This Week: Congress and the administration focus on the opioid addiction epidemic... Override of the president’s veto of legislation that would have repealed the Affordable Care Act fails, to no one’s surprise... Senate committee continues to work on “Cures” legislation... and HHS announces 12.7 million people signed up for 2016 health plans.
House of Representatives
- House Republicans Fail to Override Veto of Obamacare Repeal Bill But Replacing Affordable Care Act Remains Top of GOP Agenda
- Oversight Investigation Finds Turing and Valeant Purchased Drugs to Increase Profit
- Energy and Commerce Committee Grills CMS on Medicare’s Biosimilar Reimbursement Policy
- House Energy and Commerce Committee Seeks Input on Site-Neutral Payment Issue
- Ways and Means Chair Kevin Brady Not Interested in Curbing Drug Prices
- Senate Judiciary Committee Delays Opioid Legislation Markup
- Sen. Murray Introduces Legislation to Improve Medical Device Safety
- Senate HELP Committee Chairman Alexander May Introduce NIH Funding Language Before Cures Markup
- CDC Releases Elder Abuse Surveillance Recommendations
- Obama Administration Proposes New Funding to Address Opioid Epidemic
- Obama Budget Will Propose Changes to Cadillac Tax
- CMS Creates Rural Health Council
- CMS Indicates One-sided ACOs Will Not Be Included in Alternative Pay Models
- FDA Announces Opioid Action Plan
- Eli Lilly, Anthem Push Policy Solutions to Increase Innovation in Drug Pricing
- SAMHSA Releases Proposed Changes to Mental Health Data-Sharing Rule
- State Activities
- Arkansas: Gov. Hutchinson Talks Extension of Medicaid Expansion
- California: California Pays Insurers Millions for Hepatitis C Drugs
- Idaho: Idaho Senate Committee Hears Medicaid Expansion Plan
- Kentucky: 10 Health Systems Creating a Statewide Collaborative
- Louisiana: Gov. Edwards Pulls Medicaid Expansion Hiring Plan
- Minnesota: Uncertain Future for Minnesota’s Health Exchange
- Regulations Open for Comment
- Food and Drug Administration (FDA) Issues Final Rule to Phase Out Trans Fats
- CMS Soliciting Comments on Episode Groups as Required by MACRA
- FDA Seeks Comments on Whether It Should Define “Natural” and If So, How?
- HHS Posts Guidance for State Innovation Waivers
- CMS Issues Proposed Rule Expanding Access to Medicare Claims Data
- CMS and ONC Release RFI on Requirements for the Reporting of Quality Measures
- IOM Committee Supports Research of Mitochondrial Replacement Techniques
- Families USA Study Finds Uninsured Rate for Workers Fell Significantly in Medicaid Expansion States
House of Representatives
House Republicans Fail to Override Veto of Obamacare Repeal Bill But Replacing Affordable Care Act Remains Top of GOP Agenda
On Feb. 2, House Republicans failed to override President Barack Obama’s veto of their bill repealing major pieces of the Affordable Care Act. The repeal legislation is viewed by Republicans members of Congress as a blueprint for unraveling the law should a Republican become president. The House voted 241-186, falling short of the two-thirds majority needed to override a veto. Three Republicans voted in support of President Obama’s veto.
House Speaker Paul Ryan (R-WI) has promised that House Republicans will present an Obamacare alternative in 2016 — GOP leadership has made the same promise but failed to deliver during the six years since the law passed. Congress approved the Obamacare repeal measure through reconciliation in January, and it was the first major repeal bill to arrive at the president’s desk for a veto.
Rep. Pat Tiberi (R-OH), chairman of the Ways and Means Committee Subcommittee on Health, has said that delivering a replacement plan outlined by Speaker Paul Ryan at the recent GOP retreat is his first priority. He hopes the House will pass the plan before the Republican Convention in July.
Oversight Investigation Finds Turing and Valeant Purchased Drugs to Increase Profit
On Feb. 2, House Oversight Committee ranking member Elijah Cummings (D-MD) sent a memo to committee members regarding their investigation into Turing Pharmaceuticals. The committee obtained more than 250,000 pages of company documents and found that Turing and former CEO Martin Shkreli were explicit about their plans to purchase a life-saving drug for the purpose of increasing the price dramatically to make profits.
