Nov 16, 2015
Washington Healthcare Update
Repealing Obamacare becomes problematic in the Senate... More focus on drug prices and reimbursement... FDA asks, should we regulate “natural” and if so, how?
House of Representatives
3. State Activities
4. Regulations Open for Comment
Energy and Commerce Health Subcommittee Chair Not Seeking Reelection
House Energy and Commerce Health Subcommittee Chair Rep. Joe Pitts (R-PA) announced Nov. 6 that he will not be seeking reelection in 2016. Pitts has been
the Chair of the Health subcommittee since 2011. He played a major role in the passage of major health care bills, including the “Doc Fix,” or SGR reform,
“Track and Trace,” or Drug Supply Chain security and the 21st Century Cures bill.
Two Bills Introduced to Prevent Tax Inversions in Response to Pfizer-Allergan Talks
On Nov. 9, Rep. Mark Pocan (D-WI) introduced two bills that would prevent corporations from using tax inversions to reduce their tax bills:
1) The “Corporate Fair Share Tax Act” would restrict corporate earnings stripping or, the moving of profits abroad by loading up a U.S. subsidiary with
tax-deductible debt, by limiting the available deduction. The legislation limits the deductions a corporation may claim to a level at which the U.S.
entity’s share of interest on debt is proportionate to the U.S. entity’s share of earnings. The Treasury Department estimates this would raise revenue by
$48.6 billion over the next 10 years.
2) The “Putting America First Corporate Tax Act” changes Section 952 of the tax code to eliminate deferral of taxation on foreign profits — the
Congressional Budget Office estimates that ending this loophole would raise revenue by $114 billion over the next 10 years.
There has been renewed congressional scrutiny on the practice of moving a company’s tax headquarters abroad through a merger, brought about by Pfizer
Inc.’s pursuit of a merger with Allergan PLC.
House Judiciary Subcommittee to Hold Third Hearing on Competition in Health Care with Focus on PBMs
On Nov. 17, the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law will hold its third hearing in a
series on the state of competition in health
care. The hearing is entitled “The State of Competition in the Pharmacy Benefit Manager (PBMs) and Pharmacy Marketplaces” and will examine the state of
competition and any related competitive issues.
Ms. Amy Bricker, R.Ph.
Vice President of Retail Contracting & Strategy
Mr. David A. Balto, Esq.
Law Offices of David Balto
Ms. Natalie A. Pons, Esq.
Senior Vice President and Assistant General Counsel
Mr. Bradley J. Arthur, R.Ph.
Black Rock Pharmacy
To see a press release about the hearing, click here.
Repealing Obamacare Hits Snags in Senate
The House-passed reconciliation bill containing repeal of many provisions of the Affordable Care Act (ACA) has run into trouble in the Senate. On Nov. 10,
the Senate Parliamentarian ruled that the law’s individual and employer mandates that were included in the House bill do not meet reconciliation standards.
The Parliamentarian said those provisions were merely incidental and did not meet the budgetary standards needed for reconciliation protection.
Reconciliation legislation needs only a majority to pass in the Senate, not the usual 60 votes. Overruling that decision would require 60 votes and would
be blocked by Democrats. In addition, some Republican Senators do not think the House bill goes far enough in repealing the Affordable Care Act.
The remainder of the House bill would defund Planned Parenthood for one year and repeal the “Cadillac” tax — a tax on insurers, the medical device tax and
the Independent Payment Advisory Board, and cut the Prevention and Public Health Fund. It now looks like the Senate will not take up this legislation — or
some version of it — until after Thanksgiving.
Regardless of what passes, the President is not likely to sign the bill into law. Some are looking to the upcoming tax extender package as a possible
vehicle for repealing some provisions of Obamacare. Extenders are expected to be acted upon at the end of the year.
