blasted the cuts as short-sighted.

“These cuts are unacceptable, especially while hospitals remain on the front lines of fighting COVID-19 and the deadly Delta variant,” said Rick Pollack, president and CEO of the American Hospital Association, in a statement.

Last Updated 01/19/2022

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