The review of documents found that Turing executives underestimated the backlash in response to raising the price of the off-patent drug Daraprim by 5,000 percent — from $13.50 to $750 per tablet. One email reveals how the company expected almost all of its earnings from the price increase to be saved as profit. “We raised the price from $1,700 per bottle to $75,000... So 5,000 paying bottles at the new price is $375,000,000 — almost all of it is profit,” Shkreli wrote.
Internal documents show that Turing officials never intended to decrease the price of Daraprim as Shkreli publicly promised following the widespread objections to the price increase. Turing executives counted on Shkreli — due to his experience hiking drug prices while at Retrophin — to successfully raise Daraprim’s price without creating significant pushback from patients and payers.
Cummings also released a memo on his investigation into Valeant Pharmaceuticals Feb. 2. The Oversight Committee, in reviewing more than 75,000 pages of documents, found Valeant purchased two heart drugs — Isuprel and Nitropress — in order to dramatically increase their prices (by 525 percent and 212 percent, respectively).
According to Cummings’ investigation, Valeant Pharmaceuticals used patient assistance programs to justify raising prices of older drugs while increasing its revenues by driving patients into closed distribution systems. Valeant CEO Michael Pearson used this pricing strategy with more than just these two drugs — from 2014 to 2015, Valeant increased the prices of more than 20 other drugs by over 200 percent. The company identified revenue goals first, then set drug prices to reach these goals.
The committee’s findings come as Valeant is facing a federal probe regarding its pricing and distribution practices.
While the Oversight Committee’s investigation focuses on these two companies, Cummings said the results “show that these tactics are not limited to a few bad apples but are prominent in the industry.”
The committee held a hearing with Turing executives testifying on Feb. 4. For more information on the hearing, click here.
Energy and Commerce Committee Grills CMS on Medicare’s Biosimilar Reimbursement Policy
On Feb. 4, the House Energy and Commerce Subcommittee on Health held a hearing entitled “Examining Implementation of the Biologics Price Competition and Innovation Act.” Lawmakers grilled CMS Deputy Administrator Sean Cavanaugh about the Medicare reimbursement policy, opposed by members of both parties, designed to drive down the prices of biosimilars. Under the policy, reimbursement will be determined by combining the average price of biosimilars that copy the same brand-name biologics. Members raised concerns that the unique qualities of the biosimilars were not properly considered by CMS, and that unique price calculations for individual biosimilars are key to ensuring competitive reimbursement. Chairman Emeritus Joe Barton (R-TX) asked Cavanaugh if the agency has plans to revisit how these drugs are priced — Cavanaugh noted that CMS will monitor the market closely and there is a possibility of rulemaking in the future.
The U.S. Food and Drug Administration (FDA) drug center Director Janet Woodcock also testified at the hearing. She warned that FDA might not be able to keep up with biosimilar applications as they become more frequent due to lack of previous congressional assistance — only one application has been approved so far. She also noted, however, that FDA is beginning to collect a modest amount of user fees from biosimilar makers — $6 million in 2013, $13 million in 2014 and $23 million in 2015.
For more information or to view the hearing, click here.
House Energy and Commerce Committee Seeks Input on Site-Neutral Payment Issue
The House Energy and Commerce Committee said they are staking their jurisdictional claim over a hospital payment issue that has been a priority for the Ways and Means Committee. Chairman Fred Upton and health subcommittee leader Joe Pitts today sent a letter to health care groups asking for input on policy changes related to site-neutral payments, after last year’s budget deal included a cut to Medicare payments for services provided in hospital outpatient departments.
Hospital groups have been lobbying Hill aides for a “fix” to the provision, arguing that outpatient departments that were under construction at the time the budget deal was enacted should be exempt from the future cuts.
Ways and Means Committee Chairman Kevin Brady has committed to examining a fix this year, and Rep. Pat Tiberi, who chairs that panel’s health subcommittee, said he is also working on a fix.
Upton and Pitts write in their letter that their committee has received a great deal of feedback on the provision since it was enacted. They ask for additional comments by Feb. 19.