Senator Writes Letters Asking Stores to Pull Certain Dietary Supplements
On Nov. 9, Sen. Claire McCaskill (D-MO) wrote letters to 10 retailers
asking them to voluntarily pull from sale dietary supplements containing picamilon — a substance that does not meet the definition of a dietary ingredient.
The letters come after the Oregon Attorney General filed a complaint against General Nutrition Corporation (GNC) for selling products containing picamilon.
Sen. McCaskill has been pressing the U.S. Food and Drug Administration (FDA) to take action on the substance, which is classified as a drug in other
countries but is not approved by the FDA.
Senator Hatch Concerned with CMS Spending on Advertising
On Nov. 10, Senate Finance Committee Chairman Orrin Hatch (R-UT) wrote a
letter to the Centers for Medicare and Medicaid Services (CMS)
expressing his concern about the agency’s advertising practices related to open enrollment, citing the potential for “wasteful government spending.” The
U.S. Department of Health and Human Services says it will spend $35 million for advertising in the states using Healthcare.gov for the 2016 open enrollment
period. Hatch asked CMS to provide him with the total amount of spending on advertising and public relations from fiscal year 2011 to the present. He
requested a response by no later than Nov. 25.
Senate Finance Committee Announces Hearing on Physician Owned Distributorships
On Nov. 17, the Senate Finance Committee will hold a hearing entitled “Physician Owned Distributors: Are
They Harmful to Patients and Payers?” The hearing will focus on whether physician owned distributorships (PODs) — entities in which physicians earn revenue
from the sale of medical devices they prescribe — should be allowed.
Dr. Scott Lederhaus
President of Association for Medical Ethics
Monarch Beach, CA
Dr. John Steinmann
Board Advisor for American Association of Surgical Distributors
Ms. Suzie Draper
Vice President of Business Ethics and Compliance for Intermountain Healthcare
Salt Lake City, UT
Mr. Kevin Reynolds
Son of a Patient of a Surgeon Affiliated with a Physician Owned Distributor
To see a related press release, click
Senators Write Letter Applauding CDC Opioid Guidelines
On Nov. 10, eight senators wrote a letter to the Centers for
Disease Control and Prevention (CDC) to praise the agency for its newly released Draft Guidelines for Opioid Prescribing. The guidelines would recommend
nondrug therapy as the preferred treatment for chronic, noncancer pain, prescribe the lowest dose and least number of pills considered effective for the
patient, and regularly review the risks to the patient from the prescription drugs they are taking. The senators note that the U.S. makes up only 4.6
percent of the world’s population, but consumes around 80 percent of its opioids.
To see a related press release, click here.
FDA Requests Information Concerning Direct-to-Consumer Tests
On Nov. 2, the U.S. Food and Drug Administration (FDA) sent three manufacturers of direct-to-consumer tests requests for information. FDA is suggesting
that the products may meet the definition of medical devices and lack FDA clearance. The three manufacturers are DNA-Cardiocheck Inc., Interleukin
Genetics, Inc., and DNA4Life. This comes as policymakers are debating whether FDA or CMS should oversee laboratory-developed tests.
USP Tells FDA to Scrap Proposed Biosimilar Naming Plan and Suggests Alternative
The U.S. Pharmacopeial Convention (USP) told the U.S. Food and Drug Administration (FDA) to get rid of its proposed biosimilar naming plan and suggested an
alternative: add a suffix to the USP labeling requirements that would be used to identify and track products back to manufacturers. USP said that FDA’s
plan to convey the regulatory status of a product could weaken established scientific principles and the understanding of drug and biologic substances, and
could harm patients. USP sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured,
distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are
used in more than 140 countries.
FDA published draft guidance proposing to attach non-meaningful, four-letter suffixes to biosimilars’ nonproprietary names in order to prevent
unintentional substitution of products that haven’t been deemed interchangeable. USP contends that the FDA proposal would cause confusion and put patients
at risk due to medication errors and the disruption of pharmacy systems. It could also create obstacles to global trade by creating requirements that other
countries view to be an unfair restraint of trade.