To see the press release, click here.
Ways and Means Chair Kevin Brady Not Interested in Curbing Drug Prices
On Feb. 1, House Ways and Means Chair Kevin Brady (R-TX) said he isn’t interested in legislation to curb drug prices. He noted that the committee is convinced that competition and choice drive affordable drug prices, but that it will help create more competition by speeding up drugs approvals, as the House did in its 21st Century Cures bill. House Republicans met on Feb. 4 to discuss their alternative to the Affordable Care Act (ACA). The timeline and substance of the legislation have yet to be determined.
Senate Judiciary Committee Delays Opioid Legislation Markup
Senate Judiciary Committee postponed a markup on the Comprehensive Addiction and Recovery Act, the first major piece of legislation to address the growing opioid epidemic. The legislation would direct the administration to issue grants to states and organizations for opioid educational, preventive and treatment programs.
The Senate Judiciary Committee rescheduled the markup to Feb. 11. Committee aides cited jurisdictional and policy differences that needed to be settled as the cause of the delay. The bill is backed by numerous Republicans and Democrats in the Senate, but the White House may be more hesitant.
The Obama administration announced its own $1.1 billion proposal to combat the opioid epidemic, which focuses mainly on medication-assisted treatment programs and expanding access to care.
Sen. Murray Introduces Legislation to Improve Medical Device Safety
On Feb. 4, the Senate Health, Education, Labor, and Pensions (HELP) Committee ranking member Patty Murray (D-WA) introduced legislation, the Preventing Superbugs and Protecting Patients Act, to give additional tools to review and ensure the safety of medical devices. This legislation follows a probe into an outbreak of antibiotic-resistant infections caused by duodenoscope devices used to treat conditions of the pancreas. Murray’s legislation:
- Gives FDA authority to deny a 510(k) submission (required in order to sell certain devices) based on whether the manufacturer’s cleaning instructions work in real-life conditions and whether the manufacturer can give clear data showing the device can be cleaned between each use.
- Requires the FDA to update its guidance to clarify when manufacturers are required to get clearance from FDA to market modified devices.
To see Sen. Murray’s press release, click here.
Senate HELP Committee Chairman Alexander May Introduce NIH Funding Language Before Cures Markup
The Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) may introduce draft language on mandatory funding for the National Institutes of Health (NIH) before a March 9 markup of the Senate counterpart to the House-passed 21st Century Cures legislation. The NIH Innovation Fund would not be an actual bill, but Alexander could release the language to extend the conversation on the topic. At a hearing last year, Alexander was open to the idea of additional funding for NIH, but asked questions about where the money would go and how they could ensure the funds were spent properly. Ranking member Patty Murray (D-WA) has made the inclusion of mandatory funding for NIH and FDA in the Senate Cures bill a requirement for her support of the package.
CDC Releases Elder Abuse Surveillance Recommendations
On Jan. 29, the Centers for Disease Control and Prevention (CDC) released the Elder Abuse Surveillance: Uniform Definitions and Recommended Core Data Elements . These recommendations establish and normalize consistent definitions and data elements in order to make it easier to better understand and more effectively combat elder abuse. They define terms such as “abuse” and “neglect” in order to allow for easier comparison of data from different jurisdictions or sources. CDC worked with a wide range of stakeholders, including the Administration for Community Living (ACL), to develop these recommendations, which are consistent with ACL’s National Adult Maltreatment Reporting System (NAMRS) initiative.
Obama Administration Proposes New Funding to Address Opioid Epidemic
On Feb. 2, the Obama administration proposed $1.1 billion in new funding to combat the country’s prescription opioid abuse and heroin use epidemic, a public health problem that has drawn major attention in the 2016 presidential campaign as overdose deaths increase. According to the CDC, opioids were involved in 28,648 deaths in 2014 — a 14 percent spike in deaths from the drugs. The proposal would expand access to medication-assisted treatment for substance abuse. The president’s FY 2017 budget will include $920 million over two years to support cooperative agreements with states to expand the medication-assisted treatment.
Republican and Democratic presidential candidates have been advertising their own proposals to address the epidemic, especially in New Hampshire, the host of this week’s primary. New Hampshire has one of the highest overdose death rates in the country, with more than 350 fatal opioid overdoses last year, according to the CDC.