The Biosimilars Forum — made up of brand-name and generic drug manufacturers — noted that if FDA attaches suffixes to the nonproprietary names, the
suffixes should be meaningful (based on a given company’s name) instead of non-meaningful. The group thinks that the final rule should create a level
playing field for biosimilars and reference biologics, and that sponsors should have the flexibility to transition into the new naming system.
Companies Amgen and Sandoz Biosimilars Case Likely to Go to Supreme Court
Industry attorneys have predicted either Amgen or Sandoz will appeal to the Supreme Court the Federal Circuit’s decision concerning the biosimilar
pathway’s patent and marketing requirements. The two primary issues in this case are 1) whether the “patent dance” is mandatory and 2) when a biosimilar
applicant can provide notification of commercial marketing. The appeals court denied requests for a full hearing when a three-judge panel ruled that the
law’s patent exchange provisions are optional and the 180-day notice for commercial marketing can be issued only after the drug gets approval. Attorneys
note that it is unlikely that this decision will be the last in the case, as the Federal Circuit was severely divided on the matter.
There are three separate court cases addressing similar issues that could be affected if the Supreme Court becomes involved — two cases were brought by
Amgen against Apotex and Hospira and another by Janssen against Celltrion and Hospira.
FDA Approves First Product Marketing Orders Under the Tobacco Control Act of 2009
On Nov. 10, the U.S. Food and Drug Administration (FDA) announced
that for the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. The authorization
is for Swedish Match North America to sell eight snus smokeless products — this is the first time FDA has granted approvals under the Tobacco Control Act
of 2009, which gave it authority to regulate the industry. The FDA review found that the snus products will likely provide less toxic options if smokeless
tobacco users use them exclusively.
However, the tobacco company is not allowed to imply that their products are FDA approved, and must submit a separate application to market their products
as less harmful than others.
Insurer Announces Outcome-based Pricing for Cholesterol Drugs Ahead of HHS Drug Pricing Forum
On Nov. 9, Harvard Pilgrim announced an outcomes-based pricing contract with Amgen for cholesterol drugs in return for preferential treatment of Amgen’s
drug. Various stakeholders as well as the U.S. Department of Health and Human Services (HHS) have mentioned outcomes-based payment models as a topic to
discuss at the upcoming drug forum on Nov. 20.
Amgen agreed to discount cholesterol drugs for Harvard Pilgrim when the drugs do not reduce LDL levels by as much as was observed during clinical trials.
Amgen will further discount the drug if more patients use it than expected.
NAIC Passes New Model Law on Plan Network Access and Adequacy
On Nov. 4 the National Association of Insurance Commissioners’ (NAIC) Health Insurance Committee passed a new model law entitled “Health Benefit Plan
Network Access and Adequacy Model Act.” For the first time since 1966, the model law will update existing requirements and includes new guidelines on
telehealth, mental health, in-network protocols, provider directory requirements and the “good faith” nondiscrimination provision of the Affordable Care
Act (ACA). It makes the states responsible for having regulatory control over the information insurers include in plans as well. The full membership of the
NAIC will vote on Nov. 22 on adopting the model law and on whether to keep all the proposed revisions in each respective state.
Consumer representatives to the NAIC sent a letter to
the Health Insurance Committee applauding the model law while requesting more changes before it becomes final. While the changes weren’t made, NAIC noted
that states still have the ability to create additional rules for insurers — it is up to the states to decide if they want to make the changes.
The U.S. Department of Health and Human Services (HHS) has expressed interest in the model law and will likely put some of its guidance into federal
regulations if it passes. HHS is currently working on its own nondiscrimination rulemaking.