Around 2.2 million people need treatment for opioid abuse nationwide, but only 1 million get it, according to HHS Secretary Sylvia Burwell. The budget includes a $90 million increase for efforts across the Departments of Justice (DOJ) and Health and Human Services (HHS) to expand drug overdose prevention strategies, make medication-assisted treatment programs more available, improve access to the overdose-reversal drug naloxone and support enforcement activities.
The administration is also seeking $10 million to help distribute the Strategic Prevention Framework for Prescription Drugs to address the risk of the over-prescription of painkillers by primary care doctors.
Congress is also considering bipartisan proposals to fight the epidemic, and approved an additional $100 million to that end in the year-end budget deal. The Senate Judiciary Committee will mark up the Comprehensive Addiction and Recovery Act on Feb. 11.
Obama Budget Will Propose Changes to Cadillac Tax
President Obama’s impending budget request will reportedly propose changing his Cadillac tax on costly health benefits. According to Jason Furman, head of the president’s Council of Economic Affairs, the administration’s plan will adjust the 40 percent excise tax to account for regional differences in health care costs around the country — Congress recently decided to delay implementing the current tax for two years, until 2020.
“The most significant provision specifies that in any state where the average premium for ‘gold’ coverage on the state’s individual health insurance marketplace would exceed the Cadillac tax threshold under current law, the threshold would instead be set at the level of that average gold premium,” Furman wrote in the New England Journal of Medicine.
CMS Creates Rural Health Council
The Centers for Medicare and Medicaid Services (CMS) is creating a rural health council to help promote a strategic focus on access, economics and innovation issues across rural America. The council will review regulations for their impact on providers in rural areas and make recommendations for rural-based health policies.
The council’s goals are 1) improving access to health care in rural settings, 2) supporting the rural health care economy and 3) making sure the health care innovation agenda appropriately fits rural health care markets. Individuals in rural areas are older, have lower incomes and are more likely to lack insurance. Close to 2 million people in rural areas around the country have signed up for coverage on an Obamacare exchange and if states expand Medicaid there will be millions more. CMS Acting Administrator Andy Slavitt noted that 10 rural Maryland hospitals have multi-payer global budgets and that CMS is exploring ways to expand that model to other rural parts of the country.
For more information, click here.
CMS Indicates One-sided ACOs Will Not Be Included in Alternative Pay Models
Officials from the Centers for Medicare and Medicaid Services (CMS) said they do not plan to count bonus-only accountable care organizations (ACOs) as alternative pay models in the approaching physician pay system. CMS says the law doesn’t allow the inclusion of one-sided risk model ACOs as alternative pay models, which would get pay increases for certain physicians. “My understanding from our lawyers is that it would be a tough sell to make Track 1 fit into that legal statutory definition,” CMS Medical Officer Terri Postma said Feb. 1. Track 1 is a model in the Medicare Shared Savings Program that offers bonuses for cutting spending, but does not penalize providers for missing spending and quality-of-care goals — Postma does not believe Track 1 will fit into the legal definition of an alternative pay model.
CMS is currently putting together the rules and working on how to define the term alternative pay model.
FDA Announces Opioid Action Plan
In response to the opioid epidemic, the US Food and Drug Administration (FDA) released an action plan to reassess the agency’s approach to opioid medications. Robert Califf, FDA’s deputy commissioner for medical products and tobacco, along with other FDA leaders, headed up this call to action. The action plan comes after the White House announcement of a $1.1 billion initiative to fight the epidemic, focused on increasing access to medication-assisted treatment. The plan also follows the news that three Senate Democrats — Bernie Sanders, Ed Markey and Joe Manchin — planned to put a hold on Califf’s nomination to be FDA commissioner.
The FDA plans to:
- Expand the use of advisory committees
- Develop warnings and safety information for immediate-release (IR) opioid labeling
- Strengthen postmarket requirements
- Update the Risk Evaluation and Mitigation Strategy (REMS) Program
- Expand access to abuse-deterrent formulations (ADFs) to discourage abuse
- Support better treatment
- Reassess the risk-benefit approval framework for opioid abuse
According to anti-addiction advocates, the step that could have the largest impact is FDA’s plan to reassess the risk-benefit approval framework for opioid abuse. Califf said that approvals should reflect the larger public health impact, not just the safety of a drug for an individual patient.
To see the press release, click here.
Eli Lilly, Anthem Push Policy Solutions to Increase Innovation in Drug Pricing
On Jan. 29, Eli Lilly and Company and Anthem released a memo asking Congress and the administration to ease legislative and regulatory burdens, to make it easier for drug manufacturers and health plans to communicate about emerging products before U.S. Food and Drug Administration (FDA) approval. Their stated policy goal is as follows: Clarify federal law to confirm that manufacturers may speak openly with health plans about drugs going through the FDA approval process, particularly with regard to product efficacy, safety and pharmacoeconomic information. The companies suggest two major public policy solutions to increase innovation in pharmaceutical pricing:
- Allow for more robust communication between health plans and drugmakers before a drug is approved; and
- Address legal and regulatory barriers — including those posed by anti-kickback laws and Medicaid best price policy — that prohibit value-based payment arrangements.
“While the rest of the health care system is moving toward paying for value, payments for drugs continue to be stuck in a 20th century construct that focuses on price, regardless of the health outcomes of each patient,” Anthem’s former chief medical officer Sam Nussbaum and Eli Lilly Senior Vice President David Ricks say in a recent Health Affairs blog.
SAMHSA Releases Proposed Changes to Mental Health Data-Sharing Rule
On Feb. 5, the Substance Abuse and Mental Health Services Administration (SAMHSA) released its proposed update to 42 CFR Part 2 — the Confidentiality of Alcohol and Drug Abuse Patient Records regulations. The rule governs how data on patients’ mental health can be shared. The goal of the proposed changes is to facilitate information exchange within new health care models while giving patients new rights to know where their data goes. If patients sign a waiver allowing their data to be generally shared, they can ask providers to disclose which organizations acquired the data. Also, the proposal would give researchers additional access to Medicare claims data concerning patients with mental health or substance abuse disorders — researchers have complained that the current law suppresses this data.
For more information, click here.
- State Activities
Arkansas: Gov. Hutchinson Talks Extension of Medicaid Expansion
On Feb. 1, Arkansas Gov. Asa Hutchinson met with officials from the U.S. Department of Health and Human Services (HHS) to discuss expanding the private option — the state’s version of Medicaid expansion — beyond 2016. In December, Arkansas submitted an application to extend its 1115 Medicaid waiver and the governor outlined revisions he will be asking for in a letter to HHS Secretary Sylvia Burwell. Those include work-training referral requirements, required premiums for those with incomes above the federal poverty line, and support for employer-sponsored health insurance (when offered).
California: California Pays Insurers Millions for Hepatitis C Drugs
California paid private health plans $387.5 million to cover high-cost hepatitis C treatments for only 3,624 Medi-Cal beneficiaries between July 2014 and November 2015. Most Medi-Cal beneficiaries are in private managed care plans that are paid a flat rate per member each month — however the state began supplemental payments when the health plans raised alarm about the high cost of the new drugs. The funding will continue next year, as California’s health care agency has budgeted $303.4 million in supplemental drug payments for health plans for 2016–2017. This is the first time the state has paid extra money to plans covering expensive drugs.
Idaho: Idaho Senate Committee Hears Medicaid Expansion Plan
On Feb. 1, Idaho’s state legislature held its first hearing on a Medicaid expansion bill. The Senate Health and Welfare Committee took testimony at the hearing on the proposal to expand Medicaid. This expansion would provide health insurance to 78,000 adults in Idaho who are in the so-called gap group — working adults who do not qualify for Medicaid but do not earn enough to get subsidized insurance on the state health insurance exchange. Committee chairman Lee Heider called it an informational hearing and no vote on the legislation took place because the governor is expected to make a proposal soon.
Kentucky: 10 Health Systems Creating a Statewide Collaborative
Ten health systems in Kentucky are joining a collaborative to improve the state’s poor health outcomes. The group consists of 55 hospitals and will share best practices in an effort to reduce costs of care. According to the inaugural executive director, William Shepley, the collaborative will first focus on ways to improve cost inefficiencies by probing purchasing policies.