CMS Restarts Medicare Recovery Auditors Contracting Process
On Nov. 6, the Centers for Medicare and Medicaid Services (CMS) restarted the contracting process for
Medicare Recovery Auditors (RACs). CMS has maintained that when providers appeal payment denials, RACs will not be paid until after those appeals are denied at the second level, even
though a similar provision thwarted CMS’s last attempt to set up RAC contracts.
This summer, CMS said it planned to update the Recovery Auditors’ Statement of Work and release new Requests for Proposals. On Nov. 6 it announced the new
Requests for Proposals, including updated Statements of Work on the Federal Business Opportunities website. On the same day, CMS also released a timeline
of RAC “program enhancements.” One enhancement to be incorporated into the new contracts is that RACs “will not receive their contingency fee until after
the second level of appeal is exhausted,” the document says.
The Statement of Work also says that RACs are expected to support CMS in cases that make it to the Administrative Law Judge (ALJ) level of appeals. RACs
previously complained they wanted to be involved in more appeals because their presence at a hearing increases the probability that appeals are decided in
CMS’s favor. Under the new work statement, RACs would also need to wait 30 days after notifying providers of the results of a review before forwarding the
claim to a Medicare Administrative Contractor for a pay adjustment so that providers can request a discussion period. CMS also states that it has the
authority to settle appeals without RAC approval or input.
Because of a backlog in claims getting to the ALJ level, CMS recently settled about 300,000 claims and paid more than 1,900 hospitals about $1.3 billion
for inpatient claims denied on the basis of medical necessity that were under appeal. CMS paid 68 percent of the claims under appeal as part of the
For more information, click
CMS Announces Medicare Premiums and Deductibles for 2016
On Nov. 10, the Centers for Medicare and Medicaid Services (CMS) announced the 2016 premiums and
deductibles for Medicare Part A and Part B programs. About 30 percent of Medicare Part B beneficiaries will avoid a huge rate spike due to the Bipartisan
Budget Act signed into law recently. Now those beneficiaries will pay a monthly premium of $121.80 instead of over $150 — and most beneficiaries will
continue to pay the same monthly premium as last year, which is $104.90.
CMS Grants Special Innovation Projects
On Nov. 12, the Centers for Medicare and Medicaid Services (CMS) announced that it awarded 16 two-year Special Innovation Projects (SIPs) to 10 regional
Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs). The projects will address sepsis in long-term care, colorectal cancer screening
(CRC) and readmission reduction in rural hospitals, among other things.
MedPAC Discusses Proposed Part D Policy Option Package
At a Medicare Payment Advisory Commission (MedPAC) meeting earlier this month, commissioners began
consideration of a package of potential Part D reforms that would give plans higher incentives to control drug spending, give increased flexibility to
manage costs and give out-of-pocket protections for enrollees. The commission is also considering changes to Medicare’s reinsurance policies. MedPAC Chair
Jay Crosson laid out potential policy options at the meeting, and noted that some could hurt beneficiaries while others could hurt plans. The proposed
policy option package is as follows:
- Reduce Medicare’s reinsurance from 80 percent to 20 percent
- Limit beneficiaries’ out-of-pocket costs beyond the cap: one proposal would be for the non-Low Income Subsidy (LIS) beneficiaries and would set a
fixed-dollar copayment. For LIS beneficiaries, the proposal would provide a nominal copayment only for brand-name drugs for individuals over the
- Give plans increased flexibility by removing two drug classes — immunosuppressants and antidepressants — from the six protected classes
- Ease the procedural processes around getting approval for midyear formulary changes for high-priced drugs
- Introduce an additional tier, for example a non-preferred generic tier, for Low Income Subsidy (LIS) beneficiaries’ drugs — and also allow the plans to
use preferred pharmacy networks with different copayments for LIS beneficiaries
MedPAC will continue discussions on these ideas in March and will vote on final recommendations in April.