Louisiana: Gov. Edwards Pulls Medicaid Expansion Hiring Plan
Louisiana Gov. John Bel Edwards pulled his plan to hire 248 new health department employees for his Medicaid expansion effort as he works to get Republicans on board. The new workers would have handled enrollment of the thousands of people expected to qualify for Medicaid after expansion. The governor wants more time to speak with members of the joint House and Senate budget committee — the House’s committee members were named less than 24 hours before the scheduled hearing on the plan. The new workers would cost $10.3 million this budget year including salaries, benefits, training and equipment. Of that $10.3 million, $7.3 million would have been paid by the federal government.
Minnesota: Uncertain Future for Minnesota’s Health Exchange
Minnesota’s health exchange, MNsure, is facing questions about its future following persistent technical problems and concerns about financial stability. An auditor’s report published Jan. 28 found the exchange incorrectly deemed hundreds of thousands of residents eligible for state health programs, which cost Minnesota $115 million over five months last year. Following the report, Republican lawmakers renewed calls for closing MNsure in favor of Healthcare.gov. At the same time, state coverage advocates are making a push for the state to move marketplace enrollees into Medicaid.
A state task force created by Democratic Gov. Mark Dayton has renewed its commitment to keeping MNsure running, claiming the federal enrollment website doesn’t work as well with the state’s Medicaid program. The task force also recommended restoring Minnesota’s Medicaid coverage levels that were in place before the Affordable Care Act (ACA). The state’s Medicaid program, MinnesotaCare, covered people making up to 275 percent of the federal poverty line, but this was cut back to 200 percent to fill out the state’s marketplace. The task force estimates 43,000 people will gain coverage under a new expansion of MinnesotaCare.
Republicans are worried that taking those people from the exchange would remove necessary funding from the marketplace. Nonetheless, task force members may use a Section 1332 waiver under the ACA to expand MinnesotaCare. A few other states — Arkansas, California and Hawaii — have also expressed interest in using a waiver.
Dayton’s administration and the Democrat-controlled Senate would need approval from a Republican-run House to push expansion through for MinnesotaCare.
- Regulations Open for Comment
Food and Drug Administration (FDA) Issues Final Rule to Phase Out Trans Fats
FDA issued a final rule June 16 that gives the food manufacturers three years to phase out partially hydrogenated oils (PHOs), which are still used in a wide variety of food products from microwave popcorn to cake frosting. The decision finalizes an agency determination that PHOs, the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. Comments on the final rule are due by June 18, 2018.
More information on FDA’s decision can be found in the agency’s press release.
CMS Soliciting Comments on Episode Groups as Required by MACRA
The Centers for Medicare and Medicaid Services (CMS) is soliciting comments on episode groups and on specific clinical criteria and patient characteristics to classify patients into care episode and patient condition groups as required by Section 101(f) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), enacted April 16, 2015. The purpose of this commentary is to provide background and context to solicit stakeholder input on the episode groups that CMS has developed pursuant to Section 3003 of the Affordable Care Act (ACA). CMS is also seeking stakeholder input on the future role of episode groups in resource use measurement.
Comments should be sent to firstname.lastname@example.org by 11:59 p.m. EST on Feb. 15, 2016.
FDA Seeks Comments on Whether It Should Define “Natural” and If So, How?
Because of a series of competing citizen petitions, GMO labeling issues and congressional concern, the U.S. Food and Drug Administration (FDA) is seeking public input on whether it should define the term “natural” for use on food product labels, and, if so, how to do so.
On Nov. 12, FDA published a request for feedback. FDA policy to date has not restricted the use of the word “natural” on food labeling unless the product has added color, synthetic substances or flavoring.
FDA has received four citizen petitions over the past two years asking the agency to issue regulations on the use of the term, and in July the House of Representatives passed a proposal on GMOs that would require FDA to define the term “natural” for product labeling.
FDA seeks feedback on the following questions:
- What types of foods should be able to use the term?
- Should only raw agriculture products be able to use the term?
- Should only single-ingredient foods, such as bottled water or bagged spinach, be able to use the term?
- If multi-ingredient foods can use the term, what types of ingredients would disqualify a product from using it?
- What data or other information shows how consumers associate, confuse or compare the terms “natural” with “organic”?
- What data or other information shows how consumers associate, confuse or compare the term “natural” with the term “healthy”?
The comment period is open until Feb. 10, 2016.
HHS Posts Guidance for State Innovation Waivers
On Dec. 11, the Department of Health and Human Services (HHS) posted guidance for states interested in seeking a State Innovation Waiver under Section 1332 of the Affordable Care Act (ACA). State Innovation Waivers allow states to receive federal funding to implement alternative models of health care coverage that provide affordable coverage to their residents. The notice clarifies that the minimum length of public notice and comment periods for waiver applications is 30 days.
To see the guidance, click here.
CMS Issues Proposed Rule Expanding Access to Medicare Claims Data
The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled “Medicare Program: Expanding Uses of Medicare Data by Qualified Entities.” The rule would expand access to Medicare information by permitting certain organizations to buy and share claims data. Created under Obamacare, Medicare’s qualified entity program allows providers, employers and others access to Medicare data to analyze the performance of providers and suppliers. The rule aims to help qualified entities make business decisions that reduce costs and improve quality of care. These changes were mandated in the Medicare Access and CHIP Reauthorization Act and CMS thinks the expansion of data sharing will stir more interest in the program. If the proposal is finalized, CMS estimates the number of qualified entities will go from 13 to 20. Comments will be accepted on the proposed rule until 5 p.m. on March 29, 2016.
CMS and ONC Release RFI on Requirements for the Reporting of Quality Measures
On Feb. 1, the Centers for Medicare and Medicaid Services (CMS) extended the comment period for the Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures under CMS Programs that was released on Dec. 31, 2015. Now, the RFI has a 45-day comment period with comments due by Feb. 16, 2016. CMS and the Office of the National Coordinator for Health Information Technology (ONC) are seeking public input on a few items related to the certification of health information technology (IT), including electronic health record (EHR) products used for reporting to the: 1) EHR Incentive Programs and 2) certain CMS quality reporting programs.
CMS and ONC ask for feedback on how often to require recertification, the number of CQMs a certified Health IT Module should be required to certify to and ways to improve testing of the modules.
IOM Committee Supports Research of Mitochondrial Replacement Techniques
On Feb. 3, an Institute of Medicine committee report concluded that research involving the initiation of pregnancies with embryos that contain genetic material from three people is ethically permissible as long as certain conditions are followed. The U.S. Food and Drug Administration (FDA) sought IOM’s feedback on the ethical, social and policy concerns related to mitochondrial replacement techniques (MRT), which would be regulated by the agency. MRTs are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child — it would modify an embryo to have DNA from the father and mother, and then mtDNA from another woman. The procedure raises concerns of irreversible risks to the child and future generations. The United Kingdom was the first country to approve this technique.
The committee urged that MRT should be limited to women who are at risk of transmitting a severe mitochondrial disease that could lead to early death or serious impairment of a child. The primary concern is minimizing risk of harm to the child born as a result of MRT.
Families USA Study Finds Uninsured Rate for Workers Fell Significantly in Medicaid Expansion States
According to a study from Families USA, a state’s decision to expand Medicaid is linked to increased health insurance coverage for low-wage workers. The study found that states that expanded Medicaid in 2014 saw a 25 percent reduction in the number of uninsured working residents. The average reduction was 13 percent in states that chose not to expand Medicaid.
Of the 26 expansion states, 21 (80 percent) experienced a decrease of at least 20 percent in the number of uninsured workers in 2014. Only two of the 24 non-expansion states (8 percent) saw a decrease of at least 20 percent. Eight of the expansion states (30 percent) saw the number of uninsured workers fall by at least 30 percent. This study looked at data from the Census Bureau’s American Community Survey and considers expansion states as the 26 states that expanded Medicaid in 2014. Alaska, Indiana and Montana — states that expanded Medicaid in 2015 — were excluded. Under expansion the federal government pays 100 percent of the cost through 2016 and then that gradually declines to 90 percent.