3. State Activities
New Jersey: New Jersey Adopts a Biosimilar Substitution Measure
New Jersey Gov. Chris Christie (R) signed A. 2477 into law on Nov. 9 — an interchangeable biosimilar substitution measure that requires pharmacists to tell
prescribers after they make a switch rather than send a notification before the change. This measure mirrors an agreement between the Biotechnology
Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) to compromise language on biosimilar substitution that states could use as a
template for laws.
Under the New Jersey law, pharmacists must tell the prescriber the name of the product and manufacturer of the interchangeable biosimilar within five
business days of substitution — however, the pharmacist cannot make the substitution if the physician has expressly written that there may not be one. The
New Jersey State Board of Pharmacy must also have a link on its website with a current list of all biological products the U.S. Food and Drug
Administration (FDA) has approved as interchangeable. Until the FDA determines whether a specific biosimilar is interchangeable with its reference
biologic, the substitution policy is up to the individual states.
Ten other states — California, Washington, Utah, Texas, Tennessee, North Carolina, Louisiana, Illinois, Georgia and Colorado — have passed biosimilar
substitution laws that contain the compromise language. Eight states had already adopted substitution laws before the compromise occurred — Massachusetts,
Delaware, Indiana and Idaho (2014); Virginia, Florida, North Dakota and Oregon (2013).
4. Regulations Open for Comment
Centers for Medicare and Medicaid Services (CMS) Issues Proposed Rule to Begin Data Collection for New Fee Schedule for Medicare Clinical Diagnostic
CMS released a proposed rule Sept. 25 that initiates the agency’s next step in
implementing the Protecting Access to Medicare Act of 2014 (PAMA), a bill that requires clinical laboratories to report on private insurance payment
amounts and volumes for lab tests. Under the proposed rule, certain laboratories would be required to report private payor rate and volume data if they
receive at least $50,000 in Medicare revenues from laboratory services and more than 50 percent of their Medicare revenues from laboratory and physician
services. Laboratories would collect private payor data from July 1, 2015, through Dec. 31, 2015, and report it to CMS by March 31, 2016. CMS will post the
new Medicare rates by Nov. 1, 2016; these rates will be effective on Jan. 1, 2017. Tests that meet the criteria for being considered new advanced
diagnostic laboratory tests (ADLTs) will be paid at actual list charge for a minimum of three quarters. ADLTs are tests offered under Medicare Part B and
are furnished by only one laboratory and that either include a unique algorithm and are at a minimum an analysis of RNA or DNA, or are cleared or approved
by the U.S. Food and Drug Administration (FDA). Under PAMA, the Medicare payment amount for any test cannot be reduced by more than 10 percent compared to
the prior year’s amount during the first three years of implementation (2017-2019) and cannot be reduced by more than 15 percent in the following three
Medicare’s current fee schedule for lab tests was first adopted in 1984 and has remained relatively unchanged except to establish payments for new tests or
implement across-the-board statutory payment updates. Medicare pays approximately $8 billion a year for clinical diagnostic laboratory tests. The new
system will be updated every three years for clinical diagnostic laboratory tests (CDLTs) and every year for ADLTs to reflect market rates paid by private
payors. One hot-button issue in the proposed rule is the definition of “applicable laboratory.” PAMA defined an applicable laboratory as one that receives
a majority of its Medicare revenues under the MCLFS or the Medicare Physician Fee Schedule (MPFS). In a
fact sheet summarizing the proposed rule, CMS said it does not expect any hospital laboratory to meet the definition of “applicable laboratory” and that more than 50 percent of independent
laboratories and more than 90 percent of physician offices would likely be excluded based on the $50,000 threshold. The proposed rule was published in the Federal Register on Oct. 2. CMS will solicit comments until Nov. 24, 2015.
Department of Health and Human Services (HHS) Proposes Updates to “the Common Rule”
HHS and 15 other agencies released a notice of proposed rulemaking Sept. 2 for the Common Rule, the
existing regulatory framework to transparency and oversight for scientific research involving human subjects. The proposed changes are to address the
substantial changes that have occurred within scientific research. Current regulations have been in place since 1991 and are followed by 18 federal
agencies. Proposed updates to the rule include:
Strengthened informed consent provisions
Requirements for administrative or IRB review that would align better with the risks of the proposed research
New data security and information protection standards
Requirements for written consent for use of an individual’s biological samples, for example, blood or urine, for research with the option to consent to
their future use for unspecified studies
Requirement, in most cases, to use a single institutional review board for multisite research studies
Application of rule to clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding from a Common
Rule agency for research involving human participants.
In July 2011, HHS issued an Advance Notice of Proposed Rulemaking to seek the public’s input on updating the Common Rule. The proposed rule issued reflects
input and requests comments for HHS to consider as it drafts the final rule. HHS will take public comment on the proposed rule until Dec. 7.
For a press release detailing changes to the rule visit hhs.gov.
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 Releases Proposed Rule on Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018
On Oct. 22, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule related to federal funding methodology for the Basic Health
Plan. The document provides the methodology and data sources necessary to determine federal payment amounts made in program years 2017 and 2018 to states
that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible
to purchase coverage through Affordable Insurance Marketplaces. The Affordable Care Act provides states with an option to establish a Basic Health Program
(BHP). Federal funding will be available for BHP based on the amount of PTC and cost-sharing reductions that BHP enrollees would have received had they
been enrolled in qualified health plans (QHPs) through Marketplaces. These funds are paid to the states through trust funds dedicated to BHP, and the
states then administer the payments to standard health plans within BHP. The proposed rule is open for comment. Comments must be received by 5 p.m. on Nov.
CMS Releases a Request for Comment (RFC) on Proposed Medicaid Services “Received Through” Indian Health Service/Tribal Facility
On Oct. 27, the Centers for Medicare and Medicaid Services (CMS) released a
Request for Comment (RFC) on a proposed change being considered regarding the circumstances in which 100 percent federal funding would be available for services given to
Medicaid-eligible American Indian and Alaska Native (AI/AN) individuals through facilities of the Indian Health Service (IHS) or Tribes. This policy change
would apply to all states and is intended to improve access to care for AI/AN Medicaid beneficiaries. The RFC describes the policy options under
consideration and asks for feedback from states, Tribes, and various stakeholders. The comment period will be open until Nov. 17, 2015.
Additional information on Indian Health and Medicaid can be found here.
CMS Releases Proposed Rule with New Discharge Planning Requirements
The Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would require all hospitals develop a
written discharge plan for all inpatient and many outpatients in an attempt to reduce readmissions. The proposed rule, “Medicare and Medicaid Programs;
Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies,” would require hospitals to develop a
discharge plan based on the needs of each applicable patient within 24 hours of admission. The plan would include a medication reconciliation process.
Hospitals would be required to establish a process for patients who are transferred to a different facility or who went home.
CMS noted that the requirements could help reduce readmissions by a third. Until now, hospitals have had the ability to decide which patients need a
written discharge plan, and have increasingly used the plans to reduce readmission and avoid the Affordable Care Act’s (ACA) financial penalties. Comments
will be accepted until no later than 5 p.m. on Jan. 4, 2016.
A press release can be found here.
CMS Issues Final Rule to Ensure Medicaid Services for Beneficiaries and Issues Request for Information on the Rule
On Oct. 29, the Centers for Medicare and Medicaid Services (CMS) issued a final rule that ensures Medicaid beneficiaries have sufficient
access to covered Medicaid services. CMS said that the rule, entitled “Methods for Assuring Access to Covered Medicaid Services,” will allow states and CMS
to make more informed decisions when considering whether proposed changes to Medicaid fee-for-service payment rates are sufficient to ensure the
beneficiaries’ access to those services. States will have to create access review plans that outline how states will ensure access to health care services
and to examine how cuts to provider payments will affect the care received.
The rule strengthens CMS’s oversight of Medicaid reimbursement and beneficiary access to providers. It will go into effect in January and CMS issued a Request for Information (RFI) to get feedback on how to make
sure access requirements are being met. Comments will be accepted until no later than 5 p.m. on Jan. 4, 2016.
EEOC Issues Proposed Rule Amending the Genetic Information Nondiscrimination Act (GINA)
On Oct. 30, the U.S. Equal Employment Opportunity Commission (EEOC) issued a proposed rule clarifying
when, under the Genetic Information Nondiscrimination Act (GINA), employers who offer wellness programs as part of group health plans can provide
incentives to an employee’s spouse to provide information about his or her current or past health status. (This is different from the April EEOC
related to the Americans with Disabilities Act.) The proposed rule clarifies that an employer can offer limited incentives in exchange for the employee’s
spouse providing information about his or her current or past health status. EEOC will accept comments on the new proposed rule through Dec. 29, 2015.
A press release on the proposed rule can be found here.
CMS Soliciting Comments on Episode Groups as Required by MACRA
The Centers for Medicare and Medicaid Services (CMS) is soliciting
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
Comments should be sent to 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.
Paper Reveals that Consumers Tend to Make Poor Decisions Regarding Coverage
A recent paper from the University of Wisconsin and Carnegie Mellon
University found more evidence that consumers do not understand their health insurance choices and make poor decisions regarding coverage. The paper
examined decisions of over 50,000 employees who were provided with four plan options. Over 50 percent of the employees chose more expensive plans that did
not offer any additional coverage. The paper estimated that these employees could have saved an average of $353 per year by choosing different plans.
ACA Paper Looks at Patient Care Implications of “Concierge” Medicine
On Nov. 10, the American College of Physicians (ACP) published a paper in the Annals of Internal Medicine looking into “concierge” medicine and other forms of direct patient contracting practice (DPCP). The paper concludes
that there is little evidence on how “concierge” medicine affects quality and costs, and that it might limit low-income patients’ access to care. It
proposes several policies to mitigate any adverse effects on underserved patients and makes recommendations to physicians interested in pursuing DPCPs —
including that they should be transparent with their patients about financial responsibilities.
Study Finds Readmission Rates Falling Among Adults Receiving Joint Replacements
According to a new study from AARP, a growing number of Americans are electing for hip and knee replacements, and hospital readmissions after those
procedures are falling. Between 2009 and 2013, 73 percent more Americans got hip replacements and 46 percent more got knee replacements — and readmission
rates dropped by 20 percent. The results were mostly driven by a drop in readmissions for patients between 65 and 84 years old, so researchers attribute a
large amount of that to the new Medicare penalties for readmission.
Study Shows That Health Care Industry Isn’t Providing Adequate Security
Forrester released a new cybersecurity study showing that the health care industry still does not provide adequate security for American’s health data and
records. The industry has only complied with regulations at the lowest possible cost, according to the study. Results showed that health care companies
invest only 14 percent of IT budgets in security. Health data can draw $50 per record on the black market, which is a much larger amount than with stolen
credit cards or the like. This study comes after five huge data breaches in the last 14 months.
If you have any questions, contact the following individuals at
Kennan, Senior Vice President
Charlie Iovino, Vice
Caroline Perrin, Research Assistant
Founded in 1998, McGuireWoods Consulting LLC (MWC) is a full-service public affairs firm offering state and federal government relations, national/multistate strategies, infrastructure and economic development, strategic communications and grassroots issue management services. McGuireWoods Consulting is a subsidiary of the
McGuireWoods LLP law firm and in 2010 was ranked in the Top 20 of The National Law Journal's "The Influence 50," an annual report of the top public affairs firms in Washington, D.C.
To sign up for the Weekly Washington Healthcare Update, use our online
McGuireWoods Consulting LLC
2001 K Street
Washington, DC 20006-1040